Table 1.
Univariate analysis of clinical and pathological factors in the 5-FU and gemcitabine arms.
| Summary Statistics | Hazard Ratio (95% Confidence Interval) | |||||
|---|---|---|---|---|---|---|
| Characteristic | Level | 5-Fluorouracil | Gemcitabine | 5-Fluorouracil | Gemcitabine | Total |
| Resection Margin | n = 132 | n = 145 | n = 277 | |||
| Negative | 70 (53%) | 86 (59%) | 1 | 1 | 1 | |
| Positive | 62 (47%) | 59 (41%) | 1.80 (1.23–2.63) | 1.35 (0.94–1.94) | 1.56 (1.20–2.03) | |
| Wald χ2 = 9.05, p = 0.003 * |
Wald χ2 = 2.62 p = 0.106 |
Wald χ2 = 11.22, p = 0.001 |
||||
| WHO | n = 132 | n = 145 | n = 277 | |||
| 0 | 52 (39%) | 49 (34%) | 1 | 1 | 1 | |
| 1 | 67 (51%) | 80 (55%) | 1.26 (0.86–1.96) | 1.40 (0.94–2.07) | 1.33 (1.01–1.76) | |
| 2 | 13 (10%) | 16 (11%) | 0.68 (0.29–1.59) | 1.24 (0.68–2.25) | 0.92 (0.56–1.53) | |
| Wald χ2 = 2.89, p = 0.236 |
Wald χ2 = 2.75 p = 0.253 |
Wald χ2 = 5.24, p = 0.073 |
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| Lymph Node Status | n = 132 | n = 145 | n = 277 | |||
| Negative | 29 (22%) | 29 (20%) | 1 | 1 | 1 | |
| Positive | 103 (78%) | 116 (80%) | 2.40 (1.47–3.90) | 1.56 (0.99–2.46) | 1.94 (1.39–2.71) | |
| Wald χ2 = 12.30, p = 0.001 |
Wald χ2 = 3.63, p = 0.057 |
Wald χ2 = 15.18 p < 0.001 |
||||
| Tumor Stage | n = 131 | n = 144 | n = 275 | |||
| 01/02 | 38 (29%) | 46 (32%) | 1 | 1 | 1 | |
| 03/04 | 93 (70%) | 98 (68%) | 1.69 (1.10–2.59) | 1.39 (0.95–2.01) | 1.51 (1.15–2.00) | |
| Wald χ2= 5.81, p = 0.016 |
Wald χ2 = 2.95, p = 0.086 |
Wald χ2 = 8.47, p = 0.004 |
||||
| Tumor Grade | N = 129 | n = 142 | n = 271 | |||
| Well | 7 (5%) | 10 (7%) | 1 | 1 | 1 | |
| Moderately | 89 (67%) | 98 (68%) | 0.60 (0.37–0.96) | 0.83 (0.44–1.58) | 0.72 (0.47–1.01) | |
| Poorly | 33 (25%) | 34 (23%) | 0.67 (0.35–1.28) | 1.19 (0.58–2.44) | 0.91 (0.55–1.51) | |
| Wald χ2 = 4.54, p = 0.103 |
Wald χ2 = 2.75, p = 0.753 |
Wald χ2 = 3.60 p = 0.165 |
||||
| Local Invasion | n = 132 | n = 142 | n = 274 | |||
| No | 73 (55%) | 72 (50%) | 1 | 1 | 1 | |
| Yes | 59 (45%) | 70 (48%) | 1.25 (0.85–1.84) | 1.10 (0.77–1.58) | 1.17 (0.90–1.52) | |
| Wald χ2 = 1.31, p = 0.252 |
Wald χ2 = 0.26, p = 0.607 |
Wald χ2 = 1.37 p = 0.242 |
||||
| Maximum Tumor diameter | n = 128 | n = 139 | n = 267 | |||
| <30 mm | 69 (52%) | 58 (40%) | 1 | 1 | 1 | |
| ≥30 mm | 59 (45%) | 81 (56%) | 1.31 (0.89–1.95) | 1.64 (1.13–2.39) | 1.47 (1.12–1.92) | |
| Wald χ2 = 1.82, p = 0.177 |
Wald χ2 = 6.73, p = 0.010 |
Wald χ2 = 7.84 p = 0.005 |
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| Diabetes mellitus | n = 129 | n = 141 | n = 270 | |||
| No | 102 (77%) | 106 (73%) | 1 | 1 | 1 | |
| Yes | 27 (20%) | 35 (24%) | 1.06 (0.65–1.75) | 0.99 (0.64–1.53) | 1.02 (0.74–1.41) | |
| Wald χ2 = 0.07, p = 0.797 |
Wald χ2 = 0.00, p = 0.951 |
Wald χ2 = 0.01, p = 0.905 |
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| Gender | n = 132 | n = 145 | n = 277 | |||
| Male | 75 (57%) | 88 (61%) | 1 | 1 | 1 | |
| Female | 57 (43%) | 57 (39%) | 0.88 (0.59–1.32) | 1.25 (0.86–1.81) | 1.06 (0.81–1.39) | |
| Wald χ2= 0.38, p = 0.537 |
Wald χ2 = 1.42, p = 0.234 |
Wald χ2 = 0.16, p = 0.686 |
||||
| Age, years | n = 132 | n = 145 | n = 277 | |||
| ≥64 | 65 (49%) | 80 (55%) | 1 | 1 | 1 | |
| <64 | 67 (51%) | 65 (45%) | 1.37 (0.93–2.02) | 0.84 (0.58–1.21) | 1.07 (0.83–1.40) | |
| Wald χ2= 2.55, p = 0.110 |
Wald χ2 = 0.90, p = 0.342 |
Wald χ2 = 0.28, p = 0.598 |
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| Smoking | n = 125 | n = 128 | n = 253 | |||
| Never | 52 (39%) | 58 (40%) | 1 | 1 | 1 | |
| Ex | 51 (39%) | 52 (36%) | 0.93 (0.60–1.43) | 1.08 (0.70–1.66) | 1.00 (0.74–1.35) | |
| Current | 22 (17%) | 18 (12%) | 0.91 (0.53–1.57) | 1.76 (1.02–3.05) | 1.20 (0.81–1.78) | |
| Wald χ2 = 0.17, p = 0.917 |
Wald χ2 = 4.16, p = 0.125 |
Wald χ2 = 0.95, p = 0.623 |
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* Significant values in bold.