A multicenter retrospective study of nivolumab monotherapy in previously treated metastatic renal cell carcinoma patients: interim analysis of Japanese real-world data

Nobuyuki Hinata, Junji Yonese, Satoru Masui, Yasutomo Nakai, Suguru Shirotake, Katsunori Tatsugami, Teruo Inamoto, Masahiro Nozawa, Kosuke Ueda, Toru Etsunaga, Takahiro Osawa, Motohide Uemura, Go Kimura, Kazuyuki Numakura, Kazutoshi Yamana, Hideaki Miyake, Satoshi Fukasawa, Kenya Ochi, Hirokazu Kaneko, Hirotsugu Uemura

研究成果: Contribution to journalArticle査読

3 被引用数 (Scopus)

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Background: In a phase III clinical trial, CheckMate 025, treatment of metastatic renal cell carcinoma (mRCC) with nivolumab demonstrated superior efficacy over everolimus. However, as the clinical trial excluded patients with specific complications and poor performance status (PS), the effectiveness and safety of nivolumab in clinical practice, in which patients with various clinical complications are treated, is unclear. This study explored real-world nivolumab treatment in Japanese mRCC patients. Methods: This is an interim analysis of a multicenter, non-interventional, medical record review study (minimum follow-up: 9 months). All eligible Japanese mRCC patients who first received nivolumab between February and October 2017 were included; data cut-off was April 2019. We analyzed nivolumab treatment patterns, efficacy (including overall survival, progression-free survival, objective response rate, and duration of response) and safety (including immune-related adverse events). Results: Of 208 evaluable patients, 31.7% received nivolumab as fourth- or later line of treatment. At data cut-off, 26.9% of patients were continuing nivolumab treatment. The major reason for discontinuation was disease progression (n = 100, 65.8%). Median overall survival was not reached; the 12-month survival rate was 75.6%. Median progression-free survival was 7.1 months, the objective response rate was 22.6%, and median duration of response was 13.3 months. Patients who were excluded or limited in number in CheckMate 025, such as those with non-clear cell RCC or poor PS, also received benefits from nivolumab treatment. Immune-related adverse events occurred in 27.4% of patients (grade ≥ 3, 10.1%). Conclusion: Nivolumab was effective and well-tolerated in real-world Japanese mRCC patients. Trial registration: UMIN000033312

本文言語英語
ページ(範囲)1533-1542
ページ数10
ジャーナルInternational Journal of Clinical Oncology
25
8
DOI
出版ステータス出版済み - 8 1 2020

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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