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Docs, insurers condemn latest ‘repeal and replace’ plan
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
AGA is also concerned that there are no guarantees that states have to provide essential benefits, patients that gained coverage through the ACA would lose that coverage, and most importantly, patients with pre-existing conditions have no guarantee that they will continue to receive affordable coverage.
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
AGA is also concerned that there are no guarantees that states have to provide essential benefits, patients that gained coverage through the ACA would lose that coverage, and most importantly, patients with pre-existing conditions have no guarantee that they will continue to receive affordable coverage.
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
AGA is also concerned that there are no guarantees that states have to provide essential benefits, patients that gained coverage through the ACA would lose that coverage, and most importantly, patients with pre-existing conditions have no guarantee that they will continue to receive affordable coverage.
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.
Comments sought on VTE Guidelines
The American Society of Hematology (ASH) is seeking feedback from SVS members by Oct. 2 on its draft recommendations for ASH guidelines on VTE in the context of pregnancy and Heparin-Induced Thrombocytopenia.
The guidelines have been posted for comment. Members can review the comment page here and download the draft recommendations. The page includes a link to the online survey where members can provide their comments.
The American Society of Hematology (ASH) is seeking feedback from SVS members by Oct. 2 on its draft recommendations for ASH guidelines on VTE in the context of pregnancy and Heparin-Induced Thrombocytopenia.
The guidelines have been posted for comment. Members can review the comment page here and download the draft recommendations. The page includes a link to the online survey where members can provide their comments.
The American Society of Hematology (ASH) is seeking feedback from SVS members by Oct. 2 on its draft recommendations for ASH guidelines on VTE in the context of pregnancy and Heparin-Induced Thrombocytopenia.
The guidelines have been posted for comment. Members can review the comment page here and download the draft recommendations. The page includes a link to the online survey where members can provide their comments.
How is MACRA Data Gathering Going? Final 2017 90-day Reporting Period Begins Oct. 2
Payment adjustments for Medicare reimbursement come in 2019 -- but the adjustments are based on data being collected now, in 2017. If you have not begun collecting data as yet, you MUST begin no later than Oct. 2, 2017!
You will be required to send in your performance data no later than March 31, 2018. If your practice is participating in a CMS-approved Alternative Payment Model (APM), MIPS participation is not required. For 2017 there is currently no APM specific to vascular surgery. The SVS has formed a Task Force to develop a vascular APM.
The first payment adjustments based on performance go into effect on Jan. 1, 2019. Those members who do not participate in 2017 will receive a 4 percent penalty from Medicare.
SVS has held four webinars recently helping members learn what they need to know for the changes. View the materials here.
Payment adjustments for Medicare reimbursement come in 2019 -- but the adjustments are based on data being collected now, in 2017. If you have not begun collecting data as yet, you MUST begin no later than Oct. 2, 2017!
You will be required to send in your performance data no later than March 31, 2018. If your practice is participating in a CMS-approved Alternative Payment Model (APM), MIPS participation is not required. For 2017 there is currently no APM specific to vascular surgery. The SVS has formed a Task Force to develop a vascular APM.
The first payment adjustments based on performance go into effect on Jan. 1, 2019. Those members who do not participate in 2017 will receive a 4 percent penalty from Medicare.
SVS has held four webinars recently helping members learn what they need to know for the changes. View the materials here.
Payment adjustments for Medicare reimbursement come in 2019 -- but the adjustments are based on data being collected now, in 2017. If you have not begun collecting data as yet, you MUST begin no later than Oct. 2, 2017!
You will be required to send in your performance data no later than March 31, 2018. If your practice is participating in a CMS-approved Alternative Payment Model (APM), MIPS participation is not required. For 2017 there is currently no APM specific to vascular surgery. The SVS has formed a Task Force to develop a vascular APM.
The first payment adjustments based on performance go into effect on Jan. 1, 2019. Those members who do not participate in 2017 will receive a 4 percent penalty from Medicare.
SVS has held four webinars recently helping members learn what they need to know for the changes. View the materials here.
Do Post-Transplant Tests Show Recurring Multiple Myeloma?
After stem cell therapy, profiles may show a pattern of antibodies that can look very much like the “M spike”—the signature of the monoclonal antibody produced by multiple myeloma (MM). But that pattern, called an oligoclonal band, can be misleading.
“Oligoclonal bands should mostly be recognized as a response to treatment and not be mistaken as a recurrence of the original tumor,” says Dr. Gurmukh Singh, vice chair of clinical affairs for the Department of Pathology at the Medical College of Georgia at Augusta University.
He and his research team analyzed data from 251 patients with MM, 159 of whom had received autologous stem cell transplants. The researchers performed tests using serum protein electrophoresis/serum immunofixation electrophoresis and serum free light chain assay. Each patient had at least 3 tests, with at least 2 following the transplant.
The researchers found the incidence of oligoclonal patterns was dramatically higher in patients who had a stem cell transplant, compared with patients who had chemotherapy alone (57.9% vs 8.8%). Moreover, only 5 of the 159 patients who received a transplant had an oligoclonal pattern before treatment, but 92 had 1 afterward. More than half the oligoclonal patterns developed within the first year following transplant. The earliest pattern was detected at 2 months and a few as long as 5 years later.
The key to assessing response, Singh says, is to see where the spike appears: that is, where the monoclonal spike is at diagnosis compared with any new spikes that appear in oligoclonal bands after stem cell treatment. “If the original peak was at location A, [and] now the peak is location B, that allows us to determine that it is not the same abnormal, malignant antibody.”
The finding that 58% of patients had the oligoclonal pattern after transplant is likely an underestimate due to irregular schedule of testing, the researchers say. They add that their findings highlight the need for higher resolution electrophoretic methods to obviate the need for using mass spectrometry for clinical samples. Their results “cast more doubt on the clinical usefulness and medical necessity of the serum free light chain assay.”
Source:
Baker T. Results after stem cell transplant can confuse patients and doctors about cancer’s status. Jagwire News. https://jagwire.augusta.edu/archives/46434. Published August 2017. Accessed September 20, 2017.
