Table 1.
Patient characteristics
| Number of patients (%) |
|||
|---|---|---|---|
| Arm A (fixed dose) |
Arm B (dose adjusted) |
All (A + B) |
|
| Number of enrolled patients | 28 | 27 | 55 |
| Men | 17 (60.7) | 14 (51.9) | 31 (56.4) |
| Age (years) | |||
| Median | 63 | 59 | 62 |
| Range | 29–83 | 37–96 | 29–96 |
| Weight (Kg) | |||
| Mean | 75.8 | 72.5 | 74.2 |
| Standard Deviation | 15.2 | 13.7 | 14.4 |
| Performance Status | |||
| 0 | 7 (25.0) | 6 (22.2) | 13 (23.6) |
| 1 | 14 (50.0) | 17 (63.0) | 31 (56.4) |
| 2 | 7 (25.0) | 4 (14.8) | 11 (20.0) |
| Histologic cell type | |||
| Adenocarcinoma | 15 (53.6) | 17 (63.0) | 32 (58.2) |
| Squamous | 7 (25.0) | 5 (18.5) | 12 (21.8) |
| NSC not otherwise classified | 5 (17.9) | 2 (7.4) | 7 (12.7) |
| Adenosquamous | 0 | 1 | 1 |
| Large cell neuroendocrine | 1 | 1 | 2 |
| Sarcomatoid | 0 | 1 | 1 |
| Prior Chemotherapy | |||
| No | 4 (14.3) | 4 (14.8) | 8 (14.5) |
| 1 regimen | 19 (67.9) | 15 (55.6) | 34 (61.8) |
| 2 regimens | 5 (17.9) | 8 (29.6) | 13 (23.6) |
| Previous radiation therapy | 11 (39.3) | 11 (40.7) | 22 (40.0) |
| Smoking Status | |||
| Current | 8 (28.6) | 13 (48.1) | 21 (38.2) |
| Former | 15 (53.6) | 14 (51.9) | 29 (52.7) |
| Never | 5 (17.9) | 0 (0) | 5 (9.1) |