阿帕替尼后线治疗晚期食管鳞癌患者的疗效及安全性  

Efficacy and Safety of Apatinib Monotherapy as Subsequent-line Therapy on Patients with Advanced Esophageal Squamous Cell Carcinoma

作　　者：侯继院[1] 祁佩红[2] 王海霞[1] 龚哲[1] 单国用[1] HOU Jiyuan;QI Peihong;WANG Haixia;GONG Zhe;SHAN Guoyong(Department of Radiotherapy,Zhengzhou People’s Hospital,Zhengzhou 450003,China;Department of Imaging,Zhengzhou People’s Hospital,Zhengzhou 450003,China)

机构地区：[1]郑州人民医院放疗科,郑州450003 [2]郑州人民医院影像科,郑州450003

出　　处：《肿瘤防治研究》2022年第3期219-224,共6页Cancer Research on Prevention and Treatment

基　　金：河南省医学科技攻关计划(联合共建)项目(LHGJ20191092)。

摘　　要：目的探讨阿帕替尼后线治疗晚期ESCC患者的疗效和安全性。方法纳入56例后线接受阿帕替尼单药治疗的晚期ESCC患者。阿帕替尼治疗的起始剂量为每天500 mg或250 mg。分析患者的临床病理资料、不良反应及预后。研究主要终点为无进展生存期(PFS),次要终点为客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)和接受阿帕替尼治疗的安全性。结果56例ESCC患者均符合入选标准且均可评价疗效与不良反应。阿帕替尼单药后线治疗晚期ESCC患者的ORR为8.9%(95%CI:3.0%~19.6%),DCR为64.3%(95%CI:50.4%~76.6%)。中位PFS为3.7月(95%CI:3.19~4.21),中位OS为6.3月(95%CI:3.53~9.08)。晚期ESCC患者后线接受阿帕替尼治疗过程中相对常见的不良反应有高血压(50.0%)、乏力(41.1%)、食欲下降(35.7%)、手足综合征(30.4%)和腹泻(26.8%)等。结论阿帕替尼单药在晚期ESCC患者后线治疗中具有潜在的疗效及可耐受的安全性。但研究结果尚需要前瞻性临床研究进一步验证。Objective To investigate the efficacy and safety of apatinib monotherapy as subsequent-line therapy on patients with advanced ESCC.Methods We included 56 patients with advanced ESCC who were administered with apatinib monotherapy.The initial dosage of apatinib was 500mg or 250mg daily.Clinicopathological characteristics,adverse reaction and prognosis of the patients were analyzed.The primary endpoint of this study was PFS,the secondary endpoints were ORR,DCR,OS and safety of apatinib administration.Results All the 56 patients with ESCC corresponded with the eligibility criteria and were available for the evaluation of efficacy and adverse reaction.The ORR of the 56 patients who received apatinib monotherapy was 8.9%(95%CI:3.0%-19.6%)and DCR was 64.3%(95%CI:50.4%-76.6%).The median PFS was 3.7 months(95%CI:3.19-4.21)and the median OS was 6.3 months(95%CI:3.53-9.08).The common adverse reactions were hypertension(50.0%),fatigue(41.1%),loss of appetite(35.7%),hand-foot syndrome(30.4%)and diarrhea(26.8%).Conclusion Apatinib monotherapy demonstrates potential efficacy and tolerable safety as the further-line treatment for the patients with advanced ESCC.And the conclusion should be validated in prospective clinical studies subsequently.

关 键 词：食管鳞癌 阿帕替尼 疗效 预后 安全性 

分 类 号：R735.1[医药卫生—肿瘤]