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.
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 a 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 of premalignancies and moreover how many new NMSC occur compared to continuation of the original immunosuppressive therapy. Forty-four RTR (mean age 59.9 years, mean duration of immunosuppression 229.5 months) with skin lesions were randomized to sirolimus or continuation of their original immunosuppression. Blinded dermatological assessment at month 6 and 12 by the same dermatologist evaluated the clinical change compared to baseline. Biopsy was performed in suspected malignancy. Already the 6-month-assessment showed significant superiority of sirolimus-therapy: a stop of progression, even regression of preexisting premalignancies (p < 0.0005). This effect was increased at month 12 (p < 0.0001). Nine patients developed histologically confirmed NMSC: one in the sirolimus group, eight in the control group, p = 0.0176. Sirolimus-based immunosuppression in RTR, even when established many years after transplantation, can delay the development of premalignancies, induce regression of preexisting lesions and decelerate the incidence of new NMSC.
Salgo
R
R
Department of Dermatology and Venerology, Hospital of J.W.Goethe, University, Frankfurt, Germany. rebekka.salgo@kgu.de
Gossmann
J
J
Schöfer
H
H
Kachel
H G
HG
Kuck
J
J
Geiger
H
H
Kaufmann
R
R
Scheuermann
E H
EH
D000368:Aged; D002280:Basal Cell Carcinoma / Q000453:epidemiology / Q000209:etiology; D002294:Carcinoma, Squamous Cell / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D007165:Immunosuppression Therapy / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011230:Precancerous Conditions / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D012878:Skin Neoplasms / Q000453:epidemiology* / Q000209:etiology
D007166:Immunosuppressive Agents; D020123:Sirolimus