Beta-carotene and vitamin E in oral cancer prevention.

The ultimate proof that a putative chemopreventive agent does prevent cancer is a demonstration of reduced cancer incidence in a targeted population. However, because of practical and logistical considerations, such trials are virtually impossible to conduct for the majority of cancers. Therefore, a conclusion regarding the efficacy of chemopreventive activity is based on consideration of a variety of indirect lines of evidence, including laboratory studies, animal model systems, epidemiologic surveys, intervention trials involving reversal of premalignant changes, and the prevention of malignancies in particularly high risk subjects. Furthermore, the only agents worth testing are those with limited, or preferably, no toxicity, since the final use will be prevention in a generally healthy population. Beta-carotene and vitamin E both fulfill all the criteria for suitable chemopreventive agents; several lines of evidence point toward preventive roles for them in oral cancer. In numerous epidemiologic studies, low intake of beta-carotene has been associated with higher cancer risk. Both intake and supplemental use of vitamin E have been associated with a lowered risk of cancer. Smokers, whose habit is a major risk factor, have lower beta-carotene levels in oral mucosal cells when compared with non-smokers. In several laboratory and animal model systems, including the very relevant hamster cheek pouch model, these agents strongly inhibit oral cavity carcinogenesis. Beta-carotene and vitamin E produce regression of oral leukoplakia, a premalignant lesion for oral cancer. This has now been shown in seven clinical trials: five with beta-carotene alone, one with vitamin E, and one with a combination of both.(ABSTRACT TRUNCATED AT 250 WORDS)