Abstract
BackgroundPatients undergoing renal transplant procedures require multi-agent immunosuppressive regimens both short term (induction phase) and long term (maintenance phase) to minimize the risk of organ rejection. There are several drug classes and agents for immunosuppression. Use of these agents may increase the risk of different harms including not only infections, but also malignancies including post-transplant lymphoproliferative disorder. There is a need to identify which regimens minimize the risk of such outcomes. The objective of this systematic review and network meta-analysis of randomized and observational studies is to explore whether certain modern regimens of immunosuppression used to prevent organ rejection in renal transplant patients are associated with an increased risk of post-transplant lymphoproliferative disorder and other malignancies.Methods/design‘Modern’ regimens were defined to be those evaluated in controlled studies beginning in 1990 or later. An electronic literature search of Medline, Embase and the Cochrane Central Register of Controlled Trials has been designed by an experienced information specialist and peer reviewed by a second information specialist. Study selection and data collection will be performed by two reviewers. The outcomes of interest will include post-transplant lymphoproliferative disorder and other incident forms of malignancy occurring in adult renal transplant patients. Network meta-analyses of data from randomized and observational studies will be performed where judged appropriate based on a review of the clinical and methodological features of included studies. A sequential approach to meta-analysis will be used to combine data from different designs.DiscussionOur systematic review will include both single-agent and multi-agent modern pharmacotherapy regimens in patients undergoing renal transplantation. It will synthesize malignancy outcomes. Our work will also add to the development of methods for network meta-analysis across study designs to assess treatment safety.Trial registrationPROSPERO Registration Number: CRD42013006951
Highlights
Patients undergoing renal transplant procedures require multi-agent immunosuppressive regimens both short term and long term to minimize the risk of organ rejection
Our work will add to the development of methods for network meta-analysis across study designs to assess treatment safety
A recent editorial noted a clear need to determine which immunosuppressant combinations minimize the occurrence of post-transplant lymphoproliferative disorder (PTLD), as the types of drugs used for the induction and maintenance phases play a role in the rate and types of cancers seen [10,11,12]
Summary
What this review will add to the field The risks of PTLD and other malignancies faced by renal transplant patients as a consequence of the medications needed to minimize the risk of organ rejection are important to both patients and clinicians. There are currently few network meta-analyses combining randomized and observational studies for assessing treatment safety [33]. The issue of intensity of immunosuppression is an important one that may influence the risk of PTLD and other cancers; the extent to which intensity can be truly established at the patient level within the included studies is unclear at this time and will require further exploration of the included studies to determine. Authors’ contributions BH conceived the study, selected methods for use, drafted the protocol and gave final approval for the protocol. LJ contributed to the final study design, selected methods for use, reviewed drafts of the protocol and gave final approval for the protocol. GK conceived the study, reviewed drafts of the protocol and gave final approval for the protocol
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