Eslami Mohammadreza, Mehrabi Mahdi, Payandeh Mehrdad, Saba Fakhredin
Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.
School of paramedical, Kermanshah University of Medical Sciences, Kermanshah, Iran.
PLoS One. 2024 Aug 1;19(8):e0308247. doi: 10.1371/journal.pone.0308247. eCollection 2024.
Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin lymphoma subtype with a significant relapse rate and poor prognosis in relapsed/refractory (R/R) patients. Polatuzumab vedotin in combination with bendamustine and rituximab (Pola-BR) has demonstrated promising efficacy and safety as salvage therapy for R/R DLBCL. This systematic review protocol aims to comprehensively evaluate the efficacy of Pola-BR for the treatment of R/R DLBCL by synthesizing data from relevant randomized controlled trials.
This protocol details the eligibility criteria, search strategy, study selection, data extraction, and analysis methods for the systematic review. Randomized controlled trials comparing Pola-BR with other interventions for R/R DLBCL will be included. The primary endpoint is overall survival, with secondary endpoints being progression-free survival and incidence of adverse events. A comprehensive search will be conducted across databases such as Medline/PubMed, Cochrane Library, Web of Science, Scopus, EMBASE, ProQuest, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform (ICTRP), and ClinicalTrials.gov from the January 2000 to April 2024. To assess the potential risk of bias, the Cochrane Risk of Bias 1 tool will be used. Data synthesis will utilize fixed-effect or random-effects models, and subgroup and meta-regression analyses will examine heterogeneity. Additionally, publication bias and sensitivity analyses will be performed, and the GRADE approach will be applied to assess the certainty of the evidence.
This systematic review and meta-analysis protocol provides a rigorous framework for evaluating the efficacy of Pola-BR in the treatment of R/R DLBCL. The results will inform clinical decision-making and guideline development, addressing the unmet need for effective and tolerable treatments for this challenging patient population. Potential limitations and biases will be acknowledged, and future research directions will be discussed.
弥漫性大B细胞淋巴瘤（DLBCL）是一种侵袭性非霍奇金淋巴瘤亚型，复发率高，复发/难治性（R/R）患者预后较差。泊洛妥珠单抗联合苯达莫司汀和利妥昔单抗（Pola-BR）作为R/R DLBCL的挽救治疗已显示出有前景的疗效和安全性。本系统评价方案旨在通过综合相关随机对照试验的数据，全面评估Pola-BR治疗R/R DLBCL的疗效。
本方案详细说明了系统评价的纳入标准、检索策略、研究选择、数据提取和分析方法。将纳入比较Pola-BR与其他干预措施治疗R/R DLBCL的随机对照试验。主要终点是总生存期，次要终点是无进展生存期和不良事件发生率。将在2000年1月至2024年4月期间对Medline/PubMed、Cochrane图书馆、科学网、Scopus、EMBASE、ProQuest、欧盟临床试验注册库、世界卫生组织国际临床试验注册平台（ICTRP）和ClinicalTrials.gov等数据库进行全面检索。为评估潜在的偏倚风险，将使用Cochrane偏倚风险1工具。数据合成将采用固定效应或随机效应模型，亚组分析和meta回归分析将检验异质性。此外，将进行发表偏倚分析和敏感性分析，并应用GRADE方法评估证据的确定性。
本系统评价和荟萃分析方案为评估Pola-BR治疗R/R DLBCL的疗效提供了一个严谨的框架。研究结果将为临床决策和指南制定提供参考，满足这一具有挑战性患者群体对有效且可耐受治疗的未满足需求。将承认潜在的局限性和偏倚，并讨论未来的研究方向。
