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Tech-based cancer company raises access concerns
Oncologists are raising concerns about care access after the launch of a new company that links patients to cancer care options and clinical trials through mobile technology.
Driver, which began in September in the U.S. and China, is a global technology platform that allows patients to access treatment options across a broad network of cancer centers without leaving home. Cancer patients join the platform using a mobile app, through which Driver obtains the required consent to acquire medical records and tumor samples, and the company uses the information to recommend treatment options and clinical trials.
A separate app called Driver for Clinic enables oncologists who belong to Driver’s partner hospitals to manage their institution’s clinical trial information and quickly filter that information based on patients’ medical history to determine the patient’s eligibility for treatments.
Driver’s mission is to connect more patients to the best cancer treatments, regardless of location, said Will Polkinghorn, MD, Driver cofounder and CEO.
“Driver’s cofounders met at Harvard Medical School [in Boston] and saw firsthand the challenges of patients getting access to the latest, cutting-edge treatments available,” Dr. Polkinghorn said in an interview. “As doctors, [we] also witnessed how difficult it was for doctors to manage information in clinic and know about all the treatments that become available all around the world. Driver was created as a platform, with an app for the patient and an app for the doctor, to solve this broken marketplace.”
As part of the model, patients can review their recommended treatment options through video with an expert oncologist and select a hospital within Driver’s network for further evaluation. The company’s global network includes more than 30 leading U.S. cancer centers, including the Cleveland Clinic; multiple locations of the Mayo Clinic; the University of California, San Francisco; and Massachusetts General Hospital, Boston. The U.S. National Cancer Institute (NCI) and the Chinese National Cancer Center are founding members of Driver’s global network, according to the company.
Making more information and treatment options available is a positive for patients, said Walter Stadler, MD, chief of hematology/oncology and director of the genitourinary oncology program at the University of Chicago. However, he noted that the cost for patients to use Driver is prohibitive for many patients. Driver charges patients $3,000 up front and then a $20 monthly fee to use its service. Insurance does not subsidize the cost, nor does Driver help with travel or treatment costs, according to its website.
“It’s inequality of access,” Dr. Stadler said in an interview. “Many of us are very concerned that the clinical trials currently being conducted do not represent the general population well because they don’t represent patients with disparities … Here, we further exacerbate the problem by saying, ‘Okay, we’ll take the 5% of patients who can afford the service and expand their access, and the others, well, that’s not our problem.’ ”
Kashyap Patel, MD, secretary for the Community Oncology Alliance and CEO for the Carolina Blood and Cancer Care in Rock Hill, S.C., also sees positives and negatives about the business model. Using technology to link patients with care and clinical trials can help speed treatment and accelerate drug development, he said. But Driver’s network of large tertiary care centers in metropolitan areas poses challenges for rural cancer patients, he said.
“Access to clinical trials for patients residing in rural areas, as well as those getting their treatment in community based clinics, would not change,” Dr. Patel said in an interview. “Hence, challenges of social and demographic disparities and inequalities in clinical trial access and participation would be altered minimally. There is much greater need for such [platforms to include] community cancer clinics that would be more inclusive and encompass larger geographic areas where the majority of patients receive their care.”
Disadvantaged populations with limited access are not being overlooked by the company, according to Driver leaders. A branch of the company called Driver for All aims to increase access to optimal treatments for free through partnerships with local communities, Dr. Polkinghorn said. Driver for All has thus far partnered with Howard University Hospital in Washington to connect Howard patients to clinical trials at NCI. A partnership with Beijing Children’s Hospital and the Futang Research Center of Pediatric Development, meanwhile, is working to connect patients with rare-disease experts. Driver has funded 100% of the cost of these projects to date, according to its website.
Outside of Driver for All, Dr. Polkinghorn acknowledges that patients must bear the cost of Driver’s consumer products; however, the price should be viewed in context, he said.
“It’s important to remember that today, in order to be evaluated by 30 [plus] centers for treatment options, patients would need to fly to these centers, make appointments, and be seen by a doctor – this would require both time and resources for flights/hotels, which would cost much more than our sticker price,” he said. “So while $3,000 is a lot of money for some patients, Driver’s product is ultimately able to provide more visibility to options that simply would not be realistic today.”
James Gulley, MD, of the National Cancer Institute Center for Cancer Research, said any platform that can efficiently provide access to clinical trial options yields another source of information for patients to utilize in decision making with their health provider. Dr. Gulley, who heads the center’s genitourinary malignancies branch, declined to comment about access-to-care concerns with Driver’s model. He emphasized that patients who participate in NIH research studies are treated without charge.
“The key to finding better [cancer] treatment is to perform science-driven clinical trials,” Dr. Gulley said in an interview. “However, there are many barriers for enrollment in clinical trials. … As a government agency, NCI is open to partnering with any organization that seeks to improve access to clinical trials for cancer patients.”
NCI and Driver recently conducted a study to validate Driver’s platform; it showed that Driver’s technology successfully predicted the eligibility of patients in NCI Center for Cancer Research clinical trials. The study, presented at a recent American Society of Clinical Oncology meeting, evaluated Driver’s processing of 21 metastatic prostate cancer patients enrolled in a therapeutic NCI clinical trial within the last five years. Results showed Driver correctly predicted that 20 of the patients were “potentially eligible” for the trial in which they were enrolled, and that one was ineligible. Based on the study, a protocol is now in development for a new clinical study, which will seek to further determine the efficiency and accuracy of the clinical trial access program created by Driver, according to Dr. Gulley.
Charles Ryan, MD, director of the division of hematology, oncology, and transplantation for the University of Minnesota, Minneapolis, views Driver’s platform as a way to eliminate geographical barriers, which often keep patients from care, while at the same time enabling researchers to find the right patients for clinical trials.
“We need breakthrough technologies and opportunities for patients to be able to access the most successful and promising cancer treatments, regardless of where they live,” Dr. Ryan said in an interview. “Companies like Driver are attempting to bridge that gap by connecting patients to doctors at world class cancer institutes and direct them toward the best care for their particular condition.”
Driver’s model also allows researchers the opportunity to develop specific, unique treatment for less common cancers and remain optimistic that they can attract patients to receive such treatments as they are developed, Dr. Ryan said.
Dr. Stadler, however, worries that Driver may be giving patients the wrong perception that all it takes is a computer and medical records to determine their best treatment route.
“There’s a lot more subtlety to treatment decisions than most people would like to admit,” Dr. Stadler said. “It’s more than just a bunch of data from sophisticated laboratory tests and the written medical record. Obtaining objective information is the first step, but it’s far from the only step.”
Patients may have significant limitations in functional status that is apparent only during an in-person assessment, for example, he said. In other cases, family members may be essential in conveying information about a patient’s cognitive disabilities. Even when such information is documented, it is sometimes difficult to extract the full picture from the record alone, he said. Dr. Stadler is also bothered that the model requires physicians and hospitals to provide their skilled analyses to a for-profit company, which in turn, charges patients to review the information.
“This is our work,” he said. “I agree that patients should have the information, and I don’t mind sharing anything I have with patients, but now I’m going to share it with another business that essentially is competing with me in terms of providing guidance to patients.”
Oncologists are raising concerns about care access after the launch of a new company that links patients to cancer care options and clinical trials through mobile technology.
Driver, which began in September in the U.S. and China, is a global technology platform that allows patients to access treatment options across a broad network of cancer centers without leaving home. Cancer patients join the platform using a mobile app, through which Driver obtains the required consent to acquire medical records and tumor samples, and the company uses the information to recommend treatment options and clinical trials.
A separate app called Driver for Clinic enables oncologists who belong to Driver’s partner hospitals to manage their institution’s clinical trial information and quickly filter that information based on patients’ medical history to determine the patient’s eligibility for treatments.
Driver’s mission is to connect more patients to the best cancer treatments, regardless of location, said Will Polkinghorn, MD, Driver cofounder and CEO.
“Driver’s cofounders met at Harvard Medical School [in Boston] and saw firsthand the challenges of patients getting access to the latest, cutting-edge treatments available,” Dr. Polkinghorn said in an interview. “As doctors, [we] also witnessed how difficult it was for doctors to manage information in clinic and know about all the treatments that become available all around the world. Driver was created as a platform, with an app for the patient and an app for the doctor, to solve this broken marketplace.”
As part of the model, patients can review their recommended treatment options through video with an expert oncologist and select a hospital within Driver’s network for further evaluation. The company’s global network includes more than 30 leading U.S. cancer centers, including the Cleveland Clinic; multiple locations of the Mayo Clinic; the University of California, San Francisco; and Massachusetts General Hospital, Boston. The U.S. National Cancer Institute (NCI) and the Chinese National Cancer Center are founding members of Driver’s global network, according to the company.
Making more information and treatment options available is a positive for patients, said Walter Stadler, MD, chief of hematology/oncology and director of the genitourinary oncology program at the University of Chicago. However, he noted that the cost for patients to use Driver is prohibitive for many patients. Driver charges patients $3,000 up front and then a $20 monthly fee to use its service. Insurance does not subsidize the cost, nor does Driver help with travel or treatment costs, according to its website.
“It’s inequality of access,” Dr. Stadler said in an interview. “Many of us are very concerned that the clinical trials currently being conducted do not represent the general population well because they don’t represent patients with disparities … Here, we further exacerbate the problem by saying, ‘Okay, we’ll take the 5% of patients who can afford the service and expand their access, and the others, well, that’s not our problem.’ ”
Kashyap Patel, MD, secretary for the Community Oncology Alliance and CEO for the Carolina Blood and Cancer Care in Rock Hill, S.C., also sees positives and negatives about the business model. Using technology to link patients with care and clinical trials can help speed treatment and accelerate drug development, he said. But Driver’s network of large tertiary care centers in metropolitan areas poses challenges for rural cancer patients, he said.
“Access to clinical trials for patients residing in rural areas, as well as those getting their treatment in community based clinics, would not change,” Dr. Patel said in an interview. “Hence, challenges of social and demographic disparities and inequalities in clinical trial access and participation would be altered minimally. There is much greater need for such [platforms to include] community cancer clinics that would be more inclusive and encompass larger geographic areas where the majority of patients receive their care.”
