摘要
目的探讨中国HER2阳性早期乳腺癌患者采用曲妥珠单抗辅助治疗1年或不治疗中位随访1年的疗效和安全性。方法HERA研究为国际多中心、随机、开放Ⅲ期临床研究。入组患者为早期乳腺癌术后淋巴结阳性或高危淋巴结阴性，HER2阳性的女性，在完成了辅助或新辅助化疗、放疗（需要时）后随机接受曲妥珠单抗（商品名赫赛汀）辅助治疗1年、2年或观察（无赫赛汀治疗）。主要研究终点为无病生存时间，次要研究终点为总生存时间，无复发生存时间，无远处疾病生存时间，安全性和耐受性及心功能异常的发生率。2005年4月进行了首次计划的全球中期疗效分析，比较赫赛汀1年治疗组和观察组的疗效和安全性。本研究报告了数据库中中国入组病人的结果。结果中国8家中心的122例患者纳入全球的中期疗效分析。赫赛汀1年治疗组68例，观察组54例。中位随访1年时，赫赛汀治疗组与观察组分别发生3例和8例无病生存事件，两组2年无病生存率分别为92．9％和81．4％，绝对值提高11．5％，P=0．0489；赫赛汀治疗组与观察组2年无复发生存率分别为98．1％和81．4％，P=0．0064，无远处疾病生存率分别为98．1％和83．3％，P=0．0117。赫赛汀治疗的耐受性较好，未发现严重的心脏事件或新的安全性问题。结论赫赛汀辅助治疗1年可延长中国HER2阳性早期乳腺癌病人的2年无病生存时间、无复发生存时间和无远处疾病生存时间。
Objective To evaluate the efficacy and safety of 1-year adjuvant trastuzumab （herceptin） versus 1-year non-trastuzumab observation in Chinese patients with HER2-positive early breast cancer during a median follow-up of 1 year. Methods The HERA trim was an international, multicenter, randomized, open-label, phase m trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard adjuvant chemotherapy, radiotherapy or both in patients with HER2-positive node- positive or high-risk node-negative early breast cancer. The primary endpoint w^s disease-free survival. Secondary end points included recurrence-free survival, distant disease-free survival, overall survival and cardiac safety. The first planned interim analysis comparing the efficacy and safety of treatment with trastuzumab for 1 year versus observation were completed in April 2005. Only the outcomes of recruited Chinese patients were reported. Results A total of 122 Chinese patients from 8 participating centers were included for planned interim analysis. And they were divided into trastuzumab （ n = 68 ） and observation （n =54） groups. Three and eight disease-free survival events were observed in the trastuzumab and observation groups respectively. Two-year disease-free survival rates were 92. 9% and 81.4% respectively （P = 0. 0489） ; 2-year recurrence-free survival and distant disease-free survivals were 98.1% vs 81.4% （P =0. 0064） and 98.1% vs 83.3% （P =0. 0117） respectively. Trastuzumab was generally well-tolerated with a decent safety profile. Severe cardiotoxieity was not observed. Conclusion One-year treatment with adjuvant trastuzumab improves disease-free survival, recurrence-free survival and distant disease-free survival in Chinese patients with HER2-positive early breast cancer.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2012年第47期3345-3349,共5页
National Medical Journal of China
