Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real / Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting

Introducción y objetivo: Nivolumab es un agente inmunoterapéutico aprobado para el tratamiento de pacientes con carcinoma de células renales (CCR) avanzado tratados previamente. La experiencia en práctica clínica real, especialmente en lo referente a la aparición de reacciones adversas inmunorrelacionadas, es escasa. Presentamos la experiencia acerca de la seguridad de nivolumab en pacientes con CCR metastásico (CCRm) tratados en 9 hospitales de España. Material y métodos: Estudio retrospectivo, multicéntrico en pacientes con CCRm tratados con nivolumab entre 2016 y 2018. Se recogieron datos sociodemográficos y clínicos basales y las reacciones adversas relacionadas con el fármaco. Resultados: Los 26 pacientes incluidos presentaron una edad de 63,7 ± 11,5 años. El 96% presentaba ECOG 0-1 y el 78% un riesgo MKSCC favorable/intermedio. El 73% presentaba subtipo histológico de células claras y el 30%, metástasis de inicio. La mediana de seguimiento fue de 9 meses (rango: 1-14). El 100% de los pacientes presentó una reacción adversa de cualquier grado; las más frecuentes fueron la fatiga, la fiebre y la anemia (27%). El 23% presentó una reacción adversa de grado 3. Las reacciones adversas llevaron a la suspensión del tratamiento en 3 pacientes (11%). Conclusión: En la práctica clínica real, nivolumab presenta un perfil de seguridad favorable y manejable, similar al descrito en otros estudios

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

Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. / Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real.

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.