甲磺酸阿帕替尼治疗晚期肝内胆管癌的临床观察

Clinical observation of apatinib mesylate in advanced intrahepatic cholangiocarcinoma

目的观察和评价甲磺酸阿帕替尼治疗晚期肝内胆管癌的疗效和安全性。方法回顾性分析2018年5月至2019年5月接受甲磺酸阿帕替尼治疗的15例晚期肝内胆管癌患者,均口服甲磺酸阿帕替尼(250 mg/日,4周为1个周期),其中一线治疗1例,二线治疗6例,其余为三线及以上治疗。采用RECIST 1.1版和NCI CTC 4.0版标准分别评价近期疗效和不良反应。生存分析采用Kaplan-Meier法。结果随访截止于2019年11月1日,失访1例,13例可评价近期疗效和无进展生存时间(PFS),14例可评价总生存时间(OS)。中位治疗时间为13周。13例患者中获PR 1例,SD 8例,PD 4例;有效率为7.7%,疾病控制率为69.2%;中位PFS为75天,中位OS为294天。主要不良反应包括高血压、手足皮肤反应、口腔溃疡、腹泻和蛋白尿等,以1~2级为主,3级不良反应为2例高血压。结论甲磺酸阿帕替尼治疗晚期肝内胆管癌效果较好,且耐受性良好。

Objective To observe and evaluate the efficacy and safety of apatinib mesylate in patients with advanced intrahepatic cholangiocarcinoma.Methods We rectospectively analyzed 15 patients with advanced intrahepatic cholangiocrcinoma who were treated with apatinib mesylate from May 2018 to May 2019.All patients were treated with apatinib mesylate 250 mg per day for a cycle of 4 weeks orally.One of them was treated as first line,six of second line,and others were given as third-line and above.Recent efficacy and toxicity were assessed by RECIST version 1.1 and NCI CTC version 4.0,respectively.Survival analysis was performed by Kaplan-Meier method.Results Until November 12019,1 patient lost to follow-up.Thirteen cases could be evaluated for short-term efficacy and progression-free survival(PFS),and overall survival(OS)could be evaluated in 14 patients.The median treatment period was 13 weeks.Among the 13 patients,there were 1 case of PR,8 of SD and 4 of PD.The response rate was 7.7%with 69.2%of disease control rate.Median PFS and median OS were 75 days and 294 days,respectively.The most common side effects included hypertension,hand-foot skin reaction,oral ulcer,diarrhea and proteinuria,mainly in grade 1-2.Grade 3 side effect was only found in 2 cases of hypertension.Conclusion Apatinib mesylate is an effective and well-tolerated candidate in patients with advanced intrahepatic cholangiocarcinoma.