Table 1. Baseline characteristics.
|
Hepatic resection,
n=38 |
LLD,
n=215 |
Non-LLD,
n=226 |
|
|||
---|---|---|---|---|---|---|---|
n | % | n | % | n | % | P-value | |
Sex | |||||||
Male | 26 | 68.4 | 151 | 70.2 | 158 | 69.9 | 0.975 |
Female |
12 |
31.6 |
64 |
29.8 |
68 |
30.1 |
|
Age at randomisation | |||||||
Median (years) | 62.7 | 61.8 | 63.5 | 0.131 | |||
Range |
32–73 |
32–78 |
22–79 |
|
|||
Karnofsky performance status | |||||||
100% | 24 | 63.2 | 76 | 35.3 | 90 | 39.8 | <0.001 |
70–90% |
14 |
36.8 |
139 |
64.7 |
136 |
60.2 |
|
Localization of primary | |||||||
Colon | 23 | 60.5 | 136 | 63.3 | 128 | 56.6 | 0.365 |
Rectal |
15 |
39.5 |
79 |
36.7 |
98 |
43.4 |
|
T-stage of primary | |||||||
T1/T2 | 5 | 13.2 | 15 | 7.0 | 23 | 10.2 | 0.101 |
T3/T4 | 33 | 86.8 | 190 | 88.4 | 186 | 82.3 | |
NA |
— |
— |
10 |
4.6 |
17 |
7.5 |
|
N-stage of primary | |||||||
Nodal negative | 15 | 39.5 | 37 | 17.2 | 70 | 31.0 | <0.001 |
Nodal positive | 23 | 60.5 | 165 | 76.7 | 130 | 57.5 | |
NA |
— |
— |
13 |
6.0 |
26 |
11.5 |
|
Resection of primary | |||||||
No | 2 | 5.3 | 11 | 5.1 | 16 | 7.1 | 0.673 |
Yes |
36 |
94.7 |
204 |
94.9 |
210 |
92.9 |
|
Development of metastasis | |||||||
Synchronous | 29 | 76.3 | 159 | 74.0 | 102 | 45.1 | <0.001 |
Metachronous |
9 |
23.7 |
56 |
26.0 |
124 |
54.9 |
|
Localization of metastasis | |||||||
Liver | 38 | 100.0 | 215 | 100.0 | 150 | 68.5 | <0.001 |
Liver only | 36 | 94.7 | 215 | 100.0 | — | — | <0.001 |
Lung | 2 | 5.3 | — | — | 123 | 56.2 | <0.001 |
Lymph node | 2 | 5.3 | — | — | 74 | 33.8 | <0.001 |
Peritoneal | — | — | — | — | 15 | 6.8 | <0.001 |
Other |
— |
— |
— |
— |
13 |
5.9 |
<0.001 |
No. of metastatic sites | |||||||
1 | 36 | 94.7 | 215 | 100.0 | 40 | 17.7 | <0.001 |
⩾2 |
2 |
5.3 |
— |
— |
186 |
82.3 |
|
CEA level at baseline | |||||||
<200 ng ml−1 | 32 | 84.2 | 132 | 61.4 | 146 | 64.6 | 0.108 |
>200 ng ml−1 | 5 | 13.2 | 57 | 26.5 | 47 | 20.8 | |
NA |
1 |
2.6 |
26 |
12.1 |
33 |
14.6 |
|
Alkaline phosphatase | |||||||
⩽300 U l−1 | 28 | 73.7 | 93 | 43.3 | 112 | 49.6 | <0.001 |
>300 U l−1 | 9 | 23.7 | 107 | 49.8 | 91 | 40.3 | |
NA |
1 |
26 |
15 |
7.0 |
23 |
10.2 |
|
LDH | |||||||
⩽250 U l−1 | 32 | 84.2 | 107 | 49.8 | 131 | 58.0 | <0.001 |
>250 U l−1 | 6 | 15.8 | 106 | 49.3 | 89 | 39.4 | |
NA |
— |
— |
2 |
0.9 |
6 |
2.6 |
|
WBC | |||||||
<8.000 per μl | 26 | 68.4 | 115 | 53.5 | 130 | 57.5 | 0.224 |
⩾8.000 per μl | 12 | 31.6 | 96 | 44.7 | 88 | 40.9 | |
NA |
— |
— |
4 |
1.9 |
8 |
3.6 |
|
Haemoglobin | |||||||
⩽10 g dl−1 | 10 | 26.3 | 59 | 27.4 | 54 | 23.9 | 0.739 |
>10 g dl−1 | 28 | 73.7 | 152 | 70.7 | 165 | 73.0 | |
NA |
— |
— |
4 |
1.9 |
7 |
3.1 |
|
Platelet count | |||||||
<400.000 per μl | 32 | 84.2 | 169 | 78.6 | 182 | 80.5 | 0.666 |
⩾400.000 per μl | 6 | 15.8 | 42 | 19.5 | 37 | 16.4 | |
NA |
— |
— |
4 |
1.9 |
7 |
3.1 |
|
Koehne's Prognostic Groups | |||||||
Low | 31 | 81.6 | 212 | 98.6 | 52 | 23.0 | <0.001 |
Intermediate | 6 | 15.8 | 1 | 0.5 | 125 | 55.3 | |
High | — | — | 2 | 0.9 | 31 | 13.7 | |
NA |
1 |
2.6 |
— |
— |
18 |
8.0 |
|
Treatment | |||||||
FUFIRI | 23 | 60.5 | 94 | 43.7 | 121 | 53.5 | 0.045 |
mIROX | 15 | 39.5 | 121 | 56.3 | 105 | 46.5 |
Abbreviations: CEA=carcinogenic embryonic antigen; LDH=lactate dehydrogenase; FUFIRI=5-fuorouracil/folinic acid/irinotecan; mIROX=modified irinotecan plus oxaliplatin; NA=not assessable; WBC=white blood cell count. Statistically significant P-values are shown as bold entries.