The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
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Gómez Rueda Ana, Taus Álvaro, Álvarez Álvarez Rosa, Bernabé-Caro Reyes, Chara Luis, López-Brea Marta, Vilà Laia, Sala González Maria Ángeles, Del Barrio Díaz Aldagalán Anabel, Esteban Herrera Beatriz, López Castro Rafael, Álvarez Cabellos Ruth, Doménech Marta, Falagan Sandra, Moreno Vega Alberto, Aguado Carlos, Barba Andrés, Delgado Ureña Maria Teresa, Isla Dolores, Bellido Hernández Lorena, Fírvida Pérez José Luis, Juan-Vidal Óscar, Massutí Bartomeu, Mielgo-Rubio Xabier, Ortega Ana Laura, Catot Silvia, Dómine Manuel, Escoín-Pérez Corina, García Navalón Francisco, Gil-Bazo Ignacio, Muñoz Silvia, Rodríguez-Abreu Delvys, Villatoro Roldán Rosa María, Alonso-Jáudenes Curbera Guillermo, León-Mateos Luis, Padilla Airam, Paredes Lario Alfredo, Sánchez-Torres José Miguel, Garrido Pilar, Spanish Lung Cancer Group
Аннотация
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.