Jourdain Hugo, Albin Nicolas, Monard Adrien, Desplas David, Zureik Mahmoud, Haddy Nadia
EPI-PHARE, French National Agency for Medicine and Health Product Safety (ANSM) and the French National Health Insurance, Saint-Denis, France.
Department of Oncohematology, Avec Groupe Hospitalier Mutualiste, Grenoble, France.
Clin Transl Gastroenterol. 2024 Dec 1;15(12):e00773. doi: 10.14309/ctg.0000000000000773.
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.
We characterized T-DXd users treated for HER2+ mG/GEJ cancer using data from the French National Health Insurance database.
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).
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.
自2022年7月起，曲妥珠单抗德瓦鲁单抗（T-DXd）已通过加速批准程序在法国被批准用于治疗人表皮生长因子受体2阳性的局部晚期或转移性胃癌和胃食管交界癌（HER2+mG/GEJ）。本研究的目的是评估其在现实世界中的使用情况。
我们使用法国国家医疗保险数据库的数据，对接受T-DXd治疗的HER2+mG/GEJ癌症患者进行了特征分析。
该队列包括196名患者，大多数为男性（78.1%），中位年龄为65岁。中位总生存期达到7.7个月（95%CI：6.2-9.0）。
在现实世界中，接受T-DXd治疗的HER2+mG/GEJ癌症患者的预后低于关键临床试验中的患者，这与先前关于加速批准的报告一致。
