TABLE 1.
Subject Characteristics and Disease State
| Placebo (N = 46) | Palifermin (N = 49) | |
|---|---|---|
| Gender, male | 32 (70) | 34 (69) |
| Race/ethnicity | ||
| White | 43 (93) | 43 (88) |
| Black | 2 (4) | 2 (4) |
| Other | 1 (2) | 4 (8) |
| Age, yr, mean (SD) | 64.2 (7.7) | 61.6 (9.8) |
| AJCC stage | ||
| IIIa | 14 (30) | 19 (39) |
| IIIb | 32 (70) | 30 (61) |
| T stagea | ||
| T1 | 4 (9) | 3 (6) |
| T2 | 18 (39) | 18 (37) |
| T3 | 9 (20) | 10 (20) |
| T4 | 15 (33) | 17 (35) |
| N stage | ||
| N0/N1 | 9 (20) | 8 (16) |
| N2 | 19 (41) | 27 (55) |
| N3 | 18 (39) | 14 (29) |
| ECOG PS | ||
| 0–1 | 44 (96) | 47 (96) |
| 2 | 2 (4) | 2 (4) |
| Weight loss over last 3 mo | ||
| <5% | 35 (76) | 37 (76) |
| 5–10% | 11 (24) | 12 (24) |
| Current tobacco use | 16 (34) | 14 (29) |
| Current alcohol use | 14 (30) | 13 (27) |
Unless otherwise indicated, values are given as n (%).
a
One subject with nodal disease, unknown T stage.
AJCC, American Joint Committee on Cancer; ECOG PS, Eastern Cooperative Oncology Group performance status.