Surgical Oncology

Effective immediately, Medicare will cover annual lung cancer screening with low-dose CT for certain beneficiaries, according to a Feb. 5 national coverage determination.

To qualify, beneficiaries must be 55-77 years old, have a smoking history of at least a 30 pack-years, exhibit no signs or symptoms of lung cancer, and currently smoke or have quit within 15 years. They also must have a written screening order from their provider.

Coverage includes a counseling visit for shared decision-making, so patients know beforehand the “benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive[s], and total radiation exposure,” among other things, according to the decision memo from the Centers for Medicare & Medicaid Services.

Imaging centers are required to collect data on each screening and submit it to a CMS-approved registry.

The decision has been in the works for a while. In 2011, the National Cancer Institute–sponsored National Lung Screening Trial (NLST) showed that people aged 55-74 years with a history of heavy smoking are 20% less likely to die from lung cancer if they are screened with low-dose helical CT instead of standard chest x-ray (N. Engl. J. Med. 2011;365:395-409). Previous studies had shown that screening with standard chest x-rays does not reduce mortality from lung cancer.

Results from NLST and other studies prompted the U.S. Preventive Services Task Force in 2013 to recommend annual low-dose CT screening for adults aged 55-80 years with a 30 pack-year history; the recommendation in turn led to formal requests to CMS for coverage. In proposing coverage, the task force received almost 500 public comments “generally supportive of [expanding] Medicare coverage to include lung cancer screening,” it said.

Low-dose CT is performed at acquisition settings to minimize radiation exposure. For lung cancer screening, CMS is requiring a volumetric CT dose index (CTDIvol) of ≤ 3.0 mGy for standard-size patients – defined to be 5 feet 7 inches tall and approximately 155 pounds – with appropriate reductions or increases for smaller or larger patients.

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Effective immediately, Medicare will cover annual lung cancer screening with low-dose CT for certain beneficiaries, according to a Feb. 5 national coverage determination.

To qualify, beneficiaries must be 55-77 years old, have a smoking history of at least a 30 pack-years, exhibit no signs or symptoms of lung cancer, and currently smoke or have quit within 15 years. They also must have a written screening order from their provider.

Coverage includes a counseling visit for shared decision-making, so patients know beforehand the “benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive[s], and total radiation exposure,” among other things, according to the decision memo from the Centers for Medicare & Medicaid Services.

Imaging centers are required to collect data on each screening and submit it to a CMS-approved registry.

The decision has been in the works for a while. In 2011, the National Cancer Institute–sponsored National Lung Screening Trial (NLST) showed that people aged 55-74 years with a history of heavy smoking are 20% less likely to die from lung cancer if they are screened with low-dose helical CT instead of standard chest x-ray (N. Engl. J. Med. 2011;365:395-409). Previous studies had shown that screening with standard chest x-rays does not reduce mortality from lung cancer.

Results from NLST and other studies prompted the U.S. Preventive Services Task Force in 2013 to recommend annual low-dose CT screening for adults aged 55-80 years with a 30 pack-year history; the recommendation in turn led to formal requests to CMS for coverage. In proposing coverage, the task force received almost 500 public comments “generally supportive of [expanding] Medicare coverage to include lung cancer screening,” it said.

Low-dose CT is performed at acquisition settings to minimize radiation exposure. For lung cancer screening, CMS is requiring a volumetric CT dose index (CTDIvol) of ≤ 3.0 mGy for standard-size patients – defined to be 5 feet 7 inches tall and approximately 155 pounds – with appropriate reductions or increases for smaller or larger patients.

[email protected]

Effective immediately, Medicare will cover annual lung cancer screening with low-dose CT for certain beneficiaries, according to a Feb. 5 national coverage determination.

To qualify, beneficiaries must be 55-77 years old, have a smoking history of at least a 30 pack-years, exhibit no signs or symptoms of lung cancer, and currently smoke or have quit within 15 years. They also must have a written screening order from their provider.

Coverage includes a counseling visit for shared decision-making, so patients know beforehand the “benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive[s], and total radiation exposure,” among other things, according to the decision memo from the Centers for Medicare & Medicaid Services.

Imaging centers are required to collect data on each screening and submit it to a CMS-approved registry.

The decision has been in the works for a while. In 2011, the National Cancer Institute–sponsored National Lung Screening Trial (NLST) showed that people aged 55-74 years with a history of heavy smoking are 20% less likely to die from lung cancer if they are screened with low-dose helical CT instead of standard chest x-ray (N. Engl. J. Med. 2011;365:395-409). Previous studies had shown that screening with standard chest x-rays does not reduce mortality from lung cancer.

Results from NLST and other studies prompted the U.S. Preventive Services Task Force in 2013 to recommend annual low-dose CT screening for adults aged 55-80 years with a 30 pack-year history; the recommendation in turn led to formal requests to CMS for coverage. In proposing coverage, the task force received almost 500 public comments “generally supportive of [expanding] Medicare coverage to include lung cancer screening,” it said.

Low-dose CT is performed at acquisition settings to minimize radiation exposure. For lung cancer screening, CMS is requiring a volumetric CT dose index (CTDIvol) of ≤ 3.0 mGy for standard-size patients – defined to be 5 feet 7 inches tall and approximately 155 pounds – with appropriate reductions or increases for smaller or larger patients.

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After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.

This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.

They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.

For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.

A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.

The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.

This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).

Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.

The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.

After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.

This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.

They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.

For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.

A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.

The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.

This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).

Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.

The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.

After neoadjuvant chemotherapy, axial ultrasound helps identify residual nodal disease – information that can guide the decision to pursue lymph node surgery, according to a report published online Feb. 2 in the Journal of Clinical Oncology.

This strategy of performing axial ultrasound to guide axillary surgery can reduce the number of both false-negative and false-positive results, thus improving both the rate of undertreating residual breast cancer and the rate of overtreating lymph nodes that have been cleared of the disease, said Dr. Judy C. Boughey of the Mayo Clinic, Rochester, Minn., and her associates.

