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

研究成果: ジャーナルへの寄稿記事

43 引用 (Scopus)

抄録

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.

元の言語英語
ページ(範囲)2881-2887
ページ数7
ジャーナルJournal of Clinical Oncology
34
発行部数24
DOI
出版物ステータス出版済み - 8 20 2016

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irinotecan
Carboplatin
Paclitaxel
Cisplatin
Carcinoma
Drug Therapy
Survival
Survival Rate
Febrile Neutropenia
Leukopenia
Arthralgia
Anorexia
Peripheral Nervous System Diseases
Neutropenia
Thrombocytopenia
Antineoplastic Agents
Nausea
Disease-Free Survival
Area Under Curve
Vomiting

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

これを引用

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. / 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.

:: Journal of Clinical Oncology, 巻 34, 番号 24, 20.08.2016, p. 2881-2887.

研究成果: ジャーナルへの寄稿記事

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, JW, Kim, BG, Pignata, S, Alexandre, J, Green, J, Isonishi, S, Terauchi, F, Fujiwara, K & 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, 巻. 34, 番号 24, pp. 2881-2887. https://doi.org/10.1200/JCO.2016.66.9010
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. / 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. 2016 ; 巻 34, 番号 24. pp. 2881-2887.
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title = "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",
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.",
author = "Toru Sugiyama and Aikou Okamoto and Takayuki Enomoto and Tetsutaro Hamano and Eriko Aotani and Yasuhisa Terao and Nao Suzuki and Mikio Mikami and Nobuo Yaegashi and Kiyoko Kato and Hiroyuki Yoshikawa and Yoshihito Yokoyama and Hiroshi Tanabe and Koji Nishino and Hiroyuki Nomura and Kim, {Jae Weon} and Kim, {Byoung Gie} and Sandro Pignata and Jerome Alexandre and John Green and Seiji Isonishi and Fumitoshi Terauchi and Keiichi Fujiwara and Daisuke Aoki",
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month = "8",
day = "20",
doi = "10.1200/JCO.2016.66.9010",
language = "English",
volume = "34",
pages = "2881--2887",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "24",

}

TY - JOUR

T1 - Randomized phase III trial of irinotecan plus cisplatin compared with paclitaxel plus carboplatin as first-line chemotherapy for ovarian clear cell carcinoma

T2 - JGOG3017/GCIG trial

AU - Sugiyama, Toru

AU - Okamoto, Aikou

AU - Enomoto, Takayuki

AU - Hamano, Tetsutaro

AU - Aotani, Eriko

AU - Terao, Yasuhisa

AU - Suzuki, Nao

AU - Mikami, Mikio

AU - Yaegashi, Nobuo

AU - Kato, Kiyoko

AU - Yoshikawa, Hiroyuki

AU - Yokoyama, Yoshihito

AU - Tanabe, Hiroshi

AU - Nishino, Koji

AU - Nomura, Hiroyuki

AU - Kim, Jae Weon

AU - Kim, Byoung Gie

AU - Pignata, Sandro

AU - Alexandre, Jerome

AU - Green, John

AU - Isonishi, Seiji

AU - Terauchi, Fumitoshi

AU - Fujiwara, Keiichi

AU - Aoki, Daisuke

PY - 2016/8/20

Y1 - 2016/8/20

N2 - 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.

AB - 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.

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