The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.

The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.

The oral BRAF(V600E) kinase inhibitor vemurafenib (Zelboraf) has durable activity in non–small cell lung cancer (NSCLC) harboring BRAF V600 mutations and possibly provides greater benefit for treatment-naive patients, found the phase 2, open-label, single-arm VE-BASKET trial.

“Targetable oncogenic drivers in NSCLC with robust clinical validation include EGFR mutations and ALK and ROS1 fusions, but identifying other targetable, clinically important subgroups of NSCLC is a high priority,” wrote the investigators, who were led by Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston. Roughly 1%-4% of NSCLC patients have tumors harboring a BRAF V600 mutation, they noted.

Analyses were based on 62 patients with BRAF V600–mutant NSCLC enrolled in the trial’s NSCLC cohort or all-comers cohort. All received vemurafenib (960 mg twice daily) until disease progression or unacceptable toxicity.

Thirteen percent of the patients had not received any previous systemic therapy. Among those previously treated, the median number of systemic regimens received was two.

Results reported in JCO Precicion Oncology showed that the median treatment duration was 6.0 months for all patients (12.0 months for previously untreated patients and 5.7 months for previously treated patients).

The objective response rate, the trial’s primary endpoint, was 37.1% overall; it was similar in the previously untreated group and the previously treated group (37.5% and 37.0%, respectively). The clinical benefit rate was 48.4% overall, with a larger differential according to previous treatment at 62.5% and 46.3%.

Median progression-free survival was 6.5 months in all patients (12.9 months in those previously untreated and 6.1 months in those previously treated), and median overall survival was 15.4 months in all patients (not estimable in those previously untreated, but 15.4 months in those previously treated).

The most common adverse events of any grade were nausea (seen in 40% of patients), hyperkeratosis (34%), and decreased appetite (32%). The most common grade 3 or worse adverse event was anemia (10%). The safety profile generally resembled that previously observed among patients with melanoma, with no new signals.

“Vemurafenib showed promising activity in patients with NSCLC harboring BRAF V600 mutations,” Dr. Subbiah and colleagues concluded. “The prolonged [overall survival] … in the NSCLC population represents promising durability of effect with single-agent BRAF inhibition.”

“The apparent increase in median [progression-free survival] in previously untreated patients compared with previously treated patients warrants additional investigation of earlier treatment in this patient population,” they maintained.

Dr. Subbiah disclosed having a consulting or advisory role with or receiving research funding from numerous pharmaceutical companies. The study was sponsored by Hoffmann-La Roche.

SOURCE: Subbiah V et al. JCO Precis Oncol. 2019 June 27. doi: 10.1200/PO.18.00266.

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]

MILAN – A retrospective, multicenter study affirmed clinical trial results showing the beneficial clinical impact of dupilumab in adults with moderate to severe atopic dermatitis, Maria Fargnoli, MD, reported at the World Congress of Dermatology.

Kari Oakes/MDedge News

By the end of 4 weeks of treatment, participants’ mean Eczema Area and Severity Index (EASI) score had dropped from 33.3 to 15.3, a 54.2% reduction. At 16 weeks, the mean EASI score was 9.2, a reduction of 72.5% from baseline (P less than .001 for both time points, compared with baseline). At 16 weeks, 87.2% of patients achieved EASI 50, 60.6% achieved EASI 75, and 32.4% achieved EASI 90.

“In a real-life context, dupilumab significantly improved disease severity, pruritus, sleep loss, and quality of life in adult moderate to severe atopic dermatitis patients,” said Dr. Fargnoli, presenting results of the study during a late-breaking abstract session at the meeting. “All measures improved at 4 weeks, and a further decline was seen at 16 weeks. … These results confirm data from clinical trials, and from other real-life experiences with dupilumab.”

The study, conducted in Italy, tracked outcomes for 109 patients treated for moderate to severe atopic dermatitis at 39 centers from June 2018 to February 2019. Adult patients with EASI scores of at least 24 with contraindications, failure, or intolerance of corticosteroid therapy were included and followed for at least 16 weeks. Those who had concomitant systemic anti-inflammatory or immunomodulator use were excluded, as were those with missing data, said Dr. Fargnoli, chair of the department of dermatology at the University of L’Aquila (Italy).

Patients were given a loading dose of two 300-mg subcutaneous injections of dupilumab, followed by 300-mg injections at 2-week intervals.

Patients were assessed at baseline and after 4 and 16 weeks of treatment. In addition to EASI score, itch and sleep were measured via numeric rating scales; mean itch scores dropped from 8.4 at baseline to 4.1 after 4 weeks, and to 2.5 at 16 weeks (P less than .001 for both time points, compared with baseline).

Sleep scores also improved, from a mean 6.9 at baseline to 3.3 at four weeks, and 1.9 at 16 weeks (P less than .001 for both time points, compared with baseline).


Patients also completed the Dermatology Life Quality Index. At the 4-week mark, patients saw a reduction to 8.3 points from the baseline score of 17.6 points (out of a possible 30, with higher scores indicating worse quality of life); scores dropped to 5.4 by week 16 (P less than .001 for both time points, compared with baseline).

Dupilumab was generally well tolerated, with conjunctivitis – seen in 11% of patients – being the most commonly reported adverse event. This falls in line with other recently published real-world studies of dupilumab, Dr. Fargnoli noted.

Efficacy, as measured by EASI reduction and improvement in itch and sleep, were also comparable between the Italian cohort and clinical trial results, as well as other real-life studies in Denmark, France, the Netherlands, and Spain, she said.

Patients, about one-third female, had a mean body mass index of about 24 kg/m². Mean age was about 38 years (range, 19-80 years). The mean age of disease onset was about 14 years (range, 0-77 years).

