The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.

Autor: Gómez Rueda A; Medical Oncology Department, IRYCIS, Hospital Universitario Ramón y Cajal, Carretera Colmenar ViejoKM 9100, 28034, Madrid, Spain., Taus Á; Medical Oncology Department, Hospital del Mar, Barcelona, Spain., Álvarez Álvarez R; Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain., Bernabé-Caro R; Medical Oncology Department, Hospital Virgen del Rocío, Seville, Spain., Chara L; Medical Oncology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain., López-Brea M; Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain., Vilà L; Medical Oncology Department, Hospital Universitario Parc Taulí, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain., Sala González MÁ; OSI Bilbao Basurto, Bibao, Spain., Del Barrio Díaz Aldagalán A; HM Sanchinarro, Madrid, Spain., Esteban Herrera B; Hospital General de Segovia, Segovia, Spain., López Castro R; Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Álvarez Cabellos R; Medical Oncology Service, Hospital Universitario de Toledo, Toledo, Spain., Doménech M; Medical Oncology Department, Instituto Catalán de Oncología, Badalona, Spain.; Hospital Germans Trias i Pujol, Barcelona, Spain., Falagan S; Hospital Universitario Infanta Sofía, Madrid, Spain., Moreno Vega A; Hospital Universitario Reina Sofía, Córdoba, Spain., Aguado C; Medical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain., Barba A; Medical Oncology Department, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain., Delgado Ureña MT; Medical Oncology Department, Hospital Clínico San Cecilio, Granada, Spain., Isla D; Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Bellido Hernández L; Medical Oncology Department, Hospital Universitario de Salamanca, Salamanca, Spain., Fírvida Pérez JL; Complejo Hospitalario Universitario de Ourense, Ourense, Spain., Juan-Vidal Ó; Medical Oncology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Massutí B; Medical Oncology Department, Hospital Universitario de Alicante-ISABIAL, Alicante, Spain., Mielgo-Rubio X; Medical Oncology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain., Ortega AL; UGC de Oncología Médica, Hospital Universitario de Jaén, Jaén, Spain., Catot S; Medical Oncology Department Althaia, Xarxa Assistencial Universitària Manresa, Barcelona, Spain., Dómine M; Hospital Universitario Fundación Jiménez Díaz, IIS-FJD, Madrid, Spain., Escoín-Pérez C; Medical Oncology Department, Hospital Universitario de La Ribera, Valencia, Spain., García Navalón F; Medical Oncology Department, Hospital Universitario Son Llatzer, Mallorca, Spain., Gil-Bazo I; Medical Oncology Department, Clínica Universidad de Navarra, Pamplona, Spain.; Fundación Instituto Valenciano de Oncología, Valencia, CIBERONC, Madrid, Spain., Muñoz S; Medical Oncology Department, Hospital General de Granollers, Barcelona, Spain., Rodríguez-Abreu D; Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain., Villatoro Roldán RM; Medical Oncology Department, Hospital Costa del Sol, Málaga, Spain., Alonso-Jáudenes Curbera G; Medical Oncology Department, Complejo Hospitalario Universitario de A Coruña, Coruña, Spain., León-Mateos L; Medical Oncology Department, Complexo Hospitalario Universitario de Santiago de Compostela (SERGAS), Instituto de Investigación Sanitaria (IDIS), Santiago de Compostela, Spain., Padilla A; Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain., Paredes Lario A; Department of Medical Oncology, Hospital Universitario de Donostia, San Sebastián, Spain., Sánchez-Torres JM; Department of Medical Oncology, Hospital Universitario la Princesa, Madrid, Spain., Garrido P; Medical Oncology Department, IRYCIS, Hospital Universitario Ramón y Cajal, Carretera Colmenar ViejoKM 9100, 28034, Madrid, Spain. pilargarridol@gmail.com.
Jazyk: angličtina
Zdroj: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2024 Jul; Vol. 26 (7), pp. 1779-1789. Date of Electronic Publication: 2024 Mar 21.
DOI: 10.1007/s12094-024-03404-9
Abstrakt: Objectives: The S-REAL study aimed to assess the effectiveness of durvalumab as consolidation therapy after definitive chemoradiotherapy (CRT) in a real-world cohort of patients with locally advanced, unresectable stage III non-small cell lung cancer (LA-NSCLC) included in a Spanish early access program (EAP).
Methods: In this multicentre, observational, retrospective study we analysed data from patients treated in 39 Spanish hospitals, who started intravenous durvalumab (10 mg/kg every 2 weeks) between September 2017 and December 2018. The primary endpoint was progression-free survival (PFS). Secondary endpoints included patient characterization and adverse events of special interest (AESI).
Results: A total of 244 patients were followed up for a median of 21.9 months [range 1.2-34.7]. Median duration of durvalumab was 45.5 weeks (11.4 months) [0-145]. Median PFS was 16.7 months (95% CI 12.2-25). No remarkable differences in PFS were observed between patients with programmed cell death-ligand 1 (PD-L1) expression ≥ 1% or < 1% (16.7 versus 15.6 months, respectively). However, PFS was higher in patients who had received prior concurrent CRT (cCRT) versus sequential CRT (sCRT) (20.6 versus 9.4 months). AESIs leading to durvalumab discontinuation were registered in 11.1% of patients.
Conclusions: These results are in line with prior published evidence and confirm the benefits of durvalumab in the treatment of LA-NSCLC patients in a real-world setting. We also observed a lower incidence of important treatment-associated toxicities, such as pneumonitis, compared with the pivotal phase III PACIFIC clinical study.
(© 2024. The Author(s), under exclusive licence to Federación de Sociedades Españolas de Oncología (FESEO).)
Databáze: MEDLINE
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