フクダ　ヒロノリ   Fukuda Hironori   福田　洋典    所属   医学部 医学科（東京女子医科大学病院）    職種   助教
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Prognostic impact of early treatment interruption of nivolumab plus ipilimumab due to immune-related adverse events as first-line therapy for metastatic renal cell carcinoma: A multi-institution retrospective study.
掲載誌名	正式名：Targeted oncology. ISSNコード：17762596/1776260X
掲載区分	国外
巻・号・頁	16(4),pp.493-502
著者・共著者	ISHIHARA Hiroki†, NEMOTO Yuki, NAKAMURA Kazutaka, IKEDA Takashi, TACHIBANA Hidekazu, FUKUDA Hironori, YOSHIDA Kazuhiko, KOBAYASHI Hirohito, IIZUKA Junpei, SHIMMURA Hiroaki, HASHIMOTO Yasunobu, TAKAGI Toshio, ISHIDA Hideki, KONDO Tsunenori, TANABE Kazunari
発行年月	2021/07
概要	BACKGROUND:It remains unclear how early treatment interruption of nivolumab plus ipilimumab due to immune-related adverse events affects the outcome of previously untreated metastatic renal cell carcinoma (mRCC).OBJECTIVE:To investigate the prognostic impact of the early interruption of nivolumab plus ipilimumab, used as first-line therapy for mRCC.PATIENTS AND METHODS:We retrospectively evaluated 59 intermediate- or poor-risk mRCC patients who received nivolumab plus ipilimumab as first-line therapy. Based on whether early treatment interruption was implemented within the initial four treatment cycles (i.e., 3 months) or not, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were compared. The prognostic association was further compared with that of 186 patients treated with tyrosine kinase inhibitors (TKIs) as first-line therapy.RESULTS:Twenty-three of the 59 patients (39%) experienced interruption of nivolumab plus ipilimumab therapy. The patients with interruption had longer PFS (p = 0.0055), similar OS (p = 0.366), and likely higher ORR (p = 0.0660) than those without interruption. Of the patients treated with TKIs, 60 of 186 (32%) experienced interruption, with shorter PFS (p = 0.0121), similar OS (p = 0.378), and similar ORR (p = 0.738) than those without interruption. In the 23 patients with nivolumab plus ipilimumab interruption, high-dose corticosteroids were administered in seven patients (30%). PFS (p = 0.638), OS (p = 0.968), or ORR (p = 0.760) did not differ based on corticosteroid administration.CONCLUSIONS:Early treatment interruption, which exerted a negative effect for TKIs, was a preferable event for nivolumab plus ipilimumab when considering PFS. Furthermore, early administration of high-dose corticosteroids did not diminish the anti-tumor effect of nivolumab plus ipilimumab.
DOI	10.1007/s11523-021-00825-2
PMID	34173936