Jennifer A. Ligibel, MD, FASCO, 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, and colleagues conducted a randomized study to evaluate the impact of a telephone-based weight-loss intervention in patients with stage II or III breast cancer with a body mass index (BMI) of at least 27 kg/m2. They reported that the intervention resulted in clinically significant weight loss in the patients receiving the intervention compared with the 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 findings were presented during the 2023 ASCO Annual Meeting.1
Study Methodology
The Breast Cancer Weight Loss (BWEL) study (Alliance for Clinical Trials in Oncology A0111401; ClinicalTrials.gov identifier NCT02750826) evaluated the impact of a weight-loss intervention on invasive disease–free survival in patients with breast cancer who have a BMI of at least 27 kg/m2. 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). Between 2016 and 2021, they were randomly assigned 1:1 to a telephone-based weight-loss intervention plus health education or a health education intervention alone.
“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.”— Jennifer A. Ligibel, MD, FASCO
Tweet this quote
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. A total of 80.3% of participants were White, 12.8% were Black, and 7.3% were Hispanic. Follow-up weight was available for 2,293 patients who were disease-free at 12 months.
Key Results
The researchers found that the weight-loss intervention led to a significant decrease in weight relative to the control group. Patients who were randomly 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). In addition, these patients experienced significant weight loss (vs controls) across demographic and tumor factors; however, the effect differed significantly by menopausal status (interaction P = .0057) and race/ethnicity (interaction P = .019) but not by hormone receptor status (interaction P = .17).
KEY POINTS
- A telephone-based weight-loss intervention induced significant, clinically meaningful weight loss in patients with stage II or 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 in this patient population.
“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 weight-loss 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.
What’s Next
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,” she stated.
Commenting on the findings from the BWEL trial, 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 change this poor outcome as [having] overweight or obesity 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 targeting those groups that didn’t have as much weight loss,” she said.
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 Other Foundation. Dr. Ligibel and Dr. Gralow reported no conflicts of interest.
REFERENCE
1. Ligibel JA, Ballman KV, McCall LM, et al: Effect of a telephone-based weight loss intervention on weight at 12 months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial. 2023 ASCO Annual Meeting. Abstract 12001. Presented June 5, 2023.
