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Tsaoet AS et al. – Epidemiologic and preclinical data support the oral cancer prevention potential of green tea extract (GTE).

Methods

Randomly assigned patients with high-risk oral premalignant lesions (OPL) to receive GTE at 500, 750, or 1,000 mg/m2 or placebo TID for 12 weeks, evaluating biomarkers in baseline and 12-week biopsies

Results

OPL clinical response rate higher in all GTE arms (n = 28; 50%) versus placebo (n = 11; 18.2%) but did not reach statistical significance
2 higher-dose GTE arms [58.8% (750 and 1,000 mg/m2), 36.4% (500 mg/m2), and 18.2% (placebo)] had higher responses, suggesting dose-response effect
GTE treatment improved histology (21.4% versus 9.1%), although not statistically significant
GTE well tolerated, although higher doses increased insomnia/nervousness but produced no grade 4 toxicity
Higher mean baseline stromal vascular endothelial growth factor (VEGF) correlated with a clinical but not histologic response
Baseline scores of other biomarkers (epithelial VEGF, p53, Ki-67, cyclin D1, and p16 promoter methylation) not associated with response or survival
Baseline p16 promoter methylation (n = 5) associated with shorter cancer-free survival
Stromal VEGF and cyclin D1 expression downregulated in clinically responsive GTE patients and upregulated in nonresponsive patients at 12 weeks (versus at baseline)
Extended (median, 27.5 months) follow-up showed a median time to oral cancer of 46.4 months