Disadvantaged populations with limited access are not being overlooked by the company, according to Driver leaders. A branch of the company called Driver for All aims to increase access to optimal treatments for free through partnerships with local communities, Dr. Polkinghorn said. Driver for All has thus far partnered with Howard University Hospital in Washington to connect Howard patients to clinical trials at NCI. A partnership with Beijing Children’s Hospital and the Futang Research Center of Pediatric Development, meanwhile, is working to connect patients with rare-disease experts. Driver has funded 100% of the cost of these projects to date, according to its website.
Outside of Driver for All, Dr. Polkinghorn acknowledges that patients must bear the cost of Driver’s consumer products; however, the price should be viewed in context, he said.
“It’s important to remember that today, in order to be evaluated by 30 [plus] centers for treatment options, patients would need to fly to these centers, make appointments, and be seen by a doctor – this would require both time and resources for flights/hotels, which would cost much more than our sticker price,” he said. “So while $3,000 is a lot of money for some patients, Driver’s product is ultimately able to provide more visibility to options that simply would not be realistic today.”
James Gulley, MD, of the National Cancer Institute Center for Cancer Research, said any platform that can efficiently provide access to clinical trial options yields another source of information for patients to utilize in decision making with their health provider. Dr. Gulley, who heads the center’s genitourinary malignancies branch, declined to comment about access-to-care concerns with Driver’s model. He emphasized that patients who participate in NIH research studies are treated without charge.
“The key to finding better [cancer] treatment is to perform science-driven clinical trials,” Dr. Gulley said in an interview. “However, there are many barriers for enrollment in clinical trials. … As a government agency, NCI is open to partnering with any organization that seeks to improve access to clinical trials for cancer patients.”
NCI and Driver recently conducted a study to validate Driver’s platform; it showed that Driver’s technology successfully predicted the eligibility of patients in NCI Center for Cancer Research clinical trials. The study, presented at a recent American Society of Clinical Oncology meeting, evaluated Driver’s processing of 21 metastatic prostate cancer patients enrolled in a therapeutic NCI clinical trial within the last five years. Results showed Driver correctly predicted that 20 of the patients were “potentially eligible” for the trial in which they were enrolled, and that one was ineligible. Based on the study, a protocol is now in development for a new clinical study, which will seek to further determine the efficiency and accuracy of the clinical trial access program created by Driver, according to Dr. Gulley.
Charles Ryan, MD, director of the division of hematology, oncology, and transplantation for the University of Minnesota, Minneapolis, views Driver’s platform as a way to eliminate geographical barriers, which often keep patients from care, while at the same time enabling researchers to find the right patients for clinical trials.
“We need breakthrough technologies and opportunities for patients to be able to access the most successful and promising cancer treatments, regardless of where they live,” Dr. Ryan said in an interview. “Companies like Driver are attempting to bridge that gap by connecting patients to doctors at world class cancer institutes and direct them toward the best care for their particular condition.”
Driver’s model also allows researchers the opportunity to develop specific, unique treatment for less common cancers and remain optimistic that they can attract patients to receive such treatments as they are developed, Dr. Ryan said.
Dr. Stadler, however, worries that Driver may be giving patients the wrong perception that all it takes is a computer and medical records to determine their best treatment route.
“There’s a lot more subtlety to treatment decisions than most people would like to admit,” Dr. Stadler said. “It’s more than just a bunch of data from sophisticated laboratory tests and the written medical record. Obtaining objective information is the first step, but it’s far from the only step.”
Patients may have significant limitations in functional status that is apparent only during an in-person assessment, for example, he said. In other cases, family members may be essential in conveying information about a patient’s cognitive disabilities. Even when such information is documented, it is sometimes difficult to extract the full picture from the record alone, he said. Dr. Stadler is also bothered that the model requires physicians and hospitals to provide their skilled analyses to a for-profit company, which in turn, charges patients to review the information.
“This is our work,” he said. “I agree that patients should have the information, and I don’t mind sharing anything I have with patients, but now I’m going to share it with another business that essentially is competing with me in terms of providing guidance to patients.”
Oncologists are raising concerns about care access after the launch of a new company that links patients to cancer care options and clinical trials through mobile technology.
Driver, which began in September in the U.S. and China, is a global technology platform that allows patients to access treatment options across a broad network of cancer centers without leaving home. Cancer patients join the platform using a mobile app, through which Driver obtains the required consent to acquire medical records and tumor samples, and the company uses the information to recommend treatment options and clinical trials.
A separate app called Driver for Clinic enables oncologists who belong to Driver’s partner hospitals to manage their institution’s clinical trial information and quickly filter that information based on patients’ medical history to determine the patient’s eligibility for treatments.
Driver’s mission is to connect more patients to the best cancer treatments, regardless of location, said Will Polkinghorn, MD, Driver cofounder and CEO.
“Driver’s cofounders met at Harvard Medical School [in Boston] and saw firsthand the challenges of patients getting access to the latest, cutting-edge treatments available,” Dr. Polkinghorn said in an interview. “As doctors, [we] also witnessed how difficult it was for doctors to manage information in clinic and know about all the treatments that become available all around the world. Driver was created as a platform, with an app for the patient and an app for the doctor, to solve this broken marketplace.”
As part of the model, patients can review their recommended treatment options through video with an expert oncologist and select a hospital within Driver’s network for further evaluation. The company’s global network includes more than 30 leading U.S. cancer centers, including the Cleveland Clinic; multiple locations of the Mayo Clinic; the University of California, San Francisco; and Massachusetts General Hospital, Boston. The U.S. National Cancer Institute (NCI) and the Chinese National Cancer Center are founding members of Driver’s global network, according to the company.
Making more information and treatment options available is a positive for patients, said Walter Stadler, MD, chief of hematology/oncology and director of the genitourinary oncology program at the University of Chicago. However, he noted that the cost for patients to use Driver is prohibitive for many patients. Driver charges patients $3,000 up front and then a $20 monthly fee to use its service. Insurance does not subsidize the cost, nor does Driver help with travel or treatment costs, according to its website.
“It’s inequality of access,” Dr. Stadler said in an interview. “Many of us are very concerned that the clinical trials currently being conducted do not represent the general population well because they don’t represent patients with disparities … Here, we further exacerbate the problem by saying, ‘Okay, we’ll take the 5% of patients who can afford the service and expand their access, and the others, well, that’s not our problem.’ ”
Kashyap Patel, MD, secretary for the Community Oncology Alliance and CEO for the Carolina Blood and Cancer Care in Rock Hill, S.C., also sees positives and negatives about the business model. Using technology to link patients with care and clinical trials can help speed treatment and accelerate drug development, he said. But Driver’s network of large tertiary care centers in metropolitan areas poses challenges for rural cancer patients, he said.
“Access to clinical trials for patients residing in rural areas, as well as those getting their treatment in community based clinics, would not change,” Dr. Patel said in an interview. “Hence, challenges of social and demographic disparities and inequalities in clinical trial access and participation would be altered minimally. There is much greater need for such [platforms to include] community cancer clinics that would be more inclusive and encompass larger geographic areas where the majority of patients receive their care.”
Disadvantaged populations with limited access are not being overlooked by the company, according to Driver leaders. A branch of the company called Driver for All aims to increase access to optimal treatments for free through partnerships with local communities, Dr. Polkinghorn said. Driver for All has thus far partnered with Howard University Hospital in Washington to connect Howard patients to clinical trials at NCI. A partnership with Beijing Children’s Hospital and the Futang Research Center of Pediatric Development, meanwhile, is working to connect patients with rare-disease experts. Driver has funded 100% of the cost of these projects to date, according to its website.
Outside of Driver for All, Dr. Polkinghorn acknowledges that patients must bear the cost of Driver’s consumer products; however, the price should be viewed in context, he said.
“It’s important to remember that today, in order to be evaluated by 30 [plus] centers for treatment options, patients would need to fly to these centers, make appointments, and be seen by a doctor – this would require both time and resources for flights/hotels, which would cost much more than our sticker price,” he said. “So while $3,000 is a lot of money for some patients, Driver’s product is ultimately able to provide more visibility to options that simply would not be realistic today.”
James Gulley, MD, of the National Cancer Institute Center for Cancer Research, said any platform that can efficiently provide access to clinical trial options yields another source of information for patients to utilize in decision making with their health provider. Dr. Gulley, who heads the center’s genitourinary malignancies branch, declined to comment about access-to-care concerns with Driver’s model. He emphasized that patients who participate in NIH research studies are treated without charge.
“The key to finding better [cancer] treatment is to perform science-driven clinical trials,” Dr. Gulley said in an interview. “However, there are many barriers for enrollment in clinical trials. … As a government agency, NCI is open to partnering with any organization that seeks to improve access to clinical trials for cancer patients.”
NCI and Driver recently conducted a study to validate Driver’s platform; it showed that Driver’s technology successfully predicted the eligibility of patients in NCI Center for Cancer Research clinical trials. The study, presented at a recent American Society of Clinical Oncology meeting, evaluated Driver’s processing of 21 metastatic prostate cancer patients enrolled in a therapeutic NCI clinical trial within the last five years. Results showed Driver correctly predicted that 20 of the patients were “potentially eligible” for the trial in which they were enrolled, and that one was ineligible. Based on the study, a protocol is now in development for a new clinical study, which will seek to further determine the efficiency and accuracy of the clinical trial access program created by Driver, according to Dr. Gulley.
Charles Ryan, MD, director of the division of hematology, oncology, and transplantation for the University of Minnesota, Minneapolis, views Driver’s platform as a way to eliminate geographical barriers, which often keep patients from care, while at the same time enabling researchers to find the right patients for clinical trials.
“We need breakthrough technologies and opportunities for patients to be able to access the most successful and promising cancer treatments, regardless of where they live,” Dr. Ryan said in an interview. “Companies like Driver are attempting to bridge that gap by connecting patients to doctors at world class cancer institutes and direct them toward the best care for their particular condition.”
Driver’s model also allows researchers the opportunity to develop specific, unique treatment for less common cancers and remain optimistic that they can attract patients to receive such treatments as they are developed, Dr. Ryan said.
