Table. Patient and Disease Characteristics.
| Characteristic | Patients, No. (%) | ||
|---|---|---|---|
| Immediate surgery (n = 204) | Watch-and-wait management | ||
| Delayed surgery (n = 54) | No surgery (n = 44)a | ||
| Age, median (range), y | 51 (22-82) | 62 (31-87) | 58 (32-89) |
| Sex | |||
| Female | 78 (38) | 30 (56) | 16 (36) |
| Male | 126 (62) | 24 (44) | 28 (64) |
| DTAV ≤5 cm | 46 (23) | 26 (48) | 19 (43) |
| Months to surgery or last evaluation, median (range)b | 1.9 (0.3-3.0) | 6.3 (3.0-46.2) | 51.2 (18.3-79.3) |
| cT category | |||
| 1 | 1 (1) | 1 (2) | 0 |
| 2 | 10 (5) | 4 (7) | 4 (9) |
| 3 | 168 (82) | 39 (72) | 39 (89) |
| 4 | 25 (12) | 10 (19) | 1 (2) |
| cN category | |||
| 0 | 18 (9) | 8 (15) | 18 (41) |
| 1 | 158 (77) | 40 (74) | 25 (57) |
| 2 | 28 (14) | 6 (11) | 1 (2) |
| Pretreatment clinical stage according to AJCC 5 | |||
| II | 18 (9) | 8 (15) | 18 (41) |
| III | 186 (91) | 46 (85) | 26 (59) |
| Pathologic tumor response | |||
| Complete | 37 (18) | 7 (13) | NA |
| Incomplete | 167 (82) | 43 (80) | NA |
| Unknown | 0 | 4 (7) | NA |
| ypT category | |||
| 0 | 40 (20) | 9 (17) | NA |
| 1 | 17 (8) | 3 (6) | NA |
| 2 | 56 (27) | 21 (39) | NA |
| 3 | 86 (42) | 13 (24) | NA |
| 4 | 5 (3) | 5 (9) | NA |
| Unknown | 0 | 3 (6) | NA |
| ypN category | |||
| 0 | 150 (74) | 39 (72) | NA |
| 1/2 | 54 (26) | 11 (20) | NA |
| Unknown | 0 | 4 (7) | NA |
| Pathologic stage according to AJCC 8 | |||
| 0 | 37 (18) | 7 (13) | NA |
| I | 63 (31) | 21 (39) | NA |
| IIa | 46 (23) | 10 (19) | NA |
| IIb | 4 (2) | 1 (2) | NA |
| IIIa | 11 (5) | 4 (7) | NA |
| IIIb | 37 (18) | 7 (13) | NA |
| IIIc | 6 (3) | 0 | NA |
| Unknown | 0 | 4 (7) | NA |
| Venous invasionc | |||
| Absent | 170 (83) | 39 (72) | NA |
| Present | 34 (17) | 12 (22) | NA |
| Unknown | 0 | 3 (6) | NA |
| PNI | |||
| Absent | 165 (81) | 35 (65) | NA |
| Present | 39 (19) | 16 (30) | NA |
| Unknown | 0 | 3 (6) | NA |
| Change in AJCC 5 staged | |||
| Downstaged | 142 (70) | 37 (69) | NA |
| No change | 60 (29) | 12 (22) | NA |
| Upstaged | 2 (1) | 1 (2) | NA |
| Missing data | 0 | 4 (7) | NA |
Abbreviations: AJCC 5, AJCC Cancer Staging Manual, fifth edition; AJCC 8, AJCC Cancer Staging Manual, eighth edition; cN, clinical nodal classification; cT, clinical tumor classification; DTAV, distance of tumor from the anal verge; NA, not applicable; PNI, perineural invasion; ypN, pathologic nodal classification; ypT, pathologic tumor classification.
As of data lock on April 21, 2021.
From completion of total neoadjuvant therapy.
Small-vessel lymphatic or venous invasion or large-vessel intramural or extramural venous invasion.
Upstaged indicates postoperative pathologic category or stage higher than the pretreatment clinical category or stage; downstaged, postoperative pathologic category or stage lower than the pretreatment clinical category or stage.