Table 1 Demographic and baseline clinical characteristics
Characteristic | Level | N (%) |
|---|---|---|
Age (years; median, range) | Level 1 | 50.6 (50.1–51.5) |
Level 2 | 59.5 (53.4–69.2) | |
Total | 57.5 (50.1–69.2) | |
ECOG | Level 1 | 0: 3/3 (100%) |
Level 2 | 0: 16/16 (100%) | |
Total | 0: 19/19 (100%) | |
Tumor size | Level 1 | T1: 3/3 (100%) |
Level 2 | T1: 8/16 (50%); T2: 8/16 (50%) | |
Total | T1: 11/19 (58%); T2: 8/19 (42%) | |
Nodal status | Level 1 | N0: 2/3 (66.6%); N1: 1/3 (33.3%) |
Level 2 | N0: 9/16 (56.2%); N1: 6/16 (37.5%); N2: 1/16 (6.2%) | |
Total | N0: 11/19 (57.9%), N1: 7/19 (36.8%); N2: 1/19 (5.3%) | |
ER and/or PR > 5% | Level 1 | 3/3 (100%) |
Level 2 | 16/16 (100%) | |
Total | 19/19 (100%) | |
HER2 | Level 1 | 0/3 (0%) |
Level 2 | 0/16 (0%) | |
Total | 0/19 (0%) | |
Grade | Level 1 | G1: 3/3 (100%) |
Level 2 | G1: 9/16 (56%); G2: 6/16 (38%); G3: 1/16 (6%) | |
Total | G1: 12/19 (64%); G2: 6/19 (31%); G3: 1/19 (5%) | |
Ki67 (average, range) | Level 1 | 9% (3–15%) |
Level 2 | 11.5% (2–43%) | |
Total | 11.1% (2–43%) | |
Adjuvant/neoadjuvant chemotherapy prior to study registration | Level 1 | 0/3 (0%) |
Level 2 | Anthracyclines plus taxanes: 5/16 (31.3%); taxanes only: 1/16 (6.2%); none: 10/16 (62.5%) | |
Total | Anthracyclines plus taxanes: 5/19 (26.4%); taxanes only: 1/19 (5.3%); none: 13/19 (68.3%) | |
Letrozole time (days) at study registration (average, range)* | Level 1 | 134 (131–140) |
Level 2 | 117 (29–220)* | |
Total | 119 (29–220)* |