Dr. Stadler, however, worries that Driver may be giving patients the wrong perception that all it takes is a computer and medical records to determine their best treatment route.
“There’s a lot more subtlety to treatment decisions than most people would like to admit,” Dr. Stadler said. “It’s more than just a bunch of data from sophisticated laboratory tests and the written medical record. Obtaining objective information is the first step, but it’s far from the only step.”
Patients may have significant limitations in functional status that is apparent only during an in-person assessment, for example, he said. In other cases, family members may be essential in conveying information about a patient’s cognitive disabilities. Even when such information is documented, it is sometimes difficult to extract the full picture from the record alone, he said. Dr. Stadler is also bothered that the model requires physicians and hospitals to provide their skilled analyses to a for-profit company, which in turn, charges patients to review the information.
“This is our work,” he said. “I agree that patients should have the information, and I don’t mind sharing anything I have with patients, but now I’m going to share it with another business that essentially is competing with me in terms of providing guidance to patients.”
ESMO 2018 to highlight research on advanced breast cancer
Oncology Practice will have on-site reporters in Munich covering the European Society for Medical Oncology 2018 Congress, held October 19-23.
A total of 2,051 abstracts will be presented, covering the latest in immunotherapy, technologies of the future, biomarkers, basic and translational research, and prevention, according to an ESMO press release.
Results from four studies on advanced breast cancer will be featured in the first presidential symposium:
- LBA1 – Results of IMpassion130: Results from a global, randomized, double-blind, phase 3 study of atezolizumab + nab-paclitaxel vs. placebo + nab-paclitaxel in treatment-naive locally advanced or metastatic triple-negative breast cancer.
- LBA2 – Analyses from PALOMA-3: Overall survival with palbociclib plus fulvestrant in women with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer.
- LBA3 – Results of the phase 3 SOLAR-1 trial: Alpelisib + fulvestrant for advanced breast cancer.
- 283O PR – Results of the phase 3 trial: Chidamide, a subtype-selective histone deacetylase inhibitor, in combination with exemestane in patients with hormone receptor–positive advanced breast cancer.
Additional late-breaking plenary sessions will cover research on alectinib vs. crizotinib for treatment-naive anaplastic lymphoma kinase positive advanced non–small cell lung cancer, avelumab + axitinib vs. sunitinib as first-line treatment of advanced renal cell carcinoma, and a poly ADP-ribose polymerase inhibitor for maintenance therapy in advanced ovarian cancer
.
Oncology Practice will have on-site reporters in Munich covering the European Society for Medical Oncology 2018 Congress, held October 19-23.
A total of 2,051 abstracts will be presented, covering the latest in immunotherapy, technologies of the future, biomarkers, basic and translational research, and prevention, according to an ESMO press release.
Results from four studies on advanced breast cancer will be featured in the first presidential symposium:
- LBA1 – Results of IMpassion130: Results from a global, randomized, double-blind, phase 3 study of atezolizumab + nab-paclitaxel vs. placebo + nab-paclitaxel in treatment-naive locally advanced or metastatic triple-negative breast cancer.
- LBA2 – Analyses from PALOMA-3: Overall survival with palbociclib plus fulvestrant in women with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer.
- LBA3 – Results of the phase 3 SOLAR-1 trial: Alpelisib + fulvestrant for advanced breast cancer.
- 283O PR – Results of the phase 3 trial: Chidamide, a subtype-selective histone deacetylase inhibitor, in combination with exemestane in patients with hormone receptor–positive advanced breast cancer.
Additional late-breaking plenary sessions will cover research on alectinib vs. crizotinib for treatment-naive anaplastic lymphoma kinase positive advanced non–small cell lung cancer, avelumab + axitinib vs. sunitinib as first-line treatment of advanced renal cell carcinoma, and a poly ADP-ribose polymerase inhibitor for maintenance therapy in advanced ovarian cancer
.
Oncology Practice will have on-site reporters in Munich covering the European Society for Medical Oncology 2018 Congress, held October 19-23.
A total of 2,051 abstracts will be presented, covering the latest in immunotherapy, technologies of the future, biomarkers, basic and translational research, and prevention, according to an ESMO press release.
Results from four studies on advanced breast cancer will be featured in the first presidential symposium:
- LBA1 – Results of IMpassion130: Results from a global, randomized, double-blind, phase 3 study of atezolizumab + nab-paclitaxel vs. placebo + nab-paclitaxel in treatment-naive locally advanced or metastatic triple-negative breast cancer.
- LBA2 – Analyses from PALOMA-3: Overall survival with palbociclib plus fulvestrant in women with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer.
- LBA3 – Results of the phase 3 SOLAR-1 trial: Alpelisib + fulvestrant for advanced breast cancer.
- 283O PR – Results of the phase 3 trial: Chidamide, a subtype-selective histone deacetylase inhibitor, in combination with exemestane in patients with hormone receptor–positive advanced breast cancer.
Additional late-breaking plenary sessions will cover research on alectinib vs. crizotinib for treatment-naive anaplastic lymphoma kinase positive advanced non–small cell lung cancer, avelumab + axitinib vs. sunitinib as first-line treatment of advanced renal cell carcinoma, and a poly ADP-ribose polymerase inhibitor for maintenance therapy in advanced ovarian cancer
.
MBC care causes more money problems for uninsured – but more financial stress for the insured
PHOENIX – Metastatic breast cancer care may be a bigger financial burden for uninsured patients, but it’s actually causing more financial distress for the insured, results of a recent survey suggest.
The uninsured more often reported material burdens, such as lack of savings or refusing treatment because of cost, according to survey results reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.
By contrast, the insured reported more worry, distress, and frustration related to financial problems, reported Stephanie B. Wheeler, PhD, MPH, of the Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
That divide suggests increased health insurance coverage is not enough to tackle the problem of cancer-related financial harm, said Dr. Wheeler.
“Health insurance expansion is important,” she said, “but it’s going to be ultimately inadequate in solving the problem of financial distress in our cancer patients. We really need to be thinking about other types of interventions that can do a better job of meeting patients where they are.”
Regardless of insurance status, this survey showed an “unprecedented” high level of cancer-related financial harm in metastatic breast cancer patients as compared with previous studies of early-stage cancer patients, Dr. Wheeler said.
The online survey was completed by 1,054 individuals who were members of the Metastatic Breast Cancer Network, a patient advocacy group. Approximately 30% of participants were uninsured, Dr. Wheeler reported.
Overall, 56% of respondents reported not having enough savings to cover costs of care, while 54% stopped or refused treatment because of cost, and 49% said they had been contacted by collection agencies, survey results show.
These material burdens were “perhaps not surprisingly” significantly more often reported by the uninsured respondents, Dr. Wheeler said. What may be surprising, she added, is that psychosocial burdens were more frequently reported by the insured respondents.
The most frequently reported psychosocial burden was worry about cancer-related financial problems, reported by 68% of respondents overall, but nearly 80% of insured and around 45% of uninsured respondents (P less than .001), Dr. Wheeler said.
The least often reported psychosocial issue was worry about the effects of financial stress on the family, at 31% of all respondents. Even so, there was a significant difference in response by insurance status, with the percentage approaching 40% for the insured, but less than 20% for the uninsured (P less than .001).
This high level of worry and distress may indicate that insured cancer patients may be expecting their insurance to cover more that it does, but ultimately, it is inadequate to meet their needs, Dr. Wheeler said.
“It’s also possible that because insured participants are more often affluent – they more often have retirement and other savings to draw down – that they actually have more to lose,” she added, “and when it comes to the legacy that they leave behind for their family, that creates additional stress – not just for them as an individual, but for their entire household.”
Previous research shows that the adverse financial impacts of cancer, also referred to as financial toxicity, affect about 30% of cancer patients, Dr. Wheeler said in her presentation.
Dr. Wheeler had no relationships to disclose. Funding for the project was provided from the National Comprehensive Cancer Network and Pfizer Independent Grants for Learning & Change.
SOURCE: Wheeler SB et al. Quality Care Symposium, Abstract 32.
PHOENIX – Metastatic breast cancer care may be a bigger financial burden for uninsured patients, but it’s actually causing more financial distress for the insured, results of a recent survey suggest.
The uninsured more often reported material burdens, such as lack of savings or refusing treatment because of cost, according to survey results reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.
By contrast, the insured reported more worry, distress, and frustration related to financial problems, reported Stephanie B. Wheeler, PhD, MPH, of the Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
That divide suggests increased health insurance coverage is not enough to tackle the problem of cancer-related financial harm, said Dr. Wheeler.
“Health insurance expansion is important,” she said, “but it’s going to be ultimately inadequate in solving the problem of financial distress in our cancer patients. We really need to be thinking about other types of interventions that can do a better job of meeting patients where they are.”
Regardless of insurance status, this survey showed an “unprecedented” high level of cancer-related financial harm in metastatic breast cancer patients as compared with previous studies of early-stage cancer patients, Dr. Wheeler said.
The online survey was completed by 1,054 individuals who were members of the Metastatic Breast Cancer Network, a patient advocacy group. Approximately 30% of participants were uninsured, Dr. Wheeler reported.
Overall, 56% of respondents reported not having enough savings to cover costs of care, while 54% stopped or refused treatment because of cost, and 49% said they had been contacted by collection agencies, survey results show.
These material burdens were “perhaps not surprisingly” significantly more often reported by the uninsured respondents, Dr. Wheeler said. What may be surprising, she added, is that psychosocial burdens were more frequently reported by the insured respondents.
The most frequently reported psychosocial burden was worry about cancer-related financial problems, reported by 68% of respondents overall, but nearly 80% of insured and around 45% of uninsured respondents (P less than .001), Dr. Wheeler said.
The least often reported psychosocial issue was worry about the effects of financial stress on the family, at 31% of all respondents. Even so, there was a significant difference in response by insurance status, with the percentage approaching 40% for the insured, but less than 20% for the uninsured (P less than .001).
This high level of worry and distress may indicate that insured cancer patients may be expecting their insurance to cover more that it does, but ultimately, it is inadequate to meet their needs, Dr. Wheeler said.
“It’s also possible that because insured participants are more often affluent – they more often have retirement and other savings to draw down – that they actually have more to lose,” she added, “and when it comes to the legacy that they leave behind for their family, that creates additional stress – not just for them as an individual, but for their entire household.”