Singh G. J Clin Med Res. 2017;9(8):671-679.
doi: 10.14740/jocmr3049w.
After stem cell therapy, profiles may show a pattern of antibodies that can look very much like the “M spike”—the signature of the monoclonal antibody produced by multiple myeloma (MM). But that pattern, called an oligoclonal band, can be misleading.
“Oligoclonal bands should mostly be recognized as a response to treatment and not be mistaken as a recurrence of the original tumor,” says Dr. Gurmukh Singh, vice chair of clinical affairs for the Department of Pathology at the Medical College of Georgia at Augusta University.
He and his research team analyzed data from 251 patients with MM, 159 of whom had received autologous stem cell transplants. The researchers performed tests using serum protein electrophoresis/serum immunofixation electrophoresis and serum free light chain assay. Each patient had at least 3 tests, with at least 2 following the transplant.
The researchers found the incidence of oligoclonal patterns was dramatically higher in patients who had a stem cell transplant, compared with patients who had chemotherapy alone (57.9% vs 8.8%). Moreover, only 5 of the 159 patients who received a transplant had an oligoclonal pattern before treatment, but 92 had 1 afterward. More than half the oligoclonal patterns developed within the first year following transplant. The earliest pattern was detected at 2 months and a few as long as 5 years later.
The key to assessing response, Singh says, is to see where the spike appears: that is, where the monoclonal spike is at diagnosis compared with any new spikes that appear in oligoclonal bands after stem cell treatment. “If the original peak was at location A, [and] now the peak is location B, that allows us to determine that it is not the same abnormal, malignant antibody.”
The finding that 58% of patients had the oligoclonal pattern after transplant is likely an underestimate due to irregular schedule of testing, the researchers say. They add that their findings highlight the need for higher resolution electrophoretic methods to obviate the need for using mass spectrometry for clinical samples. Their results “cast more doubt on the clinical usefulness and medical necessity of the serum free light chain assay.”
Source:
Baker T. Results after stem cell transplant can confuse patients and doctors about cancer’s status. Jagwire News. https://jagwire.augusta.edu/archives/46434. Published August 2017. Accessed September 20, 2017.
Singh G. J Clin Med Res. 2017;9(8):671-679.
doi: 10.14740/jocmr3049w.
After stem cell therapy, profiles may show a pattern of antibodies that can look very much like the “M spike”—the signature of the monoclonal antibody produced by multiple myeloma (MM). But that pattern, called an oligoclonal band, can be misleading.
“Oligoclonal bands should mostly be recognized as a response to treatment and not be mistaken as a recurrence of the original tumor,” says Dr. Gurmukh Singh, vice chair of clinical affairs for the Department of Pathology at the Medical College of Georgia at Augusta University.
He and his research team analyzed data from 251 patients with MM, 159 of whom had received autologous stem cell transplants. The researchers performed tests using serum protein electrophoresis/serum immunofixation electrophoresis and serum free light chain assay. Each patient had at least 3 tests, with at least 2 following the transplant.
The researchers found the incidence of oligoclonal patterns was dramatically higher in patients who had a stem cell transplant, compared with patients who had chemotherapy alone (57.9% vs 8.8%). Moreover, only 5 of the 159 patients who received a transplant had an oligoclonal pattern before treatment, but 92 had 1 afterward. More than half the oligoclonal patterns developed within the first year following transplant. The earliest pattern was detected at 2 months and a few as long as 5 years later.
The key to assessing response, Singh says, is to see where the spike appears: that is, where the monoclonal spike is at diagnosis compared with any new spikes that appear in oligoclonal bands after stem cell treatment. “If the original peak was at location A, [and] now the peak is location B, that allows us to determine that it is not the same abnormal, malignant antibody.”
The finding that 58% of patients had the oligoclonal pattern after transplant is likely an underestimate due to irregular schedule of testing, the researchers say. They add that their findings highlight the need for higher resolution electrophoretic methods to obviate the need for using mass spectrometry for clinical samples. Their results “cast more doubt on the clinical usefulness and medical necessity of the serum free light chain assay.”
Source:
Baker T. Results after stem cell transplant can confuse patients and doctors about cancer’s status. Jagwire News. https://jagwire.augusta.edu/archives/46434. Published August 2017. Accessed September 20, 2017.
Singh G. J Clin Med Res. 2017;9(8):671-679.
doi: 10.14740/jocmr3049w.
Learning About Prediabetes Can be Fun
If statistics and warnings don’t get your patients’ attention about the risk of prediabetes, how about adorable puppies, hedgehogs, and baby goats? DoIHavePrediabetes.org, a CDC campaign, offers a “perfect way to spend a minute”—where viewers can take a quick prediabetes risk test while also watching cute animal videos.
The campaign builds on the success of a previous campaign that was the first of its kind to raise national awareness of prediabetes. Of the 84 million people with prediabetes, most don’t know they have it and are not aware of the long-term risks to their health.
The current campaign urges people to talk with their physicians after taking the test to confirm the diagnosis and learn about lifestyle changes. Through research-based programs such as the one the CDC offers (National Diabetes Prevention Program), people with prediabetes can lower their risk of developing type 2 diabetes by as much as 58%, and by 71% for people aged > 60 years.
The pro bono campaign was developed by Ogilvy New York. Michael Paterson, executive creative director, says, “Through a lighthearted and fun tone, we found more people were willing to take the test—and who doesn’t love to watch baby goats?”
If statistics and warnings don’t get your patients’ attention about the risk of prediabetes, how about adorable puppies, hedgehogs, and baby goats? DoIHavePrediabetes.org, a CDC campaign, offers a “perfect way to spend a minute”—where viewers can take a quick prediabetes risk test while also watching cute animal videos.
The campaign builds on the success of a previous campaign that was the first of its kind to raise national awareness of prediabetes. Of the 84 million people with prediabetes, most don’t know they have it and are not aware of the long-term risks to their health.
