Table 1.
Patient demographics and disease characteristics
| Arm A (N = 103) | Arm B (N = 120) | Total (N = 223) | |
| n (%) | n (%) | n (%) | |
| Median age (years) | 50 (33–76) | 50 (27–76) | 50 (27–76) |
| ECOG PS 0 | 96 (93) | 102 (85) | 198 (89) |
| Median tumor size (cm) | 2.4 (0.5–9.0) | 2.3 (0.2–12.3) | 2.3 (0.2–12.3) |
| Median number of involved lymph nodesa | 3 (0–23) | 4 (1–53) | 3 (0–53) |
| Surgery and radiation | |||
| BCSb | 1 (1) | 1 (1) | 2 (1) |
| BCS + RT | 33 (32) | 46 (38) | 79 (35) |
| Mastectomy | 22 (21) | 23 (19) | 45 (20) |
| Mastectomy + RT | 47 (46) | 50 (42) | 97 (43) |
| Histological gradec | |||
| I | 8 (8) | 12 (10) | 20 (9) |
| II | 45 (46) | 49 (42) | 94 (44) |
| III | 46 (46) | 56 (48) | 102 (47) |
| ER and PgR status | |||
| ER−/PgR− | 24 (23) | 33 (28) | 57 (26) |
| ER+ and/or PgR+ | 79 (77) | 87 (73) | 166 (74) |
Includes all treated patients. BCS, breast-conserving surgery; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; PgR, progesterone receptor; RT, radiation therapy.
a
One patient with node negative disease was classified as ineligible. She was treated per protocol and thus is included in the safety analyses.
b
Reasons for no RT include patient refusal and disease recurrence.
c
Grade was unknown in four and three patients on each arm respectively