Previous research shows that the adverse financial impacts of cancer, also referred to as financial toxicity, affect about 30% of cancer patients, Dr. Wheeler said in her presentation.
Dr. Wheeler had no relationships to disclose. Funding for the project was provided from the National Comprehensive Cancer Network and Pfizer Independent Grants for Learning & Change.
SOURCE: Wheeler SB et al. Quality Care Symposium, Abstract 32.
PHOENIX – Metastatic breast cancer care may be a bigger financial burden for uninsured patients, but it’s actually causing more financial distress for the insured, results of a recent survey suggest.
The uninsured more often reported material burdens, such as lack of savings or refusing treatment because of cost, according to survey results reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.
By contrast, the insured reported more worry, distress, and frustration related to financial problems, reported Stephanie B. Wheeler, PhD, MPH, of the Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
That divide suggests increased health insurance coverage is not enough to tackle the problem of cancer-related financial harm, said Dr. Wheeler.
“Health insurance expansion is important,” she said, “but it’s going to be ultimately inadequate in solving the problem of financial distress in our cancer patients. We really need to be thinking about other types of interventions that can do a better job of meeting patients where they are.”
Regardless of insurance status, this survey showed an “unprecedented” high level of cancer-related financial harm in metastatic breast cancer patients as compared with previous studies of early-stage cancer patients, Dr. Wheeler said.
The online survey was completed by 1,054 individuals who were members of the Metastatic Breast Cancer Network, a patient advocacy group. Approximately 30% of participants were uninsured, Dr. Wheeler reported.
Overall, 56% of respondents reported not having enough savings to cover costs of care, while 54% stopped or refused treatment because of cost, and 49% said they had been contacted by collection agencies, survey results show.
These material burdens were “perhaps not surprisingly” significantly more often reported by the uninsured respondents, Dr. Wheeler said. What may be surprising, she added, is that psychosocial burdens were more frequently reported by the insured respondents.
The most frequently reported psychosocial burden was worry about cancer-related financial problems, reported by 68% of respondents overall, but nearly 80% of insured and around 45% of uninsured respondents (P less than .001), Dr. Wheeler said.
The least often reported psychosocial issue was worry about the effects of financial stress on the family, at 31% of all respondents. Even so, there was a significant difference in response by insurance status, with the percentage approaching 40% for the insured, but less than 20% for the uninsured (P less than .001).
This high level of worry and distress may indicate that insured cancer patients may be expecting their insurance to cover more that it does, but ultimately, it is inadequate to meet their needs, Dr. Wheeler said.
“It’s also possible that because insured participants are more often affluent – they more often have retirement and other savings to draw down – that they actually have more to lose,” she added, “and when it comes to the legacy that they leave behind for their family, that creates additional stress – not just for them as an individual, but for their entire household.”
Previous research shows that the adverse financial impacts of cancer, also referred to as financial toxicity, affect about 30% of cancer patients, Dr. Wheeler said in her presentation.
Dr. Wheeler had no relationships to disclose. Funding for the project was provided from the National Comprehensive Cancer Network and Pfizer Independent Grants for Learning & Change.
SOURCE: Wheeler SB et al. Quality Care Symposium, Abstract 32.
REPORTING FROM THE QUALITY CARE SYMPOSIUM
Key clinical point: Survey results suggest that metastatic breast cancer care is a bigger financial burden for uninsured patients vs insured patients, though the insured have more financial distress related to that care.
Major finding: Overall, 68% of respondents said they worried about cancer-related financial problems, and significantly more insured individuals reported this worry (P less than .001).
Study details: Analysis of survey responses from 1,054 members of the Metastatic Breast Cancer Network, of whom about 30% were uninsured.
Disclosures: Funding for the project was provided from the National Comprehensive Cancer Network and Pfizer Independent Grants for Learning & Change.
Source: Wheeler SB et al. Quality Care Symposium, Abstract 32.
Investigators identify 21 genomic “hotspots” in breast cancers
Cancer geneticists have identified 21 clusters of complex chromosomal rearrangements in breast cancers that contain both known oncogenes and potential new driver loci.
A systematic analysis of chromosomal rearrangements in tissues from 560 patients with breast cancer identified 21 “hotspots,” some of which contain known oncogene chromosomal loci, and others of which contain genes not typically associated with breast cancer, reported Serena Nik-Zainal, PhD, of the University of Cambridge, England, and her colleagues.
“Detailed analysis of rearrangements at these hotspots highlights chromosomal aberrations likely driven by selection, and reveal underlying mutational processes,” they wrote in a study published online in Annals of Oncology.
The investigators sought insight into mutational mechanisms of gene amplifications by examining clustered rearrangements – somatic breakpoints occurring in high densities – in individual patients.
To see whether these rearrangements were associated with breast cancer, they identified the aforementioned chromosomal hotspots where clustered rearrangements were seen in samples from different patients.
They identified 624 cluster rearrangements in the 560 breast cancer genomes, including 17,247 within-chromosome rearrangements, and 6,509 between-chromosome translocations.
Of the 560 samples, 372 had at least one rearrangement cluster, with the frequency of clusters similar between some breast cancer types. For example, there were 0.96 rearrangements clusters per sample from patients with triple negative breast cancers, and 1.00 per sample from women with estrogen receptor–positive tumors.
“To identify loci where clusters of rearrangements recur across multiple independent tumor samples, we pooled all breakpoints in the ‘clustered’ category and sorted them according to position in the reference genome,” the investigators explained.
They used a Piecewise-Constant-Fitting algorithm to identify genome sequences where there were short inter-mutation distances between rearrangement clusters, suggesting the presence of hotspots.
In the 21 hotspots they identified, they found, as expected, common driver amplification regions (e.g., CCND1, ERBB2, ZNF217, chr8:ZNF703/FGFR1, IGF1R, and MYC), but also several hotspots near oncogenes that are not typically associated with breast cancer.
Notably, they saw simultaneous amplification of regions on chromosomes 8 and 11 (chr8:ZNF703/FGFR1 and chr11:CCND1). Amplification of these regions are frequent in estrogen receptor–positive breast cancers. The investigators propose a pathogenic model in which a chromosome 8 to chromosome 11 translocation is an early, critical event leading to breast tumor development.
“Clustered rearrangements are common in breast cancer genomes, and often associated with gene amplifications that drive oncogenesis. Understanding the process of amplicon formation, an example of which we present here for the chr8:ZNF703/FGFR1 and chr11:CCND1 co-amplifications, will be important for our understanding of the origins of a subset of breast cancers,” they concluded.
The study was supported by an award from the Wellcome Trust. Dr. Nik-Zainal and coauthor Dominik Glodzik are inventors on several patent applications. All remaining authors declared no conflicts of interest.
SOURCE: Glodzik D et al. Ann Oncol. 2018 Sept 25. doi: 10.1093/annonc/mdy404.
Cancer geneticists have identified 21 clusters of complex chromosomal rearrangements in breast cancers that contain both known oncogenes and potential new driver loci.
A systematic analysis of chromosomal rearrangements in tissues from 560 patients with breast cancer identified 21 “hotspots,” some of which contain known oncogene chromosomal loci, and others of which contain genes not typically associated with breast cancer, reported Serena Nik-Zainal, PhD, of the University of Cambridge, England, and her colleagues.
“Detailed analysis of rearrangements at these hotspots highlights chromosomal aberrations likely driven by selection, and reveal underlying mutational processes,” they wrote in a study published online in Annals of Oncology.
The investigators sought insight into mutational mechanisms of gene amplifications by examining clustered rearrangements – somatic breakpoints occurring in high densities – in individual patients.
To see whether these rearrangements were associated with breast cancer, they identified the aforementioned chromosomal hotspots where clustered rearrangements were seen in samples from different patients.
They identified 624 cluster rearrangements in the 560 breast cancer genomes, including 17,247 within-chromosome rearrangements, and 6,509 between-chromosome translocations.
Of the 560 samples, 372 had at least one rearrangement cluster, with the frequency of clusters similar between some breast cancer types. For example, there were 0.96 rearrangements clusters per sample from patients with triple negative breast cancers, and 1.00 per sample from women with estrogen receptor–positive tumors.
“To identify loci where clusters of rearrangements recur across multiple independent tumor samples, we pooled all breakpoints in the ‘clustered’ category and sorted them according to position in the reference genome,” the investigators explained.
They used a Piecewise-Constant-Fitting algorithm to identify genome sequences where there were short inter-mutation distances between rearrangement clusters, suggesting the presence of hotspots.
In the 21 hotspots they identified, they found, as expected, common driver amplification regions (e.g., CCND1, ERBB2, ZNF217, chr8:ZNF703/FGFR1, IGF1R, and MYC), but also several hotspots near oncogenes that are not typically associated with breast cancer.
Notably, they saw simultaneous amplification of regions on chromosomes 8 and 11 (chr8:ZNF703/FGFR1 and chr11:CCND1). Amplification of these regions are frequent in estrogen receptor–positive breast cancers. The investigators propose a pathogenic model in which a chromosome 8 to chromosome 11 translocation is an early, critical event leading to breast tumor development.
“Clustered rearrangements are common in breast cancer genomes, and often associated with gene amplifications that drive oncogenesis. Understanding the process of amplicon formation, an example of which we present here for the chr8:ZNF703/FGFR1 and chr11:CCND1 co-amplifications, will be important for our understanding of the origins of a subset of breast cancers,” they concluded.
The study was supported by an award from the Wellcome Trust. Dr. Nik-Zainal and coauthor Dominik Glodzik are inventors on several patent applications. All remaining authors declared no conflicts of interest.
SOURCE: Glodzik D et al. Ann Oncol. 2018 Sept 25. doi: 10.1093/annonc/mdy404.
Cancer geneticists have identified 21 clusters of complex chromosomal rearrangements in breast cancers that contain both known oncogenes and potential new driver loci.
A systematic analysis of chromosomal rearrangements in tissues from 560 patients with breast cancer identified 21 “hotspots,” some of which contain known oncogene chromosomal loci, and others of which contain genes not typically associated with breast cancer, reported Serena Nik-Zainal, PhD, of the University of Cambridge, England, and her colleagues.
