Intraperitoneal administration of cisplatin plus bevacizumab for the management of malignant ascites in ovarian epithelial cancer: results of a phase III clinical trial.

Bevacizumab is a humanized antihuman VEGF-A monoclonal antibody. This study aims to evaluate the efficacy and safety of intraperitoneal administration of cisplatin plus bevacizumab (Avastin) in the management of malignant ascites in ovarian epithelial cancer. Fifty-eight ovarian epithelial cancer patients with malignant ascites were randomly assigned to receive either intraperitoneal administration of cisplatin only (control group, n = 27, cisplatin: 40 mg/m(2) every 2 weeks, for 6 weeks) or cisplatin plus bevacizumab (study group, n = 31, cisplatin: 40 mg/m(2), bevacizumab: 300 mg, every 2 weeks for 6 weeks). All patients regularly received TC regimen (paclitaxel 135 mg/m(2) d1 + carboplatin AUC 5 d1) every 3 weeks. The outcome, quality of life (QoL) and adverse effect of the treatment were analyzed, and VEGF and CA-125 level in ascites were detected by ELISA. After treatment with cisplatin plus bevacizumab, VEGF level in ascites was significantly decreased compared to baseline (P < 0.05). Meanwhile, ascites VEGF level of study group was significantly lower than that of control group (P < 0.05). The overall response rate (ORR) of study group was significantly higher than that of control group (ORR 90.32 vs. 59.26 %, P < 0.05). QoL improvement rate of study group was also significantly higher than that of control group (93.55 vs. 48.15 %, P < 0.05). All patients were well tolerated, and no serious adverse effect occurred. Intraperitoneal administration of cisplatin plus bevacizumab is effective and safe for the management of malignant ascites in ovarian epithelial cancer.

RCT Entities:   Population Interventions Outcomes