A randomized study by Jennifer A. Ligibel, MD, Director of the Leonard P. Zakim Center for Integrative Therapies and Healthy Living at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School, evaluating the impact of a telephone-based weight loss intervention in patients with stage II or III breast cancer and overweight or obesity has found that the intervention resulted in clinically significant weight loss in the patients receiving the intervention compared with a control group. According to the study’s results, patients receiving the intervention lost an average of 4.8% (± 7.9%) of baseline body weight at 12 months vs 0.8% (± 6.4%) weight gain in the control group. Further follow-up of the trial will evaluate whether the weight loss intervention improves disease outcomes. The study is being presented during the 2023 ASCO Annual Meeting (Abstract 12001).
Study Methodology
The BWEL Study (Alliance for Clinical Trials in Oncology A0111401; ClinicalTrials.gov identifier NCT02750826) is evaluating the impact of a weight loss intervention on invasive disease–free survival in patients with breast cancer and a body mass index (BMI) of 27 kg/m2 or greater. In this part of the study, 3,136 eligible patients were within 14 months of diagnosis of stage II or III HER2-negative breast cancer. The patients had completed chemotherapy and radiation treatment (if administered) and, between 2016 and 2021, were randomly assigned 1:1 to a telephone-based weight loss intervention plus health education or health education intervention alone (control group).
The weight loss intervention was delivered by telephone-based health coaching and focused on caloric restriction and increased exercise. Patients’ height and weight were measured at baseline and at 12 months. Analysis was performed with univariable and multivariable regression models, including arm, baseline weight, menopausal status, race/ethnicity, and hormone receptor status.
A 0.05 level of significance was used. At baseline, mean BMI was 34.5 (± 5.74) kg/m2, mean age was 53.4 (± 10.58) years, and 57% of the patients were postmenopausal at the time of diagnosis. Among all participants, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. Follow-up weight was available from 2,293 patients disease-free at 12 months.
KEY POINTS
- A telephone-based weight loss intervention induced significant, clinically meaningful weight loss in patients with stage II/III breast cancer with overweight or obesity across demographic and tumor factors, but not across menopausal status or race/ethnicity.
- Longer follow-up of the study will evaluate whether the intervention improves disease outcomes.
Key Results
The researchers found that the weight loss intervention led to a significant decrease in weight relative to the control group. Patients assigned to the weight loss intervention lost an average of 4.8% (± 7.9%) of baseline body weight at 12 months vs 0.8% (± 6.4%) weight gain in the control group (P < .0001). Patients in the intervention group experienced significant weight loss (vs controls) across demographic and tumor factors; however, the effect differed significantly by menopausal status (interaction P value = .0057) and race/ethnicity (interaction P value = .019) but not by hormone receptor status (interaction P value = .17).
“A telephone-based [weight loss intervention] induced significant, clinically meaningful weight loss in breast cancer patients with overweight and obesity across demographic and tumor factors. Additional tailoring of the [intervention] could be useful to enhance weight loss in Black and younger patients. Further follow-up of the BWEL trial will evaluate whether the [weight loss intervention] improves disease outcomes,” concluded the study authors.
Future Outlook
During an ASCO premeeting press briefing on this study, Dr. Ligibel said that longer follow-up of the BWEL trial will determine whether losing weight after a breast cancer diagnosis improves disease outcomes in these patients. “Now that we have demonstrated our intervention was successful in inducing weight loss, we will be able to determine whether losing weight after a breast cancer diagnosis improved outcomes in these women, said Dr. Ligibel.
Julie R. Gralow, MD, FACP, FASCO
Commenting on the findings from the study, Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer and Executive Vice President of ASCO, said she was looking forward to seeing the follow-up data on the study’s primary endpoint, invasive disease–free survival. “It will be fascinating to see if weight loss after the diagnosis can actually change this poor outcome at the time of diagnosis. And I’ll be fascinated to hear more about the differences in menopausal status and race and maybe some future interventions that might target those groups that didn’t have as much weight loss,” said Dr. Gralow.
Disclosure: Funding for this study was provided by the National Institutes of Health, Susan G. Komen Foundation, Breast Cancer Research Foundation, and the American Cancer Society. For full disclosures of the study authors, visit meetings.asco.org.