The current campaign urges people to talk with their physicians after taking the test to confirm the diagnosis and learn about lifestyle changes. Through research-based programs such as the one the CDC offers (National Diabetes Prevention Program), people with prediabetes can lower their risk of developing type 2 diabetes by as much as 58%, and by 71% for people aged > 60 years.
The pro bono campaign was developed by Ogilvy New York. Michael Paterson, executive creative director, says, “Through a lighthearted and fun tone, we found more people were willing to take the test—and who doesn’t love to watch baby goats?”
If statistics and warnings don’t get your patients’ attention about the risk of prediabetes, how about adorable puppies, hedgehogs, and baby goats? DoIHavePrediabetes.org, a CDC campaign, offers a “perfect way to spend a minute”—where viewers can take a quick prediabetes risk test while also watching cute animal videos.
The campaign builds on the success of a previous campaign that was the first of its kind to raise national awareness of prediabetes. Of the 84 million people with prediabetes, most don’t know they have it and are not aware of the long-term risks to their health.
The current campaign urges people to talk with their physicians after taking the test to confirm the diagnosis and learn about lifestyle changes. Through research-based programs such as the one the CDC offers (National Diabetes Prevention Program), people with prediabetes can lower their risk of developing type 2 diabetes by as much as 58%, and by 71% for people aged > 60 years.
The pro bono campaign was developed by Ogilvy New York. Michael Paterson, executive creative director, says, “Through a lighthearted and fun tone, we found more people were willing to take the test—and who doesn’t love to watch baby goats?”
Cancer patients’ complaints about care
A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.
Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.
A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.
Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.
Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.
The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.
There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.
The complaints were placed in 3 categories—management, relationship, and clinical issues.
For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:
- Service issues—15%
- Delays—13%
- Finance and billing—10%
- Access and admission—6%
- Bureaucracy—2%
- Environment—2%
- Referrals—0.4%.
For 41% of the complaints, “relationship” was the primary category, which encompassed:
- Communication breakdown—15%
- Respect, dignity, caring—15%
- Patient-staff dialogue—5%
- Staff attitudes—3%
- Confidentiality—2%
- Incorrect information—1%.
For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:
- Quality of care—4%
- Skills and conduct—2%
- Patient journey—2%
- Treatment—1%
- Errors in diagnosis—1%
- Safety incidents—1%
- Examinations—0.4%.
Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints
Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.
The following aspects raised the severity level of a complaint:
- Involvement of a prescribing oncologist—27%
- Strong affect of the complainant, including anger—15%
- Allegation of a medical error or suboptimal care—6%
- Request or desire to transfer care to another provider (12%) or institution (5%)
- Mention of malpractice or a desire to pursue legal action—1%.
The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs. 
A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.
Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.
A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.
Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.
Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.
The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.
There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.
The complaints were placed in 3 categories—management, relationship, and clinical issues.
For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:
- Service issues—15%
- Delays—13%
- Finance and billing—10%
- Access and admission—6%
- Bureaucracy—2%
- Environment—2%
- Referrals—0.4%.
For 41% of the complaints, “relationship” was the primary category, which encompassed:
- Communication breakdown—15%
- Respect, dignity, caring—15%
- Patient-staff dialogue—5%
- Staff attitudes—3%
- Confidentiality—2%
- Incorrect information—1%.
For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:
- Quality of care—4%
- Skills and conduct—2%
- Patient journey—2%
- Treatment—1%
- Errors in diagnosis—1%
- Safety incidents—1%
- Examinations—0.4%.
Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints
Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.
The following aspects raised the severity level of a complaint:
- Involvement of a prescribing oncologist—27%
- Strong affect of the complainant, including anger—15%
- Allegation of a medical error or suboptimal care—6%
- Request or desire to transfer care to another provider (12%) or institution (5%)
- Mention of malpractice or a desire to pursue legal action—1%.
The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs.
A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.
Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.
A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.
Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.
Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.
The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.
There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.
The complaints were placed in 3 categories—management, relationship, and clinical issues.
For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:
- Service issues—15%
- Delays—13%
- Finance and billing—10%
- Access and admission—6%
- Bureaucracy—2%
- Environment—2%
- Referrals—0.4%.
For 41% of the complaints, “relationship” was the primary category, which encompassed:
- Communication breakdown—15%
- Respect, dignity, caring—15%
- Patient-staff dialogue—5%
- Staff attitudes—3%
- Confidentiality—2%
- Incorrect information—1%.
For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:
- Quality of care—4%
- Skills and conduct—2%
- Patient journey—2%
- Treatment—1%
- Errors in diagnosis—1%
- Safety incidents—1%
- Examinations—0.4%.
Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints
Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.
The following aspects raised the severity level of a complaint:
- Involvement of a prescribing oncologist—27%
- Strong affect of the complainant, including anger—15%
- Allegation of a medical error or suboptimal care—6%
- Request or desire to transfer care to another provider (12%) or institution (5%)
- Mention of malpractice or a desire to pursue legal action—1%.
The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs.
Severe and Difficult to Treat Asthma
Microbiome predicted response to high-fiber diet
Overweight individuals whose stool samples were abundant in Prevotella species lost about 2.3 kg more body fat on a 6-month high-fiber diet than individuals with a low ratio of Prevotella to Bacteroides, according to a randomized trial of 62 Danish adults.
The findings help explain why a high-fiber diet does not always produce meaningful weight loss, said Mads F. Hjorth, PhD, of the University of Copenhagen, and his associates. An “abundance of Prevotella” in the gut microbiome might underlie the “recent breakthrough in personalized nutrition,” they wrote in the International Journal of Obesity.
At the start of the study, 28 (45%) participants had a high (0.28; 95% confidence interval, 0.11-7.5) ratio of Prevotella to Bacteroides and 34 (55%) had a much lower ratio (0.00007) but did not otherwise differ significantly by age, sex, body weight, or fasting insulin levels. After 26 weeks, the high-Prevotella group lost an average of 3.2 kg more fat on the high-fiber diet than the control diet (P less than .001). In contrast, the low-Prevotella group lost only 0.9 kg more fat with the high-fiber diet, a statistically insignificant difference from the control diet. Changes in waistline circumference reflected the findings – the high-fiber diet produced a 4.8-cm average reduction in the high-Prevotella group, compared with a 0.8-cm reduction in the low-Prevotella group.
