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, HJM; 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

Author(s): Girard, N; Bar, J; Garrido, P; Garassino, MC; McDonald, F; Mornex, F; Filippi, AR; Smit, HJM; 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;
Details: Publication Year 2023-02,Volume 18,Issue #2,Page 181-193
Journal Title: Journal of Thoracic Oncology
Publication Type: Research 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.
Publisher: Elsevier
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
Department(s): Medical Oncology
PubMed ID: 36307040
Publisher's Version: https://doi.org/10.1016/j.jtho.2022.10.003
Open Access at Publisher's Site: https://doi.org/10.1016/j.jtho.2022.10.003
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-05-30 07:27:42

Last Modified: 2023-05-30 07:28:52