Figure 1
Distribution of patients through the trial.
Table 1
Pre-treatment patients and tumour characteristics (N = 66)
| Median age (years) | 60 (37-81) |
| Gender | |
| Male | 42 (63.6%) |
| Female | 24 (36.4%) |
| WHO performance status7 | |
| 0 | 54 (81.8%) |
| 1 | 11 (16.7%) |
| 2 | 1 (1.5 %) |
| Stage8 | |
| T2 | 9 (13.6%) |
| T3 | 50 (75.8%) |
| T4 | 7 (10.6%) |
| N0 | 9 (13.6%) |
| N1 | 34 (51.5%) |
| N2 | 23 (34.9%) |
| Tumour differentiation (grade) | |
| Well (G1) | 8 (12.1%) |
| Moderate (G2) | 35 (53.0%) |
| Poorly (G3) | 4 (6.0%) |
| Unknown or not stated (GX) | 19 (28.9%) |
| MRF distance | |
| MRF+ | 20 |
| MRF- | 44 |
| Median tumour distance from the anal verge (cm) | 6 (0-12) |
Table 2
Toxicity8 of preoperative treatment (N = 66)
| Toxicity grade (N) | |||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| Haematological | |||||
| Anaemia | 23 | 7 | 1 | 0 | 0 |
| Neutropenia | 4 | 7 | 2 | 0 | 0 |
| Thrombocytopenia | 6 | 1 | 1 | 1 | 0 |
| Non-haematological | |||||
| Fatigue | 5 | 0 | 0 | / | / |
| Nausea/vomiting | 2 | 2 | 0 | / | / |
| Hand-foot syndrome | 11 | 5 | 1 | ||
| Radiodermatitis | 7 | 18 | 5 | ||
| Diarrhoea | 11 | 3 | 2 | ||
| Urinary infection | 6 | 0 | 0 | 0 | 0 |
| Systemic infection | 0 | 1 | 0 | 1 | 0 |
| Proctitis | 6 | 2 | 0 | ||
| Thromboembolism | 2 | 2 | 0 | 0 | 1 |
| Chest pain | 1 | ||||
Table 3
| Toxicity grade (N) | ||||||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | ||
| Haematological | ||||||
| Anaemia | 23 | 1 | ||||
| Neutropenia | 1 | |||||
| Non-haematological | ||||||
| Fatigue | 2 | |||||
| Nausea/vomiting | 2 | 1 | ||||
| Hand-foot syndrome | 3 | 3 | ||||
| Diarrhoea | 1 | |||||
| Urinary infection | 2 | |||||
| Thromboembolic event | 1 | |||||
Table 4
Distribution of clinical and pathological stages
| pT0 | pT1 | pT2 | pT3 | pT4 | pN0 | pN1 | pN2 | ||
| cT1 | - | - | - | - | - | cN0 | 7 | - | - |
| cT2 | 2 | - | 3 | 4 | - | cN1 | 28 | 4 | 1 |
| cT3 | 8 | 6 | 16 | 18 | 1 | cN2 | 17 | 4 | 2 |
| cT4 | 1 | - | 1 | 1 | 2 |
Figure 2
Prognostic significance of pathologic nodal stage (pN) and pathologic tumour stage (pT) in 5-year disease free survival and overall survival in rectal cancer after preoperative chemoradiotherapy and surgery. Time (m = months).
Table 5
Univariate analysis of overall survival (OS) and disease free survival (DFS) according to patient, disease, and treatment characteristics (N = 66)
| Parameter | OS | DFS |
|---|---|---|
| Gender | ns | ns |
| Age | ns | ns |
| WHO PSa | ns | ns |
| Tumour location in the rectum | ns | ns |
| cTumour stage | ns | ns |
| cNodal stage | ns | ns |
| Type of surgery: APR vs. LAR | ns | ns |
| pT1–2 vs. pT3–4 | 0.005 | 0.002 |
| pT0 vs. pT4 | 0.009 | 0.009 |
| pN0 vs. pN+ | 0.009 | 0.005 |
| TRG 3–4 vs. 0–2 | ns | ns |
| pCR | ns | ns |
| All treatment vs. less treatment | 0.016 | 0.018 |