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J Clin Oncol. 2016 Aug 20;34(24):2881-7. doi: 10.1200/JCO.2016.66.9010. Epub 2016 Jul 11.

Randomized Phase III Trial of Irinotecan Plus Cisplatin Compared With Paclitaxel Plus Carboplatin As First-Line Chemotherapy for Ovarian Clear Cell Carcinoma: JGOG3017/GCIG Trial.

Author information

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.

PMID:
27400948
DOI:
10.1200/JCO.2016.66.9010
[Indexed for MEDLINE]

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