单药安罗替尼对不可切除或晚期骨与软组织肿瘤的疗效及安全性研究

Safety and efficacy of anlotinib in patients with unresectable or metastatic bone and soft-tissue sarcomas:a retrospective institution study

目的:本研究旨在分析安罗替尼对不可切除或晚期骨与软组织肿瘤在真实世界中的疗效和安全性。方法:搜集2018年1月—2020年12月在郑州大学第一附属医院使用安罗替尼治疗的124例不可切除或晚期骨与软组织肿瘤患者的临床资料,主要包括:年龄、性别、美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)评分、安罗替尼治疗线数、肿瘤部位、转移部位、病理亚型、手术史、安罗替尼减量与否以及药物相关不良反应等,并进行回顾性分析。近期疗效评估方法采用客观缓解率(objective response rate,ORR)及疾病控制率(disease control rate,DCR)。Kaplan-Meier方法进行生存分析,评价指标为中位无进展生存期(median progression-free survival,mPFS)和中位总生存期(median overall survival,mOS)。结果:124例入组患者的主要病理亚型为滑膜肉瘤,平滑肌肉瘤和脂肪肉瘤等。中位年龄为48.5岁(范围:9~83岁)。一线治疗采用安罗替尼的患者,其ORR和DCR值分别是26.8%和82.1%,安罗替尼二线及后线治疗患者的ORR和DCR值分别为5.9%和64.7%。对比二线及后线治疗,一线治疗采用单药安罗替尼的患者,其mPFS和mOS明显延长(mPFS:22.0 vs 7.0个月,P=0.001;mOS:51.0 vs 32.0个月,P=0.035)。安罗替尼相关的主要不良反应患者可耐受,且不良反应的主要级别为Ⅰ和Ⅱ级,本研究未发现新的安罗替尼相关不良反应信号。结论:安罗替尼治疗不可切除或晚期骨与软组织肿瘤具有很好的疗效,不良反应可耐受,且一线治疗疗效更优。

Objective:This study aims to analyze the efficacy and safety of anlotinib in the real world for patients with unresectable or metastatic bone and soft-tissue sarcomas(STSs).Methods:Clinical data of 124 patients with unresectable or metastatic bone and STSs treated with anlotinib in the First Affiliated Hospital of Zhengzhou University from January 2018 to December 2020 were retrospectively analyzed.Information on age,sex,performance status,lines of anlotinib,surgical history,reduction of anlotinib,adverse reaction,metastatic site,tumor location,pathological subtypes and combination chemotherapy was collected and analyzed.The objective response rate(ORR)and disease control rate(DCR)was analyzed for short-term efficacy.Kaplan-Meier method was performed for survival analysis,and the evaluation indexes were median progression-free survival(mPFS)and median overall survival(mOS).Results:The main pathological subtypes of 124 patients were Synovial sarcoma(SS),Leiomyosarcoma(LMS),liposarcoma(LPS).The median age was 48.5 years(9-83 years).The ORR and DCR of anlotinib used in first-line therapy were 26.8%and 82.1%,but in second-line therapy and beyond,the ORR and DCR only were 5.9%and 64.7%.There were improvement in mPFS and mOS with anlotinib in first-line therapy compared to second-line therapy and beyond(mPFS:22.0 months vs 7.0 months,P=0.001;mOS:51.0 months vs 32.0 months,P=0.035).Adverse reactions of anlotinib were well tolerated,and the main grades of adverse reactions were grade I and II.No new anlotinib-related adverse reactions were identified.Conclusion:Anlotinib has shown a definite effect in the treatment of unresectable or metastatic bone and STSs.The adverse events of anlotinib are minor and well tolerated,and the efficacy of first-line treatment is better.