title: [High concentrate A-mulsin, a new therapy concept in laryngeal leukoplakia].
abstract: BACKGROUND
  Leukoplakia, a white patch in the oral cavity or in the larynx that cannot be scraped off is a premalignant precursor of squamous cell carcinoma. It is tobacco-related and easily monitored. The rate of transformation of leukoplakia into invasive cancer is directly related to the degree of histologic abnormality. In the largest and longest study in the United States (mean follow-up, 7.2 years), the long-term transformation rate for dysplastic lesions was 36%. Surgical removal is considered the best therapy. However many patients operated on for oral leukoplakia later develop local relapses, new leukoplakias, or squamous cell carcinoma. Although leukoplakia lesions can show spontaneous regression, the response rate observed under treatment of retinoids 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 underwent induction therapy with a high dose of Retinyl Palmitate (A-Mulsin Hochkonzentrat, Mucos Pharma, Geretsried, Germany) 300.000 IU daily for the first week up to 1,500,000 IU daily 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 Patients whose lesions progressed during this period were withdrawn from the study.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. The median duration of treatment was 104 days (range 15-272).
  
  
  RESULTS
  We 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 carcinoma.
  
  
  CONCLUSIONS
  One of the main reasons for using retinyl palmitate in patients with larynx leukoplakia was to avoid general anesthesia in elderly patients who were considered as high risk patients for undergoing surgery. These results indicate that retinyl palmitate has substantial activity in larynx premalignancy. Because of its minor toxicity, it is an excellent candidate for a preventive agent for larynx cancer.
authors.affiliation: Klinik und Poliklinik für Hals-, Nasen-, Ohrenkranke, Universität München.
authors.forename: W J
authors.initials: WJ
authors.lastname: Issing
authors.forename: R
authors.initials: R
authors.lastname: Struck
authors.forename: A
authors.initials: A
authors.lastname: Naumann
authors.forename: E
authors.initials: E
authors.lastname: Kastenbauer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016588:Anticarcinogenic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002471:Cell Transformation, Neoplastic / Q000187:drug effects / Q000473:pathology; D004224:Diterpenes; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D007830:Larynx / Q000187:drug effects / Q000473:pathology; D007971:Leukoplakia / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000084562:Retinyl Esters; D014801:Vitamin A / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D016588:Anticarcinogenic Agents; D004224:Diterpenes; D000084562:Retinyl Esters; D014801:Vitamin A; C014794:retinol palmitate