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辅助性德格拉蒙化疗与希罗达化疗用于胃癌切除术后的真实世界疗效:一项倾向评分匹配分析(ASTER研究)

Real-world outcomes of Adjuvant De Gramont versus Xelox chemotherapy in reSected gasTric cancER: a propensity score-matched analysis (ASTER study).

作者信息

Zurlo Ina Valeria, Rosa Fausto, Giannarelli Diana, Trovato Giovanni, Salati Massimiliano, Spallanzani Andrea, Basso Michele, Pozzo Carmelo, Alfieri Sergio, Tortora Giampaolo, Strippoli Antonia

机构信息

Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.

Medical Oncology Unit, "Vito Fazzi" Hospital, Lecce, Italy.

出版信息

Cancer Gene Ther. 2025 Jul 26. doi: 10.1038/s41417-025-00945-1.

Abstract

The role of adjuvant chemotherapy (aCT) in gastric and esophago-gastric junction cancer (GC/EGJC) remains controversial. This study (ASTER study) aimed to compare the clinical outcomes of De Gramont (DG) versus XELOX/FOLFOX (OXA) regimens in a European real-world setting. This retrospective, bicentric study included patients treated with aCT between January 2001 and January 2018. A propensity score-matched (PSM) analysis was performed to compare oncological outcomes between DG and OXA regimens. Primary endpoints were disease-free survival (DFS) and overall survival (OS). Statistical analyses included the chi-square test, Kaplan-Meier method, and Cox proportional hazards modeling. Among 255 patients (127 DG, 128 OXA), 160 were matched (80 per arm) by PSM. Median DFS and OS did not differ significantly between groups (mDFS: 102.3 vs. 85.4 months, p = 0.91; mOS: 119.5 vs. 89.8 months, p = 0.69). In PSM-adjusted analysis, DG showed a trend towards longer DFS (p = 0.052) and significantly improved OS (p = 0.016). Multivariate analysis confirmed age, ECOG PS, resection margins, and stage as major prognostic factors. DG and OXA regimens demonstrated similar efficacy in the adjuvant treatment of resected GC/GEJC in a European cohort. Further prospective studies are warranted to optimize regimen selection and refine patient stratification.

摘要

辅助化疗(aCT)在胃癌和食管胃交界癌(GC/EGJC)中的作用仍存在争议。本研究(ASTER研究)旨在比较欧洲真实世界环境中德格拉蒙(DG)方案与XELOX/FOLFOX(OXA)方案的临床结局。这项回顾性、双中心研究纳入了2001年1月至2018年1月期间接受辅助化疗的患者。进行倾向评分匹配(PSM)分析以比较DG和OXA方案之间的肿瘤学结局。主要终点为无病生存期(DFS)和总生存期(OS)。统计分析包括卡方检验、Kaplan-Meier法和Cox比例风险模型。在255例患者中(127例接受DG方案,128例接受OXA方案),160例通过PSM进行匹配(每组80例)。两组之间的中位DFS和OS无显著差异(mDFS:102.3个月对85.4个月,p = 0.91;mOS:119.5个月对89.8个月,p = 0.69)。在PSM调整分析中,DG显示出DFS延长的趋势(p = 0.052),且OS显著改善(p = 0.016)。多变量分析证实年龄、东部肿瘤协作组体能状态(ECOG PS)、切缘和分期是主要的预后因素。在欧洲队列中,DG和OXA方案在切除的GC/GEJC辅助治疗中显示出相似的疗效。有必要进行进一步的前瞻性研究以优化方案选择并完善患者分层。

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