曲妥珠单抗地罗替康治疗转移性 HER2 阳性胃癌的真实世界环境:全国队列研究》。

IF 3 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Clinical and Translational Gastroenterology Pub Date : 2024-12-01 DOI:10.14309/ctg.0000000000000773
Hugo Jourdain, Nicolas Albin, Adrien Monard, David Desplas, Mahmoud Zureik, Nadia Haddy
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引用次数: 0

摘要

目的:曲妥珠单抗德鲁司康(T-DXd)已于 2022 年 7 月在法国通过加速审批,获准用于治疗转移性 HER2 阳性胃癌(HER2+ mGC)。本研究旨在评估其实际使用情况:我们利用法国国家健康保险的数据,对接受 HER2+ mGC 治疗的 T-DXd 用户进行了特征描述:队列包括 196 名患者,大部分为男性(78.1%),中位年龄为 65 岁。中位总生存期为 7.7 个月(95% CI:6.2-9.0):结论:在现实世界中,接受T-DXd治疗的HER2+ mGC患者的疗效低于关键临床试验中的患者,这与之前有关加速批准的报道一致。
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Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Gastric Cancer in a Real-World Setting: A Nationwide Cohort Study.

Introduction: Trastuzumab deruxtecan (T-DXd) has been approved for human epidermal growth factor receptor 2-positive locally advanced or metastatic gastric and gastroesophageal junction (HER2+ mG/GEJ) cancer since July 2022 in France, through an accelerated approval. The aim of this study was to evaluate its real-world use.

Methods: We characterized T-DXd users treated for HER2+ mG/GEJ cancer using data from the French National Health Insurance database.

Results: The cohort included 196 patients, mostly men (78.1%), with a median age of 65 years. Median overall survival reached 7.7 months (95% CI: 6.2-9.0).

Discussion: Patients treated with T-DXd for HER2+ mG/GEJ cancer in the real world showed lower outcomes than those in pivotal clinical trials, consistent with previous reports on accelerated approvals.

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来源期刊
Clinical and Translational Gastroenterology
Clinical and Translational Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
7.00
自引率
0.00%
发文量
114
审稿时长
16 weeks
期刊介绍: Clinical and Translational Gastroenterology (CTG), published on behalf of the American College of Gastroenterology (ACG), is a peer-reviewed open access online journal dedicated to innovative clinical work in the field of gastroenterology and hepatology. CTG hopes to fulfill an unmet need for clinicians and scientists by welcoming novel cohort studies, early-phase clinical trials, qualitative and quantitative epidemiologic research, hypothesis-generating research, studies of novel mechanisms and methodologies including public health interventions, and integration of approaches across organs and disciplines. CTG also welcomes hypothesis-generating small studies, methods papers, and translational research with clear applications to human physiology or disease. Colon and small bowel Endoscopy and novel diagnostics Esophagus Functional GI disorders Immunology of the GI tract Microbiology of the GI tract Inflammatory bowel disease Pancreas and biliary tract Liver Pathology Pediatrics Preventative medicine Nutrition/obesity Stomach.
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