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安罗替尼治疗晚期肉瘤的疗效与安全性

[Efficacy and safety of Anlotinib in the treatment of advanced sarcoma].

作者信息

Yan Q, Yao W T, Du X H, Guo L Y, Fan Y C

机构信息

Department of Bone and Soft Tumor, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450003, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2023 Oct 23;45(10):904-910. doi: 10.3760/cma.j.cn112152-20210820-00632.

DOI:10.3760/cma.j.cn112152-20210820-00632
PMID:37875427
Abstract

Patients 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. Data 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. Forty 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 (=0.048). In addition, the DCR of ASPS and synovial sarcoma (SS) was significantly better than that of osteosarcoma (<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, =0.024). The 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.

摘要

晚期肉瘤患者预后不佳,有效治疗方法寥寥无几。本研究旨在评估安罗替尼治疗晚期肉瘤的疗效和安全性,并探讨不良事件(AE)与疗效之间的关系。对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单药治疗的45例晚期肉瘤患者的数据进行回顾性分析。根据实体瘤疗效评价标准(RECIST)1.1版,计算客观缓解率(ORR)和疾病控制率(DCR),并记录和分析无进展生存期(PFS)及治疗相关不良事件。采用Kaplan-Meier法进行生存分析,使用Log rank检验比较生存率。40例患者接受治疗超过1.5个月并接受疗效评估。3个月后的ORR和DCR分别为7.5%(3/40)和80.0%(32/40)。总体ORR为2.5%(1/40),总DCR为27.5%(11/40),中位无进展生存期(m-PFS)为6.70个月;肺泡软组织肉瘤(ASPS)的m-PFS为10.27个月,显著长于其他肉瘤亚型(P=0.048)。此外,ASPS和滑膜肉瘤(SS)的DCR显著优于骨肉瘤(P<0.05)。最常见的不良事件为促甲状腺激素升高(17.8%,8/45)、贫血(15.6%,7/45)、疲劳(11.1%,5/45)。5例患者治疗后出现3级不良事件;治疗后发生手足综合征的患者的PFS显著长于未发生手足综合征的患者(14.10对6.00,P=0.024)。安罗替尼治疗ASPS和SS的疗效优于其他亚型。发生手足综合征组的PFS显著长于未发生手足综合征组。

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