PHILADELPHIA, Nov. 12 /PRNewswire/ -- Data from an international, multi- center study presented today at the annual American Society of Nephrology meeting reported that the incidence of both skin and non-skin cancers is significantly reduced five years after kidney transplantation in patients receiving sirolimus (Rapamune) therapy after early cyclosporine-withdrawal. This analysis was part of the largest randomized cyclosporine-withdrawal study undertaken to date, the Rapamune Maintenance Regimen (RMR) Study.
“Malignancy has now become one of the leading causes of morbidity for long-term transplant recipients and immunosuppression therapies have been implicated as the likely cause. We need to learn how to address this problem,” said Rainer Oberbauer, MD, Associate Prof of Medicine, Medical University of Vienna, Allgemeines Krankenhaus, Vienna, Austria, a principal study investigator. “One of the purposes of the RMR study is to help us design strategies that may reduce the incidence of malignancies in this population.”
Compared with the general U.S. population, at three years after kidney transplantation, patients have an approximately 90 fold increased risk of nonmelanoma skin cancers and six fold increased risk of melanomas.
Sirolimus is the first of a new class of immunosuppressants that unlike cyclosporine, have been shown to inhibit cancers in experimental models. Recent publications have shown that this property may extend to human transplant recipients. A retrospective study of the UNOS (United Network for Organ Sharing) database published in October 2005 showed that in 33,000 kidney transplant recipients, the risk of developing any post-transplant malignancy was significantly reduced in patients receiving maintenance immunosuppression with mTOR inhibitors compared with those receiving traditional calcineurin inhibitors.
The RMR Study Findings
In the RMR study, four hundred thirty patients from Europe, Australia and Canada were randomly assigned at three months after kidney transplantation to continue sirolimus therapy in combination with cyclosporine or have cyclosporine withdrawn. Data of all skin and non-skin cancers reported over five years were analyzed.
The time to development of first skin carcinoma was delayed on average by 53 months and the relative risk of skin carcinoma was lowered by 65 percent in the patients taking the Rapamune maintenance regimen. At five years, 18 patients taking Rapamune plus cyclosporine had developed non-skin cancers compared to eight patients in whom cyclosporine had been withdrawn.
This analysis is one of a serious of data reviews conducted of the RMR study. Other analyses have shown that it is possible to obtain improved kidney function and significantly improved graft survival through withdrawing cyclosporine.
The RMR study was supported by a grant from Wyeth.
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