They investigated two secondary end points of the American College of Surgeons Oncology Group Z1071 phase II clinical trial, which addressed sentinel lymph node surgery in women with initially node-positive breast cancer. The two end points were whether a normal appearance on ultrasound of sentinel lymph nodes after neoadjuvant chemotherapy denoted a decreased risk of residual cancer and whether an abnormal appearance of sentinel lymph nodes on ultrasound after neoadjuvant chemotherapy denoted an increased risk of residual cancer.

For this analysis of the ACSOG Z1071 data, Dr. Boughey and her associates assessed 611 study participants who initially had node-positive (stage T0-4, N1-2, M0) breast cancer treated at 136 medical centers, had completed neoadjuvant chemotherapy, had undergone axial ultrasound with archiving of the images, and had undergone sentinel lymph node surgery and axial dissection. A total of 70.4% of these patients had lymph nodes classified as normal on ultrasound and 29.6% had suspicious lymph nodes.

A total of 56.5% of patients with normal-appearing lymph nodes on ultrasound proved to have positive nodes on final pathology. In contrast, 71.8% – significantly more – of patients who had suspicious-looking lymph nodes on ultrasound proved to have positive nodes on final pathology (P less than .001). Women with suspicious nodal status on ultrasound also were more likely to have a higher number of positive nodes (34.5% vs 21.0%) and a larger median size of nodal metastases, representing a greater nodal disease burden, than those with normal appearance on ultrasound.

The investigators recommended a strategy in which patients with normal-appearing lymph nodes following adjuvant chemotherapy could undergo sentinel lymph node surgery. “If any of the sentinel lymph nodes were positive, the patient would undergo an axillary lymph node dissection, and if the sentinel lymph nodes were negative, then no further axillary surgery would be needed,” they wrote.

This approach yielded a false-negative rate of just 9.8% when applied to the Z1071 study population, compared with a 12.6% false-negative rate when axial ultrasound was not used to select patients for surgery. Any false-negative rate under 10% was predetermined to be acceptable when the study was designed, Dr. Boughey and her associates said (J. Clin. Oncol. 2015 [doi:10.1200/JCO.2014.57.8401]).

Among patients who had a normal node appearance on ultrasound but positive findings on sentinel lymph node surgery, 63% proved to have no additional positive nodes in the axillary lymph node dissection. “Therefore, in patients with normal axial ultrasound, sentinel lymph node surgery could be used to identify patients who may be able to avoid axillary lymph node dissection. This is being evaluated in the Alliance A11202 trial, which is currently enrolling patients and comparing axillary radiation to axillary dissection for patients with positive sentinel lymph nodes after neoadjuvant chemotherapy,” they added.

The ACOSOG Z1071 trial was supported by National Cancer Institute grants to the American College of Surgeons Oncology Group, the Alliance for Clinical Trials in Oncology, and the Alliance Statistics and Data Center. Dr. Boughey reported having no financial disclosures; one of her associates reported receiving research funding from Galena Biopharma and Antigen Express.

President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.

The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.

Courtesy of whitehouse.gov

“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”

The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.

The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.

Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.

“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).

“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.

The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.

“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”

In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.

“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”

[email protected]

On Twitter @legal_med

President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.

The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.

Courtesy of whitehouse.gov

“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”

The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.

The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.

Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.

“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).

“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.

The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.

“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”

In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.

“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”

[email protected]

On Twitter @legal_med

President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.

The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.

Courtesy of whitehouse.gov

“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”

The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.

The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.

Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.

“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).

“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.

The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.

“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”

In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.

“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”

[email protected]

On Twitter @legal_med

SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.

Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.

“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”

Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.

“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”

At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.

“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”

Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).

When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.

Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.

Dr. Gupta disclosed that he had no relevant conflicts of interest.

SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.

Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.

“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”

Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.

“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”

At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.

“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”

Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).

When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.

Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.

Dr. Gupta disclosed that he had no relevant conflicts of interest.

SAN FRANCISCO – Statin use confers a survival benefit in patients with colorectal cancer, suggests a systematic review and meta-analysis presented at the annual Gastrointestinal Cancers Symposium.

Investigators analyzed data from seven observational studies having a total of 64,773 patients with this cancer, a fifth of whom were using statins. Results showed that statin users had a nearly 30% reduction in the adjusted risk of all-cause mortality relative to nonusers, Dr. Arjun Gupta, the lead investigator, reported in a poster session at the meeting cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology.

“There is a lot of interest in non–cytotoxic chemotherapy drugs that can be used to treat cancer,” he said in an interview. “Thirty percent is a very, very significant number – we use chemotherapy drugs even if they have just a 10% survival benefit. So I am hopeful that this will help people.”

Accumulating preclinical data suggest that statins have anticancer actions, inhibiting cell proliferation and angiogenesis, and inducing apoptosis, according to Dr. Gupta, who is a resident in internal medicine at the University of Texas Southwestern Medical Center, Dallas. Previous studies have shown use to be associated with a decreased risk of developing colorectal cancer, but its impact on established disease has not been well assessed on a large scale.

“This is all observational data. There is no randomized controlled trial that’s been done,” he acknowledged. “But these data certainly seem to point out that this is something we can do. It’s a cheap and easy, safe drug which people take for years on end without any complications.”

At present, statins are approved by the Food and Drug Administration only for lipid-lowering indications, he noted. However, patients with colorectal cancer often have cardiovascular risk factors that make them candidates for statins.

“No one really gets a statin right now for colon cancer. We are just sort of lucky, maybe, that so many people with colon cancer have high cholesterol and are getting these drugs,” Dr. Gupta said. “But hopefully, my dream is 5 years down the line, it will be prescribed to people for this indication.”

Study results showed that in multivariate analyses, patients using statins were 26% less likely to die of any cause (hazard ratio, 0.74). Findings were similar whether they had colon cancer (hazard ratio, 0.79) or rectal cancer (hazard ratio, 0.63).

When analyses were restricted to studies that adjusted for concomitant use of aspirin and nonsteroidal anti-inflammatory drugs, statin users had significantly reduced risks of both all-cause mortality (hazard ratio, 0.74) and colorectal cancer–specific mortality (HR, 0.76), reported Dr. Gupta.

Patients who started using the medications after their cancer diagnosis had a significantly reduced risk of colorectal cancer-specific mortality (HR, 0.70) but not all-cause mortality.

