Table 2.
Univariate analysis of pre-treatment prognostic factors
Variable | n | Median TTP (months) | p | Hazard ratio (95 % CI) |
---|---|---|---|---|
A: Time-to-progression (TTP) | ||||
Stage of disease | ||||
Locally advanced | 48 | 4.4 | 1 | |
Metastatic | 243 | 5.1 | 0.868 | 0.97 (0.68–1.39) |
Karnofsky performance status (KPS) | ||||
90–100 % | 169 | 5.5 | 1 | |
60–80 % | 108 | 3.6 | 0.004 | 1.51 (1.14–2.01) |
Tumor grading | ||||
G1 + G2 | 117 | 6.1 | 1 | |
G3 + G4 | 125 | 4.4 | 0.008 | 1.50 (1.10–2.03) |
T stage | ||||
T1 + T2 | 48 | 5.2 | 1 | |
T3 + T4 | 209 | 4.7 | 0.412 | 0.85 (0.58–1.25) |
T (continuous) | 256 | 0.832 | 1.02 (0.84–1.25) | |
Age (at study entry) | ||||
≤63 years | 151 | 4.2 | 1 | |
≥64 years | 140 | 5.8 | 0.015 | 0.72 (0.54–0.94) |
Gender | ||||
Male | 192 | 4.5 | 1 | |
Female | 99 | 5.3 | 0.915 | 1.02 (0.77–1.34) |
Pre-treatment CA 19-9 | ||||
Not detectable* | 20 | 3.8 | 1 | |
≤1,000 U/ml | 128 | 6.1 | 0.76 (0.45–1.27) | |
>1,000 U/ml | 140 | 4.0 | 0.003 | 1.11 (0.66–1.84) |
Pre-treatment CA 19-9 | ||||
≤1,000 U/ml | 128 | 6.1 | 1 | |
>1,000 U/ml | 140 | 4.0 | 0.002 | 1.55 (1.16–2.06) |
log [CA 19-9] | 268 | <0.001 | 1.15 (1.08–1.22) | |
Pre-treatment CA 19-9 (Elecsys®) | ||||
≤1,000 U/ml | 62 | 6.6 | 1 | |
>1,000 U/ml | 61 | 3.5 | 0.002 | 2.00 (1.29–3.11) |
log [CA 19-9] | 123 | <0.001 | 1.19 (1.08–1.31) | |
LDH | ||||
≤250 U/l | 168 | 5.4 | 1 | |
>250 U/l | 79 | 3.4 | <0.001 | 2.04 (1.47–2.84) |
log [LDH] | 247 | 0.004 | 1.65 (1.18–2.31) | |
CRP | ||||
≤1.0 mg/dl | 59 | 6.1 | ||
>1.0 mg/dl | 56 | 3.8 | 0.062 | 1.52 (0.97–2.36) |
log [CRP] | 110 | 0.026 | 1.24 (1.03–1.49) | |
Bilirubin | ||||
≤1.0 mg/dl | 224 | 4.9 | 1 | |
>1.0 mg/dl | 58 | 4.4 | 0.202 | 1.26 (0.88–1.79) |
log [Bilirubin] | 282 | 0.228 | 1.14 (0.92–1.41) | |
CEA | ||||
≤4.5 ng/ml | 102 | 6.1 | ||
>4.5 ng/ml | 101 | 3.5 | <0.001 | 1.89 (1.35–2.63) |
log [CEA] | 203 | 0.004 | 1.11 (1.03–1.19) | |
Hemoglobin | ||||
≥12 g/dl | 115 | 4.1 | ||
<12 g/dl | 47 | 4.4 | 0.964 | 0.99 (0.66–1.50) |
log [Hemoglobin] | 148 | 0.351 | 2.17 (0.43–11.12) | |
B: Overall survival (OS) | ||||
Stage of disease | ||||
Locally advanced | 48 | 12.9 | 1 | |
Metastatic | 243 | 8.3 | 0.005 | 1.63 (1.16–2.32) |
Karnofsky performance status (KPS) | ||||
90–100 % | 169 | 9.9 | 1 | |
60–80 % | 108 | 8.0 | 0.037 | 1.33 (1.02–1.74) |
Tumor grading | ||||
G1 + G2 | 117 | 10.8 | 1 | |
G3 + G4 | 125 | 8.3 | 0.013 | 1.42 (1.08–1.88) |
T stage | ||||
T1 + T2 | 48 | 8.3 | 1 | |
T3 + T4 | 209 | 9.2 | 0.271 | 0.82 (0.58–1.17) |
T (continuous) | 256 | 0.290 | 0.91 (0.77–1.08) | |
Age (at study entry) | ||||
≤63 years | 151 | 9.1 | 1 | |
≥64 years | 140 | 8.8 | 0.554 | 0.93 (0.72–1.20) |
log [age] | 291 | 0.204 | 0.58 (0.26–1.34) | |
Gender | ||||
Male | 192 | 8.6 | 1 | |
Female | 99 | 9.7 | 0.196 | 0.84 (0.64–1.01) |
Pre-treatment CA 19-9 | ||||
Not detectable* | 20 | 8.9 | 1 | |
≤1,000 U/ml | 128 | 10.5 | 0.76 (0.45–1.27) | |
>1,000 U/ml | 140 | 8.0 | 0.020 | 1.11 (0.66–1.84) |
Pre-treatment CA 19-9 | ||||
≤1,000 U/ml | 128 | 10.5 | 1 | |
>1,000 U/ml | 140 | 8.0 | 0.006 | 1.46 (1.11–1.90) |
log [CA 19-9] | 268 | <0.001 | 1.13 (1.06–1.19) | |
Pre-treatment CA 19-9 (Elecsys®) | ||||
≤1,000 | 62 | 10.3 | 1 | |
>1,000 | 61 | 8.1 | 0.048 | 1.49 (1.00–2.22) |
log [CA 19-9] | 123 | 0.002 | 1.15 (1.06–1.26) | |
LDH | ||||
≤250 U/l | 168 | 9.9 | 1 | |
>250 U/l | 79 | 5.9 | <0.001 | 2.07 (1.55–2.78) |
log [LDH] | <0.001 | 1.93 (1.40–2.65) | ||
CRP | ||||
≤1.0 mg/dl | 59 | 11.4 | 1 | |
>1.0 mg/dl | 56 | 6.8 | 0.009 | 1.69 (1.14–2.52) |
log [CRP] | 115 | 0.001 | 1.40 (1.16–1.69) | |
Bilirubin | ||||
≤1.0 mg/dl | 224 | 9.7 | 1 | |
>1.0 mg/dl | 58 | 7.2 | 0.003 | 1.62 (1.18–2.24) |
log [Bilirubin] | <0.001 | 1.43 (1.20–1.70) | ||
CEA | ||||
≤4.5 ng/ml | 102 | 10.3 | 1 | |
>4.5 ng/ml | 101 | 9.0 | 0.054 | 1.35 (0.99–1.83) |
log [CEA] | 0.053 | 1.07 (1.00–1.15) | ||
Hemoglobin | ||||
≥12 g/dl | 115 | 9.0 | 1 | |
<12 g/dl | 47 | 7.1 | 0.463 | 1.15 (0.79–1.67) |
log [Hemoglobin] | 0.547 | 0.64 (0.15–2.73) |
Bold values indicate statistical significance (p < 0.05)
* Defined as CA 19-9 < 2.6 U/ml