EDINBURGH – Lenalidomide maintenance therapy after chemoimmunotherapy in high-risk chronic lymphocytic leukemia (CLL) improved progression- and event-free survival, but not overall survival, and was associated with three unexpected cases of B-cell acute lymphoblastic leukemia (B-ALL), according to 4-year follow-up in the German, phase 3 CLLM1 study.

Given these findings, and in particular the B-ALL cases, lenalidomide cannot be generally recommended as maintenance therapy in high-risk CLL, Moritz Fürstenau, MD, of the University of Cologne, reported in a poster at the International Workshop on Chronic Lymphocytic Leukemia.

At a median follow-up of 47.6 months, median progression-free survival (PFS) by investigator assessment was 54.7 months in 60 patients randomized to receive lenalidomide maintenance therapy, compared with 23.2 months for 29 who received placebo (hazard ratio, 0.22), and median event-free survival (EFS) was 46.2 months vs. 14.6 months in the groups, respectively (hazard ratio, 0.24), Dr. Fürstenau said during an oral poster presentation at the conference.

“So ... after 4 years of observation, we still see improvement in PFS, EFS, and time to next treatment,” he said, also noting that minimal residual disease (MRD) negativity was achieved by eight patients in the lenalidomide group, and in none of the patients in the placebo group.

However, overall survival was 79% and 87% in the lenalidomide and placebo groups, respectively (HR, 1.53). In total, 12 patients died, including 9 in the lenalidomide group from fatal infections, concomitant disease, CLL progression, or unknown causes. Three patients in the placebo group died from CLL progression or fatal infection.

In the lenalidomide group, hematological and solid tumor second primary malignancies were reported in three and four patients, respectively (5% and 7%), compared with zero and two patients, respectively (0% and 7%), in the placebo group.

The CLLM1 study of the German CLL Study Group evaluated maintenance with lenalidomide vs. placebo in patients with high risk of progression after first-line chemoimmunotherapy. Previously reported results also favored lenalidomide maintenance for PFS, but not OS, Dr. Fürstenau said, adding that the study was unblinded at a median follow-up of 17.9 months, and in November 2017 treatment was stopped when two cases of B-ALL were observed. A third case was reported in 2018.

The current analysis includes data available through December 2018, and the findings warrant further investigation to analyze the unexpectedly high incidence of B-ALL, he said.

The CLLM1 study was funded by Celgene.

[email protected]

EDINBURGH – Lenalidomide maintenance therapy after chemoimmunotherapy in high-risk chronic lymphocytic leukemia (CLL) improved progression- and event-free survival, but not overall survival, and was associated with three unexpected cases of B-cell acute lymphoblastic leukemia (B-ALL), according to 4-year follow-up in the German, phase 3 CLLM1 study.

Given these findings, and in particular the B-ALL cases, lenalidomide cannot be generally recommended as maintenance therapy in high-risk CLL, Moritz Fürstenau, MD, of the University of Cologne, reported in a poster at the International Workshop on Chronic Lymphocytic Leukemia.

At a median follow-up of 47.6 months, median progression-free survival (PFS) by investigator assessment was 54.7 months in 60 patients randomized to receive lenalidomide maintenance therapy, compared with 23.2 months for 29 who received placebo (hazard ratio, 0.22), and median event-free survival (EFS) was 46.2 months vs. 14.6 months in the groups, respectively (hazard ratio, 0.24), Dr. Fürstenau said during an oral poster presentation at the conference.

“So ... after 4 years of observation, we still see improvement in PFS, EFS, and time to next treatment,” he said, also noting that minimal residual disease (MRD) negativity was achieved by eight patients in the lenalidomide group, and in none of the patients in the placebo group.

However, overall survival was 79% and 87% in the lenalidomide and placebo groups, respectively (HR, 1.53). In total, 12 patients died, including 9 in the lenalidomide group from fatal infections, concomitant disease, CLL progression, or unknown causes. Three patients in the placebo group died from CLL progression or fatal infection.

In the lenalidomide group, hematological and solid tumor second primary malignancies were reported in three and four patients, respectively (5% and 7%), compared with zero and two patients, respectively (0% and 7%), in the placebo group.

The CLLM1 study of the German CLL Study Group evaluated maintenance with lenalidomide vs. placebo in patients with high risk of progression after first-line chemoimmunotherapy. Previously reported results also favored lenalidomide maintenance for PFS, but not OS, Dr. Fürstenau said, adding that the study was unblinded at a median follow-up of 17.9 months, and in November 2017 treatment was stopped when two cases of B-ALL were observed. A third case was reported in 2018.

The current analysis includes data available through December 2018, and the findings warrant further investigation to analyze the unexpectedly high incidence of B-ALL, he said.

The CLLM1 study was funded by Celgene.

[email protected]

EDINBURGH – Lenalidomide maintenance therapy after chemoimmunotherapy in high-risk chronic lymphocytic leukemia (CLL) improved progression- and event-free survival, but not overall survival, and was associated with three unexpected cases of B-cell acute lymphoblastic leukemia (B-ALL), according to 4-year follow-up in the German, phase 3 CLLM1 study.

Given these findings, and in particular the B-ALL cases, lenalidomide cannot be generally recommended as maintenance therapy in high-risk CLL, Moritz Fürstenau, MD, of the University of Cologne, reported in a poster at the International Workshop on Chronic Lymphocytic Leukemia.

At a median follow-up of 47.6 months, median progression-free survival (PFS) by investigator assessment was 54.7 months in 60 patients randomized to receive lenalidomide maintenance therapy, compared with 23.2 months for 29 who received placebo (hazard ratio, 0.22), and median event-free survival (EFS) was 46.2 months vs. 14.6 months in the groups, respectively (hazard ratio, 0.24), Dr. Fürstenau said during an oral poster presentation at the conference.

“So ... after 4 years of observation, we still see improvement in PFS, EFS, and time to next treatment,” he said, also noting that minimal residual disease (MRD) negativity was achieved by eight patients in the lenalidomide group, and in none of the patients in the placebo group.

However, overall survival was 79% and 87% in the lenalidomide and placebo groups, respectively (HR, 1.53). In total, 12 patients died, including 9 in the lenalidomide group from fatal infections, concomitant disease, CLL progression, or unknown causes. Three patients in the placebo group died from CLL progression or fatal infection.

In the lenalidomide group, hematological and solid tumor second primary malignancies were reported in three and four patients, respectively (5% and 7%), compared with zero and two patients, respectively (0% and 7%), in the placebo group.

The CLLM1 study of the German CLL Study Group evaluated maintenance with lenalidomide vs. placebo in patients with high risk of progression after first-line chemoimmunotherapy. Previously reported results also favored lenalidomide maintenance for PFS, but not OS, Dr. Fürstenau said, adding that the study was unblinded at a median follow-up of 17.9 months, and in November 2017 treatment was stopped when two cases of B-ALL were observed. A third case was reported in 2018.

The current analysis includes data available through December 2018, and the findings warrant further investigation to analyze the unexpectedly high incidence of B-ALL, he said.

The CLLM1 study was funded by Celgene.

[email protected]

Background: Active cancer places patients at increased risk for VTE. Ambulatory patients can be risk stratified using the validated Khorana score to assess risk for VTE, a complication resulting in significant morbidity, mortality, and health care costs.

There was no significant difference in overall survival, with 87% of deaths were related to cancer or cancer progression.

Bottom line: VTE is significantly lower with the use of apixaban, compared with placebo, in intermediate- to high-risk ambulatory patients with active cancer who are initiating chemotherapy.

Citation: Carrier M et al. Apixaban to prevent venous thromboembolism in patients with cancer. N Engl J Med. 2018 Dec 4. doi: 10.1056/NEJMoa1814468.
 

Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

Background: Active cancer places patients at increased risk for VTE. Ambulatory patients can be risk stratified using the validated Khorana score to assess risk for VTE, a complication resulting in significant morbidity, mortality, and health care costs.

There was no significant difference in overall survival, with 87% of deaths were related to cancer or cancer progression.

Bottom line: VTE is significantly lower with the use of apixaban, compared with placebo, in intermediate- to high-risk ambulatory patients with active cancer who are initiating chemotherapy.

Citation: Carrier M et al. Apixaban to prevent venous thromboembolism in patients with cancer. N Engl J Med. 2018 Dec 4. doi: 10.1056/NEJMoa1814468.
 

Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

Background: Active cancer places patients at increased risk for VTE. Ambulatory patients can be risk stratified using the validated Khorana score to assess risk for VTE, a complication resulting in significant morbidity, mortality, and health care costs.

There was no significant difference in overall survival, with 87% of deaths were related to cancer or cancer progression.

Bottom line: VTE is significantly lower with the use of apixaban, compared with placebo, in intermediate- to high-risk ambulatory patients with active cancer who are initiating chemotherapy.

Citation: Carrier M et al. Apixaban to prevent venous thromboembolism in patients with cancer. N Engl J Med. 2018 Dec 4. doi: 10.1056/NEJMoa1814468.
 

Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

BARCELONA – First-line flat-dose nivolumab plus weight-based ipilimumab was safe and showed encouraging clinical activity both in general and in patients with poor performance status and comorbidities in the multicenter CheckMate 817 study of patients with advanced non–small cell lung cancer.

Sharon Worcester/MDedge News

The treatment-related adverse event (TRAE) rate in 139 patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2, for example, was 63%, compared with 77% in 391 patients with good ECOG PS (score of 0-1), and the rates of grade 3-4 AEs in the groups, respectively, were 26% and 35%, Fabrice Barlesi, MD, reported at the World Conference on Lung Cancer.

In 59 patients with ECOG PS of 0-1 plus either asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection, the overall TRAE and grade 3-4 TRAE rates were 78% and 34%.

The combined TRAE and grade 3-4 TRAE rates in the two “special populations” cohorts were 67% and 28%, respectively, Dr. Barlesi, of Aix-Marseille Universite and Assistance Publique Hôpitaux de Marseille, France, said at the conference, which was sponsored by the International Association for the Study of Lung Cancer.

The overall response rate (ORR) in the ECOG PS-2 and PS-01+comorbidity groups was 19% and 37%, respectively, compared with 36% in the good PS cohort, and median duration of response in the three groups was 14.2 months, 9.7 months, and at least 18 months (median not reached), respectively.

The 1-year PFS rates were 25%, 27%, and 35% respectively, and median PFS was 3.6, 4.2, and 5.8, he said.

Among the 198 special population patients, those with PD-L1 expression of 50% or greater, 1% or greater, or less than 1% had 1-yr PFS rates of 46%, 24%, and 29% (median, 9.6, 3.2, and 3.9 months), and in those with 10 or greater mut/Mb and less than 10 mut/Mb, they were 42% and 17% (median, 8.3 and 2.8 months), respectively.

The single-arm, nonrandomized CheckMate 817 study evaluated the programmed death-ligand 1 (PD-L1) inhibitor nivolumab at a flat dose of 240 mg given intravenously every 2 weeks plus the CTLA-4 inhibitor ipilimumab at 1 mg/kg IV every 6 weeks, with treatment until disease progression or unacceptable toxicity for up to 2 years. Participants had stage IV non–small cell lung cancer (NSCLC), had received no prior systemic therapy, and had no known sensitizing EGFR or ALK alterations.

“Nivolumab and ipilimumab are immune checkpoint inhibitors with distinct ... but complementary mechanisms of action,” Dr. Barlesi said, adding that in combination they have demonstrated clinical benefit vs. chemotherapy in the first-line treatment of NSCLC.

However, data are limited on safety and efficacy of immunotherapy in patients with advanced NSCLC with other comorbidities such as brain metastases, kidney and renal disease, and HIV, as such patients – despite comprising the majority of NSCLC patients at presentation – are typically ineligible for trial registration, he explained, adding that CheckMate 817 is a multicohort, nonrandomized, phase 3b study evaluating the safety and efficacy of nivolumab plus ipilimumab in such patients.

The findings show a safety profile “clearly comparable” to that observed in prior studies using weight-based nivolumab, he noted.

“Nivolumab plus ipilimumab showed clearly encouraging clinical activity in this special population, with an overall response rate of 24%,” he said. “As expected, unfortunately, the outcomes in these special populations were affected by poor performance status, however, despite the poor performance status or comorbidities, those patients were shown to achieve durable responses ... with [an overall] duration of response at 1 year, of 57%.”

CheckMate 817 was sponsored by Bristol-Myers Squibb. Dr. Barlesi disclosed financial relationships with Abbvie, ACEA, Amgen, Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer–Ingelheim, Eisai, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, Medimmune, Merck, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis, and Takeda.

SOURCE: Barlesi F et al. WCLC 2019: Abstract OA04.02.

BARCELONA – First-line flat-dose nivolumab plus weight-based ipilimumab was safe and showed encouraging clinical activity both in general and in patients with poor performance status and comorbidities in the multicenter CheckMate 817 study of patients with advanced non–small cell lung cancer.

Sharon Worcester/MDedge News

The treatment-related adverse event (TRAE) rate in 139 patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2, for example, was 63%, compared with 77% in 391 patients with good ECOG PS (score of 0-1), and the rates of grade 3-4 AEs in the groups, respectively, were 26% and 35%, Fabrice Barlesi, MD, reported at the World Conference on Lung Cancer.

In 59 patients with ECOG PS of 0-1 plus either asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection, the overall TRAE and grade 3-4 TRAE rates were 78% and 34%.

The combined TRAE and grade 3-4 TRAE rates in the two “special populations” cohorts were 67% and 28%, respectively, Dr. Barlesi, of Aix-Marseille Universite and Assistance Publique Hôpitaux de Marseille, France, said at the conference, which was sponsored by the International Association for the Study of Lung Cancer.

The overall response rate (ORR) in the ECOG PS-2 and PS-01+comorbidity groups was 19% and 37%, respectively, compared with 36% in the good PS cohort, and median duration of response in the three groups was 14.2 months, 9.7 months, and at least 18 months (median not reached), respectively.

The 1-year PFS rates were 25%, 27%, and 35% respectively, and median PFS was 3.6, 4.2, and 5.8, he said.

Among the 198 special population patients, those with PD-L1 expression of 50% or greater, 1% or greater, or less than 1% had 1-yr PFS rates of 46%, 24%, and 29% (median, 9.6, 3.2, and 3.9 months), and in those with 10 or greater mut/Mb and less than 10 mut/Mb, they were 42% and 17% (median, 8.3 and 2.8 months), respectively.

The single-arm, nonrandomized CheckMate 817 study evaluated the programmed death-ligand 1 (PD-L1) inhibitor nivolumab at a flat dose of 240 mg given intravenously every 2 weeks plus the CTLA-4 inhibitor ipilimumab at 1 mg/kg IV every 6 weeks, with treatment until disease progression or unacceptable toxicity for up to 2 years. Participants had stage IV non–small cell lung cancer (NSCLC), had received no prior systemic therapy, and had no known sensitizing EGFR or ALK alterations.

“Nivolumab and ipilimumab are immune checkpoint inhibitors with distinct ... but complementary mechanisms of action,” Dr. Barlesi said, adding that in combination they have demonstrated clinical benefit vs. chemotherapy in the first-line treatment of NSCLC.

