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Many Cancer Patients Face Crippling Costs
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: First-time bankruptcy filings averaged 0.5% of patients at 1 year after cancer diagnosis and 1.9% at 5 years after diagnosis. Average U.S. bankruptcy rates for the entire population are 0.28%.
Data Source: SEER registry data and federal bankruptcy court records in Western Washington State from 1995-2009.
Disclosures: Dr. Ramsey’s study was funded by the National Cancer Institute.
Many Cancer Patients Face Crippling Costs
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: First-time bankruptcy filings averaged 0.5% of patients at 1 year after cancer diagnosis and 1.9% at 5 years after diagnosis. Average U.S. bankruptcy rates for the entire population are 0.28%.
Data Source: SEER registry data and federal bankruptcy court records in Western Washington State from 1995-2009.
Disclosures: Dr. Ramsey’s study was funded by the National Cancer Institute.
Many Cancer Patients Face Crippling Costs
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
Talk to Patients About Costs
According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
These studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
Over 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Neal J. Meropol was the discussant of the papers at the ASCO meeting. Dr. Meropol is chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. He is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
Talk to Patients About Costs
According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
CHICAGO – The financial costs of cancer weigh heavily on patients.
Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.
Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.
Bankruptcies Hit Lung Patients Hardest
First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.
Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.
Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.
Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.
The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.
The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.
Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.
Dr. Ramsey’s study was funded by the National Cancer Institute.
Breast Cancers Untreated in Recessions
During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.
For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.
Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.
Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."
The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.
Dr. Ennis had no relevant financial disclosures.
Chemo Costs Pinch Insured Patients
"I have had to go without groceries in the house just to get my medicine."
"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."
"I became homeless and our entire family has had to live with a friend several times."
These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.
Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).
As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.
Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.
These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.
The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.
Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.
Talk to Patients About Costs
According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.
More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.
Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.
Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: First-time bankruptcy filings averaged 0.5% of patients at 1 year after cancer diagnosis and 1.9% at 5 years after diagnosis. Average U.S. bankruptcy rates for the entire population are 0.28%.
Data Source: SEER registry data and federal bankruptcy court records in Western Washington State from 1995-2009.
Disclosures: Dr. Ramsey’s study was funded by the National Cancer Institute.
Adjuvant XELOX Improves Outcomes in Gastric Cancer
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: Compared with their counterparts assigned to observation, patients assigned to XELOX had a significant 44% reduction in the risk of recurrence, and a marginal 26% reduction in the risk of death.
Data Source: A randomized, phase III trial of adjuvant XELOX (capecitabine and oxaliplatin) in 1,035 patients with stage II, IIIA, or IIIB gastric cancer (the CLASSIC trial).
Disclosures: The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
Adjuvant XELOX Improves Outcomes in Gastric Cancer
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
CHICAGO – Patients with gastric cancer have better outcomes if they are given adjuvant capecitabine plus oxaliplatin after undergoing curative resection that includes an extended lymph-node dissection, according to results of the CLASSIC trial from China, South Korea, and Taiwan
Investigators randomized 1,035 patients to either simple observation or XELOX (the combination of capecitabine plus oxaliplatin) after surgery. A full analysis was performed early because of interim efficacy findings in favor of the chemotherapy.
Trial results, which were reported at the annual meeting of the American Society of Clinical Oncology, showed that patients in the XELOX arm had a 44% reduction in the risk of recurrence. Their 3-year, disease-free survival rate (the primary end point) was 74%, compared with 60% in the observation-only group (hazard ratio, 0.56; P less than .0001). The benefit was similar across patients with stage II, IIIA, and IIIB disease.
Additionally, early data showed a 26% reduction in the 3-year risk of death, though the latter is not yet statistically significant.
"The CLASSIC [Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer] trial met its primary end point," said Dr. Yung-Jue Bang, presenting findings on behalf of his coinvestigators. "CLASSIC demonstrates superior efficacy of adjuvant XELOX vs. observation alone following D2 [extended] lymph-node dissection. The data presented support the use of adjuvant XELOX for gastric cancer."
The positive findings for chemotherapy in this trial contrast with negative findings of similar trials that have been conducted in Western countries, Dr. Bang acknowledged. He speculated that small sample sizes (which limit statistical power) and the lesser extent of surgery in the latter trials explain the difference.
"We need some kind of good surgery to prove the effect of adjuvant chemotherapy," he elaborated on the latter point. "For patients who receive [inadequate] surgery, we may need radiotherapy to compensate" for any remaining locoregional disease."
Another recent adjuvant trial, ACTS-GC (Adjuvant Chemotherapy for Gastric Cancer With S-1), which was conducted in Japan, found that monotherapy with S-1 (an oral fluoropyrimidine that has not been approved in the United States) provided similar benefit (NEJM 2007;357:1810-20), an attendee pointed out. Should oncologists select S-1 or XELOX, and is a randomized, head-to-head comparison warranted?
"It is impossible to compare the results of this study with that of ACTS-GC," asserted Dr. Bang, an oncologist at Seoul (South Korea) National University. But he did note that in the ACTS-GC trial, the benefit for patients with stage III disease was uncertain.