“Detailed analysis of rearrangements at these hotspots highlights chromosomal aberrations likely driven by selection, and reveal underlying mutational processes,” they wrote in a study published online in Annals of Oncology.
The investigators sought insight into mutational mechanisms of gene amplifications by examining clustered rearrangements – somatic breakpoints occurring in high densities – in individual patients.
To see whether these rearrangements were associated with breast cancer, they identified the aforementioned chromosomal hotspots where clustered rearrangements were seen in samples from different patients.
They identified 624 cluster rearrangements in the 560 breast cancer genomes, including 17,247 within-chromosome rearrangements, and 6,509 between-chromosome translocations.
Of the 560 samples, 372 had at least one rearrangement cluster, with the frequency of clusters similar between some breast cancer types. For example, there were 0.96 rearrangements clusters per sample from patients with triple negative breast cancers, and 1.00 per sample from women with estrogen receptor–positive tumors.
“To identify loci where clusters of rearrangements recur across multiple independent tumor samples, we pooled all breakpoints in the ‘clustered’ category and sorted them according to position in the reference genome,” the investigators explained.
They used a Piecewise-Constant-Fitting algorithm to identify genome sequences where there were short inter-mutation distances between rearrangement clusters, suggesting the presence of hotspots.
In the 21 hotspots they identified, they found, as expected, common driver amplification regions (e.g., CCND1, ERBB2, ZNF217, chr8:ZNF703/FGFR1, IGF1R, and MYC), but also several hotspots near oncogenes that are not typically associated with breast cancer.
Notably, they saw simultaneous amplification of regions on chromosomes 8 and 11 (chr8:ZNF703/FGFR1 and chr11:CCND1). Amplification of these regions are frequent in estrogen receptor–positive breast cancers. The investigators propose a pathogenic model in which a chromosome 8 to chromosome 11 translocation is an early, critical event leading to breast tumor development.
“Clustered rearrangements are common in breast cancer genomes, and often associated with gene amplifications that drive oncogenesis. Understanding the process of amplicon formation, an example of which we present here for the chr8:ZNF703/FGFR1 and chr11:CCND1 co-amplifications, will be important for our understanding of the origins of a subset of breast cancers,” they concluded.
The study was supported by an award from the Wellcome Trust. Dr. Nik-Zainal and coauthor Dominik Glodzik are inventors on several patent applications. All remaining authors declared no conflicts of interest.
SOURCE: Glodzik D et al. Ann Oncol. 2018 Sept 25. doi: 10.1093/annonc/mdy404.
FROM ANNALS OF ONCOLOGY
Key clinical point: Chromosomal rearrangement “hotspots” contain both known breast cancer oncogenes and potential new loci that may explain the mechanism of deleterious gene amplifications.
Major finding: A chromosome 8 to 11 translocation may be the initiating event for some breast cancer subtypes.
Study details: Genomic analysis of samples from 560 patients with breast cancer.
Disclosures: The study was supported by an award from the Wellcome Trust. Dr. Nik-Zainal and coauthor Dominik Glodzik are inventors on several patent applications. All remaining authors declared no conflicts of interest.
Source: Glodzik D et al. Ann Oncol. 2018 Sep 25. doi: 10.1093/annonc/mdy404.
Breast cancer risk in type 2 diabetes related to adiposity
ORLANDO – findings from meta-analyses suggest.
In one meta-analysis of data from 21 prospective studies with a total of nearly 15.2 million women, 325,117 breast cancer cases, and a mean follow-up time of 8 years (nearly 33 million person-years), the risk of breast cancer was significantly greater among patients with diabetes than it was among patients without diabetes (summary relative risk, 1.11), Maria Bota reported at the annual scientific sessions of the American Diabetes Association.
However, there was substantial unexplained heterogeneity of results across the individual studies (I2 = 82%), said Ms. Bota, a faculty member at the International Prevention Research Institute, Lyon, France.
“When the analysis was restricted to the 12 studies that adjusted for [body mass index], the summary relative risk decreased to 1.09 and the heterogeneity also decreased to a moderate value of 32%; when the analysis was restricted to the 9 studies that did not adjust for BMI, the summary relative risk increased to 1.14 again, and the heterogeneity increased even more to 91%,” she said.
In an analysis that combined the results of the nine studies that did not adjust for BMI along with crude relative risks from studies that reported both crude and BMI-adjusted relative risks (17 studies in all), the SRR was 1.12, and heterogeneity among the studies was high at 84%.
Additionally, an analysis by menopausal status based on four studies that reported breast cancer in both pre- and postmenopausal women showed SRRs for breast cancer of 0.97 (a 3% decrease in risk) and 1.14 among diabetic vs. nondiabetic premenopausal women and postmenopausal women, respectively, she said, noting that heterogeneity was low (I2 = 0%) among the premenopausal breast cancer study groups and high (I2 = 70%) among the postmenopausal study groups.
The findings provide evidence for a moderately increased risk of breast cancer in women with T2DM, Ms. Bota said.
“However, the effect of the adjustment or lack of adjustment on the heterogeneity suggests that the higher risk of breast cancer in women with diabetes may not be due to diabetes itself, but to adiposity,” she said, adding that “this hypothesis is equally supported by our subgroup analysis according to menopausal status because we saw that the risk of breast cancer was only associated with diabetes in postmenopausal women and this pattern resembles the pattern of the risk of breast cancer associated with adiposity, which is also only increased in postmenopausal women.”
This study was limited by insufficient data for investigating the sources of heterogeneity, she said.
“Therefore we propose ... future pooled analyses based on individual data from good quality prospective studies in order to increase the study power and to do some detailed analysis of the links between adiposity, diabetes, and breast cancer,” she concluded, adding that new studies to examine those relationships only in premenopausal women are also needed
In a separate meta-analysis, she and her colleagues, including Peter Boyle, PhD, president of the International Prevention Research Institute, assessed the association between insulin treatment and breast cancer risk in patients with diabetes.
“The long-acting insulin analogues glargine and detemir have been shown in some studies to be associated with increased risk of breast cancer, and other studies have shown no association between the use of these two compounds and the risk of breast cancer,” Dr. Boyle said in a separate presentation at the ADA meeting. “It was important to sort out a little bit what was going on in the literature.”
Overall, the meta-analysis of data from 12 longitudinal cohort studies – including more than 6,000 cases of breast cancer – showed a slight increase in breast cancer risk in patients taking long-acting insulin (SRR, 1.13) with “a relatively reasonable” level of heterogeneity (I2 = 23%).
“But we see that the story is not that simple,” he said.
For example, some studies included only patients who were prescribed insulin for the first time after the study began (new users), some included only patients who were prescribed insulin before the study began (prevalent users), and some included both (ever users), which may have introduced bias in the results, he explained.
Studies of glargine included 4,168 breast cancer cases over a total of 1,418,743 person-years of observation, and studies of detemir included fewer than 2,047 breast cancer cases (not all studies reported case numbers). Among both new users of glargine and detemir, the SRR was 1.12, suggesting no real association between either glargine or detemir use and breast cancer, he said.
“One important take-home message is that you have to be careful that these pharmaco-epidemiological studies, even when working with the same database, may have conflicting results ... so we still need more robust standards in methods for [such] studies,” he concluded.
Ms. Bota reported having no disclosures. The study presented by Dr. Boyle was funded by Sanofi. Dr. Boyle is president of a charity that has received donations from Pfizer, Roche, Novartis, and Lilly.
SOURCE: Bota M. ADA 2018, Abstract 180-OR; Boyle P. ADA 2018, Abstract 133-OR.
ORLANDO – findings from meta-analyses suggest.
In one meta-analysis of data from 21 prospective studies with a total of nearly 15.2 million women, 325,117 breast cancer cases, and a mean follow-up time of 8 years (nearly 33 million person-years), the risk of breast cancer was significantly greater among patients with diabetes than it was among patients without diabetes (summary relative risk, 1.11), Maria Bota reported at the annual scientific sessions of the American Diabetes Association.
However, there was substantial unexplained heterogeneity of results across the individual studies (I2 = 82%), said Ms. Bota, a faculty member at the International Prevention Research Institute, Lyon, France.
“When the analysis was restricted to the 12 studies that adjusted for [body mass index], the summary relative risk decreased to 1.09 and the heterogeneity also decreased to a moderate value of 32%; when the analysis was restricted to the 9 studies that did not adjust for BMI, the summary relative risk increased to 1.14 again, and the heterogeneity increased even more to 91%,” she said.
In an analysis that combined the results of the nine studies that did not adjust for BMI along with crude relative risks from studies that reported both crude and BMI-adjusted relative risks (17 studies in all), the SRR was 1.12, and heterogeneity among the studies was high at 84%.
Additionally, an analysis by menopausal status based on four studies that reported breast cancer in both pre- and postmenopausal women showed SRRs for breast cancer of 0.97 (a 3% decrease in risk) and 1.14 among diabetic vs. nondiabetic premenopausal women and postmenopausal women, respectively, she said, noting that heterogeneity was low (I2 = 0%) among the premenopausal breast cancer study groups and high (I2 = 70%) among the postmenopausal study groups.
The findings provide evidence for a moderately increased risk of breast cancer in women with T2DM, Ms. Bota said.
“However, the effect of the adjustment or lack of adjustment on the heterogeneity suggests that the higher risk of breast cancer in women with diabetes may not be due to diabetes itself, but to adiposity,” she said, adding that “this hypothesis is equally supported by our subgroup analysis according to menopausal status because we saw that the risk of breast cancer was only associated with diabetes in postmenopausal women and this pattern resembles the pattern of the risk of breast cancer associated with adiposity, which is also only increased in postmenopausal women.”
This study was limited by insufficient data for investigating the sources of heterogeneity, she said.
“Therefore we propose ... future pooled analyses based on individual data from good quality prospective studies in order to increase the study power and to do some detailed analysis of the links between adiposity, diabetes, and breast cancer,” she concluded, adding that new studies to examine those relationships only in premenopausal women are also needed
In a separate meta-analysis, she and her colleagues, including Peter Boyle, PhD, president of the International Prevention Research Institute, assessed the association between insulin treatment and breast cancer risk in patients with diabetes.
