Table 1. Patient and Tumor Characteristics.
| Characteristic | No. (%)a | P valueb | |
|---|---|---|---|
| Delayed TARGIT-IORT (n = 581) | EBRT (n = 572) | ||
| Age, y | |||
| ≤50 | 30 (5.2) | 23 (4.02) | .54 |
| 51-60 | 166 (28.6) | 171 (29.9) | |
| 61-70 | 302 (52.0) | 284 (49.7) | |
| >70 | 83 (14.3) | 94 (16.4) | |
| Pathologic tumor size, mm | |||
| ≤10 | 294 (51.0) | 290 (51.8) | .79 |
| 11-20 | 249 (43.2) | 243 (43.4) | |
| >20 | 33 (5.7) | 27 (4.8) | |
| Unknown | 5 (0.9) | 12 (2.1) | |
| Grade | |||
| 1 | 305 (56.5) | 339 (63.8) | .06 |
| 2 | 204 (37.8) | 159 (29.9) | |
| 3 | 31 (5.7) | 33 (6.2) | |
| Unknown | 41 (7.1) | 41 (7.2) | |
| Margin | |||
| Free | 539 (92.9) | 520 (92.4) | .46 |
| DCIS only | 16 (2.8) | 18 (3.2) | |
| Invasive | 25 (4.3) | 25 (4.5) | |
| Unknown | 1 (0.2) | 9 (1.6) | |
| Lymphovascular invasion | |||
| Absent | 536 (94.7) | 533 (96.6) | .13 |
| Present | 30 (5.3) | 19 (3.4) | |
| Unknown | 15 (2.6) | 20 (3.5) | |
| Lymph nodes involved | |||
| 0 | 543 (93.6) | 537 (95.2) | .39 |
| 1-3 | 34 (5.9) | 26 (4.6) | |
| >3 | 3 (0.5) | 1 (0.2) | |
| Unknown | 1 (0.2) | 8 (1.4) | |
| ER status | |||
| Positive | 569 (98.3) | 550 (97.9) | .62 |
| Negative | 10 (1.7) | 12 (2.1) | |
| Unknown | 2 (0.3) | 10 (1.7) | |
| PgR status | |||
| Positive | 440 (81.8) | 423 (82.0) | .94 |
| Negative | 98 (18.2) | 93 (18.0) | |
| Unknown | 43 (7.4) | 56 (9.8) | |
| ERBB2 status | |||
| Positive | 30 (5.4) | 33 (6.0) | .65 |
| Negative | 526 (94.6) | 515 (94.0) | |
| Unknown | 25 (4.3) | 24 (4.2) | |
| Method of presentation | |||
| Screen detected | 420 (73.6) | 395 (70.5) | .26 |
| Symptomatic | 151 (26.4) | 165 (29.5) | |
| Unknown | 10 (1.7) | 12 (2.1) | |
| Endocrine therapy | |||
| Received | 336 (58.0) | 334 (59.4) | .63 |
| Did not receive | 243 (42.0) | 228 (40.6) | |
| Unknown | 2 (0.3) | 10 (1.8) | |
| Chemotherapy | |||
| Received | 26 (4.5) | 14 (2.5) | .07 |
| Did not receive | 553 (95.5) | 546 (97.5) | |
| Unknown | 2 (0.3) | 12 (2.1) | |
Abbreviations: DCIS, ductal carcinoma in situ; EBRT, whole-breast external beam radiotherapy; ER, estrogen receptor; PgR, progesterone receptor; TARGIT-IORT, targeted intraoperative radiotherapy.
a
For percentage calculation, the denominator for unknown percentages is the total number randomized (581 and 572) and the denominator for each category is the total number of known cases.
b
P values are given for differences between TARGIT-IORT and EBRT, calculated using a χ2 test for known values.