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阿帕替尼治疗骨肉瘤的疗效和安全性:中国患者单臂荟萃分析。

Efficacy and safety of apatinib in the treatment of osteosarcoma: a single-arm meta-analysis among Chinese patients.

机构信息

School of Health Sciences, Wuhan University, Wuhan, China.

出版信息

BMC Cancer. 2021 Apr 23;21(1):449. doi: 10.1186/s12885-021-08154-3.

Abstract

BACKGROUND

Osteosarcoma is a relatively rare malignant tumor with a high incidence in young people. The development of tyrosine kinase inhibitors has brought the treatment of osteosarcoma into a new stage. Apatinib, a tyrosine kinase inhibitor specifically targeting VEGFR2, has been increasingly reported as a treatment for osteosarcoma with promising outcome parameters, but there has been no systematic analysis of the treatment of osteosarcoma by apatinib.

METHODS

A single-arm meta-analysis was performed, and published literature from PubMed, Web of Science, Embase, Cochrane Library, CNKI and Wan Fang databases as of March 1, 2021 was systematically retrieved. Quality assessment is carried out in accordance with a 20 item checklist form prepared by the Institute of Health Economics (IHE). Double arcsine transformation is performed to stabilize the variance of the original ratio. When I > 50%, the random effect model is used to calculate the pooled parameters; otherwise, the fixed effect model is used. We conducted subgroup analysis according to age and apatinib dose.

RESULTS

This meta-analysis included 11 studies of 356 Chinese patients with osteosarcoma. The pooled objective remission rate (ORR) of advanced or metastatic osteosarcoma treated by oral apatinib in Chinese patients was 0.27(95%CI = 0.18-0.38). The pooled disease control rate (DCR) was 0.57 (95%CI = 0.42-0.72). The pooled median progression-free survival (mPFS) and median total survival (mOS) were 5.18 months (95%CI = 4.03-6.33) and 10.87 months (95% CI = 9.40-12.33), respectively. More than 70% of adverse reactions were mild, the most common adverse reaction was hand-foot syndrome (HFMD), with an incidence of 0.46 (95%CI = 0.35-0.58), the second was hypertension, with an incidence of 0.40 (95%CI = 0.29-0.51).

CONCLUSIONS

The efficacy of apatinib in the treatment of osteosarcoma is competitive with current evidence, and it is worth noting that its low cost can significantly improve patient compliance and increase therapeutic value.

摘要

背景

骨肉瘤是一种相对罕见的恶性肿瘤,在年轻人中的发病率较高。酪氨酸激酶抑制剂的发展将骨肉瘤的治疗带入了一个新的阶段。阿帕替尼是一种专门针对 VEGFR2 的酪氨酸激酶抑制剂,作为骨肉瘤的治疗方法,其疗效参数有很大的前景,已有越来越多的报道,但目前尚无对阿帕替尼治疗骨肉瘤的系统分析。

方法

进行了单臂荟萃分析,并系统检索了截至 2021 年 3 月 1 日PubMed、Web of Science、Embase、Cochrane Library、CNKI 和万方数据库的已发表文献。按照卫生经济研究所(IHE)制定的 20 项检查表进行质量评估。采用双反正弦变换稳定原始比值的方差。当 I > 50%时,采用随机效应模型计算汇总参数;否则,采用固定效应模型。我们根据年龄和阿帕替尼剂量进行了亚组分析。

结果

这项荟萃分析纳入了 11 项针对 356 例中国骨肉瘤患者的研究。口服阿帕替尼治疗晚期或转移性骨肉瘤的中国患者的客观缓解率(ORR)为 0.27(95%CI=0.18-0.38)。疾病控制率(DCR)为 0.57(95%CI=0.42-0.72)。中位无进展生存期(mPFS)和中位总生存期(mOS)分别为 5.18 个月(95%CI=4.03-6.33)和 10.87 个月(95%CI=9.40-12.33)。超过 70%的不良反应为轻度,最常见的不良反应是手足综合征(HFMD),发生率为 0.46(95%CI=0.35-0.58),其次是高血压,发生率为 0.40(95%CI=0.29-0.51)。

结论

阿帕替尼治疗骨肉瘤的疗效与现有证据相当,值得注意的是,其低成本可显著提高患者的依从性,增加治疗价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61e1/8063308/8650668f380f/12885_2021_8154_Fig1_HTML.jpg

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