SPOT-IT (cutaneous SCC Prevention using Topical Therapy in Immunosuppressed patients)

Cutaneous squamous cell carcinoma (cSCC) is the most common skin cancer with metastatic potential and an identifiable precancerous stage, actinic keratosis (AK). UK cSCC incidence is increasing by 5% per annum with immunosuppression as a key risk factor. Multiple primary cSCC are common, especially in immunosuppressed organ transplant recipients, and incur significant morbidity and cost. Prevention of cSCC in immunosuppressed patients is a major unmet clinical need, yet this population has previously been excluded from clinical trials.

RCT data confirm that 5-fluorouracil 5% cream (5FU, Efudix) is the most effective treatment modality for AK in immunocompetent patients but is difficult to tolerate and is likely needed to be repeated annually (twice daily for 4 weeks with a significant local skin reaction). Recent evidence combining 5FU with topical calcipotriol ointment (5FU+CAL) potentiates efficacy, reducing treatment time from 4wks to 4-6days, and may prevent cSCC. An immunological mechanism has been demonstrated, but immunosuppressed individuals were excluded. Our feasibility study (SPOT) found 5FU superior to imiquimod cream in preventing new AK in OTR and has confirmed 5FU+CAL is preferred by patients.

The SPOT-IT trial is designed as a Phase III comparison of 5FU versus standard care (sunscreen) with

embedded Phase II including 5FU+Cal with the following aims to demonstrate that:

1. 5FU-based cream (5FU or 5FU+CAL) treatment is superior to standard of care (Sunscreen + Surveillance) in cSCC prevention in immunocompromised populations.
2. The significantly shorter treatment duration for 5FU+CAL will improve tolerability / patient acceptability, improving feasibility for a long-term topical chemoprevention strategy.

If you are interested in learning more about this study or wish to enrol please contact Co-CI Dr Rubeta Matin on rubeta.matin@nhs.net or the clinical trials unit on SPOT-IT@cardiff.ac.uk