THP方案新辅助治疗HER-2阳性乳腺癌的真实世界研究  

Real-world research on THP neoadjuvant regimen in the treatmentof HER-2 positive breast cancer

作　　者：王丽君[1,2] 辛岗 胡崇珠 李雪[2] WANG Lijun;XIN Gang;HU Congzhu;LI Xue(Graduate School of Chengde Medical College,Chengde 067000,Hebei;Baoding First Central Hospital,Baoding 071000,Hebei)

机构地区：[1]承德医学院,河北承德067000 [2]保定市第一中心医院,河北保定071000

出　　处：《菏泽医学专科学校学报》2024年第2期20-24,共5页Journal of Heze Medical College

基　　金：保定市科技计划项目(2141ZF242)。

摘　　要：目的 了解THP方案在真实世界临床实践的应用状况,同时评价该方案的疗效、安全性和耐受性。方法 选择在保定市第一中心医院等河北省11家三级甲等医院接受THP方案新辅助治疗并完成序贯手术的HER-2阳性乳腺癌患者70例为研究对象,制订专用的患者资料信息收集表,专人负责收集符合纳入标准患者的临床病理资料。评估THP方案的有效性、安全性和耐受性。主要研究终点为病理完全缓解(pCR)率、≥3级不良反应的发生率、既定治疗方案完成率。结果 总人群pCR率为54.3%。亚组分析显示,cTNMⅠ-Ⅱ期、激素受体阴性、HER-2 IHC3+患者的pCR率分别显示出高于c TNMⅢ期、激素受体阳性、HER-2 IHC2+/FISH+患者的趋势,但差异无统计学意义(P>0.05)。4周期患者的pCR率显著高于4周期以上患者(P<0.05)。≥3级不良反应发生率为4.3%。既定方案完成率为98.6%。结论THP方案在河北省得到广泛应用,是HER-2阳性乳腺癌患者新辅助治疗的有效方案,安全性及耐受性良好,可以考虑作为激素受体阴性、肿瘤负荷较小、对联合化疗耐受性差患者的新辅助备选方案。Objective To understand the application status of trastuzumab plus pertuzumab combined with taxanes(THP)regimen in clinical practice,and evaluate the efficacy,safety and tolerability of THP regimen.Methods 70 patients with HER-2 positive breast cancer,who received THP neoadjuvant regimen and completed sequential surgery at 11 tertiary-level A hospitals in Hebei Province,were selected as study subjects.A special patient data collection form was developed,and specialized person were responsible for collecting the clinical pathologic data of patients who met the inclusion criteria so as to assess the effectiveness,safety and tolerability of the THP regimen.The primary study endpoints were the rate of pathologic complete response(pCR),the incidence rate of adverse events grade≥3,and completion rate of the established treatment regimen.Results The pCR rate of the total population was 54.3%.Subgroup analysis showed that the pCR rate of cTNM stage I-II,hormone receptor-negative,HER-2 IHC3+patients was higher than that of cTNM stage III,hormone receptor-positive,HER-2 IHC2+/FISH+patients,but the difference was not statistically significant(P>0.05).The pCR rate of 4 cycles of neoadjuvant therapy was higher than that with more than 4 cycles(P<0.05).The incidence rate of adverse events grade≥3 was 4.3%(3/70).The completion rate for established regiments was 98.6%(69/70).Conclusion THP regimen has been widely used in Hebei province.It is an effective neoadjuvant therapy for patients with HER-2 positive breast cancer,with good safety and tolerance.It may be considered as an alternative neoadjuvant therapy for patients with negative hormone receptors,low tumor burden,and poor tolerance to combination chemotherapy.

关 键 词：乳腺癌 人表皮生长因子受体2 新辅助治疗 完全缓解 

分 类 号：R655.8[医药卫生—外科学]