“The long-acting insulin analogues glargine and detemir have been shown in some studies to be associated with increased risk of breast cancer, and other studies have shown no association between the use of these two compounds and the risk of breast cancer,” Dr. Boyle said in a separate presentation at the ADA meeting. “It was important to sort out a little bit what was going on in the literature.”
Overall, the meta-analysis of data from 12 longitudinal cohort studies – including more than 6,000 cases of breast cancer – showed a slight increase in breast cancer risk in patients taking long-acting insulin (SRR, 1.13) with “a relatively reasonable” level of heterogeneity (I2 = 23%).
“But we see that the story is not that simple,” he said.
For example, some studies included only patients who were prescribed insulin for the first time after the study began (new users), some included only patients who were prescribed insulin before the study began (prevalent users), and some included both (ever users), which may have introduced bias in the results, he explained.
Studies of glargine included 4,168 breast cancer cases over a total of 1,418,743 person-years of observation, and studies of detemir included fewer than 2,047 breast cancer cases (not all studies reported case numbers). Among both new users of glargine and detemir, the SRR was 1.12, suggesting no real association between either glargine or detemir use and breast cancer, he said.
“One important take-home message is that you have to be careful that these pharmaco-epidemiological studies, even when working with the same database, may have conflicting results ... so we still need more robust standards in methods for [such] studies,” he concluded.
Ms. Bota reported having no disclosures. The study presented by Dr. Boyle was funded by Sanofi. Dr. Boyle is president of a charity that has received donations from Pfizer, Roche, Novartis, and Lilly.
SOURCE: Bota M. ADA 2018, Abstract 180-OR; Boyle P. ADA 2018, Abstract 133-OR.
ORLANDO – findings from meta-analyses suggest.
In one meta-analysis of data from 21 prospective studies with a total of nearly 15.2 million women, 325,117 breast cancer cases, and a mean follow-up time of 8 years (nearly 33 million person-years), the risk of breast cancer was significantly greater among patients with diabetes than it was among patients without diabetes (summary relative risk, 1.11), Maria Bota reported at the annual scientific sessions of the American Diabetes Association.
However, there was substantial unexplained heterogeneity of results across the individual studies (I2 = 82%), said Ms. Bota, a faculty member at the International Prevention Research Institute, Lyon, France.
“When the analysis was restricted to the 12 studies that adjusted for [body mass index], the summary relative risk decreased to 1.09 and the heterogeneity also decreased to a moderate value of 32%; when the analysis was restricted to the 9 studies that did not adjust for BMI, the summary relative risk increased to 1.14 again, and the heterogeneity increased even more to 91%,” she said.
In an analysis that combined the results of the nine studies that did not adjust for BMI along with crude relative risks from studies that reported both crude and BMI-adjusted relative risks (17 studies in all), the SRR was 1.12, and heterogeneity among the studies was high at 84%.
Additionally, an analysis by menopausal status based on four studies that reported breast cancer in both pre- and postmenopausal women showed SRRs for breast cancer of 0.97 (a 3% decrease in risk) and 1.14 among diabetic vs. nondiabetic premenopausal women and postmenopausal women, respectively, she said, noting that heterogeneity was low (I2 = 0%) among the premenopausal breast cancer study groups and high (I2 = 70%) among the postmenopausal study groups.
The findings provide evidence for a moderately increased risk of breast cancer in women with T2DM, Ms. Bota said.
“However, the effect of the adjustment or lack of adjustment on the heterogeneity suggests that the higher risk of breast cancer in women with diabetes may not be due to diabetes itself, but to adiposity,” she said, adding that “this hypothesis is equally supported by our subgroup analysis according to menopausal status because we saw that the risk of breast cancer was only associated with diabetes in postmenopausal women and this pattern resembles the pattern of the risk of breast cancer associated with adiposity, which is also only increased in postmenopausal women.”
This study was limited by insufficient data for investigating the sources of heterogeneity, she said.
“Therefore we propose ... future pooled analyses based on individual data from good quality prospective studies in order to increase the study power and to do some detailed analysis of the links between adiposity, diabetes, and breast cancer,” she concluded, adding that new studies to examine those relationships only in premenopausal women are also needed
In a separate meta-analysis, she and her colleagues, including Peter Boyle, PhD, president of the International Prevention Research Institute, assessed the association between insulin treatment and breast cancer risk in patients with diabetes.
“The long-acting insulin analogues glargine and detemir have been shown in some studies to be associated with increased risk of breast cancer, and other studies have shown no association between the use of these two compounds and the risk of breast cancer,” Dr. Boyle said in a separate presentation at the ADA meeting. “It was important to sort out a little bit what was going on in the literature.”
Overall, the meta-analysis of data from 12 longitudinal cohort studies – including more than 6,000 cases of breast cancer – showed a slight increase in breast cancer risk in patients taking long-acting insulin (SRR, 1.13) with “a relatively reasonable” level of heterogeneity (I2 = 23%).
“But we see that the story is not that simple,” he said.
For example, some studies included only patients who were prescribed insulin for the first time after the study began (new users), some included only patients who were prescribed insulin before the study began (prevalent users), and some included both (ever users), which may have introduced bias in the results, he explained.
Studies of glargine included 4,168 breast cancer cases over a total of 1,418,743 person-years of observation, and studies of detemir included fewer than 2,047 breast cancer cases (not all studies reported case numbers). Among both new users of glargine and detemir, the SRR was 1.12, suggesting no real association between either glargine or detemir use and breast cancer, he said.
“One important take-home message is that you have to be careful that these pharmaco-epidemiological studies, even when working with the same database, may have conflicting results ... so we still need more robust standards in methods for [such] studies,” he concluded.
Ms. Bota reported having no disclosures. The study presented by Dr. Boyle was funded by Sanofi. Dr. Boyle is president of a charity that has received donations from Pfizer, Roche, Novartis, and Lilly.
SOURCE: Bota M. ADA 2018, Abstract 180-OR; Boyle P. ADA 2018, Abstract 133-OR.
REPORTING FROM ADA 2018
Key clinical point: Adiposity accounts for the increased risk of breast cancer among women with diabetes.
Major finding: An analysis of 12 studies that adjusted for BMI showed a summary relative risk for breast cancer of 1.09 in diabetic versus nondiabetic women, with moderate study heterogeneity.
Study details: Meta-analyses including 21 and 12 studies, respectively.
Disclosures: Ms. Bota reported having no disclosures. The study presented by Dr. Boyle was funded by Sanofi. Dr. Boyle is president of a charity that has received donations from Pfizer, Roche, Novartis, and Lilly.
Source: Bota M. ADA 2018, Abstract 180-OR; Boyle P. ADA 2018, Abstract 133-OR.
Agrees that OC use clearly reduces mortality
Agrees that OC use clearly reduces mortality
Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.1,2 Newer OCs increase women’s overall survival.
In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.3
Dr. Stavros Saripanidis
Thessaloniki, Greece
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Merritt MA, Riboli E, Murphy N, et al. Reproductive factors and risk of mortality in the European Prospective Investigation into Cancer and Nutrition: a cohort study. BMC Med. 2015;13:252.
- Iversen L, Sivasubramaniam S, Lee AJ, Fielding S, Hannaford PC. Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners’ Oral Contraception Study. Am J Obstet Gynecol. 2017;216(6):580.e1–580.e9.
- Aune D, Sen A, Prasad M, et al. BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 3.74 million deaths among 30.3 million participants. BMJ. 2016;353:i2156.
Agrees that OC use clearly reduces mortality
Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.1,2 Newer OCs increase women’s overall survival.
In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.3
Dr. Stavros Saripanidis
Thessaloniki, Greece
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Agrees that OC use clearly reduces mortality
Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.1,2 Newer OCs increase women’s overall survival.
In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.3
Dr. Stavros Saripanidis
Thessaloniki, Greece
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Merritt MA, Riboli E, Murphy N, et al. Reproductive factors and risk of mortality in the European Prospective Investigation into Cancer and Nutrition: a cohort study. BMC Med. 2015;13:252.
- Iversen L, Sivasubramaniam S, Lee AJ, Fielding S, Hannaford PC. Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners’ Oral Contraception Study. Am J Obstet Gynecol. 2017;216(6):580.e1–580.e9.
- Aune D, Sen A, Prasad M, et al. BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 3.74 million deaths among 30.3 million participants. BMJ. 2016;353:i2156.
- Merritt MA, Riboli E, Murphy N, et al. Reproductive factors and risk of mortality in the European Prospective Investigation into Cancer and Nutrition: a cohort study. BMC Med. 2015;13:252.
- Iversen L, Sivasubramaniam S, Lee AJ, Fielding S, Hannaford PC. Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners’ Oral Contraception Study. Am J Obstet Gynecol. 2017;216(6):580.e1–580.e9.
- Aune D, Sen A, Prasad M, et al. BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 3.74 million deaths among 30.3 million participants. BMJ. 2016;353:i2156.
Breast cancer patients getting unnecessary scans against recommendations
PHOENIX – Despite clear guidance on lack of benefit and potential harms, many patients with early-stage breast cancers at low metastasis risk have undergone imaging tests for staging, recent retrospective studies have shown.
Nearly one-third of early-stage breast cancer patients received the unnecessary and potentially harmful interventions in one of the two studies presented at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).
Low-risk patients in that study were more likely to undergo imaging if they were younger or had triple-negative disease, among other factors, said researcher Brett Barlow, of the University of Alabama at Birmingham.
Physicians should be further educated about the low-risk nature of early-stage breast cancer, even in subgroups that are perceived to be higher risk, Mr. Barlow said in an interview.
“I think we can reassure physicians that these patients will do well and that these guidelines are based on good data,” he said “There could potentially be an element of distrust in these guidelines in these higher-risk patients, and that may be what’s driving some of these extra tests.”
According to Mr. Barlow, imaging low-risk patients is inconsistent with guidance from Choosing Wisely, an initiative designed to promote discussions between clinicians and patients about medical tests or procedures that are unnecessary.
As part of that initiative, ASCO recommended that PET, CT, and radionuclide bone scans should not be performed for staging of early-stage breast cancer at low risk for metastasis.
