阿帕替尼治疗晚期乳腺癌疗效与安全性分析  

Efficacy and safety of apatinib in patients with advanced breast cancer

作　　者：沈雪敬 张伟杰[1] 马志俊[1] 马咪静 王留兴[1] SHEN Xue-jing;ZHANG Wei-jie;MA Zhi-jun;Ma Mi-jing;WANG Liu-xing(Department of Oncology,First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,P.R.China)

机构地区：[1]郑州大学第一附属医院肿瘤科,河南郑州450052

出　　处：《中华肿瘤防治杂志》2019年第8期549-553,共5页Chinese Journal of Cancer Prevention and Treatment

基　　金：河南省医学科技攻关计划(201602068)

摘　　要：目的晚期乳腺癌患者一般体质较弱,既往治疗失败后,对化疗耐受性差、效果不明显,因此寻找疗效好、不良反应轻的新药尤为重要。本研究对阿帕替尼治疗晚期乳腺癌疗效及安全性进行分析。方法回顾性分析2016-09-06-2018-03-10郑州大学第一附属医院收治的47例既往化疗失败或复发转移后使用阿帕替尼的晚期乳腺癌患者临床资料,分析阿帕替尼单药(17例)和联合化疗(30例)患者的无进展生存期(progression free survival,PFS)、客观有效率和疾病控制率。结果 Kaplan-Meier法分析结果显示,47例晚期乳腺癌患者的中位PFS为113d(95.54～130.46)。17例阿帕替尼单药组患者中位PFS为90d,30例阿帕替尼联合化疗组患者中位PFS为113d,差异无统计学意义,P=0.672。治疗后部分缓解(partial response,PR)6例,疾病稳定(stable disease,SD)31例,疾病进展(progressive disease,PD)10例,客观有效率(objective response rate,ORR)为12.77%,疾病控制率(disease control rate,DCR)为78.72%,两组ORR(P=1.000)和DCR(P=0.512)差异均无统计学意义。多因素Cox回归结果显示,雌激素受体(estrogen receptor,ER)阳性表达(HR=0.429,95%CI:0.204～0.905,P=0.026)、治疗期间出现高血压(HR=0.452,95%CI:0.232～0.881,P=0.020)是影响阿帕替尼治疗晚期乳腺癌PFS的预后保护性因素;既往化疗次数≥4次(HR=2.197,95%CI:1.163～4.418,P=0.015)是其预后危险性因素。不良反应大多数为轻中度(1～2级),经处理可以好转或耐受。结论阿帕替尼治疗晚期乳腺癌有一定疗效,不良反应可控,耐受性好,但尚需扩大样本进一步验证。OBJECTIVE Patients with advanced breast cancer always have a poor physical condition.After prior failure treatments,they have a bad tolerance and response to chemotherapy,it is important to find a new drug which has a good effect and mild side effects to those patients.This study was to observe the efficacy and safety of apatinib. METHODS Between September 06,2016 and March 10,2018,the clinical data of 47 patients with advanced breast cancer of Department of Oncology and Breast Surgery in the First Affiliated Hospital of Zhengzhou University who had received apatinib after failure of prior lines of chemotherapy or suffering from the recurrence or metastases were retrospectively an- alyzed.The progression free survival(PFS),objective response rate(ORR)and disease control rate(DCR)between the the rapyof single agent apatinib and combination chemotherapy containing apatinib were compared.RESULTS Using the Kaplan-Meier estimating,the median PFS(mPFS) of 47 patients was 113 days (95.54 to 130.46).The mPFS was 90 days in the 17 cases single agent apatinib group and 113 days in the 30 cases apatinib combination group.The difference be- tween two groups did not reach statistical significance(P=0.672).After the therapy,6 patients had partial response, 31 patients had stable disease,and 10 patients had disease progression,ORR was 12.77%,and DCR was 78.72%.The difference of ORR and DCR between two groups neither reached statistical significance(P=1.000,P=0.512).Multivari- ate Cox proportional hazards regression analysis indicated that the positive status of estrogen receptor(ER)(HR=0.429, 95%CI:0.204-0.905,P=0.026),the hypertension during the therapy(HR=0.452,95%CI:0.232-0.881,P=0.020) were protective factors while the numbers of chemotherapy (HR=2.197,95%CI:1.163-4.418,P=0.015)were risk factors affecting PFS of breast cancer patients.The treatment-related side effects which were controlled and tolerated well were mild to moderate mostly and ranked as class 1-2.CONCLUSION Apatinib has a certain therapeutic effect, controlle

关 键 词：晚期乳腺癌 阿帕替尼 临床疗效 安全性 血管内皮生长因子受体 

分 类 号：R737.9[医药卫生—肿瘤]