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.
Chong, S., et al.Journal of the American Academy of Dermatology 2022 [record in progress].
Aims
This study aimed to examine whether topical application of sirolimus could safely reduce the incidence of keratinocyte cancer (KC) in solid organ transplant recipients.
Interventions
Forearms of patients were randomised to either receive topical Sirolimus or placebo.
Participants
29 adult solid organ transplant recipients with a history of basal cell carcinomas or squamous cell carcinomas (SCC) as well as keratotic lesions on the back of the forearms and hands.
Outcomes
Number of keratotic lesions, change in keratotic lesions, number of intraepidermal carcinoma, and number of SCC.
Follow-up
24 months
CET Conclusions
This small, blinded pilot study randomised transplant recipients with a history of basal and squamous cell carcinoma (BCC/SCC) to apply topical sirolimus to one forearm/hand and placebo to the other for 12 weeks. There was a significant reduction in the risk of keratotic lesions in the sirolimus group at 12 weeks, which resulted in a significant reduction in the risk of intraepithelial carcinomas at 24 months (4 in the sirolimus arm vs. 12 in the placebo arm). Whilst clearly small and underpowered for firm conclusions, this pilot study does provide some evidence of efficacy and feasibility in support of a larger efficacy study.
Data analysis
Strict intention-to-treat analysis
Trial registration
ACTRN12618001961235