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目的 对安罗替尼治疗骨肉瘤（OS）的疗效和安全性进行系统评价，为安罗替尼在OS治疗中的临床应用提供依据。方法 检索中国知网、万方、维普、SinoMed、PubMed、Embase、the Cochrane Library、Web of Science等数据库，纳入安罗替尼在OS治疗中的应用相关研究，检索时间从数据库建立之日起至2024年5月22日。提取文献数据，包括无进展生存期（PFS）、疾病控制率（DCR）、总缓解率（ORR）及不良事件（AEs），通过Stata 18软件分析纳入研究的敏感性和偏倚风险。结果 共纳入10项研究，共计194例OS患者。Meta分析结果显示，194例OS患者的PFS为4.96个月（95%CI:3.79～6.13,P=0.58）、DCR为69%(95%CI:0.51～0.85,P<0.01)、ORR为11%(95%CI:0.06～0.16,P <0.01)。亚组分析结果显示，安罗替尼单药组PFS为5.03个月（95%CI:3.66～6.39,P=0.39）、DCR为59%(95%CI:0.39～0.77,P=0.04)、ORR为5%(95%CI:0.01～0.12,P<0.01)；安罗替尼联合化疗组患者的PFS为4.93个月（95%CI:2.23～7.62,P=0.85）、DCR为80%(95%CI:0.58～0.96,P=0.01)、ORR为19%(95%CI:0.10～0.55,P<0.01)。AEs发生情况为手足综合征[21%(95%CI:0.01～0.51)]、高血压[22%(95%CI:0.02～0.53)]、疲劳[23%(95%CI:0.01～0.55)]等，最常见的≥Ⅲ级AEs是中性粒细胞减少[11%(95%CI:0.00～0.34)]。纳入研究敏感性高、存在发表偏倚可能性较小。结论 安罗替尼治疗OS的疗效较好、安全性较高。
Abstract：Objective To conduct a systematic evaluation of the efficacy and safety of anlotinib in the treatment of osteosarcoma(OS), aiming to provide a foundation for its clinical application in OS therapy. Methods In this study, we systematically searched multiple databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, the Cochrane Library, and Web of Science, to gather relevant studies on the application of anlotinib in the treatment of OS. Our search encompassed the entire period from the establishment of these databases up to May 22, 2024, ensuring a comprehensive review of existing literature. We extracted literature data, focusing on key metrics such as progression-free survival(PFS), disease control rate(DCR), overall response rate(ORR), and the occurrence of adverse events(AEs). Additionally, we analyzes the sensitivity and risk of bias of the included studies utilizing Stata 18 software. Results A total of 10 studies were included, involving 194 OS patients. Meta-analysis results indicated that among 194 cases, the PFS of OS patients was 4. 96 months(95% CI: 3. 79-6. 13, P=0. 58), the DCR was 69%(95% CI: 0. 51-0. 85, P<0. 01), while the ORR was 11%(95% CI: 0. 06-0. 16, P<0. 01). Subgroup analysis results indicated that in the anlotinib monotherapy group, the PFS was 5. 03 months(95% CI: 3. 66-6. 39, P=0. 39), the DCR was 59%(95% CI: 0. 39-0. 77, P=0. 04), and the ORR was 5%(95% CI: 0. 01-0. 12, P<0. 01). In contrast, in the anlotinib combined with chemotherapy group, the PFS was 4. 93 months(95% CI: 2. 23-7. 62, P=0. 85), the DCR was 80%(95% CI: 0. 58-0. 96, P=0. 01), and the ORR was 19%(95% CI: 0. 10-0. 55, P<0. 01). The AEs included hand-foot syndrome at 21%(95% CI: 0. 01-0. 51), hypertension at 22%(95% CI: 0. 02-0. 53), and fatigue at 23%(95% CI: 0. 01-0. 55), among others. The most prevalent Grade ≥Ⅲ adverse event was neutropenia, observed in 11% of patients(95% CI: 0. 00-0. 34). This study exhibited a high sensitivity and a low likelihood of publication bias. Conclusion Anlotinib demonstrates favorable efficacy and high safety in the treatment of OS.
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基本信息:
DOI：
中图分类号:R738.1
引用信息:
[1]于潍泽,张媛.安罗替尼治疗骨肉瘤疗效和安全性的系统评价[J].山东医药,2025,65(05):12-17.
基金信息:
广东省医院药学研究基金项目（2022-1115-36）