Metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer: a prospective open-label pilot trial.

<bold>Purpose: </bold>To evaluate the efficacy of metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer.<bold>Methods: </bold>Epithelial ovarian cancer patients without diabetes mellitus were allocated to non-metformin group (paclitaxel plus carboplatin) or metformin group (paclitaxel plus carboplatin plus metformin). The primary endpoint was progression-free survival (PFS) and disease-free survival (DFS).<bold>Results: </bold>A total of 20 patients were assigned to metformin group and 24 patients to non-metformin group. The baseline information in two groups had no significant difference. The PFS and DFS of patients with metformin intake versus without metformin intake was 23 versus 21 months (p = 0.68) and 29 versus 26 months (p = 0.61), respectively. The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively. Metformin effectively inhibited the increase of IGF-1 and maintained the IGFBP-1.<bold>Conclusions: </bold>Within the limitations of the small sample size, there was no evidence of meaningful effect on PFS by metformin even though evidence of modulation of IGF-1 signaling axis was apparent. [ABSTRACT FROM AUTHOR]