Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial
Year: 2025
Type: article
Study design: Clinical Trial
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.
Source: Lung Cancer
Authors: Dolores Isla, Jon Zugazagoitia, Edurne Arriola, Rosario García-Campelo, Cristina Martí Blanco, María Pilar Diz-Taín, Marta López-Brea, Alberto Luis Moreno-Vega, Luis León-Mateos, Juana Oramás, Vanesa Gutiérrez-Calderón, Margarita Majem, Alfredo Sánchez-Hernández, Carlos Aguado, Ruth Alvarez-Cabellos, Bartomeu Massutí, Amaia Moreno, José-Luis Fírvida-Pérez, Javier Valdivia, Marta González-Cordero, Marta Zafra-Poves, Manuel Dómine, Francisco Javier Garcia-Navalon, Noemí Villanueva, Mariano Provencio, Oscar Juan-Vidal, Carlos Rivas-Corredor, María Eugenia Olmedo García, Ramón Palmero, Rafael López-Castro, Enric Carcereny, José Luis Lechuga, Marta Domínguez, Ángel Callejo, Luis Paz-Ares
Institutions: Hospital Clínico Universitario Lozano Blesa, Hospital Universitario 12 De Octubre, Hospital Del Mar, Hospital del Mar Research Institute, Instituto de Investigación Biomédica de A Coruña, Hospital Universitari Sant Joan de Reus, Complejo Asistencial Universitario de León, Marqués de Valdecilla University Hospital, Instituto de Investigación Marqués de Valdecilla, Hospital Universitario Reina Sofía, Universidade de Santiago de Compostela, Servicio Gallego de Salud, Hospital Universitario de Canarias, Hospital Regional Universitario de Málaga, Hospital de Sant Pau, Consorcio Hospitalario Provincial de Castellón, Hospital Clínico San Carlos, Hospital Universitario de Toledo, Hospital General Universitario de Alicante Doctor Balmis, Hospital de Galdakao, Complejo Hospitalario de Ourense, Hospital Universitario Virgen de las Nieves, Hospital General Universitario Morales Meseguer, Hospital Universitario Fundación Jiménez Díaz, Hospital Virgen de los Lirios, Hospital Universitario Central de Asturias, Hospital Universitario Puerta de Hierro Majadahonda, Hospital Universitari i Politècnic La Fe, Institut Català d'Oncologia, Hospital de Mataró, Hospital Universitario Ramón y Cajal, Hospital Clínico Universitario de Valladolid, AstraZeneca (Spain)
Language: English
Topic: Lung Cancer Research Studies
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,390
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, International Association for the Study of Lung Cancer, American Society of Clinical Oncology, F. Hoffmann-La Roche, Helsinn, Regeneron Pharmaceuticals, Les Laboratories Pierre Fabre, BeiGene, AstraZeneca España, European Commission, Ministerio de Ciencia e Innovación, Astellas Pharma, Sociedad Española de Oncología Médica, PharmaMar, Sun Pharma, Helsinn Therapeutics, Instituto de Salud Carlos III, Daiichi Sankyo Europe
OpenAlex ID: W4414522477