真实世界中安罗替尼治疗晚期胃癌的疗效及预后相关因素分析  

Analysis of Efficacy and Prognostic Factors of Anlotinib for Patients with Advanced Gastric Cancer in the Real World

作　　者：沈珠[1] 项铮 王辉[2] 张玉松[2] 刘纯[3] 潘杰[1] SHEN Zhu;XIANG Zheng;WANG Hui;ZHANG Yu-song;LIU Chun;PAN Jie(Department of Pharmacy,The Second Affiliated Hospital of Soochow University,Suzhou 215004,China;Department of Oncology,The Second Affiliated Hospital of Soochow University,Suzhou 215004,China;Departmen of Pharmacy,The Suzhou Municipal Hospital,Suzhou 215002,China)

机构地区：[1]苏州大学附属第二医院药剂科,江苏苏州215004 [2]苏州大学附属第二医院肿瘤内科,江苏苏州215004 [3]苏州市立医院药剂科,江苏苏州215002

出　　处：《海峡药学》2024年第9期68-72,共5页Strait Pharmaceutical Journal

基　　金：江苏省医学会天晴医院药学基金(Q2019060);吴阶平医学基金(320.6750.2020-12-72);苏州市科技发展计划(SYSD2020185)。

摘　　要：目的观察盐酸安罗替尼胶囊用于晚期胃癌患者的临床疗效和安全性,寻找与预后相关的临床危险因素。方法回顾性分析2018年6月至2022年6月苏州大学附属第二医院收治的81例经组织学确诊为胃癌晚期并使用安罗替尼的患者,记录相关临床信息,治疗方案,临床疗效和安全性,分析预后影响因素。结果81例晚期胃癌患者中,完全缓解(CR)0例,部分缓解(PR)6例,疾病稳定(SD)30例,疾病控制率(DCR)46.2%。中位无进展生存时间(PFS)为2.3个月(95%CI:1.5~3.1个月),中位总生存时间(OS)为4.4个月(95%CI:3.7~5.1个月)。单因素分析显示,性别,手术与否,药物治疗方案,肝转移情况,D-二聚体值和Her2状态在PFS和OS的分层分析中均有显著差异(P<0.05)。多因素Cox回归模型分析,手术和治疗方案是影响晚期胃癌患者总生存期的独立预后因素。安罗替尼常见不良反应为乏力、手足皮肤反应、恶心、呕吐、甲状腺功能异常和高血压,发生率分别为48.1%(39/81),37.0%(30/81),29.6%(24/81),28.4%(23/81)和18.5%(15/81),未出现4级不良反应。结论与既往研究数据相比,安罗替尼用于二线及以上晚期胃癌的治疗优于传统化疗方案,且患者耐受性良好,但与阿帕替尼和雷莫芦单抗相比,并无优势。安罗替尼不同的药物治疗方案对总生存期也有影响,其中安罗替尼联合化疗的治疗方案更优,安罗替尼联合免疫的治疗方案并没有延长患者生存期。OBJECTIVE To observe the clinical efficacy and safety of Anloti nib hydrochloride capsules in patients with advanced gastric cancer,and to find the clinical prognostic factors.METHODS Retrospective analysi s was performed on 81 patients with advanced gastric cancer diagnosed histologic ally and treated in the Second Affiliated Hospital of Soochow University from Ju ne 2018 to June 2022.Relevant clinical information,treatment plan,clinical ef ficacy and safety were recorded,and prognostic factors were analyzed.R ESULTS Among 81 patients with advanced gastric cancer,0 patients had c omplete response(CR),6 patients had partial response(PR),30 patients had sta ble disease(SD),and the disease control rate(DCR)was 46.2%.Median progress ion-free survival(PFS)was 2.3 months(95%CI:1.5-3.1 months),and median overall survival(OS)was 4.4 months(95%CI:3.7-5.1 months).Univariate a nalysis showed significant differences in gender,surgery or not,drug regimen,liver metastases,D-dimer value,and Her2 status in stratified analyses of PFS and OS(P<0.05).Multivariate Cox regression analysis,surgery and drug regimen are independent prognostic factors for advanced gastric cancer.The general adverse reactions were fatigue,hand-foot-skin reaction,nausea,vomiting,abnormal thyroid function and hypertension,with the incidence of 48.1%(39/81),37.0%(30/81),29.6%(24/81),28.4%(23/81)and 18.5%(15/81),resp ectively,and no grade 4 adverse reactions occurred.CONCLUSION Compared with previous research data,anrotinib is better than traditional che motherapy in the treatment of second-line and higher advanced gastric cancer,a nd patients are well tolerated.However,there is no advantage compared with apa tinib and ramucirumab.Different drug regimens of antirotinib also had an effect on PFS and OS,among which antirotinib combined with chemotherapy was better,a nd antirotinib combined with immunization did not extend survival.

关 键 词：胃癌 安罗替尼 疗效 预后因素 

分 类 号：R969.4[医药卫生—药理学]