However, data are limited on safety and efficacy of immunotherapy in patients with advanced NSCLC with other comorbidities such as brain metastases, kidney and renal disease, and HIV, as such patients – despite comprising the majority of NSCLC patients at presentation – are typically ineligible for trial registration, he explained, adding that CheckMate 817 is a multicohort, nonrandomized, phase 3b study evaluating the safety and efficacy of nivolumab plus ipilimumab in such patients.

The findings show a safety profile “clearly comparable” to that observed in prior studies using weight-based nivolumab, he noted.

“Nivolumab plus ipilimumab showed clearly encouraging clinical activity in this special population, with an overall response rate of 24%,” he said. “As expected, unfortunately, the outcomes in these special populations were affected by poor performance status, however, despite the poor performance status or comorbidities, those patients were shown to achieve durable responses ... with [an overall] duration of response at 1 year, of 57%.”

CheckMate 817 was sponsored by Bristol-Myers Squibb. Dr. Barlesi disclosed financial relationships with Abbvie, ACEA, Amgen, Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer–Ingelheim, Eisai, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, Medimmune, Merck, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis, and Takeda.

SOURCE: Barlesi F et al. WCLC 2019: Abstract OA04.02.

BARCELONA – First-line flat-dose nivolumab plus weight-based ipilimumab was safe and showed encouraging clinical activity both in general and in patients with poor performance status and comorbidities in the multicenter CheckMate 817 study of patients with advanced non–small cell lung cancer.

Sharon Worcester/MDedge News

The treatment-related adverse event (TRAE) rate in 139 patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2, for example, was 63%, compared with 77% in 391 patients with good ECOG PS (score of 0-1), and the rates of grade 3-4 AEs in the groups, respectively, were 26% and 35%, Fabrice Barlesi, MD, reported at the World Conference on Lung Cancer.

In 59 patients with ECOG PS of 0-1 plus either asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV infection, the overall TRAE and grade 3-4 TRAE rates were 78% and 34%.

The combined TRAE and grade 3-4 TRAE rates in the two “special populations” cohorts were 67% and 28%, respectively, Dr. Barlesi, of Aix-Marseille Universite and Assistance Publique Hôpitaux de Marseille, France, said at the conference, which was sponsored by the International Association for the Study of Lung Cancer.

The overall response rate (ORR) in the ECOG PS-2 and PS-01+comorbidity groups was 19% and 37%, respectively, compared with 36% in the good PS cohort, and median duration of response in the three groups was 14.2 months, 9.7 months, and at least 18 months (median not reached), respectively.

The 1-year PFS rates were 25%, 27%, and 35% respectively, and median PFS was 3.6, 4.2, and 5.8, he said.

Among the 198 special population patients, those with PD-L1 expression of 50% or greater, 1% or greater, or less than 1% had 1-yr PFS rates of 46%, 24%, and 29% (median, 9.6, 3.2, and 3.9 months), and in those with 10 or greater mut/Mb and less than 10 mut/Mb, they were 42% and 17% (median, 8.3 and 2.8 months), respectively.

The single-arm, nonrandomized CheckMate 817 study evaluated the programmed death-ligand 1 (PD-L1) inhibitor nivolumab at a flat dose of 240 mg given intravenously every 2 weeks plus the CTLA-4 inhibitor ipilimumab at 1 mg/kg IV every 6 weeks, with treatment until disease progression or unacceptable toxicity for up to 2 years. Participants had stage IV non–small cell lung cancer (NSCLC), had received no prior systemic therapy, and had no known sensitizing EGFR or ALK alterations.

“Nivolumab and ipilimumab are immune checkpoint inhibitors with distinct ... but complementary mechanisms of action,” Dr. Barlesi said, adding that in combination they have demonstrated clinical benefit vs. chemotherapy in the first-line treatment of NSCLC.

However, data are limited on safety and efficacy of immunotherapy in patients with advanced NSCLC with other comorbidities such as brain metastases, kidney and renal disease, and HIV, as such patients – despite comprising the majority of NSCLC patients at presentation – are typically ineligible for trial registration, he explained, adding that CheckMate 817 is a multicohort, nonrandomized, phase 3b study evaluating the safety and efficacy of nivolumab plus ipilimumab in such patients.

The findings show a safety profile “clearly comparable” to that observed in prior studies using weight-based nivolumab, he noted.

“Nivolumab plus ipilimumab showed clearly encouraging clinical activity in this special population, with an overall response rate of 24%,” he said. “As expected, unfortunately, the outcomes in these special populations were affected by poor performance status, however, despite the poor performance status or comorbidities, those patients were shown to achieve durable responses ... with [an overall] duration of response at 1 year, of 57%.”

CheckMate 817 was sponsored by Bristol-Myers Squibb. Dr. Barlesi disclosed financial relationships with Abbvie, ACEA, Amgen, Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer–Ingelheim, Eisai, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, Medimmune, Merck, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis, and Takeda.

SOURCE: Barlesi F et al. WCLC 2019: Abstract OA04.02.

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

CHICAGO – Early results of a trial evaluating allogeneic mesenchymal stem cells to target aortic inflammation in patients with small abdominal aortic aneurysms (AAAs) has reported encouraging early results, according to research presented here at the annual meeting of the Midwestern Vascular Surgery Society.

Katherin Leckie, MD, an integrated vascular surgery resident in the vascular surgery division, Indiana University, Indianapolis, reported on early results from the ARREST (Aneurysm Repression With Mesenchymal Stem Cells) trial. Twenty-one patients have been enrolled so far, and early results showed that treatment with mesenchymal stem cells (MSCs) increased levels of a key anti-inflammatory cell type, the Tr1, in proportion to a key proinflammatory cell type, the Th17.

“In AAA, the Tr1:Th17 ratio is decreased,” Dr. Leckie said. AAA serum stimulates MSC secretion of IL-10. Previously, mouse studies have shown MSCs restore the Tr1:Th17 balance and prevent aneurysms, Dr. Leckie noted.

The ARREST trial is evaluating that finding in humans with small AAAs of 35-50 mm in diameter. When the trial is fully enrolled, the 36 patients are to be evenly divided between three treatment groups: placebo; 1 million MSC/kg; and 3 million MSC/kg. The primary endpoint is change in Tr1:Th17 ratio at 14 days. Secondary endpoints are change in AAA inflammation at 2 weeks and change in AAA diameter and volume at 1-5 years.

At 14 days, the high-dose group had already seen a more than 100% change in Tr1:Th17 ratio (P = .03), versus about a 35% change for the low-dose and no change for the placebo groups. At 28 days, the high-dose group’s change increased to greater than 150%, while that of the low-dose group reached around 50%, with no change in the placebo group.

The study also found a possible trend toward changes in AAA diameter among the three groups after 1 year, Dr. Leckie said. In the placebo group, AAA diameter increased 3.5 mm on average. In the low-dose group, AAA diameter increased almost 1.5 mm. However, in the high-dose group, aortic diameter actually decreased about 0.5 mm (P = .189), Dr. Leckie said.

“MSCs have significantly improved the Tr1:Th17 imbalance at 14 days,” Dr. Leckie said. “There’s also a possible trend toward decreased aortic inflammation at 14 days as well as decreased growth of AAA at 12 months.”

Dr. Leckie had no relevant financial relationships to disclose.

Social media presents some unique opportunities, as well as unique challenges, when it comes to being a tool for clinical trial recruitment.

audioundwerbung/iStockphoto

Some of those opportunities and challenges were identified following interview with 44 physicians affiliated with the City of Hope Comprehensive Cancer Center in Duarte, Calif.

“There were three main themes identified by physicians as potential advantages of social media use for trial recruitment, as follows: increased visibility and awareness, improved communications, and patient engagement,” Mina Sedrak, MD, an oncologist at City of Hope, and colleagues wrote in JAMA Open Network.

