TAILORx: Most women with intermediate risk ER+ breast cancer can safely skip chemo

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– New data from the TAILORx trial are welcome news for women with HR-positive, HER2-negative, axillary node–negative early-stage breast cancer and their oncologists caught in the gray area surrounding the need for adjuvant chemotherapy.

Results of the noninferiority phase 3 trial—the largest adjuvant breast cancer treatment trial ever conducted—show that among the 6,711 women with an intermediate Oncotype DX Breast Recurrence Score (11-25), those who received only endocrine therapy and skipped adjuvant chemotherapy did not have worse invasive disease-free survival than counterparts who received both (hazard ratio, 1.08; P=.26).

The 9-year rate of invasive disease–free survival was 83.3% with endocrine therapy alone and 84.3% with both chemotherapy and endocrine therapy, and the pattern was essentially the same for freedom from any recurrence and distant recurrence, and overall survival.

The findings are practice changing, according to lead study author Joseph A. Sparano, MD, associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice-chair of the ECOG-ACRIN Cancer Research Group.

In a video interview at the annual meeting of the American Society of Clinical Oncology, he discussed implications of the new data for decision making, results of interaction analyses showing that one size does not fit all and certain women with intermediate recurrence scores do derive benefit from adjuvant chemotherapy, as well as plans to use the tumor samples for future analyses on those that do recur.

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– New data from the TAILORx trial are welcome news for women with HR-positive, HER2-negative, axillary node–negative early-stage breast cancer and their oncologists caught in the gray area surrounding the need for adjuvant chemotherapy.

Results of the noninferiority phase 3 trial—the largest adjuvant breast cancer treatment trial ever conducted—show that among the 6,711 women with an intermediate Oncotype DX Breast Recurrence Score (11-25), those who received only endocrine therapy and skipped adjuvant chemotherapy did not have worse invasive disease-free survival than counterparts who received both (hazard ratio, 1.08; P=.26).

The 9-year rate of invasive disease–free survival was 83.3% with endocrine therapy alone and 84.3% with both chemotherapy and endocrine therapy, and the pattern was essentially the same for freedom from any recurrence and distant recurrence, and overall survival.

The findings are practice changing, according to lead study author Joseph A. Sparano, MD, associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice-chair of the ECOG-ACRIN Cancer Research Group.

In a video interview at the annual meeting of the American Society of Clinical Oncology, he discussed implications of the new data for decision making, results of interaction analyses showing that one size does not fit all and certain women with intermediate recurrence scores do derive benefit from adjuvant chemotherapy, as well as plans to use the tumor samples for future analyses on those that do recur.

– New data from the TAILORx trial are welcome news for women with HR-positive, HER2-negative, axillary node–negative early-stage breast cancer and their oncologists caught in the gray area surrounding the need for adjuvant chemotherapy.

Results of the noninferiority phase 3 trial—the largest adjuvant breast cancer treatment trial ever conducted—show that among the 6,711 women with an intermediate Oncotype DX Breast Recurrence Score (11-25), those who received only endocrine therapy and skipped adjuvant chemotherapy did not have worse invasive disease-free survival than counterparts who received both (hazard ratio, 1.08; P=.26).

The 9-year rate of invasive disease–free survival was 83.3% with endocrine therapy alone and 84.3% with both chemotherapy and endocrine therapy, and the pattern was essentially the same for freedom from any recurrence and distant recurrence, and overall survival.

The findings are practice changing, according to lead study author Joseph A. Sparano, MD, associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice-chair of the ECOG-ACRIN Cancer Research Group.

In a video interview at the annual meeting of the American Society of Clinical Oncology, he discussed implications of the new data for decision making, results of interaction analyses showing that one size does not fit all and certain women with intermediate recurrence scores do derive benefit from adjuvant chemotherapy, as well as plans to use the tumor samples for future analyses on those that do recur.

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App monitoring improves quality of IBD care

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Patients with inflammatory bowel disease who used a smartphone app designed to monitor their clinical status showed significant improvements in their quality of care in a single-center randomized study with 320 patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®

Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.



Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.

“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”

Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.

“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.

Dr. Melmed had no relevant disclosures.

SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.

*This story was updated on June 7, 2018. 

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Patients with inflammatory bowel disease who used a smartphone app designed to monitor their clinical status showed significant improvements in their quality of care in a single-center randomized study with 320 patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®

Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.



Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.

“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”

Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.

“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.

Dr. Melmed had no relevant disclosures.

SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.

*This story was updated on June 7, 2018. 

Patients with inflammatory bowel disease who used a smartphone app designed to monitor their clinical status showed significant improvements in their quality of care in a single-center randomized study with 320 patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®

Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.



Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.

“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”

Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.

“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.

Dr. Melmed had no relevant disclosures.

SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.

*This story was updated on June 7, 2018. 

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Key clinical point: Regular remote monitoring of IBD patients improved the medical care they received.

Major finding: Quality of care rose from 50% at baseline to 84% in app-monitored patients and to 65% in controls.

Study details: A single-center randomized study with 320 IBD patients.

Disclosures: The study had no commercial funding. Dr. Atreja had no disclosures.

Source: Atreja A et al. Digestive Disease Week 2018 abstract 17.

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A blood test to detect lung cancer inches toward the clinic

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Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.

In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.

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Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.

In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.

In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.

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Heading down the wrong pathway in advanced breast cancer?

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CHICAGO – In the SANDPIPER trial, the combination of the phosphatidylinositol 3-kinase (PI3K) inhibitor taselisib and the selective estrogen receptor modifier fulvestrant (Faslodex) was associated with a small but significant progression-free survival (PFS) benefit, compared with fulvestrant alone in women with advanced estrogen-receptor positive, HER2-negative breast cancer.

That 2-month PFS benefit, described as “modest” by investigators, came at the cost of significant toxicities, with nearly 50% of patients treated with the combination having grade 3 or greater toxicities, compared with 16% of patients treated with fulvestrant alone.

In this video interview from the annual meeting of the American Society of Clinical Oncology, ASCO expert Harold Burstein, MD, PhD, from the Dana-Farber Cancer Institute in Boston, questions whether the PI3K pathway, shown to be targetable in hematologic malignancies, is worth continuing to pursue in breast cancer.

Dr. Burstein had no disclosures.

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CHICAGO – In the SANDPIPER trial, the combination of the phosphatidylinositol 3-kinase (PI3K) inhibitor taselisib and the selective estrogen receptor modifier fulvestrant (Faslodex) was associated with a small but significant progression-free survival (PFS) benefit, compared with fulvestrant alone in women with advanced estrogen-receptor positive, HER2-negative breast cancer.

That 2-month PFS benefit, described as “modest” by investigators, came at the cost of significant toxicities, with nearly 50% of patients treated with the combination having grade 3 or greater toxicities, compared with 16% of patients treated with fulvestrant alone.

In this video interview from the annual meeting of the American Society of Clinical Oncology, ASCO expert Harold Burstein, MD, PhD, from the Dana-Farber Cancer Institute in Boston, questions whether the PI3K pathway, shown to be targetable in hematologic malignancies, is worth continuing to pursue in breast cancer.

Dr. Burstein had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

CHICAGO – In the SANDPIPER trial, the combination of the phosphatidylinositol 3-kinase (PI3K) inhibitor taselisib and the selective estrogen receptor modifier fulvestrant (Faslodex) was associated with a small but significant progression-free survival (PFS) benefit, compared with fulvestrant alone in women with advanced estrogen-receptor positive, HER2-negative breast cancer.

That 2-month PFS benefit, described as “modest” by investigators, came at the cost of significant toxicities, with nearly 50% of patients treated with the combination having grade 3 or greater toxicities, compared with 16% of patients treated with fulvestrant alone.

In this video interview from the annual meeting of the American Society of Clinical Oncology, ASCO expert Harold Burstein, MD, PhD, from the Dana-Farber Cancer Institute in Boston, questions whether the PI3K pathway, shown to be targetable in hematologic malignancies, is worth continuing to pursue in breast cancer.

Dr. Burstein had no disclosures.

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Global MS trends: A chaotic picture with risk as the central theme

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Mon, 06/24/2019 - 08:21

– Recent epidemiologic studies of multiple sclerosis from around the globe paint a confusing picture, with incidence up in some countries and down in others, latitudinal associations strong in some regions and waning in others, and an overall lack of well-managed databases to bring order to these findings.

Alberto Ascherio, MD, who moderated a global epidemiology session during the annual meeting of the Consortium of Multiple Sclerosis Centers, said it’s tough to draw firm conclusions from the vastly varied studies assessing epidemiologic patterns of MS around the world. Most researchers are trying to extrapolate population data from smaller groups – a process always fraught with the potential for misinterpretation.

Global data, however, converge on some of the most well-established risk factors for the disease, he said. “There seems to be no doubt that vitamin D deficiency, teenager obesity, Epstein-Barr virus infection, and smoking remain strong risk factors for MS in every database in every country that has examined this,” said Dr. Ascherio, a professor of epidemiology and nutrition at Harvard University, Boston.