Dr. Gupta disclosed that he had no relevant conflicts of interest.

Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.

Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.

roobcio/Thinkstock.com

All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.

The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).

These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.

Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.

Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.

roobcio/Thinkstock.com

All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.

The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).

These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.

Targeted biopsy using magnetic resonance/ultrasound fusion imaging increased the detection of high-risk prostate cancer by 30% and decreased the detection of low-risk prostate cancer by 17%, compared with standard biopsy, according to a report published online Jan. 27 in JAMA.

Researchers compared the two approaches in a prospective cohort study involving 1,003 men referred to the National Cancer Institute during a 7-year period for evaluation of suspected prostate cancer. All the study participants had an elevated PSA or abnormal findings on digital rectal exam plus a multiparametric MRI showing at least 1 lesion in the prostate, said Dr. M. Minhaj Siddiqui of the urologic oncology branch, National Cancer Institute, Bethesda, Md., and his associates.

roobcio/Thinkstock.com

All the patients underwent both standard extended-sextant ultrasound-guided biopsy and targeted magnetic resonance/ultrasound fusion biopsy at the same visit. The latter technique involves electronically superimposing multiparametric MR images in real time onto transrectal ultrasound images, which improves spatial localization and capture of location in three planes. The lesions were separately categorized as low-risk, intermediate-risk, or high-risk by highly experienced genitourinary radiologists.

The two image-guided biopsy techniques agreed on these classifications in 69% of cases and identified a similar number of cancers. However, targeted biopsy detected 173 high-risk tumors, compared with only 122 identified on standard biopsy, and targeted biopsy detected 213 low-risk tumors, compared with 258 identified on standard biopsy. In a subset of 170 cases, these biopsy results could be compared against pathology found at whole-gland prostatectomy. Targeted biopsy proved to be much more accurate than standard biopsy, with sensitivities of 77% and 53%, respectively, the investigators said (JAMA 2015 Jan. 27 [doi:10.1001/jama.2014.17942]).

These findings show that targeted biopsy “could significantly change the distribution of risk in men newly diagnosed with prostate cancer toward diagnosis of more high-risk disease. Although these improvements in risk stratification could translate into substantial clinical benefits, it is important to recognize that this study is preliminary” and didn’t include clinical end points such as cancer recurrence or prostate cancer–specific mortality, Dr. Siddiqui and his associates said.

SAN FRANCISCO – Patients with early gastric cancer have less postoperative morbidity if they undergo laparoscopic instead of open distal gastrectomy, according to safety results of a phase III trial presented at the at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

The trial – the first in a series by the Korean Laparo-endoscopic Gastrointestinal Surgery Study Group (KLASS-01) – was conducted among 1,416 patients with clinical stage I disease in Korea, where the proportion of esophagogastric cancers caught in early stages has increased with the introduction of a national screening program. The patients were randomized evenly to laparoscopic or open surgery.

Main results showed mortality was similarly low for the open and laparoscopic approaches. But the laparoscopic group had half the rate of wound complications and, in multivariate analysis, a 41% lower risk of postoperative morbidity.

“Laparoscopy-assisted distal gastrectomy for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complications compared with conventional open surgery,” concluded first author Dr. Hyuk-Joon Lee, a gastrointestinal surgeon at the Seoul National University Hospital, Korea.

Invited discussant Dr. Michael Kent of Harvard Medical School, director of minimally invasive thoracic surgery at Beth Israel Deaconess Medical Center, Boston, said, “It is clear that the KLASS study is the largest by far to evaluate laparoscopic gastrectomy.”

A similar trial in the setting of early colorectal cancer (N. Engl. J. Med. 2004;350:2050-9) led to rapid uptake of laparoscopic resection for those patients at high-volume centers, he noted. “Although we still await survival data from the KLASS study, I anticipate that laparoscopic gastrectomy will likewise become the preferred approach in high-volume centers, especially in countries such as Korea with a national screening program.

“However, I do not think that open gastrectomy is an operation of the past,” he added. “For one, the benefits have not been shown yet in advanced gastric cancer. Also, in low-volume centers, the expertise in laparoscopic surgery may not be sufficient to warrant this approach. I should also add that body habitus may render this operation more difficult in obese patients.”

Dr. Kent pointed out that patients with T1a disease have yet another option, endoscopic resection, which has been found to yield good results at least in a single-center retrospective study (Surg. Endosc. 2013;27:4250-8). “In regards to future clinical trials, I believe it would be important to determine which patients require surgical as opposed to an endoscopic resection,” he concluded.

A previously reported interim analysis of the KLASS-01 trial showed no significant difference in morbidity and mortality between the laparoscopic and open groups, allowing the trial to continue (Ann. Surg. 2010;251:417-20).

Eighty percent of patients on the trial had T1 disease. Within this subset, about 60% had T1a and 40% had T1b disease, Dr. Lee said.

In modified intention-to-treat analyses, patients in the laparoscopic group had a longer operation time (185 vs. 146 minutes) and fewer lymph nodes retrieved (41 vs. 43). But they had a lower estimated blood loss (119 vs. 194 mL) and shorter hospital stay (7.2 vs. 8.0 days).

The rate of surgical mortality was less than 1% and the rate of reoperation was about 1%, with no significant differences between groups.

Patients in the laparoscopic group had lower 30-day rates of postoperative morbidity (13.7% vs. 18.9%, P = .009), and the benefit of the less invasive approach remained significant after multivariate adjustment (odds ratio, 0.59; P = .001). Wound complications were half as common with laparoscopy (3.6% vs. 7.0%, P = .005).

Data on 5-year overall survival, the primary endpoint of the KLASS-01 trial, are expected later this year.

Dr. Kent asked, “In your country, for those patients with clinical T1a disease, how is a decision made regarding therapy?”

“I think if we can accurately diagnose the T stage as well as the N stage, we can surely adapt the endoscopic treatment for all the T1a cancer patients,” Dr. Lee replied. Such diagnosis has proved challenging, he added. Endoscopic resection is usually reserved for patients with tumors less than 2 cm in diameter showing differentiated histology and not invading the mucosa. “We have to move to the more accurate diagnosis of the TNM stage,” he concluded.

