阿帕替尼联合卡培他滨三线治疗晚期三阴性乳腺癌的临床观察  

Apatinib combined with capecitabine in the treatment of advanced triple-negative breast cancer as third-line therapy:An observational study

作　　者：王爱娟 过怿赟[2] 汪志求[1] WANG Aijuan;GUO Yiyun;WANG Zhiqiu(Department of Oncology,Anqing Hospital Affiliated to Anhui Medical University,Anqing 246003,Anhui,China;Center for Drug Evaluation,Yijishan Hospital of Wannan Medical College,Wuhu 241000,Anhui,China)

机构地区：[1]安徽医科大学附属安庆医院肿瘤内科,安徽安庆246003 [2]皖南医学院弋矶山医院药物评价中心,安徽芜湖241000

出　　处：《中国临床药理学与治疗学》2020年第4期433-439,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金资助项目(81173134);安徽医科大学校科学研究基金资助项目(2018xkj069)。

摘　　要：目的:探讨阿帕替尼联合卡培他滨三线治疗晚期三阴性乳腺癌的临床疗效和安全性。方法:2016年2月至2019年9月安徽医科大学附属安庆医院肿瘤内科收治的二线姑息化疗后失败的晚期三阴性乳腺癌60例,随机分为观察组(30例,阿帕替尼联合卡培他滨治疗)和对照组(30例,卡培他滨单药治疗)。观察比较两组的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)、1年生存率、总生存时间(OS)和不良反应发生情况。结果:观察组的ORR、DCR分别为26.67%、86.67%,对照组的ORR、DCR分别为6.67%、60.00%,观察组的ORR和DCR均明显高于对照组,差异具有统计学意义(P=0.038,0.020)。观察组与对照组的中位无进展生存时间(mPFS)分别为7.0个月和5.0个月,与对照组相比,观察组的PFS显著延长,差异具有统计学意义(P=0.000)。观察组的1年生存率和中位总生存时间(mOS)分别为55.30%和13.0个月,对照组的1年生存率和中位总生存时间(mOS)分别为46.30%和12.0个月,两组OS差异无统计学意义(P=0.258)。观察组高血压的发生率高于对照组,差异有统计学意义(P=0.000),经药物治疗后可控制,不良反应可耐受。结论:阿帕替尼联合卡培他滨三线治疗晚期三阴性乳腺癌具有一定的近期疗效,不良反应可耐受并可控。AIM:To investigate the efficacy and safety of apatinib combined with capecitabine in the treatment of advanced triple-negative breast cancer(TNBC)as third-line therapy.METHODS:Sixty advanced TNBC patients,who have failed to receive second-line palliative chemotherapy,were enrolled in the Department of Oncology,Anqing Hospital Affiliated to Anhui Medical University from February 2016 to September 2019.Patients were divided into observation group(n=30,received apatinib combined with capecitabine)and control group(n=30,received capecitabine)randomly.The objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),1-year survival rate,overall survival(OS)and adverse events between the two groups were observed and compared.RESULTS:ORR was 26.67%and DCR was86.67%in the observation group,while 6.67%and 60.00%in the control group,respectively.ORR and DCR in the observation group were better than those in the control group(P=0.038;0.020).Meanwhile,the median PFS was 7.0 months in the observation group,while it was 5.0 months in the control group,which indicated that the observation group exhibited a higher PFS than the control group(P=0.000).The 1-year survival rate and the median OS was 55.30%and 13.0 months in the observation group respectively,while those were 46.30%and 12.0 months in the control group respectively,the OS showed no significant differences between the two groups(P=0.258).In addition,we also found that there was significant differences in the adverse reaction such as hypertension between the two groups(P=0.000),yet it was mild and tolerable after symptomatic treatment.CONCLUSION:Apatinib combined with capecitabine in the advanced TNBC maintenance treatment has a certain survival benefit for those who failed in second-line therapy,and adverse reactions are tolerable and controllable.

关 键 词：阿帕替尼 抗血管生成药物 卡培他滨 三阴性乳腺癌 

分 类 号：R979.1[医药卫生—药品] R737.9[医药卫生—药学]