Elderly patients with acute myeloid leukemia (AML) generally have a poor prognosis, but maintenance therapy with an androgen, norethandrolone, significantly improved survival in this population, investigators report in the Journal of Clinical Oncology.

The 5-year disease-free survival was almost double in patients who received norethandrolone (31.2% vs 16.2%), and event-free survival (EFS) and overall survival (OS) were also markedly improved.

A number of hypotheses could explain why norethandrolone improves outcomes in this population. “Because androgen supplementation was initiated when the tumoral mass was decreased, it is possible that norethandrolone decreased the proliferation of remaining blast cells and/or their genetic instability in restoring proper telomere length,” wrote Arnaud Pigneux, MD, PhD, of the Centre Hospitalier Universitaire, Bordeaux (France), and his coauthors. “In addition, as in aplastic anemia, a beneficial effect could be exerted by androgens on normal hematopoietic cells recovering after the end of the postinduction aplastic phase,” they said (J Clin Oncol. 2016 Oct 17. doi: 10.1200/JCO.2016.67.6213)

The majority of patients with AML are older than 60 years of age at the time of their diagnosis, and the prognosis is particularly poor for a number of reasons, including a greater intolerance to intensive chemotherapies and the presence of comorbidities. In addition, older patients also frequently present with unfavorable prognostic features, including multidrug resistant phenotypes or poor-risk cytogenetics.

In this study, Dr. Pigneux and his team enrolled 330 patients with AML de novo or secondary to chemotherapy or radiotherapy, who were 60 years of age or older. Induction therapy of idarubicin 8 mg/m² on days 1 to 5, cytarabine 100 mg/m² on days 1 to 7, and lomustine 200 mg/m² on day 1 was administered.

Those who achieved complete or partial remission received six reinduction courses, alternating idarubicin and cytarabine, and a regimen of methotrexate and mercaptopurine. The cohort was then randomized to receive norethandrolone 10 or 20 mg/day (arm A) according to body weight, or no norethandrolone (arm B) for a 2-year maintenance therapy regimen.

Disease-free survival (DFS) was significantly improved in patients who received androgen therapy, but there was no difference between groups in patients with a high WBC count.

The 5-year DFS was 39.2% for arm A versus 15.1% in arm B for patients with a low WBC count, and 14.3% in arm A versus 20.8% in arm B for patients with a high WBC count.

From the time of inclusion, the 5-year EFS and OS were 21.5% (95% confidence interval, 15.5%-28.1%) and 26.3% (95% CI, 19.7%-33.2%), respectively, in arm A versus 12.9% (95% CI, 8.3%-18.5%) and 17.2% (95% CI, 11.9%-23.4%), respectively, in arm B.

For patients with unfavorable cytogenetics (n = 78), outcomes were better if they received norethandrolone.

The 5-year DFS for this subset was 15.79% in arm A versus 7.69% in arm B. For patients with low- or intermediate-risk cytogenetics, the 5-year DFS was 39.73% in arm A versus 19.72% in arm B.

No funding source was disclosed. Dr. Pigneux has disclosed consulting or advisory roles with Amgen, Celgene, MSD, and Novartis, and disclosed receiving funding for travel and accommodations expenses from Amgen and Pfizer. Several of the authors have disclosed relationships with industry.

Elderly patients with acute myeloid leukemia (AML) generally have a poor prognosis, but maintenance therapy with an androgen, norethandrolone, significantly improved survival in this population, investigators report in the Journal of Clinical Oncology.

The 5-year disease-free survival was almost double in patients who received norethandrolone (31.2% vs 16.2%), and event-free survival (EFS) and overall survival (OS) were also markedly improved.