SAN FRANCISCO – Patients with early gastric cancer have less postoperative morbidity if they undergo laparoscopic instead of open distal gastrectomy, according to safety results of a phase III trial presented at the at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

The trial – the first in a series by the Korean Laparo-endoscopic Gastrointestinal Surgery Study Group (KLASS-01) – was conducted among 1,416 patients with clinical stage I disease in Korea, where the proportion of esophagogastric cancers caught in early stages has increased with the introduction of a national screening program. The patients were randomized evenly to laparoscopic or open surgery.

Main results showed mortality was similarly low for the open and laparoscopic approaches. But the laparoscopic group had half the rate of wound complications and, in multivariate analysis, a 41% lower risk of postoperative morbidity.

“Laparoscopy-assisted distal gastrectomy for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complications compared with conventional open surgery,” concluded first author Dr. Hyuk-Joon Lee, a gastrointestinal surgeon at the Seoul National University Hospital, Korea.

Invited discussant Dr. Michael Kent of Harvard Medical School, director of minimally invasive thoracic surgery at Beth Israel Deaconess Medical Center, Boston, said, “It is clear that the KLASS study is the largest by far to evaluate laparoscopic gastrectomy.”

A similar trial in the setting of early colorectal cancer (N. Engl. J. Med. 2004;350:2050-9) led to rapid uptake of laparoscopic resection for those patients at high-volume centers, he noted. “Although we still await survival data from the KLASS study, I anticipate that laparoscopic gastrectomy will likewise become the preferred approach in high-volume centers, especially in countries such as Korea with a national screening program.

“However, I do not think that open gastrectomy is an operation of the past,” he added. “For one, the benefits have not been shown yet in advanced gastric cancer. Also, in low-volume centers, the expertise in laparoscopic surgery may not be sufficient to warrant this approach. I should also add that body habitus may render this operation more difficult in obese patients.”

Dr. Kent pointed out that patients with T1a disease have yet another option, endoscopic resection, which has been found to yield good results at least in a single-center retrospective study (Surg. Endosc. 2013;27:4250-8). “In regards to future clinical trials, I believe it would be important to determine which patients require surgical as opposed to an endoscopic resection,” he concluded.

A previously reported interim analysis of the KLASS-01 trial showed no significant difference in morbidity and mortality between the laparoscopic and open groups, allowing the trial to continue (Ann. Surg. 2010;251:417-20).

Eighty percent of patients on the trial had T1 disease. Within this subset, about 60% had T1a and 40% had T1b disease, Dr. Lee said.

In modified intention-to-treat analyses, patients in the laparoscopic group had a longer operation time (185 vs. 146 minutes) and fewer lymph nodes retrieved (41 vs. 43). But they had a lower estimated blood loss (119 vs. 194 mL) and shorter hospital stay (7.2 vs. 8.0 days).

The rate of surgical mortality was less than 1% and the rate of reoperation was about 1%, with no significant differences between groups.

Patients in the laparoscopic group had lower 30-day rates of postoperative morbidity (13.7% vs. 18.9%, P = .009), and the benefit of the less invasive approach remained significant after multivariate adjustment (odds ratio, 0.59; P = .001). Wound complications were half as common with laparoscopy (3.6% vs. 7.0%, P = .005).

Data on 5-year overall survival, the primary endpoint of the KLASS-01 trial, are expected later this year.

Dr. Kent asked, “In your country, for those patients with clinical T1a disease, how is a decision made regarding therapy?”

“I think if we can accurately diagnose the T stage as well as the N stage, we can surely adapt the endoscopic treatment for all the T1a cancer patients,” Dr. Lee replied. Such diagnosis has proved challenging, he added. Endoscopic resection is usually reserved for patients with tumors less than 2 cm in diameter showing differentiated histology and not invading the mucosa. “We have to move to the more accurate diagnosis of the TNM stage,” he concluded.

SAN FRANCISCO – Patients with early gastric cancer have less postoperative morbidity if they undergo laparoscopic instead of open distal gastrectomy, according to safety results of a phase III trial presented at the at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

The trial – the first in a series by the Korean Laparo-endoscopic Gastrointestinal Surgery Study Group (KLASS-01) – was conducted among 1,416 patients with clinical stage I disease in Korea, where the proportion of esophagogastric cancers caught in early stages has increased with the introduction of a national screening program. The patients were randomized evenly to laparoscopic or open surgery.

Main results showed mortality was similarly low for the open and laparoscopic approaches. But the laparoscopic group had half the rate of wound complications and, in multivariate analysis, a 41% lower risk of postoperative morbidity.

“Laparoscopy-assisted distal gastrectomy for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complications compared with conventional open surgery,” concluded first author Dr. Hyuk-Joon Lee, a gastrointestinal surgeon at the Seoul National University Hospital, Korea.

Invited discussant Dr. Michael Kent of Harvard Medical School, director of minimally invasive thoracic surgery at Beth Israel Deaconess Medical Center, Boston, said, “It is clear that the KLASS study is the largest by far to evaluate laparoscopic gastrectomy.”

A similar trial in the setting of early colorectal cancer (N. Engl. J. Med. 2004;350:2050-9) led to rapid uptake of laparoscopic resection for those patients at high-volume centers, he noted. “Although we still await survival data from the KLASS study, I anticipate that laparoscopic gastrectomy will likewise become the preferred approach in high-volume centers, especially in countries such as Korea with a national screening program.

“However, I do not think that open gastrectomy is an operation of the past,” he added. “For one, the benefits have not been shown yet in advanced gastric cancer. Also, in low-volume centers, the expertise in laparoscopic surgery may not be sufficient to warrant this approach. I should also add that body habitus may render this operation more difficult in obese patients.”

Dr. Kent pointed out that patients with T1a disease have yet another option, endoscopic resection, which has been found to yield good results at least in a single-center retrospective study (Surg. Endosc. 2013;27:4250-8). “In regards to future clinical trials, I believe it would be important to determine which patients require surgical as opposed to an endoscopic resection,” he concluded.

A previously reported interim analysis of the KLASS-01 trial showed no significant difference in morbidity and mortality between the laparoscopic and open groups, allowing the trial to continue (Ann. Surg. 2010;251:417-20).

