Dr. Allen S. Lichter:Tech solutions push drive to quality cancer care

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Dr. Allen S. Lichter:Tech solutions push drive to quality cancer care

SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Allen S. Lichter

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

Dr. Yu-Ning Wong

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

 

 

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

s.boschert@elsevier.com

On Twitter @sherryboschert

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SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Allen S. Lichter

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

Dr. Yu-Ning Wong

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

 

 

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

s.boschert@elsevier.com

On Twitter @sherryboschert

SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Allen S. Lichter

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

Dr. Yu-Ning Wong

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

 

 

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

s.boschert@elsevier.com

On Twitter @sherryboschert

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FROM A SYMPOSIUM ON QUALITY CARE SPONSORED BY THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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End-of-life care gains increasing prominence

Palliative care team approach looks promising
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End-of-life care gains increasing prominence

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Dr. Allen R. Chen

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

John Pesavento

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

 

 

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

 

 

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

Body

Regarding Dr. Chen’s study, this study does find that we can provide support to patients and their families with appropriately staffed and trained medical teams that specialize in palliative care to really decrease futile, invasive, and expensive care at the end of life. This is broad implications to our patients and their families as they talk about prognosis with their physicians, and also to the physicians taking care of these patients, who may have not had a longitudinal relationship with these patients. Immediate feedback to the caring physicians can decrease some of these high resource utilization maneuvers that don’t provide improvement in quality of life.

Dr. Jyoti D. Patel is a member of ASCO’s Cancer Communications Committee and a thoracic oncologist at Northwestern University, Chicago. She gave these remarks in an online press conference organized by ASCO.

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Body

Regarding Dr. Chen’s study, this study does find that we can provide support to patients and their families with appropriately staffed and trained medical teams that specialize in palliative care to really decrease futile, invasive, and expensive care at the end of life. This is broad implications to our patients and their families as they talk about prognosis with their physicians, and also to the physicians taking care of these patients, who may have not had a longitudinal relationship with these patients. Immediate feedback to the caring physicians can decrease some of these high resource utilization maneuvers that don’t provide improvement in quality of life.

Dr. Jyoti D. Patel is a member of ASCO’s Cancer Communications Committee and a thoracic oncologist at Northwestern University, Chicago. She gave these remarks in an online press conference organized by ASCO.

Body

Regarding Dr. Chen’s study, this study does find that we can provide support to patients and their families with appropriately staffed and trained medical teams that specialize in palliative care to really decrease futile, invasive, and expensive care at the end of life. This is broad implications to our patients and their families as they talk about prognosis with their physicians, and also to the physicians taking care of these patients, who may have not had a longitudinal relationship with these patients. Immediate feedback to the caring physicians can decrease some of these high resource utilization maneuvers that don’t provide improvement in quality of life.

Dr. Jyoti D. Patel is a member of ASCO’s Cancer Communications Committee and a thoracic oncologist at Northwestern University, Chicago. She gave these remarks in an online press conference organized by ASCO.

Title
Palliative care team approach looks promising
Palliative care team approach looks promising

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Dr. Allen R. Chen

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

John Pesavento

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

 

 

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

 

 

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Dr. Allen R. Chen

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

John Pesavento

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

 

 

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

 

 

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

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Evidence-based medicine depends on quality evidence

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Efforts to improve the quality of health care often emphasize evidence-based medicine, but flaws in how research is designed, conducted, and reported make this "a great time for skeptics, in looking at clinical trials," according to Dr. J. Russell Hoverman.

Multiple studies in recent years suggest that increasing influence from industry and researchers’ desire to emphasize positive results, as well as other factors, may be distorting choices about which studies get done and how they get reported, said Dr. Hoverman, a medical oncologist and hematologist at Texas Oncology in Austin, Tex.

Dr. J. Russell Hoverman

If researchers don’t improve the way they conduct and assess clinical trials, a lot of money could be wasted on misguided research, he said at a quality care symposium sponsored by the American Society of Clinical Oncology.

He’s not the only one making the case. Physicians at Yale recently argued for greater transparency in pharmaceutical industry–sponsored research to improve the integrity of medical research (Am. J. Public Health 2012;102:72-80).

