Metformin Active Surveillance Trial in Low-Risk Prostate Cancer.
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Fleshner Neil E, Bernardino Rui M, Izawa Jonathan, Drachenberg Darrel, Saranchuk Jeff W, Fairey Adrian, Tanguay Simon, Leveridge Michael, Saad Fred, Breau Rodney H, Shayegan Bobby, Klotz Laurence, Hersey Karen, Chowdhary Sunakshi, Chadwick Karen, Wagner Heidi, Sildva Tiiu, Alibhai Shabbir M H, Rastegar Naghmeh, Kenk Miran, Veloso Rosette, Cockburn Jessica G, Sweet Joan, O'Connell Clare, Kapusta Linda, Kubendran Aingeshaan, Azizi Tabassom, Berlin Doron, Hamilton Robert J, Lajkosz Katherine, van der Kwast Theodorus, Rendon Ricardo A, Richard Patrick O, Joshua Anthony M
Аннотация
PATIENTS AND METHODS: The Metformin Active Surveillance Trial (MAST) was a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating the efficacy of metformin in men with low-risk, localized PCa managed with AS. Eligible participants were randomly assigned 1:1 to receive either metformin (850 mg twice daily) or placebo and were followed for up to 36 months. The primary end point was time to progression, defined as therapeutic and/or pathologic progression. Progression-free survival (PFS) was assessed using Kaplan-Meier analysis and Cox proportional hazards models.
RESULTS: A total of 408 patients were randomly assigned (205 metformin, 203 placebo). After a median follow-up of 36 months, 144 participants experienced progression (70 metformin, 74 placebo), with no significant difference in PFS (hazard ratio [HR], 1.09 [95% CI, 0.79 to 1.52]; P = .59). Negative biopsy rates at 36 months were 41.0% (metformin) versus 31.1% (placebo; P = .181). In prespecified subgroup analysis, metformin was associated with increased pathologic progression among obese patients (BMI ≥ 30; HR, 2.36 [95% CI, 1.21 to 4.59]; P = .0092).
CONCLUSION: Metformin did not reduce progression in men with low-risk PCa on AS. The observed adverse effect in obese patients merits further investigation.