Eighty percent of patients on the trial had T1 disease. Within this subset, about 60% had T1a and 40% had T1b disease, Dr. Lee said.

In modified intention-to-treat analyses, patients in the laparoscopic group had a longer operation time (185 vs. 146 minutes) and fewer lymph nodes retrieved (41 vs. 43). But they had a lower estimated blood loss (119 vs. 194 mL) and shorter hospital stay (7.2 vs. 8.0 days).

The rate of surgical mortality was less than 1% and the rate of reoperation was about 1%, with no significant differences between groups.

Patients in the laparoscopic group had lower 30-day rates of postoperative morbidity (13.7% vs. 18.9%, P = .009), and the benefit of the less invasive approach remained significant after multivariate adjustment (odds ratio, 0.59; P = .001). Wound complications were half as common with laparoscopy (3.6% vs. 7.0%, P = .005).

Data on 5-year overall survival, the primary endpoint of the KLASS-01 trial, are expected later this year.

Dr. Kent asked, “In your country, for those patients with clinical T1a disease, how is a decision made regarding therapy?”

“I think if we can accurately diagnose the T stage as well as the N stage, we can surely adapt the endoscopic treatment for all the T1a cancer patients,” Dr. Lee replied. Such diagnosis has proved challenging, he added. Endoscopic resection is usually reserved for patients with tumors less than 2 cm in diameter showing differentiated histology and not invading the mucosa. “We have to move to the more accurate diagnosis of the TNM stage,” he concluded.

SAN FRANCISCO – Giving preoperative chemotherapy directly into the tumor-feeding artery and prophylactically into the common hepatic artery to target any liver micrometastases improves outcomes in patients with early colorectal cancer undergoing curative resection. But benefit is seen mainly in patients with stage III disease.

These were among the key findings of the randomized multicenter phase III PHRAC trial (Preoperative Hepatic and Regional Arterial Chemotherapy) conducted among 688 patients in China with stage II or III colorectal cancer.

Compared with curative resection alone, followed by adjuvant systemic chemotherapy with the modified FOLFOX6 regimen, the addition of preoperative arterial chemotherapy reduced the 5-year estimated risks of disease-free survival events by 40%, of liver metastases by 61%, and of death by 41% in the trial population overall, according to data reported at the annual Gastrointestinal Cancers Symposium cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology. But stratified analyses showed that these benefits were significant only among the patients with stage III disease.

“Preoperative hepatic and regional arterial chemotherapy had no effect on colorectal cancer surgery or postoperative morbidity,” commented lead investigator Jianmin Xu, an oncologist at the Zhongshan Hospital, Fudan University, in Shanghai. This therapy “is safe and feasible and can reduce liver metastasis and improve disease-free survival and overall survival, especially for the stage III patients.”

“Dr. Xu’s study was a positive study, but we have no description of the catheter problems or the number of patients who could be treated,” commented invited discussant Dr. Nancy E. Kemeny of Memorial Sloan-Kettering Cancer Center, New York. Additionally, outcomes in the control group fell short of those seen in patients treated with FOLFOX historically.

Despite accumulating evidence of benefit, the procedure is not yet ready for incorporation into routine care, according to Dr. Kemeny. “Since we don’t have a lot of information about the problems with the catheters or other problems like that, we need a larger, international study. I think one should be done because if you can prevent recurrences right away, which is what this study is suggesting, then that’s very good for these patients. We have ways of dealing with this afterwards, but it would be nice to prevent it right way. So given the fact that we already have five studies suggesting some benefit with this type of treatment, we should move into a large randomized study,” she recommended.

A session attendee noted that although colon cancer most commonly recurs in the liver, rectal cancer most commonly recurs in the pelvis. “Therefore, chemoradiotherapy is the standard of care now [for rectal cancer]. So infusional arterial chemotherapy should be used in patients with colon cancer, I think,” he said.

The patients with rectal cancer received radiation therapy after surgery if needed, Dr. Xu replied. “In the future, we will do subgroup analyses for colon cancer and for rectal cancer,” he added.

In the trial, patients from five hospitals in China were randomized to immediate curative primary surgery or to hepatic and regional arterial chemotherapy – floxuridine (FUDR), mitomycin C, and oxaliplatin delivered to both the main tumor-supplying artery and to the common hepatic artery – followed by curative primary surgery a week later. All patients received the same adjuvant therapy.

In the intention-to-treat population, estimated 5-year disease-free survival, the trial’s primary endpoint, was 75% with preoperative arterial chemotherapy versus 61% without it (hazard ratio, 0.60; P less than .001), reported Dr. Xu, who disclosed no relevant conflicts of interest. Subgroup analyses indicated that the benefit was significant in patients with stage III disease (68% vs. 51%; HR, 0.62; P = .017) but showed only a trend in patients with stage II disease (84% vs. 74%; HR, 0.64; P = .068).

Patients in the arterial chemotherapy group also were less likely to develop liver metastases (8% vs. 18%; HR, 0.39; P less than .001) and had better overall survival (81% vs. 72%, HR, 0.59; P = .003). But subgroup analyses again showed that benefit was significant only in the stage III patients.

Efficacy findings were similar in the trial’s eligible population, which excluded patients who were found to have pathologic stage I or IV disease at surgery and patients who developed metastases within 6 months of surgery.A total of 25% of patients in the arterial chemotherapy group experienced grade 3 toxicity from the procedure. However, the rate of postoperative complications did not differ significantly between the arterial chemotherapy and control groups.

SAN FRANCISCO – Giving preoperative chemotherapy directly into the tumor-feeding artery and prophylactically into the common hepatic artery to target any liver micrometastases improves outcomes in patients with early colorectal cancer undergoing curative resection. But benefit is seen mainly in patients with stage III disease.

These were among the key findings of the randomized multicenter phase III PHRAC trial (Preoperative Hepatic and Regional Arterial Chemotherapy) conducted among 688 patients in China with stage II or III colorectal cancer.

