Journal
AMERICAN JOURNAL OF TRANSPLANTATION
Volume 10, Issue 6, Pages 1385-1393Publisher
WILEY-BLACKWELL
DOI: 10.1111/j.1600-6143.2009.02997.x
Keywords
mTOR inhibitor; nonmelanoma skin cancer; renal transplant; renal transplant recipient; sirolimus; skin tumors
Categories
Funding
- Amgen
- Astra-Zeneca
- Abbott
- Novartis
- Roche
- Wyeth
- Astellas
- Essex
- Basilea
- Galderma
- Shire
- Stada
- LEO
- Stiefel
- 3M Medica
- Meda
- MDS
- Ellipse
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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.
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