Next, the researchers asked all 62 participants to follow the high-fiber diet, but did not provide them with food. After 1 year, the high-Prevotella group had maintained a 1.2-kg weight loss, compared with baseline, while the low-Prevotella group had regained 2.8 kg of body weight (P less than .001). Thus, baseline Prevotella-to-Bacteroides ratio explained a 4-kg difference in responsiveness to the high-fiber diet, the researchers concluded. The difference was even more marked when they excluded eight participants with undetectable levels of Prevotella.
Only two individuals switched from a low to a high Prevotella-to-Bacteroides ratio during the 6-month intervention period, which reflects prior findings that the intestinal microbiome is difficult to shift without “extreme changes, such as complete removal of carbohydrates from the diet,” the researchers wrote. Individual gut microbiome might affect energy absorption from different types of foods, the ability to utilize fiber, gut-brain signaling, or the secretion of hormones affecting appetite, they hypothesized. Thus, Prevotella-to-Bacteroides ratio “may serve as a biomarker to predict future weight loss success on specific diets.”
Gelesis provided funding. Dr. Hjorth and two coinvestigators reported having applied for a patent on the use of biomarkers to predict response to weight loss efforts. The remaining five researchers had no conflicts.
Overweight individuals whose stool samples were abundant in Prevotella species lost about 2.3 kg more body fat on a 6-month high-fiber diet than individuals with a low ratio of Prevotella to Bacteroides, according to a randomized trial of 62 Danish adults.
The findings help explain why a high-fiber diet does not always produce meaningful weight loss, said Mads F. Hjorth, PhD, of the University of Copenhagen, and his associates. An “abundance of Prevotella” in the gut microbiome might underlie the “recent breakthrough in personalized nutrition,” they wrote in the International Journal of Obesity.
At the start of the study, 28 (45%) participants had a high (0.28; 95% confidence interval, 0.11-7.5) ratio of Prevotella to Bacteroides and 34 (55%) had a much lower ratio (0.00007) but did not otherwise differ significantly by age, sex, body weight, or fasting insulin levels. After 26 weeks, the high-Prevotella group lost an average of 3.2 kg more fat on the high-fiber diet than the control diet (P less than .001). In contrast, the low-Prevotella group lost only 0.9 kg more fat with the high-fiber diet, a statistically insignificant difference from the control diet. Changes in waistline circumference reflected the findings – the high-fiber diet produced a 4.8-cm average reduction in the high-Prevotella group, compared with a 0.8-cm reduction in the low-Prevotella group.
Next, the researchers asked all 62 participants to follow the high-fiber diet, but did not provide them with food. After 1 year, the high-Prevotella group had maintained a 1.2-kg weight loss, compared with baseline, while the low-Prevotella group had regained 2.8 kg of body weight (P less than .001). Thus, baseline Prevotella-to-Bacteroides ratio explained a 4-kg difference in responsiveness to the high-fiber diet, the researchers concluded. The difference was even more marked when they excluded eight participants with undetectable levels of Prevotella.
Only two individuals switched from a low to a high Prevotella-to-Bacteroides ratio during the 6-month intervention period, which reflects prior findings that the intestinal microbiome is difficult to shift without “extreme changes, such as complete removal of carbohydrates from the diet,” the researchers wrote. Individual gut microbiome might affect energy absorption from different types of foods, the ability to utilize fiber, gut-brain signaling, or the secretion of hormones affecting appetite, they hypothesized. Thus, Prevotella-to-Bacteroides ratio “may serve as a biomarker to predict future weight loss success on specific diets.”
Gelesis provided funding. Dr. Hjorth and two coinvestigators reported having applied for a patent on the use of biomarkers to predict response to weight loss efforts. The remaining five researchers had no conflicts.
Overweight individuals whose stool samples were abundant in Prevotella species lost about 2.3 kg more body fat on a 6-month high-fiber diet than individuals with a low ratio of Prevotella to Bacteroides, according to a randomized trial of 62 Danish adults.
The findings help explain why a high-fiber diet does not always produce meaningful weight loss, said Mads F. Hjorth, PhD, of the University of Copenhagen, and his associates. An “abundance of Prevotella” in the gut microbiome might underlie the “recent breakthrough in personalized nutrition,” they wrote in the International Journal of Obesity.
At the start of the study, 28 (45%) participants had a high (0.28; 95% confidence interval, 0.11-7.5) ratio of Prevotella to Bacteroides and 34 (55%) had a much lower ratio (0.00007) but did not otherwise differ significantly by age, sex, body weight, or fasting insulin levels. After 26 weeks, the high-Prevotella group lost an average of 3.2 kg more fat on the high-fiber diet than the control diet (P less than .001). In contrast, the low-Prevotella group lost only 0.9 kg more fat with the high-fiber diet, a statistically insignificant difference from the control diet. Changes in waistline circumference reflected the findings – the high-fiber diet produced a 4.8-cm average reduction in the high-Prevotella group, compared with a 0.8-cm reduction in the low-Prevotella group.
Next, the researchers asked all 62 participants to follow the high-fiber diet, but did not provide them with food. After 1 year, the high-Prevotella group had maintained a 1.2-kg weight loss, compared with baseline, while the low-Prevotella group had regained 2.8 kg of body weight (P less than .001). Thus, baseline Prevotella-to-Bacteroides ratio explained a 4-kg difference in responsiveness to the high-fiber diet, the researchers concluded. The difference was even more marked when they excluded eight participants with undetectable levels of Prevotella.
