安罗替尼治疗晚期肉瘤的有效性和安全性分析

Efficacy and safety of Anlotinib in the treatment of advanced sarcoma

目的探讨安罗替尼治疗晚期肉瘤的有效性和安全性,分析不良反应与疗效间的关系。方法回顾性分析2018年6月至2021年8月在郑州大学附属肿瘤医院接受安罗替尼治疗的45例晚期肉瘤患者的临床资料。根据实体肿瘤疗效评价标准1.1版计算客观缓解率(ORR)和疾病控制率(DCR),分析无进展生存时间(PFS)与治疗相关不良反应间的关系,生存分析采用Kaplan-Meier法,生存率的比较采用Log rank检验。结果45例患者中,40例患者用药时间超过1.5个月,3个月ORR为7.5%(3/40),DCR为80.0%(32/40)。全组患者的整体ORR为2.5%(1/40),DCR为27.5%(11/40),中位PFS为6.70个月。腺泡状软组织肉瘤患者中位PFS为10.27个月,长于其他亚型的肉瘤患者(P=0.048),腺泡状软组织肉瘤、滑膜肉瘤患者的DCR[分别为100.0%(5/5)和100.0%(9/9)]明显优于骨肉瘤患者[25.0%(1/4),均P<0.05]。常见的不良反应有促甲状腺素升高(17.8%,8/45)、贫血(15.6%,7/45)、乏力(11.1%,5/45)等,5例患者治疗后出现了3级不良反应。治疗后出现手足综合征患者的PFS(14.10个月)长于未出现手足综合征的患者(6.00个月,P=0.024)。结论安罗替尼治疗腺泡状软组织肉瘤、滑膜肉瘤的疗效优于其他亚型,治疗后出现手足综合征患者的PFS明显长于未出现手足综合征的患者。

ObjectivePatients with advanced sarcomas have a dismal prognosis with few effective therapies.The purpose of this study was to evaluate the efficacy and safety of anlotinib in the treatment of advanced sarcoma and to explore the relationship between adverse events(AEs)and efficacy.MethodsData from 45 advanced sarcoma patients who received anlotinib monotherapy at Affiliated Cancer Hospital of Zhengzhou University between June 2018 and August 2021 were retrospectively analyzed.According to Response Evaluation Criteria In Solid Tumors(RECIST)Version 1.1,the objective remission rate(ORR)and disease control rate(DCR)were calculated,and the progression free survival(PFS)and treatment-related AEs were recorded and analyzed.Survival analysis was conducted using the Kaplan-Meier survival rates were compared using the Log rank test.ResultsForty patients were treated for more than 1.5 months and received efficacy evaluation.The ORR and DCR after 3 months were 7.5%(3/40)and 80.0%(32/40),respectively.The overall ORR was 2.5%(1/40),the total DCR was 27.5%(11/40),and the median progression-free survival(m-PFS)was 6.70 months;The m-PFS of alveolar soft tissue sarcoma(ASPS)was 10.27 months,which was significantly longer than that of other subtypes of sarcoma(P=0.048).In addition,the DCR of ASPS and synovial sarcoma(SS)was significantly better than that of osteosarcoma(P<0.05).The most common AEs were elevated thyroid stimulating hormone(17.8%,8/45),anemia(15.6%,7/45),fatigue(11.1%,5/45).Five patients developed grade 3 AEs after treatment;The PFS of patients with hand-foot syndrome after treatment was significantly longer than that of patients without hand-foot syndrome(14.10 vs 6.00,P=0.024).ConclusionsThe efficacy of anlotinib in the treatment of ASPS and SS is better than that of other subtypes.The PFS in the group with hand-foot syndrome was significantly longer than that of the group without hand-foot syndrome.