LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Institutul Oncologic Prof. Dr. Ion Chiricuta and UNF Iulia Hatieganu, Cluj-Napoca, Romania.
J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.
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).
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.
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-item global index, and EQ-5D VAS and utility index. Nivolumab plus ipilimumab had delayed time-to-first deterioration (hazard ratio [95% confidence interval] 0.74 [0.56 to 0.98]) and a trend for more rapid time-to-first improvement (1.24 [0.98 to 1.59]) versus chemotherapy.
Nivolumab plus ipilimumab revealed delayed deterioration and numerical improvement in symptoms and health-related quality of life versus chemotherapy in patients with advanced NSCLC and 1% or greater programmed death ligand 1 expression.
在 CheckMate 227 试验（NCT02477826）中，对于 1%或以上肿瘤程序性死亡配体 1 表达的未经治疗的 IV 期或复发性非小细胞肺癌患者，与化疗相比，纳武利尤单抗联合伊匹单抗治疗显著改善了总生存期。现将患者报告的结果（PRO）报告如下。
患者（N=1189）被随机分配至纳武利尤单抗联合伊匹单抗、纳武利尤单抗或化疗组。PRO 为探索性分析。使用肺癌症状量表（LCSS）平均症状负担指数、LCSS 3 项总指数、EQ-5D 视觉模拟量表（VAS）和 EQ-5D 效用指数进行描述性分析。采用混合效应模型重复测量和首次恶化和改善时间分析。
PRO 完成率普遍大于 80%。纳武利尤单抗联合伊匹单抗治疗的 LCSS 症状负担和总体健康状况指标的治疗期间改善，自第 24 周和第 30 周起，分别达到或超过最小有意义差异（最小临床有意义变化）；化疗的改善始终低于最小有意义差异。两种治疗方法的治疗期间平均 EQ-5D VAS 评分在第 24 周接近英国人群正常值，并在整个治疗期间保持不变。混合效应模型重复测量分析显示，纳武利尤单抗联合伊匹单抗与化疗相比，LCSS 平均症状负担指数和 3 项总指数以及 EQ-5D VAS 和效用指数的改善具有更大的数值改善。纳武利尤单抗联合伊匹单抗与化疗相比，首次恶化时间延迟（风险比[95%置信区间]0.74[0.56 至 0.98]），首次改善时间呈趋势性更快（1.24[0.98 至 1.59]）。
在程序性死亡配体 1 表达为 1%或以上的晚期非小细胞肺癌患者中，与化疗相比，纳武利尤单抗联合伊匹单抗治疗显示出症状和健康相关生活质量的恶化延迟和数值改善。