Over the last three decades, sponsorship of breast, colon, and lung cancer studies by for-profit companies increased from 4% to 57%, Dr. Hoverman noted. Industry sponsorship was associated with trial results that endorsed the experimental agent, according to one study (J. Clin. Oncol. 2008;26:5458-64).

A separate study showed that abstracts of study results presented at major oncology meetings before final publication were discordant from the published article 63% of the time. In 10% of cases, the abstract and article presented substantially different conclusions (J. Clin. Oncol. 2009;3938-44).

One example of this was a trial of a cancer treatment regimen using gemcitabine, cisplatin, and bevacizumab. The investigators initially released an early abstract reporting an improvement in progression-free survival using the regimen. "That actually changed some [oncologists’] practices," he noted. But that was before the study reached its main outcome measure – overall survival – which, in the end, did not improve significantly with the new regimen.

Only half of phase II clinical trials with positive findings lead to positive phase III trials, another study found. For some reason, industry-sponsored trials are much more likely to report positive findings, compared with all other trials – 90% and 45%, respectively (J. Clin. Oncol. 2008;26:1511-8).

When reading or interpreting abstract summaries from a medical conference, "one needs to be a little careful," Dr. Hoverman advised.

Yet another study found that only 45% of randomized clinical trials were registered, even though trial registration has been required since 2005 by the International Committee of Medical Journal Editors in order for the results to be published in participating journals.

Among the registered studies, 31% showed discrepancies between what the investigators said they would be studying and the published outcomes. Half of the studies with discrepancies could be assessed to try to figure out why this was so; of those, 83% of the time it appeared that the investigators decided to favor statistically significant findings in the published article (JAMA 2009;302:977-84).

One set of experts from within industry and from Johns Hopkins University called for "transformational change" in how randomized clinical trials are conducted (Ann. Intern. Med. 2009;151:206-209).

"Without major changes in how we conceive, design, conduct, and analyze randomized controlled trials, the nation risks spending large sums of money inefficiently to answer the wrong questions, or the right questions too late," Dr. Hoverman said.

"In fact, we probably can’t do randomized clinical trials on everything we want to know about. It’s simply impossible. There’s not enough money, and many things involve competing industries or competing members within an industry," making it unlikely that some head-to-head comparisons will ever be done, he added. "So, we are challenged to make decisions based on evidence."

The broader challenge for clinicians and researchers will be to improve the quality and integrity of medical studies while maintaining a healthy skepticism about the available evidence. Medicine has always been an art and a science. Where the science behind medicine is lacking, the art takes over.

Dr. Hoverman reported having no financial disclosures.

-- Sherry Boschert

s.boschert@elsevier.com

On Twitter @sherryboschert

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Efforts to improve the quality of health care often emphasize evidence-based medicine, but flaws in how research is designed, conducted, and reported make this "a great time for skeptics, in looking at clinical trials," according to Dr. J. Russell Hoverman.

Multiple studies in recent years suggest that increasing influence from industry and researchers’ desire to emphasize positive results, as well as other factors, may be distorting choices about which studies get done and how they get reported, said Dr. Hoverman, a medical oncologist and hematologist at Texas Oncology in Austin, Tex.

Dr. J. Russell Hoverman

If researchers don’t improve the way they conduct and assess clinical trials, a lot of money could be wasted on misguided research, he said at a quality care symposium sponsored by the American Society of Clinical Oncology.

He’s not the only one making the case. Physicians at Yale recently argued for greater transparency in pharmaceutical industry–sponsored research to improve the integrity of medical research (Am. J. Public Health 2012;102:72-80).

Over the last three decades, sponsorship of breast, colon, and lung cancer studies by for-profit companies increased from 4% to 57%, Dr. Hoverman noted. Industry sponsorship was associated with trial results that endorsed the experimental agent, according to one study (J. Clin. Oncol. 2008;26:5458-64).

A separate study showed that abstracts of study results presented at major oncology meetings before final publication were discordant from the published article 63% of the time. In 10% of cases, the abstract and article presented substantially different conclusions (J. Clin. Oncol. 2009;3938-44).

