title: 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).
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.
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
authors.forename: H
authors.initials: H
authors.lastname: Nomura
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo. Electronic address: aoki@sc.itc.keio.ac.jp.
authors.forename: D
authors.initials: D
authors.lastname: Aoki
authors.affiliation: Department of Biostatistics, Kitasato University, Tokyo.
authors.forename: F
authors.initials: F
authors.lastname: Takahashi
authors.affiliation: Department of Medical Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: N
authors.initials: N
authors.lastname: Katsumata
authors.affiliation: Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka.
authors.forename: Y
authors.initials: Y
authors.lastname: Watanabe
authors.affiliation: Department of Obstetrics and Gynecology, Kyoto University Graduate School of Medicine, Kyoto.
authors.forename: I
authors.initials: I
authors.lastname: Konishi
authors.affiliation: Department of Obstetrics and Gynecology, Social Insurance Sagamino Hospital, Sagamihara.
authors.forename: T
authors.initials: T
authors.lastname: Jobo
authors.affiliation: Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima.
authors.forename: M
authors.initials: M
authors.lastname: Hatae
authors.affiliation: Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Matsuyama.
authors.forename: M
authors.initials: M
authors.lastname: Hiura
authors.affiliation: Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Yaegashi
mesh_terms: 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
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin