Systematic Review and Meta-Analysis Expert Group (SRMEG), Universal Scientific Education and Research Network (USERN), Tehran, Iran.
Cancer Immunology Project (CIP), Universal Scientific Education and Research Network (USERN), Tehran, Iran.
PLoS One. 2022 Jul 18;17(7):e0271506. doi: 10.1371/journal.pone.0271506. eCollection 2022.
Cancers are among the most common causes of mortality and morbidity. Recently, bispecific antibodies (BsAbs) have been used for cancer treatment. The aim of this systematic review and meta-analysis will be to determine the safety and efficacy of BsAbs in the treatment of solid tumors.
We will search five electronic databases, PubMed, EMBASE, Scopus, Web of Science, and CENTRAL, in addition to Clinical-Trials.gov and metaRegister of controlled trials and backward and forward citation searching of included studies. Eligible studies will be controlled clinical trials evaluating safety and/or efficacy of BsAbs in adult patients with solid tumors. The primary outcomes will be the incidence of safety and efficacy measures. Title and/or abstract screening, full text reviewing, data collection, and quality assessment will be done by two reviewers. We will use The Cochrane Collaboration's risk of bias tool 2 (RoB2) to assess the quality of included studies. If I-square heterogeneity was greater than 40%, we will implement random effect model. Subgroup analysis and meta-regression will be undertaken if applicable. The metaprop command of STATA will be used to calculate frequency of AEs. Funnel plot, Egger's and Peter's tests will be utilized to evaluate publication bias in case of including at least ten studies. We will use sensitivity analysis to evaluate the effects of funding sources and continuity correction on effects size.
The findings of the present study will provide information on safety and efficacy of BsAbs for physicians and researchers in the management of solid tumors.
Registration on PROSPERO CRD42021227879 Also, important protocol amendments will be stated on PROSPERO registration.
癌症是最常见的死亡和发病原因之一。最近，双特异性抗体（BsAbs）已被用于癌症治疗。本系统评价和荟萃分析的目的将确定 BsAbs 在治疗实体瘤中的安全性和疗效。
我们将搜索五个电子数据库，包括 PubMed、EMBASE、Scopus、Web of Science 和 CENTRAL，此外还将搜索 Clinical-Trials.gov 和对照试验注册库以及纳入研究的回溯和前向引文搜索。合格的研究将是评估 BsAbs 在成人实体瘤患者中的安全性和/或疗效的对照临床试验。主要结局将是安全性和疗效措施的发生率。标题和/或摘要筛选、全文审查、数据收集和质量评估将由两名评审员进行。我们将使用 Cochrane 协作风险偏倚工具 2（RoB2）来评估纳入研究的质量。如果 I 平方异质性大于 40%，我们将采用随机效应模型。如果适用，将进行亚组分析和荟萃回归。STATA 的 metaprop 命令将用于计算 AEs 的频率。如果纳入至少 10 项研究，将使用漏斗图、Egger 和 Peter 检验来评估发表偏倚。我们将使用敏感性分析来评估资金来源和连续性校正对效应大小的影响。
本研究的结果将为医生和研究人员在管理实体瘤方面提供有关 BsAbs 安全性和疗效的信息。
在 PROSPERO CRD42021227879 上进行注册。此外，还将在 PROSPERO 注册上说明重要的方案修正案。