Atopic dermatitis was characterized by phenotype for each patient; groupings included classic adult type (73%), nummular dermatitis (7%), prurigo (8%), and erythrodermic dermatitis (12%). About three in four patients (76.1%) had facial involvement; 61.5% had hand involvement, and 22.9% had genital involvement.

Allergic comorbidities were reported by many patients; 44.9% had rhinitis, 38.5% had asthma, 33% had conjunctivitis, and 15.6% reported food allergies. Other notable comorbidities included psychiatric or psychological conditions, present in 11% of patients, and hypertension or other cardiovascular disorders, seen in 9.1% of patients.

Most patients had tried treatment with both cyclosporine A and corticosteroids (88.9% and 88.1%, respectively). Almost half (45.8%) had tried UV-light therapy, and about a quarter had tried methotrexate.

“The results give real-life data on patterns of treatment response according to heterogeneous atopic dermatitis phenotypes, and on long-term efficacy and safety,” said Dr. Fargnoli.

The study was not funded by any company, according to Dr. Fargnoli. She has served on the advisory board for and has received honoraria for lectures and research grants from Sanofi-Genzyme.

[email protected]

Responders to repeated transcranial magnetic stimulation for treatment of depression are more likely to engage in light physical activity, compared with those who do not respond to treatment, recent research shows.

“It is remarkable that there is so little evidence on whether treatments for depression among adults have an impact on physical activity and whether changes in physical activity mediate the outcomes of these treatments,” Matthew James Fagan, a PhD student at the University of British Columbia, Vancouver, and colleagues wrote. “Further research is required in understanding the covariation of [physical activity] with depression treatment response.”

The researchers performed a secondary analysis of 30 individuals with major depressive disorder (MDD) who underwent either repeated transcranial magnetic stimulation or intermittent theta burst stimulation for 4-6 weeks. The participants’ 17-item Hamilton Rating Scale for Depression was measured along with their level of physical activity before and after treatment. Physical activity was classified as either light physical activity (LPA) – defined as any waking activity between 1.5 and 3.0 metabolic equivalents – or moderate to vigorous physical activity (MVPA), which was defined as waking behavior at 3.0 metabolic equivalents or higher.

A total of 16 participants responded to treatment (greater than or equal to 18 on the Hamilton Rating Scale for Depression) and 14 participants were deemed nonresponders. The researchers found no significant differences in LPA or MVPA between groups at baseline, but a significant treatment effect was seen among responders who increased LPA by 55 min/day, compared with nonresponders (P = .009). There was also a nonsignificant treatment effect that increased MVPA favoring responders, according to an analysis of covariance.

“Simply, our findings indicate that patients moved more after r-TMS treatment, and this may reinforce the treatment effect,” Mr. Fagan and colleagues reported.

The researchers noted that, because the study was a secondary analysis, it did not show the long-term effect of treatment on physical activity. “Future work should systematically examine the role of PA before, during, and after depression treatments as important synergistic mechanisms may be at play in the treatment of MDD,” they wrote.

Mr. Fagan reported no relevant financial disclosures. One or more authors reported support from several entities, including Brainsway, the Canadian Institutes of Health Research, the National Institutes of Health, and the Vancouver Coastal Health Research Institute, and reported relationships with ANT Neuro, BrainCheck, Brainsway, Lundbeck, Restorative Brain Clinics, and TMS Neuro Solutions.

SOURCE: Fagan MJ et al. Ment Health Phys Act. 2019 Apr 24. doi: 10.1016/j.mhpa.2019.03.003.

Responders to repeated transcranial magnetic stimulation for treatment of depression are more likely to engage in light physical activity, compared with those who do not respond to treatment, recent research shows.

“It is remarkable that there is so little evidence on whether treatments for depression among adults have an impact on physical activity and whether changes in physical activity mediate the outcomes of these treatments,” Matthew James Fagan, a PhD student at the University of British Columbia, Vancouver, and colleagues wrote. “Further research is required in understanding the covariation of [physical activity] with depression treatment response.”

The researchers performed a secondary analysis of 30 individuals with major depressive disorder (MDD) who underwent either repeated transcranial magnetic stimulation or intermittent theta burst stimulation for 4-6 weeks. The participants’ 17-item Hamilton Rating Scale for Depression was measured along with their level of physical activity before and after treatment. Physical activity was classified as either light physical activity (LPA) – defined as any waking activity between 1.5 and 3.0 metabolic equivalents – or moderate to vigorous physical activity (MVPA), which was defined as waking behavior at 3.0 metabolic equivalents or higher.

A total of 16 participants responded to treatment (greater than or equal to 18 on the Hamilton Rating Scale for Depression) and 14 participants were deemed nonresponders. The researchers found no significant differences in LPA or MVPA between groups at baseline, but a significant treatment effect was seen among responders who increased LPA by 55 min/day, compared with nonresponders (P = .009). There was also a nonsignificant treatment effect that increased MVPA favoring responders, according to an analysis of covariance.

“Simply, our findings indicate that patients moved more after r-TMS treatment, and this may reinforce the treatment effect,” Mr. Fagan and colleagues reported.

The researchers noted that, because the study was a secondary analysis, it did not show the long-term effect of treatment on physical activity. “Future work should systematically examine the role of PA before, during, and after depression treatments as important synergistic mechanisms may be at play in the treatment of MDD,” they wrote.

Mr. Fagan reported no relevant financial disclosures. One or more authors reported support from several entities, including Brainsway, the Canadian Institutes of Health Research, the National Institutes of Health, and the Vancouver Coastal Health Research Institute, and reported relationships with ANT Neuro, BrainCheck, Brainsway, Lundbeck, Restorative Brain Clinics, and TMS Neuro Solutions.

SOURCE: Fagan MJ et al. Ment Health Phys Act. 2019 Apr 24. doi: 10.1016/j.mhpa.2019.03.003.

