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Table 3 Logistic and Cox regression models to analyze the association between TILs density and PD-L1 expression (CPS score) with ORR (CR + PR), CBR (CR + PR + SD of > 6 months), and PFS

From: Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015–04 (PANGEA-Breast) study

 

ORR

p-value

Odds ratio (95% CI)

CBR

p-value

Odds ratio (95% CI)

PFS

p-value

Hazard ratio (95% CI)

TILs

(n = 30)

Cut-Off (n, %)

≥5% (24, 80%)

<5% (6, 20%)

NA

0.556

0.47

(0.04, 5.90)

0.534

1.37

(0.51, 3.64)

≥10% (13, 43%)

<10% (17, 57%)

0.773

1.36

(0.17, 11.23)

0.554

0.50

(0.05, 4.98)

0.311

1.51

(0.68, 3.36)

≥20% (6, 20%)

<20% (24, 80%)

0.789

1.40

(0.12, 16.46)

0.699

0.56

(0.03, 10.93)

0.073

2.50

(0.92, 6.82)

PD-L1 Score (n = 29)

Cut-Off (n, %)

CPS ≥1 (14, 48%)

CPS <1 (15, 52%)

0.941

1.08

(0.13, 8.95)

0.668

1.60

(0.19, 13.69)

0.038

2.56

(1.05, 6.23)

CPS ≥5 (11, 38%)

CPS <5 (18, 62%)

0.571

0.50

(0.05, 5.51)

0.482

2.50

(0.19, 32.19)

0.053

2.34

(0.99, 5.53)

CPS ≥10 (8, 28%)

CPS <10 (21, 72%)

0.901

0.86

(0.08, 9.69)

0.793

1.43

(0.10, 20.44)

0.173

1.84

(0.77, 4.42)

CPS ≥20 (7, 24%)

CPS <20 (22, 76%)

0.965

1.06

(0.09, 12.14)

0.793

1.43

(0.10, 20.44)

0.072

2.36

(0.93, 6.01)

  1. Abbreviations: TILs Tumor-infiltrating lymphocytes, ORR Objective response rate, CBR Clinical benefit rate, PFS Progression-free survival, CPS Combined positive score, CR Complete response, PR Partial response, SD Stable disease, CI Confidence interval