Current address: Royal Adelaide Hospital, Adelaide, Australia. ClinicalTrials.gov registry number: NCT00129961 Presented in part at the American Transplant Congress, Boston, MA, May 30–June 3, 2009, at the European Society of Transplantation, Paris, France, August 30–September 2, 2009, and at the American Society of Nephrology, San Diego, CA, USA, October 29–November 1, 2009.
Randomized Controlled Trial of Sirolimus for Renal Transplant Recipients at High Risk for Nonmelanoma Skin Cancer
Article first published online: 15 MAR 2012
© Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons
American Journal of Transplantation
Volume 12, Issue 5, pages 1146–1156, May 2012
How to Cite
Campbell, S. B., Walker, R., Tai, S. S., Jiang, Q. and Russ, G. R. (2012), Randomized Controlled Trial of Sirolimus for Renal Transplant Recipients at High Risk for Nonmelanoma Skin Cancer. American Journal of Transplantation, 12: 1146–1156. doi: 10.1111/j.1600-6143.2012.04004.x
- Issue published online: 26 APR 2012
- Article first published online: 15 MAR 2012
- Received 07 July 2011, revised 08 November 2011 and accepted for publication 06 December 2011
- Calcineurin inhibitor;
- kidney transplantation;
- nonmelanoma skin cancer;
Sirolimus has antineoplastic effects and may reduce skin cancer rates in kidney transplant patients. This prospective, multicenter, randomized, open-label, controlled trial randomized 86 kidney transplant recipients (≥1 year posttransplant) with history of nonmelanoma skin cancer (NMSC) to continue calcineurin inhibitor (CNI) or convert to sirolimus. Patients were stratified by number of NMSC lesions (0–5, 6–20) in previous year. Primary end point was number of biopsy-confirmed new NMSC lesions per patient-year. Yearly NMSC rate was significantly lower with sirolimus (1.31 vs. 2.48 lesions/patient-year; p = 0.022). Squamous cell carcinoma occurred at a lower rate in the sirolimus versus CNI group (p = 0.038); basal cell carcinoma rate was similar in both. A lower proportion of patients receiving sirolimus developed new or recurrent NMSC (56.4% vs. 80.9%; p = 0.015) or new squamous cell carcinoma (41.0% vs. 70.2%; p = 0.006). No sirolimus patients and one CNI continuation patient experienced acute rejection. Incidence of treatment-emergent adverse events was similar between groups; however, discontinuation rates related to adverse events were significantly higher with sirolimus (46.2% vs. 0%; p < 0.001). In kidney transplant recipients with history of NMSC, conversion from CNI to sirolimus reduced rates of NMSC, without increasing acute rejection risk.