A number of hypotheses could explain why norethandrolone improves outcomes in this population. “Because androgen supplementation was initiated when the tumoral mass was decreased, it is possible that norethandrolone decreased the proliferation of remaining blast cells and/or their genetic instability in restoring proper telomere length,” wrote Arnaud Pigneux, MD, PhD, of the Centre Hospitalier Universitaire, Bordeaux (France), and his coauthors. “In addition, as in aplastic anemia, a beneficial effect could be exerted by androgens on normal hematopoietic cells recovering after the end of the postinduction aplastic phase,” they said (J Clin Oncol. 2016 Oct 17. doi: 10.1200/JCO.2016.67.6213)

The majority of patients with AML are older than 60 years of age at the time of their diagnosis, and the prognosis is particularly poor for a number of reasons, including a greater intolerance to intensive chemotherapies and the presence of comorbidities. In addition, older patients also frequently present with unfavorable prognostic features, including multidrug resistant phenotypes or poor-risk cytogenetics.

In this study, Dr. Pigneux and his team enrolled 330 patients with AML de novo or secondary to chemotherapy or radiotherapy, who were 60 years of age or older. Induction therapy of idarubicin 8 mg/m² on days 1 to 5, cytarabine 100 mg/m² on days 1 to 7, and lomustine 200 mg/m² on day 1 was administered.

Those who achieved complete or partial remission received six reinduction courses, alternating idarubicin and cytarabine, and a regimen of methotrexate and mercaptopurine. The cohort was then randomized to receive norethandrolone 10 or 20 mg/day (arm A) according to body weight, or no norethandrolone (arm B) for a 2-year maintenance therapy regimen.

Disease-free survival (DFS) was significantly improved in patients who received androgen therapy, but there was no difference between groups in patients with a high WBC count.

The 5-year DFS was 39.2% for arm A versus 15.1% in arm B for patients with a low WBC count, and 14.3% in arm A versus 20.8% in arm B for patients with a high WBC count.

From the time of inclusion, the 5-year EFS and OS were 21.5% (95% confidence interval, 15.5%-28.1%) and 26.3% (95% CI, 19.7%-33.2%), respectively, in arm A versus 12.9% (95% CI, 8.3%-18.5%) and 17.2% (95% CI, 11.9%-23.4%), respectively, in arm B.

For patients with unfavorable cytogenetics (n = 78), outcomes were better if they received norethandrolone.

The 5-year DFS for this subset was 15.79% in arm A versus 7.69% in arm B. For patients with low- or intermediate-risk cytogenetics, the 5-year DFS was 39.73% in arm A versus 19.72% in arm B.

No funding source was disclosed. Dr. Pigneux has disclosed consulting or advisory roles with Amgen, Celgene, MSD, and Novartis, and disclosed receiving funding for travel and accommodations expenses from Amgen and Pfizer. Several of the authors have disclosed relationships with industry.

Elderly patients with acute myeloid leukemia (AML) generally have a poor prognosis, but maintenance therapy with an androgen, norethandrolone, significantly improved survival in this population, investigators report in the Journal of Clinical Oncology.

The 5-year disease-free survival was almost double in patients who received norethandrolone (31.2% vs 16.2%), and event-free survival (EFS) and overall survival (OS) were also markedly improved.

A number of hypotheses could explain why norethandrolone improves outcomes in this population. “Because androgen supplementation was initiated when the tumoral mass was decreased, it is possible that norethandrolone decreased the proliferation of remaining blast cells and/or their genetic instability in restoring proper telomere length,” wrote Arnaud Pigneux, MD, PhD, of the Centre Hospitalier Universitaire, Bordeaux (France), and his coauthors. “In addition, as in aplastic anemia, a beneficial effect could be exerted by androgens on normal hematopoietic cells recovering after the end of the postinduction aplastic phase,” they said (J Clin Oncol. 2016 Oct 17. doi: 10.1200/JCO.2016.67.6213)

The majority of patients with AML are older than 60 years of age at the time of their diagnosis, and the prognosis is particularly poor for a number of reasons, including a greater intolerance to intensive chemotherapies and the presence of comorbidities. In addition, older patients also frequently present with unfavorable prognostic features, including multidrug resistant phenotypes or poor-risk cytogenetics.

