Table 1.
Patient and tumor characteristics for the modified intention-to-treat population
| Characteristic | LET (n = 66) mean ± SD or n and % | LET + ZOL (n = 65) mean ± SD or n and % | Total (n = 131) mean ± SD or n and % |
|---|---|---|---|
| Age (years) |
|
|
|
| Mean ± SD |
70.6 ± 8.3 |
71.1 ± 9.1 |
70.8 ± 8.7 |
| Median (range) |
71.0 (54.0–89.0) |
70.0 (54.0–88.0) |
71.0 (54.0–89.0) |
| Height (cm) |
|
|
|
| Mean ± SD |
162.3 ± 6.7 |
162.5 ± 7.0 |
162.4 ± 6.8 |
| Median (range) |
163 (150–185) |
163 (144–180) |
163 (144–185) |
| Body weight (kg) |
|
|
|
| Mean ± SD |
70.7 ± 12.9 |
71.6 ± 16.9 |
71.2 ± 15.0 |
| Median (range) |
69.0 (47.0–114.0) |
70.0 (41.0–150.0) |
69.2 (41.0–150.0) |
| BMI (kg/m2) |
|
|
|
| Mean ± SD |
26.9 ± 4.8 |
27.0 ± 5.8 |
26.9 ± 5.3 |
| Median (range) |
26.3 (17.0–40.4) |
26.2 (16.6–55.1) |
26.2 (16.6–55.1) |
| Postmenopausal state: yes |
65 (100.0) |
66 (100.0) |
131 (100.0) |
| Age group |
|
|
|
| < 65 years |
15 (22.7) |
16 (24.6) |
31 (23.7) |
| ≥ 65 years |
51 (77.3) |
49 (75.4) |
100 (76.3) |
| Ethnicity: Caucasian |
65 (100.0) |
66 (100.0) |
131 (100.0) |
| Histological type |
|
|
|
| Invasive ductal |
44 (66.7) |
48 (73.8) |
92 (70.2) |
| Invasive lobular |
12 (18.2) |
8 (12.3) |
20 (15.3) |
| Invasive ductal and lobular |
2 (3.0) |
3 (4.6) |
5 (3.8) |
| Other |
8 (12.1) |
6 (9.2) |
14 (10.7) |
| Grading |
|
|
|
| G1 |
10 (15.2) |
10 (15.4) |
20 (15.3) |
| G2 |
47 (71.2) |
46 (70.8) |
93 (71.0) |
| G3 |
9 (13.6) |
8 (12.3) |
17 (13.0) |
| GX |
0 (0.0) |
1 (1.5) |
1 (0.8) |
| T staging |
|
|
|
| T in situ |
1 (1.5) |
0 (0.0) |
1 (0.8) |
| T1 |
6 (9.1) |
5 (7.9) |
11 (8.5) |
| T2 |
48 (72.7) |
40 (63.5) |
88 (68.2) |
| T3 |
8 (12.1) |
8 (12.7) |
16 (12.4) |
| T4 |
3 (4.5) |
10 (15.9) |
13 (10.1) |
| Data lacking |
0 |
2 |
2 |
| N staging |
|
|
|
| 0 |
44 (66.7) |
36 (55.4) |
80 (61.1) |
| 1 |
20 (30.3) |
27 (41.5) |
47 (36.0) |
| 2 |
1 (1.5) |
0 (0.0) |
1 (0.8) |
| X |
1 (1.5) |
2 (3.1) |
3 (2.3) |
| M staging |
|
|
|
| 0 |
65 (98.5) |
65 (100) |
130 (99.2) |
| X |
1 (1.5) |
0 (0) |
1 (0.8) |
| Data lacking |
0 |
|
|
| Estrogen receptor status |
|
|
|
| Negative |
2 (3.0) |
2 (3.1) |
4 (3.1) |
| Positive |
64 (97.0) |
63 (96.9) |
127 (96.9) |
| Progesterone receptor status |
|
|
|
| Negative |
7 (10.6) |
6 (9.2) |
13 (9.9) |
| Positive |
59 (89.4) |
59 (90.8) |
118 (90.1) |
| ECOG performance status |
|
|
|
| 0 |
42 (63.6) |
38 (58.5) |
80 (61.1) |
| 1 |
20 (30.3) |
24 (36.9) |
44 (33.6) |
| 2 |
4 (6.1) |
3 (4.6) |
7 (5.3) |
| 3 | 0 (0) | 0 (0.0) | 0 (0) |
BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; LET, letrozole alone; LET + ZOL, letrozole plus zoledronic acid; SD, standard deviation.