Background
Methods
Patients
Quality of life assessment
The GERCOR and Köhne prognostic indices
Statistical analysis
Results
Patient characteristics
All patients | Available QoL | Missing QoL | All patients | |||||
---|---|---|---|---|---|---|---|---|
Variable
| Class | N | % | N | % | N | % | P |
Age
| ≤65 | 353 | 57 | 138 | 55 | 215 | 58 | |
>65 | 267 | 43 | 111 | 45 | 156 | 42 | 0.2900 | |
Gender
| Male | 367 | 59 | 151 | 61 | 216 | 58 | |
Female | 252 | 41 | 98 | 39 | 154 | 42 | 0.5739 | |
PS
| 0 | 333 | 54 | 122 | 49 | 211 | 57 | |
1 | 239 | 38 | 110 | 44 | 129 | 35 | ||
2 | 48 | 8 | 17 | 7 | 31 | 8 | 0.0611 | |
Number of sites
| 1 | 354 | 58 | 147 | 59 | 207 | 57 | |
>1 | 260 | 42 | 102 | 41 | 158 | 43 | 0.5672 | |
Liver involvement
| No | 149 | 24 | 52 | 21 | 97 | 27 | |
Yes | 460 | 76 | 197 | 79 | 263 | 73 | 0.0872 | |
Metastases
| Synchronous | 415 | 68 | 168 | 68 | 247 | 68 | |
Metachronous | 196 | 32 | 80 | 32 | 116 | 32 | 0.9374 | |
Adjuvant chemotherapy
| No | 488 | 79 | 200 | 81 | 288 | 78 | |
Yes | 130 | 21 | 48 | 19 | 82 | 22 | 0.4013 | |
Tumour site
| Colon | 398 | 64 | 160 | 64 | 238 | 64 | |
Rectum | 211 | 34 | 86 | 35 | 125 | 35 | ||
both | 11 | 2 | 3 | 1 | 8 | 1 | 0.6730 | |
LDH
| ≤1xULN | 380 | 61 | 134 | 56 | 246 | 66 | |
>1xULN | 240 | 39 | 115 | 44 | 125 | 34 | 0.0017 | |
ALP
| ≤1xULN | 350 | 56 | 129 | 52 | 221 | 60 | |
>1xULN | 270 | 44 | 120 | 48 | 150 | 40 | 0.0560 | |
CEA
| ≤1xULN | 177 | 28 | 61 | 25 | 116 | 31 | |
>1xULN | 443 | 72 | 188 | 75 | 255 | 69 | 0.0673 | |
EuroQoL
| ||||||||
Mobility
| 1 | 223 | 81 | 223 | 81 | |||
2-3 | 54 | 19 | 54 | 19 | ||||
Self-care
| 1 | 255 | 93 | 255 | 93 | |||
2-3 | 19 | 7 | 19 | 7 | ||||
Usual activities
| 1 | 193 | 71 | 193 | 71 | |||
2-3 | 79 | 29 | 79 | 29 | ||||
Pain/discomfort
| 1 | 137 | 50 | 137 | 50 | |||
2-3 | 138 | 50 | 138 | 50 | ||||
Anxiety/depression
| 1 | 145 | 53 | 145 | 53 | |||
2-3 | 130 | 47 | 130 | 47 | ||||
VAS score
| 70 [10–100] ** |
Univariate analysis
Univariate analysis | Multivariate analysis | Multivariate analysis | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Model not including QoL | Full model, including QoL | |||||||||
Variable
| Class | HR | 95% CI | P | HR | 95% CI | P | HR | 95% CI | P |
Age
| ≤65 | 1 | ||||||||
>65 | 1.42 | 1.06 – 1.89 | 0.0178 | |||||||
Gender
| Male | 1 | ||||||||
Female | 1.06 | 0.79 – 1.42 | 0.6945 | |||||||
PS
| 0 | 1 | 1 | 1 | ||||||
1-2 | 1.84 | 1.38 – 2.46 | <0.0001 | 1.98 | 1.44 – 2.73 | <0.0001 | 1.87 | 1.35 – 2.59 | 0.0002 | |
Number of sites
| 1 | 1 | 1 | 1 | ||||||
>1 | 1.47 | 1.10 – 1.97 | 0.0094 | 1.48 | 1.08 – 2.05 | 0.0160 | 1.48 | 1.07 – 2.04 | 0.0176 | |
Liver involvement
| No | 1 | ||||||||
Yes | 1.14 | 0.795 – 1.65 | 0.4699 | |||||||
Metastases
| Synchronous | 1 | ||||||||
Metachronous | 0.89 | 0.61 – 1.29 | 0.5403 | |||||||
Adjuvant chemotherapy
| No | 1 | ||||||||
Yes | 0.95 | 0.76 – 1.19 | 0.68 | |||||||
LDH
| ≤1xULN | 1 | 1 | 1 | ||||||
>1xULN | 2.04 | 1.48 – 2.80 | <0.0001 | 1.93 | 1.39 – 2.68 | <0.0001 | 1.83 | 1.31 – 2.55 | 0.0004 | |
APL
| ≤1xULN | 1 | ||||||||
>1xULN | 1.60 | 1.20 – 2.14 | 0.0016 | |||||||
CEA
| ≤1xULN | 1 | ||||||||
>1xULN | 1.48 | 1.01 – 2.18 | 0.0444 | |||||||
EuroQoL
| ||||||||||
Mobility
| 1 | 1 | 1 | |||||||
2-3 | 1.90 | 1.33 – 2.71 | 0.0004 | 1.66 | 1.12 – 2.48 | 0.0117 | ||||
Self-care
| 1 | 1 | ||||||||
2-3 | 1.52 | 0.88 – 2.62 | 0.1322 | |||||||
Usual activities
| 1 | 1 | ||||||||