In this study, Dr. Pigneux and his team enrolled 330 patients with AML de novo or secondary to chemotherapy or radiotherapy, who were 60 years of age or older. Induction therapy of idarubicin 8 mg/m² on days 1 to 5, cytarabine 100 mg/m² on days 1 to 7, and lomustine 200 mg/m² on day 1 was administered.

Those who achieved complete or partial remission received six reinduction courses, alternating idarubicin and cytarabine, and a regimen of methotrexate and mercaptopurine. The cohort was then randomized to receive norethandrolone 10 or 20 mg/day (arm A) according to body weight, or no norethandrolone (arm B) for a 2-year maintenance therapy regimen.

Disease-free survival (DFS) was significantly improved in patients who received androgen therapy, but there was no difference between groups in patients with a high WBC count.

The 5-year DFS was 39.2% for arm A versus 15.1% in arm B for patients with a low WBC count, and 14.3% in arm A versus 20.8% in arm B for patients with a high WBC count.

From the time of inclusion, the 5-year EFS and OS were 21.5% (95% confidence interval, 15.5%-28.1%) and 26.3% (95% CI, 19.7%-33.2%), respectively, in arm A versus 12.9% (95% CI, 8.3%-18.5%) and 17.2% (95% CI, 11.9%-23.4%), respectively, in arm B.

For patients with unfavorable cytogenetics (n = 78), outcomes were better if they received norethandrolone.

The 5-year DFS for this subset was 15.79% in arm A versus 7.69% in arm B. For patients with low- or intermediate-risk cytogenetics, the 5-year DFS was 39.73% in arm A versus 19.72% in arm B.

No funding source was disclosed. Dr. Pigneux has disclosed consulting or advisory roles with Amgen, Celgene, MSD, and Novartis, and disclosed receiving funding for travel and accommodations expenses from Amgen and Pfizer. Several of the authors have disclosed relationships with industry.

Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.

There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.

To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.

Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).

Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.

Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.

“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.

They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.

This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.

More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.

Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.

Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.

“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.

They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.

Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”

The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.

Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.

There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.

To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.

Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).

Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.

Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.

“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.

They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.

This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.

More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.

Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.

Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.

“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.

They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.

Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”

The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.

Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.

There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.

To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.

Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).

Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.

Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.

“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.

They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.

This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.

More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.

Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.

Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.

“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.

They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.

Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”

The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Approximately 20% of adult cancer survivors in the United States – roughly 2.5 million – take medication for anxiety or depression, a rate that is approximately twice that of the general population, according to a report published online in Journal of Clinical Oncology.

Considering that previous research reported that more than 30% of cancer survivors discuss psychosocial concerns with their medical providers, this finding suggests that “even more survivors might benefit from pharmacologic treatment than were receiving treatment at the time of this study,” said Nikki A. Hawkins, PhD, of the Centers for Disease Control and Prevention, and her associates.

“If left unaddressed and untreated, anxiety and depression have been found to negatively affect health behaviors, the body’s inflammatory response, and even survival.” Yet rates of medication use have not been examined until now, the investigators noted.

Dr. Hawkins and her associates analyzed data from the National Health Interview Surveys for 2010 through 2013 to determine population-based prevalence rates. Their study population comprised a nationally representative sample of 48,181 adults, of whom 3,184 were cancer survivors.

Compared with the general population, cancer survivors were approximately twice as likely to self-report taking medication for anxiety (16.8% vs 8.6%), depression (14.1% vs 7.8%), both conditions (11.8% vs 6.1%), and one or both conditions combined (19.1% vs 10.3%). When these results were extrapolated to the entire country, an estimated 2.5 million cancer survivors were found to currently use these medications, the investigators reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.67.7690).

