第3期CheckMate 649研究表明，与化疗（chemo）相比，使用Nivolumab和化疗（NIVO+chemo）作为Her2阴性晚期胃癌、胃食管交界区癌和食管腺癌（GC/GEJC/EAC）患者的一线治疗，可以获得更卓越的总生存率。此次事后试验分析旨在评估使用质量调整的免疫突破抑制剂（NIVO）+化疗是否能够带来更好的治疗效果，以进一步解释不同的健康状态和治疗毒性对生命质量（QoL）的影响。由CheckMate 649的数据，我们评估了要达到预设的临床重要的相对Q-TWiST增益值（≥10%）所需的质量调整生存率增益，比较了接受NIVO+化疗和单纯化疗的所有随机患者和具有程序性细胞死亡配体1（PD-L1）联合阳性评分（CPS）≥5的患者。 在所有随机患者中，接受Nivo+ chemie的人与单纯接受化疗的人相比，平均Q-TWiST增益1.8个月（95% CI 0.9，2.7）。相对的Q-TWiST增益估计为12.8%。 PD-L1 CPS≥5的患者从Nivo+ chemie中获得更大的质量调整生存率增益，估计Q-TWiST增益为2.8个月（95% CI 1.5，4.1），相对增长20.6%。在不同的生命质量效用值下进行的亚组分析和敏感性分析均表明，与单纯化疗相比，Nivo+ chemie更有利。随访时间越长，NIVO+ chemie的Q-TWiST增益就越高。在未接受过治疗的GC/GEJC/EAC患者中，与化疗治疗相比，NIVO+chemo在质量调整的生存上获得了显著和临床重要的增益。©2023年作者（们）。

The phase 3 CheckMate 649 established superior overall survival of nivolumab in combination with chemotherapy (NIVO + chemo) compared with chemotherapy (chemo) alone as a first-line treatment for patients with Her2-negative advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC). This post hoc trial analysis aimed to evaluate the benefit of NIVO + chemo using quality-adjusted time without symptoms or toxicity (Q-TWiST) to further account for quality of life (QoL) in different health states depending on disease progression and treatment toxicity.Using data from CheckMate 649, we evaluated the quality-adjusted survival gain associated with NIVO + chemo compared with chemo alone among all randomized patients and repeated similar analyses among those with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 5. Relative Q-TWiST gains of ≥ 10% were predefined as clinically important.In all randomized patients, those receiving NIVO + chemo had a mean Q-TWiST gain of 1.8 (95% CI 0.9, 2.7) months compared with those receiving chemo alone. The relative Q-TWiST gain was estimated to be 12.8%. Patients with PD-L1 CPS ≥ 5 had greater quality-adjusted survival gain from NIVO + chemo with an estimated Q-TWiST gain of 2.8 (95% CI 1.5, 4.1) months, representing a relative gain of 20.6%. Subgroup analyses and sensitivity analyses with various QoL utility values yielded consistent findings in favor of NIVO + chemo compared with chemo alone. Q-TWiST gain from NIVO + chemo increased with longer duration of follow-up.NIVO + chemo was associated with a statistically significant and clinically important gain in quality-adjusted survival compared with chemo alone among previously untreated patients with advanced GC/GEJC/EAC.© 2023. The Author(s).