-Original-

A Phase II Study of Paclitaxel and Carboplatin with a Biweekly Schedule in Patients with Epithelial Ovarian Cancer: Gynecologic Cancer Network Trial

Koichi Yoneyama¹, Hideki Konishi², Tetsuro Yahata³, Kazuyuki Fujita³, Yoichi Aoki⁴, Daisuke Doi⁵, Takashi Matsushima⁵, Shoji Kodama⁶, Shigeru Honma⁶, Hisamori Kato⁷, Hiroki Nakayama⁷, Seiryu Kamoi⁸, Hirobumi Asakura⁵, Toshiyuki Takeshita¹ and Kenichi Tanaka³

¹Department of Obstetrics and Gynecology, Nippon Medical School Hospital
²Department of Obstetrics and Gynecology, Kato Women's Clinic
³Division of Obstetrics and Gynecology, Graduate School of Medical and Dental Sciences, Niigata University
⁴Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus
⁵Department of Obstetrics and Gynecology, Nippon Medical School Musashi Kosugi Hospital
⁶Division of Gynecology, Niigata Prefectural Cancer Center Hospital
⁷Department of Gynecology, Kanagawa Cancer Center Hospital
⁸Department of Obstetrics and Gynecology, Nippon Medical School Chiba Hokusoh Hospital

Aim: The objective of this multicenter phase II study was to evaluate the effects of biweekly paclitaxel and carboplatin combination chemotherapy on response rate and toxicities in patients with epithelial ovarian cancer.
Patients and Methods: Patients with International Federation of Gynecology and Obstetrics stage II to IV ovarian cancer received paclitaxel at a dose of 120 mg/m² and carboplatin at an area under the curve of 3 mg/mL per minute every 2 weeks for 8 or more cycles. Inclusion criteria included an Eastern Cooperative Oncology Group performance status of 0 to 2 and no previous chemotherapy. Informed consent was obtained from each patient before the start of treatment.
Results: From March 2003 through July 2009, 42 patients from 5 institutions were eligible to be evaluated for response and toxicity. The median age was 60.5 years (age range, 34-81 years). The International Federation of Gynecology and Obstetrics stage was stage II in 3 patients, stage III in 31 patients, and stage IV in 8 patients. The response rate was 66.7% (95% confidence interval: 50.5%-80.4%). Sixty-nine percent (29 of 42) of patients received 8 or more cycles of chemotherapy. The median progression-free survival was 18.5 months, and overall survival was 59.1 months. The most common grade 3 or 4 hematological toxicity was neutropenia (61.0%). No patients had grade 3 or 4 thrombocytopenia. The most common grade 3 nonhematological toxicities were neuropathy (4.9%) and nausea (2.4%).
Conclusion: Paclitaxel combined with carboplatin using a biweekly schedule is a safe and effective chemotherapy regimen for patients with epithelial ovarian cancer. Our results suggest that a biweekly schedule is well tolerated and is less toxic than a triweekly schedule.

J Nippon Med Sch 2014; 81: 28-34

Keywords
phase II study, paclitaxel, carboplatin, biweekly schedule, ovarian cancer

Correspondence to
Koichi Yoneyama, Department of Obstetrics and Gynecology, Nippon Medical School Hospital, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
kyone@nms.ac.jp

Received, April 14, 2013
Accepted, July 3, 2013