Telephone-Based Intervention Produces Weight Loss in Postmenopausal Women With Breast Cancer Receiving Letrozole
Obesity is associated with poorer outcome in women with operable breast cancer. In the LISA study reported in the Journal of Clinical Oncology, Goodwin et al found that a 24-month telephone-based intervention was effective in reducing body weight in postmenopausal breast cancer patients receiving adjuvant letrozole.
Study Details
In this multicenter trial, 338 postmenopausal women with T1-3, N0-3, M0 breast cancer and body mass index (BMI) ≥ 24 to 40 kg/m2 who had received definitive surgery and were receiving letrozole were randomly assigned to mail-based delivery of general health information alone (n = 167) or combined with a 24-month telephone-based weight loss intervention (n = 171). Adjuvant chemotherapy had to be completed at ≥ 4 weeks prior to entry. The initial recruitment target was 2,150 patients, and the study’s initial primary endpoint was disease-free survival; however, accrual was stopped due to loss of funding.
The weight-loss intervention included diet (500–1,000 kcal per day deficit) and physical activity (150–200 minutes of moderate intensity physical activity per week) targets to achieve weight loss of up to 10%. The program included: an initial recommended daily intake of 1,250, 1,500, or 1,750 kcal and reduction in fat to approximately 20% of calories, with increased intake of fruits, vegetables, and grains; gradual increase in moderate-intensity aerobic physical activity (walking for the majority of participants); and behavioral change–motivation elements, including relapse prevention, reduction of emotional distress, and time management.
The intervention was delivered by trained lifestyle coaches from a call center at the University of Ottawa. A total of 19 telephone contacts were scheduled during the intensive phase (weeks 0, 1, 2, 3, and 4), consolidation phase (every 2 weeks during months 2–3 and monthly during months 4–6), and maintenance phase (every 2 months during months 7–12 and every 3 months during months 13–24). Body weight was measured in the clinic.
Adjuvant chemotherapy had been used in 56% of the lifestyle intervention group and in 59% of the control group, and 91% and 81% had HER2-negative disease.
Weight Loss
Mean weight loss was significantly greater in the lifestyle intervention group at 6 months (4.3 vs 0.6 kg, or 5.3% vs 0.7%, P < .001) and at 24 months (3.1 vs 0.3 kg, or 3.6% vs 0.4%, P < .001). Weight loss in the intervention group was consistent across BMI strata and according to receipt or no receipt of adjuvant chemotherapy.
Weight loss remained significant in the intervention group on multivariate analysis (P < .001). Other factors associated with weight loss were higher baseline level of moderate-intensity physical activity (P = .009) and improved quality of life on the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30; P =.035).
Other Changes
Over the study period, total activity level increased by a median of 80 to 150 minutes in the weight loss intervention group and 5 to 115 minutes in the control group (P = .004). A significantly greater decrease in total fat (P = .010) was observed in the intervention group and significantly greater decreases in total carbohydrates (P = .035) and fiber (P = .037) were observed in the control group.
The mean change in the Short Form-36 physical component score was significantly greater across time points in the intervention group (P = .005); there was no significant difference between groups in changes in the mental component score. There was a greater mean increase in the EORTC QLQ-C30 physical condition score in the intervention group (P < .001).
Safety
The intervention and control groups had similar frequencies of hospitalization (22% and 29%, P = .14) and medical events (77% and 82%, P = .32), with minor musculoskeletal (45% and 53%), gastrointestinal (17% and 18%), and respiratory events (11% and 16%) being most common. One non–breast cancer–related death occurred in each group.
The investigators concluded, “A telephone-based [lifestyle intervention] led to significant weight loss that was still evident at 24 months, without adverse effects on [quality of life], hospitalizations, or medical events. Adequately powered randomized trials with cancer end points are needed.”
Pamela J. Goodwin, MD, Mount Sinai Hospital, Toronto, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by Novartis Pharmaceuticals. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
