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吉妥珠单抗奥佐米星(GO)单药治疗和联合低甲基化药物治疗急性髓系白血病的系统荟萃分析。

Gemtuzumab ozogamicin (GO) as monotherapy and in combination with hypomethylation agents in the treatment of acute myeloid leukemia: a systematic meta-analysis.

机构信息

Taixing People's Hospital, Taixing, People's Republic of China.

School of Medicine, Southeast University, Nanjing, People's Republic of China.

出版信息

Hematology. 2022 Dec;27(1):300-309. doi: 10.1080/16078454.2022.2042964.

DOI:10.1080/16078454.2022.2042964
PMID:35225170
Abstract

OBJECTIVES

To explore whether the addition of HMA to GO could bring additional clinical benefits to AML patients.

BACKGROUND

Several studies have shown the HMA plus GO combination showed exciting results. However, the comparison of the clinical efficacy and safety profile of this combination with GO monotherapy has not been witnessed.

METHODS

We performed a systematic review and meta-analysis of 18 clinical trials regarding the mono-GO therapy alone or the HMA + GO combination. The random-effect model or fixed-effect model was applied to the study based on heterogeneity.

RESULTS

Pooled data of HMA + GO combination are more effective than mono-GO therapy among the unfit acute myeloid leukemia (AML) patients, based on the evaluation of overall response rate (ORR) (HMA + GO vs. mono-GO, 48% vs. 25%), composite complete remission (CRc) (HMA + GO vs. mono-GO, 42% vs. 25%). But pooled data of CRc and ORR showed no notable difference among R/R AML patients. Safety profiles have demonstrated that the HMA + GO combination was tolerable, considering the relatively low toxicities.

CONCLUSION

HMA + GO combination, more effective and better tolerated than mono-GO therapy should be recommended to treat unfit AML patients instead of R/R AML patients.

摘要

目的

探讨 HMA 联合 GO 是否能为 AML 患者带来额外的临床获益。

背景

多项研究表明 HMA 联合 GO 的组合显示出令人兴奋的结果。然而,尚未观察到这种联合与 GO 单药治疗的临床疗效和安全性特征的比较。

方法

我们对单独使用 GO 单药治疗或 HMA+GO 联合治疗的 18 项临床试验进行了系统评价和荟萃分析。根据异质性,采用随机效应模型或固定效应模型对研究进行分析。

结果

基于总体缓解率(ORR)(HMA+GO 与 GO 单药治疗相比,48%对 25%)和复合完全缓解率(CRc)(HMA+GO 与 GO 单药治疗相比,42%对 25%)的评估,HMA+GO 联合治疗在不适合接受急性髓细胞白血病(AML)治疗的患者中比 GO 单药治疗更有效。但在复发/难治性 AML 患者中,CRc 和 ORR 的汇总数据无显著差异。安全性特征表明,HMA+GO 联合治疗具有良好的耐受性,因为其毒性相对较低。

结论

与 GO 单药治疗相比,HMA+GO 联合治疗更有效且耐受性更好,应推荐用于治疗不适合接受 AML 治疗的患者,而不是复发/难治性 AML 患者。

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