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
• Wong HY
• Althabteh A
• Cox C
• Stevenson PH
• Brown S
• Griffin A
• Isbel N
• Siller G
• Soyer HP
• Schaider H
• Roy E
• Campbell S
• Green AC
• Khosrotehrani K
• Stevenson P

CET Conclusion

Reviewer:

Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford

Conclusion:

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.

Methodological quality

Jadad score	5
Allocation concealment	YES
Data analysis	INTENTION TO TREAT

Study Details

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

Metadata

Funding:	Non-industry funding
Publication type:	Randomized Controlled Trial, Randomised Controlled Trial
Trial registration:	ACTRN12618001961235
Organ:	Various; Kidney; Liver; Heart; Lung
Language:	English
Author email:	k.khosrotehrani@uq.edu.au
MeSH terms:	Carcinoma, Squamous Cell; Chemoprevention; Double-Blind Method; Humans; Organ Transplantation; Pilot Projects; Sirolimus; Skin Neoplasms; Transplant Recipients; W36ZG6FT64 (Sirolimus); Kidney Transplantation; Liver Transplantation; Lung Transplantation; Heart Transplantation