Compared with curative resection alone, followed by adjuvant systemic chemotherapy with the modified FOLFOX6 regimen, the addition of preoperative arterial chemotherapy reduced the 5-year estimated risks of disease-free survival events by 40%, of liver metastases by 61%, and of death by 41% in the trial population overall, according to data reported at the annual Gastrointestinal Cancers Symposium cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology. But stratified analyses showed that these benefits were significant only among the patients with stage III disease.

“Preoperative hepatic and regional arterial chemotherapy had no effect on colorectal cancer surgery or postoperative morbidity,” commented lead investigator Jianmin Xu, an oncologist at the Zhongshan Hospital, Fudan University, in Shanghai. This therapy “is safe and feasible and can reduce liver metastasis and improve disease-free survival and overall survival, especially for the stage III patients.”

“Dr. Xu’s study was a positive study, but we have no description of the catheter problems or the number of patients who could be treated,” commented invited discussant Dr. Nancy E. Kemeny of Memorial Sloan-Kettering Cancer Center, New York. Additionally, outcomes in the control group fell short of those seen in patients treated with FOLFOX historically.

Despite accumulating evidence of benefit, the procedure is not yet ready for incorporation into routine care, according to Dr. Kemeny. “Since we don’t have a lot of information about the problems with the catheters or other problems like that, we need a larger, international study. I think one should be done because if you can prevent recurrences right away, which is what this study is suggesting, then that’s very good for these patients. We have ways of dealing with this afterwards, but it would be nice to prevent it right way. So given the fact that we already have five studies suggesting some benefit with this type of treatment, we should move into a large randomized study,” she recommended.

A session attendee noted that although colon cancer most commonly recurs in the liver, rectal cancer most commonly recurs in the pelvis. “Therefore, chemoradiotherapy is the standard of care now [for rectal cancer]. So infusional arterial chemotherapy should be used in patients with colon cancer, I think,” he said.

The patients with rectal cancer received radiation therapy after surgery if needed, Dr. Xu replied. “In the future, we will do subgroup analyses for colon cancer and for rectal cancer,” he added.

In the trial, patients from five hospitals in China were randomized to immediate curative primary surgery or to hepatic and regional arterial chemotherapy – floxuridine (FUDR), mitomycin C, and oxaliplatin delivered to both the main tumor-supplying artery and to the common hepatic artery – followed by curative primary surgery a week later. All patients received the same adjuvant therapy.

In the intention-to-treat population, estimated 5-year disease-free survival, the trial’s primary endpoint, was 75% with preoperative arterial chemotherapy versus 61% without it (hazard ratio, 0.60; P less than .001), reported Dr. Xu, who disclosed no relevant conflicts of interest. Subgroup analyses indicated that the benefit was significant in patients with stage III disease (68% vs. 51%; HR, 0.62; P = .017) but showed only a trend in patients with stage II disease (84% vs. 74%; HR, 0.64; P = .068).

Patients in the arterial chemotherapy group also were less likely to develop liver metastases (8% vs. 18%; HR, 0.39; P less than .001) and had better overall survival (81% vs. 72%, HR, 0.59; P = .003). But subgroup analyses again showed that benefit was significant only in the stage III patients.

Efficacy findings were similar in the trial’s eligible population, which excluded patients who were found to have pathologic stage I or IV disease at surgery and patients who developed metastases within 6 months of surgery.A total of 25% of patients in the arterial chemotherapy group experienced grade 3 toxicity from the procedure. However, the rate of postoperative complications did not differ significantly between the arterial chemotherapy and control groups.

SAN FRANCISCO – Giving preoperative chemotherapy directly into the tumor-feeding artery and prophylactically into the common hepatic artery to target any liver micrometastases improves outcomes in patients with early colorectal cancer undergoing curative resection. But benefit is seen mainly in patients with stage III disease.

These were among the key findings of the randomized multicenter phase III PHRAC trial (Preoperative Hepatic and Regional Arterial Chemotherapy) conducted among 688 patients in China with stage II or III colorectal cancer.

Compared with curative resection alone, followed by adjuvant systemic chemotherapy with the modified FOLFOX6 regimen, the addition of preoperative arterial chemotherapy reduced the 5-year estimated risks of disease-free survival events by 40%, of liver metastases by 61%, and of death by 41% in the trial population overall, according to data reported at the annual Gastrointestinal Cancers Symposium cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology. But stratified analyses showed that these benefits were significant only among the patients with stage III disease.

“Preoperative hepatic and regional arterial chemotherapy had no effect on colorectal cancer surgery or postoperative morbidity,” commented lead investigator Jianmin Xu, an oncologist at the Zhongshan Hospital, Fudan University, in Shanghai. This therapy “is safe and feasible and can reduce liver metastasis and improve disease-free survival and overall survival, especially for the stage III patients.”

“Dr. Xu’s study was a positive study, but we have no description of the catheter problems or the number of patients who could be treated,” commented invited discussant Dr. Nancy E. Kemeny of Memorial Sloan-Kettering Cancer Center, New York. Additionally, outcomes in the control group fell short of those seen in patients treated with FOLFOX historically.

Despite accumulating evidence of benefit, the procedure is not yet ready for incorporation into routine care, according to Dr. Kemeny. “Since we don’t have a lot of information about the problems with the catheters or other problems like that, we need a larger, international study. I think one should be done because if you can prevent recurrences right away, which is what this study is suggesting, then that’s very good for these patients. We have ways of dealing with this afterwards, but it would be nice to prevent it right way. So given the fact that we already have five studies suggesting some benefit with this type of treatment, we should move into a large randomized study,” she recommended.

A session attendee noted that although colon cancer most commonly recurs in the liver, rectal cancer most commonly recurs in the pelvis. “Therefore, chemoradiotherapy is the standard of care now [for rectal cancer]. So infusional arterial chemotherapy should be used in patients with colon cancer, I think,” he said.

The patients with rectal cancer received radiation therapy after surgery if needed, Dr. Xu replied. “In the future, we will do subgroup analyses for colon cancer and for rectal cancer,” he added.

In the trial, patients from five hospitals in China were randomized to immediate curative primary surgery or to hepatic and regional arterial chemotherapy – floxuridine (FUDR), mitomycin C, and oxaliplatin delivered to both the main tumor-supplying artery and to the common hepatic artery – followed by curative primary surgery a week later. All patients received the same adjuvant therapy.

