BACKGROUND: Larynx leukoplakia can be a premalignant precursor of squamous cell carcinoma, is often tobacco related, and can be monitored easily by indirect laryngoscopy. One of the main motivations for using retinyl palmitate in patients with larynx leukoplakia was to avoid general anesthesia for the elderly patients, who are considered to be at high risk for undergoing direct laryngoscopy. Our study investigates for the first time the effectiveness and toxicity of high-dose retinyl palmitate in the treatment of larynx leukoplakia. METHODS: Treatment was divided into two phases. In the first phase, all patients underwent induction therapy with a high-dose of retinyl palmitate (A-Mulsin Hochkonzentrat, Mucos Pharma, Geretsried, Germany) with 300,000 IU/day for the first week and up to 1,500,000 IU/day, in patients with resistant lesions, in the fifth week. Patients whose lesions progressed during this period were withdrawn from the study. In the second phase, patients whose lesions responded to treatment or remained stable were then assigned to a maintenance therapy of 150,000 IU/day. RESULTS: We observed a complete remission rate of 75% (15 of 20 patients). Among the 5 patients with partial response, 3 relapsed. The median duration of treatment and follow up was 18 months (range 12-24 months). CONCLUSIONS: These results indicate that retinyl palmitate has substantial activity in larynx leukoplakias. Furthermore, only minor side effects make it an excellent candidate as a preventive agent for larynx cancer.
BACKGROUND:Larynx leukoplakia can be a premalignant precursor of squamous cell carcinoma, is often tobacco related, and can be monitored easily by indirect laryngoscopy. One of the main motivations for using retinyl palmitate in patients with larynx leukoplakia was to avoid general anesthesia for the elderly patients, who are considered to be at high risk for undergoing direct laryngoscopy. Our study investigates for the first time the effectiveness and toxicity of high-dose retinyl palmitate in the treatment of larynx leukoplakia. METHODS: Treatment was divided into two phases. In the first phase, all patients underwent induction therapy with a high-dose of retinyl palmitate (A-Mulsin Hochkonzentrat, Mucos Pharma, Geretsried, Germany) with 300,000 IU/day for the first week and up to 1,500,000 IU/day, in patients with resistant lesions, in the fifth week. Patients whose lesions progressed during this period were withdrawn from the study. In the second phase, patients whose lesions responded to treatment or remained stable were then assigned to a maintenance therapy of 150,000 IU/day. RESULTS: We observed a complete remission rate of 75% (15 of 20 patients). Among the 5 patients with partial response, 3 relapsed. The median duration of treatment and follow up was 18 months (range 12-24 months). CONCLUSIONS: These results indicate that retinyl palmitate has substantial activity in larynx leukoplakias. Furthermore, only minor side effects make it an excellent candidate as a preventive agent for larynx cancer.