Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study

作者：Goldman JW, Garassino MC, Chen Y, Özgüroğlu M, Dvorkin M, Trukhin D, Statsenko G, Hotta K, Ji JH, Hochmair MJ, Voitko O, Havel L, Poltoratskiy A, Losonczy G, Reinmuth N, Patel N, Laud PJ, Shire N, Jiang H, Paz-Ares L · 发表于：Lung cancer (Amsterdam, Netherlands) · 年份：2020 · DOI：10.1016/j.lungcan.2020.09.003 · 研究领域：Lung Neoplasms、Antibodies, Monoclonal、Antineoplastic Combined Chemotherapy Protocols、Cisplatin、Etoposide、Humans、Patient Reported Outcome Measures、Platinum、Quality of Life

OBJECTIVES: In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs). MATERIALS AND METHODS: Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed. RESULTS: In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was stat...