Phase II clinical trial of bevacizumab with albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma

Abstract

ObjectiveWe examined the safety and efficacy of combining bevacizumab with albumin-bound (ab-) paclitaxel to treat patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinoma. MethodsPatients had measurable disease per RECIST guidelines, progressing within 6months after a prior course of platinum-based treatment. Patients received ab-paclitaxel 100mg/m2 given by intravenous infusion over 30min on days 1, 8, and 15 of a 28-day cycle with bevacizumab 10mg/kg given on days 1 and 15. ResultsForty-eight patients with an average 1.8 prior lines of treatment participated. The overall response rate was 50% (24/48) (95% CI, 34.8% – 65.1%), with 4 complete and 20 partial responses. Fourteen patients (29%) had stable disease, whereas eight (17%) had progressive disease, and two (4%) were not evaluable. Patients received a median of 6 treatment cycles (range, 1 – 31cycles). The median progression-free survival was 8.08months (95% CI, 5.78 – 10.15months); 6month progression-free rate was 62.5% (95% CI, 47.8%–77.2%); median overall survival was 17.15months (95% CI, 13.57 – 23.82months). Grade 3–4 adverse events included gastrointestinal disorders (18.8%), neutropenia (8.3%), and hypertension (6.3%). ConclusionsAb-paclitaxel with bevacizumab clearly demonstrates antitumor activity and manageable toxicity profile in patients with recurrent, platinum-resistant ovarian carcinoma. This regimen should be evaluated in a larger randomized trial.