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    Brief report: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial

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    Authors
    Faivre-Finn, Corinne
    Vicente, D.
    Kurata, T.
    Planchard, D.
    Paz-Ares, L.
    Vansteenkiste, J. F.
    Spigel, D. R.
    Garassino, M. C.
    Reck, M.
    Senan, S.
    Naidoo, J.
    Rimner, A.
    Wu, Y. L.
    Gray, J. E.
    Özgüroğlu, M.
    Lee, K. H.
    Cho, B. C.
    Kato, T.
    de Wit, M.
    Newton, M.
    Wang, L.
    Thiyagarajah, P.
    Antonia, S. J.
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    Affiliation
    The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Introduction: In the Phase 3, placebo-controlled PACIFIC trial of patients with unresectable, stage III NSCLC without disease progression after concurrent chemoradiotherapy, consolidative durvalumab was associated with significant improvements in the primary end points of overall survival (OS) (hazard ratio [HR] = 0.68; 95% confidence interval [CI]: 0.53-0.87; p = 0.00251; data cutoff, March 22, 2018) and progression-free survival (PFS) (blinded independent central review; Response Evaluation Criteria in Solid Tumors version 1.1) (HR = 0.52; 95% CI: 0.42-65; p < 0.0001; February 13, 2017) with manageable safety. Here, we report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized. Methods: Patients with WHO performance status of 0 or 1 (and any tumor programmed death-ligand 1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg) or placebo, administered every 2 weeks (≤12 months), stratified by age, sex, and smoking history. OS and PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS and PFS rates were estimated by the Kaplan-Meier method. Results: Overall, 709 of 713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of March 20, 2020 (median follow-up = 34.2 months; range: 0.2-64.9), updated OS (HR = 0.71; 95% CI: 0.57-0.88) and PFS (HR = 0.55; 95% CI: 0.44-0.67) remained consistent with the primary analyses. The median OS for durvalumab was reached (47.5 mo; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively. Conclusion: These updated exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab after chemoradiotherapy. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression-free (placebo, 19.5%).
    Citation
    Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, et al. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021.
    Journal
    Journal of Thoracic Oncology
    URI
    http://hdl.handle.net/10541/623779
    DOI
    10.1016/j.jtho.2020.12.015
    PubMed ID
    33476803
    Additional Links
    https://dx.doi.org/10.1016/j.jtho.2020.12.015
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.jtho.2020.12.015
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