Salvage bevacizumab (rhuMAB VEGF)-based therapy after multiple prior cytotoxic regimens in advanced refractory epithelial ovarian cancer

Objectives. Bevacizumab (BEV) is a humanized monoclonal antibody against vascular endothelial growth factor. We reviewed our experience with BEV in patients with recurrent advanced epithelial ovarian cancer who had failed multiple prior chemotherapeutic regimens. Methods. Thirty-two patients not participating in an ongoing clinical trial were treated with BEV (15 mg/kg every 3 weeks IV). Demographic and clinicopathologic data, clinical outcomes, and adverse events were extracted from patient charts. RECIST and CA-125 Rustin criteria were retrospectively applied to evaluate response and progression. Median progression-free survival (PFS) and overall survival (OS) were determined using Kaplan-Meier methods. Adverse events were retrospectively categorized using the common terminology criteria for adverse events version 3. Results. The median patient age was 57 years (range 35-80) with 84% being Caucasian and 50% having a GOG performance status of 2. FIGO stages included 80% stage III and 10% stage TV. The tumors were mostly grades 2 (29%) and 3 (64%) and serous histological subtype (69%). All patients had failed multiple prior cytotoxic chemotherapies (median of 5 (range 2-10)) prior to BEV. The median duration of follow-up was 4.8 months (range 0.4-16.3). Twenty-three patients were treated with BEV alone, 2 received BEV with another chemotherapy regimen (5-FU/lecovorin plus oxaliplatin, cyclophosphamide), and 8 initially received BEV alone, followed by BEV with capcitabine, cyclophosphamide, docetaxel, carboplatin, or weekly paclitaxel. A median of 6 cycles (range 1-20) with 196 total doses of BEV was administered. One patient was lost to follow-up after cycle 1. We observed a 16% response rate (all in those treated with BEV alone) with 62.5% of patients demonstrating stable disease. Median OS was 6.9 months, and the median PFS was 5.5 months. Three grade 3 and no grade 4 adverse events were observed. Grade 3 toxicities included hypertension, proteinuria, and enterocutaneous fistula. The fistula occurred after 5 cycles of BEV in a patient who had undergone 7 debulking surgeries prior to BEV. Conclusions. BEV is generally well tolerated after multiple prior cytotoxic regimens and results in significant clinical benefit among women with recurrent ovarian cancer. (c) 2006 Elsevier Inc. All rights reserved.