SPOT-IT

Cutaneous SCC Prevention using Topical Therapy in Immunosuppressed Patients.

Cutaneous squamous cell carcinoma (cSCC) is one of the commonest types of skin cancer with numbers increasing by 5% every year in the UK. Some cSCC may develop from areas of sun-damaged skin called actinic keratoses (AK) arising on visible skin that has been regularly exposed to sunlight.

Immunocompromised people, including organ transplant recipients, have a much higher risk of developing new cSCC skin cancers than not immunosuppressed individuals. cSCC skin cancer prevention is, therefore, especially important for this population.

There are several treatments available for AK that can help with the prevention of skin cancer. Sunscreen, for example, prevents the development of AK when applied daily. 5-Fluorouracil 5% cream (5FU) is a form of topical chemotherapy that is most effective to reduce the chance of cSCC. However, this treatment is difficult to tolerate, as it causes red skin with pain, weeping/crusting and a distressing appearance that may last up to 6 weeks.

Recently, it was shown that combining 5FU with a vitamin D ointment called calcipotriol (CAL/Dovonex) boosts the effectiveness of 5FU such that only a 4 to 6-day treatment course is needed, with any common side effects settling within 2 weeks.  Patients who used this treatment found it more tolerable but there are no large studies investigating the effectiveness of the combination treatment or comparing sunscreen with 5FU alone.

The purpose of the study is to compare standard of care sunscreen only to topical 5FU cream with an additional study arm comparing a topical 5FU+CAL combination (aimed to prevent the development of cSCC).

Immunocompromised patients with a previously treated cSCC skin cancer will be identified from dermatology outpatient clinics. All patients will be randomly assigned to one of the three study arms and advised to apply daily sunscreen. All participants will be monitored by the study team at the same timepoints during the study.  The topical treatment will be repeated each year for 3 years and the time it takes to develop a new cSCC skin cancer, if any, over the 3-year trial period will be recorded.  Participants will be asked about their experience of side effects, quality of life and how acceptable the treatments are. We hope this trial will help us find out the most acceptable and effective way to prevent cSCC in immunocompromised individuals

If this trial shows that 5FU and/or 5FU+CAL are effective at preventing the development of new cSCC skin cancers in immunocompromised people, this strategy is likely to become the new standard of care for the NHS immunocompromised population. This should bring substantial patient benefits and could reduce NHS health costs.