Table 4 Univariate and multivariate analysis on increase in TILs ≥ 10% as response variable

Treatment arm

 Control

21

16 (76.2%)

5 (23.8%)

1

Ref

Ref

Ref

 Experimental

37

28 (75.7%)

9 (24.3%)

–

1.03 [0.29;3.60]

0.978

0.68

Ki67

 ≤ 15%

21

19 (90.5%)

2 (9.52%)

0.075

Ref

Ref

Ref

 16–29%

23

17 (73.9%)

6 (26.1%)

–

3.35 [0.60;18.9]

0.183

1.55

 ≥ 30%

14

8 (57.1%)

6 (42.9%)

–

7.12 [1.18;43.1]

0.033

2.81

Menopausal status

 Pre-menopausal

27

19 (70.4%)

8 (29.6%)

0.545

Ref

Ref

Ref

 Post-menopausal

31

25 (80.6%)

6 (19.4%)

–

0.57 [0.17;1.92]

0.384

0.21

Surrogate molecular subtype

 Luminal A-like

27

24 (88.9%)

3 (11.1%)

0.089

Ref

Ref

Ref

 Luminal B-like

21

14 (66.7%)

7 (33.3%)

–

4.00 [0.89;18.0]

0.076

1.4

 TNBC

10

6 (60.0%)

4 (40.0%)

–

5.33 [0.93;30.5]

0.078

0.13

Histological Subtype

 Carcinoma NOS (ductal)

14

11 (78.6%)

3 (21.4%)

0.742

Ref

Ref

Ref

 Invasive lobular carcinoma

37

27 (73.0%)

10 (27.0%)

–

1.36 [0.31;5.90]

0.717

1.02

 Others

7

6 (85.7%)

1 (14.3%)

–

0.61 [0.05;7.24]

0.76

0.01

Histological grade

 G1

17

15 (88.2%)

2 (11.8%)

0.061

Ref

Ref

Ref

 G2

34

26 (76.5%)

8 (23.5%)

–

2.31 [0.43;12.3]

0.353

0.34

 G3

7

3 (42.9%)

4 (57.1%)

–

10.0 [1.22;81.8]

0.041

1.5

RANK/ RANKL H-Scores (Median [1Q; 3Q])*

 RANK TUMOR

55

0.00 [0.00;2.00]

7.50 [0.00;34.8]

0.012

1.05 [1.01;1.09]

0.026

1.15

 RANKL TUMOR

55

0.00 [0.00;2.00]

0.00 [0.00;4.50]

0.612

1.00 [0.98;1.02]

0.821

0.99

 RANK STROMA

56

0.00 [0.00;3.00]

4.50 [0.00;10.5]

0.147

1.06 [0.96;1.17]

0.225

0.99

 RANKL STROMA

55

0.00 [0.00;2.00]

1.00 [0.00;8.00]

0.115

1.08 [0.96;1.22]

0.182

1.11