Table 2.
Total number of patients, total numbers in each arm and proportion of patients receiving supplemental EBRT among those randomised to receive TARGIT-IORT.
| Allocated TARGIT-IORT | Allocated EBRT | |||||
|---|---|---|---|---|---|---|
| Total no. | Characteristics of 1140 patients in the TARGIT arm | Characteristics of 241 patients allocated TARGIT who received supplemental EBRT | Characteristics of 899 patients allocated TARGIT who did not receive supplemental EBRT | Proportion (%) in TARGIT arm receiving supplemental EBRT | Characteristics of 1158 patients in the EBRT arm | |
| Overall | 2298 | 1140 | 241 | 899 | 1158 | |
| Age (years) | ||||||
| ≤50 | 216 | 117 | 24 | 93 | 20.5% | 99 |
| 51–60 | 737 | 362 | 81 | 281 | 22.4% | 375 |
| 61–70 | 1005 | 481 | 100 | 381 | 20.8% | 524 |
| >70 | 340 | 180 | 36 | 144 | 20.0% | 160 |
| Tumour size | ||||||
| ≤10 mm | 739 | 369 | 58 | 311 | 15.7% | 370 |
| 11–20 mm | 1128 | 571 | 121 | 450 | 21.2% | 557 |
| >20 mm | 366 | 176 | 59 | 117 | 33.5% | 190 |
| Grade | ||||||
| Grade 1 | 561 | 275 | 42 | 233 | 15.3% | 286 |
| Grade 2 | 1236 | 621 | 148 | 473 | 23.8% | 615 |
| Grade 3 | 443 | 226 | 50 | 176 | 22.1% | 217 |
| Margins | ||||||
| Negative | 2000 | 1007 | 191 | 816 | 19.0% | 993 |
| Positive | 252 | 119 | 49 | 70 | 41.2% | 133 |
| Invasive lobular carcinoma at final histology | ||||||
| Negative | 2112 | 1053 | 208 | 845 | 19.8% | 1059 |
| Positive | 120 | 58 | 30 | 28 | 51.7% | 62 |
| Lymphovascular invasion | ||||||
| Absent | 1877 | 931 | 172 | 759 | 18.5% | 946 |
| Present | 357 | 185 | 63 | 122 | 34.1% | 172 |
| Nodal status | ||||||
| Negative | 1765 | 872 | 147 | 725 | 16.9% | 893 |
| 1–3 nodes | 418 | 213 | 76 | 137 | 35.7% | 205 |
| 4 or more | 70 | 41 | 17 | 24 | 41.5% | 29 |
| ER status | ||||||
| Positive | 2035 | 1005 | 218 | 787 | 21.7% | 1030 |
| Negative | 207 | 114 | 20 | 94 | 17.5% | 93 |
| PgR status | ||||||
| Positive | 1816 | 895 | 191 | 704 | 21.3% | 921 |
| Negative | 413 | 220 | 47 | 173 | 21.4% | 193 |
| HER2 status | ||||||
| Positive | 320 | 156 | 41 | 115 | 26.3% | 164 |
| Negative | 1845 | 920 | 188 | 732 | 20.4% | 925 |
| Method of presentation | ||||||
| Screen-detected | 1494 | 739 | 148 | 591 | 20.0% | 755 |
| Symptomatic | 719 | 364 | 86 | 278 | 23.6% | 355 |
| Total number | 1140 | 241 | 899 | – | 1158 | |
| Local recurrences (invasive/DCIS/unknown) cumulative incidence |
15/6/3 1.3%/0.5%/0.3% |
2/1/0 0.8%/0.4%/0% |
13/5/3 1.4%/0.6%/0.3% |
– |
9/1/1 0.8%/0.1%/0.1% |
|
| Cumulative incidence of any type of local recurrence |
24 2.11% |
3 1.24% |
21 2.35% |
11 0.95% |
||
| Deaths (cumulative incidence) | 42 (3.7%) | 14 (5.8%) | 28 (3.1%) | – | 56 (4.8%) | |
| Alive without local recurrence | 94.15% (92.6–95.4) | 93.46% (89.4–96.0) | 94.33% (92.6–95.7) | – | 94.19% (92.6–94.4) | |
LRFS local recurrence-free survival.
Of the 1140 randomised to TARGIT-IORT, 241 received supplemental EBRT after TARGIT-IORT during lumpectomy. The local recurrence and mortality and local control values are at complete follow-up of 5 years.