"So at this time, my suggestion is we can consider doublet [XELOX] especially for stage III patients," he said. "I don’t want to do another study comparing S-1 and XELOX because we have to move forward."
Discussant Dr. Florian Lordick, an oncologist with the Klinikum Braunschweig (Germany), said that a key question is whether the CLASSIC trial results can be transferred to Western countries. "I would answer [that] there are some caveats," he commented.
Those caveats include the comparatively older age of patients with gastric cancer in Western countries, which might reduce tolerance for adjuvant chemotherapy; the greater prevalence of proximal cancers, for which neoadjuvant chemotherapy has shown benefit; and the less-frequent use of D2 resection.
"D2 resection was mandatory in the CLASSIC trial, and a median of 42 lymph nodes – I repeat, 42 lymph nodes – [was] examined. ... This is not uniformly the standard in many Western centers," he pointed out. For example, in the U.S. Intergroup 0116 and U.K. MAGIC trials in gastric cancer, only 10% and 41% of resections, respectively, were D2 resections.
"So one could ask the question, does the surgical approach determine the optimal adjuvant treatment strategy?" Dr. Lordick said. "We have seen compelling results for adjuvant chemotherapy following radical resection, D2 resection, which is the standard of care in Asia. For those centers that perform more subradical resection ... the addition of adjuvant radiation makes sense."
Patients were eligible for the CLASSIC trial if they had stage II, IIIA, or IIIB gastric cancer, had undergone a D2 dissection in the preceding 6 weeks with neither macroscopic nor microscopic evidence of residual disease, and had not received any chemotherapy or radiation therapy.
Sufficiency of extent of surgery was rigorously ensured through quality assurance meetings, the use of a standard operating procedure for surgical technique, and a requirement of photographic documentation, Dr. Bang noted.
The patients were assigned in nearly equal numbers to observation or eight cycles (6 months) of the XELOX regimen, consisting of capecitabine (Xeloda) 1,000 mg/m2 b.i.d on days 1-14 plus oxaliplatin (Eloxatin) 130 mg/m2 on day 1 of 3-week cycles.
"We chose 3-year disease-free survival as our primary end point because most relapses in gastric cancer occur within 2 or 3 years, and the survival after relapse is around 1 year," he commented. "In addition, there is evidence that 3-year disease-free survival is a surrogate end point for 5-year overall survival."
The patients had a median age of about 56 years, and 71% were male. The median time between surgery and randomization was 1.12 months.
At the trial’s preplanned interim analysis, the median follow-up was 34.4 months. The median number of cycles of therapy received was eight for both capecitabine and oxaliplatin. The median dose intensity was 85% and 98%, respectively.
"The safety of adjuvant XELOX in gastric cancer was consistent with the known safety profile of XELOX, with no new or unexpected findings," Dr. Bang reported. The rate of grade 3/4 adverse events was 54% in the XELOX arm and 6% in the observation arm. Two patients in the former arm died of treatment-related causes.
In intention-to-treat analyses, the 3-year rate of disease-free survival benefit was apparent. "The two curves separated early and the difference was well maintained," he commented.
In subgroup analyses, hazard ratios consistently favored XELOX. Analyses according to histologic tumor type are still ongoing, but HER2 testing was not done in the study.
There was also a trend toward a better 3-year rate of overall survival with XELOX (HR, 0.74; P = .0775). "The overall survival curves started to separate at 24 months; however, at this time point, the data are not mature enough," he said. "Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival."
The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: Compared with their counterparts assigned to observation, patients assigned to XELOX had a significant 44% reduction in the risk of recurrence, and a marginal 26% reduction in the risk of death.
Data Source: A randomized, phase III trial of adjuvant XELOX (capecitabine and oxaliplatin) in 1,035 patients with stage II, IIIA, or IIIB gastric cancer (the CLASSIC trial).
Disclosures: The trial was sponsored by Sanofi-Aventis and Roche. Dr. Bang reported that he is a consultant to and receives honoraria from Roche. Dr. Lordick reported that he is a consultant to Amgen and Ganymed; receives honoraria from Amgen, Fresenius, Merck Serono, Pfizer, and Roche; and receives research funding from Fresenius, GlaxoSmithKline, Merck Serono, and Sanofi-Aventis.
Vitamin D Supplementation Prevents Breast Cancer Therapy-Related Bone Loss
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: 25(OH)D concentration increments due to supplementation prevent aromatase inhibitor–associated bone loss, independently of baseline 25(OH)D concentrations. Increasing levels of 25(OH)D concentrations at 3 months were inversely correlated to absolute bone loss (–0.004 g/cm2 , [–0.007 to –0.004], (P = .003), at 1 year.
Data Source: Prospective cohort study of 156 postmenopausal nonosteoporotic women using adjuvant aromatase inhibitors in early breast cancer.
