安罗替尼单药在晚期食管鳞癌患者后线治疗中的疗效及安全性

Efficacy and safety of anlotinib monotherapy as the further-line treatment for patients with advanced esophageal squamous cell carcinoma

目的本研究旨在探讨安罗替尼单药在晚期晚期食管鳞癌(esophageal squamous cell carcinoma,ESCC)患者中的疗效及安全性。方法 本研究为回顾性分析,纳入2018年6月至2020年10月后线接受安罗替尼单药治疗且符合入排标准的晚期食管鳞癌患者63例。安罗替尼的起始剂量为12 mg和10 mg。通过科室的患者病历记录及医院的电子病历系统整理分析患者的基本人口学资料、接受治疗的疗效数据、生存预后情况及接受治疗过程中的不良反应情况。研究的主要终点为无进展生存期(progression free survival,PFS),次要研究终点为客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、总生存期(overall survival,OS),安全性及针对部分不良反应的预后分析。结果 63例食管鳞癌患者符合研究的筛选标准并且均可以评价疗效与不良反应。最佳的疗效评估结果表明部分缓解患者6例,疾病稳定患者35例,疾病进展患者22例。因此,安罗替尼单药后线治疗晚期食管鳞癌患者的ORR为9.5%,DCR为65.1%。预后数据表明63例食管鳞癌患者的中位PFS为3.6个月(95%CI:2.45~4.75),中位OS为7.5个月(95%CI:5.05~9.95)。不良反应的结果表明,晚期食管鳞癌患者后线接受安罗替尼治疗过程中相对常见的不良反应有:高血压35例(55.6%),疲劳33例(52.4%),食欲下降27例(42.9%)和手足综合征25例(39.7%)。发生高血压的患者相对于没有出现高血压不良反应的患者中位PFS明显较长(4.8个月vs 2.8个月),差异有统计学意义(P=0.03)。结论 安罗替尼单药在晚期食管鳞癌患者后线治疗中具有初步的疗效及可耐受的安全性。

Objective Effective regimens were relatively rare as the further line treatment for patients with advanced Esophageal Squamous Cell Carcinoma(ESCC).The results of previous clinical study exhibited that anlotinib demonstrated superior efficacy and manageable safety profile as the second-line treatment for advanced ESCC.However,preliminary clinical data in the real world are still not available.Consequently,the purpose of present study was to investigate the efficacy and safety of anlotinib monotherapy for patients with advanced ESCC in real world.Methods This study was designed as a retrospective study.A total of 63 patients with advanced ESCC who met the eligibility criteria and received anlotinib monotherapy from June 2018 to October 2020 were included.The initial dosage of anlotinib was 12 mg and 10 mg.Basic demographic data of patients,efficacy data of the treatment,survival status and safety profile during the treatment were documented and analyzed through the medical records of the patients in the department and the electronic medical record system in the hospital.The primary endpoint of this study was progression free survival(PFS),the secondary endpoints were objective response rate(ORR),disease control rate(DCR),overall survival(OS),safety profile and prognostic analysis according to adverse reaction.Results All the 63 patients corresponded with the eligibility criteria and were available for the evaluation of efficacy and adverse reactions.The best overall response of the patients indicated that partial response was observed in 6 patients,stable disease was noted in 35 patients and progressive disease was seen in 22 patients.Therefore,the ORR of the 63 patients receiving anlotinib monotherapy was 9.5% and DCR was65.1%.Prognostic data suggested that the median PFS of the 63 patients with advanced ESCC was 3.6 months(95%CI:2.45 ~ 4.75),and the median OS was 7.5 months(95%CI:5.05 ~ 9.95).In terms of the safety profile,the relatively common adverse reactions of the patients with advanced ESCC who were treated with anlotinib were hypertension(35 patients,55.6%),fatigue(33 patients,52.4%),loss of appetite(27 patients,42.9%)and handfoot syndrome(25 patients,39.7%).Given that hypertension was the most common adverse reaction,we performed the association analysis between hypertension status and PFS.And the results suggested that the median PFS of the patients with hypertension was longer than that of those without hypertension(4.8 months vs.2.8 months),and the difference was statistically significant(P = 0.03).Conclusion Anlotinib monotherapy demonstrated potential and preliminary efficacy and tolerable safety as the further line treatment for patients with advanced ESCC.