Table 1. Clinical data of enrolled patients: Comparison of basic study parameters between test and validation sets.
Significant differences in the pre- and posttherapeutic therapy was due to the French cohort (GER – German cohort, FRA –French cohort, uT and uN – T-stage and lymph node status assessed by ultrasound, cM – clinically assessed distant metastases, 5-FU – 5-Fluorouracil, Ox – Oxaliplatin, RT – Radiotherapy, ypT and ypN – histopathologically assessed T-stage and lymph node status after preoperative therapy, yM – status of distant metastases after preoperative therapy, DFS – disease-free survival, CSS- cancer-specific survival)
| Parameter | Pilot Set | Test Set | Validation Set (GER) | Validation Set (FRA) | adj. p value |
|---|---|---|---|---|---|
| n | 11 | 61 | 71 | 42 | |
| Age [years] | 1.0 | ||||
| mean ± sd | 66 ± 7.7 | 64 ± 11 | 63 ± 10 | 67 ± 10 | |
| median (min; max) | 65 (50; 77) | 64 (36; 81) | 63 (38; 80) | 69 (42; 80) | |
| Gender | 1.0 | ||||
| female | 5 (45.5%) | 18 (29.5%) | 19 (26.8%) | 18 (42.9%) | |
| male | 6 (54.5%) | 43 (70.5%) | 52 (73.2%) | 24 (57.1%) | |
| uT | 1.0 | ||||
| 2 | 0 (0.0%) | 1 (1.6%) | 3 (4.3%) | 5 (11.9%) | |
| 3 | 10 (90.9%) | 57 (93.4%) | 63 (90.0%) | 36 (85.7%) | |
| 4 | 1 (9.1%) | 3 (4.9%) | 4 (5.7%) | 1 (2.4%) | |
| NA | 0 | 0 | 1 | 0 | |
| uN | 1.0 | ||||
| 0 | 1 (9.1%) | 17 (27.9%) | 24 (35.8%) | 13 (31.0%) | |
| 1 | 10 (90.9%) | 44 (72.1%) | 43 (64.2%) | 29 (69.0%) | |
| NA | 0 | 0 | 4 | 0 | |
| cM | 0.3 | ||||
| 0 | 11 (100.0%) | 60 (98.4%) | 63 (88.7%) | 42 (100.0%) | |
| 1 | 0 (0.0%) | 1 (1.6%) | 8 (11.3%) | 0 (0.0%) | |
| Preoperative Therapy | 0.01 | ||||
| 5-FU + RT | 4 (36.4%) | 31 (50.8%) | 46 (64.8%) | 6 (14.3%) | |
| 5-FU + Oxaliplatin + RT | 7 (63.6%) | 30 (49.2%) | 25 (35.2%) | 0 (0.0%) | |
| RT mono | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 36 (85.7%) | |
| Surgery | 0.26 | ||||
| APE | 1 (9.1%) | 21 (34.4%) | 13 (18.3%) | 17 (40.5%) | |
| LAR | 10 (90.9%) | 40 (65.6%) | 58 (81.7%) | 25 (59.5%) | |
| Postoperative Therapy | 0.01 | ||||
| 5-FU mono | 3 (27.3%) | 28 (45.9%) | 34 (50.7%) | 6 (14.3%) | |
| 5-FU + Oxaliplatin | 7 (63.6%) | 30 (49.2%) | 23 (34.3%) | 0 (0.0%) | |
| none | 1 (9.1%) | 3 (4.9%) | 10 (14.9%) | 36 (85.7%) | |
| NA | 0 | 0 | 4 | 0 | |
| Cause of non- cancer-specific death | 1.0 | ||||
| 2nd malignancy | 1 (100.0%) | 1 (14.3%) | 0 (0.0%) | 0 (0.0%) | |
| heart failure | 0 (0.0%) | 4 (57.1%) | 1 (50.0%) | 5 (100.0%) | |
| Pneumonia | 0 (0.0%) | 1 (14.3%) | 0 (0.0%) | 0 (0.0%) | |
| pulmonary embolism | 0 (0.0%) | 1 (14.3%) | 0 (0.0%) | 0 (0.0%) | |
| surgical complication | 0 (0.0%) | 0 (0.0%) | 1 (50.0%) | 0 (0.0%) | |
| ypT | 1.0 | ||||
| 0 | 4 (36.4%) | 7 (11.5%) | 15 (21.1%) | 5 (12.5%) | |
| 1 | 0 (0.0%) | 8 (13.1%) | 8 (11.3%) | 2 (5.0%) | |
| 2 | 2 (18.2%) | 13 (21.3%) | 15 (21.1%) | 19 (47.5%) | |
| 3 | 3 (27.3%) | 31 (50.8%) | 29 (40.8%) | 14 (35.0%) | |
| 4 | 2 (18.2%) | 2 (3.3%) | 4 (5.6%) | 0 (0.0%) | |
| NA | 0 | 0 | 0 | 2 | |
| ypN | 1.0 | ||||
| negative | 9 (81.8%) | 35 (57.4%) | 49 (69.0%) | 28 (70.0%) | |
| positive | 2 (18.2%) | 26 (42.6%) | 22 (31.0%) | 12 (30.0%) | |
| NA | 0 | 0 | 0 | 2 | |
| yM | 1.0 | ||||
| 0 | 11 (100.0%) | 48 (78.7%) | 55 (77.5%) | 28 (66.7%) | |
| 1 | 0 (0.0%) | 13 (21.3%) | 16 (22.5%) | 14 (33.3%) | |
| DFS probability | 0.29 | ||||
| 36-month estimate | 1 | 0.81 | 0.68 | 0.72 | |
| 60-month estimate | 0.78 | 0.64 | |||
| CSS probability | 1.0 | ||||
| 36-month estimate | 0.91 | 0.92 | 0.86 | ||
| 60-month estimate | 0.87 | 0.74 |