Phase II trial of docetaxel in advanced or metastatic endometrial cancer: a Japanese Cooperative Study.
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.
Katsumata
N
N
Department of Medical Oncology, National Cancer Center Hospital, 104-0045 Tokyo, Japan. nkatsuma@ncc.go.jp
Noda
K
K
Nozawa
S
S
Kitagawa
R
R
Nishimura
R
R
Yamaguchi
S
S
Aoki
D
D
Susumu
N
N
Kuramoto
H
H
Jobo
T
T
Ueki
K
K
Ueki
M
M
Kohno
I
I
Fujiwara
K
K
Sohda
Y
Y
Eguchi
F
F
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D000231:Adenocarcinoma, Papillary / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D000077143:Docetaxel; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use*
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel