低剂量阿帕替尼联合化疗二线治疗晚期胃癌的有效性和安全性  

Efficiency and safety of low-dose Apatinib in combination with chemotherapy as second-line treatment in advanced gastric cancer

作　　者：邱志远[1] 田广玉 濮勇[2] 张坤 张召 张军 QIU Zhi-yuan;TIAN Guang-yu;PU Yong;ZHANG Kun;ZHANG Zhao;ZHANG Jun(Department of Oncology,the Affiliated People＇s Hospital of Jiangsu University,Zhenjiang 212002,Jiangsu,CHINA;Department of General Surgery,the Affiliated People＇s Hospital of Jiangsu University,Zhenjiang 212002,Jiangsu,CHINA;Department of General Surgery,the Third People＇s Hospital of Danyang,Zhenjiang 212300,Jiangsu,CHINA)

机构地区：[1]江苏大学附属人民医院肿瘤科,江苏镇江212002 [2]江苏大学附属人民医院普外科,江苏镇江212002 [3]丹阳市第三人民医院普外科,江苏丹阳212300

出　　处：《海南医学》2018年第19期2699-2703,共5页Hainan Medical Journal

基　　金：江苏省自然科学基金(编号:BK20161354);江苏省镇江市社会发展基金(编号:SH2015062)

摘　　要：目的探讨低剂量阿帕替尼联合化疗二线治疗晚期胃癌的有效性和安全性。方法选取江苏大学附属人民医院2015年11月至2017年11月经病理确诊的50例一线化疗失败晚期胃癌患者为研究对象,给予阿帕替尼250 mg/d或500 mg/d口服,化疗方案为单药化疗(替吉奥或者多西他赛),按照体表面积给药,28 d为一个周期。观察临床疗效及不良反应,直至疾病进展。应用Kaplan-Meier法进行生存分析,Cox比例风险模型分析独立预后因素。结果根据RECIST标准评价疗效,其中完全缓解率为0 (0/50),部分缓解率为10%(5/50),疾病稳定率为62%(31/50),疾病进展为28%(14/50);客观缓解率为10%,疾病控制率为72%;中位无进展生存期为(115.0±6.5) d(95%CI 102.3～127.7),中位生存时间为(181±15.3) d (95%CI 151.2～211.1);Cox回归模型显示,高血压、白细胞减少、转移部位数目和ECOG是影响患者OS的独立预后因素(P<0.05);常见的不良反应是白细胞减少(50%)、高血压(42%)和蛋白尿(12%),发生高血压、白细胞减少的患者阿帕替尼疗效较好。结论阿帕替尼联合化疗二线治疗晚期胃癌有较好的疾病控制及生存获益,不良反应可控制,值得临床上应用。Objective To evaluate the efficacy and safety of low-dose Apatinib in combination with chemotherapy as second-line treatment in the treatment of advanced gastric cancer. Methods Between November 2015 and November 2017, totally 50 patients in the Affiliated People＇s Hospital of Jiangsu University with pathologically confirmed advanced gastric cancer who failed first-line chemotherapy were enrolled and followed up retrospectively. Apatinib was administered as 500 mg or 250 mg daily through each 4-week cycle until disease progression. Single-drug chemotherapy was used and cycled every 28 days. Clinical efficacy and adverse events were observed. Kaplan-Meier method was used for survival analysis, and Cox＇s proportional hazards model was used for analysis of independent prognostic factors. Results All the patients were evaluated for therapeutic effects according to the Response Evaluation Criteria in Solid Tumors（RECIST） standard. The complete response rate, partial response rate, stable disease rate,and progressive disease rate were 0（0/50）, 10%（5/50）, 62%（31/50）, and 28%（14/50）, respectively. The objective response rate and the disease control rate were 10% and 72%, respectively. The median progression-free survival time and median overall survival time were（115.0±6.5） days（95% CI 102.3-127.7） and（181±15.3） days（95% CI 151.2-211.1）,respectively. Cox＇s proportional hazards model analysis showed that hypertension, leukopenia, number of metastatic sites and ECOG were independent prognostic factors. The main adverse events were leucopenia（50%）, hypertension（42%）, and proteinuria（12%）, and patients with hypertension and leukopenia had better efficacy during Apatinib therapy.Conclusion Apatinib in advanced gastric cancer patients after failure of first-line chemotherapy is still beneficial in terms of disease control rate and survival, and adverse events are tolerable.

关 键 词：阿帕替尼 胃癌 靶向治疗 疗效 安全性 

分 类 号：R735.2[医药卫生—肿瘤]