Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial
Por:
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
Publicada:
1 nov 2025
Ahead of Print:
1 sep 2025
Resumen:
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.
Filiaciones:
Isla, D:
Univ Hosp Lozano Blesa, Med Oncol, San Juan Bosco 15, Zaragoza 50009, Spain
Zugazagoitia, J:
Hosp Univ 12 Octubre, Med Oncol, Madrid, Spain
Arriola, E:
Hosp del Mar, Res Inst Barcelona, Dept Med Oncol, Barcelona, Spain
García-Campelo, R:
Univ Hosp A Coruna, Biomed Res Inst Coruna INIBIC, Med Oncol, La Coruna, Spain
Blanco, CM:
Hosp Univ St Joan de Reus, Med Oncol, Reus, Spain
Diz-Taín, MP:
Complejo Asistencial Univ Leon, Med Oncol, Leon, Spain
Lopez-Brea, M:
Hosp Univ Marques de Valdecilla, Med Oncol, IDIVAL, Santander, Spain
Moreno-Vega, AL:
Hosp Univ Reina Sofia, Med Oncol, Cordoba, Spain
León-Mateos, L:
Univ Santiago de Compostela, Univ Clin Hosp Santiago de Compostela SERGAS, Med Oncol, Santiago De Compostela, Spain
Oramás, J:
Hosp Univ Canarias, Med Oncol, Tenerife, Spain
Gutiérrez-Calderón, V:
Hosp Reg Univ Malaga, Med Oncol, Malaga, Spain
Majem, M:
Hosp Santa Creu & Sant Pau, Med Oncol, Barcelona, Spain
Sánchez-Hernández, A:
Consorcio Hosp Prov Castellon, Med Oncol, Castellon de La Plana, Spain
Aguado, C:
Hosp Clin San Carlos, Med Oncol, Madrid, Spain
Alvarez-Cabellos, R:
Hosp Univ Toledo, Med Oncol, Toledo, Spain
Massutí, B:
Alicante Univ Dr Balmis Hosp, Med Oncol, Alicante, Spain
Moreno, A:
Galdakao Usansolo Hosp, Med Oncol, Galdakao, Spain
Fírvida-Pérez, JL:
Complexo Hosp Univ Ourense, Med Oncol, Orense, Spain
Valdivia, J:
Hosp Univ Virgen de las Nieves, Med Oncol, IBIS, Granada, Spain
González-Cordero, M:
Hosp Univ Badajoz, Med Oncol, Badajoz, Spain
Zafra-Poves, M:
Morales Meseguer Hosp, Med Oncol, Murcia, Spain
Dómine, M:
Hosp Univ Fdn Jimenez Diaz, Oncol, Madrid, Spain
Garcia-Navalon, FJ:
Hosp Virgen de Los Lirios, Oncol, Alcoy, Spain
Villanueva, N:
Hosp Univ Cent Asturias, Med Oncol, Oviedo, Spain
Provencio, M:
Hosp Univ Puerta de Hierro Majadahonda, Med Oncol Serv, Majadahonda, Spain
Juan-Vidal, O:
Hosp Univ & Politecn La Fe, Med Oncol, Valencia, Spain
Rivas-Corredor, C:
Mataro Hosp, Catalan Inst Oncol ICO, Med Oncol, SOM Barcelones Nord & Maresme, Barcelona, Spain
García, MEO:
Hosp Univ Ramon Y Cajal, Med Oncol, Madrid, Spain
Palmero, R:
Catalan Inst Oncol, Med Oncol, Lhospitalet De Llobregat, Spain
López-Castro, R:
Hosp Clin Univ Valladolid, Med Oncol, Valladolid, Spain
Carcereny, E:
Catalan Inst Oncol Badalona, Med Oncol, Badalona, Spain
Lechuga, JL:
AstraZeneca Farmaceut Spain, OBU Med Dept, Madrid, Spain
Domínguez, M:
AstraZeneca Farmaceut Spain, OBU Med Dept, Madrid, Spain
Callejo, A:
AstraZeneca Farmaceut Spain, OBU Med Dept, Madrid, Spain
Paz-Ares, L:
Hosp Univ 12 Octubre, Med Oncol Serv, Madrid, Spain
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