Table 1. Baseline Characteristics of the 29 Study Patients.
| Characteristic | No. (%) | ||
|---|---|---|---|
| Cohort 1: nivolumab (n = 14) | Cohort 2: nivolumab + ipilimumab (n = 15) | Overall (n = 29) | |
| Age, median (range), y | 64.4 (39.1-81.0) | 65.2 (32.5-78.4) | 65.2 (32.5-81.0) |
| Sex | |||
| Male | 10 (71.4) | 8 (53.3) | 18 (62.1) |
| Female | 4 (28.6) | 7 (46.7) | 11 (37.9) |
| Smoker | |||
| No | 11 (78.6) | 8 (53.3) | 19 (65.5) |
| Former, ≤10 pack-year | 1 (7.1) | 6 (40.0) | 7 (24.1) |
| Former, >10 pack-year | 2 (14.3) | 1 (6.7) | 3 (10.3) |
| Primary tumor site | |||
| Oral tongue | 7 (50.0) | 9 (60.0) | 16 (55.2) |
| Gingiva | 1 (7.1) | 1 (6.7) | 2 (6.9) |
| Retromolar trigone | 2 (14.3) | 3 (20.0) | 5 (17.2) |
| Alveolar ridge | 2 (14.3) | 1 (6.7) | 3 (10.3) |
| Buccal mucosa | 1 (7.1) | 1 (6.7) | 2 (6.9) |
| Hard palate | 1 (7.1) | 0 | 1 (3.4) |
| Pretreatment clinical T-stagea | |||
| 2 | 10 (71.4) | 10 (66.7) | 20 (69.0) |
| 3 | 0 | 1 (6.7) | 1 (3.4) |
| 4 | 4 (28.6) | 4 (26.7) | 8 (27.6) |
| Pretreatment clinical N-stagea | |||
| N0 | 5 (35.7) | 6 (40.0) | 11 (37.9) |
| N1 | 4 (28.6) | 0 | 4 (13.8) |
| N2b | 5 (35.7) | 8 (53.3) | 13 (44.8) |
| N2c | 0 | 1 (6.7) | 1 (3.4) |
| AJCC overall clinical disease stagea | |||
| II | 4 (28.6) | 4 (26.7) | 8 (27.6) |
| III | 3 (21.4) | 0 | 3 (10.3) |
| IVA | 7 (50.0) | 11 (73.3) | 18 (62.1) |
a
American Joint Committee on Cancer, 7th Edition staging.