Abstract
6007 Background: Loss of heterozygosity (LOH) profiles predict oral cancer (OC) risk in patients (pts) with oral premalignant lesions (OPL). We conducted a randomized, multi-center, double-blind, placebo-controlled, personalized medicine trial of the EGFR inhibitor erlotinib in pts with OPLs defined as high risk by molecular criteria. Our primary hypothesis was that erlotinib would improve oral cancer-free survival (OCFS) in the high-risk, LOH+ population. Methods: Pts with histological evidence of an OPL (with or without a prior history of invasive OC) underwent LOH profiling at 3p14, 9p21, 4q, 8p, 11p, 13q, 17p. LOH+ pts were defined as those with prior OC and LOH at 3p14 and/or 9p21; or those without prior OC and LOH at 3p14 and/or 9p21 plus an additional chromosomal site. LOH- pts received no treatment. LOH+ pts were stratified by history of OC, then randomized (1:1) to erlotinib 150 mg po daily for 12 months or placebo and were assessed every 3-6 months for development of invasive OC. Primary endpoin...
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