Sendur Mehmet A N, Aksoy Sercan, Ozdemir Nuriye Y, Yazici Ozan, Zengin Nurullah, Altundag Kadri
Yildirim Beyazit University, Department of Medical Oncology , Ankara , Turkey.
Curr Med Res Opin. 2014 Dec;30(12):2535-42. doi: 10.1185/03007995.2014.965775. Epub 2014 Sep 29.
INTRODUCTION: Trastuzumab is the first anti-HER-2 humanized monoclonal antibody. The benefit of adjuvant trastuzumab has been shown in randomized phase III trials. Despite trastuzumab being recommended for 52 weeks in the adjuvant treatment of HER-2 positive breast cancer according to the current breast cancer guidelines, there is still no consensus on the optimal duration of adjuvant trastuzumab. The aim of our study is to investigate the efficacy and safety of adjuvant trastuzumab for 9 weeks and 52 weeks in axillary lymph node positive HER-2 positive breast cancer patients. PATIENTS AND METHODS: A total of 271 HER-2 and axillary node positive breast cancer patients who received trastuzumab in adjuvant treatment between the years 2005 and 2013 were retrospectively analyzed. Patients with axillary node positive HER-2 positive breast cancer who were non-metastatic were enrolled to the study. Patients were allocated to the 9 week trastuzumab group (n = 155) or the 52 week trastuzumab group (n = 116). Kaplan-Meier survival analysis was carried out for disease free survival (DFS) and overall survival (OS). Two-sided p values of <0.05 were considered statistically significant. The most important limitation of our manuscript is the retrospective design. RESULTS: The median follow-up time for this analysis was 34 (4-95) months. Patients' clinical and pathological characteristics were well balanced between the two treatment arms. In the 9 week trastuzumab treatment group, the DFS rate was 96.7%, 84.8% and 74.9% in the first, third and fifth years respectively, whereas in the 52 week trastuzumab treatment group it was 94.3%, 80.0% and 80.0% (P = 0.76). In the 9 week trastuzumab treatment group, the OS rate was 99.3%, 92.2% and 88.3% in the first, third and fifth years respectively, whereas in the 52 week trastuzumab treatment group it was 99.0%, 94.7% and 78.6% (P = 0.99). In both groups, symptomatic heart failure was not reported but asymptomatic left ventricular ejection fraction (LVEF) decline was observed 3 (1.9%) and 18 (15.5%) patients in the 9 week and 52 week trastuzumab treatment groups, respectively (P < 0.001). CONCLUSION: In our study, the efficacy of trastuzumab for 52 weeks and 9 weeks was similar in node-positive HER-2 positive breast cancer. Cardiotoxicity was significantly increased in the 52 week trastuzumab arm compared to the 9 week trastuzumab arm.
引言：曲妥珠单抗是首个抗HER-2人源化单克隆抗体。辅助性曲妥珠单抗的获益已在随机III期试验中得到证实。尽管根据当前乳腺癌指南，曲妥珠单抗在HER-2阳性乳腺癌辅助治疗中推荐使用52周，但关于辅助性曲妥珠单抗的最佳疗程仍未达成共识。我们研究的目的是调查辅助性曲妥珠单抗治疗9周和52周对腋窝淋巴结阳性HER-2阳性乳腺癌患者的疗效和安全性。 患者与方法：对2005年至2013年间接受曲妥珠单抗辅助治疗的271例HER-2和腋窝淋巴结阳性乳腺癌患者进行回顾性分析。纳入非转移性腋窝淋巴结阳性HER-2阳性乳腺癌患者。患者被分配至9周曲妥珠单抗组（n = 155）或52周曲妥珠单抗组（n = 116）。对无病生存期（DFS）和总生存期（OS）进行Kaplan-Meier生存分析。双侧p值<0.05被认为具有统计学意义。我们手稿最重要的局限性是回顾性设计。 结果：本次分析的中位随访时间为34（4 - 95）个月。两组治疗组患者的临床和病理特征均衡。在9周曲妥珠单抗治疗组中，第1年、第3年和第5年的DFS率分别为96.7%、84.8%和74.9%，而在52周曲妥珠单抗治疗组中分别为94.3%、80.0%和80.0%（P = 0.76）。在9周曲妥珠单抗治疗组中，第1年、第3年和第5年的OS率分别为99.3%、92.2%和88.3%，而在52周曲妥珠单抗治疗组中分别为99.0%、94.7%和78.6%（P = 0.99）。两组均未报告有症状的心力衰竭，但9周和52周曲妥珠单抗治疗组分别有3例（1.9%）和18例（15.5%）患者观察到无症状左心室射血分数（LVEF）下降（P < 0.001）。 结论：在我们的研究中，曲妥珠单抗治疗52周和9周对淋巴结阳性HER-2阳性乳腺癌的疗效相似。与9周曲妥珠单抗组相比，52周曲妥珠单抗组的心脏毒性显著增加。
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