A Propensity-Matched Retrospective Comparative Study with Historical Control to Determine the Real-World Effectiveness of Durvalumab after Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer

SIMPLE SUMMARY: The PACIFIC trial demonstrated the survival benefits of durvalumab consolidation (DC) in patients with unresectable stage III non–small cell lung cancer (NSCLC). In this retrospective cohort study, using a propensity score-matched analysis, we investigated the effectiveness of DC after concurrent chemoradiotherapy (CCRT) and compared DC after CCRT with a historical control in this regard. DC was tolerable and consistently associated with survival benefits (compared with a lack of DC) in real-world contexts. This study suggested that the outcomes of the PACIFIC trial could be successfully translated into real practice and that DC after CCRT could be established as a new standard of care for stage III NSCLC. ABSTRACT: This study aimed to add real-world evidence to the literature regarding the effectiveness and safety of durvalumab consolidation (DC) after concurrent chemoradiotherapy (CCRT) in the treatment of unresectable stage III non-small cell lung cancer (NSCLC). Using a hospital-based NSCLC patient registry and propensity score matching in a 2:1 ratio, we conducted a retrospective cohort study of patients with unresectable stage III NSCLC who completed CCRT with and without DC. The co-primary endpoints were 2-year progression-free survival and overall survival. For the safety evaluation, we evaluated the risk of any adverse events requiring systemic antibiotics or steroids. Of 386 eligible patients, 222 patients—including 74 in the DC group—were included in the analysis after propensity score matching. Compared with CCRT alone, CCRT with DC was associated with increased progression-free survival (median: 13.3 vs. 7.6 months, hazard ratio[HR]: 0.63, 95% confidence interval[CI]: 0.42–0.96) and overall survival (HR: 0.47, 95% CI: 0.27–0.82) without an increased risk of adverse events requiring systemic antibiotics or steroids. While there were differences in patient characteristics between the present real-world study and the pivotal randomized controlled trial, we demonstrated significant survival benefits and tolerable safety with DC after the completion of CCRT.