Table 1. Baseline Patient Characteristics.
| Characteristic | Patients, No. (%) (N = 33) |
|---|---|
| Age, median (range), y | 63.2 (32-80) |
| Sex | |
| Female | 18 (55) |
| Male | 15 (45) |
| Race and ethnicitya | |
| Asian | 1 (3) |
| Hispanic | 0 |
| Non-Hispanic | 33 (100) |
| White | 31 (94) |
| Other | 1 (3) |
| ECOG performance status | |
| 0 | 30 (91) |
| 1 | 3 (9) |
| Autoimmune history | |
| Yes | 3 (9) |
| No | 30 (91) |
| Smoking history | |
| Never or ≤10 pack-years | 17 (52) |
| Former (>10 pack-years) | 15 (45) |
| Current | 1 (3) |
| Primary site of diseaseb | |
| Oral tongue | 13 (39) |
| Buccal gingiva | 10 (30) |
| Palatal gingiva | 1 (3) |
| Alveolar ridge mucosa | 9 (27) |
| No. of target lesions | |
| 1 | 23 (70) |
| 2 | 7 (21) |
| 3 | 3 (9) |
| High-risk oral leukoplakia subtype | |
| PVL | 29 (88) |
| PVL with 4-quadrant involvement | 2 (6) |
| Localized leukoplakia with moderate dysplasia | 1 (3) |
| Erythroleukoplakia | 1 (3) |
| Worst degree of dysplasia identified on biopsy at baseline | |
| None | 0 |
| Mild | 24 (73) |
| Moderate | 8 (24) |
| Severe or carcinoma in situ | 1 (3) |
| Prior early-stage oral cavity squamous cell carcinoma diagnosis | |
| Yes | 8 (24) |
| No | 25 (76) |
| Doses of nivolumab received (1-4), median (range) | 4 (1-4) |
| Time from first dose of immunotherapy to posttreatment biopsy, median (range), d | 115 (29-171) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PVL, proliferative verrucous leukoplakia.
a
As classified by the participant (other denotes multiple races).
b
Denotes the largest or primary site of oral leukoplakia at trial enrollment, as many patients had multifocal sites of involvement in the oral cavity.