Table 1.
Baseline characteristics
|
BC2001 trial |
BCON trial |
Combined dataset |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 64 Gy in 32 fractions (n=279) | 55 Gy in 20 fractions (n=177) | Standardised difference, % | 64 Gy in 32 fractions (n=97) | 55 Gy in 20 fractions (n=229) | Standardised difference, % | 64 Gy in 32 fractions (n=376) | 55 Gy in 20 fractions (n=406) | Standardised difference, % | ||
| Sex | ||||||||||
| Female | 50 (18%) | 37 (21%) | .. | 17 (18%) | 48 (21%) | .. | 67 (18%) | 85 (21%) | .. | |
| Male | 229 (82%) | 140 (79%) | 7·5% | 80 (82%) | 181 (79%) | 8·7% | 309 (82%) | 321 (79%) | 7·9% | |
| Age, years | 71·4 (8·7) | 71·6 (7·9) | 1·3% | 72·6 (7·6) | 73·0 (7·8) | −5·4% | 71·7 (8·4) | 72·4 (7·8) | 7·9% | |
| Radiotherapy plus radiosensitiser | 111 (40%) | 71 (40%) | 0·7% | 49 (51%) | 116 (51%) | 0·3% | 160 (43%) | 187 (46%) | 7·1% | |
| Reduced high-dose volume radiotherapy | 75 (27%) | 35 (20%) | 16·9% | 0 | 0 | .. | 75 (20%) | 35 (9%) | 32·8% | |
| Tumour stage | ||||||||||
| 1 | 1* (<1%) | 0 | .. | 13 (13%) | 17 (7%) | .. | 14 (4%) | 17 (4%) | .. | |
| 2 | 251 (90%) | 129 (73%) | .. | 68 (70%) | 147 (64%) | .. | 319 (85%) | 276 (68%) | .. | |
| 3 | 20 (7%) | 40 (23%) | .. | 14 (14%) | 54 (24%) | .. | 34 (9%) | 94 (23%) | .. | |
| 4 | 7 (3%) | 8 (5%) | 47·6% | 2 (2%) | 10 (4%) | 32·1% | 9 (2%) | 18 (4%) | 42·6% | |
| Unknown | 0 | 0 | .. | 0 | 1 | .. | 0 | 1 | .. | |
| Tumour grade | ||||||||||
| 1 | 1 (<1%) | 0 | .. | 0 | 0 | .. | 1 (<1%) | 0 | .. | |
| 2 | 40 (14%) | 19 (11%) | .. | 16 (16%) | 30 (13%) | .. | 56 (15%) | 49 (12%) | .. | |
| 3 | 236 (85%) | 156 (89%) | 13·9% | 81 (84%) | 198 (87%) | 9·4% | 317 (85%) | 354 (88%) | 11·1% | |
| Unknown | 2 | 2 | .. | 0 | 1 | .. | 2 | 3 | .. | |
| Extent of resection | ||||||||||
| Biopsy or not resected | 24 (9%) | 23 (13%) | .. | 25 (26%) | 62 (28%) | .. | 49 (13%) | 85 (22%) | .. | |
| Complete | 175 (63%) | 81 (47%) | .. | 46 (47%) | 83 (38%) | .. | 221 (59%) | 164 (42%) | .. | |
| Partial | 77 (28%) | 70 (40%) | 34·4% | 26 (27%) | 73 (33%) | 19·6% | 103 (28%) | 143 (36%) | 36·1% | |
| Unknown | 3 | 3 | .. | 0 | 11 | .. | 3 | 14 | .. | |
| Neoadjuvant chemotherapy | 65 (23%) | 69 (39%) | 34·4% | 0 | 0 | .. | 65 (17%) | 69 (17%) | 0·8% | |
| Haemoglobin, g/dL† | 13·1 (1·8) | 12·6 (1·8) | 27·4% | 13·8 (1·7) | 13·6 (1·6) | 11·3% | 13·2 (1·8) | 13·1 (1·8) | 5·7% | |
Data are n (%), mean (SD), or n. Standardised difference represents the difference in means or proportions divided by its standard error; it is therefore a measure of the average difference between groups expressed in standard deviation units. A difference greater than 10% expresses that the observed difference between fractionation groups is more than 10% of the observed variability. Percentages were calculated for total number of patients without missing values.
This tumour was deemed to be pathological stage T1, but radiological staging confirmed the tumour as T3 and the patient was considered to be eligible for the trial.
Unknown in four patients receiving 64 Gy in 32 fractions (one in BC2001 and three in BCON) and two patients receiving 55 Gy in 20 fractions (BCON).