Background. Larynx leukoplakia can be a premalignant precursor of squa
mous cell carcinoma, is often tobacco related, and can be monitored ea
sily by indirect laryngoscopy. One of the main motivations for using r
etinyl palmitate in patients with larynx leukoplakia was to avoid gene
ral anesthesia for the elderly patients, who are considered to be at h
igh risk for undergoing direct laryngoscopy. Our study investigates fo
r the first time the effectiveness and toxicity of high-dose retinyl p
almitate in the treatment of larynx leukoplakia. Methods. Treatment wa
s divided into two phases. In the first phase, all patients underwent
induction therapy with a high-dose of retinyl palmitate (A-Mulsin Hoch
konzentrat(TM), Mucos Pharma, Geretsried, Germany) with 300,000 IU/day
for the first week and up to 1,500,000 IU/day, in patients with resis
tant lesions, in the fifth week. Patients whose lesions progressed dur
ing this period were withdrawn from the study. In the second phase, pa
tients whose lesions responded to treatment or remained stable were th
en assigned to a maintenance therapy of 150,000 IU/day. Results. We ob
served 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). Conclusion
s. These results indicate that retinyl palmitate has substantial activ
ity in larynx leukoplakias. Furthermore, only minor side effects make
it an excellent candidate as a preventive agent for larynx cancer. (C)
1996 John Wiley & Sons, Inc.