Table 3.
Histopathological tumour characteristics
|
Randomised patients |
Non-randomised patients |
||||
|---|---|---|---|---|---|
| Organ preservation (n=27) | Radical surgery (n=28) | Organ preservation (n=61) | Radical surgery(n=7) | ||
| TNM (y)pT stage | |||||
| 0 | 7 (26%) | 0 | 20 (33%) | 0 | |
| 1 | 6 (22%) | 14 (50%) | 18 (30%) | 1 (14%) | |
| 2 | 8 (30%) | 13 (46%) | 12 (20%) | 6 (86%) | |
| 3 | 5 (19%) | 1 (4%) | 4 (7%) | 0 | |
| x | 0 | 0 | 1 (2%) | 0 | |
| Clinical complete response with no surgery | 1 (4%) | 0 | 5 (8%) | 0 | |
| All cases with a complete response | 8 (30%) | 0 | 25 (41%) | 0 | |
| Kikuchi substaging of pT1 tumours | |||||
| Submucosal tumour stage 1 | 2 (33%) | 2 (14%) | 7 (39%) | 0 | |
| Submucosal tumour stage 2 | 1 (17%) | 3 (21%) | 6 (33%) | 0 | |
| Submucosal tumour stage 3 | 3 (50%) | 9 (64%) | 5 (38%) | 1 (100%) | |
| TNM pN stage | |||||
| 0 | 3 (11%) | 23 (82%) | 0 | 7 (100%) | |
| 1 | 0 | 3 (10%) | 0 | 0 | |
| 2 | 0 | 1 (4%) | 0 | 0 | |
| x | 24 (89%) | 1 (4%) | 60 (100%) | 0 | |
| Surgical resection margin <1 mm | |||||
| Clear | 23 (85%) | 26 (93%) | 49 (82%) | 7 (100%) | |
| Involved adenoma | 0 | 1 (4%) | 1 (2%) | 0 | |
| Involved carcinoma (deep) | 3 (11%) | 1 (4%) | 1 (2%) | 0 | |
| Involved carcinoma (mucosal) | 0 | 0 | 0 | 0 | |
| No surgery | 1 (4%) | 0 | 5 (8%) | 0 | |
| Missing | 0 | 0 | 4 (6%) | 0 | |
| Positive lymphatic invasion | 0 | 5 (18%) | 1 (2%) | 1 (14%) | |
| Positive vascular invasion | 2 (8%) | 7 (25%) | 4 (7%) | 0 | |
| Tumour differentiation | |||||
| Well or moderately differentiated | 17 (63%) | 26 (93%) | 31 (51%) | 7 (100%) | |
| Poorly differentiated | 2 (7%) | 2 (7%) | 3 (5%) | 0 | |
| Pathological complete response | 7 (26%) | 0 | 19 (31%) | 0 | |
| Complete response* | 1 (4%) | 0 | 5 (8%) | 0 | |
| Tumour diameter, mm | 3 (0–17) | 10 (0–30) | 4 (0–45) | 8 (2–30) | |
| Radiotherapy response (Dworak 5-point system) | |||||
| Complete | 7 (26%) | 0 | 19 (31%) | ·· | |
| Good | 5 (19%) | 2 (67%) | 15 (25%) | ·· | |
| Moderate | 6 (22%) | 0 | 7 (11%) | ·· | |
| Mild | 4 (15%) | 0 | 4 (7%) | ·· | |
| No surgery | 1 (4%) | 0 | 5 (8%) | ·· | |
| Missing | 3 (11%) | 1 (33%) | 5 (8%) | ·· | |
| High-risk histopathological feature present† | 16/27 (59%) | 24/28 (86%) | 24/61 (39%) | 7/7 (100%) | |
*
Including pathological and clinical complete response.
†
Comparison of proportion of randomised patients with one or more histopathological feature considered high risk for relapse following local excision (maximum tumour diameter >30 mm, R1 resection, predominantly poor differentiation, presence of lymphatic or venous invasion and depth of invasion ≥submucosal tumour stage 3; p=0·03, χ2 test).