Table 1 Baseline clinical characteristics of patients in the XELIRI and FOLFIRI arms, data are shown as n (%) or as n (range)
XELIRI | FOLFIRI | ||
|---|---|---|---|
n = 41 | n = 46 | p | |
Median age-years | 63 (47–75) | 62 (34–75) | 0.33 |
Gender | |||
Male | 26 (63%) | 27 (59%) | 0.38 |
Female | 15 (37%) | 19 (41%) | 0.40 |
WHO performance status | |||
Performance status 0 | 31 (75%) | 36 (78%) | 0.82 |
Performance status 1 | 10 (25%) | 10 (22%) | 0.85 |
Primary tumour | |||
Colon | 30 (73%) | 40 (87%) | 0.23 |
Rectum | 11 (27%) | 6 (13%) | 0.22 |
Initial stage of disease at diagnosis | |||
Stage 1 | 0 | 1 (2%) | - |
Stage 2 | 7 (17%) | 3 (7%) | 0.21 |
Stage 3 | 6 (15%) | 14 (30%) | 0,07 |
Stage 4 | 28 (68%) | 28 (61%) | 1.0 |
Previous adjuvant treatment* | |||
Yes | 6 (15%) | 10 (22%) | 0.32 |
No | 35 (85%) | 36 (78%) | 0.91 |
Median time from diagnosis to randomisation (months) | 1.87 (0.7–65.5) | 2.1 (0.26–55.7) | 0.77 |
Number of liver metastases | |||
1 – 4 | 15 (37%) | 11 (24%) | 0.43 |
5 – 10 | 8 (19%) | 10 (22%) | 0.81 |
> 10 | 18 (44%) | 25 (54%) | 0.28 |
Liver involvement (%) | |||
< 25 | 14 (34%) | 10 (22%) | 0.41 |
25 – 50 | 13 (32%) | 14 (30%) | 0.85 |
> 50 | 14 (34%) | 21 (45%) | 0.24 |
Median size of liver metastases (cm) | 4.0 (1.5 – 12.4) | 5.0 (0.5–15.0) | 0.10 |
Bilateral liver metastases, n (%) | 35 (85%) | 37 (80%) | 0.81 |
Baseline CEA | |||
Normal | 8 (19%) | 10 (22%) | 0.64 |
> 3.5 μg/l | 33 (81%) | 36 (78%) | 0.72 |
Baseline LDH | |||
Normal | 25 (61%) | 18 (39%) | 0.28 |
> 4.12 μkat/l | 15 (37%) | 26 (56%) | 0.09 |
Reasons for initial unresectability | |||
Location of metastases | 10 (24%) | 8 (17%) | 0.52 |
Number of metastases | 25 (61%) | 30 (65%) | 0.71 |
Size of metastases | 6 (15%) | 8 (17%) | 0.84 |