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


DOI: 10.1038/s41523-020-0149-z

npj Breast Cancer (2020)6:6

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 and Kathleen I. Pritchard

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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/m2receiving 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.