“Most physicians cited social media as a useful platform to increase awareness and visibility of clinical trials, recognizing it as a means to reach large populations and easily spread information about available trials,” the authors wrote. “They described social media as a way to easily disseminate clinical trial information online to patients, caregivers, and other physicians because of the large number of users on these platform.”

The interviewed physicians also identified a number of disadvantages of using social media for clinical trial recruitment, including increased administrative burden, risk of misinformation, lack of guidance, and limited outreach.

Physicians expressed “apprehension about the potential of social media to oversimplify trials or spread misinformation” and “concerns that information might be misconstrued because of the nature of the Internet,” Dr. Sedrak and colleagues wrote.

Three themes were identified by physicians when prompted to talk about potential strategies for effectively using social media for clinical trial recruitment, including institutional support, evidence, training.

“Physicians expressed interest in using social media for recruitment if they were provided institutional resources to manage recruitment efforts on social media,” the authors noted. Physicians also called for the establishment of methodology to guide physicians on how to use social media as a recruitment tool. Third, they wanted more education on how to use social media as a recruitment tool.

Even as the context of these findings reveal the pros and cons, Dr. Sedrak and colleagues observed that “our findings revealed that physicians are not currently comfortable with or prepared to effectively use social media for cancer clinical trial recruitment. Although their are some aspects of these new modes of communication that physicians are enthusiastic about (i.e., increased visibility and awareness), several important concerns remain. Notably, many physicians felt uncomfortable with the idea of using social media because of increased administrative burden and concerns of the complexities of clinical trials would not be appropriately communicated.”

Authors noted the limitations of the research, particularly that all the interviewers were affiliated with the same cancer center and may not be generalizable to wider practice settings. It also did not include the perspective of nonphysician research personnel, who are more involved in the recruitment aspects.

“Further research is needed to address potential concerns that may arise in the future and gain a more comprehensive understanding of the risks and benefits that social media pose in clinical settings,” the authors noted. “Before social media can be integrated into clinical trials, specific guidelines must be defined for such use.”

They noted that the American Society of Clinical Oncology is working on such guidelines.

SOURCE: Sedark MS et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911528. doi: 10.1001/jamanetworkopen.2019.11528.

Social media presents some unique opportunities, as well as unique challenges, when it comes to being a tool for clinical trial recruitment.

audioundwerbung/iStockphoto

Some of those opportunities and challenges were identified following interview with 44 physicians affiliated with the City of Hope Comprehensive Cancer Center in Duarte, Calif.

“There were three main themes identified by physicians as potential advantages of social media use for trial recruitment, as follows: increased visibility and awareness, improved communications, and patient engagement,” Mina Sedrak, MD, an oncologist at City of Hope, and colleagues wrote in JAMA Open Network.

“Most physicians cited social media as a useful platform to increase awareness and visibility of clinical trials, recognizing it as a means to reach large populations and easily spread information about available trials,” the authors wrote. “They described social media as a way to easily disseminate clinical trial information online to patients, caregivers, and other physicians because of the large number of users on these platform.”

The interviewed physicians also identified a number of disadvantages of using social media for clinical trial recruitment, including increased administrative burden, risk of misinformation, lack of guidance, and limited outreach.

Physicians expressed “apprehension about the potential of social media to oversimplify trials or spread misinformation” and “concerns that information might be misconstrued because of the nature of the Internet,” Dr. Sedrak and colleagues wrote.

Three themes were identified by physicians when prompted to talk about potential strategies for effectively using social media for clinical trial recruitment, including institutional support, evidence, training.

“Physicians expressed interest in using social media for recruitment if they were provided institutional resources to manage recruitment efforts on social media,” the authors noted. Physicians also called for the establishment of methodology to guide physicians on how to use social media as a recruitment tool. Third, they wanted more education on how to use social media as a recruitment tool.

Even as the context of these findings reveal the pros and cons, Dr. Sedrak and colleagues observed that “our findings revealed that physicians are not currently comfortable with or prepared to effectively use social media for cancer clinical trial recruitment. Although their are some aspects of these new modes of communication that physicians are enthusiastic about (i.e., increased visibility and awareness), several important concerns remain. Notably, many physicians felt uncomfortable with the idea of using social media because of increased administrative burden and concerns of the complexities of clinical trials would not be appropriately communicated.”

Authors noted the limitations of the research, particularly that all the interviewers were affiliated with the same cancer center and may not be generalizable to wider practice settings. It also did not include the perspective of nonphysician research personnel, who are more involved in the recruitment aspects.

“Further research is needed to address potential concerns that may arise in the future and gain a more comprehensive understanding of the risks and benefits that social media pose in clinical settings,” the authors noted. “Before social media can be integrated into clinical trials, specific guidelines must be defined for such use.”

They noted that the American Society of Clinical Oncology is working on such guidelines.

SOURCE: Sedark MS et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911528. doi: 10.1001/jamanetworkopen.2019.11528.

Social media presents some unique opportunities, as well as unique challenges, when it comes to being a tool for clinical trial recruitment.

audioundwerbung/iStockphoto

Some of those opportunities and challenges were identified following interview with 44 physicians affiliated with the City of Hope Comprehensive Cancer Center in Duarte, Calif.

“There were three main themes identified by physicians as potential advantages of social media use for trial recruitment, as follows: increased visibility and awareness, improved communications, and patient engagement,” Mina Sedrak, MD, an oncologist at City of Hope, and colleagues wrote in JAMA Open Network.

“Most physicians cited social media as a useful platform to increase awareness and visibility of clinical trials, recognizing it as a means to reach large populations and easily spread information about available trials,” the authors wrote. “They described social media as a way to easily disseminate clinical trial information online to patients, caregivers, and other physicians because of the large number of users on these platform.”

The interviewed physicians also identified a number of disadvantages of using social media for clinical trial recruitment, including increased administrative burden, risk of misinformation, lack of guidance, and limited outreach.

Physicians expressed “apprehension about the potential of social media to oversimplify trials or spread misinformation” and “concerns that information might be misconstrued because of the nature of the Internet,” Dr. Sedrak and colleagues wrote.

Three themes were identified by physicians when prompted to talk about potential strategies for effectively using social media for clinical trial recruitment, including institutional support, evidence, training.

“Physicians expressed interest in using social media for recruitment if they were provided institutional resources to manage recruitment efforts on social media,” the authors noted. Physicians also called for the establishment of methodology to guide physicians on how to use social media as a recruitment tool. Third, they wanted more education on how to use social media as a recruitment tool.

Even as the context of these findings reveal the pros and cons, Dr. Sedrak and colleagues observed that “our findings revealed that physicians are not currently comfortable with or prepared to effectively use social media for cancer clinical trial recruitment. Although their are some aspects of these new modes of communication that physicians are enthusiastic about (i.e., increased visibility and awareness), several important concerns remain. Notably, many physicians felt uncomfortable with the idea of using social media because of increased administrative burden and concerns of the complexities of clinical trials would not be appropriately communicated.”

Authors noted the limitations of the research, particularly that all the interviewers were affiliated with the same cancer center and may not be generalizable to wider practice settings. It also did not include the perspective of nonphysician research personnel, who are more involved in the recruitment aspects.

“Further research is needed to address potential concerns that may arise in the future and gain a more comprehensive understanding of the risks and benefits that social media pose in clinical settings,” the authors noted. “Before social media can be integrated into clinical trials, specific guidelines must be defined for such use.”

They noted that the American Society of Clinical Oncology is working on such guidelines.

SOURCE: Sedark MS et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911528. doi: 10.1001/jamanetworkopen.2019.11528.

