PACIFIC Stage IIIA-N2 Exploratory Analysis
Study Design:
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Patient Characteristics:
a Patients with all other stages (including stages IIIA-N0/N1 and IIIB).
b No sample collected or no valid test result.
c Based on the definitive platinum-based chemotherapy regimen only.
d Based on the last cycle of therapy before entering the study.
Results:
a Patients with all other stages (including stages IIIA-N0/N1 and IIIB). DCO = 13 February 2017 (DCO for the primary analysis of PFS): median follow-up of 14.5 months(range: 0.2-29.9 months).
a Patients with all other stages (including stages IIIA-N0/N1 and IIIB). DCO = 22 March 2018 (DCO for the primary analysis of OS): median follow-up of 25.2 months(range: 0.2-43.1 months).
Study Design:Among 713 unresectable, stage III NSCLC with no disease progression after ≥2 cycles of platinum-based,concurrent CRT patients wererandomized 2:1 to receive durvalumab or placebo 1-42 days after CRT. 287 (40%) had stage IIIA-N2 disease. The primary endpoints were PFS (assessed byblinded independent central review according to RECIST version 1.1) and OS. This post-hoc, exploratory analysis of these endpoints was conducted in subgroupscomprising patients with or without stage IIIA-N2 NSCLC; the subgroup without stage IIIA-N2 disease included patients with all other stages.
Reference: 1. Senan S. et al (2022), Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis fromthe PACIFIC trial,ESMO Open Vol.7:2 (2022).