Hidekazu Tachibana1, Tsunenori Kondo2, Hiroki Ishihara3, Toshio Takagi3, Kazunari Tanabe3. 1. Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan. Electronic address: tachibana.hidekazu@twmu.ac.jp. 2. Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan. 3. Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Abstract
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.
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.
Authors: Łukasz Mielczarek; Anna Brodziak; Paweł Sobczuk; Maciej Kawecki; Agnieszka Cudnoch-Jędrzejewska; Anna M Czarnecka Journal: Cancer Chemother Pharmacol Date: 2021-03-25 Impact factor: 3.333