One example of this was a trial of a cancer treatment regimen using gemcitabine, cisplatin, and bevacizumab. The investigators initially released an early abstract reporting an improvement in progression-free survival using the regimen. "That actually changed some [oncologists’] practices," he noted. But that was before the study reached its main outcome measure – overall survival – which, in the end, did not improve significantly with the new regimen.

Only half of phase II clinical trials with positive findings lead to positive phase III trials, another study found. For some reason, industry-sponsored trials are much more likely to report positive findings, compared with all other trials – 90% and 45%, respectively (J. Clin. Oncol. 2008;26:1511-8).

When reading or interpreting abstract summaries from a medical conference, "one needs to be a little careful," Dr. Hoverman advised.

Yet another study found that only 45% of randomized clinical trials were registered, even though trial registration has been required since 2005 by the International Committee of Medical Journal Editors in order for the results to be published in participating journals.

Among the registered studies, 31% showed discrepancies between what the investigators said they would be studying and the published outcomes. Half of the studies with discrepancies could be assessed to try to figure out why this was so; of those, 83% of the time it appeared that the investigators decided to favor statistically significant findings in the published article (JAMA 2009;302:977-84).

One set of experts from within industry and from Johns Hopkins University called for "transformational change" in how randomized clinical trials are conducted (Ann. Intern. Med. 2009;151:206-209).

"Without major changes in how we conceive, design, conduct, and analyze randomized controlled trials, the nation risks spending large sums of money inefficiently to answer the wrong questions, or the right questions too late," Dr. Hoverman said.

"In fact, we probably can’t do randomized clinical trials on everything we want to know about. It’s simply impossible. There’s not enough money, and many things involve competing industries or competing members within an industry," making it unlikely that some head-to-head comparisons will ever be done, he added. "So, we are challenged to make decisions based on evidence."

The broader challenge for clinicians and researchers will be to improve the quality and integrity of medical studies while maintaining a healthy skepticism about the available evidence. Medicine has always been an art and a science. Where the science behind medicine is lacking, the art takes over.

Dr. Hoverman reported having no financial disclosures.

-- Sherry Boschert

s.boschert@elsevier.com

On Twitter @sherryboschert

Efforts to improve the quality of health care often emphasize evidence-based medicine, but flaws in how research is designed, conducted, and reported make this "a great time for skeptics, in looking at clinical trials," according to Dr. J. Russell Hoverman.

Multiple studies in recent years suggest that increasing influence from industry and researchers’ desire to emphasize positive results, as well as other factors, may be distorting choices about which studies get done and how they get reported, said Dr. Hoverman, a medical oncologist and hematologist at Texas Oncology in Austin, Tex.

Dr. J. Russell Hoverman

If researchers don’t improve the way they conduct and assess clinical trials, a lot of money could be wasted on misguided research, he said at a quality care symposium sponsored by the American Society of Clinical Oncology.

He’s not the only one making the case. Physicians at Yale recently argued for greater transparency in pharmaceutical industry–sponsored research to improve the integrity of medical research (Am. J. Public Health 2012;102:72-80).

Over the last three decades, sponsorship of breast, colon, and lung cancer studies by for-profit companies increased from 4% to 57%, Dr. Hoverman noted. Industry sponsorship was associated with trial results that endorsed the experimental agent, according to one study (J. Clin. Oncol. 2008;26:5458-64).

A separate study showed that abstracts of study results presented at major oncology meetings before final publication were discordant from the published article 63% of the time. In 10% of cases, the abstract and article presented substantially different conclusions (J. Clin. Oncol. 2009;3938-44).

One example of this was a trial of a cancer treatment regimen using gemcitabine, cisplatin, and bevacizumab. The investigators initially released an early abstract reporting an improvement in progression-free survival using the regimen. "That actually changed some [oncologists’] practices," he noted. But that was before the study reached its main outcome measure – overall survival – which, in the end, did not improve significantly with the new regimen.

Only half of phase II clinical trials with positive findings lead to positive phase III trials, another study found. For some reason, industry-sponsored trials are much more likely to report positive findings, compared with all other trials – 90% and 45%, respectively (J. Clin. Oncol. 2008;26:1511-8).

When reading or interpreting abstract summaries from a medical conference, "one needs to be a little careful," Dr. Hoverman advised.

