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Poster display session

1015 - Prospective cohort study of bevacizumab plus standard platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer: Japanese Gynecologic Oncology Group study (JGOG3022)

Date

09 Sep 2017

Session

Poster display session

Presenters

Kazuyoshi Kato

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

K. Kato1, S. Komiyama2, N. Takeshima1, H. Takano3, A. Inoue4, A. Hongo5, M. Asai-Sato6, A. Arakawa7, K. Kubushiro2, S. Kamiura8, T. Sugiyama9

Author affiliations

  • 1 Department Of Gynecology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 2 Department Of Obstetrics And Gynecology, Toho University Ohashi Medical Center, 153-8515 - Tokyo/JP
  • 3 Department Of Obstetrics And Gynecology, The Jikei University Kashiwa Hospital, 277-8567 - Kashiwa/JP
  • 4 Department Of Obstetrics And Gynecology, Ehime University Hospital, 791-0295 - Ehime/JP
  • 5 Department Of Obstetrics And Gynecology, Kagawa Prefectural Central Hospital, 760-8557 - Takamatsu/JP
  • 6 Department Of Obstetrics And Gynecology, Yokohama City University Hospital, 236-0004 - Yokohama/JP
  • 7 Department Of Obstetrics And Gynecology, Nagoya City University Graduate School of Medical Sciences, 467-8602 - Nagoya/JP
  • 8 Department Of Gynecology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
  • 9 Department Of Obstetrics And Gynecology, Iwate Medical University School of Medicine, 020-8505 - Morioka/JP
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Resources

Abstract 1015

Background

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.

Methods

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.

Results

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.

Conclusions

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

JGOG3022

Legal entity responsible for the study

Japanese Gynecologic Oncology Group

Funding

Chugai Pharmaceutical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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