EDINBURGH – Treatment induction with obinutuzumab and ibrutinib followed by a minimal residual disease (MRD)–driven treatment strategy in patients with chronic lymphocytic leukemia (CLL) yields a high long-term complete response rate and prolonged progression-free and overall survival, according to findings from the phase 2 ICLL-07 trial.

The intent-to-treat (ITT) complete response rate at 16 months in 135 patients who were treated with this strategy was 62%, Anne-Sophie Michallet, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

Patients in the multicenter, open-label trial conducted by the French Innovative Leukemia Organization (FILO) were previously untreated, medically fit patients with CLL and no 17p deletion. They were enrolled between November 2015 and May 2017 to receive eight 1,000 mg IV doses of obinutuzumab over six 4-week cycles along with oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib at a dose of 420 mg daily for 9 months.

Ten patients (7.7%) achieved complete response with bone marrow MRD less than 0.01% (undetectable) at 9 months and, by study protocol, continued on only the ibrutinib for 6 additional months. The remaining 120 evaluable patients received four 4-week cycles of fludarabine/cyclophosphamide along with the obinutuzumab and ibrutinib for 6 additional months, explained Dr. Michallet of Centre Léon Bérard, Lyon, France.

The ITT rate at 16 months – the primary endpoint of the study – was achieved with no more than four cycles of fludarabine/cyclophosphamide and obinutuzumab, and exceeded the primary objective of demonstrating a 30% or higher rate of complete response with bone marrow MRD less than 0.01% at the month 16 ITT analysis, she said.

“The ... strategy yielded an overall response rate of 100%, a complete response rate, according to iwCLL [criteria], of 73%, a bone marrow MRD–undetectable rate of 79% [in the ITT population],” she said, adding that the primary objective was achieved with a complete response with a peripheral blood and bone marrow MRD–undetectable rate of 62%.

Response assessments at months 9 and 16 involved whole-body computed tomography scans with tumor measurements and bone marrow trephine biopsy for patients in clinical complete response. MRD testing was performed by eight-color flow cytometry in both peripheral blood and bone marrow.

After month 16, response was clinically assessed every 3 months, and peripheral blood MRD was assessed every 6 months until month 40.

“With a median follow-up of 26.3 months, the 2-year progression-free survival and overall survival were, respectively, 97% and 97.5%,” Dr. Michallet said, noting that the longitudinal follow-up of peripheral blood MRD in the entire cohort showed durability of a deep response. The rate of peripheral blood MRD less than 0.01% at 22 months was 77% in the 10 patients who received only ibrutinib after the 9-month assessment, and 93% in those who received fludarabine/cyclophosphamide after the 9-month assessment.

In patients with immunoglobulin heavy gene variable (IGHV) mutations, the rate of peripheral blood MRD less than 0.01% at month 22 was 96%, and in those without IGHV mutations, the rate was 77%, she noted.

The findings demonstrate that the approach has merit in medically fit, treatment-naive patients with CLL and no 17p deletion, she said, explaining that the fixed-duration, MRD-driven strategy used in this study was developed to “avoid or at least reduce chemotherapy exposure” in the first-line treatment of such patients.

Indeed, the approach was associated with “a high [complete response] rate, a high level of undetectable bone marrow MRD, an acceptable safety profile, and a sustained MRD negativity rate at 12 months after the end of the treatment,” she said.

“This highly effective strategy combining a BTK inhibitor and abbreviated immunochemotherapy deserves further investigation with randomized trials,” she concluded.

ICLL-07 FILO was funded by Roche and Janssen. Dr. Michallet reported having no disclosures.

[email protected]

EDINBURGH – Treatment induction with obinutuzumab and ibrutinib followed by a minimal residual disease (MRD)–driven treatment strategy in patients with chronic lymphocytic leukemia (CLL) yields a high long-term complete response rate and prolonged progression-free and overall survival, according to findings from the phase 2 ICLL-07 trial.

The intent-to-treat (ITT) complete response rate at 16 months in 135 patients who were treated with this strategy was 62%, Anne-Sophie Michallet, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

Patients in the multicenter, open-label trial conducted by the French Innovative Leukemia Organization (FILO) were previously untreated, medically fit patients with CLL and no 17p deletion. They were enrolled between November 2015 and May 2017 to receive eight 1,000 mg IV doses of obinutuzumab over six 4-week cycles along with oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib at a dose of 420 mg daily for 9 months.

Ten patients (7.7%) achieved complete response with bone marrow MRD less than 0.01% (undetectable) at 9 months and, by study protocol, continued on only the ibrutinib for 6 additional months. The remaining 120 evaluable patients received four 4-week cycles of fludarabine/cyclophosphamide along with the obinutuzumab and ibrutinib for 6 additional months, explained Dr. Michallet of Centre Léon Bérard, Lyon, France.

The ITT rate at 16 months – the primary endpoint of the study – was achieved with no more than four cycles of fludarabine/cyclophosphamide and obinutuzumab, and exceeded the primary objective of demonstrating a 30% or higher rate of complete response with bone marrow MRD less than 0.01% at the month 16 ITT analysis, she said.

“The ... strategy yielded an overall response rate of 100%, a complete response rate, according to iwCLL [criteria], of 73%, a bone marrow MRD–undetectable rate of 79% [in the ITT population],” she said, adding that the primary objective was achieved with a complete response with a peripheral blood and bone marrow MRD–undetectable rate of 62%.

Response assessments at months 9 and 16 involved whole-body computed tomography scans with tumor measurements and bone marrow trephine biopsy for patients in clinical complete response. MRD testing was performed by eight-color flow cytometry in both peripheral blood and bone marrow.

After month 16, response was clinically assessed every 3 months, and peripheral blood MRD was assessed every 6 months until month 40.

“With a median follow-up of 26.3 months, the 2-year progression-free survival and overall survival were, respectively, 97% and 97.5%,” Dr. Michallet said, noting that the longitudinal follow-up of peripheral blood MRD in the entire cohort showed durability of a deep response. The rate of peripheral blood MRD less than 0.01% at 22 months was 77% in the 10 patients who received only ibrutinib after the 9-month assessment, and 93% in those who received fludarabine/cyclophosphamide after the 9-month assessment.

In patients with immunoglobulin heavy gene variable (IGHV) mutations, the rate of peripheral blood MRD less than 0.01% at month 22 was 96%, and in those without IGHV mutations, the rate was 77%, she noted.

The findings demonstrate that the approach has merit in medically fit, treatment-naive patients with CLL and no 17p deletion, she said, explaining that the fixed-duration, MRD-driven strategy used in this study was developed to “avoid or at least reduce chemotherapy exposure” in the first-line treatment of such patients.

Indeed, the approach was associated with “a high [complete response] rate, a high level of undetectable bone marrow MRD, an acceptable safety profile, and a sustained MRD negativity rate at 12 months after the end of the treatment,” she said.

“This highly effective strategy combining a BTK inhibitor and abbreviated immunochemotherapy deserves further investigation with randomized trials,” she concluded.

ICLL-07 FILO was funded by Roche and Janssen. Dr. Michallet reported having no disclosures.

[email protected]

EDINBURGH – Treatment induction with obinutuzumab and ibrutinib followed by a minimal residual disease (MRD)–driven treatment strategy in patients with chronic lymphocytic leukemia (CLL) yields a high long-term complete response rate and prolonged progression-free and overall survival, according to findings from the phase 2 ICLL-07 trial.

The intent-to-treat (ITT) complete response rate at 16 months in 135 patients who were treated with this strategy was 62%, Anne-Sophie Michallet, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

Patients in the multicenter, open-label trial conducted by the French Innovative Leukemia Organization (FILO) were previously untreated, medically fit patients with CLL and no 17p deletion. They were enrolled between November 2015 and May 2017 to receive eight 1,000 mg IV doses of obinutuzumab over six 4-week cycles along with oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib at a dose of 420 mg daily for 9 months.

