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

• Published in: Journal of clinical oncology Vol. 34; no. 24; pp. 2881 - 2887
• Main Authors: Sugiyama, Toru, Okamoto, Aikou, Enomoto, Takayuki, Hamano, Tetsutaro, Aotani, Eriko, Terao, Yasuhisa, Suzuki, Nao, Mikami, Mikio, Yaegashi, Nobuo, Kato, Kiyoko, Yoshikawa, Hiroyuki, Yokoyama, Yoshihito, Tanabe, Hiroshi, Nishino, Koji, Nomura, Hiroyuki, Kim, Jae-Weon, Kim, Byoung-Gie, Pignata, Sandro, Alexandre, Jerome, Green, John, Isonishi, Seiji, Terauchi, Fumitoshi, Fujiwara, Keiichi, Aoki, Daisuke
• Format: Journal Article
• Language: English
• Published: United States 20-08-2016
• Subjects: Adenocarcinoma, Clear Cell - drug therapy; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Carboplatin - administration & dosage; Carboplatin - adverse effects; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease-Free Survival; Female; Humans; Middle Aged; Ovarian Neoplasms - drug therapy; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Survival Rate
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2016.66.9010

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.
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.
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.
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.