Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial

Background Immunotherapy trials involving patients with extensive-stage small cell lung cancer (ES-SCLC) from real-world clinical practice are needed. We aimed to evaluate the safety and effectiveness of durvalumab plus platinum-etoposide as a first-line treatment in a real-world population of patie...

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Detalles Bibliográficos
Autores: Isla, D, Zugazagoitia, J, Arriola, E, García-Campelo, R, Blanco, CM, Diz-Taín, MP, Lopez-Brea, M, Moreno-Vega, AL, León-Mateos, L, Oramás, J, Gutiérrez-Calderón, V, Majem, M, Sánchez-Hernández, A, Aguado, C, Alvarez-Cabellos, R, Massutí, B, Moreno, A, Fírvida-Pérez, JL, Valdivia, J, González-Cordero, M, Zafra-Poves, M, Dómine, M, Garcia-Navalon, FJ, Villanueva, N, Provencio, M, Juan-Vidal, O, Rivas-Corredor, C, García, MEO, Palmero, R, López-Castro, R, Carcereny, E, Lechuga, JL, Domínguez, M, Callejo, A, Paz-Ares, L
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p19568
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/19568
Access Level:acceso abierto
Palabra clave:Durvalumab
Extensive-stage small cell lung cancer
Adverse events
Immune-mediated adverse events
Real-world
Descripción
Sumario:Background Immunotherapy trials involving patients with extensive-stage small cell lung cancer (ES-SCLC) from real-world clinical practice are needed. We aimed to evaluate the safety and effectiveness of durvalumab plus platinum-etoposide as a first-line treatment in a real-world population of patients with ES-SCLC. Patients and methods A prospective, single-arm study was conducted in adult patients who had histologically or cytologically confirmed ES-SCLC and a WHO/ECOG PS of 0-2 (a maximum of 30 % of patients with a PS of 2 were allowed). Patients received durvalumab plus platinum-etoposide for up to 6 cycles, followed by durvalumab every 4 weeks as a single agent. The primary outcomes included the incidence of grade >= 3 adverse events (AEs) and immune-mediated AEs (imAEs). Results Between December 2020 and April 2021, 101 patients were included in this trial. Grade 3 or higher AEs occurred in 77 patients (76.2 %) and were considered treatment-related in 58 patients (57.4 %). Thirty-eight patients (37.6 %) reported at least one imAE, all of which were considered treatment related. Among the 82 imAEs reported during the study, 68 (82.9 %) were grade 1-2. The median overall survival was 9.6 months (95 % CI, 7.8 to 11.3), and the 12-month and 24-month overall survival rates were 40.7 % (31.1 % to 50.3 %) and 25.4 % (95 % CI, 16.8 % to 34.0 %), respectively. Conclusions This phase 3B trial suggests that first-line treatment of patients with ES-SCLC with an initial regimen of up to six cycles of durvalumab plus platinum-etoposide followed by maintenance with durvalumab is feasible providing more options in daily clinical practice for the management of these patients depending on their characteristics. Trial registration: NCT04712903.

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