Ten patients (7.7%) achieved complete response with bone marrow MRD less than 0.01% (undetectable) at 9 months and, by study protocol, continued on only the ibrutinib for 6 additional months. The remaining 120 evaluable patients received four 4-week cycles of fludarabine/cyclophosphamide along with the obinutuzumab and ibrutinib for 6 additional months, explained Dr. Michallet of Centre Léon Bérard, Lyon, France.

The ITT rate at 16 months – the primary endpoint of the study – was achieved with no more than four cycles of fludarabine/cyclophosphamide and obinutuzumab, and exceeded the primary objective of demonstrating a 30% or higher rate of complete response with bone marrow MRD less than 0.01% at the month 16 ITT analysis, she said.

“The ... strategy yielded an overall response rate of 100%, a complete response rate, according to iwCLL [criteria], of 73%, a bone marrow MRD–undetectable rate of 79% [in the ITT population],” she said, adding that the primary objective was achieved with a complete response with a peripheral blood and bone marrow MRD–undetectable rate of 62%.

Response assessments at months 9 and 16 involved whole-body computed tomography scans with tumor measurements and bone marrow trephine biopsy for patients in clinical complete response. MRD testing was performed by eight-color flow cytometry in both peripheral blood and bone marrow.

After month 16, response was clinically assessed every 3 months, and peripheral blood MRD was assessed every 6 months until month 40.

“With a median follow-up of 26.3 months, the 2-year progression-free survival and overall survival were, respectively, 97% and 97.5%,” Dr. Michallet said, noting that the longitudinal follow-up of peripheral blood MRD in the entire cohort showed durability of a deep response. The rate of peripheral blood MRD less than 0.01% at 22 months was 77% in the 10 patients who received only ibrutinib after the 9-month assessment, and 93% in those who received fludarabine/cyclophosphamide after the 9-month assessment.

In patients with immunoglobulin heavy gene variable (IGHV) mutations, the rate of peripheral blood MRD less than 0.01% at month 22 was 96%, and in those without IGHV mutations, the rate was 77%, she noted.

The findings demonstrate that the approach has merit in medically fit, treatment-naive patients with CLL and no 17p deletion, she said, explaining that the fixed-duration, MRD-driven strategy used in this study was developed to “avoid or at least reduce chemotherapy exposure” in the first-line treatment of such patients.

Indeed, the approach was associated with “a high [complete response] rate, a high level of undetectable bone marrow MRD, an acceptable safety profile, and a sustained MRD negativity rate at 12 months after the end of the treatment,” she said.

“This highly effective strategy combining a BTK inhibitor and abbreviated immunochemotherapy deserves further investigation with randomized trials,” she concluded.

ICLL-07 FILO was funded by Roche and Janssen. Dr. Michallet reported having no disclosures.

[email protected]

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.

Both the Society of Hospital Medicine and Jefferson College of Population Health, of Thomas Jefferson University in Philadelphia, share a goal to educate physicians to be effective leaders and managers in the pursuit of health care quality, safety, and population health, and they have entered into a partnership with this in mind.

Alexis Skoufalos, EdD, associate dean, strategic development, for Jefferson College of Population Health, recently spoke with The Hospitalist to discuss the importance of population health to hospital medicine professionals, the health care landscape as a whole, and the benefits of this new partnership with SHM.
 

Can you explain the importance of population health in the current health care landscape?

Many people confuse population health with public health. While they are related, they are different disciplines. Public health focuses on prevention and health promotion (clean water, vaccines, exercise, using seat belts, and so on), but it stops there.

Population health builds on the foundation of public health and goes a step further, working to connect health and health care delivery. It takes a more holistic approach, looking at what we need to do inside and outside the delivery system to help people to get and stay healthy, as well as take better care of them when they do get sick.

We work to identify and understand the health impact of social and environmental factors, while also looking for ways to make health care delivery safer, better, and more affordable and accessible.

This can get complicated. It involves sorting through lots of information to uncover the best way to meet the needs of a specific group, whether that is a community, a neighborhood, or a patient with a particular condition.

It’s about taking the time to really look at things from different vantage points. You won’t see the same view if you are looking at something through a telescope as you would looking through a microscope. That information can help you to adjust your perspective to identify the best course of action.

In order to be successful in improving population health, providers need to understand how to work with the other stakeholders in the health care ecosystem. Collaboration and coordination are the best ways to optimize the resources available.

It is important for delivery systems to establish good working relationships with community nonprofit and service organizations, faith-based organizations, social service providers, school systems, and federal, state, and local government.

At Jefferson, we thought it was important to create a college and programs that would prepare professionals across the workforce for this new challenge.
 

How did this partnership between SHM and Jefferson College of Population Health come to fruition?

Hospitalists are an important link with a person’s primary care team. The work they do to prepare a person and their family for successful discharge to the community after a hospital stay can make all the difference in a person’s recovery, condition management, and preventing readmission to the hospital.

Because both of our organizations are based in Philadelphia, we have had longstanding connections with SHM leadership. It was only natural for us to talk with SHM about how we can build upon the society’s excellent continuing education offerings and work together to provide members with additional content that can equip them to advance their careers.
 

How did SHM and Jefferson College of Population Health identify the mutually beneficial educational offerings in each institution that are included in this partnership?

Members of our respective leadership teams got together to complete a detailed review of the offerings from each organization. SHM’s Leadership Academy and JCPH’s Population Health Academy are rigorous continuing education programs that can provide physicians with excellent just-in-time information they can put to use right away.

After a careful examination of the curriculum, JCPH determined that SHM members can apply the credits they earn from completing two qualified sessions from the Leadership Academy to satisfy the elective course requirement for a Master’s degree. (Note: This does not apply to the Population Health Intelligence Program, which does not include an elective course.)
 

How will this partnership benefit Jefferson College of Population Health?

Our mission is to prepare health care leaders with the skills and tools they need to be effective in improving population health. Clinicians who work in a hospital setting have a key role to play.

We are also dedicated to making a difference right here in Philadelphia. The more students we have in our programs, the more of an impact we (and they) will have in improving outcomes in our own community.

We need to move the needle and get Philadelphia County out of the basement in terms of health rankings. We have a responsibility to do what we can to make a difference, and we appreciate the partnership with SHM to make it happen.
 

What other components of the partnership are especially noteworthy to highlight?

In addition to what I’ve already discussed, the following are some of the significant benefits that SHM members are entitled to as a result of the partnership with JCPH:

• 15% discount on tuition for any JCPH online graduate degree program.
• Registration discount for JCPH’s Population Health Academy in Philadelphia.
• Special registration rate for Annual Population Health Colloquium.

For more information about this partnership, visit hospitalmedicine.org/jefferson.






 

Both the Society of Hospital Medicine and Jefferson College of Population Health, of Thomas Jefferson University in Philadelphia, share a goal to educate physicians to be effective leaders and managers in the pursuit of health care quality, safety, and population health, and they have entered into a partnership with this in mind.

Alexis Skoufalos, EdD, associate dean, strategic development, for Jefferson College of Population Health, recently spoke with The Hospitalist to discuss the importance of population health to hospital medicine professionals, the health care landscape as a whole, and the benefits of this new partnership with SHM.
 

Can you explain the importance of population health in the current health care landscape?

Many people confuse population health with public health. While they are related, they are different disciplines. Public health focuses on prevention and health promotion (clean water, vaccines, exercise, using seat belts, and so on), but it stops there.

Population health builds on the foundation of public health and goes a step further, working to connect health and health care delivery. It takes a more holistic approach, looking at what we need to do inside and outside the delivery system to help people to get and stay healthy, as well as take better care of them when they do get sick.