Yet another study found that only 45% of randomized clinical trials were registered, even though trial registration has been required since 2005 by the International Committee of Medical Journal Editors in order for the results to be published in participating journals.

Among the registered studies, 31% showed discrepancies between what the investigators said they would be studying and the published outcomes. Half of the studies with discrepancies could be assessed to try to figure out why this was so; of those, 83% of the time it appeared that the investigators decided to favor statistically significant findings in the published article (JAMA 2009;302:977-84).

One set of experts from within industry and from Johns Hopkins University called for "transformational change" in how randomized clinical trials are conducted (Ann. Intern. Med. 2009;151:206-209).

"Without major changes in how we conceive, design, conduct, and analyze randomized controlled trials, the nation risks spending large sums of money inefficiently to answer the wrong questions, or the right questions too late," Dr. Hoverman said.

"In fact, we probably can’t do randomized clinical trials on everything we want to know about. It’s simply impossible. There’s not enough money, and many things involve competing industries or competing members within an industry," making it unlikely that some head-to-head comparisons will ever be done, he added. "So, we are challenged to make decisions based on evidence."

The broader challenge for clinicians and researchers will be to improve the quality and integrity of medical studies while maintaining a healthy skepticism about the available evidence. Medicine has always been an art and a science. Where the science behind medicine is lacking, the art takes over.

Dr. Hoverman reported having no financial disclosures.

-- Sherry Boschert

s.boschert@elsevier.com

On Twitter @sherryboschert

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QOPI Raises Adherence to Oncology Guidelines - but Some Efforts Lag

QOPI Implementation Improves Cancer Care
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Outpatient oncology practices that voluntarily participated in a quality-improvement program markedly increased their adoption of newly recommended treatments, but continued to do poorly in smoking cessation efforts and in discussing fertility preservation.

From the start and throughout the period studied, 156 oncology practices reported high rates of recommending adjuvant chemotherapy according to guidelines for breast, colorectal, or non–small cell lung cancer, Dr. Michael N. Neuss said in an online press conference sponsored by the American Society of Clinical Oncology (ASCO).

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Dr. Michael N. Neuss

These participants in ASCO’s Quality Oncology Practice Initiative (QOPI) improved their mean overall scores for adherence to recommended care from 71% to 85%, Dr. Neuss and his associates reported. The study was to be presented at ASCO’s Quality Care Symposium in San Diego on Nov. 30, 2012.

Use of new clinical practices based on new guidelines or clinical evidence improved from 5% to 69% between 2006 and 2010. That’s "quite a remarkable improvement," said Dr. Neuss, chief medical officer at the Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tenn.

These new practices included pathologic examination of at least 12 regional lymph nodes for surgically resected colon cancer, which zoomed from nonexistent at the start of the study to 60% compliance within 6 months and 100% of practices complying after 5 years. Use of the antinausea drug aprepitant (Emend) improved from 20% of practices to 60%.

Clinicians were quick to adopt two clinical practices that were introduced during the study period. Genetic testing to predict response to treatment in patients with metastatic colorectal cancer increased from just over 60% of practices to more than 80%. Testing for KRAS gene alterations when administering anti–epidermal growth factor receptor therapy increased from approximately 55% to approximately 85% of practices.

Throughout the study, close to 90% or more of physicians reported recommendations for adjuvant chemotherapy that concorded with guidelines. "On many adjuvant treatment measures, it appears that QOPI participants are already doing very well," Dr. Neuss said.

In the areas of smoking and fertility, however, practices were resistant to change despite strong evidence promoting specific care. Although physicians documented patients’ smoking status 90%-95% of the time, rates of smoking cessation counseling topped out at about 35%.

"Similarly, there’s a good reason to tell people who may be rendered infertile by chemotherapy of this problem and of potential solutions to it," but no more than 30% of patients got discussions of infertility risks and only approximately 15% heard about fertility preservation options, Dr. Neuss said.

Data came from a larger cohort of approximately 2,000 physicians in 308 practices (comprising 15%-20% of U.S. oncologists) who participated in QOPI beta testing from 2006-2010. Twice yearly, physicians reviewed patients’ charts and filed a structured online report on an average of 100 preidentified measures that the QOPI uses to assess quality of care. Within 2 weeks, the practice would receive a report from QOPI on how the practice’s rates of compliance with recommended care compared with the ideal, rates for all practices in QOPI, and rates for practices similar to their own.

