論文

査読有り 国際誌
2017年7月1日

Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study.

Japanese journal of clinical oncology
  • Yoshihiko Tomita
  • ,
  • Satoshi Fukasawa
  • ,
  • Nobuo Shinohara
  • ,
  • Hiroshi Kitamura
  • ,
  • Mototsugu Oya
  • ,
  • Masatoshi Eto
  • ,
  • Kazunari Tanabe
  • ,
  • Go Kimura
  • ,
  • Junji Yonese
  • ,
  • Masahiro Yao
  • ,
  • Robert J Motzer
  • ,
  • Hirotsugu Uemura
  • ,
  • M Brent McHenry
  • ,
  • Elmer Berghorn
  • ,
  • Seiichiro Ozono

47
7
開始ページ
639
終了ページ
646
記述言語
英語
掲載種別
DOI
10.1093/jjco/hyx049

Background: Nivolumab improved overall survival (OS) and objective response rate (ORR) versus everolimus in previously treated patients with advanced renal cell carcinoma in the phase III CheckMate 025 study (minimum follow-up: 14 months). We report efficacy and safety in the global and Japanese populations (minimum follow-up: 26 months). Methods: Patients were randomized 1:1 to receive nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10-mg tablet orally once daily. Primary endpoint: OS, key secondary endpoints: ORR, progression-free survival and safety. Results: Of 410 (nivolumab) and 411 (everolimus) patients, 37 (9%) and 26 (6%), respectively, were Japanese. Median OS for the global population was 26.0 months (nivolumab) and 19.7 months (everolimus; hazard ratio 0.73 [95% confidence interval [CI]: 0.61-0.88]; P = 0.0006), with medians not reached for Japanese patients. ORR for the global population was 26% (nivolumab) versus 5% (everolimus; odds ratio 6.13; 95% CI: 3.77-9.95); ORR for Japanese patients: 43% versus 8% (odds ratio 9.14; 95% CI: 1.76-88.33). In Japanese patients, any-grade treatment-related adverse events (AEs) occurred in 78% (Grade 3-4, 19%; most common, anemia [5%]) treated with nivolumab and 100% (Grade 3-4, 58%; most common, hypertriglyceridemia [12%]) treated with everolimus; the most common with nivolumab was diarrhea (19%) and with everolimus was stomatitis (77%). Quality of life was stable in the nivolumab arm. Conclusions: With >2 years of follow-up, Japanese patients had a higher response rate with nivolumab versus everolimus that was more pronounced yet consistent with the global population, with median OS not reached, and a favorable safety profile.

リンク情報
DOI
https://doi.org/10.1093/jjco/hyx049
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/28419248
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5896687

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