We work to identify and understand the health impact of social and environmental factors, while also looking for ways to make health care delivery safer, better, and more affordable and accessible.

This can get complicated. It involves sorting through lots of information to uncover the best way to meet the needs of a specific group, whether that is a community, a neighborhood, or a patient with a particular condition.

It’s about taking the time to really look at things from different vantage points. You won’t see the same view if you are looking at something through a telescope as you would looking through a microscope. That information can help you to adjust your perspective to identify the best course of action.

In order to be successful in improving population health, providers need to understand how to work with the other stakeholders in the health care ecosystem. Collaboration and coordination are the best ways to optimize the resources available.

It is important for delivery systems to establish good working relationships with community nonprofit and service organizations, faith-based organizations, social service providers, school systems, and federal, state, and local government.

At Jefferson, we thought it was important to create a college and programs that would prepare professionals across the workforce for this new challenge.
 

How did this partnership between SHM and Jefferson College of Population Health come to fruition?

Hospitalists are an important link with a person’s primary care team. The work they do to prepare a person and their family for successful discharge to the community after a hospital stay can make all the difference in a person’s recovery, condition management, and preventing readmission to the hospital.

Because both of our organizations are based in Philadelphia, we have had longstanding connections with SHM leadership. It was only natural for us to talk with SHM about how we can build upon the society’s excellent continuing education offerings and work together to provide members with additional content that can equip them to advance their careers.
 

How did SHM and Jefferson College of Population Health identify the mutually beneficial educational offerings in each institution that are included in this partnership?

Members of our respective leadership teams got together to complete a detailed review of the offerings from each organization. SHM’s Leadership Academy and JCPH’s Population Health Academy are rigorous continuing education programs that can provide physicians with excellent just-in-time information they can put to use right away.

After a careful examination of the curriculum, JCPH determined that SHM members can apply the credits they earn from completing two qualified sessions from the Leadership Academy to satisfy the elective course requirement for a Master’s degree. (Note: This does not apply to the Population Health Intelligence Program, which does not include an elective course.)
 

How will this partnership benefit Jefferson College of Population Health?

Our mission is to prepare health care leaders with the skills and tools they need to be effective in improving population health. Clinicians who work in a hospital setting have a key role to play.

We are also dedicated to making a difference right here in Philadelphia. The more students we have in our programs, the more of an impact we (and they) will have in improving outcomes in our own community.

We need to move the needle and get Philadelphia County out of the basement in terms of health rankings. We have a responsibility to do what we can to make a difference, and we appreciate the partnership with SHM to make it happen.
 

What other components of the partnership are especially noteworthy to highlight?

In addition to what I’ve already discussed, the following are some of the significant benefits that SHM members are entitled to as a result of the partnership with JCPH:

• 15% discount on tuition for any JCPH online graduate degree program.
• Registration discount for JCPH’s Population Health Academy in Philadelphia.
• Special registration rate for Annual Population Health Colloquium.

For more information about this partnership, visit hospitalmedicine.org/jefferson.






 

Both the Society of Hospital Medicine and Jefferson College of Population Health, of Thomas Jefferson University in Philadelphia, share a goal to educate physicians to be effective leaders and managers in the pursuit of health care quality, safety, and population health, and they have entered into a partnership with this in mind.

Alexis Skoufalos, EdD, associate dean, strategic development, for Jefferson College of Population Health, recently spoke with The Hospitalist to discuss the importance of population health to hospital medicine professionals, the health care landscape as a whole, and the benefits of this new partnership with SHM.
 

Can you explain the importance of population health in the current health care landscape?

Many people confuse population health with public health. While they are related, they are different disciplines. Public health focuses on prevention and health promotion (clean water, vaccines, exercise, using seat belts, and so on), but it stops there.

Population health builds on the foundation of public health and goes a step further, working to connect health and health care delivery. It takes a more holistic approach, looking at what we need to do inside and outside the delivery system to help people to get and stay healthy, as well as take better care of them when they do get sick.

We work to identify and understand the health impact of social and environmental factors, while also looking for ways to make health care delivery safer, better, and more affordable and accessible.

This can get complicated. It involves sorting through lots of information to uncover the best way to meet the needs of a specific group, whether that is a community, a neighborhood, or a patient with a particular condition.

It’s about taking the time to really look at things from different vantage points. You won’t see the same view if you are looking at something through a telescope as you would looking through a microscope. That information can help you to adjust your perspective to identify the best course of action.

In order to be successful in improving population health, providers need to understand how to work with the other stakeholders in the health care ecosystem. Collaboration and coordination are the best ways to optimize the resources available.

It is important for delivery systems to establish good working relationships with community nonprofit and service organizations, faith-based organizations, social service providers, school systems, and federal, state, and local government.

At Jefferson, we thought it was important to create a college and programs that would prepare professionals across the workforce for this new challenge.
 

How did this partnership between SHM and Jefferson College of Population Health come to fruition?

Hospitalists are an important link with a person’s primary care team. The work they do to prepare a person and their family for successful discharge to the community after a hospital stay can make all the difference in a person’s recovery, condition management, and preventing readmission to the hospital.

Because both of our organizations are based in Philadelphia, we have had longstanding connections with SHM leadership. It was only natural for us to talk with SHM about how we can build upon the society’s excellent continuing education offerings and work together to provide members with additional content that can equip them to advance their careers.
 

How did SHM and Jefferson College of Population Health identify the mutually beneficial educational offerings in each institution that are included in this partnership?

Members of our respective leadership teams got together to complete a detailed review of the offerings from each organization. SHM’s Leadership Academy and JCPH’s Population Health Academy are rigorous continuing education programs that can provide physicians with excellent just-in-time information they can put to use right away.

After a careful examination of the curriculum, JCPH determined that SHM members can apply the credits they earn from completing two qualified sessions from the Leadership Academy to satisfy the elective course requirement for a Master’s degree. (Note: This does not apply to the Population Health Intelligence Program, which does not include an elective course.)
 

How will this partnership benefit Jefferson College of Population Health?

Our mission is to prepare health care leaders with the skills and tools they need to be effective in improving population health. Clinicians who work in a hospital setting have a key role to play.

We are also dedicated to making a difference right here in Philadelphia. The more students we have in our programs, the more of an impact we (and they) will have in improving outcomes in our own community.

We need to move the needle and get Philadelphia County out of the basement in terms of health rankings. We have a responsibility to do what we can to make a difference, and we appreciate the partnership with SHM to make it happen.
 

What other components of the partnership are especially noteworthy to highlight?

In addition to what I’ve already discussed, the following are some of the significant benefits that SHM members are entitled to as a result of the partnership with JCPH:

• 15% discount on tuition for any JCPH online graduate degree program.
• Registration discount for JCPH’s Population Health Academy in Philadelphia.
• Special registration rate for Annual Population Health Colloquium.

For more information about this partnership, visit hospitalmedicine.org/jefferson.






 

BARCELONA – Cancer drug prices are significantly higher in the United States than in Europe, and they don’t correlate with clinical benefit in either region, according to an analysis of drug costs and value-related scores between 2009 and 2018.

Of 63 cancer drugs approved by the Food and Drug Administration between 2009 and 2017 and by the European Medicines Agency as of December 31, 2018, 46 (73%) were approved for solid tumors, and 17 (27%) for hematologic malignancies. Median cancer drug prices in Europe were 52% lower than U.S. prices, Kerstin N. Vokinger, MD, Academic Chair For Health Policy at the Institute For Primary Care, University Hospital Zürich, and colleagues found.

The findings were released via press release at the European Society for Medical Oncology (ESMO) Congress and will be part of a poster discussion session there.