Responders to repeated transcranial magnetic stimulation for treatment of depression are more likely to engage in light physical activity, compared with those who do not respond to treatment, recent research shows.

“It is remarkable that there is so little evidence on whether treatments for depression among adults have an impact on physical activity and whether changes in physical activity mediate the outcomes of these treatments,” Matthew James Fagan, a PhD student at the University of British Columbia, Vancouver, and colleagues wrote. “Further research is required in understanding the covariation of [physical activity] with depression treatment response.”

The researchers performed a secondary analysis of 30 individuals with major depressive disorder (MDD) who underwent either repeated transcranial magnetic stimulation or intermittent theta burst stimulation for 4-6 weeks. The participants’ 17-item Hamilton Rating Scale for Depression was measured along with their level of physical activity before and after treatment. Physical activity was classified as either light physical activity (LPA) – defined as any waking activity between 1.5 and 3.0 metabolic equivalents – or moderate to vigorous physical activity (MVPA), which was defined as waking behavior at 3.0 metabolic equivalents or higher.

A total of 16 participants responded to treatment (greater than or equal to 18 on the Hamilton Rating Scale for Depression) and 14 participants were deemed nonresponders. The researchers found no significant differences in LPA or MVPA between groups at baseline, but a significant treatment effect was seen among responders who increased LPA by 55 min/day, compared with nonresponders (P = .009). There was also a nonsignificant treatment effect that increased MVPA favoring responders, according to an analysis of covariance.

“Simply, our findings indicate that patients moved more after r-TMS treatment, and this may reinforce the treatment effect,” Mr. Fagan and colleagues reported.

The researchers noted that, because the study was a secondary analysis, it did not show the long-term effect of treatment on physical activity. “Future work should systematically examine the role of PA before, during, and after depression treatments as important synergistic mechanisms may be at play in the treatment of MDD,” they wrote.

Mr. Fagan reported no relevant financial disclosures. One or more authors reported support from several entities, including Brainsway, the Canadian Institutes of Health Research, the National Institutes of Health, and the Vancouver Coastal Health Research Institute, and reported relationships with ANT Neuro, BrainCheck, Brainsway, Lundbeck, Restorative Brain Clinics, and TMS Neuro Solutions.

SOURCE: Fagan MJ et al. Ment Health Phys Act. 2019 Apr 24. doi: 10.1016/j.mhpa.2019.03.003.

A 46-year-old woman presents with a BMI of 28, a 4-year history of type 2 diabetes mellitus (T2DM), and an A1C of 9.8%. The patient is currently being treated with intensive medical therapy (IMT), including metformin 2000 mg/d, sitagliptin 100 mg/d, and insulin glargine 12 U/d, with minimal change in A1C. Should you recommend bariatric surgery?

One in 11 Americans has diabetes, and at least 95% of those have T2DM.^2,3 The treatment of T2DM is generally multimodal to target the various mechanisms that cause hyperglycemia. Strategies may include making lifestyle modifications, decreasing insulin resistance, increasing insulin secretion, replacing insulin, and targeting incretin-hormonal pathways.

The American Diabetes Association (ADA) recommends diet, exercise, and behavioral modifications as firstline therapy for diabetes management, but these methods are often inadequate.² In addition to various pharmacotherapeutic strategies for some populations with T2DM, the ADA recommends bariatric surgery for those with a BMI ≥ 35 and uncontrolled hyper­glycemia.^2,4

However, this recommendation is based only on short-term studies. For example, in a single-center, nonblinded RCT of 60 patients with a BMI ≥ 35, the average baseline A1C levels of 8.65 ± 1.45% were reduced to 7.7 ± 0.6% in the IMT group and to 6.4 ± 1.4% in the gastric-bypass group at 2 years.⁵ In another study, a randomized double-blind trial involving 60 moderately obese patients (BMI, 25-35), gastric bypass yielded better outcomes than sleeve gastrectomy: 93% of patients in the former group and 47% of those in the latter group achieved remission of T2DM over a 12-month period.⁶

The current study by Schauer et al examined the long-term outcomes of IMT alone vs bariatric surgery with IMT for the treatment of T2DM in patients who are overweight or obese.¹

STUDY SUMMARY

5-year follow-up: surgery + IMT works

This study was a 5-year follow-up of a nonblinded, single-center RCT comparing IMT alone to IMT with Roux-en-Y gastric bypass or sleeve gastrectomy in 150 patients with T2DM.¹ Patients were included if they were ages 20 to 60, had a BMI of 27 to 43, and had an A1C > 7%. Patients with a history of bariatric surgery, complex abdominal surgery, or uncontrolled medical or psychiatric disorders were excluded.

Patients were randomly placed in a 1:1:1 fashion into 3 groups: IMT (as defined by the ADA) only, IMT and gastric bypass, or IMT and sleeve gastrectomy. The primary outcome was the number of patients with an A1C ≤ 6%. Secondary outcomes included weight loss, glucose control, lipid levels, blood pressure, medication use, renal function, adverse effects, ophthalmologic outcomes, and quality of life.

Continue to: Of the 150 patients...

Of the 150 patients, 1 died during the follow-up period, leaving 149. Of these, 134 completed the 5-year follow-up. Eight patients in the IMT group and 1 patient in the sleeve gastrectomy group never initiated assigned treatment, and 6 patients were lost to follow-up. One patient from the IMT group and 1 patient from the sleeve gastrectomy group crossed over to the gastric bypass group.

Results. More patients in the bariatric surgery and sleeve gastrectomy groups achieved an A1C of ≤ 6% than in the IMT group (14 of 49 gastric bypass patients, 11 of 47 sleeve gastrectomy patients, and 2 of 38 IMT patients). Compared with those in the IMT group, the patients in the 2 surgery groups showed greater reductions from baseline in body weight and triglyceride levels and greater increases from baseline in HDL cholesterol levels; they also required less antidiabetes medication for glycemic control (see Table).¹

WHAT’S NEW?

