Girard, Nicolas, Bar, Jair, Garrido, Pilar, Garassino, Marina C, McDonald, Fiona, Mornex, Francoise, Filippi, Andrea R, Smit, Hans JM, Peters, Solange, Field, John K ORCID: 0000-0003-3951-6365 et al (show 13 more authors)
(2023)
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, 18 (2).
pp. 181-193.
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Abstract
<h4>Introduction</h4>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).<h4>Methods</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>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.
Item Type: | Article |
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Uncontrolled Keywords: | Consolidation therapy, Immunotherapy, Locally advanced NSCLC, PD-L1 inhibition, Real-world data |
Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
Depositing User: | Symplectic Admin |
Date Deposited: | 29 Nov 2022 11:51 |
Last Modified: | 09 Mar 2023 00:40 |
DOI: | 10.1016/j.jtho.2022.10.003 |
Related URLs: | |
URI: | https://livrepository.liverpool.ac.uk/id/eprint/3166439 |