Switch to a Sirolimus‐Based Immunosuppression in Long‐Term Renal Transplant Recipients: Reduced Rate of (Pre‐)Malignancies and Nonmelanoma Skin Cancer in a Prospective, Randomized, Assessor‐Blinded, Controlled Clinical Trial

摘要: Renal transplant recipients (RTR) have a 50-200-fold higher risk for nonmelanoma-skin cancer (NMSC) causing high rates of morbidity and sometimes mortality. Cohort-studies gave evidence that sirolimus-based immunosuppression may inhibit skin tumor growth. This single-center, prospective, assessor-blinded, randomized trial investigated if switching to sirolimus treatment inhibits the progression premalignancies moreover how many new NMSC occur compared continuation original immunosuppressive therapy. Forty-four RTR (mean age 59.9 years, mean duration 229.5 months) with lesions were or their immunosuppression. Blinded dermatological assessment at month 6 12 by same dermatologist evaluated clinical change baseline. Biopsy was performed in suspected malignancy. Already 6-month-assessment showed significant superiority sirolimus-therapy: stop progression, even regression preexisting (p < 0.0005). effect increased 0.0001). Nine patients developed histologically confirmed NMSC: one group, eight control p = 0.0176. Sirolimus-based RTR, when established years after transplantation, can delay development premalignancies, induce decelerate incidence NMSC.