The investigators found no association between monthly treatment cost and the American Society of Clinical Oncology Value Framework (ASCO-VF) or the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) scores in any country. They also found no association between the price differential in the United States and Europe and either ASCO-VF (P = .599) or ESMO-MBCS (P = .321) scores.

For the analysis, they assessed U.S. average sales prices or, when those weren’t available, wholesale acquisition costs as of Feb. 1, 2019, and compared them with comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland.

ASCO-VF and ESMO-MCBS scores were then assessed based on the highest score from pivotal trials supporting each solid tumor drug.

The median monthly cost for drugs with low-benefit scores on ESMO-MCBS ranged from $4,361-$5,273 in the European countries, compared with $12,436 in the United States, according to the release.

“Drug costs were not associated with clinical benefit score in any of the countries we looked at. For example, some of the more expensive drugs for prostate and lung cancer in Switzerland had lower ESMO-MCBS scores, while cheaper drugs had higher scores,” said Dr. Vokinger, who also is affiliated with the Program on Regulation, Therapeutics, and Law at Harvard Medical School, Boston. “It is important that drug pricing is aligned with clinical value and that our limited resources are spent on innovative medicines that offer improved outcomes.”

Barbara Kiesewetter, MD, of the Medical University of Vienna and a member of the ESMO-MCBS Working Group, said the findings underscore the importance of using the scoring systems in clinical practice to assist in treatment-related decision making.

The ESMO-MCBS, for example, is available online, easy to use, and helps explain “the factors that are used to grade the clinical benefit of medicines.

“It’s very important to have this validated score not only for daily decision making, but to influence reimbursement decisions and reduce treatment disparities,” she said, also noting in the release that “[c]ost is one of the main reasons why patients are denied access to the newer anticancer drugs.”

“By showing which drugs are most likely to be worth the higher cost, we can hopefully improve access to the drugs with greatest value so that patients receive standardized, optimal therapy wherever they live,” she said.

The study was funded by the Swiss Cancer League. The authors reported having no conflicts of interest.

SOURCE: Vokinger KN et al. ESMO 2019, Abstract 1631PD-PR.

BARCELONA – Cancer drug prices are significantly higher in the United States than in Europe, and they don’t correlate with clinical benefit in either region, according to an analysis of drug costs and value-related scores between 2009 and 2018.

Of 63 cancer drugs approved by the Food and Drug Administration between 2009 and 2017 and by the European Medicines Agency as of December 31, 2018, 46 (73%) were approved for solid tumors, and 17 (27%) for hematologic malignancies. Median cancer drug prices in Europe were 52% lower than U.S. prices, Kerstin N. Vokinger, MD, Academic Chair For Health Policy at the Institute For Primary Care, University Hospital Zürich, and colleagues found.

The findings were released via press release at the European Society for Medical Oncology (ESMO) Congress and will be part of a poster discussion session there.

The investigators found no association between monthly treatment cost and the American Society of Clinical Oncology Value Framework (ASCO-VF) or the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) scores in any country. They also found no association between the price differential in the United States and Europe and either ASCO-VF (P = .599) or ESMO-MBCS (P = .321) scores.

For the analysis, they assessed U.S. average sales prices or, when those weren’t available, wholesale acquisition costs as of Feb. 1, 2019, and compared them with comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland.

ASCO-VF and ESMO-MCBS scores were then assessed based on the highest score from pivotal trials supporting each solid tumor drug.

The median monthly cost for drugs with low-benefit scores on ESMO-MCBS ranged from $4,361-$5,273 in the European countries, compared with $12,436 in the United States, according to the release.

“Drug costs were not associated with clinical benefit score in any of the countries we looked at. For example, some of the more expensive drugs for prostate and lung cancer in Switzerland had lower ESMO-MCBS scores, while cheaper drugs had higher scores,” said Dr. Vokinger, who also is affiliated with the Program on Regulation, Therapeutics, and Law at Harvard Medical School, Boston. “It is important that drug pricing is aligned with clinical value and that our limited resources are spent on innovative medicines that offer improved outcomes.”

Barbara Kiesewetter, MD, of the Medical University of Vienna and a member of the ESMO-MCBS Working Group, said the findings underscore the importance of using the scoring systems in clinical practice to assist in treatment-related decision making.

The ESMO-MCBS, for example, is available online, easy to use, and helps explain “the factors that are used to grade the clinical benefit of medicines.

“It’s very important to have this validated score not only for daily decision making, but to influence reimbursement decisions and reduce treatment disparities,” she said, also noting in the release that “[c]ost is one of the main reasons why patients are denied access to the newer anticancer drugs.”

“By showing which drugs are most likely to be worth the higher cost, we can hopefully improve access to the drugs with greatest value so that patients receive standardized, optimal therapy wherever they live,” she said.

The study was funded by the Swiss Cancer League. The authors reported having no conflicts of interest.

SOURCE: Vokinger KN et al. ESMO 2019, Abstract 1631PD-PR.

BARCELONA – Cancer drug prices are significantly higher in the United States than in Europe, and they don’t correlate with clinical benefit in either region, according to an analysis of drug costs and value-related scores between 2009 and 2018.

Of 63 cancer drugs approved by the Food and Drug Administration between 2009 and 2017 and by the European Medicines Agency as of December 31, 2018, 46 (73%) were approved for solid tumors, and 17 (27%) for hematologic malignancies. Median cancer drug prices in Europe were 52% lower than U.S. prices, Kerstin N. Vokinger, MD, Academic Chair For Health Policy at the Institute For Primary Care, University Hospital Zürich, and colleagues found.

The findings were released via press release at the European Society for Medical Oncology (ESMO) Congress and will be part of a poster discussion session there.

The investigators found no association between monthly treatment cost and the American Society of Clinical Oncology Value Framework (ASCO-VF) or the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) scores in any country. They also found no association between the price differential in the United States and Europe and either ASCO-VF (P = .599) or ESMO-MBCS (P = .321) scores.

For the analysis, they assessed U.S. average sales prices or, when those weren’t available, wholesale acquisition costs as of Feb. 1, 2019, and compared them with comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland.

ASCO-VF and ESMO-MCBS scores were then assessed based on the highest score from pivotal trials supporting each solid tumor drug.

The median monthly cost for drugs with low-benefit scores on ESMO-MCBS ranged from $4,361-$5,273 in the European countries, compared with $12,436 in the United States, according to the release.

“Drug costs were not associated with clinical benefit score in any of the countries we looked at. For example, some of the more expensive drugs for prostate and lung cancer in Switzerland had lower ESMO-MCBS scores, while cheaper drugs had higher scores,” said Dr. Vokinger, who also is affiliated with the Program on Regulation, Therapeutics, and Law at Harvard Medical School, Boston. “It is important that drug pricing is aligned with clinical value and that our limited resources are spent on innovative medicines that offer improved outcomes.”

Barbara Kiesewetter, MD, of the Medical University of Vienna and a member of the ESMO-MCBS Working Group, said the findings underscore the importance of using the scoring systems in clinical practice to assist in treatment-related decision making.

The ESMO-MCBS, for example, is available online, easy to use, and helps explain “the factors that are used to grade the clinical benefit of medicines.

“It’s very important to have this validated score not only for daily decision making, but to influence reimbursement decisions and reduce treatment disparities,” she said, also noting in the release that “[c]ost is one of the main reasons why patients are denied access to the newer anticancer drugs.”

“By showing which drugs are most likely to be worth the higher cost, we can hopefully improve access to the drugs with greatest value so that patients receive standardized, optimal therapy wherever they live,” she said.

The study was funded by the Swiss Cancer League. The authors reported having no conflicts of interest.

SOURCE: Vokinger KN et al. ESMO 2019, Abstract 1631PD-PR.