What is the routine treatment for superficial Basal Cell Carcinoma (BCC) using Efudix (Fluorouracil)?

From the Guidelines

Efudix (5-fluorouracil) is a recommended treatment for superficial basal cell carcinoma (BCC), with a standard regimen of applying a thin layer of the cream to the affected area twice daily for 3-6 weeks, as it has been shown to be effective in treating superficial BCCs with cure rates of 80-90% 1. The treatment regimen for Efudix typically involves washing the area with mild soap and water, patting dry, then applying the cream with a clean finger or cotton swab, covering the lesion and a small margin of surrounding skin.

• Leave the medication on for at least 4 hours before washing.
• During treatment, the skin will become red, inflamed, and may develop crusting or erosions - these reactions indicate the treatment is working.
• Protect the treated area from sun exposure as this can worsen irritation.
• The full treatment course must be completed even if the lesion appears to clear early. After treatment, the skin typically heals within 1-2 weeks. Efudix works by interfering with DNA synthesis in rapidly dividing cells, selectively destroying cancerous and precancerous cells while sparing normal skin. This treatment is particularly effective for superficial BCCs, though deeper or larger BCCs may require alternative treatments like surgery or radiation, as noted in the guidelines for the management of basal cell carcinoma 1. However, the most recent and highest quality study 1 supports the use of Efudix for superficial BCC, making it a recommended treatment option.

From the FDA Drug Label

INDICATIONS AND USAGE: Fluorouracil Cream USP is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. The success rate with Fluorouracil Cream USP is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.

The routine for superficial BCC using Efudix (Fluorouracil) is to apply the 5% strength cream.

• Key points:
  • Useful for superficial basal cell carcinomas when conventional methods are impractical
  • Success rate is approximately 93%
  • Diagnosis should be established prior to treatment 2

From the Research

Efudix Routine for Superficial BCC

• Efudix, also known as fluorouracil, is a topical cream used to treat superficial basal cell carcinoma (BCC) 3, 4, 5, 6.
• The efficacy of Efudix in treating superficial BCC has been studied in several clinical trials, with reported cure rates ranging from 80% to 90% 3, 4, 5.
• A study published in The Lancet Oncology found that topical fluorouracil was non-inferior to photodynamic therapy (PDT) for the treatment of superficial BCC, with a cure rate of 80.1% at 12 months 3.
• Another study published in Dermatologic Surgery found that 5% fluorouracil cream was effective in treating superficial BCC, with a histologic cure rate of 90% and a mean time to clinical cure of 10.5 weeks 4.
• The treatment regimen for Efudix typically involves applying the cream twice daily for 4 weeks, although the exact regimen may vary depending on the individual patient and the severity of the tumor 3, 4, 5.

Comparison with Other Treatments

• Efudix has been compared to other treatments for superficial BCC, including imiquimod and PDT 3, 7, 5.
• A study published in The Lancet Oncology found that imiquimod was superior to PDT for the treatment of superficial BCC, with a cure rate of 83.4% at 12 months 3.
• Another study published in the Journal of the American Academy of Dermatology found that imiquimod 5% cream was effective in treating superficial BCC, with a histologic clearance rate of 100% in the twice-daily regimen 7.
• The choice of treatment for superficial BCC depends on various factors, including the size and location of the tumor, the patient's overall health, and the potential side effects of the treatment 6.

Side Effects and Tolerability

• Efudix can cause side effects, including local skin reactions such as redness, swelling, and itching 3, 4, 5.
• A study published in The Lancet Oncology found that patients treated with Efudix reported moderate to severe local skin reactions, including swelling, erosion, and crust formation 3.
• However, the majority of patients found the treatment to be well-tolerated, with only a few patients reporting severe side effects 4, 5.