{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T04:24:05Z","timestamp":1747196645406,"version":"3.40.5"},"reference-count":31,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0308247","type":"journal-article","created":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T18:32:37Z","timestamp":1722537157000},"page":"e0308247","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Polatuzumab vedotin combined with bendamustine and rituximab for relapsed\/refractory diffuse large B-cell lymphoma: A systematic review protocol"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6439-9431","authenticated-orcid":true,"given":"Mohammadreza","family":"Eslami","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahdi","family":"Mehrabi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mehrdad","family":"Payandeh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fakhredin","family":"Saba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2024,8,1]]},"reference":[{"key":"pone.0308247.ref001","doi-asserted-by":"crossref","first-page":"12106","DOI":"10.1182\/blood-2022-169045","article-title":"Diffuse Large B-Cell Lymphoma (DLBCL): A Structured Literature Review of the Epidemiology, Treatment Guidelines, and Real-World Treatment Patterns","volume":"140","author":"M Garg","year":"2022","journal-title":"Blood"},{"key":"pone.0308247.ref002","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1056\/NEJMra2027612","article-title":"Diffuse Large B-Cell Lymphoma","volume":"384","author":"DL Longo","year":"2021","journal-title":"New England Journal of Medicine"},{"key":"pone.0308247.ref003","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1002\/ajh.26151","article-title":"2021 Update on Diffuse large B cell lymphoma: A review of current data and potential applications on risk stratification and management","volume":"96","author":"S Susanibar-Adaniya","year":"2021","journal-title":"Am J Hematol"},{"key":"pone.0308247.ref004","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1182\/hematology.2022000332","article-title":"Sequencing therapy in relapsed DLBCL","volume":"2022","author":"CR Flowers","year":"2022","journal-title":"Hematology"},{"key":"pone.0308247.ref005","doi-asserted-by":"crossref","DOI":"10.1016\/S1470-2045(18)30864-7","article-title":"Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1\u20132 trial","volume":"20","author":"FL Locke","year":"2019","journal-title":"Lancet Oncol"},{"key":"pone.0308247.ref006","doi-asserted-by":"crossref","DOI":"10.1056\/NEJMoa2116596","article-title":"Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma","volume":"386","author":"MR Bishop","year":"2022","journal-title":"New England Journal of Medicine"},{"key":"pone.0308247.ref007","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1200\/JCO.19.00172","article-title":"Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma","author":"LH Sehn","year":"2020","journal-title":"Journal of Clinical Oncology"},{"key":"pone.0308247.ref008","doi-asserted-by":"crossref","first-page":"699128","DOI":"10.3389\/fimmu.2021.699128","article-title":"Regulatory Dendritic Cells Induced by Bendamustine Are Associated With Enhanced Flt3 Expression and Alloreactive T-Cell Death","volume":"12","author":"MS Molina","year":"2021","journal-title":"Front Immunol"},{"key":"pone.0308247.ref009","doi-asserted-by":"crossref","first-page":"2415","DOI":"10.1016\/j.biopha.2018.11.121","article-title":"The applications of anti-CD20 antibodies to treat various B cells disorders","volume":"109","author":"Z Payandeh","year":"2019","journal-title":"Biomedicine & Pharmacotherapy"},{"key":"pone.0308247.ref010","doi-asserted-by":"crossref","first-page":"9464","DOI":"10.1182\/blood-2022-157679","article-title":"Polatuzumab Vedotin Plus Bendamustine and Rituximab in Relapsed\/Refractory Diffuse Large B-Cell Lymphoma (R\/R DLBCL): Final Results of a Phase Ib\/II Randomized Study and Single-Arm Extension (Ext) Study","volume":"140","author":"LH Sehn","year":"2022","journal-title":"Blood"},{"key":"pone.0308247.ref011","doi-asserted-by":"crossref","first-page":"3940","DOI":"10.1158\/1078-0432.CCR-22-0560","article-title":"Statistical Considerations for Analyses of Time-To-Event Endpoints in Oncology Clinical Trials: Illustrations with CAR-T Immunotherapy Studies","volume":"28","author":"Y Li","year":"2022","journal-title":"Clinical Cancer Research"},{"key":"pone.0308247.ref012","unstructured":"Gliklich RE, Dreyer NA, Leavy MB. Adverse Event Detection, Processing, and Reporting. 2014 [cited 5 Mar 2024]. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK208615\/"},{"key":"pone.0308247.ref013","doi-asserted-by":"crossref","first-page":"6711","DOI":"10.1182\/blood-2022-168325","article-title":"Comparison of Several Salvage Treatments of Relapsed\/Refractory Large B-Cell Lymphoma Including Chimeric Antigen Receptor T-Cell Therapy: A Systematic Review and Meta-Analysis","volume":"140","author":"J Kim","year":"2022","journal-title":"Blood"},{"key":"pone.0308247.ref014","doi-asserted-by":"crossref","first-page":"5821","DOI":"10.1182\/blood-2019-127664","article-title":"Systematic Literature Review of the Clinical Evidence in Relapsed\/Refractory (R\/R) Large B-Cell Lymphoma","volume":"134","author":"DG Maloney","year":"2019","journal-title":"Blood"},{"key":"pone.0308247.ref015","doi-asserted-by":"crossref","first-page":"4877","DOI":"10.1007\/s12325-020-01507-7","article-title":"A