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Nationwide Real-Life Safety and Treatment Exposure Data on Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III, Locally Advanced, Non-small Cell Lung Cancer: Analysis of Patients Enrolled in the French Early Access Program

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Abstract

Purpose

Consolidation immunotherapy with the PD-L1 inhibitor durvalumab following concurrent chemoradiotherapy (cCRT) has shown a significant survival improvement and is now a standard of care in patients with unresectable stage III or non-operable non-small cell lung cancer (NSCLC).

Methods

In this early access program cohort, demographic, disease characteristics and safety data were collected for 576 patients from 188 centers, who received durvalumab 10 mg/kg intravenous infusion every 2 weeks, until disease progression or unacceptable toxicity or for a maximum of 12 months following cCRT. Durvalumab exposure data were available for 402 patients.

Results

Overall, 576 patients were included, 72.9% were men, median age 64.0 years, 52.3% had a stage IIIB disease. PD-L1 status captured in 445 (77%) patients was positive (48.1%), negative (32.6%), unknown (19.3%). At the end of cCRT, adverse events (AEs) all grade ≤ 2, were reported in 22.7% of patients, mainly esophagitis (6.3%). The main reasons of discontinuation were completion of the planned 12 months of consolidation treatment (42.1% patients), disease progression (28.6%) and adverse events (19.5%). Treatment completion was similar in PDL-1 positive and PDL-1 negative patients groups. 20.7% patients had a SAE drug reaction and 17.7% stopped treatment mainly due to SAE. ADR rate and early treatment discontinuation were higher in patients > 70 years old. Death due to AEs occurred in 7 patients, 2 had interstitial lung disease.

Conclusion

Safety data with durvalumab consolidation after cCRT in a large cohort of patients with stage III NSCLC are reported in this real-life cohort. Consistent data were reported both in the PD-L1 positive and PD-L1 negative NSCLC patients in daily practice.

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Data Availability

Data and Material available upon request.

Code Availability

Not applicable.

References

  1. Locher C, Debieuvre D, Coëtmeur D et al (2013) Major changes in lung cancer over the last ten years in France: The KBP-CPHG studies. Lung Cancer 81:32–38

    Article  Google Scholar 

  2. Detterbeck FC, Boffa DJ, Kim AW, et al. (2017) The eighth edition lung cancer stage classification. Chest. 151(1):193–203.

  3. Postmus PE, Kerr KM, Oudkerk M et al (2017) Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. https://doi.org/10.1093/annonc/mdx222

    Article  PubMed  Google Scholar 

  4. Ettinger DS, Aisner DL, Wood DE et al (2018) NCCN guidelines insights: non-small cell lung cancer, Version 5.2018. J Natl Compr Canc Netw 16(7):807–821

    Article  Google Scholar 

  5. Goldstraw P, Chansky K, Crowley J et al (2016) J Thorac Oncol 11(1):39–51

    Article  Google Scholar 

  6. Antonia SJ, Villegas A, Daniel D et al (2017) Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. N Engl J Med 377(20):1919–1929

    Article  CAS  Google Scholar 

  7. Antonia SJ, Villegas A, Daniel D et al (2018) Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med 379(24):2342–2350

    Article  CAS  Google Scholar 

  8. Hui R, Özgüroğlu M, Villegas A et al (2019) Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol 20(12):1670–1680

    Article  CAS  Google Scholar 

  9. Gray JE, Villegas A, Daniel D et al (2020) Three-year overall survival with durvalumab after chemoradiotherapy in stage III NSCLC-update from PACIFIC. J Thorac Oncol 15(2):288–293

    Article  CAS  Google Scholar 

  10. Paz-Ares L, Spira A, Raben D et al (2020) Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol 31(6):798–806

    Article  CAS  Google Scholar 

  11. Faivre-Finn C, Vicente D, Kurata T et al (2021) Four-year survival with durvalumab after chemoradiotherapy in stage III NSCLC-an update from the PACIFIC trial. J Thorac Oncol S1556–0864(21):00022–00028

    Google Scholar 

  12. ANSM. https://www.ansm.sante.fr/Activites/Autorisations-temporaires-d-utilisation-ATU/Qu-est-ce-qu-une-autorisation-temporaire-d-utilisation/(offset)/1.

