Eribulin mesylate (halichondrin B analog E7389) in platinum‐resistant and platinum‐sensitive ovarian cancer

Abstract BACKGROUND: Eribulin mesylate is a tubulin inhibitor with activity superior to paclitaxel in NIH:OVCAR‐3 human epithelial ovarian cancer xenograft models. In this study, the authors assessed the efficacy of eribulin in platinum‐resistant and platinum‐sensitive recurrent ovarian cancer. METHODS: Patients with recurrent, measurable epithelial ovarian cancer who had received ≤2 prior cytotoxic regimens and who had adequate organ function were enrolled into 2 separate cohorts: 1) platinum‐resistant patients (who had a progression‐free interval <6 months after their last platinum‐based therapy) and 2) platinum‐sensitive patients (who had a progression‐free interval ≥6 months after their last platinum‐based therapy). Eribulin 1.4 mg/m 2 was administered over 15 minutes intravenously on days 1 and 8 every 21 days. Efficacy was determined by objective response on computed tomography studies. RESULTS: In the platinum‐resistant cohort , 37 patients enrolled, and 36 patients were evaluable for response and toxicity. Two patients achieved a partial response (5.5%), and 16 patients (44%) had stable disease as their best response. The median progression‐free survival was 1.8 months (95% confidence interval, 1.4‐2.8 months). In the platinum‐sensitive cohort , 37 patients enrolled, and all were evaluable for response. Seven patients achieved a partial response (19%). The median progression‐free survival was 4.1 months (95% confidence interval, 2.8‐5.8 months). The major toxicity was grade 3 or 4 neutropenia (42% of platinum‐resistant patients; 54% of platinum‐sensitive patients). CONCLUSIONS: Eribulin produced an objective response in 5.5% of women with platinum‐resistant, recurrent ovarian cancer and in 19% of women with platinum‐sensitive disease. The median progression‐free survival was 1.8 months in the platinum‐resistant group and 4.1 months in the platinum‐sensitive group. Cancer 2012. © 2011 American Cancer Society.