Resumen de The S‑REAL study: Spanish real‑world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy
Ana Gomez Rueda, Pilar Garrido López, Álvaro Taus-García, Rosa Álvarez Álvarez, Reyes Bernabé-Caro, Luis Enrique Chara Velarde, Marta López-Brea, Laia Vilà Martínez, Maria Ángeles Sala Gonzalez, Anabel del Barrio Díaz Aldagalán, Beatriz Esteban Herrera, R. Lopez Castro, Ruth Álvarez Cabellos, Marta Doménech Catalán, Sandra Falagán Martínez, A. L. Moreno Vega, Carlos Aguado de la Rosa, Andrés Barba, María Teresa Delgado Ureña, Dolores Isla Casado, Lorena Bellido, José Luis Fírvida Pérez, Óscar Juan Vidal, Bartomeu Massuti Sureda, Xabier Mielgo, Ana Laura Ortega Granados, Silvia Catot Tort, Manuel Dómine Gómez, Corina Escoin Pérez, Francisco García Navalón, Ignacio Gil-Bazo, Silvia Muñoz Hita, Delvys Rodríguez Abreu, Rosa María Villatoro Rodlán, Guillermo Alonso-Jaúdenes Curbera, Luis León Mateos, Airam Padilla Álvarez, Alfredo Paredes Lario, José Miguel Sánchez Torres
Objectives The S-REAL study aimed to assess the efectiveness of durvalumab as consolidation therapy after defnitive 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 diferences 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 confrm the benefts 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.
