Table 1.
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.
One patient with node negative disease was classified as ineligible. She was treated per protocol and thus is included in the safety analyses.
Reasons for no RT include patient refusal and disease recurrence.
Grade was unknown in four and three patients on each arm respectively