Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer Protocol for an overview of systematic reviews with meta-analyses

Background: Anti-programmed cell death 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) drugs treatment-related adverse events (AEs) are not uniform based on current study for patients with cancer. The study aimed to provide a complete toxicity profile and toxicity spectrum for anti-PD-1 and anti-PD-L1 drugs. Methods: All systematic reviews (SRs) with meta-analyses (MAs) relate to the anti-PD-1 and anti-PD-L1 drugs and SRs will be searched in the database of PubMed, Embase, Cochrane Library, and Web of Science from inception to February 2019. Eligible publications must have reported site, organ, or system level data on treatment-related AEs. The following will extract from each SRs: first author, year of publication, country of origin, number of origin study, number of patients enrolled, participant characteristics, duration of cancer diagnosis, cancer types, detailed description of treatment, and occurrence of AEs. Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) and A Measurements Tool to Assess Systematic Reviews 2 (AMSTAR-2) will be used to assess the reporting and methodological quality of SRs/MAs. The characteristics of the included SRs/MAs and their quality will descriptively summarized using systematically structured tables. A network meta-analysis (NMAs) approach versus a narrative synthesis will be used to examine data synthesis considered. Odds ratios and 95% credibility intervals will be used as summary statistics. Evidence mapping (EM) method will to present the evidence landscape related to anti-PD-1 and anti-PD-L1 drugs treatment-related AEs for patients with cancer. Discussion: The results of the overview will be submitted to a peer-reviewed journal for publication. Ethics and dissemination: Because this study is not a clinical study, and we will search and evaluate only existing sources of literature. So, ethical approval is not required.