神戸大学附属図書館デジタルアーカイブ
https://hdl.handle.net/20.500.14094/90009237

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メタデータID
90009237
アクセス権
open access
出版タイプ
Version of Record
タイトル
Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial
著者
Kiyota, Naomi ; Tahara, Makoto ; Mizusawa, Junki ; Kodaira, Takeshi ; Fujii, Hirofumi ; Yamazaki, Tomoko ; Mitani, Hiroki ; Iwae, Shigemichi ; Fujimoto, Yasushi ; Onozawa, Yusuke ; Hanai, Nobuhiro ; Ogawa, Takenori ; Hara, Hiroki ; Monden, Nobuya ; Shimura, Eiji ; Minami, Shujiro ; Fujii, Takashi ; Tanaka, Kaoru ; Homma, Akihiro ; Yoshimoto, Seiichi ; Oridate, Nobuhiko ; Omori, Koichi ; Ueda, Tsutomu ; Okami, Kenji ; Ota, Ichiro ; Shiga, Kiyoto ; Sugasawa, Masashi ; Asakage, Takahiro ; Saito, Yuki ; Murono, Shigeyuki ; Nishimura, Yasumasa ; Nakamura, Kenichi ; Hayashi, Ryuichi ; the Head and Neck Cancer Study Group of the Japan Clinical Oncology Group (JCOG-HNCSG)
著者ID
A1407
研究者ID
1000040515037
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=5fd898ae58a689e3520e17560c007669
著者名
Kiyota, Naomi
清田, 尚臣
キヨタ, ナオミ
所属機関名
医学部附属病院
著者名
Tahara, Makoto
著者名
Mizusawa, Junki
著者名
Kodaira, Takeshi
著者名
Fujii, Hirofumi
著者名
Yamazaki, Tomoko
著者名
Mitani, Hiroki
著者名
Iwae, Shigemichi
著者名
Fujimoto, Yasushi
著者名
Onozawa, Yusuke
著者名
Hanai, Nobuhiro
著者名
Ogawa, Takenori
著者名
Hara, Hiroki
著者名
Monden, Nobuya
著者名
Shimura, Eiji
著者名
Minami, Shujiro
著者名
Fujii, Takashi
著者名
Tanaka, Kaoru
著者名
Homma, Akihiro
著者名
Yoshimoto, Seiichi
著者名
Oridate, Nobuhiko
著者名
Omori, Koichi
著者名
Ueda, Tsutomu
著者名
Okami, Kenji
著者名
Ota, Ichiro
著者名
Shiga, Kiyoto
著者名
Sugasawa, Masashi
著者名
Asakage, Takahiro
著者名
Saito, Yuki
著者名
Murono, Shigeyuki
著者名
Nishimura, Yasumasa
著者名
Nakamura, Kenichi
著者名
Hayashi, Ryuichi
著者名
the Head and Neck Cancer Study Group of the Japan Clinical Oncology Group (JCOG-HNCSG)
言語
English (英語)
収録物名
Journal of Clinical Oncology
巻(号)
40(18)
ページ
1980-1990
出版者
American Society of Clinical Oncology
刊行日
2022-06-20
公開日
2022-05-24
注記
Published online March 01, 2022
抄録
PURPOSE The standard treatment for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (100 mg/m2). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m2) yields comparable efficacy with 3-weekly cisplatin in postoperative high-risk LA-SCCHN is unknown. PATIENTS AND METHODS In this multi-institutional open-label phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin (100 mg/m2) or with weekly cisplatin (40 mg/m2) to confirm the noninferiority of weekly cisplatin. The primary end point of phase II was the proportion of treatment completion, and that of phase III was overall survival. A noninferiority margin of hazard ratio was set at 1.32. RESULTS Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients). At the planned third interim analysis in the phase III part, after a median follow-up of 2.2 (interquartile range 1.19-3.56) years, chemoradiotherapy with weekly cisplatin was noninferior to 3-weekly cisplatin in terms of overall survival, with a hazard ratio of 0.69 (99.1% CI, 0.374 to 1.273 [< 1.32], one-sided P for noninferiority = .0027 < .0043). Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly v weekly, 49% v 35% and 12% v 7%, respectively), as were renal impairment and hearing impairment. No treatment-related death was reported in the 3-weekly arm, and two (1.6%) in the weekly arm. CONCLUSION Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN. These findings suggest that chemoradiotherapy with weekly cisplatin can be a possible treatment option for these patients.
カテゴリ
医学部附属病院
学術雑誌論文
権利
© 2022 by American Society of Clinical Oncology.
CC license
Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
関連情報
DOI
https://doi.org/10.1200/JCO.21.01293