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.

From: New clinical and biological insights from the international TARGIT-A randomised trial of targeted intraoperative radiotherapy during lumpectomy for breast cancer

   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)
  1. LRFS local recurrence-free survival.
  2. 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.