RT Journal Article
T1 Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
A1 Spigel, David R
A1 Faivre-Finn, Corinne
A1 Gray, Jhanelle E
A1 Vicente, David
A1 Planchard, David
A1 Paz-Ares, Luis
A1 Vansteenkiste, Johan F
A1 Garassino, Marina C
A1 Hui, Rina
A1 Quantin, Xavier
A1 Rimner, Andreas
A1 Wu, Yi-Long
A1 Özgüroğlu, Mustafa
A1 Lee, Ki H
A1 Kato, Terufumi
A1 de Wit, Maike
A1 Kurata, Takayasu
A1 Reck, Martin
A1 Cho, Byoung C
A1 Senan, Suresh
A1 Naidoo, Jarushka
A1 Mann, Helen
A1 Newton, Michael
A1 Thiyagarajah, Piruntha
A1 Antonia, Scott J
AB 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  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. 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. 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.
YR 2022
FD 2022-02-02
LK http://hdl.handle.net/10668/20386
UL http://hdl.handle.net/10668/20386
LA en
DS RISalud
RD Apr 5, 2025