Only two individuals switched from a low to a high Prevotella-to-Bacteroides ratio during the 6-month intervention period, which reflects prior findings that the intestinal microbiome is difficult to shift without “extreme changes, such as complete removal of carbohydrates from the diet,” the researchers wrote. Individual gut microbiome might affect energy absorption from different types of foods, the ability to utilize fiber, gut-brain signaling, or the secretion of hormones affecting appetite, they hypothesized. Thus, Prevotella-to-Bacteroides ratio “may serve as a biomarker to predict future weight loss success on specific diets.”
Gelesis provided funding. Dr. Hjorth and two coinvestigators reported having applied for a patent on the use of biomarkers to predict response to weight loss efforts. The remaining five researchers had no conflicts.
FROM THE INTERNATIONAL JOURNAL OF OBESITY
Key clinical point: Fecal ratio of Prevotella to Bacteroides predicted amount of fat lost on a high-fiber diet.
Major finding: After 26 weeks, individuals with a high Prevotella-to-Bacteroides ratio lost an average of 2.3 kg more fat than individuals with a low ratio (P = .04).
Data source: A randomized prospective trial of 62 adults with increased waist circumference.
Disclosures: Gelesis provided funding. Dr. Hjorth and two coinvestigators reported that they have applied for a patent on the use of biomarkers to predict response to weight loss efforts. The remaining five researchers had no conflicts.
How APL cells evade the immune system
New research has revealed a way in which acute promyelocytic leukemia (APL) cells evade destruction by the immune system.
The study showed how group 2 innate lymphoid cells (ILC2s) are recruited by leukemic cells to suppress an essential anticancer immune response.
Researchers believe this newly discovered immunosuppressive axis likely holds sway in other cancers, and it might be disrupted by therapies already in use to treat other diseases.
Camilla Jandus, MD, PhD, of the Ludwig Institute for Cancer Research in Lausanne, Switzerland, and her colleagues described this research in Nature Communications.
“ILCs are not very abundant in the body, but, when activated, they secrete large amounts of immune factors,” Dr Jandus said. “In this way, they can dictate whether a response will be pro-inflammatory or anti-inflammatory.”
ILC1, 2, and 3 have been shown to play a role in inflammation and autoimmune diseases. However, their role in cancer has remained unclear.
To address that question, Dr Jandus and her colleagues began with the observation that one subtype of the cells, ILC2s, are abnormally abundant and hyperactivated in patients with APL.
The researchers examined ILC2 immunology in patients with active APL and compared it to that of APL patients in remission.
“Our analyses suggest that, in patients with this leukemia, ILC2s are at the beginning of a novel immunosuppressive axis, one that is likely to be active in other types of cancer as well,” Dr Jandus said.
She and her colleagues found that APL cells secrete large quantities of PGD2 and express high levels of B7H6 on their surface. Both of these molecules bind to receptors on ILC2s—CRTH2 and NKp30, respectively—activating the ILC2s and prompting them to secrete interleukin-13 (IL-13).
The IL-13 switches on and expands the population of monocytic myeloid-derived immune cells (M-MDSCs). These cells suppress immune responses and allow leukemic cells to evade immune system attack.
The researchers tested these findings in a mouse model of APL. Like patients, mice with APL displayed abnormal activation of ILC2s and M-MDSCs.
However, interfering with all the signals of the immunosuppressive axis restored anti-cancer immunity and prolonged survival in the mice.
Treating mice with a PGD2 inhibitor, an NKp30-blocking antibody, and an anti-IL-13 antibody resulted in reduced APL cell engraftment and a decrease in PGD2, ILC2s, and M-MDSCs. These mice also had significantly longer survival than untreated control mice (P<0.05).
Dr Jandus and her colleagues noted that antibodies against IL-13 and inhibitors of PGD2 are already in clinical use for other diseases, and antibodies that interfere with NKp30-B7H6 binding are in clinical development.
“We also found that this immunosuppressive axis may be operating in other types of cancer; in particular, prostate cancer,” Dr Jandus said. “We believe that some ILCs, like ILC2s, might suppress immune responses, while others might stimulate them. That’s what we are investigating in other types of tumors now.”
This research was supported by the Novartis Foundation for Medical-Biological Research, Ludwig Cancer Research, the Swiss National Science Foundation, Fondazione San Salvatore, ProFemmes UNIL, Fondation Pierre Mercier pour la Science, the Swiss Cancer League, and the Foundation for the Fight against Cancer.
New research has revealed a way in which acute promyelocytic leukemia (APL) cells evade destruction by the immune system.
The study showed how group 2 innate lymphoid cells (ILC2s) are recruited by leukemic cells to suppress an essential anticancer immune response.
Researchers believe this newly discovered immunosuppressive axis likely holds sway in other cancers, and it might be disrupted by therapies already in use to treat other diseases.
Camilla Jandus, MD, PhD, of the Ludwig Institute for Cancer Research in Lausanne, Switzerland, and her colleagues described this research in Nature Communications.
“ILCs are not very abundant in the body, but, when activated, they secrete large amounts of immune factors,” Dr Jandus said. “In this way, they can dictate whether a response will be pro-inflammatory or anti-inflammatory.”
ILC1, 2, and 3 have been shown to play a role in inflammation and autoimmune diseases. However, their role in cancer has remained unclear.
To address that question, Dr Jandus and her colleagues began with the observation that one subtype of the cells, ILC2s, are abnormally abundant and hyperactivated in patients with APL.
The researchers examined ILC2 immunology in patients with active APL and compared it to that of APL patients in remission.
“Our analyses suggest that, in patients with this leukemia, ILC2s are at the beginning of a novel immunosuppressive axis, one that is likely to be active in other types of cancer as well,” Dr Jandus said.
She and her colleagues found that APL cells secrete large quantities of PGD2 and express high levels of B7H6 on their surface. Both of these molecules bind to receptors on ILC2s—CRTH2 and NKp30, respectively—activating the ILC2s and prompting them to secrete interleukin-13 (IL-13).
The IL-13 switches on and expands the population of monocytic myeloid-derived immune cells (M-MDSCs). These cells suppress immune responses and allow leukemic cells to evade immune system attack.
