Safety and efficacy of nivolumab therapy in patients with metastatic renal cell carcinoma and impaired kidney function.

Autor: Sengul N; Servicio de Oncología Médica, Facultad de Medicina Cerrahpasa, Universidad de Estambul-Cerrahpasa, Estambul, Turkey., Gültürk I; Departamento de Oncología Médica, Bakirkoy Hospital de Formación e Investigación Dr. Sadi Konuk, Estambul, Turkey. Electronic address: gulturkilkay@gmail.com., Yilmaz M; Departamento de Oncología Médica, Bakirkoy Hospital de Formación e Investigación Dr. Sadi Konuk, Estambul, Turkey., Celik E; Servicio de Oncología Médica, Facultad de Medicina Cerrahpasa, Universidad de Estambul-Cerrahpasa, Estambul, Turkey., Paksoy N; Servicio de Oncología Médica, Instituto de Oncología, Facultad de Medicina, Universidad de Estambul, Estambul, Turkey., Yekedüz E; Servicio de Oncología Médica, Facultad de Medicina, Universidad de Ankara, Ankara, Turkey., Ürün Y; Servicio de Oncología Médica, Facultad de Medicina, Universidad de Ankara, Ankara, Turkey., Basaran M; Servicio de Oncología Médica, Instituto de Oncología, Facultad de Medicina, Universidad de Estambul, Estambul, Turkey., Özgüroğlu M; Servicio de Oncología Médica, Facultad de Medicina Cerrahpasa, Universidad de Estambul-Cerrahpasa, Estambul, Turkey.
Jazyk: English; Spanish; Castilian
Zdroj: Actas urologicas espanolas [Actas Urol Esp (Engl Ed)] 2024 May; Vol. 48 (4), pp. 273-280. Date of Electronic Publication: 2024 Apr 01.
DOI: 10.1016/j.acuroe.2024.04.002
Abstrakt: Introduction: Patients with renal insufficiency, usually defined as those with creatinine clearance < 40 mL/min, were excluded from pivotal clinical trials, especially in studies involving nivolumab therapy in patients with renal cell carcinoma (RCC). The aim of the study is to evaluate the efficacy and safety of nivolumab in patients with metastatic RCC (mRCC) stratified according to creatinine clearance.
Material and Methods: Data from mRCC patients treated with nivolumab were retrospectively analyzed. Patients were classified into two categories according to their estimated glomerular filtration rate (eGFR); the first category (C1) included patients with eGFR < 40 mL/min/1.73 m 2 and the second category (C2) included those with eGFR ≥ 40 mL/min/1.73 m 2 .
Results: Of the 95 patients enrolled, 1. group included 26 patients (27.4%) and 2. group included 69 patients (72.6%). None of the pts in category 1 were on hemodialysis. Overall incidence of adverse events was not statistically different between the two groups (P = .469). The overall response rate ORR was 50% in the first group and 42.0% in the second group (P = .486). Median overall survival (OS) was longer with 23.3 months in the 2. group versus 11 months in the 1. group (P = .415).
Conclusion: Renal insufficiency is a common problem in patients with advanced renal cancer since they often undergo nephrectomy and their renal function may also worsen while receiving tyrosine kinase inhibitor therapy. We found that there is no significant difference in the safety and efficacy of nivolumab treatment between two groups. Nivolumab appears to be a safe and effective agent in patients with renal impairment.
(Copyright © 2024 AEU. Published by Elsevier España, S.L.U. All rights reserved.)
Databáze: MEDLINE