  13. Spigel DR, Faivre-Finn C (2021) Gray JE Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial. ASCO 39:8511

    Google Scholar 

  14. SmPC Imfinzi®.

  15. Blonde L, Khunti K, Harris SB et al (2018) Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician. Adv Ther 35(11):1763–1774

    Article  Google Scholar 

  16. Maissenhaelter BE, Woolmore AL, Schlag PM (2018) Real-world evidence research based on big data: Motivation-challenges-success factors. Onkologe (Berl) 24(Suppl 2):91–98

    Article  Google Scholar 

  17. Desilets A, Blanc-Durand F, Lau S et al (2021) Durvalumab therapy following chemoradiation compared with a historical cohort treated with chemoradiation alone in patients with stage III non-small cell lung cancer: A real-world multicentre study. Eur J Cancer 142:83–91

    Article  CAS  Google Scholar 

  18. Taugner J, Käsmann L, Eze C et al (2021) Durvalumab after chemoradiotherapy for PD-L1 expressing inoperable stage III NSCLC leads to significant improvement of local-regional control and overall survival in the real-world setting. Cancers (Basel) 13(7):1613

    Article  CAS  Google Scholar 

  19. Faehling M, Schumann C, Christopoulos P et al (2020) Durvalumab after definitive chemoradiotherapy in locally advanced unresectable non-small cell lung cancer (NSCLC): Real-world data on survival and safety from the German expanded-access program (EAP). Lung Cancer 150:114–122

    Article  Google Scholar 

  20. EPAR (European public assessment report) Imfinzi®.

  21. Girard N, J.M. Smit H, Sibille A et al., et al. PACIFIC-R Real-World Study:

  22. Treatment Duration and Interim Analysis of Progression-Free Survival in Unresectable Stage III NSCLC Patients Treated with Durvalumab After Chemoradiotherapy. Presented at European Lung Cancer Congress 2021 – LBA 1171MO

  23. Brody R, Zhang Y, Ballas M et al (2017) PD-L1 expression in advanced NSCLC: Insights into risk stratification and treatment selection from a systematic literature review. Lung Cancer 112:200–215

    Article  Google Scholar 

Download references

Acknowledgements

The authors are grateful to the patients, their families, the physicians who participated in this study and the study project team. Medical writing support and editing was provided by Eltium under the direction of the authors and was funded by Astrazeneca.

Funding

AstraZeneca France.

Author information

Authors and Affiliations

  1. Centre Léon Bérard, Lyon, France

    Virginie Avrillon

  2. Institut Curie, Paris, France

    Catherine Daniel

  3. Institut du Cancer de Montpellier, Montpellier, France

    Pierre Boisselier

  4. Institut Gustave Roussy, Villejuif, France

    Cécile Le Péchoux

  5. Centre Hospitalier Intercommunal de Créteil, Créteil, France

    Christos Chouaid

Authors
  1. Virginie Avrillon
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  2. Catherine Daniel
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  3. Pierre Boisselier
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  4. Cécile Le Péchoux
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  5. Christos Chouaid
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Contributions

All authors whose names appear on the submission. made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work; drafted the work or revised it critically for important intellectual content; approved the version to be published; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Virginie Avrillon.

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Conflict of interest

Virginie Avrillon: Consultant/Honoraria’s: BMS, Pfizer, Roche; Catherine Daniel: Consultant/ Honoraria’s: Astrazeneca, BMS, Amgen; Pierre Boisselier: Consultant/ Honoraria’s: Astrazeneca, BMS, Merck, MSD; Cécile Le Péchoux: Consultant/Honoraria’s/Grants to institution: Astrazeneca, Roche, Nanobiotix, Eli-Lilly, Medscap, PriMEOncology Amgen; Christos Chouaid: Consultant/ Honoraria’s: BMS, MSD, BI, Roche, AZ, Amgen, Eli-Lilly, Sandoz, Janssen, MundiPhaema, GSK, Sanofi, Bayer, Novartis, Takeda, Pfizer, Research project funding: BMS, BI, Roche, AZ, Amgen, Novartis, Takeda.

Ethical Approval

This early access program cohort was requested by the French Health Authorities (ANSM) and was closely followed by them during the study conduct.

Consent to Participate

All patients have given their consent to participate in this early access program cohort and have received an information note on the collection of their data for this early access program and have given their consent.

Consent for Publication

All patients have received an information note on the publication of the aggregate results and have given their consent.

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Avrillon, V., Daniel, C., Boisselier, P. et al. Nationwide Real-Life Safety and Treatment Exposure Data on Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III, Locally Advanced, Non-small Cell Lung Cancer: Analysis of Patients Enrolled in the French Early Access Program. Lung 200, 95–105 (2022). https://doi.org/10.1007/s00408-022-00511-8

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  • DOI: https://doi.org/10.1007/s00408-022-00511-8

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