Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks
| Autor: | Kurt Gebauer, Mary L. Owens, Christopher J Quirk, Patti Stampone |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
medicine.medical_specialty
Chemotherapy Erythema business.industry medicine.medical_treatment Phases of clinical research Imiquimod Dermatology medicine.disease Surgery Superficial basal cell carcinoma Regimen Internal medicine Medicine Basal cell carcinoma Dosing medicine.symptom business medicine.drug |
| Zdroj: | Australasian Journal of Dermatology. 47:258-265 |
| ISSN: | 0004-8380 |
| DOI: | 10.1111/j.1440-0960.2006.00313.x |
| Popis: | SUMMARY Imiquimod 5% cream is approved in the USA, Europe and Australia to treat superficial basal cell carcinoma, using a regimen of once daily, 5 times per week for 6 weeks. Vehicle-controlled, phase III clinical trials show that imiquimod is safe and effective for treating superficial basal cell carcinoma with dosing 5 or 7 times per week for 6 weeks. This phase III, open-label study evaluates the long-term (5 years) clinical efficacy and safety of dosing once daily, for which this manuscript reports the 2-year time point in the follow-up period. For the 169 enrolled subjects, the tumour selected for treatment was assessed clinically to determine initial clearance at the 12-week post-treatment visit. If clinically clear of superficial basal cell carcinoma, subjects entered a 5-year, long-term follow-up period. Subjects were evaluated for recurrence at the 3-, 6-, 12- and 24-month follow-up visits. The initial clearance rate at 12 weeks post treatment was 94.1%. The proportion of subjects who were clinically clear at the 2-year follow-up visit was estimated to be 82.0%. Imiquimod was tolerated when applied daily, with erythema reported for all subjects participating in the study. The recurrence rate observed suggests that once daily dosing and 5×/week dosing yield similar clearance rates, but daily dosing increases local skin reactions. |
| Databáze: | OpenAIRE |
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