The researchers tested these findings in a mouse model of APL. Like patients, mice with APL displayed abnormal activation of ILC2s and M-MDSCs.
However, interfering with all the signals of the immunosuppressive axis restored anti-cancer immunity and prolonged survival in the mice.
Treating mice with a PGD2 inhibitor, an NKp30-blocking antibody, and an anti-IL-13 antibody resulted in reduced APL cell engraftment and a decrease in PGD2, ILC2s, and M-MDSCs. These mice also had significantly longer survival than untreated control mice (P<0.05).
Dr Jandus and her colleagues noted that antibodies against IL-13 and inhibitors of PGD2 are already in clinical use for other diseases, and antibodies that interfere with NKp30-B7H6 binding are in clinical development.
“We also found that this immunosuppressive axis may be operating in other types of cancer; in particular, prostate cancer,” Dr Jandus said. “We believe that some ILCs, like ILC2s, might suppress immune responses, while others might stimulate them. That’s what we are investigating in other types of tumors now.”
This research was supported by the Novartis Foundation for Medical-Biological Research, Ludwig Cancer Research, the Swiss National Science Foundation, Fondazione San Salvatore, ProFemmes UNIL, Fondation Pierre Mercier pour la Science, the Swiss Cancer League, and the Foundation for the Fight against Cancer.
New research has revealed a way in which acute promyelocytic leukemia (APL) cells evade destruction by the immune system.
The study showed how group 2 innate lymphoid cells (ILC2s) are recruited by leukemic cells to suppress an essential anticancer immune response.
Researchers believe this newly discovered immunosuppressive axis likely holds sway in other cancers, and it might be disrupted by therapies already in use to treat other diseases.
Camilla Jandus, MD, PhD, of the Ludwig Institute for Cancer Research in Lausanne, Switzerland, and her colleagues described this research in Nature Communications.
“ILCs are not very abundant in the body, but, when activated, they secrete large amounts of immune factors,” Dr Jandus said. “In this way, they can dictate whether a response will be pro-inflammatory or anti-inflammatory.”
ILC1, 2, and 3 have been shown to play a role in inflammation and autoimmune diseases. However, their role in cancer has remained unclear.
To address that question, Dr Jandus and her colleagues began with the observation that one subtype of the cells, ILC2s, are abnormally abundant and hyperactivated in patients with APL.
The researchers examined ILC2 immunology in patients with active APL and compared it to that of APL patients in remission.
“Our analyses suggest that, in patients with this leukemia, ILC2s are at the beginning of a novel immunosuppressive axis, one that is likely to be active in other types of cancer as well,” Dr Jandus said.
She and her colleagues found that APL cells secrete large quantities of PGD2 and express high levels of B7H6 on their surface. Both of these molecules bind to receptors on ILC2s—CRTH2 and NKp30, respectively—activating the ILC2s and prompting them to secrete interleukin-13 (IL-13).
The IL-13 switches on and expands the population of monocytic myeloid-derived immune cells (M-MDSCs). These cells suppress immune responses and allow leukemic cells to evade immune system attack.
The researchers tested these findings in a mouse model of APL. Like patients, mice with APL displayed abnormal activation of ILC2s and M-MDSCs.
However, interfering with all the signals of the immunosuppressive axis restored anti-cancer immunity and prolonged survival in the mice.
Treating mice with a PGD2 inhibitor, an NKp30-blocking antibody, and an anti-IL-13 antibody resulted in reduced APL cell engraftment and a decrease in PGD2, ILC2s, and M-MDSCs. These mice also had significantly longer survival than untreated control mice (P<0.05).
Dr Jandus and her colleagues noted that antibodies against IL-13 and inhibitors of PGD2 are already in clinical use for other diseases, and antibodies that interfere with NKp30-B7H6 binding are in clinical development.
“We also found that this immunosuppressive axis may be operating in other types of cancer; in particular, prostate cancer,” Dr Jandus said. “We believe that some ILCs, like ILC2s, might suppress immune responses, while others might stimulate them. That’s what we are investigating in other types of tumors now.”
This research was supported by the Novartis Foundation for Medical-Biological Research, Ludwig Cancer Research, the Swiss National Science Foundation, Fondazione San Salvatore, ProFemmes UNIL, Fondation Pierre Mercier pour la Science, the Swiss Cancer League, and the Foundation for the Fight against Cancer.
‘Very daring study’ of neoadjuvant AI/CDKi combo in early BC is hypothesis generating
MADRID – For women with luminal breast cancer who are not initially candidates for breast-conserving surgery, neoadjuvant therapy with an aromatase inhibitor and a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor offered a slightly higher residual cancer burden prior to surgery, but a significantly better safety profile than conventional chemotherapy with similar near-term safety outcomes, results of a phase 2 parallel group, noncomparative trial suggested.
Among 60 patients evaluable for response in an interim analysis of the UNICANCER NeoPAL trial, one patient (3.3%) treated with a combination of letrozole (Femara) and palbociclib (Ibrance) had a residual cancer burden (RCB) score of 0 (equivalent to a pathologic complete response; pCR), whereas three patients (10%) treated with FEC 100 chemotherapy (5-fluorouracil, epirubicin, and cyclophosphamide) had RCB 0 or I, reported Paul-Henri Cottu, MD, of the Institut Curie in Paris.
Following the interim analysis, the independent data monitoring committee for the NeoPAL trial recommended halting accrual; accrual was stopped in November 2016, after 106 patients had been randomized.
The IDMC also recommended that patients in the letrozole/palbociclib arm who did not have an RCB of 0 or I be offered adjuvant chemotherapy.
“Please note that 70% of those patients refused adjuvant chemotherapy,” Dr. Cottu said.
The investigators set out to test whether letrozole and palbociclib, which have been shown to have synergistic antiproliferative activity against advanced luminal breast cancer, could have similar benefits in the neoadjuvant setting.
