Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: a Japanese Gynecologic Oncology Group study (JGOG2041).
BACKGROUND
The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma.


METHODS
Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity.


RESULTS
Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different.


CONCLUSIONS
The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.
Nomura
H
H
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
Aoki
D
D
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo. Electronic address: aoki@sc.itc.keio.ac.jp.
Takahashi
F
F
Department of Biostatistics, Kitasato University, Tokyo.
Katsumata
N
N
Department of Medical Oncology, National Cancer Center Hospital, Tokyo.
Watanabe
Y
Y
Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka.
Konishi
I
I
Department of Obstetrics and Gynecology, Kyoto University Graduate School of Medicine, Kyoto.
Jobo
T
T
Department of Obstetrics and Gynecology, Social Insurance Sagamino Hospital, Sagamihara.
Hatae
M
M
Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima.
Hiura
M
M
Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Matsuyama.
Yaegashi
N
N
Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin