• Urologic oncology · Jun 2019

    Association between immune-related adverse events and prognosis in patients with metastatic renal cell carcinoma treated with nivolumab.

    • Hiroki Ishihara, Toshio Takagi, Tsunenori Kondo, Chie Homma, Hidekazu Tachibana, Hironori Fukuda, Kazuhiko Yoshida, Junpei Iizuka, Hirohito Kobayashi, Masayoshi Okumi, Hideki Ishida, and Kazunari Tanabe.
    • Department of Urology, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: i_hiroki_319@yahoo.co.jp.
    • Urol. Oncol. 2019 Jun 1; 37 (6): 355.e21-355.e29.

    ObjectivesImmune-related adverse events (irAEs) develop in a subset of patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors. The relationship between presence of irAEs and prognosis in these patients remains unknown. Thus, we evaluated the prognostic impact of irAEs caused by nivolumab therapy in mRCC patients who had received prior molecular-targeted therapies.MethodsWe retrospectively evaluated 47 patients with mRCC who were treated with nivolumab after receiving at least 1 molecular-targeted therapy. The irAEs assessed in this study included cutaneous, gastrointestinal, endocrine, pulmonary, hepatobiliary, renal, and other (rheumatic disease and pancreatitis) manifestations. The grade of irAEs was defined based on the Common Terminology Criteria for Adverse Events version 4.0.ResultsIn total, 23/47 patients (48.9%) experienced 29 irAEs. The most frequent irAE was rash/pruritus (12/23, 52.2%). The median progression-free survival (PFS) and overall survival after the initiation of nivolumab therapy were significantly longer in patients with irAEs than in those without irAEs (PFS: 13.1 vs. 4.87 months, P < 0.0001; overall survival: 26.0 vs. not reached, P = 0.0072). The multivariate analysis of PFS showed that irAE development was an independent prognostic factor (hazard ratio: 0.25, P = 0.0009). Additionally, the 2-cycle landmark analysis showed that PFS was significantly longer in patients with irAEs than in those without irAEs (median: not reached vs. 6.28 months, P = 0.0279).ConclusionsThis retrospective study revealed a significant association between nivolumab-associated irAEs and prognosis in previously treated mRCC. Further prospective studies are necessary to confirm our findings.Copyright © 2019 Elsevier Inc. All rights reserved.

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