[The chemoprevention of oral carcinoma with vitamin A and/or N-acetylcysteine]

Abstract

EUROSCAN (EUROpean Study on Chemoprevention with vitamin A and N-acetylcysteine) is a study which has the aim to demonstrate the efficacy of vitamin A and N-acetylcysteine in the prevention of second primary tumours in patients treated for lung, larynx and oral cancer. In this study are involved more than 50 medical centres in all Europe, co-ordinated by European Organization for research and Treatment of Cancer (EORTC). In December 1993 almost 2300 patients have been randomized; at the present day, in our department, we follow 29 patients curatively treated for oral cancer (pTNM: pT1N0M0, pT2N0M0, pT2N1M0) and, for this reason, at high risk to develop local recurrences or second primary tumours. These patients are allocated to four different arms according to the drugs they take: vitamin A as retinol palmitate (300,000 UI a day for the first year and 150,000 UI for the second year), N-acetylcysteine (600 mg a day for two years), both these drugs, no drugs (control group). During follow-up all the patients have clinical examinations and blood tests (in patients taking vitamin A) every 3-6 months. The randomization is expected to stop around September 1994, when, probably, the number of 2600 patients will be reached. The first analysis allowing a conclusion on chemopreventive efficacy of retinol and N-acetylcysteine will be performed not before September 1996 with a median follow-up time of more than 3 years.(ABSTRACT TRUNCATED AT 250 WORDS)