Imiquimod Cream Preceded by Superficial Curettage vs Surgical Excision for Nodular Basal Cell Carcinoma: A Secondary Analysis of a Randomized Clinical Trial.
Summary
In a 5-year secondary analysis of the SCIN randomized trial (n=145), superficial curettage plus 5% imiquimod was significantly less effective than surgical excision for nodular BCC. Tumor-free survival at 5 years was 77.8% with curettage/imiquimod versus 98.2% with excision; noninferiority of the noninvasive approach could not be concluded.
Key Findings
- Five-year tumor-free survival: 77.8% (imiquimod after curettage) vs 98.2% (surgical excision).
- Relative risk of treatment failure was 15.93 (95% CI, 2.10–120.64) for curettage/imiquimod vs excision.
- Most treatment failures occurred within the first year; competing risk analysis corroborated findings.
Clinical Implications
For nodular BCC, surgical excision remains the standard with superior long-term control. If a patient prefers noninvasive therapy, clinicians should counsel on higher recurrence risk and plan close surveillance, especially in the first year.
Why It Matters
Provides long-term comparative effectiveness data that clarify trade-offs between noninvasive therapy and surgery for nodular BCC, informing patient counseling and shared decision-making.
Limitations
- Secondary analysis; trial powered for 1-year outcomes, not necessarily for 5-year noninferiority.
- Modest sample size and two-center setting; lack of blinding inherent to interventions.
Future Directions
Prospective trials comparing optimized topical/immunomodulatory regimens versus surgery with patient-reported outcomes and cost-effectiveness, and biomarkers predicting responders.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized clinical trial with long-term follow-up (secondary analysis).
- Study Design
- OTHER