小剂量阿帕替尼治疗晚期乳腺癌的效果和安全性分析  

Efficacy and safety analysis of low-dose apatinib in the treatment of advanced breast cancer

作　　者：曾天宇 孙春晓[1] 杨帆[1] 李俊[1] 李薇[1] 殷咏梅[1] ZENG Tianyu;SUN Chunxiao;YANG Fan;LI Jun;LI Wei;YIN Yongmei(Department of Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China)

机构地区：[1]南京医科大学第一附属医院肿瘤科,南京210029

出　　处：《临床肿瘤学杂志》2020年第5期451-455,共5页Chinese Clinical Oncology

基　　金：中国临床肿瘤学科学基金资助项目(2018,Y-sy2018-242)。

摘　　要：目的探讨小剂量阿帕替尼治疗晚期乳腺癌的效果和安全性。方法回顾性分析本院2017年3月至2019年2月收治的71例晚期乳腺癌患者的临床资料,其中45例接受小剂量阿帕替尼(250 mg,每日1次口服,21天为1个周期)治疗(阿帕替尼组),余26例仅接受标准化疗方案(化疗组),2个周期后分别采用实体瘤疗效评价标准(RECIST)1.1版和美国国家癌症研究所常见不良反应事件评价标准(NCI-CTC AE)4.03版评估疗效和不良反应,根据随访数据进行生存分析并采用Cox比例风险回归模型进行多因素分析。结果两组均完成2个周期及以上治疗,可进行疗效评价,均无获CR者,其中阿帕替尼组45例获PR 11例、SD 26例和PD 8例,总有效率(RR)和疾病控制率(DCR)分别为24.4%和82.2%,而化疗组26例获PR 1例、SD 12例和PD 13例,RR和DCR分别为3.8%和50.0%。阿帕替尼组的RR和DCR均优于化疗组,差异有统计学意义(P<0.05)。阿帕替尼组的中位无进展生存期(PFS)为4.1个月,优于化疗组的3.0个月(P<0.05);单因素分析发现前期接受蒽环类药物(5.5个月vs.3.2个月)或贝伐单抗(4.9个月vs.3.8个月)治疗者拥有更长的PFS(P<0.05)。多因素分析显示前期曾接受蒽环类药物(OR=2.156,95%CI:1.264~4.156)或贝伐单抗治疗(OR=1.956,95%CI:1.368~3.458)均为延长PFS的独立因素。阿帕替尼组患者的不良反应多为高血压、贫血和手足综合症,多为1~2级。结论晚期乳腺癌患者可从小剂量阿帕替尼治疗中获益,尤其是既往曾接受蒽环类药物或贝伐单抗者,且不良反应较轻,值得进一步深入研究。Objective To investigate the efficacy and safety of low-dose apatinib in the treatment of advanced breast cancer.Methods Clinical data of 71 patients with advanced breast cancer admitted to our hospital from March 2017 to February 2019 were analyzed retrospectively.Among them,45 patients received low-dose apatinib(250 mg,once daily oral,21 days as a cycle)treatment(apatinib group),and 26 patients only received standard chemotherapy(chemotherapy group).After two cycles,the therapeutic effect and adverse reactions were evaluated by response evaluation criteria in solid tumors(RECIST)version 1.1 and national cancer institute common terminology criteria for adverse events(NCI-CTC AE)version 4.03.Survival analysis was conducted according to the follow-up data and multivariate analysis was conducted by Cox risk proportion regression model.Results Both groups completed at least two cycles of treatment,and the curative effect could be evaluated.There was no CR patient in both groups.There was PR in 11 cases,SD in 26 cases and PD in 8 cases among 45 patients in apatinib group with response rate(RR)of 24.4%and disease control rate(DCR)of 82.2%.Moreover,there were PR in 1 case,SD in 12 cases and PD in 13 cases among 26 patients in chemotherapy group with RR of 3.8%and DCR of 50.0%.Both RR and DCR of apatinib group were better than those of chemotherapy group(P<0.05).The median progression-free survival(PFS)of apatinib group was 4.1 months,better than 3.0 months of chemotherapy group(P<0.05).Univariate analysis showed that patients who had received anthracycline drugs(5.5 months vs.3.2 months)or bevacizumab(4.9 months vs.3.8 months)had longer PFS(P<0.05).Multivariate analysis showed that previous treatment with anthracycline(OR=2.156,95%CI:1.264-4.156)or bevacizumab(OR=1.956,95%CI:1.368-3.458)were independent factors for prolonging PFS.The adverse reactions of patients in apatinib group were mainly hypertension,anemia and hand foot syndrome,and mostly grade 1 to 2.Conclusion Patients with advanced breast cancer can benefit f

关 键 词：乳腺癌 阿帕替尼 疗效 预后 

分 类 号：R737.9[医药卫生—肿瘤]