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

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

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Isla D
  • Zugazagoitia J
  • Arriola E
  • García-Campelo R
  • Martí Blanco C
  • Diz-Taín MP
  • López-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
  • Rivas-Corredor C
  • Olmedo García ME
  • Palmero R
  • López-Castro R
  • Carcereny E
  • Lechuga JL
  • Domínguez M
  • Callejo Á
  • Paz-Ares L

Grupos

Abstract

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.

Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.

Datos de la publicación

ISSN/ISSNe:
0169-5002, 1872-8332

LUNG CANCER  ELSEVIER IRELAND LTD

Tipo:
Article
Páginas:
108763-108763
PubMed:
41033130
Factor de Impacto:
1,399 SCImago ℠
Cuartil:
Q1 SCImago ℠

Documentos

  • No hay documentos

Métricas

Filiaciones mostrar / ocultar

Keywords

  • Adverse events; Durvalumab; Extensive-stage small cell lung cancer; Immune-mediated adverse events; Real-world

Cita

Compartir