"It’s entirely up to you how you act on that result or ignore it," he said.

Each practice provided at least two rounds of data (averaging six rounds) and reported on 30 or more patients per round. The analysis looked at 50 measures of quality that did not change during the study period in seven modules – core quality measures, symptom management, end-of-life care, non-Hodgkin’s lymphoma, breast cancer, colorectal cancer, and non–small cell lung cancer.

The study excluded practices that did not provide a full data set, were located outside the United States, or that presented trainee data. The investigators developed a logistic regression model to accommodate varied performance at the start of QOPI, which normalized performance among groups and allowed assessment of each practice’s improvement.

QOPI has moved beyond beta testing and now includes more than 800 registered oncology practices participating, he said.

Dr. Neuss reported having no financial disclosures.

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Dr. Jyoti D. Patel

This analysis of ASCO’s participation in QOPI really does show that implementation improves practice for patients. I think this is especially important as we adopt new standard practices such as genetic testing for tumor mutations, or use of new anti-nausea drugs, in which there are so many moving targets and so many people involved that we want to make sure we capture all parameters. One of the things that treatment at a QOPI center emphasizes is that patients get quality cancer care regardless of treatment center.

Dr. Jyoti D. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

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Dr. Jyoti D. Patel

This analysis of ASCO’s participation in QOPI really does show that implementation improves practice for patients. I think this is especially important as we adopt new standard practices such as genetic testing for tumor mutations, or use of new anti-nausea drugs, in which there are so many moving targets and so many people involved that we want to make sure we capture all parameters. One of the things that treatment at a QOPI center emphasizes is that patients get quality cancer care regardless of treatment center.

Dr. Jyoti D. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

Body

Courtesy ASTRO


Dr. Jyoti D. Patel

This analysis of ASCO’s participation in QOPI really does show that implementation improves practice for patients. I think this is especially important as we adopt new standard practices such as genetic testing for tumor mutations, or use of new anti-nausea drugs, in which there are so many moving targets and so many people involved that we want to make sure we capture all parameters. One of the things that treatment at a QOPI center emphasizes is that patients get quality cancer care regardless of treatment center.

Dr. Jyoti D. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

Title
QOPI Implementation Improves Cancer Care
QOPI Implementation Improves Cancer Care

Outpatient oncology practices that voluntarily participated in a quality-improvement program markedly increased their adoption of newly recommended treatments, but continued to do poorly in smoking cessation efforts and in discussing fertility preservation.

From the start and throughout the period studied, 156 oncology practices reported high rates of recommending adjuvant chemotherapy according to guidelines for breast, colorectal, or non–small cell lung cancer, Dr. Michael N. Neuss said in an online press conference sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy American Society of Clinical Oncology
Dr. Michael N. Neuss

These participants in ASCO’s Quality Oncology Practice Initiative (QOPI) improved their mean overall scores for adherence to recommended care from 71% to 85%, Dr. Neuss and his associates reported. The study was to be presented at ASCO’s Quality Care Symposium in San Diego on Nov. 30, 2012.

Use of new clinical practices based on new guidelines or clinical evidence improved from 5% to 69% between 2006 and 2010. That’s "quite a remarkable improvement," said Dr. Neuss, chief medical officer at the Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tenn.

These new practices included pathologic examination of at least 12 regional lymph nodes for surgically resected colon cancer, which zoomed from nonexistent at the start of the study to 60% compliance within 6 months and 100% of practices complying after 5 years. Use of the antinausea drug aprepitant (Emend) improved from 20% of practices to 60%.

Clinicians were quick to adopt two clinical practices that were introduced during the study period. Genetic testing to predict response to treatment in patients with metastatic colorectal cancer increased from just over 60% of practices to more than 80%. Testing for KRAS gene alterations when administering anti–epidermal growth factor receptor therapy increased from approximately 55% to approximately 85% of practices.

Throughout the study, close to 90% or more of physicians reported recommendations for adjuvant chemotherapy that concorded with guidelines. "On many adjuvant treatment measures, it appears that QOPI participants are already doing very well," Dr. Neuss said.

