What are alternative treatments to Efudex (fluorouracil) for actinic keratosis or superficial basal cell carcinoma in Alberta?

From the Guidelines

Alternative treatments to Efudex (fluorouracil) for actinic keratosis or superficial basal cell carcinoma in Alberta include imiquimod cream, diclofenac gel, ingenol mebutate, cryotherapy, photodynamic therapy, and surgical options. Based on the most recent evidence from 2021, imiquimod 5% cream (Aldara) is a strongly recommended treatment option, applied 2-3 times weekly for 4-16 weeks, stimulating the immune system to target abnormal cells 1. Other treatment options include:

• Diclofenac 3% gel (Solaraze) which requires twice-daily application for 60-90 days and works by reducing inflammation
• Ingenol mebutate (Picato) which offers a shorter treatment course of just 2-3 days
• Cryotherapy which uses liquid nitrogen to freeze and destroy lesions in a single visit
• Photodynamic therapy which combines a photosensitizing agent with light exposure to selectively destroy abnormal cells
• Surgical options including curettage, excision, or Mohs surgery for more invasive cases Treatment selection depends on factors like lesion location and size, patient preference, cost considerations, and coverage by Alberta Health Services or private insurance, as outlined in the guidelines for the management of actinic keratosis 1. Some treatments may require referral to a dermatologist, particularly for basal cell carcinoma management, and the choice of treatment should be based on the individual patient's needs and circumstances, taking into account the potential benefits and risks of each treatment option, as discussed in the guidelines 1. It is also important to consider the patient's medical history, current medications, and any potential allergies or sensitivities when selecting a treatment option, as well as the potential for combination therapy, as conditionally recommended in the guidelines 1. Overall, the treatment of actinic keratosis and superficial basal cell carcinoma requires a comprehensive approach, taking into account the individual patient's needs and circumstances, and the most recent evidence-based guidelines, as outlined in the 2021 guidelines for the management of actinic keratosis 1.

From the FDA Drug Label

In two double-blind, vehicle-controlled clinical studies, 436 subjects with AK were randomized to treatment with either imiquimod cream or vehicle cream 2 times per week for 16 weeks. Complete clearance included clearance of all baseline lesions, as well as any new or sub-clinical AK lesions which appeared during therapy. Complete and partial clearance rates are shown in the table below. Table 11: Clearance Rates (AK) Complete Clearance Rates (100% AK Lesions Cleared) Study Imiquimod Cream Vehicle Study 46% (49/107) 3% (3/110) AK1 Study 44% (48/108) 4% (4/111) AK2 In two double-blind, vehicle-controlled clinical studies, 364 subjects with primary sBCC were treated with imiquimod cream or vehicle cream 5 times per week for 6 weeks. Data on composite clearance (defined as both clinical and histological clearance) are shown in the table below Table 12: Composite Clearance Rates at 12 Weeks Post-Treatment for Superficial Basal Cell Carcinoma Study Imiquimod Cream Vehicle Cream Study sBCC1 70% (66/94) 2% (2/89) Study sBCC2 80% (73/91) 1% (1/90)

Alternative to Efudex in Alberta:

• Imiquimod cream is an alternative treatment for actinic keratosis (AK) and superficial basal cell carcinoma (sBCC) 2.
• The treatment regimen for AK is 2 times per week for 16 weeks, and for sBCC is 5 times per week for 6 weeks 2.
• Key points to consider:
  • Imiquimod cream has been shown to be effective in clearing AK lesions and sBCC tumors.
  • Local skin reactions are common, but most are mild to moderate.
  • Patients should be instructed on proper application technique and warned about potential local skin reactions and systemic signs and symptoms 2.

From the Research

Alternative Treatments to Efudex

In Alberta, due to the backorder of Efudex (fluorouracil), alternative treatments for actinic keratosis or superficial basal cell carcinoma can be considered. Some of these alternatives include:

• Imiquimod: an immune response modifier approved by the FDA for the treatment of actinic keratosis and superficial basal cell carcinoma lesions 3, 4, 5, 6
• Photodynamic therapy: a topical, non-surgical treatment option for superficial basal cell carcinoma 6
• Cryotherapy: a destructive technique used to treat actinic keratosis and superficial basal cell carcinoma 7
• Electrodessication: a destructive technique used to treat actinic keratosis and superficial basal cell carcinoma 3, 7
• Ingenol mebutate: a topical drug used to treat actinic keratosis 7
• Hedgehog pathway inhibitors: a treatment option for basal cell carcinoma 7

Considerations for Treatment Choice

When choosing an alternative treatment to Efudex, several factors should be considered, including:

• Tumor size, location, and histopathological subtype 7
• Physician experience with the treatment modality 7
• Patient preference 7
• Potential adverse events 6, 7
• Cosmetic outcome 7

Efficacy of Alternative Treatments

The efficacy of alternative treatments to Efudex has been studied in several clinical trials. For example, imiquimod has been shown to be effective in treating actinic keratosis and superficial basal cell carcinoma, with a clinical cure rate of 80-85% at 12 months 4. Photodynamic therapy has also been shown to be effective, with a tumor-free rate of 72.8% at 12 months 6. Cryotherapy and electrodessication have also been used to treat actinic keratosis and superficial basal cell carcinoma, although their efficacy may vary depending on the specific treatment protocol and patient population 3, 7.