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

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

Highlights

► 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.

Abstract

Objective

We 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.

Methods

Patients 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.

Results

Forty-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%).

Conclusions

Ab-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.