The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.
Autores de IDIVAL
Autores ajenos al IDIVAL
- Gómez Rueda A
- Taus Á
- Álvarez Álvarez R
- Bernabé-Caro R
- Chara L
- Vilà L
- Sala González MÁ
- Del Barrio Díaz Aldagalán A
- Esteban Herrera B
- López Castro R
- Álvarez Cabellos R
- Doménech M
- Falagan S
- Moreno Vega A
- Aguado C
- Barba A
- Delgado Ureña MT
- Isla D
- Bellido Hernández L
- Fírvida Pérez JL
- Juan-Vidal Ó
- Massutí B
- Mielgo-Rubio X
- Ortega AL
- Catot S
- Dómine M
- Escoín-Pérez C
- García Navalón F
- Gil-Bazo I
- Muñoz S
- Rodríguez-Abreu D
- Villatoro Roldán RM
- Alonso-Jáudenes Curbera G
- León-Mateos L
- Padilla A
- Paredes Lario A
- Sánchez-Torres JM
- Garrido P
- Spanish Lung Cancer Group
Unidades
Abstract
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).
Datos de la publicación
- ISSN/ISSNe:
- 1699-048X, 1699-3055
- Tipo:
- Article
- Páginas:
- 1779-1789
- PubMed:
- 38512450
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico SPRINGER
Citas Recibidas en Web of Science: 7
Documentos
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Filiaciones
Keywords
- Chemoradiotherapy; Durvalumab; NSCLC; PD-L1; PFS; Real-world