In the intention-to-treat population, estimated 5-year disease-free survival, the trial’s primary endpoint, was 75% with preoperative arterial chemotherapy versus 61% without it (hazard ratio, 0.60; P less than .001), reported Dr. Xu, who disclosed no relevant conflicts of interest. Subgroup analyses indicated that the benefit was significant in patients with stage III disease (68% vs. 51%; HR, 0.62; P = .017) but showed only a trend in patients with stage II disease (84% vs. 74%; HR, 0.64; P = .068).

Patients in the arterial chemotherapy group also were less likely to develop liver metastases (8% vs. 18%; HR, 0.39; P less than .001) and had better overall survival (81% vs. 72%, HR, 0.59; P = .003). But subgroup analyses again showed that benefit was significant only in the stage III patients.

Efficacy findings were similar in the trial’s eligible population, which excluded patients who were found to have pathologic stage I or IV disease at surgery and patients who developed metastases within 6 months of surgery.A total of 25% of patients in the arterial chemotherapy group experienced grade 3 toxicity from the procedure. However, the rate of postoperative complications did not differ significantly between the arterial chemotherapy and control groups.

The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.

Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.

Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).

Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.

The women were followed for a median of 7.2 years.

Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.

Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.

“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.

The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.

These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.

However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.

This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.

The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.

Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.

Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).

Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.

The women were followed for a median of 7.2 years.

Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.

Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.

“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.

The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.

These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.

However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.

This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.

The ipsilateral local failure rate in women with good-risk ductal carcinoma in situ was low with observation after breast-conserving surgery, but was significantly lower with the addition of radiotherapy, according to findings from a prospective, randomized, Radiation Therapy Oncology Group trial.

Failure occurred in 19 of 298 patients in the observation group, compared with 2 of 287 patients in the radiotherapy group; the cumulative rates of ipsilateral local failure at 7 years were 6.7% and 0.9% in the groups, respectively (hazard ratio, 0.11), Dr. Beryl McCormick of Memorial Sloan Kettering Cancer Center, New York, and her colleagues reported online Jan. 19 in the Journal of Clinical Oncology.

Local failures were invasive in 42% of cases in the observation arm and in one of the two patients in the radiotherapy arm. The 7-year cumulative mastectomy incidence was 2.8% in the observation arm and 1.5% in the radiotherapy arm. Survival was excellent and did not differ between the arms, the investigators said (J. Clin. Oncol. 2015 Jan. 19 [doi:10.1200/JCO.2014.57.9029]).

Study subjects were women with a mean age of 58 years and mammographically detected low- or intermediate-grade ductal carcinoma in situ (DCIS) that measured less than 2.5 cm with margins of at least 3 mm. Those assigned to the radiotherapy group underwent whole-breast radiotherapy at a dose of 50 Gy in 25 fractions, 50.4 Gy in 28 fractions, or 42.5 Gy in 16 fractions, and most received tamoxifen, which was required in both arms when the study opened before being made optional in 2001.

The women were followed for a median of 7.2 years.

Grade 1 and 2 toxicities occurred more often in the radiotherapy group (30% vs. 76%), but grade 3 and 4 toxicities occurred in 4% of women in both groups. Late toxicity in the radiotherapy patients was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of subjects, the investigators said.

Breast-conserving surgery and radiation have been shown to produce results that are equivalent to mastectomy in patients with DCIS, and in four large prospective trials, radiation therapy reduced the risk of local failure by at least 50%. About half of the recurrences in those trials were DCIS and half were invasive breast cancer, but survival was excellent regardless of local treatment, the investigators explained.

“More recently, an understanding of DCIS as not just one disease but a group of related subtypes of cancers has emerged, with a spectrum of local failure risk. Is there a low-risk DCIS for which the benefit of radiotherapy would not be seen?” they wrote.

The current study was designed to address the question of radiotherapy benefit in a good-risk DCIS subset. Although it didn’t meet the targeted accrual of 1,790 patients and was thus closed early, the findings – along with those from an Eastern Cooperative Oncology Group trial, “imply that clinical pathologic criteria can be used to define a cohort of patients with DCIS who can be expected to have a much lower rate of in-breast recurrence without radiotherapy in the first 7 years after lumpectomy than previously reported in past randomized trials,” they said.

These data may support decisions to forego adjuvant radiotherapy after breast-conserving surgery, particularly given the low mastectomy rate, but they also confirm that radiotherapy provides significant benefit with respect to further reducing local failure risk, they added.

However, given historic patterns of increasing local failure rates over 10 to 15 years, longer follow-up of these patients is needed to fully realize the rates of local failure, they said.

This study was supported by grants from the National Institutes of Health. Dr. McCormick reported having no disclosures.

Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.

“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).

Courtesy Wikimedia Commons/Nephron /Creative Commons License

In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.

Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).

“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”

This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.

[email protected]

Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.

“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).

Courtesy Wikimedia Commons/Nephron /Creative Commons License

In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.

Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).

“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”

This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.

[email protected]

Although significantly fewer patients with stage IV colorectal cancer have undergone primary tumor resection (PTR) since 1988, overall rates of patient survival have improved over that period, according to the results of a study published in JAMA.

“The role of PTR for asymptomatic patients remains controversial. Some physicians advocate PTR to prevent the development of symptoms associated with an intact primary tumor,” wrote lead author Chung-Yuan Hu, Ph.D., of the University of Texas M.D. Anderson Cancer Center in Houston, and his associates. “Approximately 10%-25% of patients with intact primary tumors will develop symptoms, but there is considerable morbidity (4%-30%) and mortality (2%-10%) associated with noncurative PTR” (JAMA Surg. [doi:10.1001/jamasurg.2014.2253]).

Courtesy Wikimedia Commons/Nephron /Creative Commons License

In a retrospective cohort study, Dr. Hu and his colleagues used data on 64,157 patients diagnosed with stage IV colon or rectal cancer between Jan. 1, 1988, and Dec. 31, 2010, from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) CRC registry. The primary outcome measured was difference in PTR rates over the study period. Included subjects had either undergone PTR or not, and investigators calculated rates of PTR and median relative survival for each year. Joinpoint regression analyses were used to determine when a “significant change” in PTR rate had occurred, while logistic regression analyses were used to assess factors associated with PTR.

