First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1

作者：Martin Reck, Tudor–Eliade Ciuleanu, Jong Seok Lee, Michael Schenker, Clarisse Audigier-Valette, Bogdan Żurawski, Helena Linardou, Gregory A. Otterson, Pamela Salman, Makoto Nishio, Emmanuel de la Mora Jimenez, Krysztof Lesniewski-Kmak, István Albert, Samreen Ahmed, Konstantinos Syrigos, John R. Penrod, Yong Yuan, Steven I. Blum, Faith E. Nathan, Xiaowu Sun, Alejandro Moreno‐Koehler, Fiona Taylor, Kenneth J. O’Byrne · 发表于：Journal of Thoracic Oncology · 年份：2021 · DOI：10.1016/j.jtho.2020.12.019 · 被引用次数：43 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment

INTRODUCTION: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% or greater tumor programmed death ligand 1 expression had significantly improved overall survival with nivolumab plus ipilimumab versus chemotherapy. We present the patient-reported outcomes (PROs). METHODS: Patients (N = 1189) were randomized to nivolumab plus ipilimumab, nivolumab, or chemotherapy. PROs were exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index, LCSS 3-item global index, EQ-5D visual analog scale (VAS), and EQ-5D utility index were analyzed descriptively. Mixed-effect model repeated measures and time-to-first deterioration and improvement analyses were conducted. RESULTS: PRO completion rates were generally greater than 80%. On-treatment improvements from baseline in LCSS measures of symptom burden and global health status with nivolumab plus ipilimumab generally met or exceeded the minimal important difference (smallest clinically meaningful change) from weeks 24 and 30, respectively; improvements with chemotherapy generally remained below the minimal important difference. Mean on-treatment EQ-5D VAS scores for both treatments approached the U.K. population norm at week 24, remaining so throughout the treatment period. Mixed-effect model repeated measures analyses revealed numerically greater improvements from baseline with nivolumab plus ipilimumab versus chemotherapy across LCSS average symptom burden index and 3-...