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

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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.

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Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to privacy or ethical restrictions.

Abbreviations

AE:

Adverse events

AESI:

Adverse events of special interest

cCRT:

Concurrent chemoradiotherapy

CT:

Chemotherapy

EAP:

Expanded access program

IQR:

Interquartile range

LA-NSCLC:

Locally advanced non-small cell lung cancer

OS:

Overall survival

PD-L1:

Programmed cell death ligand-1

PFS:

Progression-free survival

Q1:

Quartile 1 (25%)

Q3:

Quartile 3 (75%)

sCRT:

Sequential chemoradiotherapy

SD:

Standard deviation

SOC:

Standard of care

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Acknowledgements

This work was sponsored and conducted through the Spanish Lung Cancer Group (GECP). The authors would like to thank all the patients and families involved in the S-REAL study as well as all participating researchers and teams. Without their help, this study would not have been possible. The authors would also like to thank Susana Cañón Sánchez, PhD (Medical Statistics Consulting S.L., Valencia, Spain) for providing scientific and medical writing support, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Author information

Authors and Affiliations

  1. Medical Oncology Department, IRYCIS, Hospital Universitario Ramón y Cajal, Carretera Colmenar ViejoKM 9100, 28034, Madrid, Spain

    Ana Gómez Rueda & Pilar Garrido

  2. Medical Oncology Department, Hospital del Mar, Barcelona, Spain

    Álvaro Taus

  3. Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain

    Rosa Álvarez Álvarez

  4. Medical Oncology Department, Hospital Virgen del Rocío, Seville, Spain

    Reyes Bernabé-Caro

  5. Medical Oncology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain

    Luis Chara

  6. Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Marta López-Brea

  7. Medical Oncology Department, Hospital Universitario Parc Taulí, Institut d’Investigació I Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain

    Laia Vilà

  8. OSI Bilbao Basurto, Bibao, Spain

    Maria Ángeles Sala González

  9. HM Sanchinarro, Madrid, Spain

    Anabel del Barrio Díaz Aldagalán

  10. Hospital General de Segovia, Segovia, Spain

    Beatriz Esteban Herrera

  11. Hospital Clínico Universitario de Valladolid, Valladolid, Spain

    Rafael López Castro

  12. Medical Oncology Service, Hospital Universitario de Toledo, Toledo, Spain

    Ruth Álvarez Cabellos

  13. Medical Oncology Department, Instituto Catalán de Oncología, Badalona, Spain

    Marta Doménech

  14. Hospital Germans Trias i Pujol, Barcelona, Spain

    Marta Doménech

  15. Hospital Universitario Infanta Sofía, Madrid, Spain

    Sandra Falagan

  16. Hospital Universitario Reina Sofía, Córdoba, Spain

    Alberto Moreno Vega

  17. Medical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain

    Carlos Aguado

  18. Medical Oncology Department, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain

    Andrés Barba

  19. Medical Oncology Department, Hospital Clínico San Cecilio, Granada, Spain

    Maria Teresa Delgado Ureña

  20. Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain

    Dolores Isla

  21. Medical Oncology Department, Hospital Universitario de Salamanca, Salamanca, Spain

    Lorena Bellido Hernández

  22. Complejo Hospitalario Universitario de Ourense, Ourense, Spain

    José Luis Fírvida Pérez

  23. Medical Oncology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain

    Óscar Juan-Vidal

  24. Medical Oncology Department, Hospital Universitario de Alicante-ISABIAL, Alicante, Spain

    Bartomeu Massutí

  25. Medical Oncology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain

    Xabier Mielgo-Rubio

  26. UGC de Oncología Médica, Hospital Universitario de Jaén, Jaén, Spain

    Ana Laura Ortega

  27. Medical Oncology Department Althaia, Xarxa Assistencial Universitària Manresa, Barcelona, Spain

    Silvia Catot

  28. Hospital Universitario Fundación Jiménez Díaz, IIS-FJD, Madrid, Spain

    Manuel Dómine

  29. Medical Oncology Department, Hospital Universitario de La Ribera, Valencia, Spain

    Corina Escoín-Pérez

  30. Medical Oncology Department, Hospital Universitario Son Llatzer, Mallorca, Spain

    Francisco García Navalón

  31. Medical Oncology Department, Clínica Universidad de Navarra, Pamplona, Spain

    Ignacio Gil-Bazo

  32. Fundación Instituto Valenciano de Oncología, Valencia, CIBERONC, Madrid, Spain

    Ignacio Gil-Bazo

  33. Medical Oncology Department, Hospital General de Granollers, Barcelona, Spain

    Silvia Muñoz

  34. Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

    Delvys Rodríguez-Abreu

  35. Medical Oncology Department, Hospital Costa del Sol, Málaga, Spain

    Rosa María Villatoro Roldán

  36. Medical Oncology Department, Complejo Hospitalario Universitario de A Coruña, Coruña, Spain

    Guillermo Alonso-Jáudenes Curbera

  37. Medical Oncology Department, Complexo Hospitalario Universitario de Santiago de Compostela (SERGAS), Instituto de Investigación Sanitaria (IDIS), Santiago de Compostela, Spain

    Luis León-Mateos

  38. Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain

    Airam Padilla

  39. Department of Medical Oncology, Hospital Universitario de Donostia, San Sebastián, Spain

    Alfredo Paredes Lario

  40. Department of Medical Oncology, Hospital Universitario la Princesa, Madrid, Spain

    José Miguel Sánchez-Torres

Authors
  1. Ana Gómez Rueda
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  2. Álvaro Taus
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  3. Rosa Álvarez Álvarez
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  4. Reyes Bernabé-Caro
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  8. Maria Ángeles Sala González
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  14. Sandra Falagan
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  39. Pilar Garrido
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Consortia

the Spanish Lung Cancer Group

Contributions

Study conception and design: PG. All authors participated in data collection, data review and interpretation. All authors reviewed and approved the final version of the manuscript.

