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Phase II Clinical Trial of Bevacizumab with Albumin-bound Paclitaxel in Patients with Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma.

Gynecol Oncol. 2012 Sep 4;

Authors: Tillmanns TD, Lowe MP, Walker MS, Stepanski EJ, Schwartzberg LS


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 6months after a prior course of platinum-based treatment. Patients received ab-paclitaxel 100mg/m(2) given by intravenous infusion over 30minutes on days 1, 8, 15 of a 28-daycycle with bevacizumab 10mg/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% to 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 to 31cycles). The median progression-free survival was 8.08months (95% CI, 5.78 to 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 to 23.82months). 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.

PMID: 22960352 [PubMed - as supplied by publisher]