Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting

Actas Urol Esp (Engl Ed). 2019 Sep;43(7):364-370. doi: 10.1016/j.acuro.2019.03.005. Epub 2019 May 13.
[Article in English, Spanish]

Abstract

Introduction and objectives: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain.

Material and methods: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected.

Results: The mean age of the 26 patients included was 63.7±11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%).

Conclusion: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies.

Keywords: Carcinoma de células renales metastásico; Checkpoint inhibitors; Immunotherapy; Inhibidores de puntos de control; Inmunoterapia; Metastatic renal cell carcinoma; Nivolumab; Safety; Seguridad; Tolerabilidad; Tolerability.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / secondary
  • Female
  • Humans
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / pathology
  • Male
  • Middle Aged
  • Nivolumab / adverse effects
  • Nivolumab / therapeutic use*
  • Retrospective Studies
  • Spain

Substances

  • Antineoplastic Agents, Immunological
  • Nivolumab