What are the treatment options for superficial basal cell carcinoma (BCC)?

From the Guidelines

Superficial basal cell carcinoma should be treated with topical imiquimod 5% cream applied once daily, five days per week for 6-12 weeks, as it has been shown to be effective in treating multiple superficial BCC with an 85% 5-year disease-free rate and better cosmetic outcomes compared to surgical excision 1.

Treatment Options

The treatment of superficial basal cell carcinoma (sBCC) involves several options, including:

• Topical therapy with imiquimod 5% cream or 5-fluorouracil (5-FU) cream
• Surgical options such as standard excision with 4mm margins, curettage and electrodesiccation, or Mohs micrographic surgery
• Cryotherapy for smaller lesions
• Photodynamic therapy for superficial BCCs

Rationale for Imiquimod

The choice of imiquimod as the first-line treatment is based on its efficacy and cosmetic outcomes. A prospective trial reported an 85% 5-year disease-free rate in superficial BCC treated with imiquimod 1. Additionally, a phase III randomized trial showed that imiquimod provided an 84% rate of clinical success, defined as absence of initial treatment failure or signs of recurrence at 3 years from start of treatment, with better cosmetic outcomes compared to surgical excision 1.

Considerations

Treatment choice depends on tumor size, location, patient age, and comorbidities. Follow-up examinations are essential every 6-12 months after treatment to monitor for recurrence, as patients with one BCC have a 30-50% chance of developing another within five years. While other options like photodynamic therapy and cryotherapy are available, imiquimod remains a preferred choice due to its efficacy and cosmetic outcomes, as supported by the most recent and highest quality study 1.

From the FDA Drug Label

1. 2 Superficial Basal Cell Carcinoma 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. The entire target tumor was then excised and examined histologically for the presence of tumor. Efficacy was assessed by the complete response rate defined as the proportion of subjects with clinical (visual) and histological clearance of the sBCC lesion at 12 weeks post-treatment Of imiquimod-treated subjects, 6% (11/178) who had both clinical and histological assessments post-treatment, and who appeared to be clinically clear had evidence of tumor on excision of the clinically-clear treatment area. 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) Total 75% (139/185) 2% (3/179)

Treatment of Superficial Basal Cell Carcinoma: Imiquimod cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm.

• The recommended dosing is 5 times per week for a full 6 weeks.
• The treatment area should be washed with mild soap and water 8 hours following Imiquimod Cream application.
• Patients should have regular follow-up to re-evaluate the treatment site 2.
• The efficacy of imiquimod cream for the treatment of sBCC was evaluated in two double-blind, vehicle-controlled clinical studies, with a composite clearance rate of 75% at 12 weeks post-treatment 2.
• A separate 5-year, open-label study was conducted to assess the recurrence of sBCC treated with imiquimod cream, with an estimated rate of subjects who clinically cleared and remained clear of 79% at 24 months 2.

From the Research

Treatment Options for Superficial Basal Cell Carcinoma

• Photodynamic therapy (PDT) is a common treatment for superficial basal cell carcinoma, but its effectiveness compared to other treatments has been debated 3, 4.
• Topical imiquimod cream has been shown to be effective in treating superficial basal cell carcinoma, with studies demonstrating high clinical and histologic clearance rates 5, 6.
• Topical fluorouracil cream is another treatment option, with studies showing it to be non-inferior to PDT 3, 4.

Comparison of Treatment Outcomes

• A study comparing PDT, imiquimod, and fluorouracil found that imiquimod was superior to PDT, with a higher proportion of patients tumor-free at 12 months (83.4% vs 72.8%) 3, 4.
• Another study found that imiquimod was effective in treating large superficial basal cell carcinomas, with successful outcomes reported in several cases 6.
• A retrospective study found that sequential treatment with PDT and imiquimod resulted in a low long-term recurrence rate of 10% 7.

Adverse Effects and Tolerability

• PDT has been associated with moderate to severe pain and burning sensation during treatment, as well as local skin reactions such as redness and itching 3, 4.
• Imiquimod has been associated with local skin reactions such as erythema, erosion, and scabbing/crusting, which correlated with treatment response 5.
• Fluorouracil has been associated with local skin reactions such as swelling, erosion, and itching, as well as a higher risk of serious adverse events such as local wound infections 3, 4.