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Table 1 Baseline clinical characteristics of patients in the XELIRI and FOLFIRI arms, data are shown as n (%) or as n (range)

From: Capecitabine plus Irinotecan (XELIRI regimen) compared to 5-FU/LV plus Irinotecan (FOLFIRI regimen) as neoadjuvant treatment for patients with unresectable liver-only metastases of metastatic colorectal cancer: a randomised prospective phase II trial

  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
  1. * Adjuvant treatment with chemotherapy ± radiotherapy