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Annals of Oncology 11:1531-1536, 2000
© 2000 European Society for Medical Oncology

research-article

A phase II trial of docetaxel in platinum pre-treated patients with advanced epithelial ovarian cancer: A Japanese Cooperative Study

N. Katsumata1,, R. Tsunematsu1, K. Tanaka2, Y. Terashima3, S. Ogita4, H. Hoshiai5, I. Kohno6, K. Hirabayashi7, M. Yakushiji8, K. Noda9 and T. Taguchi10

1Department of Medical Oncology & Gynecologic Oncology, National Cancer Center Hospital Tokyo
2Department of Obstetrics and Gynecology, Niigata University School of Medicine Niigata City
3Department of Obstetrics and Gynecology, Jikei University School of Medicine Tokyo
4Department of Obstetrics and Gynecology, Osaka City University Medical School Osaka City
5Department of Obstetrics and Gynecologi, Kinki University School of Medical Osaka City
6Department of Obstetrics and Gynecology, Kawasaki Medical School Kurashiki City
7Department of Obstetrics and Gynecology, Fukuyama National Hospital Fukuyama City
8Department of Obstetrics and Gynecology, Kurume University School of Medicine Kurume City
9Kinki University Osaka City
10Japan Society for Cancer Chemotherapy Tokyo, Japan

Correspondence to: N. Katsumata, MD Department of Medical & Gynecologic Oncology National Cancer Center Hospital 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan E-mail: nkatsuma{at}gan2.ncc.go.jp

Background: This phase II study was conducted to evaluate the efficacy and toxicity of docetaxel in Japanese patients with advanced ovarian cancer.

Patients and methods: Docetaxel was administered at a dose of 70 mg/m2 intravenously to patients with platinum pretreated advanced ovarian cancer. Treatment was repeated every three weeks. No routine corticosteroid premedication was given.

Results: Ninety patients with advanced ovarian cancer were entered and sixty were assessable for response. The overall response rate was 28% in the assessable patients (95% confidence interval (95% CI): 17.5%–41.4%). CA125 responses were seen in 8 (24%) of 34 assessable patients for CA125 criteria. The 36 platinum-refractory patients had a response rate of 25% compared with 33% in the platinum-sensitive patients. The predominant toxicity was neutropenia, with 86% of the patients experiencing grade 3 or 4. Hypersensitivity reactions occurred in 37% of the patients and were not life threatening. Edema was mild and infrequent.

Conclusion:Docetaxel at 70 mg/m2 demonstrated effectiveness as a treatment of both platinum-sensitive and platinum-refractory ovarian cancer patients, with a low incidence of severe hypersensitivity reactions and edema.

advanced ovarian cancer, chemotherapy, docetaxel, phase II trial


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