Big benefits, minimal adverse effects

Prior studies evaluating the effect of gastric bypass surgery on diabetes were observational or had a shorter follow-up duration. This study demonstrates that bariatric surgery plus IMT has long-term benefits with minimal adverse events, compared with IMT alone.^1,5 Additionally, this study supports recommendations for bariatric surgery as treatment for T2DM in patients with a BMI ≥ 27, which is below the starting BMI (35) recommended by the ADA.^1,4

CAVEATS

Surgery is not without risks

The risk for surgical complications—eg, gastrointestinal bleeding, severe hypoglycemia requiring intervention, and ketoacidosis—in this patient population is significant.¹ Other potential complications include gastrointestinal leak, stroke, and infection.¹ Additionally, long-term complications from bariatric surgery are emerging and include choledocholithiasis, intestinal obstruction, and esophageal pathology.⁷ Extensive patient counseling is necessary to ensure that patients make an informed decision regarding surgery.

This study utilized surrogate markers (A1C, lipid levels, and body weight) as disease-oriented outcome measures. Patient-oriented outcomes, such as morbidity and mortality, were not explored in this study.

Continue to: Due to the small sample size...

Due to the small sample size of the study, it is unclear if the outcomes of the 2 surgery groups were significantly different. Patients who underwent gastric bypass surgery had more weight loss and used less diabetes medication at the end of follow-up, compared with patients who underwent sleeve gastrectomy. More information is needed to determine which gastric surgery is preferable for the treatment of T2DM while minimizing adverse effects. However, both of the procedures had outcomes superior to those of IMT, and selection of a particular type of surgery should be a joint decision between the patient and provider.

CHALLENGES TO IMPLEMENTATION

Access and cost may be barriers

The major barriers to implementation are access to, and cost of, bariatric surgery.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[2]:102-104).

A 46-year-old woman presents with a BMI of 28, a 4-year history of type 2 diabetes mellitus (T2DM), and an A1C of 9.8%. The patient is currently being treated with intensive medical therapy (IMT), including metformin 2000 mg/d, sitagliptin 100 mg/d, and insulin glargine 12 U/d, with minimal change in A1C. Should you recommend bariatric surgery?

One in 11 Americans has diabetes, and at least 95% of those have T2DM.^2,3 The treatment of T2DM is generally multimodal to target the various mechanisms that cause hyperglycemia. Strategies may include making lifestyle modifications, decreasing insulin resistance, increasing insulin secretion, replacing insulin, and targeting incretin-hormonal pathways.

The American Diabetes Association (ADA) recommends diet, exercise, and behavioral modifications as firstline therapy for diabetes management, but these methods are often inadequate.² In addition to various pharmacotherapeutic strategies for some populations with T2DM, the ADA recommends bariatric surgery for those with a BMI ≥ 35 and uncontrolled hyper­glycemia.^2,4

However, this recommendation is based only on short-term studies. For example, in a single-center, nonblinded RCT of 60 patients with a BMI ≥ 35, the average baseline A1C levels of 8.65 ± 1.45% were reduced to 7.7 ± 0.6% in the IMT group and to 6.4 ± 1.4% in the gastric-bypass group at 2 years.⁵ In another study, a randomized double-blind trial involving 60 moderately obese patients (BMI, 25-35), gastric bypass yielded better outcomes than sleeve gastrectomy: 93% of patients in the former group and 47% of those in the latter group achieved remission of T2DM over a 12-month period.⁶

The current study by Schauer et al examined the long-term outcomes of IMT alone vs bariatric surgery with IMT for the treatment of T2DM in patients who are overweight or obese.¹

STUDY SUMMARY

5-year follow-up: surgery + IMT works

This study was a 5-year follow-up of a nonblinded, single-center RCT comparing IMT alone to IMT with Roux-en-Y gastric bypass or sleeve gastrectomy in 150 patients with T2DM.¹ Patients were included if they were ages 20 to 60, had a BMI of 27 to 43, and had an A1C > 7%. Patients with a history of bariatric surgery, complex abdominal surgery, or uncontrolled medical or psychiatric disorders were excluded.

Patients were randomly placed in a 1:1:1 fashion into 3 groups: IMT (as defined by the ADA) only, IMT and gastric bypass, or IMT and sleeve gastrectomy. The primary outcome was the number of patients with an A1C ≤ 6%. Secondary outcomes included weight loss, glucose control, lipid levels, blood pressure, medication use, renal function, adverse effects, ophthalmologic outcomes, and quality of life.

Continue to: Of the 150 patients...

Of the 150 patients, 1 died during the follow-up period, leaving 149. Of these, 134 completed the 5-year follow-up. Eight patients in the IMT group and 1 patient in the sleeve gastrectomy group never initiated assigned treatment, and 6 patients were lost to follow-up. One patient from the IMT group and 1 patient from the sleeve gastrectomy group crossed over to the gastric bypass group.

Results. More patients in the bariatric surgery and sleeve gastrectomy groups achieved an A1C of ≤ 6% than in the IMT group (14 of 49 gastric bypass patients, 11 of 47 sleeve gastrectomy patients, and 2 of 38 IMT patients). Compared with those in the IMT group, the patients in the 2 surgery groups showed greater reductions from baseline in body weight and triglyceride levels and greater increases from baseline in HDL cholesterol levels; they also required less antidiabetes medication for glycemic control (see Table).¹

WHAT’S NEW?

