Treatment Characteristics and Real-World Progression-Free Survival in Patients with Unresectable Stage III NSCLC who Received Durvalumab After Chemoradiotherapy: Findings from the PACIFIC-R Study
Menée à l'aide de données internationales portant sur 1 399 patients atteints d'un cancer du poumon non à petites cellules de stade III non résécable (durée médiane de suivi : 23,5 mois), cette étude analyse l'efficacité, du point de vue de la survie sans progression dans un contexte de vie réelle et de la survie globale, du durvalumab après une chimioradiothérapie définitive
Introduction: The Phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program (EAP). Here, we report treatment characteristics and a pre-planned analysis of real-world progression-free survival (rwPFS). Methods: PACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every-2-weeks) within an EAP between September-2017 and December-2018. The primary endpoints are investigator-assessed rwPFS and overall survival (analyzed by Kaplan-Meier method). Results: As of November 30, 2020, the full analysis set comprised 1,399 patients from 11 countries (median follow-up duration, 23.5 months). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% CI: 19.1–24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 vs. 19.3 months) and among patients with programmed cell death-ligand 1 (PD-L1) expression ≥1% versus <1% (22.4 vs. 15.6 months). Overall, 16.5% of patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis/interstitial lung disease. Conclusions: Consolidation durvalumab following definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was higher among patients who received concurrent versus sequential CRT and patients with higher PD-L1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors.