Sirolimus and Secondary Skin-cancer Prevention in Kidney Transplantation.
Euvrard S, Morelon E, et al.New England Journal of Medicine, 367(4): 329-339, 2012.
Aims
To evaluate the efficacy of sirolimus for the secondary prevention of skin cancers in kidney transplant recipients receiving calcineurin inhibitors.
Interventions
Convert to sirolimus from calcineurin inhibitors versus continue receiving calcineurin inhibitors.
Participants
120 kidney transplant recipients who had at least one cutaneous squamous-cell carcinoma.
Outcomes
The primary endpoint was survival free of new cutaneous squamous-cell carcinoma at 2 years. Secondary endpoints included the time until the onset of new cutaneous squamous-cell carcinoma, occurrence of other skin and non-skin tumours, and graft function. Safety assessment included physical examination, adverse events and changes in laboratory parameters.
Follow-up
2 years
CET Conclusions
There was a significant reduction in the occurrence of subsequent squamous cell carcinomas in the two year follow up period in patients who had been switched to sirolimus from a calcineurin inhibitor. However there were a number of significant adverse events in the sirolimus switch patients including pneumonitis. Thus there is further evidence that sirolimus does provide a management protocol for patients with squamous cell carcinomas of the skin after renal transplantation but associated with this will be a definite risk of serious adverse events.
Data analysis
Available case analysis
Trial registration
NCT00133887 (ClinicalTrials.gov); 2004-004947-23 (EUDRACT) & 2005-004509-27 (EUDRACT).