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).

TitleRandomized 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).
Publication TypeJournal Article
Year of Publication2011
AuthorsNomura, H, Aoki, D, Takahashi, F, Katsumata, N, Watanabe, Y, Konishi, I, Jobo, T, Hatae, M, Hiura, M, Yaegashi, N
JournalAnn Oncol
Volume22
Issue3
Pagination636-42
Date Published2011 Mar
ISSN1569-8041
KeywordsAdult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Carcinoma, Cisplatin, Endometrial Neoplasms, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Paclitaxel, Taxoids, Treatment Outcome
Abstract

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.PATIENTS AND 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 (Pā€‰=ā€‰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.CONCLUSION: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.

DOI10.1093/annonc/mdq401
Alternate JournalAnn. Oncol.
PubMed ID20696677