“Interestingly, medication use did not vary significantly by time since cancer diagnosis, which is consistent with recent research that has shown elevated rates of depression and mental disorders for cancer survivors as much as 10 years after diagnosis,” they wrote.

The highest rates (greater than 20%) of antianxiety and antidepressant use occurred among patients who were middle aged (those aged 40-64 years), had never married, had three or more chronic health conditions, expected to have a short survival time, or had ovarian or uterine cancer.

Nine types of cancer were included in this study: breast, prostate, melanoma, cervical, colorectal, hematologic, ovarian/uterine, “short survival,” and other. Of these, patients with prostate cancer were the least likely to use antianxiety or antidepressant medications, and patients with ovarian/uterine and short survival cancers were the most likely to.

“Efforts to improve the psychosocial care of cancer survivors will be aided by continued tracking of the treatment received for mental health. Good medical care requires systematic evaluation, screening for new problems, and making adjustments to the prescribed therapies as needed, and survivors’ mental health deserves the same detailed, evidence-based, and ongoing attention,” Dr. Hawkins and her associates said.

This study was supported by the Centers for Disease Control and Prevention. Dr. Hawkins and her associates reported having no relevant financial disclosures.

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

Adding seribantumab to paclitaxel did not extend survival as was hoped in unselected patients with platinum-resistant or refractory ovarian cancer, according to a report published online in Journal of Clinical Oncology.

However, exploratory analyses of data from this manufacturer-sponsored open-label phase II trial showed that certain biomarkers might identify a subgroup of patients who may benefit from the addition of seribantumab, said Joyce F. Liu, MD, of Dana-Farber Cancer Institute, Boston, and her associates.

[email protected]

The U.S. Preventive Services Task Force (USPSTF) has issued a B-level recommendation for interventions given during pregnancy and after birth to support breastfeeding.

The Task Force cites “adequate” evidence that breastfeeding provides substantial health benefits for children and moderate health benefits for women. While they found evidence to support individual-level interventions, such as education and psychosocial support, system-level interventions were not shown to be effective. The recommendation appears online in JAMA (2016 Oct 25;316[16]:1688-93).

The recommendation updates a previous one issued in 2008, in which the USPSTF also recommended breastfeeding support interventions with a grade of B. The new recommendation is based on a review of 43 studies of individual-level primary care interventions in support of breastfeeding, and nine system-level interventions. The authors evaluated the available evidence on breastfeeding initiation, duration, and exclusivity, as well as breastfeeding’s effects on child and maternal health outcomes. They determined that support from a professional lactation consultant or a peer group was effective in producing any or exclusive breastfeeding, while systemwide interventions, such as the World Health Organization’s Baby-Friendly Hospital Initiative offered inconsistent benefits. The evidence review was also published in JAMA (2016;316[16]:1694-1705).

Thinkstock

[email protected]

On Twitter @whitneymcknight

The U.S. Preventive Services Task Force (USPSTF) has issued a B-level recommendation for interventions given during pregnancy and after birth to support breastfeeding.

The Task Force cites “adequate” evidence that breastfeeding provides substantial health benefits for children and moderate health benefits for women. While they found evidence to support individual-level interventions, such as education and psychosocial support, system-level interventions were not shown to be effective. The recommendation appears online in JAMA (2016 Oct 25;316[16]:1688-93).

The recommendation updates a previous one issued in 2008, in which the USPSTF also recommended breastfeeding support interventions with a grade of B. The new recommendation is based on a review of 43 studies of individual-level primary care interventions in support of breastfeeding, and nine system-level interventions. The authors evaluated the available evidence on breastfeeding initiation, duration, and exclusivity, as well as breastfeeding’s effects on child and maternal health outcomes. They determined that support from a professional lactation consultant or a peer group was effective in producing any or exclusive breastfeeding, while systemwide interventions, such as the World Health Organization’s Baby-Friendly Hospital Initiative offered inconsistent benefits. The evidence review was also published in JAMA (2016;316[16]:1694-1705).

