Durvalumab after sequential chemoradiotherapy in unresectable stage III non-small-cell lung cancer - final analysis from the phase II PACIFIC-6 trial
Background - Durvalumab after concurrent chemoradiotherapy (cCRT) is the standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). However, patients often receive sequential chemoradiotherapy (sCRT) due to factors including advanced age or frailty, comorbidities,...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
June 2025
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| In: |
ESMO open
Year: 2025, Jahrgang: 10, Heft: 6, Pages: 1-9 |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2025.105071 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.esmoop.2025.105071 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2059702925009408 
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| Verfasserangaben: | M.C. Garassino, J. Khalifa, M. Reck, C. Chouaid, H. Bischoff, N. Reinmuth, L. Cove-Smith, T. Mansy, D.L. Cortinovis, M.R. Migliorino, A. Delmonte, J. Garcia Sánchez, L.E. Chara Velarde, R. Bernabe, L. Paz-Ares, P. Chander, I. Diaz Perez, K. Foroutanpour, U. Emeribe & C. Faivre-Finn |
| Zusammenfassung: | Background - Durvalumab after concurrent chemoradiotherapy (cCRT) is the standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). However, patients often receive sequential chemoradiotherapy (sCRT) due to factors including advanced age or frailty, comorbidities, or disease- or access-related concerns. The phase II PACIFIC-6 trial (NCT03693300) evaluated the safety of durvalumab after sCRT in this setting. Interim results indicated a similar safety profile to that observed with durvalumab after cCRT, with encouraging preliminary efficacy. We report outcomes from the final analysis. - Patients and methods - Adults with unresectable, stage III NSCLC, Eastern Cooperative Oncology Group performance status ≤2, and no disease progression following platinum-based sCRT were enrolled to receive durvalumab 1500 mg intravenously once every 4 weeks for up to 24 months. The primary endpoint was the incidence of grade 3/4 adverse events (AEs) possibly related to treatment (PRAEs) occurring within 6 months. Secondary endpoints included overall survival (OS) and progression-free survival (PFS; investigator assessed as per RECIST v1.1). - Results - As of 20 March 2023, 117 patients (65.8% aged ≥65 years; 98.3% with past or present comorbidities) were enrolled. Overall, 27.4% of patients had grade 3/4 AEs and 6.0% had grade 3/4 PRAEs, including two patients (1.7%) with pneumonitis. Three patients (2.6%) had fatal AEs, with one (0.9%) having a fatal PRAE (pneumonitis). Overall, 27.4% discontinued durvalumab due to AEs. Median follow-up was 32.6 and 30.2 months among patients censored for OS and PFS, respectively. Median OS was 39.0 months [95% confidence interval (CI) 30.6 months-not calculable]; 3-year OS rate was 56.5% (95% CI 46.4% to 65.5%). Median PFS was 13.1 months (95% CI 7.4-19.9 months); 2-year PFS rate was 35.3% (95% CI 26.5% to 44.3%). - Conclusions - Durvalumab after sCRT was well tolerated and could be an alternative treatment strategy when cCRT is not feasible. Confirmatory randomized phase III data are awaited. |
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| Beschreibung: | Online verfügbar: 27. Mai 2025 Gesehen am 24.09.2025 |
| Beschreibung: | Online Resource |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2025.105071 |