摘要
目的评价曲妥珠单抗与蒽环类药物同步应用于乳腺癌辅助治疗的安全性和疗效。方法采用前瞻性、随机、对照方法，对符合入组标准的乳腺癌患者按照1：1随机方法分为试验组和对照组。试验组采用曲妥珠单抗和蒽环类药物同步治疗，对照组采用曲妥珠单抗和蒽环类序贯治疗。研究的主要终点为心脏安全性，次要终点为无病生存时间（DFS）和总生存时间（OS）。结果共109例乳腺癌患者入组，其中试验组55例，对照组54例。共出现心脏不良事件12例（11．0％），均表现为无症状的左室射血分数（LVEF）下降，其中试验组5例（9．1％），对照组7例（13．0％），差异无统计学意义（P=0．556）。试验组和对照组患者在入组前和治疗后3、6、9、12个月的LVEF差异也无统计学意义（P〉0．05）。109例患者中，有10例（9．2％）患者出现复发转移，其中试验组4例（7．3％），对照组6例（11．1％），两组患者的DFS差异无统计学意义（P=0．724）。两组患者均未出现死亡病例。结论在乳腺癌辅助治疗中，曲妥珠单抗与蒽环类药物同步治疗并不增加患者心脏不良事件的风险，安全性良好，其疗效还有待于进一步随访。
Objective To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer. Methods It is a prospective, randomized and controlled trial. Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen. The primary endpoint was cardiac safety. The second endpoints were disease-free survival （DFS） and overall survival （OS）. Results One hundred and nine breast cancer patients were enrolled and randomized in this trial. Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline. The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction （LVEF）. There was no significant difference between concurrent and sequential groups in cardiac event rates （9.1% vsl3.0%, P = 0.556）, neither of LVEF values at basline or at 3, 6, 9 and 12 months during trastuzumab treatment （ P 〉 0.05 ）. Four patients （7. 3% ） in the concurrent group suffered local recurrences or distant metastases, and 6 participants （11.1% ） in the sequential group had distant metastases. There was no significant difference between the two groups in DFS （P = 0. 724）. There was no death in beth groups. Conclusions Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events. Further research is needed to determine the efficacy of this treatment regimen.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2014年第2期132-136,共5页
Chinese Journal of Oncology
基金
“十一五”国家科技支撑计划课（2006BA102A09）
北京市科委科技计划研发攻关课题（D090507043409009）
北京自然科学基金（7132192）
北京协和医院青年基金（pumch-2013-095）