Findings indicated that 43,273 (67.4%) of the patients analyzed for the study had undergone PTR; overall, between 1988 and 2010, annual PTR rates declined from 74.5% to 57.4%, respectively (P < .001). “Significant change” was noted between 1998 and 2001 and from 2001 to 2010: –0.41% and –2.39%, respectively (P < .001 in both cases). However, median annual survival rates improved substantially from 1988 to 2009, changing from 8.6% to 17.8%, respectively (P < .001).

“Despite the availability of more effective chemotherapeutic options, a considerable number of patients with stage IV CRC continue to undergo PTR,” wrote the authors. “Our findings indicate potential overuse of PTR among these patients and highlight a need to better understand the clinical decisions and outcomes associated with that treatment.”

This study was supported in part by grants from the National Institute of Health’s National Cancer Institute, and the American Society of Clinical Oncology Foundation Career Development Award. Authors reported no financial conflicts of interest.

[email protected]

Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.

Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology

After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.

“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.

Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.

Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”

“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”

In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).

Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.

The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).

The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”

Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”

In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.

Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”

But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”

Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.

Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology

After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.

“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.

Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.

Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”

“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”

In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).

Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.

The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).

The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”

Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”

In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.

Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”

But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”

Patients with locally advanced rectal cancer who have a complete response to neoadjuvant therapy can skip surgery with little compromise in outcomes, according to a retrospective review that will be reported this week at the annual Gastrointestinal Cancers Symposium.

Investigators at the Memorial Sloan-Kettering Cancer Center in New York studied 145 patients with stage I to III rectal cancer who received neoadjuvant therapy there between 2006 and 2013. The meeting was cosponsored by the AGA Institute, the American Society of Clinical Oncology, ASTRO, and the Society of Surgical Oncology

After a median follow-up of 3.5 years, there were no significant differences in disease-specific or overall survival between patients who had a clinical complete response to neoadjuvant therapy of radiation and chemotherapy and skipped surgery, and patients who underwent rectal resection (the current standard strategy in the United States) with a pathologic complete response. Additionally, more than three-fourths of the group skipping surgery had preservation of rectal function.

“Nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” senior investigator Dr. Philip B. Paty, a surgical oncologist at Memorial Sloan-Kettering Cancer Center, New York, commented in a press briefing held before the symposium.

Ideally, the findings would be tested in a randomized trial, he said; however, “there’s too many factors and too much patient autonomy involved here, so that no one really believes asking people to sign up for a randomized trial where rectal resection is decided by a flip of the coin would ever accrue patients.” Short of that, rigorous prospective studies, such as a phase II trial now open at the center, will provide critical information.

Press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland, commented, “These are important findings for patients with rectal cancer because removal of the rectum can result in altered bowel habits or the need for permanent colostomy. This study set the bar very high, comparing the results of nonoperative management to the results seen in patients who had no cancer left under the microscope at the time of surgery, and in this study, the nonoperative management appears to compare favorably.”

“We do need longer follow-up though, to be sure that these patients will have disease-specific survival that equals what is achieved with surgery in the long term,” she cautioned, such as the conventional 5 years of observation patients typically receive. “And then of course a prospective study also would be helpful to see the effects of this approach.”

In the study, Dr. Paty and colleagues identified 73 patients who had a clinical complete response (no cancer detected on physical exam, endoscopy, or imaging) to neoadjuvant therapy of radiation and chemotherapy and—by mutual agreement of physician and patient—had nonoperative management (watchful waiting), consisting initially of follow-up at 3- to 4-month intervals by digital rectal and endoscopic exams and at 6-month intervals by imaging. They used as a comparison group 72 patients who underwent standard total mesorectal excision and had a pathologic complete response (no viable cancer cells found microscopically in the resected tissue).

Results showed that 74% of the patients who did not have surgery had a sustained clinical complete response, with no regrowth of tumor during follow-up, reported Dr. Paty. Among the other 26% whose tumors regrew, most of the recurrences were clinically detectable and all patients had successful resections with clean margins. Overall, 77% of the nonsurgical patients had rectal preservation and 98% had local control.

The nonsurgical group did not differ significantly from the surgical group with respect to 4-year rates of disease-specific survival (91% vs. 96%) and overall survival (91% vs. 95%).

The investigators plan to report quality of life data in the future, Dr. Paty said. “But I think it’s pretty obvious to everyone who’s managed these patients that if you can avoid rectal surgery, the quality of life and particularly bowel function is far superior to those who have had rectal resection.”

Successful nonoperative management hinges critically on careful patient selection, close follow-up, and use of salvage surgery, he stressed. Additionally, “the informed consent process in nonoperative management is extremely important, and I always tell patients that they are taking a slight risk. It’s hard to imagine that not operating is going to have 100% equivalent cancer outcomes as operating. That is hard to believe. So we never sell it as being absolutely as good, but …with good follow-up, the results seem to be very close if not equivalent.”

In his experience, most patients are willing to accept this option. “In fact, I have only had two patients [out of more than 100] decline nonoperative management when I thought they were candidates—both young, both with young children, both not wanting to take even the slightest risk of leaving cancer in the rectal wall or their body,” he commented.

Adoption of nonoperative management has been slow in the United States for a variety of reasons, according to Dr. Paty. “I think the bottom line is that practicing watch and wait, nonoperative management is more difficult for the surgeon. It requires first the judgment that the cancer’s gone. You have to follow the patient longer after radiation; sometimes the complete response will take up to 3 months. And there is also the medical-legal issue of deviating from the standard of care. … So I think it was operationally a difficult thing to do, it didn’t fit with the existing paradigm very well.”

But that is changing as more data roll in. “What’s happened in the last I will say 2-3 years is that there are centers publishing their experience, ours being the largest outside Brazil and the first in North America. Another group in the Netherlands has published a group of about 25 patients,” he explained. “Talking with people at meetings around the world, centers are adopting it, and I think that many leaders in clinical trials in rectal cancer recognize that this option is not only reasonable, but perhaps it’s necessary to inform patients that it is an option.”