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dc.contributor.authorde Wit, M.
dc.contributor.authorGray, J. E.
dc.contributor.authorVillegas, A.
dc.contributor.authorDaniel, D.
dc.contributor.authorVicente, D.
dc.contributor.authorMurakami, S.
dc.contributor.authorHui, R.
dc.contributor.authorKurata, T.
dc.contributor.authorChiappori, A.
dc.contributor.authorLee, K. H.
dc.contributor.authorCho, B. C.
dc.contributor.authorPlanchard, D.
dc.contributor.authorPaz-Ares, L.
dc.contributor.authorFaivre-Finn, Corinne
dc.contributor.authorVansteenkiste, J. F.
dc.contributor.authorSpigel, D. R.
dc.contributor.authorWadsworth, C.
dc.contributor.authorTaboada, M.
dc.contributor.authorDennis, P. A.
dc.contributor.authorOzguroglu, M.
dc.contributor.authorAntonia, S. J.
dc.contributor.authorReck, M.
dc.date.accessioned2020-11-16T07:49:07Z
dc.date.available2020-11-16T07:49:07Z
dc.date.issued2019en
dc.identifier.citationDe Wit M, Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, et al. Three-year overall survival update from the PACIFIC trial. Oncology Research and Treatment. 2019;42:76-en
dc.identifier.urihttp://hdl.handle.net/10541/623370
dc.description.abstractBackground: In the PACIFIC study of patients with unresectable, St. III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.42-65; P< 0.0001) and overall survival (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251). Safety was similar and durvalumab had no detrimental effect on patient- reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients with WHO PS 0/1 who received ?2 cycles of platinum- based CRT were randomized (2:1), 1-42 days following CRT, to receive durvalumab 10 mg/kg i.v. every 2 weeks or placebo, up to 12 months, and stratified by age, sex, and smoking history. OS was analyzed using a stratified log-rank test in the ITT population. Medians and OS rates at 12, 24 and 36 months were estimated by Kaplan-Meier method. Results: In total, 713 patients were randomized of whom 709 received treatment (durvalumab, n=473; placebo, n=236). The last patient had completed the protocol-defined 12 months of study treatment in May 2017. As of Jan 31, 2019 (data cutoff), 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months (range, 0.2-51.3). Updated OS remained consistent with that previously reported (stratified HR 0.69, 95% CI, 0.55-0.86), with the median not reached (NR; 95% CI, 38.4 months-NR) with durvalumab versus 29.1 months (95% CI, 22.1-35.1) with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. After discontinuation, 43.3% and 57.8% in the durvalumab and placebo groups, respectively, received subsequent anticancer therapy (9.7% and 26.6% subsequently received immunotherapy). OS subgroup results will be presented. Conclusions: Updated OS data from PACIFIC, including 3-year survival rates (ITT & PD-L1 ?1% subgroup), underscore the long-term clinical benefit with durvalumab following CRT and further establish the PACIFIC regimen as the standard of care in this population.en
dc.language.isoenen
dc.titleThree-year overall survival update from the PACIFIC trialen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentVivantes Netzwerk Gesundheit GmbH, Berlin, Germanyen
dc.identifier.journalOncology Research and Treatmenten
dc.description.noteen]


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