1. ¹Department of Medical Oncology, National Cancer Center Hospital, 104-0045 Tokyo, Japan
2. ²Kinki University, Osakasayama, Japan
3. ³Department of Obstetrics and Gynecology, School of Medicine, Keio University, 160-8582 Tokyo, Japan
4. ⁴Department of Gynecology, Hyogo Medical Center for Adults, 673-8558 Akashi, Japan
5. ⁵Department of Obstetrics and Gynecology, Kitasato University, 228-8555 Sagamihara, Japan
6. ⁶Department of Obstetrics and Gynecology, Osaka Medical College, 569-8686 Takatsuki, Japan
7. ⁷Department of Obstetrics and Gynecology, Kawasaki Medical School, 701-0192 Kurashiki, Japan
8. ⁸Department of Obstetrics and Gynecology, Aso Iizuka Hospital, 820-8505 Iizuka, Japan

Correspondence: Dr N Katsumata, E-mail: nkatsuma@ncc.go.jp

Received 22 July 2005; Revised 19 September 2005; Accepted 19 September 2005; Published online 18 October 2005.

Abstract

The purpose of this study was to determine whether docetaxel has antitumour activity in patients with advanced or recurrent endometrial carcinoma. Chemotherapy-naïve or previously treated patients (one regimen) with histopathologically documented endometrial carcinoma and Eastern Cooperative Oncology Group performance status 2 entered the study. Docetaxel 70 mg m^-2 was administered intravenously on day 1 of a 3-week cycle up to a maximum of six cycles. If patients responded well to docetaxel, additional cycles were administered until progressive disease or unacceptable toxicity occurred. Of 33 patients with a median age of 59 years (range, 39–74 years) who entered the study, 14 patients (42%) had received one prior chemotherapy regimen. In all, 32 patients were evaluable for efficacy, yielding an overall response rate of 31% (95% confidence interval, 16.1–50.0%); complete response and partial response (PR) were 3 and 28%, respectively. Of 13 pretreated patients, three (23%) had a PR. The median duration of response was 1.8 months. The median time to progression was 3.9 months. The predominant toxicity was grade 3–4 neutropenia, occurring in 94% of the patients, although febrile neutropenia arose in 9% of the patients. Oedema was mild and infrequent. Docetaxel has antitumour activity in patients with advanced or recurrent endometrial carcinoma, including those previously treated with chemotherapy; however, the effect was transient and accompanied by pronounced neutropenia in most patients.