1) The document discusses prevention and treatment strategies for oral squamous cell carcinoma (OSCC), a common type of oral cancer. 2) It describes a proposed phase IIB clinical trial called EPOC that would test the drug Erlotinib for preventing oral cancer in high-risk patients. 3) A second proposed clinical trial would test the drug Pioglitazone for treating oral pre-malignant lesions and examining effects on histology, biomarkers, and cancer risk.

1. ET Retreat 2009 T Meiller DDS, PhD

7. Pre-malignant and malignant epithelial lesions Oral Pathology Acquisitions DS SCC CIS Severe Dysplasia Moderate Dysplasia Mild Dysplasia Hyperkeratosis Hyperortho-keratosis Hyperpara-keratosis Acanthosis Years 41 2 9 13 23 15 103 80 109 1997 52 10 15 10 18 6 90 80 95 1998 69 4 9 12 17 7 85 74 103 1999 64 3 7 8 12 3 80 78 75 2000 97 6 8 10 19 12 90 89 129 2001 91 6 12 11 20 10 107 112 178 2002 87 8 9 25 16 4 98 88 138 2003 56 7 12 8 9 3 94 95 133 2004 71 12 13 12 26 5 78 117 132 2005 65 2 11 18 16 2 97 84 139 2006 69 4 14 19 26 7 105 118 170 2007 83 6 10 14 32 0 102 120 130 2008 36 1 8 7 19 3 51 78 86 2009*

9. Erlotinib Prevention of Oral Cancer (EPOC) NCI P01 CA106451 IEN alone Proportion of cases not developing SOM (%) IEN plus cancer history

10. Microdissection DNA extraction PCR Patient eligibility determined within 7 business days Data entered in Web-based database for automatic calculations Determining Protocol Eligibility by LOH DNA fragment separation and quantification