2-3 | 1.20 | 0.88 – 1.64 | 0.2553 | |||||||
Pain/discomfort
| 1 | 1 | ||||||||
2-3 | 1.39 | 1.04 – 1.86 | 0.0239 | |||||||
Anxiety/depression
| 1 | 1 | ||||||||
2-3 | 1.45 | 1.09 – 1.93 | 0.0116 | |||||||
VAS score
| 1.001 | 0.996 – 1.005 | 0.7975 | |||||||
Harrell’s C index
| 0.65 [0.61 – 0.69] | 0.67 [0.63 – 0.71] | ||||||||
0.65* | 0.66* | |||||||||
Schemper statistic
| 9.32% | 10.42% |
Multivariate analysis
Improvement of prognostic indices
Köhne prognostic index | |||||
---|---|---|---|---|---|
Variable | HR (95% CI) | P value | c-index | Schemper (%) | NRI (95% CI) |
Köhne (2 vs. 1) | 1.18 [0.96 – 1.47] | =0.1200 | |||
Köhne (3 vs. 1) | 2.66 [1.84 – 3.85] | <0.0001 | 0.54 [0.51 -0.57] *0.54 | 1.6 | |
Improvement of the Köhne prognostic index with clinical and QoL factors: complete-case analysis
| |||||
Köhne (2 vs. 1) | 1.11 [0.80 – 1.55] | =0.5114 | NRI at 12 months = 0.23 ([0.07; 0.46]) | ||
NRI at 24 months = 0.31 ([0.16; 0.44]) | |||||
Köhne (3 vs. 1) | 2.17 [1.25 – 3.75] | =0.0056 | |||
NRI at 36 months = 0.27 ([0.02; 0.50]) | |||||
LDH (>1ULN vs. ≤ 1ULN) | 2.09 [1.53 – 2.87] | <0.0001 | 0.67 [0.63 -0.71] | 10.8 | |
Mobility (2–3 vs. 1) | 1.56 [1.05 – 2.32] | =0.0266 | *0.66 | ||
Pain/discomfort (2–3 vs. 1) | 1.60 [1.17 – 2.18] | =0.0031 | |||
Improvement of the Köhne prognostic index with clinical and QoL factors after multiple imputation
| |||||
Köhne (2 vs. 1) | 1.24 [0.97 – 1.58] | =0.0780 | |||
Köhne (3 vs. 1) | 2.15 [1.43 – 3.24] | =0.0002 | |||
LDH (>1ULN vs. ≤ 1ULN) | 1.99 [1.61 – 2.46] | <0.0001 | 0.66 [0.59 -0.73] | 8.63 [7.74 – 10.8] | |
Mobility (2–3 vs. 1) | 1.39 [1.06 – 1.83] | =0.0191 | R = 65% | ||
Pain/discomfort (2–3 vs. 1) | 1.67 [1.20 – 2.31] | =0.0031 | R = 113% |
Improvement of the Köhne prognostic index
GERCOR prognostic index | |||||
---|---|---|---|---|---|
Variable | HR (95% CI) | P value | c-index | Schemper (%) | NRI (95% CI) |
GERCOR (2 vs. 1) | 1.82 [1.43 – 2.33] | <0.0001 | |||
GERCOR (3 vs. 1) | 3.10 [2.38 – 4.05] | <0.0001 | 0.63 [0.61 -0.66] *0.63 | 6.44 | |
Improvement of the GERCOR prognostic index clinical and QoL factors: complete-case analysis
| |||||
GERCOR (2 vs. 1) | 1.70 [1.14 – 2.54] | =0.0090 | NRI at 12 months = 0.35 [0.06; 0.44] | ||
GERCOR (3 vs. 1) | 3.35 [2.20 – 5.10] | <0.0001 | 0.67 [0.63 -0.71] *0.67 | 11.52 | NRI at 24 months = 0.27 [0.04; 0.38] |
NRI at 36 months = 0.28 [0.01; 0.45] | |||||
Mobility (2–3 vs. 1) | 1.77 [1.19 – 2.62] | =0.0047 | |||
Anxiety/depression (2–3 vs. 1) | 1.41 [1.03 – 1.92] | =0.0314 | |||
Improvement of the GERCOR prognostic index clinical and QoL factors: multiple imputation
| |||||
GERCOR (2 vs. 1) | 1.77 [1.36 – 2.30] | <0.0001 | |||
GERCOR (3 vs. 1) | 2.49 [1.84 – 3.38] | <0.0001 | |||
ALP (>1ULN vs. ≤ 1ULN) | 1.25 [1.00 – 1.57] | =0.0480 | 0.67 [0.64 -0.71] | 9.56 [8.76 – 11.52] | |
Mobility (2–3 vs. 1) | 1.42 [1.08 – 1.86] | =0.0120 | R = 60% | ||
Pain/discomfort (2–3 vs. 1) | 1.55 [1.10 – 2.20] | =0.0140 | R = 138% |
0 point | 1 point | 2 points | 3 points | 4 points | 5 points | 6 points | 7 points | |
---|---|---|---|---|---|---|---|---|
Köhne | Köhne I | Köhne II | Köhne III | |||||
LDH | ≤ 1ULN | >1ULN | ||||||
Mobility score | 1 | 2-3 | ||||||
Pain/discomfort score | 1 | 2-3 |
0 point | 1 point | 2 points | 3 points | 4 points | |
---|---|---|---|---|---|
GERCOR | GERCOR I | GERCOR II | GERCOR III | ||
Mobility score | 1 | 2-3 | |||
Pain/discomfort score | 1 | 2-3 |