Disclosures: Dr. Sonia Servitja disclosed no relevant relationships. Chair and invited discussant Dr. Thomas J. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
Vitamin D Supplementation Prevents Breast Cancer Therapy-Related Bone Loss
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: 25(OH)D concentration increments due to supplementation prevent aromatase inhibitor–associated bone loss, independently of baseline 25(OH)D concentrations. Increasing levels of 25(OH)D concentrations at 3 months were inversely correlated to absolute bone loss (–0.004 g/cm2 , [–0.007 to –0.004], (P = .003), at 1 year.
Data Source: Prospective cohort study of 156 postmenopausal nonosteoporotic women using adjuvant aromatase inhibitors in early breast cancer.
Disclosures: Dr. Sonia Servitja disclosed no relevant relationships. Chair and invited discussant Dr. Thomas J. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
Vitamin D Supplementation Prevents Breast Cancer Therapy-Related Bone Loss
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
CHICAGO – The bone loss associated with aromatase inhibitors was significantly slowed with increasing supplements of vitamin D in a prospective cohort study of 156 postmenopausal women.
"The bone loss was less, the higher your vitamin D level was maintained," said session chair Dr. Thomas J. Smith of Massey Cancer Center of Virginia Commonwealth University. "This is one of the first intervention studies," he said. "And the results are pretty striking."
Dr. Sonia Servitja of Hospital del Mar in Barcelona, and colleagues, assessed the association between 25-hydroxy-vitamin D (25(OH)D) concentrations and bone loss at baseline, after 3 months of supplementation, and after 1 year, in patients receiving aromatase inhibitor therapy for early-stage breast cancer.
The 156 women in the prospective cohort had hormone-positive breast cancer and had initiated aromatase inhibitors from January 2006 to June 2009.
All patients received daily oral calcium (1 g) and vitamin D3 (800 IU). Patients with a baseline level of 25(OH)D less than 30 ng/mL received additional oral vitamin D3. The women were a mean age of 62 years with a mean age of menopause onset of 50 years.
The magnitude of the bone-loss prevention correlated with incremental increases in 25(OH)D concentrations.
Each 10-ng/mL increase in 25(OH)D concentration at 3 months appeared to be associated with a 0.55% decrease in bone loss, which was almost a third of the average bone loss experienced by these patients, according to the study findings, presented as a poster at the annual meeting of the American Society of Clinical Oncology.
The findings suggest that vitamin D supplementation at doses higher than the standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.
Patients who achieved 25(OH)D concentrations greater than or equal to 40 ng/mL at 3 months experienced significantly reduced bone loss. In addition, 25(OH)D increases at 3 months were protective for relative bone loss (adjusted beta for each quintile 1.01%, P value less than .001).
Dr. Servitja disclosed no relevant relationships. Dr. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: 25(OH)D concentration increments due to supplementation prevent aromatase inhibitor–associated bone loss, independently of baseline 25(OH)D concentrations. Increasing levels of 25(OH)D concentrations at 3 months were inversely correlated to absolute bone loss (–0.004 g/cm2 , [–0.007 to –0.004], (P = .003), at 1 year.
Data Source: Prospective cohort study of 156 postmenopausal nonosteoporotic women using adjuvant aromatase inhibitors in early breast cancer.
Disclosures: Dr. Sonia Servitja disclosed no relevant relationships. Chair and invited discussant Dr. Thomas J. Smith disclosed research funding from the American Cancer Society and the National Cancer Institute.
Chemo Changes Fail to Improve Surgical Outcomes in Rectal Cancer
CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.
Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.
"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.
"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.
The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.
"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.
Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.
NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.
All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m2 on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m2 twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 4.
More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.
The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).
Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).
Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).
And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?
Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.
For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.
Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.
Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.
CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.
Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.
"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.
"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.
The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.
"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.
Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.
NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.
All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m2 on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m2 twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 4.
More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.
The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).
Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).
Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).
And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?
Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.
For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.
Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.
Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.
CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.
Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.
"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.
"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.
The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.
"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.
Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.
NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.
All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m2 on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m2 twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m2 once weekly for 5 weeks) in group 4.
More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.
The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).
Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).
Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).
And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?
Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.
For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.
Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.
Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: Surgical down-staging rates were similar in comparisons of CVI 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).
Data Source: A study of 1,608 patients with stage II and III carcinoma of the rectum who were being treated preoperatively.
Disclosures: Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.
Hepcidin Levels Predict ESA and IV Iron Responses
CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.
Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.
Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).
The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.
"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.
Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.
This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).
Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.
"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.
"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.
Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.
"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."
The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.
darbepoetin alfa, intravenous iron, hemoglobin response,
CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.
Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.
Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).
The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.
"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.
Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.
This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).
Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.
"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.
"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.
Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.
"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."
The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.
CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.
Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.
Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).
The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.
"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.
Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.
This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).
Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.
"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.
"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.
Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.
"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."
The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.
darbepoetin alfa, intravenous iron, hemoglobin response,
darbepoetin alfa, intravenous iron, hemoglobin response,
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: Forty-seven patients with lower serum hepcidin levels who received darbepoetin and four to five doses of intravenous iron had hemoglobin response rates of 92%-95% and required no red blood cell transfusions.
Data Source: Phase III MS04CC trial of 489 cancer patients with chemotherapy-associated anemia.
Disclosures: The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.