Patient-Reported Outcomes With Consolidation Durvalumab Versus Placebo After Concurrent Chemoradiotherapy in Limited-Stage SCLC: Results From the Phase 3 ADRIATIC Trial

INTRODUCTION: In the first interim analysis of the phase 3 ADRIATIC trial, consolidation durvalumab significantly improved overall survival and progression-free survival (primary end points) versus placebo in patients with limited-stage SCLC without disease progression after concurrent chemoradiotherapy. We report the patient-reported outcomes. METHODS: Patients received durvalumab, durvalumab-tremelimumab, or placebo every 4 weeks for up to 24 months. Patient-reported global health status/quality of life (QoL), functioning, and symptoms, assessed using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30-item and QoL Questionnaire-Lung Cancer 13-item (secondary end points), are reported for durvalumab and placebo only; the durvalumab-tremelimumab arm remained blinded at this analysis. Change from baseline (for prespecified key scales), time to deterioration (TTD), and improvement rates (all scales) were evaluated. A score change of more than or equal to 10 from baseline was considered a clinically meaningful deterioration or improvement. Analyses were not alpha controlled. RESULTS: In both arms (durvalumab, n = 264; placebo, n = 266), mean score changes in prespecified key scales from baseline up to 24 months were small and not clinically meaningful. There were no between-arm differences in TTD except for arm or shoulder pain (longer with durvalumab versus placebo [median TTD: 25.7 versus 9.1 mo; hazard ratio: 0.70 (95% confidence interval: 0.51-0.94)]) and similar improvement rates between arms for most scales; a higher improvement rate for chest pain was observed with durvalumab versus placebo (odds ratio: 2.28 [95% confidence interval: 1.08-4.95]). CONCLUSIONS: Consolidation durvalumab after concurrent chemoradiotherapy did not compromise patients' global health status/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for limited-stage SCLC.