Big benefits, minimal adverse effects

Prior studies evaluating the effect of gastric bypass surgery on diabetes were observational or had a shorter follow-up duration. This study demonstrates that bariatric surgery plus IMT has long-term benefits with minimal adverse events, compared with IMT alone.^1,5 Additionally, this study supports recommendations for bariatric surgery as treatment for T2DM in patients with a BMI ≥ 27, which is below the starting BMI (35) recommended by the ADA.^1,4

CAVEATS

Surgery is not without risks

The risk for surgical complications—eg, gastrointestinal bleeding, severe hypoglycemia requiring intervention, and ketoacidosis—in this patient population is significant.¹ Other potential complications include gastrointestinal leak, stroke, and infection.¹ Additionally, long-term complications from bariatric surgery are emerging and include choledocholithiasis, intestinal obstruction, and esophageal pathology.⁷ Extensive patient counseling is necessary to ensure that patients make an informed decision regarding surgery.

This study utilized surrogate markers (A1C, lipid levels, and body weight) as disease-oriented outcome measures. Patient-oriented outcomes, such as morbidity and mortality, were not explored in this study.

Continue to: Due to the small sample size...

Due to the small sample size of the study, it is unclear if the outcomes of the 2 surgery groups were significantly different. Patients who underwent gastric bypass surgery had more weight loss and used less diabetes medication at the end of follow-up, compared with patients who underwent sleeve gastrectomy. More information is needed to determine which gastric surgery is preferable for the treatment of T2DM while minimizing adverse effects. However, both of the procedures had outcomes superior to those of IMT, and selection of a particular type of surgery should be a joint decision between the patient and provider.

CHALLENGES TO IMPLEMENTATION

Access and cost may be barriers

The major barriers to implementation are access to, and cost of, bariatric surgery.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[2]:102-104).

A 46-year-old woman presents with a BMI of 28, a 4-year history of type 2 diabetes mellitus (T2DM), and an A1C of 9.8%. The patient is currently being treated with intensive medical therapy (IMT), including metformin 2000 mg/d, sitagliptin 100 mg/d, and insulin glargine 12 U/d, with minimal change in A1C. Should you recommend bariatric surgery?

One in 11 Americans has diabetes, and at least 95% of those have T2DM.^2,3 The treatment of T2DM is generally multimodal to target the various mechanisms that cause hyperglycemia. Strategies may include making lifestyle modifications, decreasing insulin resistance, increasing insulin secretion, replacing insulin, and targeting incretin-hormonal pathways.

The American Diabetes Association (ADA) recommends diet, exercise, and behavioral modifications as firstline therapy for diabetes management, but these methods are often inadequate.² In addition to various pharmacotherapeutic strategies for some populations with T2DM, the ADA recommends bariatric surgery for those with a BMI ≥ 35 and uncontrolled hyper­glycemia.^2,4

However, this recommendation is based only on short-term studies. For example, in a single-center, nonblinded RCT of 60 patients with a BMI ≥ 35, the average baseline A1C levels of 8.65 ± 1.45% were reduced to 7.7 ± 0.6% in the IMT group and to 6.4 ± 1.4% in the gastric-bypass group at 2 years.⁵ In another study, a randomized double-blind trial involving 60 moderately obese patients (BMI, 25-35), gastric bypass yielded better outcomes than sleeve gastrectomy: 93% of patients in the former group and 47% of those in the latter group achieved remission of T2DM over a 12-month period.⁶

The current study by Schauer et al examined the long-term outcomes of IMT alone vs bariatric surgery with IMT for the treatment of T2DM in patients who are overweight or obese.¹

STUDY SUMMARY

5-year follow-up: surgery + IMT works

This study was a 5-year follow-up of a nonblinded, single-center RCT comparing IMT alone to IMT with Roux-en-Y gastric bypass or sleeve gastrectomy in 150 patients with T2DM.¹ Patients were included if they were ages 20 to 60, had a BMI of 27 to 43, and had an A1C > 7%. Patients with a history of bariatric surgery, complex abdominal surgery, or uncontrolled medical or psychiatric disorders were excluded.

Patients were randomly placed in a 1:1:1 fashion into 3 groups: IMT (as defined by the ADA) only, IMT and gastric bypass, or IMT and sleeve gastrectomy. The primary outcome was the number of patients with an A1C ≤ 6%. Secondary outcomes included weight loss, glucose control, lipid levels, blood pressure, medication use, renal function, adverse effects, ophthalmologic outcomes, and quality of life.

Continue to: Of the 150 patients...

Of the 150 patients, 1 died during the follow-up period, leaving 149. Of these, 134 completed the 5-year follow-up. Eight patients in the IMT group and 1 patient in the sleeve gastrectomy group never initiated assigned treatment, and 6 patients were lost to follow-up. One patient from the IMT group and 1 patient from the sleeve gastrectomy group crossed over to the gastric bypass group.

Results. More patients in the bariatric surgery and sleeve gastrectomy groups achieved an A1C of ≤ 6% than in the IMT group (14 of 49 gastric bypass patients, 11 of 47 sleeve gastrectomy patients, and 2 of 38 IMT patients). Compared with those in the IMT group, the patients in the 2 surgery groups showed greater reductions from baseline in body weight and triglyceride levels and greater increases from baseline in HDL cholesterol levels; they also required less antidiabetes medication for glycemic control (see Table).¹

WHAT’S NEW?

Big benefits, minimal adverse effects

Prior studies evaluating the effect of gastric bypass surgery on diabetes were observational or had a shorter follow-up duration. This study demonstrates that bariatric surgery plus IMT has long-term benefits with minimal adverse events, compared with IMT alone.^1,5 Additionally, this study supports recommendations for bariatric surgery as treatment for T2DM in patients with a BMI ≥ 27, which is below the starting BMI (35) recommended by the ADA.^1,4

CAVEATS

Surgery is not without risks

The risk for surgical complications—eg, gastrointestinal bleeding, severe hypoglycemia requiring intervention, and ketoacidosis—in this patient population is significant.¹ Other potential complications include gastrointestinal leak, stroke, and infection.¹ Additionally, long-term complications from bariatric surgery are emerging and include choledocholithiasis, intestinal obstruction, and esophageal pathology.⁷ Extensive patient counseling is necessary to ensure that patients make an informed decision regarding surgery.

