Dx-Rx Institute, Baunevaenget 76, DK-3480 Fredensborg, Denmark.
Oncology. 2010;78(1):26-33. doi: 10.1159/000288295. Epub 2010 Feb 25.
Amplification of the HER2 gene and over-expression of the HER2 protein in gastric cancer have been shown in a large number of studies. HER2 positivity can be detected in approximately 20% of patients, which is a characteristic associated with poor prognosis. Preclinical in vitro and in vivo studies have demonstrated that both trastuzumab and lapatinib are effective in different gastric cancer models and have thus lead to the initiation of clinical studies. In the first phase III study, the ToGA trial, HER2-positive patients with advanced gastroesophageal and gastric adenocarcinoma were randomized to receive 5-fluorouracil/capecitabine and cisplatin either alone or in combination with trastuzumab. A statically significant gain in overall survival was seen in the patients who received the combined treatment of trastuzumab and chemotherapy. It is expected that the encouraging results from the ToGA trial will have an immediate impact on the management of patients and that routine HER2 testing of patients with advanced gastric cancer will be initiated within a relatively short period of time.
大量研究表明，胃癌中存在 HER2 基因扩增和 HER2 蛋白过表达。大约 20%的患者可检测到 HER2 阳性，这是与预后不良相关的特征。临床前体外和体内研究表明，曲妥珠单抗和拉帕替尼在不同的胃癌模型中均有效，因此开展了临床研究。在首个 III 期临床试验 ToGA 试验中，HER2 阳性的晚期胃食管和胃腺癌患者被随机分配接受氟尿嘧啶/卡培他滨和顺铂单独治疗或联合曲妥珠单抗治疗。接受曲妥珠单抗联合化疗治疗的患者的总生存期有显著获益。预计 ToGA 试验的令人鼓舞的结果将立即对患者的治疗产生影响，并且在相对较短的时间内将开始对晚期胃癌患者进行常规 HER2 检测。
