Table 1. Baseline characteristics of patients.
| Characteristic | Phase I (N=18) | Phase II (N=83) |
|---|---|---|
| Sex, n (%) | ||
| Male | 12 (67) | 50 (60) |
| Female | 6 (33) | 33 (40) |
| Race, n (%) | ||
| White | 18 (100) | 82 (99) |
| Asian | 0 | 1 (1) |
| Age, years, median (range) | 55 (36–72) | 56 (25–78) |
| ECOG performance status, n (%) | ||
| 0 | 4 (22) | 52 (63) |
| 1 | 14 (78) | 28 (34) |
| Missing | 0 | 3 (4) |
| Previous therapy, n (%) | ||
| Radiotherapy | 4 (22) | 11 (13) |
| Anticancer surgery | 18 (100) | 46 (55) |
| Adjuvant systemic anticancer treatment | 5 (28) | 18 (22) |
| Metastatic sites (⩾20% of patients), n (%) | ||
| Lung | 16 (89) | 53 (64) |
| Liver | 9 (50) | 40 (48) |
| Abdomen | 7 (39) | 12 (14) |
| Pelvis | 5 (28) | 4 (5) |
| Lymph node | 4 (22) | 34 (41) |
| Spleen | 4 (22) | 5 (6) |
| Number of tumour sites, n (%)a | ||
| 1 | 1 (6) | 8 (10) |
| 2 | 3 (17) | 20 (24) |
| 3 | 4 (22) | 16 (19) |
| ⩾4 | 10 (56) | 38 (46) |
| Missing | 0 | 1 (1) |
| AJCC stage, n (%)a,b | ||
| IV M1a | 0 | 4 (5) |
| IV M1b | 1 (6) | 12 (14) |
| IV M1c | 16 (89) | 66 (80) |
| Missing | 1 (6) | 1 (1) |
| Lactate dehydrogenase levels, n (%) | ||
| <10% over ULN | 4 (22) | 54 (65) |
| ⩾10% over ULN | 12 (67) | 26 (31) |
| Missing | 2 (11) | 3 (4) |
Abbreviations: AJCC=American Joint Committee on Cancer; ECOG=Eastern Cooperative Oncology Group; ULN=upper limit of normal.
a
Percentages do not add up to 100% due to rounding up of numbers.
b
For the phase II study, AJCC stage was supplied separately by the medical expert.