Table 1.

Patient demographics

(A) Oral IEN patient demographics and histopathologic diagnoses
Patient no.Age (y)Patient and lesion characteristicsMultifocal §Recurrent Size (cm) Histopathologic diagnosis
GenderSmoking *Alcohol High-risk site Pretreatment diagnosisPosttreatment diagnosis
174MYNNNN2.3 × 0.8Severe dysplasia, can't rule out superficially invasive SCCPrimarily moderate, focally severe
275MYYYYY1.8 × 0.8Mild dysplasiaHyperparakeratosis, atypia
359MYYNYY1.0 × 1.0Severe dysplasiaModerate dysplasia
575FYNNYN0.8 × 0.6Mild dysplasiaHyperkeratosis, atypia
644MNYNNY0.6 × 0.4Hyperkeratosis, atypiaHyperorthokeratosis, atypia
758MNYYNY2.1 × 0.6Moderate dysplasiaModerate dysplasia
876FYYYNN1.2 × 0.5Mild dysplasiaFocal carcinoma in situ
926FY **YNYY0.3 × 0.3Hyperkeratosis, atypiaHyperkeratosis
1066MYNYNN2.2 × 1.2Moderate dysplasiaHyperparakeratosis, atypia
1159FYNNYN2.0 × 1.0Hyperkeratosis, atypiaMild dysplasia
1256FNNNYN1.2 × 1.0Hyperkeratosis, atypiaHyperkeratosis, atypia
1359FNYYNY2.2 × 0.6Hyperkeratosis, atypiaHyperkeratosis, atypia
1444FNYYYY2.2 × 0.8Severe dysplasiaModerate dysplasia, candida
1543MYNNYN1.2 × 0.5Hyperkeratosis, atypia,Hyperkeratosis, atypia,
1755FYcYNYY0.8 × 0.4Mild dysplasiaModerate dysplasia
1873FYNYYN2.0 × 1.0Focal moderate dysplasiaModerate dysplasia
1964FYYYNY2.5 × 1.5Focal moderate dysplasiaFocal severe dysplasia
2062MYYNYN2.0 × 1.0Mild dysplasiaMild dysplasia
2158FYYNNN2.5 × 1.0Moderate dysplasiaModerate dysplasia
2253FYNNNN1.0 × 1.0Hyperkeratosis, atypiaHyperkeratosis, atypia
RangeTotalsTotalsTotalsTotalsTotalsTotalsHistopathologic change
26–76 (mean, 59.0)M = 8/F = 12Y = 15/N = 5Y = 12/N = 8Y = 8/N = 12Y = 11/N = 9Y = 9/N = 11Decrease in grade = 7 (35%), increase in grade = 4 (20%), stable disease = 9 (45%)
(B) Clinical trial disease status follow-up information
Patient no.Follow-up (mo)Treatment site ††Other oral sites
17Progression to well-differentiated SCC (moderate, focally severe dysplasia)No other lesions observed
223Mild dysplasia (atypia)Mild dysplasia at one new site
313Moderate dysplasia (moderate dysplasia)Developed verrucous carcinoma at two sites
518No recurrence ‡‡Atypia at one new site
720Moderate dysplasia (moderate dysplasia)No other lesions observed
915No recurrence ‡‡Atypia at one new site
1016Mild dysplasia (atypia)No other lesions observed
1410Severe dysplasia (moderate dysplasia posttreatment-former resection site of oral SCC)Atypia at one new site
153No recurrence ‡‡Atypia at several new sites
193Moderate to severe dysplasia (focally severe dysplasia)Moderate dysplasia at one new site
217Atypia (moderate dysplasia)No other oral lesions observed
  • * “Y”, history of smoking; “N”, no history of smoking.

  • “Y”, current alcohol use; “N”, no alcohol use.

  • “Y”, Lesion location at high risk for progression to SCC (lateroventral tongue, floor of mouth, tonsillar pillar); “N”, lesion location at lower risk for progression to SCC (buccal mucosa, gingiva, hard/soft palate).

  • § “Y”, multiple IEN lesions observed clinically; “N”, isolated clinical disease.

  • “Y”, selected site represents recurrent disease; “N”, selected site presents new disease.

  • Pretreatment lesional size.

  • ** Indicates quit smoking ≤1 year ago.

  • †† For recurrent lesions, the diagnosis at follow-up is listed first and then succeeded by posttreatment diagnosis in parentheses as previously listed in Table 1A.

  • ‡‡ No recurrent lesional tissue was identified clinically.