It is indicated for the management of grade I/II hyperkeratotic AK.
The 5-FU/SA combination under review is administered once daily to affected lesions, until lesions have cleared or for a maximum of 12 weeks. SA is a keratolytic, and the theory behind its use is to improve penetration of the combination in hyperkeratotic AK. 5-FU is an antimetabolite that is already approved as monotherapy for treatment of AK, although at a concentration of 5%. The submitted product is a combination of two topical therapies, 5-fluorouracil 0.5% (5-FU) and salicylic acid 10% (SA). 2 Patient input to the CADTH Common Drug Review (CDR) suggests that cosmetic issues are a major concern for patients, and this can have a negative impact on self-confidence.
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1, 5 Detectable AK may be associated with a field change where the surrounding skin is also altered and subclinical lesions may be present. 1 A skin biopsy may be required when there is clinical doubt or suspicion of invasive malignancy. 4, 5 Patients with AK are usually referred to dermatologists and diagnosis is frequently made on clinical appearance alone. 2ĪK typically manifests as 2 mm to 6 mm scaly macules, papules, or plaques that are skin to reddish-brown in colour, and may be flat or thickened (hyperkeratotic). In Canada, 74,100 new cases of non-melanoma skin cancers (NMSCs) and 270 deaths due to these cancers were predicted for 2011. 3 The risk of malignant transformation is higher in patients who are immunocompromised. Mathematical models derived from a study predicted that for an individual with an average of 7.7 AKs, the probability of developing an SCC at the same or nearby site within a 10-year period is approximately 10. 2 The rate of progression from AK to SCC is unknown. 1 However, AK lesions may develop into invasive squamous cell carcinoma (SCC) if left untreated.
According to the British Association of Dermatologists, 15% to 25% of actinic keratosis (AK) lesions spontaneously resolve during a one-year period.
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