A-MULSIN HOCHKONZENTRAT, A NEW CONCEPT IN THE TREATMENT OF LEUKOPLAKIA OF THE LARYNX

Background: Leukoplakia, a white patch in the oral cavity or in the la rynx that cannot be scraped off is a premalignant precursor of squamou s cell carcinoma. It is tobacco-related and easily monitored. The rate of transformation of leukoplakia into invasive cancer is directly rel ated to the degree of histologic abnormality. In the largest and longe st study in the United States (mean follow-up, 7.2 years), the long-te rm transformation rate for dysplastic lesions was 36%. Surgical remova l is considered the best therapy. However many patients operated on fo r oral leukoplakia later develop local relapses, new leukoplakias, or squamous cell carcinoma. Although leukoplakia lesions can show spontan eous regression, the response rate observed under treatment of retinoi ds is much greater. Methods: In our study, high-dose retinyl palmitate was used for the first time on leukoplakias of the larynx. The study was conducted in two phases. In the first phase, all patients underwen t induction therapy with a high dose of Retinyl Palmitate (A-Mulsin Ho chkonzentrat(TM). Mucos Pharma, Geretsried, Germany) 300 000 IU daily for the first week up to 1 500 000 IU daily in the fifth week. Patient s whose lesions progressed during this period were withdrawn from the study. In the second phase, patients whose lesions responded to treatm ent or remained stable were then assigned to a maintenance therapy. Th e median duration of treatment was 104 days (range 15-272). Results: W e observed a complete remission rate of 65% (20 out of 31 patients), a partial remission in 8 patients (26%) and a relaps in three patients (9%) during the next 15 months follow-up. Relapses were mainly seen in patients with a history of a carcinoma in situ or squamous cell carci noma. Conclusions: One of the main reasons for using retinyl palmitate in patients with larynx leukoplakia was to avoid general anesthesia i n elderly patients who were considered as high risk patients for under going surgery. These results indicate that retinyl palmitate has subst antial activity in larynx premalignancy. Because of its minor toxicity , it is an excellent candidate for a preventive agent for larynx cance r.