In the areas of smoking and fertility, however, practices were resistant to change despite strong evidence promoting specific care. Although physicians documented patients’ smoking status 90%-95% of the time, rates of smoking cessation counseling topped out at about 35%.

"Similarly, there’s a good reason to tell people who may be rendered infertile by chemotherapy of this problem and of potential solutions to it," but no more than 30% of patients got discussions of infertility risks and only approximately 15% heard about fertility preservation options, Dr. Neuss said.

Data came from a larger cohort of approximately 2,000 physicians in 308 practices (comprising 15%-20% of U.S. oncologists) who participated in QOPI beta testing from 2006-2010. Twice yearly, physicians reviewed patients’ charts and filed a structured online report on an average of 100 preidentified measures that the QOPI uses to assess quality of care. Within 2 weeks, the practice would receive a report from QOPI on how the practice’s rates of compliance with recommended care compared with the ideal, rates for all practices in QOPI, and rates for practices similar to their own.

"It’s entirely up to you how you act on that result or ignore it," he said.

Each practice provided at least two rounds of data (averaging six rounds) and reported on 30 or more patients per round. The analysis looked at 50 measures of quality that did not change during the study period in seven modules – core quality measures, symptom management, end-of-life care, non-Hodgkin’s lymphoma, breast cancer, colorectal cancer, and non–small cell lung cancer.

The study excluded practices that did not provide a full data set, were located outside the United States, or that presented trainee data. The investigators developed a logistic regression model to accommodate varied performance at the start of QOPI, which normalized performance among groups and allowed assessment of each practice’s improvement.

QOPI has moved beyond beta testing and now includes more than 800 registered oncology practices participating, he said.

Dr. Neuss reported having no financial disclosures.

Outpatient oncology practices that voluntarily participated in a quality-improvement program markedly increased their adoption of newly recommended treatments, but continued to do poorly in smoking cessation efforts and in discussing fertility preservation.

From the start and throughout the period studied, 156 oncology practices reported high rates of recommending adjuvant chemotherapy according to guidelines for breast, colorectal, or non–small cell lung cancer, Dr. Michael N. Neuss said in an online press conference sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy American Society of Clinical Oncology
Dr. Michael N. Neuss

These participants in ASCO’s Quality Oncology Practice Initiative (QOPI) improved their mean overall scores for adherence to recommended care from 71% to 85%, Dr. Neuss and his associates reported. The study was to be presented at ASCO’s Quality Care Symposium in San Diego on Nov. 30, 2012.

Use of new clinical practices based on new guidelines or clinical evidence improved from 5% to 69% between 2006 and 2010. That’s "quite a remarkable improvement," said Dr. Neuss, chief medical officer at the Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tenn.

These new practices included pathologic examination of at least 12 regional lymph nodes for surgically resected colon cancer, which zoomed from nonexistent at the start of the study to 60% compliance within 6 months and 100% of practices complying after 5 years. Use of the antinausea drug aprepitant (Emend) improved from 20% of practices to 60%.

Clinicians were quick to adopt two clinical practices that were introduced during the study period. Genetic testing to predict response to treatment in patients with metastatic colorectal cancer increased from just over 60% of practices to more than 80%. Testing for KRAS gene alterations when administering anti–epidermal growth factor receptor therapy increased from approximately 55% to approximately 85% of practices.

Throughout the study, close to 90% or more of physicians reported recommendations for adjuvant chemotherapy that concorded with guidelines. "On many adjuvant treatment measures, it appears that QOPI participants are already doing very well," Dr. Neuss said.

In the areas of smoking and fertility, however, practices were resistant to change despite strong evidence promoting specific care. Although physicians documented patients’ smoking status 90%-95% of the time, rates of smoking cessation counseling topped out at about 35%.

"Similarly, there’s a good reason to tell people who may be rendered infertile by chemotherapy of this problem and of potential solutions to it," but no more than 30% of patients got discussions of infertility risks and only approximately 15% heard about fertility preservation options, Dr. Neuss said.

