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Inicio Actas Urológicas Españolas (English Edition) Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life exp...
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Vol. 43. Issue 7.
Pages 364-370 (September 2019)
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Vol. 43. Issue 7.
Pages 364-370 (September 2019)
Original article
DOI: 10.1016/j.acuroe.2019.03.010
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
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J. Amores Bermúdeza,
Corresponding author
Fjavier.amoresber@gmail.com

Corresponding author.
, I. Osman Garcíab, M. Unda Urzáizc, P. Jiménez Marrerod, M.J. Ledo Ceperoe, R. Llarenaf, J. Flores Martíng, J.I. Abad Vivas-Pérezh, M. Rodrigo Aliagai, A. Juarez Sotoa
a Servicio de Urología, Hospital Universitario de Jerez, Jerez, Spain
b Servicio de Urología, Hospital Virgen del Rocío, Sevilla, Spain
c Servicio de Urología, Hospital Universitario Basurto, Bilbao, Spain
d Servicio de Urología, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
e Servicio de Urología, Hospital Universitario Puerta del Mar, Cádiz, Spain
f Servicio de Urología, Hospital de Cruces, Baracaldo, Spain
g Servicio de Urología, Complejo Hospitalario de Jaén, Jaén, Spain
h Servicio de Urología, Hospital de Poniente, El Ejido (Almería), Spain
i Servicio de Urología, Hospital General Universitario de Castellón, Castellón, Spain
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Tables (3)
Table 1. Sociodemographic and clinical characteristics of patients.
Table 2. Frequency of adverse reactions related to the drug during follow-up (median: 9 months).
Table 3. Characteristics of patients with grade 3 adverse reactions.
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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, multicenter 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 favorable 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 anemia 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 favorable outcomes, similar to those reported by other studies.

Keywords:
Metastatic renal cell carcinoma
Nivolumab
Checkpoint inhibitors
Immunotherapy
Safety
Tolerability
Resumen
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.

Palabras clave:
Carcinoma de células renales metastásico
Nivolumab
Inhibidores de puntos de control
Inmunoterapia
Seguridad
Tolerabilidad

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