Q-TWiST analysis of first-line nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma from CheckMate 649: 4-year follow-up results.

IF 5.1 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastric Cancer Pub Date : 2025-09-01 Epub Date: 2025-07-09 DOI:10.1007/s10120-025-01634-6

Daniel Lin, Wenying Quan, Marne Garretson, Viktor Chirikov, Clara Chen, Prianka Singh, Catherine Davis, Ryan Sugarman

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引用次数: 0

Abstract

Background: Nivolumab plus chemotherapy demonstrated clinically significant improvement in quality-adjusted survival versus chemotherapy alone as first-line treatment for advanced non-HER2-positive gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC) in the CheckMate 649 post-hoc quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis at 1-year minimum follow-up. We report Q-TWiST analysis results at 4-year minimum follow-up.

Methods: Q-TWiST methodology was applied post-hoc to CheckMate 649 study data from all randomized patients, patients with PD-L1 combined positive score (CPS) ≥ 1, and patients with PD-L1 CPS ≥ 5. Relative Q-TWiST gains ≥ 10% were predefined as clinically important and ≥ 15% as clearly clinically important.

Results: Among all randomized patients, patients with PD-L1 CPS ≥ 1, and patients with PD-L1 CPS ≥ 5, mean (95% CI) absolute Q-TWiST gains of 3.4 (1.8-5.1), 4.2 (2.4-6.1), and 5.4 (3.0-7.7) months with nivolumab plus chemotherapy versus chemotherapy were observed, respectively. These translated to clearly clinically important relative Q-TWiST gains of 20.5%, 26.1%, and 33.4% in each population; relative Q-TWiST gains benefit remained clearly clinically important in all subgroups (15.7%, 20.3%, and 26.4%) after expanding the analysis to include grade 2 adverse events. Greater Q-TWiST gains were observed with nivolumab plus chemotherapy across most subgroups in all randomized patients and patients with PD-L1 CPS ≥ 1 and across all subgroups in patients with PD-L1 CPS ≥ 5.

Conclusion: Clearly clinically important benefit in quality-adjusted survival with first-line nivolumab plus chemotherapy versus chemotherapy was observed across all evaluated PD-L1 CPS expression levels in patients with advanced GC/GEJC/EAC from CheckMate 649 with 4-year minimum follow-up.

Trial registration: ClinicalTrials.gov identifier, NCT02872116.

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来自CheckMate 649的晚期胃癌、胃食管结癌或食管腺癌患者的一线纳武单抗加化疗与化疗的Q-TWiST分析：4年随访结果。

背景：在至少1年随访的CheckMate 649事后无症状或毒性质量调整时间（Q-TWiST）分析中，纳伏单抗加化疗作为晚期非her2阳性胃癌、胃食管结癌和食管腺癌（GC/GEJC/EAC）的一线治疗，在质量调整生存率方面表现出临床显着改善。我们报告了至少4年随访的Q-TWiST分析结果。方法：采用Q-TWiST方法对所有随机患者、PD-L1联合阳性评分(CPS)≥1和PD-L1 CPS≥5的患者的CheckMate 649研究数据进行事后分析。相对Q-TWiST增益≥10%预定义为临床重要，≥15%为临床明显重要。结果：在所有随机患者中，PD-L1 CPS≥1的患者和PD-L1 CPS≥5的患者，纳武单抗加化疗与化疗相比，平均（95% CI）绝对Q-TWiST增益分别为3.4（1.8-5.1）、4.2（2.4-6.1）和5.4（3.0-7.7）个月。这在每个人群中转化为明显具有临床意义的相对Q-TWiST增益分别为20.5%、26.1%和33.4%；在将分析范围扩大到包括2级不良事件后，相对Q-TWiST获益在所有亚组（15.7%，20.3%和26.4%）中仍然具有明显的临床重要性。在所有随机患者和PD-L1 CPS≥1的患者中，在所有PD-L1 CPS≥5的患者中，在所有亚组中，纳沃单抗加化疗均观察到更大的Q-TWiST增益。结论：在CheckMate 649的晚期GC/GEJC/EAC患者中，通过至少4年的随访，在所有评估的PD-L1 CPS表达水平中，一线纳volumab加化疗与化疗相比，在质量调整生存率方面明显具有重要的临床意义。试验注册：ClinicalTrials.gov识别码，NCT02872116。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gastric Cancer 医学-胃肠肝病学

CiteScore

14.70

自引率

2.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.