Characteristics* | Phase I (n = 14) | Phase II (n = 49) |
---|---|---|
Eligible | 14 (100%) | 45 (92%) |
Evaluable | 11 (79%) | 36 (73%) |
Median age (range) years | 59.0 (30.0–69.0) | 63.0 (37.0–71.0) |
Sex | ||
Male | 7 (50%) | 33 (67%) |
Female | 7 (50%) | 16 (33%) |
WHO performance status | ||
0 | 4 (29%) | 14 (29%) |
1 | 10 (71%) | 31 (63%) |
2 | 0 | 4 (8%) |
Primary tumour site | ||
Colon | 9 (64%) | 17 (35%) |
Rectum | 4 (29%) | 22 (45%) |
Colon rectosigmoid | 1 (7%) | 10 (20%) |
Organ involved | ||
Median number | 2 (1–4) | 2 (1–4) |
Liver | 10 (71%) | 42 (86%) |
Lung | 6 (43%) | 17 (35%) |
Lymph node | 1 (7%) | 10 (20%) |
Other soft tissue | 0 | 11 (22%) |
Abdominal cavity | 2 (14%) | 3 (6%) |
Peritoneum | 1 (7%) | 0 |
Bone | 1 (7%) | 0 |
Skin | 0 | 1 (2%) |
Other | 2 (14%) | 5 (10%) |
Prior therapy | ||
Surgery | 12 (86%) | 42 (86%) |
Radiotherapy | 3 (21%) | 14 (29%) |
Adjuvant chemotherapy | 4 (29%) | 12 (24%) |
Surgery + radiotherapy | 3 (21%) | 12 (24%) |
Surgery + chemotherapy | 4 (29%) | 12 (24%) |
Radiotherapy + chemotherapy | 2 (14%) | 7 (14%) |
Surgery + radiotherapy + chemotherapy | 2 (14%) | 7 (14%) |