The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer

Pamela J Goodwin; Roanne J Segal; Michael Vallis; Jennifer A Ligibel; Gregory R Pond; André Robidoux; Brian Findlay; Julie R Gralow; Som D Mukherjee; Mark Levine; Kathleen I Pritchard

doi:10.1038/s41523-020-0149-z

The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer

NPJ Breast Cancer. 2020 Feb 21:6:6. doi: 10.1038/s41523-020-0149-z. eCollection 2020.

Authors

Affiliations

¹ 1Department of Medicine, Division of Clinical Epidemiology at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON Canada.
² 2Department of Internal Medicine, Division of Medical Oncology, Ottawa Hospital Regional Cancer Center, University of Ottawa, Ottawa, ON Canada.
³ Primary Care, Capital Health, Department of Family Medicine, Dalhousie University, Halifax, Nova Scotia UK.
⁴ 4Department of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA USA.
⁵ 5Department of Oncology, Ontario Clinical Oncology Group, Juravinski Hospital and Cancer Center, McMaster University, Hamilton, ON Canada.
⁶ 6Faculty of Medicine, Department of Nutrition, Research Center, Centre Hospitalier de l'Université de Montréal, Montréal, QC Canada.
⁷ 7Department of Oncology, Niagara Health System, Walker Family Cancer Center, McMaster University, Hamilton, ON Canada.
⁸ 8Department of Medicine, Division of Oncology, University of Washington School of Medicine, Seattle, WA USA.
⁹ 9Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON Canada.
¹⁰ 10Division of Medical Oncology & Hematology, Sunnybrook Odette Cancer Center, Ontario Clinical Oncology Group, University of Toronto, Toronto, ON Canada.

Abstract

Obesity has been associated with poor breast cancer (BC) outcomes. We investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact BC outcomes. We conducted a multicenter trial randomizing women 1:1 to mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity, and behavior and involved 19 calls over 2 years to achieve up to 10% weight loss. In all, 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI) ≥24 kg/m² receiving adjuvant letrozole were randomized (enrolment ended due to funding loss). The primary outcome was disease-free survival (DFS); secondary outcome was Overall Survival (OS). At 8 years' median follow-up, in a planned analysis, DFS and OS were compared using the Kaplan-Meier method. Baseline BMI and other characteristics were similar between study arms. In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71 (95% confidence interval [CI]: 0.41-1.24, p = 0.23). Although loss of funding reduced sample size, we view these hypothesis generating results as compatible with our hypothesis of a potential beneficial effect of a lifestyle intervention on DFS. They provide support for completion of ongoing randomized controlled trials of the effect of lifestyle interventions in BC outcomes.

Keywords: Breast cancer.