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

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

Medicine

Medicine

Research output: Contribution to journal › Article › peer-review

34 Citations (Scopus)

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.

Original language	English
Article number	6
Journal	npj Breast Cancer
Volume	6
Issue number	1
DOIs	https://doi.org/10.1038/s41523-020-0149-z
Publication status	Published - Dec 1 2020

Bibliographical note

Funding Information:
This work was supported by Novartis Pharmaceuticals Inc. Canada and sponsored by the Ontario Clinical Oncology Group. Novartis had no role in the trial conduct, analysis or interpretation of results. ClinicalTrials.gov Identifier: NCT00463489 first posted 20 April 2007. Prior presentation: presented, in part, as an abstract and poster at the 41st San Antonio Breast Cancer Symposium, San Antonio, TX, 4–8 December 2018.

Publisher Copyright:
© 2020, The Author(s).

ASJC Scopus Subject Areas

Oncology
Radiology Nuclear Medicine and imaging
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1038/s41523-020-0149-z

Cite this

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title = "The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer",

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{\textquoteright} 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.",

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note = "Funding Information: This work was supported by Novartis Pharmaceuticals Inc. Canada and sponsored by the Ontario Clinical Oncology Group. Novartis had no role in the trial conduct, analysis or interpretation of results. ClinicalTrials.gov Identifier: NCT00463489 first posted 20 April 2007. Prior presentation: presented, in part, as an abstract and poster at the 41st San Antonio Breast Cancer Symposium, San Antonio, TX, 4–8 December 2018. Publisher Copyright: {\textcopyright} 2020, The Author(s).",

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N2 - 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.

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

Abstract

Bibliographical note

ASJC Scopus Subject Areas

UN SDGs

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