Introduction: In the first interim analysis of the phase 3 ADRIATIC trial, consolidation durvalumab significantly improved overall survival and progression-free survival (primary endpoints) versus placebo in patients with limited-stage small-cell lung cancer (LS-SCLC) without disease progression after concurrent chemoradiotherapy (cCRT). 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 (GHS/QoL), functioning, and symptoms, assessed using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30/Questionnaire-Lung Cancer 13 (secondary endpoints), 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 examined. A score change of ≥10 from baseline was considered a clinically meaningful deterioration/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/shoulder pain (longer with durvalumab versus placebo [median TTD: 25.7 versus 9.1 months; HR: 0.70 (95% CI: 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% CI: 1.08-4.95]). Conclusions: Consolidation durvalumab following cCRT did not compromise patients' GHS/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for LS-SCLC.
Patient-Reported Outcomes with Consolidation Durvalumab Versus Placebo Following Concurrent Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer: Results from the Phase 3 ADRIATIC Trial
Novello, Silvia
;
2026-01-01
Abstract
Introduction: In the first interim analysis of the phase 3 ADRIATIC trial, consolidation durvalumab significantly improved overall survival and progression-free survival (primary endpoints) versus placebo in patients with limited-stage small-cell lung cancer (LS-SCLC) without disease progression after concurrent chemoradiotherapy (cCRT). 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 (GHS/QoL), functioning, and symptoms, assessed using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30/Questionnaire-Lung Cancer 13 (secondary endpoints), 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 examined. A score change of ≥10 from baseline was considered a clinically meaningful deterioration/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/shoulder pain (longer with durvalumab versus placebo [median TTD: 25.7 versus 9.1 months; HR: 0.70 (95% CI: 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% CI: 1.08-4.95]). Conclusions: Consolidation durvalumab following cCRT did not compromise patients' GHS/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for LS-SCLC.
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