ムラガキ　ヨシヒロ   Muragaki Yoshihiro   村垣　善浩    所属   医学部 医学科（東京女子医科大学病院）    職種   客員教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Radiotherapy Combined With Nivolumab or Temozolomide for Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter: An International Randomized Phase 3 Trial.
掲載誌名	正式名：Neuro-oncology 略　 称：Neuro Oncol ISSNコード：15235866/15228517
掲載区分	国外
出版社	Oxford University Press
巻・号・頁	25(1),pp.123-134
著者・共著者	OMURO Antonio†, BRANDES Alba A., CARPENTIER Antoine F., IDBAIH Ahmed, REARDON David A., CLOUGHESY Timothy, SUMRALL Ashley, BAEHRING Joachim, van den BENT Martin, BAHR Oliver, LOMBARDI Giuseppe, MULHOLLANDI Pau, TABATABAI Ghazaleh, LASSEN Ulrik, SEPULVEDA Juan Manuel, KHASRAW Mustafa, VAULEON Elodie, MURAGAKI Yoshihiro, DI GIACOMO Anna Maria, BUTOWSKI Nicholas, ROTH Patrick, QIAN Xiaozhong, FU Alex Z., LIU Yanfang, POTTER Von, CHALAMANDARIS Alexandros-Georgios, TATSUOKA Kay, LIM Michael, WELLER Michael
発行年月	2023/01/05
概要	BACKGROUND:Addition of temozolomide (TMZ) to radiotherapy (RT) improves overall survival (OS) in glioblastoma, but previous studies suggest that patients with tumors harboring an unmethylated MGMT promoter derive minimal benefit. The aim of this open-label, phase 3 CheckMate 498 study was to evaluate the efficacy of nivolumab (NIVO)+RT compared with TMZ+RT in newly diagnosed glioblastoma with unmethylated MGMT promoter.METHODS:Patients were randomized 1:1 to standard RT (60 Gy) + NIVO (240 mg every 2 weeks for 8 cycles, then 480 mg every 4 weeks) or RT+TMZ (75 mg/m 2 daily during RT and 150-200 mg/m 2/day 5/28 days during maintenance). The primary endpoint was OS.RESULTS:A total of 560 patients were randomized, 280 to each arm. Median OS was 13.4 months (95% CI, 12.6-14.3) with NIVO+RT and 14.9 months (95% CI, 13.3-16.1) with TMZ+RT (hazard ratio [HR], 1.31; 95% CI, 1.09-1.58; P=0.0037). Median progression-free survival was 6.0 months (95% CI, 5.7-6.2) with NIVO+RT and 6.2 months (95% CI, 5.9-6.7) with TMZ+RT (HR, 1.38; 95% CI, 1.15-1.65). Response rates were 7.8% (9/116) with NIVO+RT and 7.2% (8/111) with TMZ+RT; grade 3/4 treatment-related adverse event (TRAE) rates were 21.9% and 25.1%, and any-grade serious TRAE rates were 17.3% and 7.6%, respectively.CONCLUSIONS:The study did not meet the primary endpoint of improved OS; TMZ+RT demonstrated a longer median OS than NIVO+RT. No new safety signals were detected with NIVO in this study. The difference between the study treatment arms is consistent with the use of TMZ+RT as standard of care for glioblastoma.
DOI	10.1093/neuonc/noac099
PMID	35419607