Department of Medical Oncology, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.
Onco Targets Ther. 2013 Apr 9;6:341-7. doi: 10.2147/OTT.S40851. Print 2013.
The efficacy of trastuzumab in Chinese breast cancer (BC) patients has rarely been reported. This study was designed to compare the clinical outcomes of HER2-positive BC patients receiving or not receiving trastuzumab treatment and HER2-negative BC patients.
This study involved three groups of patients. The first group was 115 human epidermal growth factor receptor 2 (HER2)-positive BC patients treated with trastuzumab who were enrolled at Sun Yat-sen University Cancer Center between January 2002 and July 2010; the second group was a matched control group of 115 HER2-positive patients who did not receive trastuzumab treatment; the third group was a matched group of 115 HER2-negative patients who received conventional therapy in the adjuvant setting. The primary endpoint was 3-year and 5-year disease-free survival (3-DFS and 5-DFS, respectively). The Kaplan-Meier method, log-rank test, and multivariate Cox proportional hazard regression model were used for survival analysis. The differences in survival rates among the three groups were also analyzed according to two different periods: 2002-2006 and 2007-2010.
The median duration of follow-up was 36 months (range, 12-111 months). The 3-DFS rates in the HER2-negative group, the HER2-positive group who received trastuzumab treatment, and the HER2-positive group who did not receive trastuzumab treatment were 82.6%, 89.6%, and 67.0%, respectively. The 3-DFS rate for the total study population was statistically significant (P < 0.001). Further analysis indicated a statistically significant difference in 3-DFS between either of the first two groups and the third group (P < 0.01), but the difference between the first two groups was not statistically significant (P = 0.157). Among the three groups, the 3-DFS rates during 2002-2006 did not have a significant difference compared with that during 2007-2010.
This study has further confirmed the efficacy of trastuzumab for HER2-positive operable BC in Chinese patients. It has also demonstrated that the 3-DFS and 5-DFS rates between HER2-positive patients receiving trastuzumab treatment and HER2-negative patients are comparable.
曲妥珠单抗在中国乳腺癌（BC）患者中的疗效鲜有报道。本研究旨在比较曲妥珠单抗治疗与未治疗的 HER2 阳性 BC 患者以及 HER2 阴性 BC 患者的临床结局。
本研究纳入三组患者。第一组为 115 例 2002 年 1 月至 2010 年 7 月在中山大学肿瘤防治中心接受曲妥珠单抗治疗的人表皮生长因子受体 2（HER2）阳性 BC 患者；第二组为 115 例匹配的 HER2 阳性未接受曲妥珠单抗治疗的患者；第三组为 115 例接受辅助常规治疗的 HER2 阴性患者。主要终点为 3 年和 5 年无病生存率（3-DFS 和 5-DFS）。采用 Kaplan-Meier 法、对数秩检验和多因素 Cox 比例风险回归模型进行生存分析。还根据两个不同时期（2002-2006 年和 2007-2010 年）分析三组患者的生存率差异。
中位随访时间为 36 个月（范围：12-111 个月）。HER2 阴性组、接受曲妥珠单抗治疗的 HER2 阳性组和未接受曲妥珠单抗治疗的 HER2 阳性组的 3-DFS 率分别为 82.6%、89.6%和 67.0%。总研究人群的 3-DFS 率有统计学意义（P<0.001）。进一步分析表明，前两组与第三组的 3-DFS 差异有统计学意义（P<0.01），但两组之间差异无统计学意义（P=0.157）。三组患者 2002-2006 年与 2007-2010 年 3-DFS 率无显著差异。
本研究进一步证实了曲妥珠单抗治疗中国可手术 HER2 阳性 BC 患者的疗效，并且表明接受曲妥珠单抗治疗的 HER2 阳性患者与 HER2 阴性患者的 3-DFS 和 5-DFS 率相当。
