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

Toru Sugiyama, Aikou Okamoto, Takayuki Enomoto, Tetsutaro Hamano, Eriko Aotani, Yasuhisa Terao, Nao Suzuki, Mikio Mikami, Nobuo Yaegashi, Kiyoko Kato, Hiroyuki Yoshikawa, Yoshihito Yokoyama, Hiroshi Tanabe, Koji Nishino, Hiroyuki Nomura, Jae Weon Kim, Byoung Gie Kim, Sandro Pignata, Jerome Alexandre, John GreenSeiji Isonishi, Fumitoshi Terauchi, Keiichi Fujiwara, Daisuke Aoki

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56 Citations (Scopus)

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/m2 on days 1, 8, and 15 plus cisplatin 60 mg/m2 on day 1 (CPT-P group) every 4 weeks for six cycles or paclitaxel 175 mg/m2 plus carboplatin area under the curve 6.0mg/mL/min on day 1 every 3 weeks for six cycles (TC group). The primary end point was progressionfree 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.

Original languageEnglish
Pages (from-to)2881-2887
Number of pages7
JournalJournal of Clinical Oncology
Volume34
Issue number24
DOIs
Publication statusPublished - 2016 Aug 20

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Sugiyama, T., Okamoto, A., Enomoto, T., Hamano, T., Aotani, E., Terao, Y., Suzuki, N., Mikami, M., Yaegashi, N., Kato, K., Yoshikawa, H., Yokoyama, Y., Tanabe, H., Nishino, K., Nomura, H., Kim, J. W., Kim, B. G., Pignata, S., Alexandre, J., ... Aoki, D. (2016). 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. Journal of Clinical Oncology, 34(24), 2881-2887. https://doi.org/10.1200/JCO.2016.66.9010