医学
内科学
曲妥珠单抗
化疗
卡培他滨
养生
恶心
危险系数
胃肠病学
化疗方案
癌症
不利影响
中性粒细胞减少症
呕吐
临床终点
肿瘤科
外科
随机对照试验
乳腺癌
置信区间
结直肠癌
作者
Lin Shen,Jian Xu,Feng Yi Feng,Shun Chang Jiao,Li wei Wang,Jin Li,Zhong Guan,Shu Kui Qin,Jie jun Wang,Shufei Yu,Ya jie Wang,Ye ning Jin,Min Tao,Lei Zheng,Liang Pan
出处
期刊:PubMed
日期:2013-04-01
卷期号:35 (4): 295-300
被引量:11
标识
DOI:10.3760/cma.j.issn.0253-3766.2013.04.012
摘要
To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the first-line treatment of HER-2-positive advanced gastric or gastro-oesophageal junction cancer.Fifteen Chinese research centers are involved in the BO18255 (ToGA) study. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumor showed overexpression of HER-2 protein by immunohistochemistry +++ or FISH-positive. Patients were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab. The primary endpoint was overall survival.Eighty-five Chinese patients were enrolled in this study, of whom 84 were included in the primary analysis: trastuzumab plus chemotherapy (FP/H) (n = 36) and chemotherapy alone (FP)(n = 48). The median follow-up was 15.2 months in the FP/H group and 14.2 months in the FP group. The median survival time was 12.6 months in the FP/H group compared with 9.7 months in the FP group [hazard ratio 0.72, 95%CI (0.40; 1.29)]. Grade 3/4 adverse events were higher in the FP/H(63.9%)than FP (47.9%) groups, including neutropenia, vomiting and nausea. Two mild cardiac adverse events occurred in the FP/H group. Severe adverse events occurred in 3 cases of both two groups, respectively.Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastro-oesophageal junction cancer. These results are consistent with the results of ToGA whole population trial. Trastuzumab in combination with chemotherapy can be considered as a new option for patients with HER-2-positive advanced gastric or gastro-oesophageal junction cancer.
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