Table 1.

Clinical trial patient demographics, histologic diagnoses, and follow-up information

A. Oral IEN patient demographics and histopathologic diagnoses pretreatment and posttreatment
Patient no.AgePatient and lesion characteristics
Histopathologic diagnosis
GenderSmoking*AlcoholHigh-risk siteMultifocal§RecurrentSize (cm)Pretreatment diagnosisPosttreatment diagnosis
174MYNNNN2.3 × 0.8Severe dysplasia, cannot rule out superficially invasive SCCModerate, focally severe dysplasia
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
1543MYNNYN1.2 × 0.5Hyperkeratosis, atypiaHyperkeratosis, atypia
1755FY**YNYY0.8 × 0.4Mild dysplasiaModerate dysplasia
1873FYNYYN2.0 × 1.0Focal moderate dysplasiaModerate dysplasia
1964FYYYNY2.5 × 1.5Focal moderate dysplasiaFocal severe dysplasia

Histopathologic change

26-76M = 7Y = 12Y = 10Y = 8Y = 10Y = 9Decrease in grade = 7
F = 10N = 5N = 7N = 9N = 7N = 8Increase in grade = 4
Stable disease = 6
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
25Mild dysplasia (atypia)Mild dysplasia at one new site
313Moderate dysplasia (moderate dysplasia)Developed verrucous carcinoma at 2 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)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
  • * 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, and tonsillar pillar); N, lesion location at lower risk for progression to SCC (buccal mucosa, gingival, and 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.

  • Size of oral IEN lesion before treatment.

  • ** Indicates quit smoking ≤1 y ago.

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

  • ‡‡ No recurrent lesional tissue was identified clinically.