TY - JOUR
T1 - Five-Year Survival Outcomes From the PACIFIC Trial
T2 - Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
AU - Spigel, David R.
AU - Faivre-Finn, Corinne
AU - Gray, Jhanelle E.
AU - Vicente, David
AU - Planchard, David
AU - Paz-Ares, Luis
AU - Vansteenkiste, Johan F.
AU - Garassino, Marina C.
AU - Hui, Rina
AU - Quantin, Xavier
AU - Rimner, Andreas
AU - Wu, Yi Long
AU - Özgüroǧlu, Mustafa
AU - Lee, Ki H.
AU - Kato, Terufumi
AU - De Wit, Maike
AU - Kurata, Takayasu
AU - Reck, Martin
AU - Cho, Byoung C.
AU - Senan, Suresh
AU - Naidoo, Jarushka
AU - Mann, Helen
AU - Newton, Michael
AU - Thiyagarajah, Piruntha
AU - Antonia, Scott J.
N1 - Publisher Copyright:
© 2020 American Society of Clinical Oncology.
PY - 2022/4/20
Y1 - 2022/4/20
N2 - PURPOSEThe 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.METHODSPatients 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.RESULTSSeven 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.CONCLUSIONThese 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.
AB - PURPOSEThe 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.METHODSPatients 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.RESULTSSeven 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.CONCLUSIONThese 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.
UR - http://www.scopus.com/inward/record.url?scp=85125441729&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.01308
DO - 10.1200/JCO.21.01308
M3 - Article
C2 - 35108059
AN - SCOPUS:85125441729
SN - 0732-183X
VL - 40
SP - 1301
EP - 1311
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -