A phase II trial of paclitaxel, carboplatin, and bevacizumab in advanced and recurrent endometrial carcinoma (EMCA).

ABSTRACT

OBJECTIVE: To evaluate the effect of adding bevacizumab to adjuvant paclitaxel and carboplatin and as maintenance on progression-free survival (PFS) in advanced or recurrent endometrial carcinoma (EMCA). METHODS: A phase II trial was conducted in patients with measurable disease. Paclitaxel (175mg/m(2)/3h), carboplatin (AUC 5) and bevacizumab (15mg/kg) were administered q 21 days. Patients with a complete response after 6-8cycles received maintenance therapy with bevacizumab 15mg/kg q 21 days for 16cycles. Based on GOG 177 which had a 6-month PFS rate of 59%, an increase in 6-month PFS to 72% with the treatment regimen was considered of clinical interest. RESULTS: 15 patients were enrolled on protocol when accrual to the study was discontinued due to the initiation of a national randomized phase II trial. A total of 127 courses (median 8, range 1-20) of carboplatin, paclitaxel, and bevacizumab combination therapy were administered. One patient suffered a bowel perforation after her first course of therapy and was inevaluable for response. Fourteen of the 15 patients (93%, 95% CI 82-100) were progression free at 6months. The median follow-up was 36months (7-58+). The median PFS was 18months (CI 11-25). Five complete responses and 6 partial responses were seen for an overall response rate of 73% (CI 45-91). The median overall survival was 58months (CI 48-68). CONCLUSIONS: The bevacizumab, paclitaxel, and carboplatin regimen is active and tolerable in advanced and recurrent EMCA. Its impact awaits results of the recently completed randomized phase II trial.