They screened for women with luminal breast cancer who had newly diagnosed stage II or III breast cancer with biopsy-proven endocrine receptor–positive, human epidermal growth factor receptor 2–negative tumors, using the Prosigna test, based on the PAM50 gene signature assay. Women with node-positive luminal A or luminal B disease were enrolled and randomized to receive either letrozole 2.5 mg and palbociclib 125 mg daily for 3 out of every 4 weeks over 19 weeks, or three cycles of FEC 100, followed by three cycles of docetaxel 100 mg/m2 every 3 weeks, followed by surgery.
An interim analysis was planned after 30 patients were evaluable for RCB in the experimental arm, and, as prespecified, the trial was stopped for futility when fewer than five patients had an RCB of 0 or I.
The safety analysis, conducted with all 106 patients randomized, showed that letrozole/palbocilib was associated with more frequent grade 3 neutropenia (23% vs. 10% of patients with FEC), but less grade 4 neutropenia (1% vs. 11%, respectively), and no febrile neutropenia vs. 6% in the chemotherapy arm.
There were 2 serious adverse events with the AI/CDK-inhibitor combination vs. 17 with chemotherapy. Dose reductions or interruptions were less frequent with letrozole/palbociclib (10 and 16), and only two patients in the experimental arm required premature cessation of therapy vs. seven in the chemotherapy arm.
The final response analysis in 103 patients showed that the rate of RCB 0 or I was 7.7% with letrozole/palbociclib and 15.7% with chemotherapy. Respective rates of RCB II-III were 92.3% and 84.3%.
Clinical response rates were similar in each study arm, with approximately 30% complete responses and 44% partial responses.
In each arm, slightly less than one-third of patients underwent mastectomy, and a little more than two-thirds were able to have breast-conserving surgery after neoadjuvant therapy.
The patients will be followed out to at least 3 years to see whether those patients in the letrozole/palbociclib arm who turned down subsequent chemotherapy will have worse survival than patients who decided to undergo it, Dr. Cottu said.
Invited discussant Nadia Harbeck, MD, PhD, of the University of Munich called the NeoPAL trial “a very daring study.”
“This is not a practice-changing trial, but it’s a very, very interesting hypothesis-generating trial,” she said.
She said that the choice of RCB was probably not the best endpoint in a trial of endocrine-based therapy vs. chemotherapy.
“I think the challenge remains to identify those patients with luminal early breast cancer for whom an endocrine-based approach – not endocrine, but endocrine-based – will improve outcome, either replacing chemotherapy in the intermediate-risk setting or as an add-on in high-risk disease,” she said.
The study was funded by Pfizer and Nanostring. Dr. Cottu disclosed advisory board participation and travel support from Pfizer and others, and research support from Roche, Novartis, and AstraZeneca. Dr. Harbeck disclosed advising and consulting fees from Pfizer, Nanostring, and other companies.
MADRID – For women with luminal breast cancer who are not initially candidates for breast-conserving surgery, neoadjuvant therapy with an aromatase inhibitor and a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor offered a slightly higher residual cancer burden prior to surgery, but a significantly better safety profile than conventional chemotherapy with similar near-term safety outcomes, results of a phase 2 parallel group, noncomparative trial suggested.
Among 60 patients evaluable for response in an interim analysis of the UNICANCER NeoPAL trial, one patient (3.3%) treated with a combination of letrozole (Femara) and palbociclib (Ibrance) had a residual cancer burden (RCB) score of 0 (equivalent to a pathologic complete response; pCR), whereas three patients (10%) treated with FEC 100 chemotherapy (5-fluorouracil, epirubicin, and cyclophosphamide) had RCB 0 or I, reported Paul-Henri Cottu, MD, of the Institut Curie in Paris.
Following the interim analysis, the independent data monitoring committee for the NeoPAL trial recommended halting accrual; accrual was stopped in November 2016, after 106 patients had been randomized.
The IDMC also recommended that patients in the letrozole/palbociclib arm who did not have an RCB of 0 or I be offered adjuvant chemotherapy.
“Please note that 70% of those patients refused adjuvant chemotherapy,” Dr. Cottu said.
The investigators set out to test whether letrozole and palbociclib, which have been shown to have synergistic antiproliferative activity against advanced luminal breast cancer, could have similar benefits in the neoadjuvant setting.
They screened for women with luminal breast cancer who had newly diagnosed stage II or III breast cancer with biopsy-proven endocrine receptor–positive, human epidermal growth factor receptor 2–negative tumors, using the Prosigna test, based on the PAM50 gene signature assay. Women with node-positive luminal A or luminal B disease were enrolled and randomized to receive either letrozole 2.5 mg and palbociclib 125 mg daily for 3 out of every 4 weeks over 19 weeks, or three cycles of FEC 100, followed by three cycles of docetaxel 100 mg/m2 every 3 weeks, followed by surgery.
An interim analysis was planned after 30 patients were evaluable for RCB in the experimental arm, and, as prespecified, the trial was stopped for futility when fewer than five patients had an RCB of 0 or I.
The safety analysis, conducted with all 106 patients randomized, showed that letrozole/palbocilib was associated with more frequent grade 3 neutropenia (23% vs. 10% of patients with FEC), but less grade 4 neutropenia (1% vs. 11%, respectively), and no febrile neutropenia vs. 6% in the chemotherapy arm.
There were 2 serious adverse events with the AI/CDK-inhibitor combination vs. 17 with chemotherapy. Dose reductions or interruptions were less frequent with letrozole/palbociclib (10 and 16), and only two patients in the experimental arm required premature cessation of therapy vs. seven in the chemotherapy arm.
The final response analysis in 103 patients showed that the rate of RCB 0 or I was 7.7% with letrozole/palbociclib and 15.7% with chemotherapy. Respective rates of RCB II-III were 92.3% and 84.3%.
Clinical response rates were similar in each study arm, with approximately 30% complete responses and 44% partial responses.
In each arm, slightly less than one-third of patients underwent mastectomy, and a little more than two-thirds were able to have breast-conserving surgery after neoadjuvant therapy.
