Effect of weekly administration of bevacizumab, gemcitabine, and oxaliplatin in patients with heavily pretreated ovarian cancer.

Abstract

5037 Background: The combination therapy of gemcitabine with oxaliplatin (GEMOX) has high activity in patients with ovarian cancer. Bevacizumab (B), a vascular endothelial growth factor specific antibody, enhances chemotherapeutic efficacy through its anti-angiogenic function in various types of tumors. We evaluated the effect of weekly administration of B and GEMOX in heavily-pretreated patients with recurrent or refractory ovarian cancers (ROC). Methods: Nineteen patients with ROC received at least three or more cycles of weekly-B and GEMOX consisting of B (2mg/kg), gemcitabine (300mg/m2) and oxaliplatin (30mg/m2). The treatment was continued until the development of progressive disease. The response and adverse effects (AE) were evaluated using the response evaluation criteria in solid tumors (RECIST), CA125 Gynecologic Cancer Intergroup (GCIG) criteria, and common terminology criteria for adverse events (CTCAE) version 3.0. Results: Seventeen (89%) of the 19 patients were primarily stage 3 or 4. Fifteen patients (79%) had received more than three regimens of chemotherapy. All patients were pretreated with a platinum-containing regimen within 6 months and 16 of these patients (84%) were pretreated within 3 months. According to the RECIST evaluation, 2 patients (11%) had a complete response (CR), 6 patients (32%) had a partial remission (PR) and 5 patients (26%) had a stable disease (SD). The response rate (RR; CR+PR) and clinical benefit rate (CBR; CR+PR+SD) were 42% and 68%, respectively. In 10 patients with serous adenocarcinoma, RR was 60%. In 6 patients pretreated with weekly B and pegylated liposomal doxorubicin (PLD), RR was 50%. Median progression-free survival was 5 months (range: 2-11 months). Hematological adverse effects (AE) with grade 3/4 were leukopenia (16%), neutropenia (10%), thrombocytopenia (5%), however, all AE were manageable. Conclusions: Weekly B and GEMOX administration had significant activity with mild AE in patients with ROC especially in serous adenocarcinoma. Notably, the activity was also observed in patients pretreated with weekly B and PLD. These results warrant further prospective study.