Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study

Girard N, Bar J, Garrido P, Garassino MC, McDonald F, Mornex F, Filippi AR, Smit HJ, Peters S, Field JK, Christoph DC, Sibille A, Fietkau R, Haakensen VD, Chouaid C, Markman B, Hiltermann TJN, Taus A, Sawyer W, Allen A, Chander P, Licour M, Solomon B (2022)

Publication Type: Journal article

Publication year: 2022

Journal

DOI: 10.1016/j.jtho.2022.10.003

Abstract

Introduction: The phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III NSCLC and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program. Here, we report treatment characteristics and a preplanned analysis of real-world progression-free survival (rwPFS). Methods: PACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every 2 wk) within an early access program between September 2017 and December 2018. The primary end points are investigator-assessed rwPFS and overall survival (analyzed by Kaplan–Meier method). Results: As of November 30, 2020, the full analysis set comprised 1399 patients from 11 countries (median follow-up duration, 23.5 mo). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% confidence interval: 19.1–24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 versus 19.3 mo) and among patients with programmed cell death-ligand 1 expression greater than or equal to 1% versus less than 1% (22.4 versus 15.6 mo). Overall, 16.5% of the patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis or interstitial lung disease. Conclusions: Consolidation durvalumab after definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was longer among patients who received concurrent versus sequential CRT and patients with higher programmed cell death-ligand 1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors.

Authors with CRIS profile

Involved external institutions

Institut Curie France (FR) Chaim Sheba Medical Center at Tel HaShomer / המרכז הרפואי עש חיים שיבא – תל השומר‎‎ Israel (IL) Universidad de Alcalá (UAH) Spain (ES) University of Chicago United States (USA) (US) Royal Marsden Hospital / The Royal Marsden NHS Foundation Trust United Kingdom (GB) Hospices Civils de Lyon (CHU) France (FR) Policlinico San Matteo Pavia Fondazione IRCCS Italy (IT) Rijnstate Ziekenhuis Netherlands (NL) Lausanne University Hospital / Centre hospitalier universitaire vaudois (CHUV) Switzerland (CH) The University of Liverpool United Kingdom (GB) Kliniken Essen-Mitte Germany (DE) Centre Hospitalier Universitaire de Liège (CHU Liège) Belgium (BE) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet Norway (NO) Hôpital Intercommunal de Créteil (CHIC) France (FR) Cabrini Health Australia (AU) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen Netherlands (NL) Hospital del Mar Spain (ES) University of Cambridge United Kingdom (GB) Peter MacCallum Cancer Centre Australia (AU)

How to cite

APA:

Girard, N., Bar, J., Garrido, P., Garassino, M.C., McDonald, F., Mornex, F.,... Solomon, B. (2022). Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2022.10.003

MLA:

Girard, Nicolas, et al. "Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study." Journal of Thoracic Oncology (2022).

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