H Nomura1, D Aoki2, F Takahashi3, N Katsumata4, Y Watanabe5, I Konishi6, T Jobo7, M Hatae8, M Hiura9, N Yaegashi10. 1. Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo. 2. Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo. Electronic address: aoki@sc.itc.keio.ac.jp. 3. Department of Biostatistics, Kitasato University, Tokyo. 4. Department of Medical Oncology, National Cancer Center Hospital, Tokyo. 5. Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka. 6. Department of Obstetrics and Gynecology, Kyoto University Graduate School of Medicine, Kyoto. 7. Department of Obstetrics and Gynecology, Social Insurance Sagamino Hospital, Sagamihara. 8. Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima. 9. Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Matsuyama. 10. Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.
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 (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. CONCLUSION: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.
RCT Entities:
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 (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. CONCLUSION: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.
Authors: Seung Un Seo; Hyuk Ki Cho; Kyoung-Jin Min; Seon Min Woo; Shin Kim; Jong-Wook Park; Sang Hyun Kim; Yung Hyun Choi; Young Sam Keum; Jin Won Hyun; Hyun Ho Park; Sang-Han Lee; Dong Eun Kim; Taeg Kyu Kwon Journal: Cell Death Dis Date: 2017-02-09 Impact factor: 8.469