Abstract

BackgroundThere are limited data on the clinical benefits of adding surgical resection in patients with recurrent or metastatic gastrointestinal stromal tumors (GISTs). This protocol outlines the planned scope and methods for a systematic review and meta-analysis update that will compare the clinical outcomes of surgical resection combined with tyrosine kinase inhibitor (TKI) with TKI treatment alone in patients with recurrent or metastatic GISTs.MethodsThis review will update a previously published systematic review by our team. This protocol is presented in accordance with the PRISMA-P guideline. PubMed, Embase, and Cochrane Central Register of Controlled Trials will be systematically searched and supplemented by a secondary screening of the references of all included studies. We will include randomized controlled trials (RCTs) and non-randomized studies (NRS) in this review update. The outcomes evaluated will be overall survival and progression-free survival. Two reviewers will independently screen and select studies, extract data from the included studies, and assess the risk of bias of the included studies. Data extracted from RCTs and NRS will be analysed and reported separately. Preplanned subgroup analyses and sensitivity analyses are detailed within this protocol. The strength of the body of evidence will be assessed using GRADE.DiscussionThis systematic review and meta-analysis update will provide a current assessment of the evidence for the role of surgery in patients with recurrent or metastatic advanced GISTs. These findings will be used by the Chinese Society of Clinical Oncology (CSCO) GIST guideline recommendations on surgical treatment for recurrent or metastatic advanced GIST patients in China.Systematic review registrationThis protocol was prospectively registered in the Open Science Framework Registry (https://osf.io/xus7m).

Highlights

  • Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract

  • Systematic review registration: This protocol was prospectively registered in the Open Science Framework Registry

  • Various treatment strategies including surgery combined with tyrosine kinase inhibitors (TKIs), resumption of imatinib (IM), IM dose escalation or other targeting agents have been investigated to improve the survival of patients with recurrent or metastatic gastrointestinal stromal tumors (GISTs) [7,8,9,10,11,12]

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Summary

Methods

This review will update a previously published systematic review and meta-analysis by our team [13]. Protocol and registration The present protocol has been registered at the Open Science Framework Registry (https://osf.io/xus7m) This protocol is presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) guidelines (see PRISMA-P checklist in Additional file 1, [14]). Other inclusion criteria: Studies with a minimum of 60 months of follow-up reporting survival (time to event) outcomes. We will manually screen the references of all included articles to further identify additional studies meeting the eligibility criteria, and their full texts will be retrieved. Two authors will independently screen all articles identified from the database search based on the eligibility criteria outlined above. Data analysis If identified as possible (the studies retrieved have quantitative data reported that can be combined), the extracted data will be aggregated into a meta-analysis by STATA version 15.0 (STATA, College Station, TX) software.

Discussion
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