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

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 6 months after a prior course of platinum-based treatment. Patients received ab-paclitaxel 100 mg/m2 given by intravenous infusion over 30 min on days 1, 8, and 15 of a 28-day cycle with bevacizumab 10 mg/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 – 31 cycles). The median progression-free survival was 8.08 months (95% CI, 5.78 – 10.15 months); 6 month progression-free rate was 62.5% (95% CI, 47.8%–77.2%); median overall survival was 17.15 months (95% CI, 13.57 – 23.82 months). 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.

► Ab-paclitaxel with bevacizumab demonstrated substantial antitumor activity with response rate of 50% and median PFS of 8.08 months. ► Toxicity profile was manageable with the most common grade 3–4 adverse events including gastrointestinal disorders, neutropenia, and hypertension.