Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma and End-stage Renal Disease at 2 Centers

This retrospective study evaluated the safety and efficacy of nivolumab for metastatic renal cell carcinoma in 7 patients with end-stage renal disease (ESRD) and 55 patients without ESRD. No significant differences were observed in immune-related adverse events or the objective response rate. Thus, nivolumab may be useful in sequential therapy for patients with metastatic renal cell carcinoma and ESRD. Introduction: There is scarce information regarding nivolumab treatment for metastatic renal cell carcinoma (mRCC) in patients with end-stage renal disease (ESRD). This study investigated the safety and efficacy of nivolumab in patients with mRCC and ESRD. Materials and Methods: This 2-center retrospective study evaluated 62 patients who were administered nivolumab for mRCC between June 2013 and August 2018. The ESRD group (n = 7) and non-ESRD group (n = 55) were compared in terms of their immune-related adverse events (irAEs), objective response rate, progression-free survival, and overall survival. Results: All 7 patients with ESRD were male (median age, 67 years; range, 52-73 years), and their median duration of nivolumab use was 6.0 months (range, 1.8-8.2 months). One patient experienced a partial response, and 4 patients had stable disease. The objective response rate was lower in the ESRD group than in the non-ESRD group (16.7% vs. 37.5%; P = .25). Relative to the non-ESRD group, the ESRD group had slightly lower rates of all irAEs (42.9% vs. 58.7%) and grade 3 or higher irAEs (14.3% vs. 21.7%). The irAEs in the ESRD group were skin rash (grade 1), diarrhea (grade 1), and severe fatigue (grade 3) after the first nivolumab infusion, which required treatment discontinuation. The Kapan-Meier curves revealed no significant differences between the ESRD and non-ESRD groups in terms of progression-free (P = .63) and overall survival (P = .62). Conclusion: It may be possible to safely and effectively use nivolumab for select patients with mRCC and ESRD. (C) 2019 Elsevier Inc. All rights reserved.