曲妥珠单抗和帕妥珠单抗联合不同化疗方案新辅助治疗HER-2阳性乳腺癌真实世界疗效及安全性观察  

Neoadjuvant treatment of HER-2 positive breast cancer with trastuzumab plus pertu-zumab combined with different chemotherapy regimens in real-world clinical practice:clinical efficacy and safety evaluation

作　　者：岳瑞雪[1] 胡崇珠[1] 郝鑫[2] 杨进强[3] 韩猛[4] 崔国忠[5] 王建军 张志生[7] 孔凡庭[8] 张维[9] 何文博[10] 李现桥[11] 周新平[12] Ruixue Yue;Chongzhu Hu;Xin Hao;Jinqiang Yang;Meng Han;Guozhong Cui;Jianjun Wang;Zhisheng Zhang;Fanting Kong;Wei Zhang;Wenbo He;Xianqiao Li;Xinping Zhou(The First Department of Breast Surgery,Baoding NO.1 Central Hospital,Baoding 071000,China;Department of Breast Surgery,The Affiliated Hospital of Hebei University,Baoding 071000,China;Department of Glandular Vascular Surgery,Harrison International Peace Hospital,Hengshui 053000,China;Department of Breast Disease Center,The First Hospital of Qinhuangdao,Qinhuangdao 066000,China;The Second Department of Thyroid Breast Surgery,Cangzhou Central Hospital,Cangzhou 061001,China;Department of Breast Surgery,Hebei Petrochina Central Hospital,Langfang 065000,China;Department of Breast surgery,The First Affiliated Hospital of Hebei North University,Zhangjiakou 075000,China;Department of Breast Surgery,Xingtai People's Hospital,Xingtai 054001,China;The First Department of Thyroid Breast Surgery,Cangzhou Central Hospital,Cangzhou 061001,China;Department of Glandular Surgery,Dingzhou People's Hospital,Dingzhou 073000,China;The First Department of Breast Surgery,The Affiliated Hospital of Hebei University of Engineering,Handan 056001,China;Department of Breast Surgery,Handan Central Hospital,Handan 056001,China)

机构地区：[1]保定市第一中心医院乳腺外一科,河北省保定市071000 [2]河北大学附属医院乳腺外科 [3]哈励逊国际和平医院(衡水市人民医院)腺体血管外科 [4]秦皇岛市第一医院乳腺外科 [5]沧州市中心医院甲乳外二科 [6]河北中石油中心医院乳腺外科 [7]河北北方学院附属第一医院乳腺外科 [8]邢台市人民医院乳腺外科 [9]沧州市中心医院甲乳外一科 [10]定州市人民医院腺体外科 [11]河北工程大学附属医院乳腺外一科 [12]邯郸市中心医院乳腺外科

出　　处：《中国肿瘤临床》2023年第5期248-254,共7页Chinese Journal of Clinical Oncology

基　　金：保定市科技计划项目(编号:2141ZF242)资助。

摘　　要：目的:比较曲妥珠单抗和帕妥珠单抗(trastuzumab plus pertuzumab,HP)联合紫杉类+铂类(TCbHP)、紫杉类单药(THP)、蒽环类序贯紫杉类(AC-THP)三种化疗方案在真实世界临床实践中新辅助治疗HER-2阳性乳腺癌的疗效、安全性及耐受性。方法:回顾性分析2019年6月至2021年12月于保定市第一中心医院等河北省共11家三级甲等医院接受三种方案新辅助治疗并完成后续手术的180例HER-2阳性乳腺癌患者的临床病理资料,其中TCbHP组78例、THP组70例、AC-THP组32例,比较三种治疗方案的疗效、安全性及耐受性,并采用统计学方法分析临床病理因素对总体病理完全缓解(total pathologic complete response,tpCR)率的影响。结果:总人群tpCR率为58.9%(106/180)。TCbHP组的tpCR率为64.1%(50/78),高于THP组的54.3%(38/70)和AC-THP组的56.3%(18/32),差异无统计学意义(P=0.454)。TCbHP组的3级及以上不良反应发生率为12.8%(10/78),高于THP组的4.3%(3/70)和AC-THP组的9.4%(3/32),差异无统计学意义(P=0.255)。THP组的既定方案完成率为98.6%(69/70),高于TCbHP组的92.3%(72/78)和AC-THP组的90.6%(29/32),差异无统计学意义(P=0.147)。180例患者中绝经后组与绝经前组的tpCR率分别为65.4%(70/107)与49.3%(36/73),HER-2免疫组织化学法(IHC)3+组与HER-2 IHC2+且荧光原位杂交(FISH)+组的tpCR率分别为65.0%(102/157)与17.4%(4/23),激素受体(HR)阴性组与HR阳性组的tpCR率分别为78.0%(64/82)与42.9%(42/98),白蛋白结合型紫杉醇组与其他紫杉类药物组的tpCR率分别为66.3%(65/98)与50.0%(41/82),组间进行比较差异均具有统计学意义(均P<0.05)。Logistic回归多因素分析表明,HER-2 IHC3+、HR阴性、使用白蛋白结合型紫杉醇为tpCR率的独立影响因素。结论:TCbHP、THP、AC-THP方案新辅助治疗HER-2阳性乳腺癌在真实世界临床实践中疗效确切,安全性及耐受性良好。TCbHP方案可考虑作为HER-2阳性乳腺癌新辅助治疗的优选方案。Objective::To evaluate the efficacy,safety,and tolerability of trastuzumab plus pertuzumab(HP)combined with taxane+platinum(TCbHP),taxane(THP),and anthracycline sequential taxane(AC-THP)in the neoadjuvant therapy of HER-2 positive breast cancer in real-world clinical practice.Methods:A retrospective investigation was conducted on the clinicopathological data of 180 patients with HER-2 positive breast cancer who received one of the three regimens of neoadjuvant therapy and underwent the follow-up surgeries between June 2019 and December 2021 at 113A-grade hospitals,including Baoding NO.1 Central Hospital.Among the patients,78,70,and 32 were assigned to the TCbHP,THP,and AC-THP groups,respectively.The effectiveness,safety,and tolerability of the three regimens were compared in addition to examining the influence of clinicopathological factors on the total pathologic complete response(tpCR)rate.Results:The overall tpCR rate was 58.9%(106/180).The TCbHP group’s tpCR rate was 64.1%(50/78),which was higher than THP group’s 54.3%(38/70)and AC-THP group’s 56.3%(18/32),with no significant difference(P=0.454).The incidence of≥grade 3 adverse reactions in the TCbHP group was 12.8%(10/78),which was higher than THP group’s 4.3%(3/70)and AC-THP group’s 9.4%(3/32),with no significant difference(P=0.255).The THP group completed the given approaches at a rate of 98.6%(69/70),which was higher than TCbHP group’s 92.3%(72/78)and AC-THP group’s 90.6%(29/32),with no significant difference(P=0.147).The tpCR rates of the 180 patients were 65.4%(70/107)and 49.3%(36/73)in the postmenopausal and premenopausal groups,respectively.In the HER-2 immunohistochemistry(IHC)3+group and HER-2 IHC2+fluorescence in situ hybridization+group,the tpCR rates were 65.0%(102/157)and 17.4%(4/23),respectively.The hormone receptor(HR)-negative and-positive groups had tpCR rates of 78.0%(64/82)and 42.9%(42/98),respectively.The tpCR rates were 66.3%(65/98)and 50.0%(41/82)in the albumin-bound paclitaxel group and other paclitaxel drug group,respe

关 键 词：新辅助治疗 HER-2阳性 乳腺癌 

分 类 号：R737.9[医药卫生—肿瘤]