TY - JOUR
T1 - Patient-Reported Outcomes With Consolidation Durvalumab Versus Placebo After Concurrent Chemoradiotherapy in Limited-Stage SCLC
T2 - Results From the Phase 3 ADRIATIC Trial
AU - Novello, Silvia
AU - Spigel, David R.
AU - Fang, Jian
AU - Chen, Yuanbin
AU - Zenke, Yoshitaka
AU - Lee, Ki Hyeong
AU - Navarro, Alejandro
AU - Buchmeier, Eva Lotte
AU - Chang, John Wen Cheng
AU - Shiraishi, Yoshimasa
AU - Özgüroğlu, Mustafa
AU - Kim, Yu Jung
AU - Hoa, Nguyen Thi Thai
AU - Hashemi, Sayed M.S.
AU - Chiang, Anne C.
AU - Turner, Ralph
AU - Mann, Helen
AU - Olivo, Yuka
AU - Jiang, Haiyi
AU - Senan, Suresh
N1 - Publisher Copyright:
© 2026 The Author(s). Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer. This is an open access article under the CC BY-NC-ND license. http://creativecommons.org/licenses/by-nc-nd/4.0/
PY - 2026/6
Y1 - 2026/6
N2 - 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.
AB - 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.
KW - ADRIATIC
KW - Consolidation
KW - Durvalumab
KW - Limited-stage small cell lung cancer
KW - Patient-reported outcomes
UR - https://www.scopus.com/pages/publications/105036197230
U2 - 10.1016/j.jtho.2026.103564
DO - 10.1016/j.jtho.2026.103564
M3 - Article
C2 - 41621752
AN - SCOPUS:105036197230
SN - 1556-0864
VL - 21
JO - Journal of thoracic oncology
JF - Journal of thoracic oncology
IS - 6
M1 - 103564
ER -