There is a lack of evidence that demonstrates a benefit for those imaging modalities in patients with newly identified ductal carcinoma in situ (DCIS) or clinical stage I or II disease, the society said at the time.
Unnecessary imaging can result in unnecessary invasive procedures, overtreatment, radiation exposure, and misdiagnosis, the society said in the guidance, which was published in 2012.
Despite the guidance, 262 out of 872 patients with stage 0-II breast cancer (30%) seen during 2013-2015 underwent imaging, according to results of the single-center retrospective cohort study Mr. Barlow and his coauthors described in a poster presentation.
The median age of the patients who underwent unnecessary imaging was 55 years versus 60 years for patients who did not, according to the researchers.
Risk of inappropriate imaging was increased in younger patients, those with triple-negative disease versus those with any hormone receptor–positive disease, those with higher-stage breast cancer, and those without Medicare insurance, investigators found.
Although it’s unclear whether there were any formal, institution-level efforts to promote the ASCO recommendations during the 2013-2015 period, it was “definitely a topic of debate at the time,” Mr. Barlow said.
“Something we hope to evaluate further is whether we have improved,” he said. “It’s important to set a baseline and see how we did in this area. We look forward to reevaluating that in a few years to see.”
In a separate study, investigators reviewed records from Mount Sinai Health System in New York and found that unnecessary scans were performed in 19% of patients diagnosed with stage I-II breast cancer during 2014-2015.
No cases of metastatic disease were found in 733 patients included in the study, and 43% had false-positive findings, according to Ana I. Velazquez Manana, MD, MS, of Mount Sinai Beth Israel Foundation, New York, and her coinvestigators.
Imaging increased costs by $4,480 per patient, according to the investigators, who found in multivariate analysis that the unnecessary scans were associated with young age, presence of T2 tumor, positive lymph nodes, and triple-negative disease.
“Further educational efforts are needed to avoid unnecessary scans in patients with early-stage breast cancer,” the researchers wrote in an abstract describing the results.
Mr. Barlow reported no disclosures, while one coauthor reported disclosures related to Carevive Systems, Genentech/Roche, Medscape, Pack Health, and Pfizer. Dr. Velazquez Manana and her coauthors had no relationships to disclose, and their study was funded by the Medical Student Rotation for Underrepresented Populations.
SOURCE: Barlow B et al. Quality Care Symposium, Abstract 51. Velazquez Manana AI et al. Quality Care Symposium, Abstract 52.
PHOENIX – Despite clear guidance on lack of benefit and potential harms, many patients with early-stage breast cancers at low metastasis risk have undergone imaging tests for staging, recent retrospective studies have shown.
Nearly one-third of early-stage breast cancer patients received the unnecessary and potentially harmful interventions in one of the two studies presented at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).
Low-risk patients in that study were more likely to undergo imaging if they were younger or had triple-negative disease, among other factors, said researcher Brett Barlow, of the University of Alabama at Birmingham.
Physicians should be further educated about the low-risk nature of early-stage breast cancer, even in subgroups that are perceived to be higher risk, Mr. Barlow said in an interview.
“I think we can reassure physicians that these patients will do well and that these guidelines are based on good data,” he said “There could potentially be an element of distrust in these guidelines in these higher-risk patients, and that may be what’s driving some of these extra tests.”
According to Mr. Barlow, imaging low-risk patients is inconsistent with guidance from Choosing Wisely, an initiative designed to promote discussions between clinicians and patients about medical tests or procedures that are unnecessary.
As part of that initiative, ASCO recommended that PET, CT, and radionuclide bone scans should not be performed for staging of early-stage breast cancer at low risk for metastasis.
There is a lack of evidence that demonstrates a benefit for those imaging modalities in patients with newly identified ductal carcinoma in situ (DCIS) or clinical stage I or II disease, the society said at the time.
Unnecessary imaging can result in unnecessary invasive procedures, overtreatment, radiation exposure, and misdiagnosis, the society said in the guidance, which was published in 2012.
Despite the guidance, 262 out of 872 patients with stage 0-II breast cancer (30%) seen during 2013-2015 underwent imaging, according to results of the single-center retrospective cohort study Mr. Barlow and his coauthors described in a poster presentation.
The median age of the patients who underwent unnecessary imaging was 55 years versus 60 years for patients who did not, according to the researchers.
Risk of inappropriate imaging was increased in younger patients, those with triple-negative disease versus those with any hormone receptor–positive disease, those with higher-stage breast cancer, and those without Medicare insurance, investigators found.
Although it’s unclear whether there were any formal, institution-level efforts to promote the ASCO recommendations during the 2013-2015 period, it was “definitely a topic of debate at the time,” Mr. Barlow said.
“Something we hope to evaluate further is whether we have improved,” he said. “It’s important to set a baseline and see how we did in this area. We look forward to reevaluating that in a few years to see.”
In a separate study, investigators reviewed records from Mount Sinai Health System in New York and found that unnecessary scans were performed in 19% of patients diagnosed with stage I-II breast cancer during 2014-2015.
No cases of metastatic disease were found in 733 patients included in the study, and 43% had false-positive findings, according to Ana I. Velazquez Manana, MD, MS, of Mount Sinai Beth Israel Foundation, New York, and her coinvestigators.
Imaging increased costs by $4,480 per patient, according to the investigators, who found in multivariate analysis that the unnecessary scans were associated with young age, presence of T2 tumor, positive lymph nodes, and triple-negative disease.
“Further educational efforts are needed to avoid unnecessary scans in patients with early-stage breast cancer,” the researchers wrote in an abstract describing the results.
Mr. Barlow reported no disclosures, while one coauthor reported disclosures related to Carevive Systems, Genentech/Roche, Medscape, Pack Health, and Pfizer. Dr. Velazquez Manana and her coauthors had no relationships to disclose, and their study was funded by the Medical Student Rotation for Underrepresented Populations.
SOURCE: Barlow B et al. Quality Care Symposium, Abstract 51. Velazquez Manana AI et al. Quality Care Symposium, Abstract 52.
PHOENIX – Despite clear guidance on lack of benefit and potential harms, many patients with early-stage breast cancers at low metastasis risk have undergone imaging tests for staging, recent retrospective studies have shown.
Nearly one-third of early-stage breast cancer patients received the unnecessary and potentially harmful interventions in one of the two studies presented at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).
Low-risk patients in that study were more likely to undergo imaging if they were younger or had triple-negative disease, among other factors, said researcher Brett Barlow, of the University of Alabama at Birmingham.
Physicians should be further educated about the low-risk nature of early-stage breast cancer, even in subgroups that are perceived to be higher risk, Mr. Barlow said in an interview.
“I think we can reassure physicians that these patients will do well and that these guidelines are based on good data,” he said “There could potentially be an element of distrust in these guidelines in these higher-risk patients, and that may be what’s driving some of these extra tests.”
According to Mr. Barlow, imaging low-risk patients is inconsistent with guidance from Choosing Wisely, an initiative designed to promote discussions between clinicians and patients about medical tests or procedures that are unnecessary.
As part of that initiative, ASCO recommended that PET, CT, and radionuclide bone scans should not be performed for staging of early-stage breast cancer at low risk for metastasis.
There is a lack of evidence that demonstrates a benefit for those imaging modalities in patients with newly identified ductal carcinoma in situ (DCIS) or clinical stage I or II disease, the society said at the time.
Unnecessary imaging can result in unnecessary invasive procedures, overtreatment, radiation exposure, and misdiagnosis, the society said in the guidance, which was published in 2012.
Despite the guidance, 262 out of 872 patients with stage 0-II breast cancer (30%) seen during 2013-2015 underwent imaging, according to results of the single-center retrospective cohort study Mr. Barlow and his coauthors described in a poster presentation.
The median age of the patients who underwent unnecessary imaging was 55 years versus 60 years for patients who did not, according to the researchers.
Risk of inappropriate imaging was increased in younger patients, those with triple-negative disease versus those with any hormone receptor–positive disease, those with higher-stage breast cancer, and those without Medicare insurance, investigators found.
Although it’s unclear whether there were any formal, institution-level efforts to promote the ASCO recommendations during the 2013-2015 period, it was “definitely a topic of debate at the time,” Mr. Barlow said.
“Something we hope to evaluate further is whether we have improved,” he said. “It’s important to set a baseline and see how we did in this area. We look forward to reevaluating that in a few years to see.”
In a separate study, investigators reviewed records from Mount Sinai Health System in New York and found that unnecessary scans were performed in 19% of patients diagnosed with stage I-II breast cancer during 2014-2015.
No cases of metastatic disease were found in 733 patients included in the study, and 43% had false-positive findings, according to Ana I. Velazquez Manana, MD, MS, of Mount Sinai Beth Israel Foundation, New York, and her coinvestigators.
Imaging increased costs by $4,480 per patient, according to the investigators, who found in multivariate analysis that the unnecessary scans were associated with young age, presence of T2 tumor, positive lymph nodes, and triple-negative disease.
“Further educational efforts are needed to avoid unnecessary scans in patients with early-stage breast cancer,” the researchers wrote in an abstract describing the results.
Mr. Barlow reported no disclosures, while one coauthor reported disclosures related to Carevive Systems, Genentech/Roche, Medscape, Pack Health, and Pfizer. Dr. Velazquez Manana and her coauthors had no relationships to disclose, and their study was funded by the Medical Student Rotation for Underrepresented Populations.
SOURCE: Barlow B et al. Quality Care Symposium, Abstract 51. Velazquez Manana AI et al. Quality Care Symposium, Abstract 52.
REPORTING FROM THE QUALITY CARE SYMPOSIUM
Key clinical point: Many patients with early breast cancers at low metastasis risk received imaging tests for staging despite ASCO recommendations against such testing.
Major finding: In two studies, 30% and 19% of low-risk breast cancer patients underwent imaging for staging.
Study details: Two single-center, retrospective cohort studies that included 872 and 733 patients, respectively.
Disclosures: In one study, researchers reported disclosures related to Carevive Systems, Genentech/Roche, Medscape, Pack Health, and Pfizer. The second study was funded by the Medical Student Rotation for Underrepresented Populations.
Source: Barlow B et al. Quality Care Symposium, Abstract 51; Velazquez Manana AI et al. Quality Care Symposium, Abstract 52.
High Risk Breast Cancer Screening Pilot Program in Accordance With National Guidelines
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Metastatic breast cancer lesions immunologically depleted compared with primary
The immune microenvironment of metastatic breast cancer lesions is relatively inert and depleted versus primary tumors, results of a recent study suggest.
“These results predict that immune therapy may be more successful in early stage breast cancers rather than in metastatic disease,” Lajos Pusztai, MD, and study coinvestigators reported in Annals of Oncology.
However, metastatic breast cancers showed high expression levels of some targetable molecules that may provide a “foundation for rational immunotherapy combination strategies,” wrote Dr. Pusztai, director of breast cancer translational research at Yale Cancer Center, New Haven, Conn., and his coinvestigators.
The investigators looked at tumor PD-L1 protein expression, tumor infiltrating lymphocyte (TIL) count, and mRNA expression for 730 immune-related genes in both primary and metastatic cancer samples obtained from pathologists at Yale.
The study included one cohort with full sections of paired metastatic and primary tumors from 45 patients, and a second cohort of tissue microarrays from 55 other patients.
Compared with primary lesions, metastatic lesions had substantially lower levels of PD-L1 expression and TIL counts, the investigators found.
Staining of PD-L1 was primarily seen in stromal immune cells, rather than tumor cells, according to investigators. The median stromal PD-L1 positivity was 14% for metastases and 52% for primary tumors in the first cohort (P = .0004), and 7% for metastases and 22% for primary tumors in the second cohort (P = .03).
They also reported significant decreased TIL counts in metastatic lesions for both the first (P = .026) and second (P = .089) cohorts, the report shows.
Immune gene expression profiling results, similarly, showed that most immune cell types and functions were “depleted” in the metastatic lesions, including a decreased mRNA expression of CTLA4, Dr. Pusztai and his colleagues reported.
The “lesser immunogenicity” of metastatic breast cancer cells was shown by decreased expression of immune proteasome and MHC class I genes, along with increased expression of HLA-E, which has been shown to suppress immunity, and reduced presence of dendritic cells, they said.
However, they also found high expression of targetable molecules in metastatic lesions. Those included macrophage markers such as CD68 and CD163, cytokine ligand/receptor pairs that mediate pro-tumorigenic effects, such as CCL2/CCR2 and CXCR4/CXCL12, and signaling molecules such as STAT-3 and JAK2, among others.
“We suggest that targeting these molecules may lead to synergy with PD1/PD-L1 blockade in metastatic breast cancer,” they wrote.
The work by Dr. Pusztai and his colleagues was supported by the Breast Cancer Research Foundation, Susan G Komen for the Cure, Department of Defense Breast Cancer Research Program Awards, and the Rosztoczy Foundation. The authors declared no conflicts of interest.
SOURCE: Szekely B, et al. Ann Oncol. 2018 Sep 10. doi: 10.1093/annonc/mdy399.
The immune microenvironment of metastatic breast cancer lesions is relatively inert and depleted versus primary tumors, results of a recent study suggest.
“These results predict that immune therapy may be more successful in early stage breast cancers rather than in metastatic disease,” Lajos Pusztai, MD, and study coinvestigators reported in Annals of Oncology.
However, metastatic breast cancers showed high expression levels of some targetable molecules that may provide a “foundation for rational immunotherapy combination strategies,” wrote Dr. Pusztai, director of breast cancer translational research at Yale Cancer Center, New Haven, Conn., and his coinvestigators.
The investigators looked at tumor PD-L1 protein expression, tumor infiltrating lymphocyte (TIL) count, and mRNA expression for 730 immune-related genes in both primary and metastatic cancer samples obtained from pathologists at Yale.
The study included one cohort with full sections of paired metastatic and primary tumors from 45 patients, and a second cohort of tissue microarrays from 55 other patients.
Compared with primary lesions, metastatic lesions had substantially lower levels of PD-L1 expression and TIL counts, the investigators found.
Staining of PD-L1 was primarily seen in stromal immune cells, rather than tumor cells, according to investigators. The median stromal PD-L1 positivity was 14% for metastases and 52% for primary tumors in the first cohort (P = .0004), and 7% for metastases and 22% for primary tumors in the second cohort (P = .03).
They also reported significant decreased TIL counts in metastatic lesions for both the first (P = .026) and second (P = .089) cohorts, the report shows.
Immune gene expression profiling results, similarly, showed that most immune cell types and functions were “depleted” in the metastatic lesions, including a decreased mRNA expression of CTLA4, Dr. Pusztai and his colleagues reported.
The “lesser immunogenicity” of metastatic breast cancer cells was shown by decreased expression of immune proteasome and MHC class I genes, along with increased expression of HLA-E, which has been shown to suppress immunity, and reduced presence of dendritic cells, they said.
However, they also found high expression of targetable molecules in metastatic lesions. Those included macrophage markers such as CD68 and CD163, cytokine ligand/receptor pairs that mediate pro-tumorigenic effects, such as CCL2/CCR2 and CXCR4/CXCL12, and signaling molecules such as STAT-3 and JAK2, among others.
“We suggest that targeting these molecules may lead to synergy with PD1/PD-L1 blockade in metastatic breast cancer,” they wrote.
The work by Dr. Pusztai and his colleagues was supported by the Breast Cancer Research Foundation, Susan G Komen for the Cure, Department of Defense Breast Cancer Research Program Awards, and the Rosztoczy Foundation. The authors declared no conflicts of interest.
SOURCE: Szekely B, et al. Ann Oncol. 2018 Sep 10. doi: 10.1093/annonc/mdy399.
The immune microenvironment of metastatic breast cancer lesions is relatively inert and depleted versus primary tumors, results of a recent study suggest.
“These results predict that immune therapy may be more successful in early stage breast cancers rather than in metastatic disease,” Lajos Pusztai, MD, and study coinvestigators reported in Annals of Oncology.
However, metastatic breast cancers showed high expression levels of some targetable molecules that may provide a “foundation for rational immunotherapy combination strategies,” wrote Dr. Pusztai, director of breast cancer translational research at Yale Cancer Center, New Haven, Conn., and his coinvestigators.
The investigators looked at tumor PD-L1 protein expression, tumor infiltrating lymphocyte (TIL) count, and mRNA expression for 730 immune-related genes in both primary and metastatic cancer samples obtained from pathologists at Yale.
The study included one cohort with full sections of paired metastatic and primary tumors from 45 patients, and a second cohort of tissue microarrays from 55 other patients.
Compared with primary lesions, metastatic lesions had substantially lower levels of PD-L1 expression and TIL counts, the investigators found.
Staining of PD-L1 was primarily seen in stromal immune cells, rather than tumor cells, according to investigators. The median stromal PD-L1 positivity was 14% for metastases and 52% for primary tumors in the first cohort (P = .0004), and 7% for metastases and 22% for primary tumors in the second cohort (P = .03).
They also reported significant decreased TIL counts in metastatic lesions for both the first (P = .026) and second (P = .089) cohorts, the report shows.
Immune gene expression profiling results, similarly, showed that most immune cell types and functions were “depleted” in the metastatic lesions, including a decreased mRNA expression of CTLA4, Dr. Pusztai and his colleagues reported.
The “lesser immunogenicity” of metastatic breast cancer cells was shown by decreased expression of immune proteasome and MHC class I genes, along with increased expression of HLA-E, which has been shown to suppress immunity, and reduced presence of dendritic cells, they said.
However, they also found high expression of targetable molecules in metastatic lesions. Those included macrophage markers such as CD68 and CD163, cytokine ligand/receptor pairs that mediate pro-tumorigenic effects, such as CCL2/CCR2 and CXCR4/CXCL12, and signaling molecules such as STAT-3 and JAK2, among others.
“We suggest that targeting these molecules may lead to synergy with PD1/PD-L1 blockade in metastatic breast cancer,” they wrote.
The work by Dr. Pusztai and his colleagues was supported by the Breast Cancer Research Foundation, Susan G Komen for the Cure, Department of Defense Breast Cancer Research Program Awards, and the Rosztoczy Foundation. The authors declared no conflicts of interest.
SOURCE: Szekely B, et al. Ann Oncol. 2018 Sep 10. doi: 10.1093/annonc/mdy399.
FROM ANNALS OF ONCOLOGY
Key clinical point: The immune microenvironment of metastatic breast cancer lesions is relatively inert and depleted versus primary tumors.
Major finding: Median stromal PD-L1 positivity was 14% for metastases and 52% for primary tumors in one cohort (P = .0004), and 7% versus 22% in a second (P = .03).
Study details: Analysis of breast cancer tissue samples (primary tumor and metastatic lesions) from 90 patients
Disclosures: The work was supported by the Breast Cancer Research Foundation, the Susan Komen for the Cure, Department of Defense Breast Cancer Research Program Awards, and the Rosztoczy Foundation. The study authors declared no conflicts of interest.
Source: Szekely B et al. Ann Oncol. 2018 Sep 10. doi: 10.1093/annonc/mdy399.
Outcomes similar for concurrent versus sequential treatment in HER2-positive breast cancers
Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.
Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.
The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.
In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m2 of fluorouracil, 75 mg/m2 epirubicin, and 500 mg/m2 cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m2 and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.
Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.
As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.
The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”
The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.
SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.
Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.
Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.
The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.
In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m2 of fluorouracil, 75 mg/m2 epirubicin, and 500 mg/m2 cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m2 and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.
Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.
As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.
The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”
The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.
SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.
Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.
Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.
The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.
In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m2 of fluorouracil, 75 mg/m2 epirubicin, and 500 mg/m2 cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m2 and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.
Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.
As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.
The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”
The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.
SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.
FROM JAMA ONCOLOGY
Key clinical point: Sequencing of chemotherapy, paclitaxel, and trastuzumab did not affect outcomes in women with HER2-positive breast cancers.
Major finding: There were no significant differences in disease-free survival or overall survival among treated with concurrent or sequential therapy.
Study details: A phase 3, randomized trial in 280 women with operable HER2-positive breast cancers.
Disclosures: The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.
Source: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.