Systematic Review of the Clinical Efficacy of Treatments in Relapsed or Refractory Diffuse Large B Cell Lymphoma","volume":"37","author":"PO Thuresson","year":"2020","journal-title":"Adv Ther"},{"key":"pone.0308247.ref016","doi-asserted-by":"crossref","first-page":"1031","DOI":"10.4143\/crt.2022.1658","article-title":"Efficacy of Salvage Treatments in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Including Chimeric Antigen Receptor T-Cell Therapy: A Systematic Review and Meta-Analysis","volume":"55","author":"J Kim","year":"2023","journal-title":"Cancer Res Treat"},{"key":"pone.0308247.ref017","first-page":"148","article-title":"Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement","volume":"20","author":"D Moher","year":"2016","journal-title":"Revista Espanola de Nutricion Humana y Dietetica"},{"key":"pone.0308247.ref018","article-title":"The PRISMA 2020 statement: an updated guideline for reporting systematic reviews","volume":"372","author":"MJ Page","year":"2021","journal-title":"BMJ"},{"key":"pone.0308247.ref019","article-title":"The Cochrane Collaboration\u2019s tool for assessing risk of bias in randomised trials","volume":"343","author":"JPT Higgins","year":"2011","journal-title":"BMJ"},{"key":"pone.0308247.ref020","first-page":"37","volume":"126","author":"S Minozzi","year":"2020","journal-title":"The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application"},{"key":"pone.0308247.ref021","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/j.jclinepi.2023.06.015","article-title":"Risk-of-bias assessment using Cochrane\u2019s revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review","volume":"161","author":"TF Crocker","year":"2023","journal-title":"J Clin Epidemiol"},{"key":"pone.0308247.ref022","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/j.jclinepi.2022.09.003","article-title":"Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study","volume":"152","author":"S Minozzi","year":"2022","journal-title":"J Clin Epidemiol"},{"key":"pone.0308247.ref023","doi-asserted-by":"crossref","DOI":"10.1002\/jrsm.1695","article-title":"Frequency of use and adequacy of Cochrane risk of bias tool 2 in non-Cochrane systematic reviews published in 2020: Meta-research study","volume":"15","author":"A Babi\u0107","year":"2024","journal-title":"Res Synth Methods"},{"key":"pone.0308247.ref024","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1177\/09645284221076508","article-title":"Application of the revised Cochrane risk of bias tool for acupuncture trials: a preliminary comparative analysis of inter-rater reliability","volume":"40","author":"SR Jeon","year":"2022","journal-title":"Acupuncture in medicine: journal of the British Medical Acupuncture Society"},{"key":"pone.0308247.ref025","article-title":"How to review and assess a systematic review and meta-analysis article: A methodological study (secondary publication)","author":"SK Myung","year":"2023","journal-title":"Journal of Educational Evaluation for Health Professions"},{"key":"pone.0308247.ref026","doi-asserted-by":"crossref","first-page":"1088","DOI":"10.2307\/2533446","article-title":"Operating Characteristics of a Rank Correlation Test for Publication Bias","volume":"50","author":"CB Begg","year":"1994","journal-title":"Biometrics"},{"key":"pone.0308247.ref027","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1136\/bmj.315.7109.629","article-title":"Bias in meta-analysis detected by a simple, graphical test","volume":"315","author":"M Egger","year":"1997","journal-title":"Br Med J"},{"key":"pone.0308247.ref028","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1111\/j.0006-341X.2000.00455.x","article-title":"Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis","volume":"56","author":"S Duval","year":"2000","journal-title":"Biometrics"},{"key":"pone.0308247.ref029","doi-asserted-by":"crossref","first-page":"3112","DOI":"10.1002\/sim.1565","article-title":"Methods for Meta-analysis in Medical Research. Alex J. Sutton, Keith R. Abrams, David R. Jones, Trevor A. Sheldon and Fujian Song, Wiley, Chichester, U.K., 2000. No. of pages: xvii+317. ISBN 0-471-49066-0","volume":"22","author":"G. Schwarzer","year":"2003","journal-title":"Stat Med"},{"key":"pone.0308247.ref030","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1136\/bmj.39489.470347.AD","article-title":"GRADE: an emerging consensus on rating quality of evidence and strength of recommendations","volume":"336","author":"GH Guyatt","year":"2008","journal-title":"BMJ"},{"key":"pone.0308247.ref031","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1056\/NEJMra2027612","article-title":"Diffuse Large B-Cell Lymphoma","volume":"384","author":"DL Longo","year":"2021","journal-title":"New England Journal of Medicine"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0308247","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T18:33:30Z","timestamp":1722537210000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0308247"}},"subtitle":[],"editor":[{"given":"Chen","family":"Li","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2024,8,1]]},"references-count":31,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2024,8,1]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0308247","relation":{},"ISSN":["1932-6203"],"issn-type":[{"type":"electronic","value":"1932-6203"}],"subject":[],"published":{"date-parts":[[2024,8,1]]}}}