The GOG-218 and ICON-7 studies showed that addition of bevacizumab (BEV) to front-line treatment for patients (pts) with advanced ovarian cancer increased progression free survival. Based on this result, BEV has been widely used in the front-line treatment. However, sufficient safety information of addition of BEV is not available in Japan. This prospective cohort study is conducted to assess the safety of addition of BEV to front-line treatment.
Eligible pts have FIGO stage III–IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, were aged ≥20 years and have ECOG PS 0–2. Prior neoadjuvant chemotherapy was permitted. The primary cohort was defined as pts who received tri-weekly paclitaxel/carboplatin (PC) plus BEV, and the exploratory cohort as pts who received other platinum based regimen plus BEV. BEV is continued at the same dose as a single agent until disease progression or unacceptable toxicity. The primary objective is to assess safety (NCI-CTCAE v4.03) of the primary cohort.
A total of 346 pts (Primary/exploratory cohort: 303/43) were enrolled from 79 institutions from Apr 2015 to Feb 2016. The data of primary cohort of 293 pts were analyzed as of 31 Mar 2017. The median age was 58 years (range: 27–83). The majority of the histologic type was Serous adenocarcinoma (65.2%) followed by Clear cell adenocarcinoma (12.3%) and Endometrioid adenocarcinoma (10.6%). Up-front surgery was performed in 203 pts (69.3%), and interval debulking surgery following neoadjuvant chemotherapy was performed in 90 pts (30.7%). A total of 45 serious adverse events occurred. Two pts (0.6%) developed a gastrointestinal perforation (grade 2) or fistula (grade 3). Thromboembolic events, hypertension, and hematuria of grade 3 or greater occurred in 3 (1.0%), 2 (0.7%), and 1 pt (0.3%), respectively.
Addition of bevacizumab to platinum based front-line chemotherapy can be safely administrated for advanced ovarian cancer pts in Japan. The rates of gastrointestinal and thromboembolic toxicity were relatively low as compared with the previous studies.
Clinical trial identification
Legal entity responsible for the study
Japanese Gynecologic Oncology Group
Chugai Pharmaceutical Co., Ltd.
All authors have declared no conflicts of interest.