KOBAYASHI Hirohito    Department   School of Medicine(Tokyo Women's Medical University Adachi Medical Center), School of Medicine    Position   Associate Professor
Article types	Original article
Language	English
Peer review	Peer reviewed
Title	Efficacy and safety of immune checkpoint inhibitors in elderly patients with metastatic renal cell carcinoma.
Journal	Formal name：International urology and nephrology Abbreviation：Int Urol Nephrol ISSN code：03011623/15732584
Domestic / Foregin	Foregin
Volume, Issue, Page	54(1),pp.47-54
Author and coauthor	NEMOTO Yuki†, ISHIHARA Hiroki*, NAKAMURA Kazutaka, TACHIBANA Hidekazu, FUKUDA Hironori, YOSHIDA Kazuhiko, KOBAYASHI Hirohito, IIZUKA Junpei, SHIMMURA Hiroaki, HASHIMOTO Yasunobu, TANABE Kazunari, KONDO Tsunenori, TAKAGI Toshio
Publication date	2022/01
Summary	PURPOSE:To clarify the efficacy and safety profile of immune checkpoint inhibitors (ICIs) for elderly patients with metastatic renal cell carcinoma (mRCC).METHODS:We retrospectively evaluated 149 mRCC patients treated with nivolumab monotherapy as subsequent therapy (n = 89) and nivolumab plus ipilimumab as first-line therapy (n = 60) at 5 affiliated institutions. The patients were divided according to age: > 70 (elderly) vs. ≤ 70 years (young). Efficacy was analyzed by comparing progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) between elderly and young patients. Safety was assessed by comparing the incidence rates of immune-related adverse events (irAEs).RESULTS:In the nivolumab monotherapy group, 34/89 patients (38%) were classified as elderly. There was no significant difference in PFS (p = 0.607), OS (p = 0.383), ORR (p = 0.0699), or DCR (p = 0.881) between elderly and young patients. In the nivolumab plus ipilimumab group, 20/60 patients (33%) were classified as elderly. There was no significant difference in PFS (p = 0.995), OS (p = 0.714), ORR (p = 0.763), or DCR (p = 1.000) between the two groups. The incidence rate of irAEs was not significantly different in the nivolumab (any grade: p = 0.121; grade ≥ 3: p = 0.542) or in the nivolumab plus ipilimumab (any grade: p = 0.666; grade ≥ 3: p = 0.576) group; a higher rate of gastrointestinal irAEs was observed in elderly than in young patients (any grade 15% vs. 3%).CONCLUSIONS:The efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab were comparable between elderly and young patients. Thus, chronological age alone should not be a contraindication in the use of ICIs for mRCC.
DOI	10.1007/s11255-021-03042-y
PMID	34704214