This study utilized surrogate markers (A1C, lipid levels, and body weight) as disease-oriented outcome measures. Patient-oriented outcomes, such as morbidity and mortality, were not explored in this study.

Continue to: Due to the small sample size...

Due to the small sample size of the study, it is unclear if the outcomes of the 2 surgery groups were significantly different. Patients who underwent gastric bypass surgery had more weight loss and used less diabetes medication at the end of follow-up, compared with patients who underwent sleeve gastrectomy. More information is needed to determine which gastric surgery is preferable for the treatment of T2DM while minimizing adverse effects. However, both of the procedures had outcomes superior to those of IMT, and selection of a particular type of surgery should be a joint decision between the patient and provider.

CHALLENGES TO IMPLEMENTATION

Access and cost may be barriers

The major barriers to implementation are access to, and cost of, bariatric surgery.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[2]:102-104).

Adults with obesity and depression who participated in a program that addressed weight and mood saw improvement in weight loss and depressive symptoms at 12 months, results of a randomized, controlled trial of almost 350 patients show.

“To our knowledge, this study was the first and largest RTC of integrated collaborative care for coexisting obesity and depression,” wrote Jun Ma, MD, PhD, of the Institute of Health Research and Policy at the University of Illinois at Chicago, and colleagues.

Dr. Ma and colleagues enrolled 409 patients in the RAINBOW (Research Aimed at Improving Both Mood and Weight) trial between September 2014 and January 2017 from family and internal medicine departments at four medical centers in California. The RAINBOW intervention combined usual care with a weight loss treatment program used in diabetes prevention, problem-solving therapy, and prescriptions for antidepressants if indicated. About 71% of the trial participants were non-Hispanic white adults, 70% were women, and 69% had a college education.

Half the patients were randomized to receive usual care consisting of seeing personal physicians, receiving information on obesity and depression services at the clinic, and wireless activity-tracking devices. Patients were enrolled in the trial if they scored at least 10 points in the nine-item Patient Health Questionaire (PHQ-9) and had a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher in Asian adults. The mean age in the cohort was 51.0 years, the mean BMI was 37.7, and the mean PHQ-9 score was 13.8.

Of the 344 patients (84.1%) who completed follow-up at 12 months, there was a decrease in mean BMI from 36.7 to 35.9 for patients who received the collaborative care intervention, compared with no change in BMI for patients who received usual care alone (between-group mean difference, −0.7; 95% confidence interval, −1.1 to −0.2; P = .01). Depressive symptoms also improved in the intervention group, with mean 20-item Depression Symptom Checklist scores decreasing from 1.5 at baseline to 1.1 at 12 months, compared with a decrease from 1.5 at baseline to 1.4 at 12 months in the usual-care group (between-group mean difference, −0.2; 95% CI, −0.4 to 0; P = .01). Overall, there were 47 adverse events or serious adverse events, with 27 events in the collaborative-care intervention group and 20 events in the usual-care group involving musculoskeletal injuries such as fracture and meniscus tear.

The authors said it is unknown whether the outcomes they observed can be sustained over longer periods of time. In addition, they cited the relative demographic homogeneity of the study sample as one of several limitations.

The study was funded in part by Palo Alto Medical Foundation Research Institute, the University of Illinois at Chicago, and an award from the National Heart, Lung, and Blood Institute. One author, Philip W. Lavori, PhD, reported receiving personal fees from Palo Alto Medical Foundation Research Institute. The other authors reported no relevant financial disclosures.

SOURCE: Ma J et al. JAMA. 2019. doi: 10.1001/jama2019.0557.

Adults with obesity and depression who participated in a program that addressed weight and mood saw improvement in weight loss and depressive symptoms at 12 months, results of a randomized, controlled trial of almost 350 patients show.

“To our knowledge, this study was the first and largest RTC of integrated collaborative care for coexisting obesity and depression,” wrote Jun Ma, MD, PhD, of the Institute of Health Research and Policy at the University of Illinois at Chicago, and colleagues.

Dr. Ma and colleagues enrolled 409 patients in the RAINBOW (Research Aimed at Improving Both Mood and Weight) trial between September 2014 and January 2017 from family and internal medicine departments at four medical centers in California. The RAINBOW intervention combined usual care with a weight loss treatment program used in diabetes prevention, problem-solving therapy, and prescriptions for antidepressants if indicated. About 71% of the trial participants were non-Hispanic white adults, 70% were women, and 69% had a college education.

Half the patients were randomized to receive usual care consisting of seeing personal physicians, receiving information on obesity and depression services at the clinic, and wireless activity-tracking devices. Patients were enrolled in the trial if they scored at least 10 points in the nine-item Patient Health Questionaire (PHQ-9) and had a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher in Asian adults. The mean age in the cohort was 51.0 years, the mean BMI was 37.7, and the mean PHQ-9 score was 13.8.

Of the 344 patients (84.1%) who completed follow-up at 12 months, there was a decrease in mean BMI from 36.7 to 35.9 for patients who received the collaborative care intervention, compared with no change in BMI for patients who received usual care alone (between-group mean difference, −0.7; 95% confidence interval, −1.1 to −0.2; P = .01). Depressive symptoms also improved in the intervention group, with mean 20-item Depression Symptom Checklist scores decreasing from 1.5 at baseline to 1.1 at 12 months, compared with a decrease from 1.5 at baseline to 1.4 at 12 months in the usual-care group (between-group mean difference, −0.2; 95% CI, −0.4 to 0; P = .01). Overall, there were 47 adverse events or serious adverse events, with 27 events in the collaborative-care intervention group and 20 events in the usual-care group involving musculoskeletal injuries such as fracture and meniscus tear.