The patients will be followed out to at least 3 years to see whether those patients in the letrozole/palbociclib arm who turned down subsequent chemotherapy will have worse survival than patients who decided to undergo it, Dr. Cottu said.
Invited discussant Nadia Harbeck, MD, PhD, of the University of Munich called the NeoPAL trial “a very daring study.”
“This is not a practice-changing trial, but it’s a very, very interesting hypothesis-generating trial,” she said.
She said that the choice of RCB was probably not the best endpoint in a trial of endocrine-based therapy vs. chemotherapy.
“I think the challenge remains to identify those patients with luminal early breast cancer for whom an endocrine-based approach – not endocrine, but endocrine-based – will improve outcome, either replacing chemotherapy in the intermediate-risk setting or as an add-on in high-risk disease,” she said.
The study was funded by Pfizer and Nanostring. Dr. Cottu disclosed advisory board participation and travel support from Pfizer and others, and research support from Roche, Novartis, and AstraZeneca. Dr. Harbeck disclosed advising and consulting fees from Pfizer, Nanostring, and other companies.
MADRID – For women with luminal breast cancer who are not initially candidates for breast-conserving surgery, neoadjuvant therapy with an aromatase inhibitor and a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor offered a slightly higher residual cancer burden prior to surgery, but a significantly better safety profile than conventional chemotherapy with similar near-term safety outcomes, results of a phase 2 parallel group, noncomparative trial suggested.
Among 60 patients evaluable for response in an interim analysis of the UNICANCER NeoPAL trial, one patient (3.3%) treated with a combination of letrozole (Femara) and palbociclib (Ibrance) had a residual cancer burden (RCB) score of 0 (equivalent to a pathologic complete response; pCR), whereas three patients (10%) treated with FEC 100 chemotherapy (5-fluorouracil, epirubicin, and cyclophosphamide) had RCB 0 or I, reported Paul-Henri Cottu, MD, of the Institut Curie in Paris.
Following the interim analysis, the independent data monitoring committee for the NeoPAL trial recommended halting accrual; accrual was stopped in November 2016, after 106 patients had been randomized.
The IDMC also recommended that patients in the letrozole/palbociclib arm who did not have an RCB of 0 or I be offered adjuvant chemotherapy.
“Please note that 70% of those patients refused adjuvant chemotherapy,” Dr. Cottu said.
The investigators set out to test whether letrozole and palbociclib, which have been shown to have synergistic antiproliferative activity against advanced luminal breast cancer, could have similar benefits in the neoadjuvant setting.
They screened for women with luminal breast cancer who had newly diagnosed stage II or III breast cancer with biopsy-proven endocrine receptor–positive, human epidermal growth factor receptor 2–negative tumors, using the Prosigna test, based on the PAM50 gene signature assay. Women with node-positive luminal A or luminal B disease were enrolled and randomized to receive either letrozole 2.5 mg and palbociclib 125 mg daily for 3 out of every 4 weeks over 19 weeks, or three cycles of FEC 100, followed by three cycles of docetaxel 100 mg/m2 every 3 weeks, followed by surgery.
An interim analysis was planned after 30 patients were evaluable for RCB in the experimental arm, and, as prespecified, the trial was stopped for futility when fewer than five patients had an RCB of 0 or I.
The safety analysis, conducted with all 106 patients randomized, showed that letrozole/palbocilib was associated with more frequent grade 3 neutropenia (23% vs. 10% of patients with FEC), but less grade 4 neutropenia (1% vs. 11%, respectively), and no febrile neutropenia vs. 6% in the chemotherapy arm.
There were 2 serious adverse events with the AI/CDK-inhibitor combination vs. 17 with chemotherapy. Dose reductions or interruptions were less frequent with letrozole/palbociclib (10 and 16), and only two patients in the experimental arm required premature cessation of therapy vs. seven in the chemotherapy arm.
The final response analysis in 103 patients showed that the rate of RCB 0 or I was 7.7% with letrozole/palbociclib and 15.7% with chemotherapy. Respective rates of RCB II-III were 92.3% and 84.3%.
Clinical response rates were similar in each study arm, with approximately 30% complete responses and 44% partial responses.
In each arm, slightly less than one-third of patients underwent mastectomy, and a little more than two-thirds were able to have breast-conserving surgery after neoadjuvant therapy.
The patients will be followed out to at least 3 years to see whether those patients in the letrozole/palbociclib arm who turned down subsequent chemotherapy will have worse survival than patients who decided to undergo it, Dr. Cottu said.
Invited discussant Nadia Harbeck, MD, PhD, of the University of Munich called the NeoPAL trial “a very daring study.”
“This is not a practice-changing trial, but it’s a very, very interesting hypothesis-generating trial,” she said.
She said that the choice of RCB was probably not the best endpoint in a trial of endocrine-based therapy vs. chemotherapy.
“I think the challenge remains to identify those patients with luminal early breast cancer for whom an endocrine-based approach – not endocrine, but endocrine-based – will improve outcome, either replacing chemotherapy in the intermediate-risk setting or as an add-on in high-risk disease,” she said.
The study was funded by Pfizer and Nanostring. Dr. Cottu disclosed advisory board participation and travel support from Pfizer and others, and research support from Roche, Novartis, and AstraZeneca. Dr. Harbeck disclosed advising and consulting fees from Pfizer, Nanostring, and other companies.
AT ESMO 2017
Key clinical point:
Major finding: One patient (3.3%) assigned to letrozole/palbociclib had a residual cancer burden score of 0 or I, compared with three patients (10%) assigned to chemotherapy.
Data source: Interim analysis of a phase 2 parallel group trial with 60 patients evaluable for response and 106 evaluable for safety.
Disclosures: The study was funded by Pfizer and Nanostring. Dr. Cottu disclosed advisory board participation and travel support from Pfizer and others and research support from Roche, Novartis, and AstraZeneca. Dr. Harbeck disclosed advising and consulting fees from Pfizer, Nanostring, and other companies.