Table 1.
Patient characteristics, clinical and treatment features.
| Patient characteristics and clinical features | ||||
|---|---|---|---|---|
| Patient number | 213 | |||
| Overall dataset | Training set | Validation set | P-value | |
| Median age at diagnosis [years] (range) | 64 (26-83) | 64 (28 - 83) | 57 (26 - 79) | 0.31 |
| Median interval between end of nCRT and surgery [weeks] (range) | 11 (7-24) | 10 (7-24) | 8 (11-16) | 0.65 |
| Median length of nCRT [weeks] (range) | 5 (2-9) | 5 (2 - 9) | 5 (3-8) | 0.51 |
| Median time of follow-up [months] | 61 (14-119) | 60 (13-119) | 70 (41-104) | 0.23 |
| Median PFS [months] (range) | 51 (3-114) | 51 (4-114) | 49 (3-108) | 0.32 |
| Sex | 0.60 | |||
| Male Female |
136 (64%) 77 (36%) |
121 (63%) 71 (37%) |
15 (71%) 6 (29%) |
|
| cT | 0.19 | |||
| 2 3 4 |
14 (7%) 132 (62%) 67 (31%) |
11 (6%) 118 (61%) 63 (33%) |
3 (14%) 14 (67%) 4 (19%) |
|
| cN | 0.35 | |||
| 0 1 2 |
13 (6%) 68 (32%) 132 (62%) |
11 (7%) 59 (30%) 122 (63%) |
2 (10%) 9 (43%) 10 (47%) |
|
| ycT | 0.42 | |||
| 0 1 2 3 4 NA |
36 (17%) 11 (5%) 73 (34%) 70 (33%) 21 (10%) 2 (1%) |
29 (16%) 10 (5%) 67 (35%) 64 (33%) 20 (10%) 2 (1%) |
7 (34%) 1 (5%) 6 (28%) 6 (28%) 1 (5%) 0 (0%) |
|
| ycN | 0.98 | |||
| 0 1 2 3 NA |
96 (45%) 86 (40%) 28 (13%) 1 (<1%) 2 (1%) |
86 (45%) 78 (40%) 25 (13%) 1 (<1%) 2 (1%) |
10 (48%) 8 (38%) 3 (14%) 0 (0%) 0 (0%) |
|
| MRI response type | 0.42 | |||
| Complete Partial Stable |
32 (15%) 178 (84%) 3 (1%) |
25 (13%) 165 (86%) 2 (1%) |
7 (33%) 13 (62%) 1 (5%) |
|
| Radiotherapy Dose | ||||
| 50.4 Gy 55 Gy |
18 (8%) 195 (92%) |
15 (8%) 177 (92%) |
3 (14%) 18 (86%) |
0.43 |
| Concomitant neoadjuvant CT type | 0.36 | |||
| with Oxaliplatinum without Oxaliplatinum |
142 (67%) 71 (33%) |
127 (66%) 65 (34%) |
15 (72%) 6 (28%) |
|
| Adjuvant CT type | 0.85 | |||
| with Oxaliplatinum without Oxaliplatinum no adjuvant CT |
76 (19%) 41 (36%) 96 (45%) |
69 (36%) 37 (19%) 86 (45%) |
7 (33%) 4 (19%) 10 (48%) |
|
| Surgical procedure | 0.49 | |||
| APR AR TEM |
48 (23%) 154 (72%) 11 (5%) |
43 (22%) 140 (73%) 9 (5%) |
5 (24%) 14 (67%) 2 (9%) |
|
| ypT | 0.49 | |||
| 0 1 2 3 4 NA |
55 (26%) 6 (3%) 60 (28%) 83 (39%) 6 (3%) 3 (1%) |
51 (27%) 3 (2%) 53 (28%) 77 (40%) 6 (3%) 2 (1%) |
6 (29%) 0 (0%) 7 (33%) 7 (33%) 0 (0%) 1 (5%) |
|
| ypN | 0.56 | |||
| 0 1 2 NA |
152 (71%) 38 (18%) 8 (4%) 15 (7%) |
138 (72%) 35 (18%) 7 (4%) 12 (6%) |
14 (67%) 3 (14%) 1 (5%) 3 (14%) |
|
| pCR | 0.59 | |||
| Yes No NA |
53 (25%) 156 (73%) 4 (2%) |
141 (73%) 48 (25%) 3 (2%) |
15 (71%) 5 (24%) 1 (5%) |
|
| Response | 0.12 | |||
| TRG=1 TRG>1 NA |
55 (26%) 146 (69%) 12 (5%) |
50 (26%) 133 (69%) 9 (5%) |
5 (24%) 13 (62%) 3 (14%) |
|
| Distant metastases event at 2 years | 0.08 | |||
| Yes No |
36 (17%) 177 (83%) |
29 (15%) 163 (85%) |
7 (33%) 14 (67%) |
|
Distant PFS, distant progression-free survival; CT, chemotherapy; pCR, pathological complete response; TRG, tumor regression grade; nCRT, neoadjuvant chemoradiation therapy; AR, anterior resection; APR, abdominal-perineal resection; TEM, transanal endoscopic microsurgery; NA, not available.