The authors said it is unknown whether the outcomes they observed can be sustained over longer periods of time. In addition, they cited the relative demographic homogeneity of the study sample as one of several limitations.

The study was funded in part by Palo Alto Medical Foundation Research Institute, the University of Illinois at Chicago, and an award from the National Heart, Lung, and Blood Institute. One author, Philip W. Lavori, PhD, reported receiving personal fees from Palo Alto Medical Foundation Research Institute. The other authors reported no relevant financial disclosures.

SOURCE: Ma J et al. JAMA. 2019. doi: 10.1001/jama2019.0557.

Adults with obesity and depression who participated in a program that addressed weight and mood saw improvement in weight loss and depressive symptoms at 12 months, results of a randomized, controlled trial of almost 350 patients show.

“To our knowledge, this study was the first and largest RTC of integrated collaborative care for coexisting obesity and depression,” wrote Jun Ma, MD, PhD, of the Institute of Health Research and Policy at the University of Illinois at Chicago, and colleagues.

Dr. Ma and colleagues enrolled 409 patients in the RAINBOW (Research Aimed at Improving Both Mood and Weight) trial between September 2014 and January 2017 from family and internal medicine departments at four medical centers in California. The RAINBOW intervention combined usual care with a weight loss treatment program used in diabetes prevention, problem-solving therapy, and prescriptions for antidepressants if indicated. About 71% of the trial participants were non-Hispanic white adults, 70% were women, and 69% had a college education.

Half the patients were randomized to receive usual care consisting of seeing personal physicians, receiving information on obesity and depression services at the clinic, and wireless activity-tracking devices. Patients were enrolled in the trial if they scored at least 10 points in the nine-item Patient Health Questionaire (PHQ-9) and had a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher in Asian adults. The mean age in the cohort was 51.0 years, the mean BMI was 37.7, and the mean PHQ-9 score was 13.8.

Of the 344 patients (84.1%) who completed follow-up at 12 months, there was a decrease in mean BMI from 36.7 to 35.9 for patients who received the collaborative care intervention, compared with no change in BMI for patients who received usual care alone (between-group mean difference, −0.7; 95% confidence interval, −1.1 to −0.2; P = .01). Depressive symptoms also improved in the intervention group, with mean 20-item Depression Symptom Checklist scores decreasing from 1.5 at baseline to 1.1 at 12 months, compared with a decrease from 1.5 at baseline to 1.4 at 12 months in the usual-care group (between-group mean difference, −0.2; 95% CI, −0.4 to 0; P = .01). Overall, there were 47 adverse events or serious adverse events, with 27 events in the collaborative-care intervention group and 20 events in the usual-care group involving musculoskeletal injuries such as fracture and meniscus tear.

The authors said it is unknown whether the outcomes they observed can be sustained over longer periods of time. In addition, they cited the relative demographic homogeneity of the study sample as one of several limitations.

The study was funded in part by Palo Alto Medical Foundation Research Institute, the University of Illinois at Chicago, and an award from the National Heart, Lung, and Blood Institute. One author, Philip W. Lavori, PhD, reported receiving personal fees from Palo Alto Medical Foundation Research Institute. The other authors reported no relevant financial disclosures.

SOURCE: Ma J et al. JAMA. 2019. doi: 10.1001/jama2019.0557.

George J. Broze Jr., MD, a former professor of medicine at Washington University School of Medicine in St. Louis, died following a heart attack on June 19, 2019, at the age of 72.

Dr. Broze was born in Seattle. He earned a bachelor’s degree from the University of Washington in Seattle and a medical degree from the University of Washington School of Medicine in St. Louis. Dr. Broze completed his internship and residency at North Carolina Memorial Hospital in Chapel Hill.

Dr. Broze became a clinical fellow in hematology at Washington University in 1976 and began teaching there in 1979. Dr. Broze practiced at the Jewish Hospital, Barnes Hospital, and Barnes-Jewish Hospital.

Dr. Broze’s research was focused on hemostasis and the relationship between coagulation and inflammation. He and his colleagues isolated and characterized tissue factor pathway inhibitor, uncovered a pathway for coagulation factor XI activation, and characterized the protein Z-dependent protease inhibitor serpinA10.

Dr. Broze is survived by his wife, two sons, and brother.

In happier news, Thomas J. Smith, MD, of the Johns Hopkins University School of Medicine in Baltimore, has won the Walther Cancer Foundation Palliative and Supportive Care in Oncology Endowed Award and Lecture from the American Society of Clinical Oncology.

The award is given to someone who “has made significant contributions to palliative care practice and research in oncology,” according to ASCO. Dr. Smith and his colleagues are known for their work showing that end-of-life palliative care can improve patient symptoms and quality of life while reducing the cost of care.

Dr. Smith will receive the award and deliver a keynote address at the 2019 Supportive Care in Oncology Symposium, which is set to take place Oct. 25-26 in San Francisco.

Meanwhile, Asya Nina Varshavsky-Yanovsky, MD, PhD, has joined Fox Chase Cancer Center in Philadelphia as an assistant professor in the hematology and bone marrow transplant programs within the department of hematology/oncology.

Dr. Varshavsky-Yanovsky earned her MD and PhD from the Technion-Israel Institute of Technology in Haifa, Israel. She joined Fox Chase Cancer Center/Temple University in 2016 for a 3-year fellowship in hematology/oncology.

Susmitha Apuri, MD, has joined Florida Cancer Specialists & Research Institute and is seeing patients in Inverness. She is board certified in medical oncology, hematology, and internal medicine.

