Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
A Co-clinical Trial of Exercise Therapy in Breast Cancer Prevention.
СтатьяРандомизированное исследованиеКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Jones Lee W, Lavery Jessica A, Tsai Brandon L, Moskowitz Chaya S, Lee Catherine P, Harrison Jenna, Michalski Meghan G, Stoeckel Kurtis, Graham Courtenay, Iyengar Neil M, Bhanot Umeshkumar, Linkov Irina, Jain Mala, Jochelson Maxine S, Monetti Mara, Seewaldt Victoria L, Pilewskie Melissa L, Pribil Patrick, Zhu Chenghao, Arbet Jaron, Mangino Debra A, Boutros Paul C
Аннотация
PURPOSE: We conducted a mouse-human co-clinical trial to evaluate the biological efficacy of exercise therapy in breast cancer prevention.
PATIENTS AND METHODS: In a phase I randomized trial, 75 nonexercising women at high risk of breast cancer were allocated to receive (1:1 ratio) usual care or one of three exercise therapy dose regimens: 75, 150, or 300 minutes/week for 24 consecutive weeks. Biological efficacy was evaluated by changes in breast epithelial cell proliferation (Ki67). Correlative proteomic analysis of paired tissue and plasma samples was also performed. A corresponding preclinical study tested the dose-response effect of exercise therapy on breast tumor latency.
RESULTS: Change in Ki67 was not different between groups (global P value = 0.2). Among participants with paired Ki67 measures, the mean (SD) change in Ki67 was: -1.26 (4.32) for 75 minutes/week, -1.74 (5.04) for 150 minutes/week, -0.45 (5.16) for 300 minutes/week, and 3.40 (5.53) for usual care (global P value = 0.04). Only 150 minutes/week is associated with significant reductions in Ki67 compared with usual care (Bonferroni-adjusted P value = 0.03). The "response rate" (reduction in Ki67) was 29% for usual care compared with 52% for 150 minutes/week. Proteomics revealed a marked reduction in genes involved in epithelial-mesenchymal transition in the tissues of responding patients. In the preclinical study, only 150 minutes/week significantly delayed tumor latency compared with control (Benjamini-Hochberg-adjusted P value = 0.02).
CONCLUSIONS: Exercise therapy is a promising strategy for the early interception of breast cancer in high-risk women. See related commentary by McTiernan, p. 3353.
PATIENTS AND METHODS: In a phase I randomized trial, 75 nonexercising women at high risk of breast cancer were allocated to receive (1:1 ratio) usual care or one of three exercise therapy dose regimens: 75, 150, or 300 minutes/week for 24 consecutive weeks. Biological efficacy was evaluated by changes in breast epithelial cell proliferation (Ki67). Correlative proteomic analysis of paired tissue and plasma samples was also performed. A corresponding preclinical study tested the dose-response effect of exercise therapy on breast tumor latency.
RESULTS: Change in Ki67 was not different between groups (global P value = 0.2). Among participants with paired Ki67 measures, the mean (SD) change in Ki67 was: -1.26 (4.32) for 75 minutes/week, -1.74 (5.04) for 150 minutes/week, -0.45 (5.16) for 300 minutes/week, and 3.40 (5.53) for usual care (global P value = 0.04). Only 150 minutes/week is associated with significant reductions in Ki67 compared with usual care (Bonferroni-adjusted P value = 0.03). The "response rate" (reduction in Ki67) was 29% for usual care compared with 52% for 150 minutes/week. Proteomics revealed a marked reduction in genes involved in epithelial-mesenchymal transition in the tissues of responding patients. In the preclinical study, only 150 minutes/week significantly delayed tumor latency compared with control (Benjamini-Hochberg-adjusted P value = 0.02).
CONCLUSIONS: Exercise therapy is a promising strategy for the early interception of breast cancer in high-risk women. See related commentary by McTiernan, p. 3353.