吡咯替尼联合优替德隆、卡培他滨在晚期HER-2阳性乳腺癌中的临床疗效和安全性分析  

Clinical efficacy and safety of Pyrotinib combined with Utidelone and Capecitabine on advanced HER-2 positive breast cancer

作　　者：黄冶秋 张逸雯 万冬冬 吴亮 HUANG Yeqiu;ZHANG Yiwen;WAN Dongdong(Department of Oncology,Haimen District People's Hospital of Nantong City,Jiangsu,Nantong 226100,China)

机构地区：[1]江苏省南通市海门区人民医院肿瘤科,226100 [2]江苏省南通市海门区人民医院内分泌科,226100

出　　处：《河北医药》2025年第2期263-266,270,共5页Hebei Medical Journal

基　　金：南通市科技项目(编号:MS12021057)。

摘　　要：目的探讨吡咯替尼联合优替德隆和卡培他滨在晚期人类表皮生长因子受体-2(HER-2)阳性乳腺癌患者中的近期疗效,并观察治疗相关药物不良反应发生率。方法选取2020年6月至2022年6月南通大学附属海门医院肿瘤科确诊的晚期HER-2阳性乳腺癌患者96例,随机数字分组法分为对照组和研究组,每组48例。对照组患者给予吡咯替尼联合卡培他滨治疗,研究组患者给予吡咯替尼联合优替德隆和卡培他滨治疗,共治疗6个周期。比较2组患者近期疗效,并按照国际癌症组织通用不良反应术语标准5.0版本(CTCAEV5.0)评价药物治疗相关不良反应。结果研究组患者客观缓解率(ORR)为85.42%,高于对照组的66.67%,差异有统计学意义(χ^(2)=4.631,P=0.031);研究组患者疾病控制率(DCR)为97.92%,虽高于对照组的93.75%,差异无统计学意义(χ^(2)=1.043,P=0.307)。研究组患者中位无进展生存期(PFS)、中位总生存期(OS)分别为(13.6±3.8)个月、(22.5±5.3)个月,长于对照组的(9.8±2.1)个月、(18.6±4.2)个月,差异有统计学意义(t=7.652、8.902,P<0.05)。研究组患者恶心呕吐、骨髓抑制、疲劳乏力和腹泻发生率虽高于对照组,差异无统计学意义(χ^(2)=0.396、0.677、0.416、0.668,P>0.05);研究组患者肌肉关节疼痛和周围性神经病发生率显著高于对照组,差异有统计学意义(χ^(2)=7.069、11.658,P<0.05)。结论吡咯替尼联合优替德隆和卡培他滨在晚期HER-2阳性乳腺癌患者中近期疗效肯定,有效延长生存期,治疗相关不良反应可控可耐受,为临床治疗提供新的思路。Objective To explore the short-term efficacy and adverse drug events of Pyrotinib combined with Utidelone and Capecitabine in patients with advanced human epidermal growth factor receptor-2(HER-2)positive breast cancer.Methods From June 2020 to June 2022,96 patients with advanced HER-2 positive breast cancer diagnosed by the Department of Oncology,Haimen Hospital,Nantong University were recruited,and randomly divide into the control group(n=48)and study group(n=48).Patients in the control group were treated with Pyrotinib combined with Capecitabine,while those in the study group were treated with Pyrotinib combined with Utidelone and Capecitabine for a total of 6 cycles.Short-t erm efficacy was compared between groups.Adverse drug events were evaluated based on the Common Terminology Criteria for Adverse Events(CTCAE)v5.0.Results The objective response rate(ORR)of patients in the study group was significantly higher than that of the control group(85.42%vs 66.67%,χ^(2)=4.631,P=0.031).The disease control rate(DCR)of the study group was higher than that of control group,but without a significant difference(97.92%vs 93.75%,χ^(2)=1.043,P=0.307).The median progression-free survival(PFS,13.6±3.8 months vs 9.8±2.1 months,t=7.652)and overall survival(OS,22.5±5.3 months vs 18.6±4.2 months,t=8.902)of the study group were significantly longer than those of control group(both P<0.05).The incidence of nausea and vomiting,bone marrow suppression,fatigue,fatigue,and diarrhea in the study group was higher than that of the control group,but without significant differences(χ^(2)=0.396,0.677,0.416 and 0.668,respectively;all P>0.05).The incidence of muscle joint pain and peripheral neuropathy in the study group was significantly higher than that of the control group(χ^(2)=7.069 and 11.658,respectively;both P<0.05).Conclusion The combination of Pyrotinib,Utidelone and Capecitabine has a positive short-term effect on advanced HER-2 positive breast cancer,which effectively prolongs the survival period,with controllable and toler

关 键 词：人类表皮生长因子受体-2 乳腺肿瘤 吡咯替尼 优替德隆 卡培他滨 临床研究 

分 类 号：R737.9[医药卫生—肿瘤]