Toru Sugiyama1, Aikou Okamoto2, Takayuki Enomoto1, Tetsutaro Hamano1, Eriko Aotani1, Yasuhisa Terao1, Nao Suzuki1, Mikio Mikami1, Nobuo Yaegashi1, Kiyoko Kato1, Hiroyuki Yoshikawa1, Yoshihito Yokoyama1, Hiroshi Tanabe1, Koji Nishino1, Hiroyuki Nomura1, Jae-Weon Kim1, Byoung-Gie Kim1, Sandro Pignata1, Jerome Alexandre1, John Green1, Seiji Isonishi1, Fumitoshi Terauchi1, Keiichi Fujiwara1, Daisuke Aoki1. 1. Toru Sugiyama, Iwate Medical University, Iwate; Aikou Okamoto, Hiroshi Tanabe, and Seiji Isonishi, The Jikei University School of Medicine; Tetsutaro Hamano, Kitasato University; Yasuhisa Terao, Juntendo University; Mikio Mikami, Tokai University; Hiroyuki Nomura and Daisuke Aoki, Keio University; Fumitoshi Terauchi, Tokyo Medical University, Tokyo; Takayuki Enomoto and Koji Nishino, Niigata University, Niigata; Eriko Aotani, Kanagawa Academy of Science and Technology; Nao Suzuki, St Marianna University, Kanagawa; Nobuo Yaegashi, Tohoku University, Miyagi; Kiyoko Kato, Kyushu University, Fukuoka; Hiroyuki Yoshikawa, University of Tsukuba, Ibaraki; Yoshihito Yokoyama, Hirosaki University, Aomori; Keiichi Fujiwara, Saitama Medical University International Medical Center, Saitama, Japan; Jae-Weon Kim, Seoul National University; Byoung-Gie Kim, Sungkyunkwan University, Seoul, South Korea; Sandro Pignata, Istituto Nazionale Tumori di Napoli, Naples, Italy; Jerome Alexandre, Hôpital Hôtel-Dieu, Montreal, Quebec, Canada; and John Green, University of Liverpool, Liverpool, United Kingdom. 2. Toru Sugiyama, Iwate Medical University, Iwate; Aikou Okamoto, Hiroshi Tanabe, and Seiji Isonishi, The Jikei University School of Medicine; Tetsutaro Hamano, Kitasato University; Yasuhisa Terao, Juntendo University; Mikio Mikami, Tokai University; Hiroyuki Nomura and Daisuke Aoki, Keio University; Fumitoshi Terauchi, Tokyo Medical University, Tokyo; Takayuki Enomoto and Koji Nishino, Niigata University, Niigata; Eriko Aotani, Kanagawa Academy of Science and Technology; Nao Suzuki, St Marianna University, Kanagawa; Nobuo Yaegashi, Tohoku University, Miyagi; Kiyoko Kato, Kyushu University, Fukuoka; Hiroyuki Yoshikawa, University of Tsukuba, Ibaraki; Yoshihito Yokoyama, Hirosaki University, Aomori; Keiichi Fujiwara, Saitama Medical University International Medical Center, Saitama, Japan; Jae-Weon Kim, Seoul National University; Byoung-Gie Kim, Sungkyunkwan University, Seoul, South Korea; Sandro Pignata, Istituto Nazionale Tumori di Napoli, Naples, Italy; Jerome Alexandre, Hôpital Hôtel-Dieu, Montreal, Quebec, Canada; and John Green, University of Liverpool, Liverpool, United Kingdom. aikou@jikei.ac.jp.
Abstract
PURPOSE: Clear cell carcinoma (CCC) is a rare histologic subtype that demonstrates poor outcomes in epithelial ovarian cancer. The Japanese Gynecologic Oncology Group conducted the first randomized phase III, CCC-specific clinical trial that compared irinotecan and cisplatin (CPT-P) with paclitaxel plus carboplatin (TC) in patients with CCC. PATIENTS AND METHODS: Six hundred sixty-seven patients with stage I to IV CCC of the ovary were randomly assigned to receive irinotecan 60 mg/m(2) on days 1, 8, and 15 plus cisplatin 60 mg/m(2) on day 1 (CPT-P group) every 4 weeks for six cycles or paclitaxel 175 mg/m(2) plus carboplatin area under the curve 6.0 mg/mL/min on day 1 every 3 weeks for six cycles (TC group). The primary end point was progression-free survival. Secondary end points were overall survival, overall response rate, and adverse events. RESULTS:Six hundred nineteen patients were clinically and pathologically eligible for evaluation. With a median follow-up of 44.3 months, 2-year progression-free survival rates were 73.0% in the CPT-P group and 77.6% in TC group (hazard ratio, 1.17; 95% CI, 0.87 to 1.58; P = .85). Two-year overall survival rates were 85.5% with CPT-P and 87.4% with TC (hazard ratio, 1.13; 95% CI, 0.80 to 1.61; one-sided P = .76). Grade 3/4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia occurred more frequently with CPT-P, whereas grade 3/4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain occurred more frequently with TC. CONCLUSION: No significant survival benefit was found for CPT-P. Both regimens were well tolerated, but the toxicity profiles differed significantly. Treatment with existing anticancer agents has limitations to improving the prognosis of CCC.
RCT Entities:
PURPOSE:Clear cell carcinoma (CCC) is a rare histologic subtype that demonstrates poor outcomes in epithelial ovarian cancer. The Japanese Gynecologic Oncology Group conducted the first randomized phase III, CCC-specific clinical trial that compared irinotecan and cisplatin (CPT-P) with paclitaxel plus carboplatin (TC) in patients with CCC. PATIENTS AND METHODS: Six hundred sixty-seven patients with stage I to IV CCC of the ovary were randomly assigned to receive irinotecan 60 mg/m(2) on days 1, 8, and 15 plus cisplatin 60 mg/m(2) on day 1 (CPT-P group) every 4 weeks for six cycles or paclitaxel 175 mg/m(2) plus carboplatin area under the curve 6.0 mg/mL/min on day 1 every 3 weeks for six cycles (TC group). The primary end point was progression-free survival. Secondary end points were overall survival, overall response rate, and adverse events. RESULTS: Six hundred nineteen patients were clinically and pathologically eligible for evaluation. With a median follow-up of 44.3 months, 2-year progression-free survival rates were 73.0% in the CPT-P group and 77.6% in TC group (hazard ratio, 1.17; 95% CI, 0.87 to 1.58; P = .85). Two-year overall survival rates were 85.5% with CPT-P and 87.4% with TC (hazard ratio, 1.13; 95% CI, 0.80 to 1.61; one-sided P = .76). Grade 3/4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia occurred more frequently with CPT-P, whereas grade 3/4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain occurred more frequently with TC. CONCLUSION: No significant survival benefit was found for CPT-P. Both regimens were well tolerated, but the toxicity profiles differed significantly. Treatment with existing anticancer agents has limitations to improving the prognosis of CCC.
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