Dr. Apuri earned her medical degree from NTR University of Health Sciences in Vijayawada, India; completed her internship and residency in internal medicine at the University of Miami Miller School of Medicine; and completed her fellowship in hematology/oncology at the University of South Florida/H. Lee Moffitt Cancer and Research Institute in Tampa. Her research and practice interests include malignant and nonmalignant hematology as well as breast, lung, and colorectal cancer.

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.

[email protected]

George J. Broze Jr., MD, a former professor of medicine at Washington University School of Medicine in St. Louis, died following a heart attack on June 19, 2019, at the age of 72.

Dr. Broze was born in Seattle. He earned a bachelor’s degree from the University of Washington in Seattle and a medical degree from the University of Washington School of Medicine in St. Louis. Dr. Broze completed his internship and residency at North Carolina Memorial Hospital in Chapel Hill.

Dr. Broze became a clinical fellow in hematology at Washington University in 1976 and began teaching there in 1979. Dr. Broze practiced at the Jewish Hospital, Barnes Hospital, and Barnes-Jewish Hospital.

Dr. Broze’s research was focused on hemostasis and the relationship between coagulation and inflammation. He and his colleagues isolated and characterized tissue factor pathway inhibitor, uncovered a pathway for coagulation factor XI activation, and characterized the protein Z-dependent protease inhibitor serpinA10.

Dr. Broze is survived by his wife, two sons, and brother.

In happier news, Thomas J. Smith, MD, of the Johns Hopkins University School of Medicine in Baltimore, has won the Walther Cancer Foundation Palliative and Supportive Care in Oncology Endowed Award and Lecture from the American Society of Clinical Oncology.

The award is given to someone who “has made significant contributions to palliative care practice and research in oncology,” according to ASCO. Dr. Smith and his colleagues are known for their work showing that end-of-life palliative care can improve patient symptoms and quality of life while reducing the cost of care.

Dr. Smith will receive the award and deliver a keynote address at the 2019 Supportive Care in Oncology Symposium, which is set to take place Oct. 25-26 in San Francisco.

Meanwhile, Asya Nina Varshavsky-Yanovsky, MD, PhD, has joined Fox Chase Cancer Center in Philadelphia as an assistant professor in the hematology and bone marrow transplant programs within the department of hematology/oncology.

Dr. Varshavsky-Yanovsky earned her MD and PhD from the Technion-Israel Institute of Technology in Haifa, Israel. She joined Fox Chase Cancer Center/Temple University in 2016 for a 3-year fellowship in hematology/oncology.

Susmitha Apuri, MD, has joined Florida Cancer Specialists & Research Institute and is seeing patients in Inverness. She is board certified in medical oncology, hematology, and internal medicine.

Dr. Apuri earned her medical degree from NTR University of Health Sciences in Vijayawada, India; completed her internship and residency in internal medicine at the University of Miami Miller School of Medicine; and completed her fellowship in hematology/oncology at the University of South Florida/H. Lee Moffitt Cancer and Research Institute in Tampa. Her research and practice interests include malignant and nonmalignant hematology as well as breast, lung, and colorectal cancer.

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.

[email protected]

George J. Broze Jr., MD, a former professor of medicine at Washington University School of Medicine in St. Louis, died following a heart attack on June 19, 2019, at the age of 72.

Dr. Broze was born in Seattle. He earned a bachelor’s degree from the University of Washington in Seattle and a medical degree from the University of Washington School of Medicine in St. Louis. Dr. Broze completed his internship and residency at North Carolina Memorial Hospital in Chapel Hill.

Dr. Broze became a clinical fellow in hematology at Washington University in 1976 and began teaching there in 1979. Dr. Broze practiced at the Jewish Hospital, Barnes Hospital, and Barnes-Jewish Hospital.

Dr. Broze’s research was focused on hemostasis and the relationship between coagulation and inflammation. He and his colleagues isolated and characterized tissue factor pathway inhibitor, uncovered a pathway for coagulation factor XI activation, and characterized the protein Z-dependent protease inhibitor serpinA10.

Dr. Broze is survived by his wife, two sons, and brother.

In happier news, Thomas J. Smith, MD, of the Johns Hopkins University School of Medicine in Baltimore, has won the Walther Cancer Foundation Palliative and Supportive Care in Oncology Endowed Award and Lecture from the American Society of Clinical Oncology.

The award is given to someone who “has made significant contributions to palliative care practice and research in oncology,” according to ASCO. Dr. Smith and his colleagues are known for their work showing that end-of-life palliative care can improve patient symptoms and quality of life while reducing the cost of care.

Dr. Smith will receive the award and deliver a keynote address at the 2019 Supportive Care in Oncology Symposium, which is set to take place Oct. 25-26 in San Francisco.

Meanwhile, Asya Nina Varshavsky-Yanovsky, MD, PhD, has joined Fox Chase Cancer Center in Philadelphia as an assistant professor in the hematology and bone marrow transplant programs within the department of hematology/oncology.

Dr. Varshavsky-Yanovsky earned her MD and PhD from the Technion-Israel Institute of Technology in Haifa, Israel. She joined Fox Chase Cancer Center/Temple University in 2016 for a 3-year fellowship in hematology/oncology.

Susmitha Apuri, MD, has joined Florida Cancer Specialists & Research Institute and is seeing patients in Inverness. She is board certified in medical oncology, hematology, and internal medicine.

Dr. Apuri earned her medical degree from NTR University of Health Sciences in Vijayawada, India; completed her internship and residency in internal medicine at the University of Miami Miller School of Medicine; and completed her fellowship in hematology/oncology at the University of South Florida/H. Lee Moffitt Cancer and Research Institute in Tampa. Her research and practice interests include malignant and nonmalignant hematology as well as breast, lung, and colorectal cancer.

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.

[email protected]