Thinkstock

[email protected]

On Twitter @whitneymcknight

The U.S. Preventive Services Task Force (USPSTF) has issued a B-level recommendation for interventions given during pregnancy and after birth to support breastfeeding.

The Task Force cites “adequate” evidence that breastfeeding provides substantial health benefits for children and moderate health benefits for women. While they found evidence to support individual-level interventions, such as education and psychosocial support, system-level interventions were not shown to be effective. The recommendation appears online in JAMA (2016 Oct 25;316[16]:1688-93).

The recommendation updates a previous one issued in 2008, in which the USPSTF also recommended breastfeeding support interventions with a grade of B. The new recommendation is based on a review of 43 studies of individual-level primary care interventions in support of breastfeeding, and nine system-level interventions. The authors evaluated the available evidence on breastfeeding initiation, duration, and exclusivity, as well as breastfeeding’s effects on child and maternal health outcomes. They determined that support from a professional lactation consultant or a peer group was effective in producing any or exclusive breastfeeding, while systemwide interventions, such as the World Health Organization’s Baby-Friendly Hospital Initiative offered inconsistent benefits. The evidence review was also published in JAMA (2016;316[16]:1694-1705).

Thinkstock

[email protected]

On Twitter @whitneymcknight

NEW YORK – Monoclonal antibodies may soon have more of a role in the front-line treatment setting for multiple myeloma and as part of precollection/transplant regimens–or “so-called in vivo purges,” according to Tomer M. Mark, MD, of the department of clinical medicine at the Cornell University, New York.

They could also be used both in the preclinical setting for smoldering multiple myeloma, and for maintenance following transplant, which makes sense given that they are, for the most part, not myelosuppressive and have “very tolerable toxicities,” he said.

Myeloma is “sort of catching up to lymphoma in terms of antibody use and development. ... Approval trials are underway,” Dr. Mark said at Imedex: Lymphoma & Myeloma, an international congress on hematologic malignancies.

The successes of the phase III trials CASTOR and POLLUX in patients with relapsed and refractory multiple myeloma have paved the way for trials to examine daratumumab in first-line combination therapy.

In POLLUX, progression-free survival, time to progression, and overall response rate were superior with daratumumab in combination with lenalidomide/dexamethasone, as compared with lenalidomide/dexamethasone alone, in relapsed or refractory multiple myeloma patients. In CASTOR, daratumumab in combination with bortezomib and dexamethasone was superior to bortezomib and dexamethasone alone in a similar patient population. Of note, the effect was attenuated in those with multiple prior lines of treatment, which is, perhaps, an argument for moving monoclonal antibodies closer to the start of therapy, he said.

Daratumumab (Darzalex), which targets CD38, is currently indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.

Similarly, elotuzumab (Empliciti), an immunostimulatory monoclonal antibody targeting a cell-surface receptor with both direct activation of natural killer cells and the capacity to trigger antibody-dependent, cell-mediated cytotoxicity of myeloma cells, is indicated in combination with lenalidomide/dexamethasone in patients who have received one to three therapies. Elotuzumab was shown in one trial to be associated with progression-free survival of 68% at 1 and 41% at 2 years when used with lenalidomide/dexamethasone. Patients receiving elotuzumab had a relative reduction of 30% in the risk of disease progression or death as compared with the control group.

In an ongoing trial with initial results reported at the 2015 American Society of Hematology annual meeting, elotuzumab with bortezomib/dexamethasone was associated with a more modest improvement in median progression-free survival, which was 9.9 months with triple therapy and 6.8 months with bortezomib/dexamethasone alone.

Both drugs have shown activity as single agents. In a phase I study, elotuzumab was associated with disease stability in 26% of patients, Dr. Mark said. Daratumumab, used as monotherapy in a study of relapsed or relapsed/refractory multiple myeloma patients, was associated with good overall response and progression-free survival, and “quite amazing” overall survival of 65%.

