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Observational Study
. 2023 Feb;18(2):181-193.
doi: 10.1016/j.jtho.2022.10.003. Epub 2022 Oct 25.

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

Nicolas Girard  1 , Jair Bar  2 , Pilar Garrido  3 , Marina C Garassino  4 , Fiona McDonald  5 , Françoise Mornex  6 , Andrea R Filippi  7 , Hans J M Smit  8 , Solange Peters  9 , John K Field  10 , Daniel C Christoph  11 , Anne Sibille  12 , Rainer Fietkau  13 , Vilde D Haakensen  14 , Christos Chouaid  15 , Ben Markman  16 , T Jeroen N Hiltermann  17 , Alvaro Taus  18 , William Sawyer  19 , Allison Allen  20 , Pratibha Chander  20 , Muriel Licour  21 , Benjamin Solomon  22
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Free article
Observational Study

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

Nicolas Girard et al. J Thorac Oncol. 2023 Feb.
Free article

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.

Keywords: Consolidation therapy; Immunotherapy; Locally advanced NSCLC; PD-L1 inhibition; Real-world data.

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