Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou, China.
Int J Cancer. 2014 May 15;134(10):2468-77. doi: 10.1002/ijc.28559. Epub 2013 Nov 8.
The monoclonal antibody trastuzumab has brought survival benefit to patients with advanced gastric cancer (AGC) that have human epidermal growth factor receptor 2 (HER2) over expression or amplification. This study was designed to compare the clinical outcomes of HER2-negative and HER2-positive AGC patients with or without trastuzumab treatment. There were three groups of patients enrolled for analysis. Group A was 51 HER2-positive AGC patients treated with trastuzumab and chemotherapy; group B was a matched control group of 47 HER2-positive patients who received chemotherapy only; group C was a matched group of 251 HER2-negative patients who received chemotherapy. All the patients were enrolled at Sun Yat-sen University Cancer Center or Zhongshan Hospital, Fudan University between January 2010 and December 2012. The primary endpoint was overall survival (OS). The Kaplan-Meier method and log-rank test were used for survival analysis. The median duration of follow-up was 13.5 months (range 5-18.6 months). The median OS of these three groups of patients was 14.8 months, 11.3 months and 14.4 months respectively (p < 0.001). The survival difference between group A and B was significant, p < 0.001. Similarly, there was significant difference between group B and C, p < 0.001. Moreover the survival between group A and C was comparable, p = 0.281. The median progression-free survival for these three groups was 7.4, 6.0 and 7.2 months. Multivariate analysis confirmed that trastuzumab treatment was an independent prognostic factor in group A and B patients (p = 0.017). HER2 positive was an independent adverse prognostic factor in group B and C patients (p = 0.013).
曲妥珠单抗为人表皮生长因子受体 2(HER2)过表达或扩增的晚期胃癌(AGC)患者带来了生存获益。本研究旨在比较曲妥珠单抗治疗与未治疗的 HER2 阴性和 HER2 阳性 AGC 患者的临床结局。共纳入三组患者进行分析。A 组为 51 例接受曲妥珠单抗联合化疗的 HER2 阳性 AGC 患者;B 组为 47 例接受单纯化疗的 HER2 阳性患者,为匹配对照组;C 组为 251 例接受化疗的 HER2 阴性患者,为匹配对照组。所有患者均于 2010 年 1 月至 2012 年 12 月在中山大学肿瘤防治中心或复旦大学中山医院就诊。主要终点为总生存期(OS)。采用 Kaplan-Meier 法和对数秩检验进行生存分析。中位随访时间为 13.5 个月(范围 5-18.6 个月)。三组患者的中位 OS 分别为 14.8 个月、11.3 个月和 14.4 个月(p<0.001)。A 组和 B 组的生存差异有统计学意义(p<0.001)。B 组和 C 组的生存差异也有统计学意义(p<0.001)。此外,A 组和 C 组的生存差异无统计学意义(p=0.281)。三组患者的中位无进展生存期分别为 7.4、6.0 和 7.2 个月。多因素分析证实,曲妥珠单抗治疗是 A 组和 B 组患者的独立预后因素(p=0.017)。HER2 阳性是 B 组和 C 组患者的独立不良预后因素(p=0.013)。