Other monoclonal antibodies in development include isatuximab (anti-CD38), lorvotuzumab mertansine (anti-CD56), and indatuximab ravtansine (anti-CD128), Dr. Mark said.

Dr. Mark reported receiving research funding from Celgene and Amgen, serving on speakers bureaus for Celgene, Millennium, Amgen, and Bristol-Myers Squibb, and serving on an advisory committee for Celgene and Millennium.

[email protected]

NEW YORK – Monoclonal antibodies may soon have more of a role in the front-line treatment setting for multiple myeloma and as part of precollection/transplant regimens–or “so-called in vivo purges,” according to Tomer M. Mark, MD, of the department of clinical medicine at the Cornell University, New York.

They could also be used both in the preclinical setting for smoldering multiple myeloma, and for maintenance following transplant, which makes sense given that they are, for the most part, not myelosuppressive and have “very tolerable toxicities,” he said.

Myeloma is “sort of catching up to lymphoma in terms of antibody use and development. ... Approval trials are underway,” Dr. Mark said at Imedex: Lymphoma & Myeloma, an international congress on hematologic malignancies.

The successes of the phase III trials CASTOR and POLLUX in patients with relapsed and refractory multiple myeloma have paved the way for trials to examine daratumumab in first-line combination therapy.

In POLLUX, progression-free survival, time to progression, and overall response rate were superior with daratumumab in combination with lenalidomide/dexamethasone, as compared with lenalidomide/dexamethasone alone, in relapsed or refractory multiple myeloma patients. In CASTOR, daratumumab in combination with bortezomib and dexamethasone was superior to bortezomib and dexamethasone alone in a similar patient population. Of note, the effect was attenuated in those with multiple prior lines of treatment, which is, perhaps, an argument for moving monoclonal antibodies closer to the start of therapy, he said.

Daratumumab (Darzalex), which targets CD38, is currently indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.

Similarly, elotuzumab (Empliciti), an immunostimulatory monoclonal antibody targeting a cell-surface receptor with both direct activation of natural killer cells and the capacity to trigger antibody-dependent, cell-mediated cytotoxicity of myeloma cells, is indicated in combination with lenalidomide/dexamethasone in patients who have received one to three therapies. Elotuzumab was shown in one trial to be associated with progression-free survival of 68% at 1 and 41% at 2 years when used with lenalidomide/dexamethasone. Patients receiving elotuzumab had a relative reduction of 30% in the risk of disease progression or death as compared with the control group.

In an ongoing trial with initial results reported at the 2015 American Society of Hematology annual meeting, elotuzumab with bortezomib/dexamethasone was associated with a more modest improvement in median progression-free survival, which was 9.9 months with triple therapy and 6.8 months with bortezomib/dexamethasone alone.

Both drugs have shown activity as single agents. In a phase I study, elotuzumab was associated with disease stability in 26% of patients, Dr. Mark said. Daratumumab, used as monotherapy in a study of relapsed or relapsed/refractory multiple myeloma patients, was associated with good overall response and progression-free survival, and “quite amazing” overall survival of 65%.

Other monoclonal antibodies in development include isatuximab (anti-CD38), lorvotuzumab mertansine (anti-CD56), and indatuximab ravtansine (anti-CD128), Dr. Mark said.

Dr. Mark reported receiving research funding from Celgene and Amgen, serving on speakers bureaus for Celgene, Millennium, Amgen, and Bristol-Myers Squibb, and serving on an advisory committee for Celgene and Millennium.

[email protected]

NEW YORK – Monoclonal antibodies may soon have more of a role in the front-line treatment setting for multiple myeloma and as part of precollection/transplant regimens–or “so-called in vivo purges,” according to Tomer M. Mark, MD, of the department of clinical medicine at the Cornell University, New York.

