A Prospective Double-Blinded Randomized Controlled Trial Comparing the Intraoperative Injection of Technetium Tc 99m Tilmanocept with Technetium Tc 99m Sulfur Colloid in Breast Cancer Lymphatic Mapping
Table 1
Demographic and clinical data.
Tilmanocept (n = 48)
TSC 2 (n = 38)
Total (n = 86)
value
Age (years)
Mean±SD
66.3 ± 10.1
66.0 ± 10.7
66.2 ± 10.3
0.87
Range
(39.0–82.9)
(38.5–87.1)
(38.5–87.1)
BMI (kg/m2)
Mean± SD
30.7 ± 7.8
30.9 ± 7.5
30.8 ± 7.6
0.91
Range
(21.0–54.9)
(19.1–50.7)
(19.1–54.9)
Tumor size (cm)
Mean± SD
1.1 ± 1.0
1.2 ± 0.8
1.1 ± 0.9
0.69
Range
(0.1–4.7)
(0.1–3.5)
(0.1–4.7)
Preoperative histology
Ductal
37 (80.4%)
31 (83.8%)
68 (81.6%)
0.91
Lobular
5 (10.9%)
3 (8.1%)
8 (9.6%)
Mixed
4 (8.7%)
3 (8.1%)
7 (8.4%)
Tumor grade
1
13 (27.7%)
11 (29.7%)
24 (28.6%)
0.63
2
26 (55.3%)
17 (46.0%)
43 (51.2%)
3
8 (17.0%)
9 (24.3%)
17 (20.2%)
LVI
No
47 (97.9)
37 (97.4)
84 (97.7)
0.81
YES
1 (2.1)
1 (2.6)
2 (2.3)
Location
UOQ
28 (58.3)
26 (26.4)
54 (62.8)
0.40
UIQ
12 (25.0)
7 (18.4)
19 (22.1)
LOQ
5 (10.4)
1 (2.6)
6 (7.0)
LIQ
1 (2.1)
3 (7.9)
4 (4.7)
Subareolar
2 (4.2)
1 (2.60
3 (3.5)
T stage
T0
1 (2.1)
1 (2.8)
2 (2.4)
1.0
T1
40 (85.1)
30 (83.3)
70 (84.3)
T2
6 (12.8)
5 (13.9)
11 (13.3)
N Stage
SLN neg
46 (95.83)
34 (89.47)
48 (55.81)
0.40
SLN POS
2 (4.17)
4 (10.53)
38 (44.19)
ER
+
45 (93.8)
33 (86.8)
78 (90.7)
0.46
−
3 (6.2)
5 (13.2)
8 (9.3)
PR
+
42 (87.5)
34 (89.5)
76 (88.4)
0.78
−
6 (12.5)
4 (10.5)
10 (11.6)
HER2
+
2 (4.2)
3 (8.1)
5 (5.9)
0.65
−
46 (95.8)
34 (91.9)
80 (94.1)
SD, standard deviation; BMI, body mass index; LVI, lymphovascular invasion; UOQ, upper outer quadrant; UIQ, upper inner quadrant; LOQ, lower outer quadrant; LIQ, lower inner quadrant; ER, estrogen receptor; PR, progesterone receptor; HER2, human epidermal growth factor receptor 2.
