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.

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Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_D36FA0602240
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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
Journal of thoracic oncology
Author(s)
Girard N., Bar J., Garrido P., Garassino M.C., McDonald F., Mornex F., Filippi A.R., Smit HJM, Peters S., Field J.K., Christoph D.C., Sibille A., Fietkau R., Haakensen V.D., Chouaid C., Markman B., Hiltermann TJN, Taus A., Sawyer W., Allen A., Chander P., Licour M., Solomon B.
ISSN
1556-1380 (Electronic)
ISSN-L
1556-0864
Publication state
Published
Issued date
02/2023
Peer-reviewed
Oui
Volume
18
Number
2
Pages
181-193
Language
english
Notes
Publication types: Journal Article ; Observational Study
Publication Status: ppublish
Abstract
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).
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).
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.
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
Humans, Antineoplastic Agents, Immunological/therapeutic use, Carcinoma, Non-Small-Cell Lung/drug therapy, Chemoradiotherapy, Cohort Studies, Ligands, Lung Neoplasms/drug therapy, Progression-Free Survival, Retrospective Studies, Consolidation therapy, Immunotherapy, Locally advanced NSCLC, PD-L1 inhibition, Real-world data
Pubmed
Web of science
Open Access
Yes
Create date
08/11/2022 9:54
Last modification date
28/02/2023 7:14
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