They could also be used both in the preclinical setting for smoldering multiple myeloma, and for maintenance following transplant, which makes sense given that they are, for the most part, not myelosuppressive and have “very tolerable toxicities,” he said.

Myeloma is “sort of catching up to lymphoma in terms of antibody use and development. ... Approval trials are underway,” Dr. Mark said at Imedex: Lymphoma & Myeloma, an international congress on hematologic malignancies.

The successes of the phase III trials CASTOR and POLLUX in patients with relapsed and refractory multiple myeloma have paved the way for trials to examine daratumumab in first-line combination therapy.

In POLLUX, progression-free survival, time to progression, and overall response rate were superior with daratumumab in combination with lenalidomide/dexamethasone, as compared with lenalidomide/dexamethasone alone, in relapsed or refractory multiple myeloma patients. In CASTOR, daratumumab in combination with bortezomib and dexamethasone was superior to bortezomib and dexamethasone alone in a similar patient population. Of note, the effect was attenuated in those with multiple prior lines of treatment, which is, perhaps, an argument for moving monoclonal antibodies closer to the start of therapy, he said.

Daratumumab (Darzalex), which targets CD38, is currently indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.

Similarly, elotuzumab (Empliciti), an immunostimulatory monoclonal antibody targeting a cell-surface receptor with both direct activation of natural killer cells and the capacity to trigger antibody-dependent, cell-mediated cytotoxicity of myeloma cells, is indicated in combination with lenalidomide/dexamethasone in patients who have received one to three therapies. Elotuzumab was shown in one trial to be associated with progression-free survival of 68% at 1 and 41% at 2 years when used with lenalidomide/dexamethasone. Patients receiving elotuzumab had a relative reduction of 30% in the risk of disease progression or death as compared with the control group.

In an ongoing trial with initial results reported at the 2015 American Society of Hematology annual meeting, elotuzumab with bortezomib/dexamethasone was associated with a more modest improvement in median progression-free survival, which was 9.9 months with triple therapy and 6.8 months with bortezomib/dexamethasone alone.

Both drugs have shown activity as single agents. In a phase I study, elotuzumab was associated with disease stability in 26% of patients, Dr. Mark said. Daratumumab, used as monotherapy in a study of relapsed or relapsed/refractory multiple myeloma patients, was associated with good overall response and progression-free survival, and “quite amazing” overall survival of 65%.

Other monoclonal antibodies in development include isatuximab (anti-CD38), lorvotuzumab mertansine (anti-CD56), and indatuximab ravtansine (anti-CD128), Dr. Mark said.

Dr. Mark reported receiving research funding from Celgene and Amgen, serving on speakers bureaus for Celgene, Millennium, Amgen, and Bristol-Myers Squibb, and serving on an advisory committee for Celgene and Millennium.

[email protected]

Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”

TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”

TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”

TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.

The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.

Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).

AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.

LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.

The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.

Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).

AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.

LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.

The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.

Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).

AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.

A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment  comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.

Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?

Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.

Related: ASCO's Chemotherapy Administration Safety Standards

To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.

Related: Palliative Chemotherapy May Be Harmful

The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.

The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.

Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.

A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment  comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.

Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?

Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.

Related: ASCO's Chemotherapy Administration Safety Standards

To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.

Related: Palliative Chemotherapy May Be Harmful

The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.

The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.

Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.

A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment  comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.

Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?

Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.

Related: ASCO's Chemotherapy Administration Safety Standards

To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.

Related: Palliative Chemotherapy May Be Harmful

The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.

The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.

Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.

Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.

In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.

However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.

• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.

• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.

• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.

• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.

That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.

“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”

“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”

Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.

CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”

CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.

[email protected]

Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.

In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.

However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.

• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.

• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.

• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.

• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.

That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.

“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”

“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”

Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.

CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”

CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.

[email protected]

Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.

In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.

However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.

• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.

• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.

• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.

• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.

That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.

“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”

“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”

Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.

CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”

CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.

[email protected]