Corresponding author

Correspondence to Pilar Garrido.

Ethics declarations

Conflict of interest

AGR has received speaker and consultant honoraria from AstraZeneca, Amgen and Takeda, and travel support from AstraZeneca, Takeda and MSD; AT has received personal fees and non-financial support from Pfizer, Roche, BMS, MSD, and AstraZeneca; RAA has received consultant and speaker honoraria from Boehringer, Novartis, Pharmamar and Roche, conference registration support from MSD Oncology, and has participated as PI coordinator in projects sponsored by Boehringer, Cebiotex, Janssen Oncology, Novartis, Rain Therapeutics and Roche; RBC has received speaker and/or consultant honoraria from Pfizer, Janssen, Sanofi, AstraZeneca, Bristol Myers, Roche, Takeda and Jannsen, and research funding from Roche; LV has received consultant honorarium from Boehringer Ingelheim, AstraZeneca and Sanofi and speaker honoraria from AstraZeneca, Sanofi, MSD, Pfizer and Roche. MASG has received speaker and lecturer honoraria from Takeda and Roche, and travel/meeting attendance support from Roche and PharmaMar; MD has received grants from Roche and travel/meeting attendance support from Lilly; SF has received speaker honorarium from Pfizer and Sanofi, and travel support from AstraZeneca and MSD; CA has received consultant honorarium from AstraZeneca, BMS, MSD and Novartis, research funding from MSD, Mirati and AstraZeneca, and travel support from Roche, Novartis, Takeda and Pierre Fabre; AB has received speaker and consultant honoraria from BMS, Roche, MSD, Sanofi and Takeda, and travel support from MSD, Roche and BMS; DI has received speaker/consultant honoraria from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Hoffmann-La Roche, Janssen, Lilly, Merck, MSD, Novartis, Pfizer, Sanofi and Takeda​, has participated in clinical trials sponsored by Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Hoffmann-La Roche, GSK, Janssen, Lilly, Merck, Mirati Therapeutics, MSD, Novartis, Pfizer and Sanofi, ​and has received research grants from AstraZeneca, BMS, Hoffmann-La Roche and GSK; LBH has received speaker honorarium from Roche, BMS and AstraZeneca, consultant honorarium from Boehringer and Sanofi, and meeting attendance support from MSD, Novartis, Sanofi and AstraZeneca; JLFP has received consultant and speaker honoraria from AstraZeneca; BM has received personal fees from Roche, BMS, MSD, Boehringer Ingelheim and Pfizer; XMR has received speaker and/or consultant honoraria from Novartis, Roche, Pfizer, Astra Zeneca and MSD, grants from BMS, travel/meeting attendance support from Roche, Lilly and MSD, and declares his membership of the boards of the Spanish Group for Transversal Oncology and Research in Orphan and Infrequent Tumors (GETTHI) and the Spanish Group for Cancer Immuno-Biotherapy (GETICA); MD has received consultant and/or speaker honoraria from AstraZeneca, Boehringer Ingelheim, Janssen Cilag, BMS MSD, Pfizer, Roche, Sanofi and Takeda; IGB has received consultant and/or speaker honoraria from MSD Oncology, Lilly, AstraZeneca and BMS/Celgene, Roche and Amgen, and travel support from MSD Oncology, Lilly and Daiichi Sankyo; DR-A has received consultant and speaker honoraria from Roche/Genentech, AstraZeneca, BMS, Boehringer Ingelheim, MSD, Merck Serono, Eli Lilly, Gilead, Sanofi, Regeneron, Incyte, Pfizer, Takeda and Novartis, and travel support from Roche, BMS, MSD, Sanofi, Regeneron and Novartis; GAJC has received speaker/consultant honoraria from AstraZeneca and Roche; LLM has received consultant/speaker honoraria from AstraZeneca; JMST has received speaker/consultant honoraria from AstraZeneca; PG has received consultant honorarium from Abbvie, Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi Sankyo, GlaxoSmithKline, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and Takeda, and direct funding from Medscape and Touch Medical. All other authors have no conflict of interest to declare.

Ethical approval (Research involving human participants and/or animals) and Informed consent

This study followed the Helsinki Declaration, Good Clinical Practices and the Spanish Organic Law 3/2018 of 5 December on the Protection of Personal Data and digital rights guarantee. The study was approved by the Ethics Committee of Hospital Puerta de Hierro de Majadahonda (Madrid). Written informed consent was obtained from all enrolled patients. Patient medical information obtained for this study was confidential and was only disclosed to the researchers and third parties involved, as detailed in the informed consent form signed by the patients. Confidentiality standards were maintained by assigning each patient a unique subject identification number.

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Gómez Rueda, A., Taus, Á., Álvarez Álvarez, R. et al. The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy. Clin Transl Oncol (2024). https://doi.org/10.1007/s12094-024-03404-9

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