|
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%)
|
- *N (%) unless otherwise stated. WHO = World Health Organization.
