Study | ARMS (N patients) | ypT stage N (%) | ypN stage N (%) | pCR N (%) | Local recurrence N (%) | Distant recurrence N (%) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 |  | ypT0 | ypTis | ypT1 | ypT2 | ypT3 | ypT4 | ypN0 | ypN1 | ypN2 | ypNx |  |  |  |
EudraCT | EXP. ARM (28) | 7 (25%) | 1 (4%) | 1 (4%) | 4 (14%) | 13 (46%) | 1 (4%) | 13 (46%) | 9 (32%) | 5 (18%) | – | 7 (25%) | – | – |
CONTROL (29) | 8 (28%) | 1 (3%) | 1 (3%) | 5 (17%) | 12 (41%) | 1 (3%) | 16 (55%) | 9 (31%) | 3 (10%) | 8 (28%) | ||||
GCR-3 | EXP. ARM (56) | * | * | * | * | * | * | * | * | * | * | 8 (14%) | 3 (5%) | 13 (23%) |
CONTROL (52) | 7 (13%) | 1 (2%) | 11 (21%) | |||||||||||
POLISH II | EXP. ARM (261) | 24 (12%) | – | 5 (3%) | 53 (26%) | 92 (46%) | 28 (14%) | 136 (68%) | 37 (19%) | 27 (14%) | – | 24 (12%) | – | 62 (25%) |
CONTROL (254) | 37 (17%) | 3 (1%) | 47 (22%) | 110 (51%) | 19 (9%) | 150 (69%) | 43 (20%) | 26 (12%) | 37 (17%) | 75 (29%) | ||||
WAIT | EXP. ARM (25) | 5 (20%) | – | 1 (4%) | 5 (20%) | 13 (52%) | 1 (4%) | 16 (73%) | 5 (20%) | 4 (16%) | – | – | – | – |
CONTROL (24) | 6 (25%) | 2 (8%) | 4 (17%) | 11 (46%) | 1 (4%) | 19 (79%) | 2 (8%) | 3 (13%) | ||||||
KCSG CO 14-03 | EXP. ARM (53) | 6 (14%) | 0 | 1 (2%) | 12 (27%) | 24 (55%) | 1 (2%) | 28 (64%) | 15 (34%) | 1 (2%) | – | 6 (14%) | – | – |
CONTROL (55) | 3 (6%) | 1 (2%) | 1 (2%) | 8 (15%) | 39 (75%) | 0 | 27 (52%) | 20 (28%) | 5 (10%) | 3 (6%) | ||||
FOWARC | ARM TNT + RT (165) | 84 (87%) | 65 (44%) | – | 41 (27%) | – | – | |||||||
ARM TNT (165) | 54 (35%) | 98 (65%) | 10 (7%) | |||||||||||
CONTROL (165) | 53 (37%) | 90 (63%) | 20 (14%) | |||||||||||
RAPIDO | EXP. ARM (462) | 129 (30%) | 2 (< 1%) | 17 (4%) | 82 (19%) | 157 (37%) | 36 (9%) | 317 (75%) | 75 (18%) | 31 (7%) | – | 120 (28%) | 29 (22%) | 86 (67%) |
CONTROL (450) | 69 (17%) | 1 (< 1%) | 17 (4%) | 96 (24%) | 190 (48%) | 25 (6%) | 273 (69%) | 78 (20%) | 47 (12%) | 57 (14%) | 17 (13%) | 123 (81%) | ||
PRODIGE-23 | EXP. ARM (231) | 60 (28%) | 3 (1%) | 11 (5%) | 57 (27%) | 77 (36%) | 4 (2%) | 175 (83%) | 30 (14%) | 7 (3%) | 0 | 59 (28%) | – | – |
CONTROL (230) | 27 (13%) | 2 (1%) | 17 (8%) | 62 (29%) | 103 (48%) | 4 (2%) | 145 (67%) | 49 (23%) | 20 (9%) | 1 (1%) | 26 (12%) |
Pathologoical outcomes, second part | Â | Â | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Study | Arms (N patients) | CRM | Resection limits N (%) | Lymphovascular invasion N (%) | Perinervous invasion N (%) | TRG N (%) | |||||
 |  |  > 1 mm |  ≤ 1 mm | R0 | R1 | R2 |  |  | 1 | 2 | 3 |
EudraCT | EXP. ARM (28) | 27 (96%) | 1 (4%) | – | – | – | – | – | – | – | – |
CONTROL (29) | 25 (86%) | 4 (14%) | |||||||||
GCR-3 | EXP. ARM (56) | – | – | 48 (86%) | 2 (4%) | 2 (4%) | – | – | – | ||
CONTROL (52) | 45 (87%) | 1 (2%) | – | ||||||||
POLISH II | EXP. ARM (261) | – | – | 178 (71%) | 20 (8%) | 5 (2%) | – | – | – | ||
CONTROL (254) | 202 (77%) | 17 (7%) | 1 (1%) | ||||||||
WAIT | EXP. ARM (25) | – | – | 23 (92%) | 2 (8%) | – | – | – | – | ||
CONTROL (24) | 22 (92%) | 2 (8%) | |||||||||
KCSG CO 14-03 | EXP. ARM (53) | 37 (84%) | 7 (16%) | – | – | – | 7 (16%) | 24 (55%) | 7 (16%) | ||
CONTROL (55) | 47 (90%) | 4 (7%) | 13 (25%) | 28 (54%) | 7 (14%) | ||||||
FOWARC | ARM TNT + RT (165) | – | – | 134 (90%) | 10 (7%) | 5 (3%) | – | – | 102 (69%) | 46 (31%) | |
ARM TNT (165) | 136 (89%) | 8 (5%) | 8 (5%) | 50 (33%) | 102 (67%) | ||||||
CONTROL (165) | 128 (91%) | 8 (6%) | 5 (3%) | 70 (49%) | 71 (50%) | ||||||
RAPIDO | EXP. ARM (462) | 385 (91%) | 38 (9%) | 382 (90%) | 38 (9%) | 3 (1%) | – | – | – | ||
CONTROL (450) | 363 (91%) | 35 (9%) | 360 (90%) | 37 (9%) | 1 (< 1%) | ||||||
PRODIGE-23 | EXP. ARM (231) | 149 (95%) | 8 (5%) | 201 (95%) | 20 (5%) | 0 | 17 (8%) | 15 (7%) | 88 (48%) | 71 (38%) | 26 (14%) |
CONTROL (230) | 173 (94%) | 11 (6%) | 202 (94%) | 10 (5%) | 2 (1%) | 20 (9%) | 24 (11%) | 57 (32%) | 99 (55%) | 23 (13%) |