Bevacizumab combined with platinum–taxane chemotherapy as first-line treatment for advanced ovarian cancer: a prospective observational study of safety and efficacy in Japanese patients (JGOG3022 trial)

• DOI: 10.1007/s10147-018-1319-y
• Publication Date: 2018-07-20T03:50:02Z
• Authors: Shinichi Komiyama; Kazuyoshi Kato; Yuki Inokuchi; Hirokuni Takano; Takashi Matsumoto; Atsushi Hongo; Mikiko Asai-Sato; Atsushi Arakawa; Shoji Kamiura; Tsutomu Tabata; Nobuhiro Takeshima; Toru Sugiyama
• Keywords: Adult; Paclitaxel; Docetaxel; Carboplatin; 03 medical and health sciences; 0302 clinical medicine; Japan; Antineoplastic Combined Chemotherapy Protocols; Humans; Prospective Studies; Aged; Aged, 80 and over; Ovarian Neoplasms; Middle Aged; Prognosis; Adenocarcinoma, Mucinous; Cystadenocarcinoma, Serous; Endometrial Neoplasms; 3. Good health; Bevacizumab; Original Article; Female; Neoplasm Recurrence, Local; Adenocarcinoma, Clear Cell

This was the first large-scale prospective observational Japanese study evaluating the safety and efficacy of bevacizumab combined with paclitaxel and carboplatin for newly diagnosed advanced ovarian cancer.Patients were prospectively enrolled in the primary analysis cohort if they had Stage III or IV epithelial ovarian/fallopian tube/primary peritoneal cancer and were scheduled to receive paclitaxel plus carboplatin every 3 weeks in Cycles 1-6 and bevacizumab every 3 weeks in Cycles 2-22. Primary endpoints were bevacizumab-specific adverse events and adverse events ≥ Grade 3. Secondary endpoints were progression-free survival (PFS) and the response rate.Among 346 patients enrolled, 293 patients formed the primary analysis cohort. Regarding bevacizumab-specific adverse events ≥ grade 3, incidence rates of thromboembolic events (1.4%), gastrointestinal perforation (0.3%), fistula (0.7%), wound dehiscence (0%), and bleeding (0%) were very low. While incidence rates of hypertension (23.2%) and proteinuria (12.6%) were high, all such events were tolerable. No patient with prior bowel resection developed perforation or fistula. Median PFS was 16.3 months (95% CI 14.5-18.9). The response rate was 77.5% (95% CI 67.4-85.7). The response rate was 63.6% in patients with clear cell carcinoma, which tended to be better than previously reported. The median platinum-free interval was 11.5 months, and the platinum-resistant recurrence rate was 24.5%.Combining bevacizumab with chemotherapy was tolerable and efficacy was acceptable in Japanese patients with advanced epithelial ovarian cancer. Bevacizumab seems to reduce platinum-resistant recurrence and is promising for clear cell carcinoma.