Table 1.
Radiotherapy details of patients in first and second acute toxicity substudies.
| Radiotherapy (RT) details | Acute toxicity substudy 1 |
Acute toxicity substudy 2 |
||||
|---|---|---|---|---|---|---|
| 40 Gy/15F | 27 Gy/5F | 26 Gy/5F | 40 Gy/15F | 27 Gy/5F | 26 Gy/5F | |
| N = 64a | N = 62 | N = 63 | N = 55b | N = 44 | N = 61 | |
| N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
| Radiotherapy received | ||||||
| Yes | 64 (100) | 62 (100) | 63 (100) | 54 (98) | 44 (100) | 61 (100) |
| No | 0 | 1 (2)c | 0 | 1 (2)d | 0 | 0 |
| Boost received | ||||||
| Yes | 11 (17) | 11 (18) | 7 (11) | 0 | 0 | 0 |
| No | 53 (83) | 51 (82) | 56 (89) | 54 (100) | 44 (100) | 61 (100) |
| Treatment duration in patients receiving no boost (including weekends and bank holidays)e | ||||||
| Median (IQR) | 22 (21–23) | 5 (5–7) | 7 (5–7) | 21 (20–22) | 6 (5–7) | 6 (5–7) |
| Range | 1–25 | 5–11 | 1–9 | 15–23 | 5-8 | 5-8 |
| Treatment duration in patients receiving boost (including weekends and bank holidays) | ||||||
| Median (IQR) | 30 (26–33) | 18 (12–20) | 14 (12–17) | – | – | – |
| Range | 22–35 | 7–20 | 7–21 | – | – | – |
| Whole breast – total fractions | ||||||
| 5 | 0 | 62 (100) | 63 (100) | 0 | 44 (100) | 61 (100) |
| 15 | 63 (98) | 0 | 0 | 54 (100) | 0 | 0 |
| Otherf | 1 (2) | 0 | 0 | 0 | 0 | 0 |
| Whole breast – total dose (Gy) | ||||||
| 26 | 0 | 0 | 63 (100) | 0 | 0 | 61 (100) |
| 27 | 0 | 62 (100) | 0 | 0 | 44 (100) | 0 |
| 40 | 63 (98) | 0 | 0 | 54 (100) | 0 | 0 |
| Other6 | 1 (2) | 0 | 0 | 0 | 0 | 0 |
| Bolus used (mastectomy patients only) | ||||||
| Yes | 1 (100) | 1 (33) | 3 (50) | 2 (40) | 1 (50) | 5 (100) |
| No | 0 | 2 (67) | 3 (50) | 3 (60) | 1 (50) | 0 |
| Dose homogeneity constraints achieved | ||||||
| Yes | 62 (97) | 61 (98) | 60 (95) | 53 (98) | 44 (100) | 60 (98) |
| No | 2 (3) | 1 (2) | 3 (5) | 1 (2) | 0 | 1 (2) |
| Organs at risk dose constraints achieved | ||||||
| Yes | 64 (100) | 61 (98) | 62 (98) | 53 (98) | 44 (100) | 61 (100) |
| No | 0 | 1 (2) | 1 (2) | 1 (2) | 0 | 0 |
| Any deviations from RT | ||||||
| Yes | 1 (2) | 0 | 0 | 1 (2) | 0 | 0 |
| No | 63 (98) | 62 (100) | 63 (100) | 53 (98) | 44 (100) | 61 (100) |
| Whole breast RT extended by >3 days | ||||||
| Yes | 0 | 0 | 0 | 0 | 0 | 0 |
| No | 64 (100) | 62 (100) | 63 (100) | 54 (100) | 44 (100) | 61 (100) |
Includes one patient randomised to receive 26 Gy/5F who was treated with 40 Gy/15F due to patient choice, this patient is included in 40 Gy/15F group for all subsequent analyses.
Includes one patient randomised to receive 26 Gy/5F who was treated with 40 Gy/15F due to coverage issues, this patient is included in 40 Gy/15F group for all subsequent analyses.
Patient refused any radiotherapy after randomisation.
Patient withdrew consent prior to radiotherapy.
Treatment duration for 40 Gy/15F patients with no boost is 19 days if it starts on a Monday and 21 days if it starts Tuesday to Friday. 27 Gy/5F and 26 Gy/5F patients have 5 days treatment if it starts on a Monday and 7 days if it starts Tuesday to Friday.
One patient randomised to 40 Gy/15F who chose to discontinue radiotherapy after receiving 32 Gy/12F.