Daniel Lin, Wenying Quan, Marne Garretson, Viktor Chirikov, Clara Chen, Prianka Singh, Catherine Davis, Ryan Sugarman
{"title":"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。","authors":"Daniel Lin, Wenying Quan, Marne Garretson, Viktor Chirikov, Clara Chen, Prianka Singh, Catherine Davis, Ryan Sugarman","doi":"10.1007/s10120-025-01634-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02872116.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":"935-944"},"PeriodicalIF":5.1000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378121/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Daniel Lin, Wenying Quan, Marne Garretson, Viktor Chirikov, Clara Chen, Prianka Singh, Catherine Davis, Ryan Sugarman\",\"doi\":\"10.1007/s10120-025-01634-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02872116.</p>\",\"PeriodicalId\":12684,\"journal\":{\"name\":\"Gastric Cancer\",\"volume\":\" \",\"pages\":\"935-944\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378121/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastric Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10120-025-01634-6\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastric Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10120-025-01634-6","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
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.
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.
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.
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