Data came from a larger cohort of approximately 2,000 physicians in 308 practices (comprising 15%-20% of U.S. oncologists) who participated in QOPI beta testing from 2006-2010. Twice yearly, physicians reviewed patients’ charts and filed a structured online report on an average of 100 preidentified measures that the QOPI uses to assess quality of care. Within 2 weeks, the practice would receive a report from QOPI on how the practice’s rates of compliance with recommended care compared with the ideal, rates for all practices in QOPI, and rates for practices similar to their own.

"It’s entirely up to you how you act on that result or ignore it," he said.

Each practice provided at least two rounds of data (averaging six rounds) and reported on 30 or more patients per round. The analysis looked at 50 measures of quality that did not change during the study period in seven modules – core quality measures, symptom management, end-of-life care, non-Hodgkin’s lymphoma, breast cancer, colorectal cancer, and non–small cell lung cancer.

The study excluded practices that did not provide a full data set, were located outside the United States, or that presented trainee data. The investigators developed a logistic regression model to accommodate varied performance at the start of QOPI, which normalized performance among groups and allowed assessment of each practice’s improvement.

QOPI has moved beyond beta testing and now includes more than 800 registered oncology practices participating, he said.

Dr. Neuss reported having no financial disclosures.

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QOPI Raises Adherence to Oncology Guidelines - but Some Efforts Lag
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FROM THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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Inside the Article

Vitals

Major Finding: Adherence to recommended care increased from 71% to 85%, but rates of smoking cessation and infertility-risk counseling topped out at about 35% and 30%, respectively.

Data Source: This was a prospective analysis of 156 practices participating in ASCO’s Quality Oncology Practice Initiative (QOPI) in 2006-2010.

Disclosures: Dr. Neuss reported having no financial disclosures.

Patients' Worry, Not Risk, Drives Double Mastectomies

We Need to Educate Our Patients
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Patients' Worry, Not Risk, Drives Double Mastectomies

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Sarah T. Hawley

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

 

 

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.

Body

The findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease," said Dr. Jyoti D. Patel, who moderated the press conference.

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Dr. Jyoti Patel
Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," Dr. Patel said.

Dr. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

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breast cancer patients, women, worry, localized cancer, spread, prophylactic double mastectomy, contralateral disease, Sarah T. Hawley, Ph.D., American Society of Clinical Oncology, ASCO, unnecessary surgery, cancer spreading from one breast to the other, BRCA1, BRCA2 mutations, family history, ovarian cancer, Society of Surgical Oncology,
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The findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease," said Dr. Jyoti D. Patel, who moderated the press conference.

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Dr. Jyoti Patel
Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," Dr. Patel said.

Dr. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

Body

The findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease," said Dr. Jyoti D. Patel, who moderated the press conference.

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Dr. Jyoti Patel
Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," Dr. Patel said.

Dr. Patel, a thoracic oncologist at Northwestern University in Chicago, is a member of ASCO’s Cancer Communications Committee.

Title
We Need to Educate Our Patients
We Need to Educate Our Patients

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Sarah T. Hawley

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

 

 

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

Dr. Sarah T. Hawley

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

 

 

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.

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Patients' Worry, Not Risk, Drives Double Mastectomies
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breast cancer patients, women, worry, localized cancer, spread, prophylactic double mastectomy, contralateral disease, Sarah T. Hawley, Ph.D., American Society of Clinical Oncology, ASCO, unnecessary surgery, cancer spreading from one breast to the other, BRCA1, BRCA2 mutations, family history, ovarian cancer, Society of Surgical Oncology,
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breast cancer patients, women, worry, localized cancer, spread, prophylactic double mastectomy, contralateral disease, Sarah T. Hawley, Ph.D., American Society of Clinical Oncology, ASCO, unnecessary surgery, cancer spreading from one breast to the other, BRCA1, BRCA2 mutations, family history, ovarian cancer, Society of Surgical Oncology,
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FROM A PRESS CONFERENCE SPONSORED BY THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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Inside the Article

Vitals

Major Finding: Eighty percent of 107 women who underwent contralateral prophylactic mastectomy had no clinical indication for the procedure. A high level of worry doubled the odds of choosing the procedure.

Data Source: Investigators studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history.

Disclosures: Dr. Hawley reported having no financial disclosures.