RT Journal Article
T1 Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial.
A1 Faivre-Finn, Corinne
A1 Vicente, David
A1 Kurata, Takayasu
A1 Planchard, David
A1 Paz-Ares, Luis
A1 Vansteenkiste, Johan F
A1 Spigel, David R
A1 Garassino, Marina C
A1 Reck, Martin
A1 Senan, Suresh
A1 Naidoo, Jarushka
A1 Rimner, Andreas
A1 Wu, Yi-Long
A1 Gray, Jhanelle E
A1 Özgüroğlu, Mustafa
A1 Lee, Ki H
A1 Cho, Byoung C
A1 Kato, Terufumi
A1 de Wit, Maike
A1 Newton, Michael
A1 Wang, Lu
A1 Thiyagarajah, Piruntha
A1 Antonia, Scott J
K1 Durvalumab
K1 Locally advanced NSCLC
K1 Overall survival
K1 PACIFIC
K1 Progression-free survival
AB In the Phase 3, placebo-controlled PACIFIC trial of patients with unresectable, stage III NSCLC without disease progression after concurrent chemoradiotherapy, consolidative durvalumab was associated with significant improvements in the primary end points of overall survival (OS) (hazard ratio [HR] = 0.68; 95% confidence interval [CI]: 0.53-0.87; p = 0.00251; data cutoff, March 22, 2018) and progression-free survival (PFS) (blinded independent central review; Response Evaluation Criteria in Solid Tumors version 1.1) (HR = 0.52; 95% CI: 0.42-65; p  Patients with WHO performance status of 0 or 1 (and any tumor programmed death-ligand 1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg) or placebo, administered every 2 weeks (≤12 months), stratified by age, sex, and smoking history. OS and PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS and PFS rates were estimated by the Kaplan-Meier method. Overall, 709 of 713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of March 20, 2020 (median follow-up = 34.2 months; range: 0.2-64.9), updated OS (HR = 0.71; 95% CI: 0.57-0.88) and PFS (HR = 0.55; 95% CI: 0.44-0.67) remained consistent with the primary analyses. The median OS for durvalumab was reached (47.5 mo; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively. These updated exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab after chemoradiotherapy. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression-free (placebo, 19.5%).
YR 2021
FD 2021-01-19
LK http://hdl.handle.net/10668/17007
UL http://hdl.handle.net/10668/17007
LA en
DS RISalud
RD Apr 18, 2025