阿帕替尼治疗晚期结直肠癌的有效性和安全性

Efficacy and safety of apatinib in the treatment of advanced colorectal cancer

目的探讨阿帕替尼治疗晚期结直肠癌的有效性和安全性。方法选取河南科技大学第一附属医院2018年1月至2019年12月收治的60例二线化疗失败的晚期结直肠癌患者,患者口服阿帕替尼(500 mg/d,28 d治疗周期)片剂。由于不良事件导致的治疗中断被允许不超过14 d。阿帕替尼的剂量减少(从500 mg/d减少到250 mg/d)被允许用于处理与治疗相关的不良事件。患者接受治疗,直到疾病进展、出现不可接受的毒性、死亡或因任何其他原因停用阿帕替尼。通过对患者的既往资料、电话、门诊等进行随访。对失访病例以最后一次的随访时间为准,对截止到随访日存活患者也按删失处理。本研究的主要观察指标为无进展生存期,次要观察指标为近期疗效和不良反应。结果接受阿帕替尼治疗的患者的中位无进展生存期为3.0个月(95%CI:1.924~4.076个月)。中位总生存期为5.4个月(95%CI:3.384~7.417个月)。60例患者的不良事件一般较轻,主要为1~2级。在我们的分析中没有出现4级不良事件。在研究期间,没有患者死于药物相关的原因。结论阿帕替尼被证明对晚期mCRC提供中等疗效。需要一项多中心前瞻性研究来确定阿帕替尼单药治疗晚期mCRC的价值。

Objective To investigate the efficacy and safety of apatinib in the treatment of advanced colorectal cancer.Methods From January 2018 to December 2019,60 patients with advanced colorectal cancer who failed second-line chemotherapy were selected in the First Affiliated Hospital of Henan University of science and technology.The patients were treated with oral apatinib(500 mg/D,28 day treatment cycle)tablets.Interruption of treatment due to adverse events was allowed for no more than 14 days.Dose reduction of apatinib(from 500 mg/D to 250 mg/D)was allowed for treatment-related adverse events.Patients were treated until disease progression,unacceptable toxicity,death,or discontinuation of apatinib for any other reason.Through the patient’s past information,telephone,outpatient follow-up.For the lost cases,the last follow-up time shall be taken as the standard,and the survival patients up to the follow-up day shall also be deleted.The main outcome measures were progression free survival,and the secondary outcome measures were short-term efficacy and adverse reactions.Results The median progression free survival was 3.0 months(95%CI:1.924-4.076 months).The median overall survival was 5.4 months(95%CI:3.384-7.417 months).The adverse events of 60 patients were generally mild,mainly grade 1-2.There were no grade 4 adverse events in our analysis.No patients died of drug-related causes during the study period.Conclusions Apatinib has been shown to provide moderate efficacy for advanced MCRC.A multicenter prospective study is needed to determine the value of apatinib monotherapy for advanced MCRC.