He sat down for a video interview to pick apart some of the findings from studies in Australia, New Zealand, Western Europe, Canada, and the United States.

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– Recent epidemiologic studies of multiple sclerosis from around the globe paint a confusing picture, with incidence up in some countries and down in others, latitudinal associations strong in some regions and waning in others, and an overall lack of well-managed databases to bring order to these findings.

Alberto Ascherio, MD, who moderated a global epidemiology session during the annual meeting of the Consortium of Multiple Sclerosis Centers, said it’s tough to draw firm conclusions from the vastly varied studies assessing epidemiologic patterns of MS around the world. Most researchers are trying to extrapolate population data from smaller groups – a process always fraught with the potential for misinterpretation.

Global data, however, converge on some of the most well-established risk factors for the disease, he said. “There seems to be no doubt that vitamin D deficiency, teenager obesity, Epstein-Barr virus infection, and smoking remain strong risk factors for MS in every database in every country that has examined this,” said Dr. Ascherio, a professor of epidemiology and nutrition at Harvard University, Boston.

He sat down for a video interview to pick apart some of the findings from studies in Australia, New Zealand, Western Europe, Canada, and the United States.

– Recent epidemiologic studies of multiple sclerosis from around the globe paint a confusing picture, with incidence up in some countries and down in others, latitudinal associations strong in some regions and waning in others, and an overall lack of well-managed databases to bring order to these findings.

Alberto Ascherio, MD, who moderated a global epidemiology session during the annual meeting of the Consortium of Multiple Sclerosis Centers, said it’s tough to draw firm conclusions from the vastly varied studies assessing epidemiologic patterns of MS around the world. Most researchers are trying to extrapolate population data from smaller groups – a process always fraught with the potential for misinterpretation.

Global data, however, converge on some of the most well-established risk factors for the disease, he said. “There seems to be no doubt that vitamin D deficiency, teenager obesity, Epstein-Barr virus infection, and smoking remain strong risk factors for MS in every database in every country that has examined this,” said Dr. Ascherio, a professor of epidemiology and nutrition at Harvard University, Boston.

He sat down for a video interview to pick apart some of the findings from studies in Australia, New Zealand, Western Europe, Canada, and the United States.

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Focus on preventing comorbidities in MS, physician urges

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– Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”

These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.

“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.

According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.

Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).

“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.

 

 


He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”

As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.

As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.

“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”

He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”

Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”
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– Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”

These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.

“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.

According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.

Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).

“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.

 

 


He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”

As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.

As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.

“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”

He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”

Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”

 

– Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”

These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.

“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.

According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.

Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).

“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.

 

 


He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”

As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.

As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.

“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”

He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”

Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”
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Pregnancy may be ideal time to consider switching MS drugs

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Fri, 01/18/2019 - 17:42
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– Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.

“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.

From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.

Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.

Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.

Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).

Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”

 

 


The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.

Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.

More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.

The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”

Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.

As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.

The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.

SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.

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– Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.

“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.

From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.

Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.

Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.

Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).

Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”

 

 


The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.

Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.

More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.

The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”

Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.

As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.

The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.

SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.

“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.

From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.

Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.

Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.

Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).

Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”

 

 


The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.

Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.

More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.

The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”

Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.

As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.

The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.

SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.

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Key clinical point: Multiple sclerosis relapse rates are similar before and after pregnancy, suggesting it may be a good time to consider switching medications if feasible.

Major finding: 49% of women who were pregnant after MS diagnosis reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Those who had relapses prior to pregnancy were more likely to have them afterward, too.

Study details: Survey of 109 women who became pregnant after MS diagnosis.

Disclosures: Teva funded the study. Several study authors report various disclosures, including relationships with Teva.

Source: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.

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MS clinic thrives by making regular care a ‘loss leader’

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– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

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Metastatic colorectal cancer chemo costs double in Washington vs. British Columbia

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First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

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First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

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Key clinical point: The higher cost for metastatic CRC systemic therapy in the United States versus Canada does not translate to better survival. 

Major finding: Monthly cost of first-line systemic therapy was $12,345 in western Washington vs. $6,195 in British Columbia (P less than .01), but median overall survival was statistically indistinguishable (21.4 vs. 22.1 months).

Study details: A cohort study of 2,197 patients with newly diagnosed metastatic CRC from a regional database linking western Washington SEER to claims from two large commercial insurers and from the BC (British Columbia) Cancer Agency database. 

Disclosures: Dr. Yezefski disclosed that he had no relevant conflicts of interest. The study received funding from the Fred Hutchinson Cancer Research Center and the BC Cancer Agency.

Source: Yezefski et al. Abstract LBA3579. 

 

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Geriatric assessments enhance patient care in advanced cancer

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CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

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CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

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