Updated 4-year survival analyses from PACIFIC
dc.contributor.author | De Wit, M. | |
dc.contributor.author | Faivre-Finn, Corinne | |
dc.contributor.author | Reck, M. | |
dc.date.accessioned | 2020-11-16T07:49:06Z | |
dc.date.available | 2020-11-16T07:49:06Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | De Wit M, Faivre-Finn C, Reck M. Updated 4-year survival analyses from PACIFIC. Oncology Research and Treatment. 2020;43(SUPPL 4):147- | en |
dc.identifier.uri | http://hdl.handle.net/10541/623369 | |
dc.description.abstract | Background: In the phase 3 PACIFIC trial, durvalumab versus placebo significantly improved progression-free survival (PFS; stratified HR 0.52, 95% CI 0.42-0.65; P< 0.001; median 16.8 vs 5.6 months; data cutoff [DCO], 13 Feb 2017) and overall survival (OS; stratified HR 0.68, 95% CI 0.53- 0.87; P=0.0025; median not reached vs 28.7 months; DCO, 22 Mar 2018). Durvalumab exhibited a manageable safety profile and had no detrimental effect on pt-reported outcomes. These results therefore established the PACIFIC regimen (durvalumab following concurrent chemoradiotherapy [cCRT]) as standard of care for pts with unresectable, Stage III NSCLC and no disease progression after prior cCRT. In addition, OS benefit with durvalumab was maintained at ~3 years after randomization (stratified HR 0.69, 95% CI 0.55-0.86; DCO, 31 Jan 2019) and was observed across most pt subgroups. We will report updated, exploratory subgroup analyses of 4-year survival (DCO, 20 Mar 2020) and the first update to PFS for the ITT population since the primary analysis of OS. Methods: Pts with WHO PS 0/1 (any tumour PD-L1 status) who received ?2 cycles of platinum-based cCRT were randomised (2:1), 1-42 days following cCRT, to receive durvalumab 10 mg/kg intravenously q2w or placebo, for up to 12 months, and stratified by age, sex, and smoking history. Primary endpoints were PFS (blinded independent central review; RECIST v1.1) and OS. For time-to-event endpoints, treatment effects within pt subgroups, defined by baseline characteristics and prior treatment, will be estimated by hazard ratios from unstratified Cox-proportional-hazards models, with medians and 95% CIs estimated by Kaplan-Meier method. Expected results: Using the latest DCO (20 Mar 2020), ~4 years after the last pt was randomized, exploratory analyses to characterize outcomes in subgroups, based on baseline pt and disease characteristics and prior treatment, will be presented. In addition, updated results for PFS and OS, including 48-month survival rates, will be presented for the ITT population. Expected Conclusions: The updated subgroup analyses from the PACIFIC trial will provide further insight into long-term survival benefit with durvalumab after cCRT, including the durability of PFS. | en |
dc.language.iso | en | en |
dc.title | Updated 4-year survival analyses from PACIFIC | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | Vivantes Klinikum Neukollln, Berlin, Germany | en |
dc.identifier.journal | Oncology Research and Treatment | en |
dc.description.note | en] |