Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
AuthorsSpigel, D. R.
Gray, J. E.
Vansteenkiste, J. F.
Garassino, M. C.
Wu, Y. L.
Lee, K. H.
de Wit, M.
Cho, B. C.
Antonia, S. J.
AffiliationSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN. The University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. Hospital Universitario Virgen Macarena, Seville, Spain. Department of Medical Oncology, Thoracic Unit, Gustave Roussy, Villejuif, France. Universidad Complutense, CiberOnc, CNIO and Hospital Universitario 12 de Octubre, Madrid, Spain. University Hospitals KU Leuven, Leuven, Belgium. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Department of Hematology/Oncology, The University of Chicago, Chicago, IL. Westmead Hospital and the University of Sydney, Sydney, New South Wales, Australia. Montpellier Cancer Institute (ICM) and Montpellier Cancer Research Institute (IRCM), INSERM U1194, University of Montpellier, Montpellier, France. Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY. Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey. Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. Kanagawa Cancer Center, Yokohama, Japan. Vivantes Klinikum Neukölln, Berlin, Germany. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan. Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany. Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands. Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy at John Hopkins University, Baltimore, MD. AstraZeneca, Cambridge, United Kingdom. AstraZeneca, Gaithersburg, MD.
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AbstractPURPOSE The phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non–small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; P = .00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; P < .0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned. METHODS Patients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method. RESULTS Seven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months [all patients]; 61.6 months [censored patients]), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 v 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 v 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS. CONCLUSION These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.
CitationSpigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2022.
JournalJournal of Clinical Oncology
- Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial.
- Authors: Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Özgüroğlu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ
- Issue date: 2021 May
- Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC.
- Authors: Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Özgüroğlu M, Antonia SJ
- Issue date: 2020 Feb
- Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
- Authors: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M, PACIFIC Investigators.
- Issue date: 2018 Dec 13
- Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial.
- Authors: Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C
- Issue date: 2020 Jun
- Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
- Authors: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Özgüroğlu M, PACIFIC Investigators.
- Issue date: 2017 Nov 16