Table 1.
Patient sociodemographic and clinical characteristics, post randomization.
| Variable | Placebo (n = 24) |
Everolimus (n = 28) |
|---|---|---|
| Age (years), mean (SD) | 57.3 (8.4) | 58.8 (7.3) |
| Gender | ||
| Male | 20 (83%) | 23 (82%) |
| Female | 4 (17%) | 5 (18%) |
| Race | ||
| African-American | 3 (12%) | 3 (11%) |
| Caucasian | 21 (88%) | 25 (89%) |
| Tumor primary site | ||
| Oral Cavity | 5 (21%) | 6 (21%) |
| Oropharynx | 14 (58%) | 14 (50%) |
| Larynx | 1 (4%) | 7 (25%) |
| Hypopharynx | 4 (17%) | 1 (4%) |
| Tumor stage | ||
| T1 | 0 (0%) | 5 (18%) |
| T2 | 10 (42%) | 3 (11%) |
| T3 | 6 (25%) | 4 (14%) |
| T4A or 4B | 8 (33%) | 16 (57%) |
| Nodal stage | ||
| N0 | 2 (8%) | 3 (11%) |
| N1 | 1 (4%) | 1 (4%) |
| N2 | 4 (17%) | 4 (14%) |
| N2B | 9 (38%) | 6 (21%) |
| N2C | 7 (29%) | 11 (39%) |
| N3 | 1 (4%) | 3 (11%) |
| Karnofsky Performance Score | ||
| 100 | 5 (21%) | 5 (18%) |
| 90 | 9 (38%) | 13 (46%) |
| 80 | 9 (38%) | 9 (32%) |
| Unknown | 1 (4%) | 1 (4%) |
| HPV (p16 or ISH) result | ||
| Negative | 14 (58%) | 16 (57%) |
| Positive | 10 (42%) | 12 (43%) |
| TP53 mutation status | ||
| Wild type | 13 (54%) | 15 (54%) |
| Mutated | 10 (42%) | 13 (46%) |
| Days from end of definitive treatment to study drug initiation, mean (SD) | 93 (30) | 115 (97) |
| Pack-years smoking, mean (SD) | 31.9 (24.8)1 | 48.5 (32.4)2 |
| Treatments administered | ||
| Surgery | 10 (42%) | 15 (54%) |
| RT | 23 (96%) | 23 (82%) |
| Induction chemotherapy | 4 (17%) | 5 (18%) |
1
12 missing observations
2
16 missing observations