High dose therapy with the vitamin A analogue isotretinoin has been shown to inhibit the progression of precancerous oral leukoplakias into oral cancer. The use of this drug is limited, however, by its toxicity. The trial described here was designed to determine whether a lower, less toxic dose of isotretinoin would be effective in the treatment of leukoplakia. The efficacy of [beta]-carotene was also evaluated. This agent was chosen for study because epidemiologic data have suggested that it may have a protective effect against oral cancer, and because it is essentially non-toxic.
Seventy patients with oral leukoplakia received three months of high-dose (1.5 mg/kg body weight/day) isotretinoin therapy. Patients with positive responses to this treatment were then randomly assigned to nine months of treatment with either low-dose isotretinoin (0.5 mg/kg/day) or [beta]-carotene (30 mg/day).
Low-dose isotretinoin was significantly more effective than [beta]-carotene in inhibiting the progression of oral leukoplakia. Only 8% of the patients in the isotretinoin group showed progression of their disease, as compared with 55% of the [beta]-carotene group. Both agents were well tolerated.
The findings of this study indicate that, when preceded by high-dose isotretinoin therapy, low-dose isotretinoin therapy is more effective than [beta]-carotene in the treatment of oral leukoplakia.
Scott M Lippman et al, Comparison of Low-Dose Isotretinoin with Beta Carotene To Prevent Oral Carcinogenesis, New England J Medicine 328(1):15-20 (7 Jan 1993) [Reprints: Scott M Lippman, MD, Department of Medical Oncology, Box 80, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston TX 770301]
See also William J Richtsmeier, Biologic Modifiers and Chemoprevention of Cancer of the Oral Cavity [Editorial], New England J Medicine 328(1):58-59 (7 Jan 1993)
COPYRIGHT 1993 Frost & Sullivan
COPYRIGHT 2004 Gale Group
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