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化疗与阿来替尼治疗克唑替尼预处理的 ALK 阳性非小细胞肺癌患者:系统评价和荟萃分析的方案。

Chemotherapy versus alectinib for the treatment of crizotinib-pretreated ALK-positive patients with non small cell lung cancer: A protocol for systematic review and meta-analysis.

机构信息

Department of Respiratory Medicine, XianYang Central Hospital, Shaanxi, China,Queen Mary School, Nanchang University, Jiangxi, China,Department of Chest Surgery, XianYang Central Hospital, Shaanxi, China.

出版信息

Medicine (Baltimore). 2022 Mar 18;101(11). doi: 10.1097/MD.0000000000029064.

Abstract

BACKGROUND

There are no evidence-based data in the literature to demonstrate that alectinib shows a clinically relevant advantage over chemotherapy in anaplastic lymphoma kinase-positive non-small cell lung cancer pretreated with crizotinib. Therefore, we designed this systematic review and meta-analysis protocol to reveal whether the safety and efficacy of alectinib are indeed superior to chemotherapy alone in this special group of patients.

METHODS

This protocol will be written following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement guidelines. We will search databases from Web of Science, Embase, PubMed, Wanfang Data, Scopus, Science Direct, Cochrane Library from their inception to June 2022, restricting them to human subjects and clinical trials. Outcomes include progression-free survival, central nervous system progression, and incidence of adverse events. Pooled analyses will be calculated using fixed-effect models, whereas random-effect models will be applied in case of significant heterogeneity across studies. Any disagreements will be discussed and resolved in discussions with the third reviewer.

RESULTS

We hypothesized that alectinib would be superior to chemotherapy in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer pretreated with crizotinib.

CONCLUSIONS

The review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.

OSF REGISTRATION NUMBER

10.17605/OSF.IO/PQF53.

摘要

背景

在先前接受克唑替尼治疗的间变性淋巴瘤激酶阳性非小细胞肺癌患者中,阿来替尼相较于化疗具有临床相关优势,目前尚无相关循证医学证据。因此,我们设计了本次系统评价和荟萃分析方案,旨在揭示阿来替尼在该特殊患者群体中的安全性和疗效是否确实优于单独化疗。

方法

本方案将按照系统评价和荟萃分析报告规范(Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols)的要求进行编写。我们将从建库起至 2022 年 6 月,在 Web of Science、Embase、PubMed、万方数据、Scopus、Science Direct、Cochrane Library 等数据库中进行检索,限定为人类研究和临床试验。结局指标包括无进展生存期、中枢神经系统进展和不良事件发生率。如果各研究间存在显著异质性,将采用随机效应模型进行汇总分析;否则,将采用固定效应模型进行汇总分析。任何分歧将通过与第三位审稿人讨论解决。

结果

我们假设,在先前接受克唑替尼治疗的间变性淋巴瘤激酶阳性非小细胞肺癌患者中,阿来替尼相较于化疗具有优势。

结论

本综述将通过提供有说服力的证据和改善临床实践指导,为现有文献增添新内容。

OSF 注册号:10.17605/OSF.IO/PQF53。

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