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

  • Ana Gómez Rueda [1] ; Pilar Garrido [1] ; Álvaro Taus [2] ; Rosa Álvarez Álvarez [23] ; Reyes Bernabé Caro [24] ; Luis Chara [3] ; Marta López Brea [4] ; Laia Vilà [5] ; Maria Ángeles Sala González [25] ; Anabel del Barrio Díaz Aldagalán [6] ; Beatriz Esteban Herrera [7] ; Rafael López Castro [8] ; Ruth Álvarez Cabellos [26] ; Marta Doménech [27] ; Sandra Falagan [28] ; Alberto Moreno Vega [9] ; Carlos Aguado [10] ; Andrés Barba [11] ; Maria Teresa Delgado Ureña [29] ; Dolores Isla [12] ; Lorena Bellido Hernández [13] ; José Luis Fírvida Pérez [14] ; Óscar Juan Vidal [30] ; Bartomeu Massutí [31] ; Xabier Mielgo Rubio [15] ; Ana Laura Ortega [16] ; Silvia Catot [32] ; Manuel Dómine [17] ; Corina Escoín Pérez [33] ; Francisco García Navalón [34] ; Ignacio Gil Bazo [18] ; Silvia Muñoz [19] ; Delvys Rodríguez Abreu [20] ; Rosa María Villatoro Roldán [21] ; Guillermo Alonso Jáudenes Curbera [35] ; Luis León Mateos [36] ; Airam Padilla [37] ; Alfredo Paredes Lario [22] ; José Miguel Sánchez Torres [38]
    1. [1] Hospital Ramón y Cajal

      Hospital Ramón y Cajal

      Madrid, España

    2. [2] Hospital del Mar

      Hospital del Mar

      Barcelona, España

    3. [3] Hospital Universitario de Guadalajara

      Hospital Universitario de Guadalajara

      Guadalajara, España

    4. [4] Hospital Universitario Marqués de Valdecilla

      Hospital Universitario Marqués de Valdecilla

      Santander, España

    5. [5] Universitat Autònoma de Barcelona

      Universitat Autònoma de Barcelona

      Barcelona, España

    6. [6] Hospital Universitario HM Sanchinarro

      Hospital Universitario HM Sanchinarro

      Madrid, España

    7. [7] Complejo Asistencial de Segovia

      Complejo Asistencial de Segovia

      Segovia, España

    8. [8] Hospital Universitario de Valladolid

      Hospital Universitario de Valladolid

      Valladolid, España

    9. [9] Hospital Universitario Reina Sofia

      Hospital Universitario Reina Sofia

      Cordoba, España

    10. [10] Hospital Clínico San Carlos de Madrid

      Hospital Clínico San Carlos de Madrid

      Madrid, España

    11. [11] Hospital de la Santa Creu i Sant Pau

      Hospital de la Santa Creu i Sant Pau

      Barcelona, España

    12. [12] Hospital Clínico Universitario Lozano Blesa

      Hospital Clínico Universitario Lozano Blesa

      Zaragoza, España

    13. [13] Hospital Universitario de Salamanca

      Hospital Universitario de Salamanca

      Salamanca, España

    14. [14] Complexo Hospitalario Universitario de Ourense

      Complexo Hospitalario Universitario de Ourense

      Ourense, España

    15. [15] Fundación Hospital Alcorcón

      Fundación Hospital Alcorcón

      Alcorcón, España

    16. [16] Hospital Universitario de Jaén

      Hospital Universitario de Jaén

      Jaén, España

    17. [17] Fundación Jiménez Díaz

      Fundación Jiménez Díaz

      Madrid, España

    18. [18] Clínica Universitaria de Navarra

      Clínica Universitaria de Navarra

      Pamplona, España

    19. [19] Hospital General de Granollers

      Hospital General de Granollers

      Barcelona, España

    20. [20] Universidad de Las Palmas de Gran Canaria

      Universidad de Las Palmas de Gran Canaria

      Gran Canaria, España

    21. [21] Hospital Costa Del Sol

      Hospital Costa Del Sol

      Marbella, España

    22. [22] Hospital Universitario de Donostia

      Hospital Universitario de Donostia

      San Sebastián, España

    23. [23] Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain
    24. [24] Medical Oncology Department, Hospital Virgen del Rocío, Seville, Spain
    25. [25] OSI Bilbao Basurto, Bibao, Spain
    26. [26] Medical Oncology Service, Hospital Universitario de Toledo, Toledo, Spain
    27. [27] Medical Oncology Department, Instituto Catalán de Oncología, Badalona, Spain
    28. [28] Hospital Universitario Infanta Sofía, Madrid, Spain
    29. [29] Medical Oncology Department, Hospital Clínico San Cecilio, Granada, Spain
    30. [30] Medical Oncology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain
    31. [31] Medical Oncology Department, Hospital Universitario de Alicante-ISABIAL, Alicante, Spain
    32. [32] Medical Oncology Department Althaia, Xarxa Assistencial Universitària Manresa, Barcelona, Spain
    33. [33] Medical Oncology Department, Hospital Universitario de La Ribera, Valencia, Spain
    34. [34] Medical Oncology Department, Hospital Universitario Son Llatzer, Mallorca, Spain
    35. [35] Medical Oncology Department, Complejo Hospitalario Universitario de A Coruña, Coruña, Spain
    36. [36] Medical Oncology Department, Complexo Hospitalario Universitario de Santiago de Compostela (SERGAS), Instituto de Investigación Sanitaria (IDIS), Santiago de Compostela, Spain
    37. [37] Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain
    38. [38] Department of Medical Oncology, Hospital Universitario la Princesa, Madrid, Spain
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  • Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 26, Nº. 7, 2024, págs. 1779-1789
  • Idioma: inglés
  • Texto completo no disponible (Saber más ...)
  • Resumen

    • 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.

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