安罗替尼后线治疗晚期转移性结直肠癌的临床观察

Efficacy and safety of anlotinib as post third-1ine chemotherapy for metastatic colorectal cancer

目的探讨盐酸安罗替尼后线治疗晚期结直肠癌的效果和安全性。方法给予本院2018年5月至2019年1月收治的既往曾接受三线及以上标准治疗的晚期转移性结直肠癌41例患者盐酸安罗替尼胶囊(12 mg/d)治疗,连续用药2周停1周。根据RECIST 1.1版标准和NCI CTC 4.0版标准评价疗效和不良反应,根据随访数据分析影响预后的因素。结果41例患者至随访结束死亡5例,其余36例无获完全缓解病例,2例部分缓解、15例稳定和19例进展,有效率和疾病控制率分别为4.9%和41.5%。全组随访9.2~20.1个月,中位随访时间为10.8个月,中位无进展生存期(PFS)为1.9个月。性别、年龄、原发灶部位、饮酒史、放疗史、免疫治疗史和Ras突变与PFS无关(P>0.05),而肝转移和肺转移与PFS有关(P<0.05)。肝转移是影响安罗替尼后线治疗晚期转移性结直肠癌PFS的独立预后因素(HR=2.94,95%CI=1.35~6.36,P=0.006)。最常见不良反应为高血压、乏力、恶心呕吐和蛋白尿,发生率依次为26.83%(11/41)、24.39%(10/41)、17.07%(7/41)和14.63%(6/41),均未出现4级不良反应。结论盐酸安罗替尼后线治疗晚期结直肠癌具有良好的效果与安全性,可在临床上推广。

Objective To investigate the efficacy and safety of anlotinib as post third-line therapy in patients with metastatic colorectal cancer.Methods Anlotinib of 12 mg was administered daily to 41 patients with metastatic colorectal cancer who had received over third-1ine standardized treatment from May 2018 to January 2019.The efficacy was evaluated by RECIST 1.1 and safety was evaluated by NCI CTC 4.0.The prognostic factors were analyzed according to the follow-up data.Results Among the 41 patients,5 patients died at the end of the follow-up.No complete remission was found in the remaining 36 cases including 2 cases of partial remission,15 cases of stable disease and 19 cases of progress disease.The effective rate and disease control rate were 4.9%and 41.5%,respectively.The patients were followed up for 9.2-20.1 months with a median of 10.8 months and a median progression-free survival(PFS)of 1.9 months.Gender,age,primary lesion location,drinking history,radiotherapy history,immunotherapy history and Ras mutation were not associated with PFS(P>0.05),while liver metastasis and lung metastasis were associated with PFS(P<0.05).Liver metastasis was an independent prognostic factor for PFS in patients with advanced metastatic colorectal cancer(HR=2.94,95%CI=1.35-6.36,P=0.006).The most common adverse reactions were hypertension,fatigue,nausea and vomiting and proteinuria with the corresponding incidence rates of 26.83%(11/41),24.39%(10/41),17.07%(7/41)and 14.63%(6/41).There were no grade 4 adverse reactions.Conclusion Anlotinib as a post third-line therapy for metastatic colorectal cancer is feasible with high disease control rate and minor side effects,and should be spread in the clinical application.