Dantal J, et al. - Researchers previously found sirolimus to be effective as a preventive against the development of subsequent skin cancers in kidney transplant recipients with previous cutaneous squamous cell carcinomas, but follow-up was limited to 2 years. For this study, they extended the TUMORAPA randomized trial of sirolimus-based immunosuppressive regimen vs calcineurin inhibitor–based immunosuppression to 5 years. Findings revealed that even at 5 years, the antitumoral impact of converting from calcineurin inhibitors to sirolimus was sustained and reasonable sirolimus tolerance was reported.

Methods

• This study included kidney transplant recipients receiving calcineurin inhibitors with at least one cutaneous squamous cell carcinoma.
• Randomization of these subjects to receive sirolimus as a substitute for calcineurin inhibitors (n=64) or to maintain their initial treatment (n=56) was carried out.
• Survival free of squamous cell carcinoma at 5 years was the primary end point.
• The occurrence of other skin cancers, renal function, treatment tolerance, and patient and graft survival were the secondary end points.

Results

• The sirolimus group vs the calcineurin inhibitor group had significantly longer survival free of cutaneous squamous cell carcinoma (P=.007).
• Significantly less patients with new skin cancers were detected in the sirolimus group vs the calcineurin inhibitor group: 22% vs 59% for squamous cell carcinomas (P < .001), 34% vs 66% for other skin cancers (P < .001), and 20% vs 37.5% for basal cell carcinomas (P < .05).
• Both groups had similar outcomes in terms of kidney graft function, patients, and graft survival.
• A decrese was noted in the mean number of serious adverse effects per patient in the sirolimus group; from 1.16 during the first 2 years, to 0.83 between years 2 and 5.