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Efficacy and safety of first‐line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study
Author(s) -
Tanaka Toshikazu,
Hatakeyama Shingo,
Numakura Kazuyuki,
Kido Koichi,
Noro Daisuke,
Oikawa Masaaki,
Hosogoe Shogo,
Tokui Noriko,
Yamamoto Hayato,
Narita Shintaro,
Ito Hiroyuki,
Yoneyama Takahiro,
Hashimoto Yasuhiro,
Kawaguchi Toshiaki,
Habuchi Tomonori,
Ohyama Chikara
Publication year - 2020
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/iju.14363
Subject(s) - medicine , nivolumab , ipilimumab , renal cell carcinoma , adverse effect , oncology , incidence (geometry) , cancer , immunotherapy , physics , optics
Objectives To investigate the efficacy and safety of first‐line nivolumab plus ipilimumab for patients treated with metastatic renal cell carcinoma. Methods We retrospectively evaluated 52 metastatic renal cell carcinoma patients who were treated with nivolumab plus ipilimumab between August 2015 and January 2020. Data on patient characteristics, treatment parameters and adverse events were obtained. Oncological outcomes were assessed according to the International Metastatic Renal Cell Carcinoma Database Consortium prognostic model. Furthermore, differences in treatment parameters between patients with objective response (responders) and non‐responders were compared. Results The median age and follow‐up periods were 69 years and 8.2 months, respectively. The 1‐year progression‐free survival and overall survival rates were 55% and 75%, respectively. The objective response rate was 39%, and it was significantly different between the International Metastatic Renal Cell Carcinoma Database Consortium intermediate‐ and poor‐risk groups (52% vs 24%). We observed 36 (69%) any immune‐related adverse events, and 19 (37%) severe immune‐related adverse events (grades III–V). The International Metastatic Renal Cell Carcinoma Database Consortium poor‐risk group and higher value of initial C‐reactive protein (≥1.0 mg/dL) were significantly associated with non‐responders. Patients with two factors (the International Metastatic Renal Cell Carcinoma Database Consortium poor‐risk group plus C‐reactive protein ≥1.0 mg/dL) had a significantly poor overall survival than those with none or a single factor. Conclusions In our experience, treatment response to nivolumab plus ipilimumab is comparable with that of the CheckMate 214 clinical trial, but the incidence of treatment‐related adverse events is lower. The International Metastatic Renal Cell Carcinoma Database Consortium poor‐risk group and initial C‐reactive protein value might have a prognostic value for poor survival.