Parameters | No. of patients | Univariate* | Multivariate† | ||
p Value‡ | HR (95% CI) | p Value‡ | HR (95% CI) | ||
Training series (n=44) | |||||
Prognostic signature | |||||
Low risk (ref)/high risk | 37/7 | <0.001 | 18.2 (4.5 to 74.1) | <0.001 | 24.6 (5.4 to 111.5) |
Age | |||||
Continuous | 44 | 0.16 | 1.0 (0.9 to 1.0) | 0.06 | 0.9 (0.9 to 1.0) |
Gender | |||||
Female (ref)/male | 30/14 | 0.74 | 1.3 (0.3 to 5.1) | ||
Tumour localisation | |||||
Colon(ref)/rectum | 40/4 | ||||
No. of lymph nodes examined | |||||
n<12 (ref)/n≥12 | 5/39 | 0.99 | 1.0 (0.1 to 8.2) | ||
Microsatellite instability | |||||
Unstable (ref)/stable | 9/35 | 0.44 | 2.3 (0.3 to 18.3) | ||
Adjuvant therapy | |||||
No (ref)/yes | 40/4 | ||||
Validation series I (n=52) | |||||
Prognostic signature | |||||
Low risk (ref)/high risk | 45/7 | 0.02 | 3.6 (1.3 to 10.1) | 0.001 | 6.4 (2.1 to 19.6) |
Age | |||||
Continuous | 52 | 0.07 | 1.0 (1.0 to 1.1) | 0.01 | 1.1 (1.0 to 1.1) |
Gender | |||||
Female (ref)/male | 30/22 | 0.68 | 1.2 (0.5 to 3.0) | ||
Tumour localisation | |||||
Colon (ref)/rectum | 32/20 | 0.75 | 0.9 (0.3 to 2.2) | ||
Microsatellite instability | |||||
Unstable (ref)/stable/NA | 2/49/1 | ||||
Validation series II (n=108) | |||||
Prognostic signature | |||||
Low risk (ref)/high risk | 91/17 | 0.001 | 6.5 (2.2 to 19.7) | 0.004 | 5.1 (1.7 to 15.5) |
Age | |||||
Continuous | 108 | 0.20 | 1.0 (0.9 to 1.0) | ||
Gender | |||||
Female (ref)/male | 48/60 | 0.65 | 0.8 (0.3 to 2.3) | ||
Tumour localisation | |||||
Colon (ref)/rectum | 96/12 | 0.15 | 2.6 (0.7 to 9.4) | ||
Adjuvant therapy | |||||
No (ref)/yes/NA | 72/22/14 | 0.02 | 3.7 (1.3 to 11.1) | 0.04 | 3.3 (1.1 to 9.9) |
↵* p Values and HR were not calculated when there were <5 samples in either of the groups.
↵† Validation series I: n=51; validation series II: n=94.
↵‡ p Values calculated from Wald statistics; statistically significant p values (<0.05) in bold.
NA, information not available; ref, reference group in calculation of HR.