Chemoprevention of cutaneous squamous cell carcinoma and its precursors in solid organ transplant recipients using topical sirolimus: a randomized, double-blind, placebo-controlled pilot trial - Supplementary materials

The files below contain the supplemental methods outlining ethics statement, study design & intervention, outcome measures, and statistical analysis. The results for recruitment, compliance, and rention as well as the safety of topical sirolimus in solid organ transplant patients (SOTRs) are also included.

Immunosuppression in solid organ transplant recipients (SOTR) greatly increases the risk of keratinocyte cancer (KC), indisputably a significant burden in terms of morbidity, mortality and cost. Switching calcineurin inhibitors to sirolimus is a major strategy that has resulted in a two-fold reduction in the risk of SCC, but is poorly tolerated with many serious adverse events 1, 2.
To circumvent these, we explored whether topical sirolimus applied topically could safely reduce the incidence of KC in the field of cancerisation in a randomized, double-blind, placebo-controlled, single-arm trial whereby patients received intervention on the dorsum of one hand and forearm and placebo on the dorsum of the contralateral hand and forearm chosen randomly.
At 12 weeks, the number of keratotic lesions was reduced in each patient by 31+/-5% (from an average of 9.7 to 7.9, p=0.0001) in the treated side whereas it increased marginally on the vehicle side (6+/-6%, p=0.0006).