Topical bleomycin for the treatment of dysplastic oral leukoplakia

BACKGROUND Because malignant transformation of dysplastic oral leukoplakia has been reported in up to 43% of cases, these lesions must be managed. METHODS This study evaluated the use of topical 1% bleomycin in dimethylsulfoxide for the treatment of dysplastic oral lesions. Bleomycin was applied once daily for 14 consecutive days to lesions of the oral mucosa in 19 patients. Immediate posttreatment biopsies and the clinical response were evaluated and clinical follow‐up was conducted for as long as possible. RESULTS The mean age of the patients at diagnosis was 59.4 years and 74% were tobacco users. Seventy‐five percent of patients had resolution of dysplasia at follow‐up biopsy, with a mean improvement of two histologic grades of dysplasia after topical chemotherapy. Ninety‐four percent of the patients attained at least partial responses. After a mean follow‐up period of 3.4 years, 31.6% of patients had no clinically visible lesions and 47.4% of patients had clinically benign lesions of homogeneous leukoplakia or minimal visible leukoplakia. In 2 patients (11%) malignant transformation occurred a mean of 1.75 years after bleomycin treatment. CONCLUSIONS Topical bleomycin may prevent the potential progression of leukoplakia through dysplasia to carcinoma. Close follow‐up of all patients with dysplasia is required. Cancer 1998;83:629‐634. © 1998 American Cancer Society. This study demonstrates a potential role for topical bleomycin in the management of dysplastic oral leukoplakia.