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Table 2 Cox regression analyses of BCFi and OS in patients randomised to no adjuvant medical treatment

From: Tumour-infiltrating lymphocytes as a prognostic and tamoxifen predictive marker in premenopausal breast cancer: data from a randomised trial with long-term follow-up

  Univariable Multivariablea
Variable BCFi OS BCFi OS
HR (95% CI); P value
TILs, categoryb
All subtypes (n = 221) (n = 213)
  Low (Ref.) 1.00 1.00 1.00 1.00
  Intermediate 1.10 (0.78–1.54); 0.61 1.26 (0.88–1.80); 0.21 0.61 (0.40–0.93); 0.02c 0.65 (0.41–1.02); 0.06
  High 0.40 (0.22–0.71); 0.002 0.52 (0.29–0.95); 0.03 0.22 (0.11–0.43); < 0.001 0.23 (0.11–0.48); < 0.001
ER+/HER2− (n = 136) (n = 135)
  Low (Ref.) 1.00 1.00 1.00 1.00
  Intermediate 1.02 (0.63–1.64); 0.94 1.02 (0.61–1.71); 0.95 0.69 (0.42–1.15); 0.16 0.65 (0.37–1.15); 0.14
  High 0.40 (0.14–1.09); 0.07 0.55 (0.20–1.52); 0.25 0.20 (0.06–0.60); 0.004 0.30 (0.10–0.96); 0.04
HER2+ (n = 38) (n = 35)
  Low (Ref.) 1.00 1.00 1.00 1.00
  Intermediate 1.47 (0.62–3.49); 0.39 1.07 (0.45–2.56); 0.88 0.47 (0.14–1.60); 0.23 0.38 (0.11–1.31); 0.13
  High 0.28 (0.08–0.97); 0.05 0.27 (0.08–0.96); 0.04 0.06 (0.01–0.56); 0.01 0.05 (0.01–0.39); 0.005
TNBC (n = 47) (n = 43)
  Low (Ref.) 1.00 1.00 1.00 1.00
  Intermediate 0.76 (0.31–1.87); 0.55 1.24 (0.49–3.14); 0.65 0.59 (0.21–1.67); 0.32 1.02 (0.34–3.11); 0.97
  High 0.27 (0.08–0.88); 0.03 0.44 (0.14–1.36); 0.16 0.38 (0.11–1.39); 0.15 0.59 (0.16–2.26); 0.44
Covariables (n = 216–221) (n = 213)
  Age (years)
   < 40 (Ref.) 1.00 1.00 1.00 1.00
   ≥ 40 0.72 (0.49–1.04); 0.08 0.65 (0.44–0.96); 0.03 0.60 (0.40–0.89); 0.01 0.56 (0.37–0.85); 0.006
  Nodal status
   0 (Ref.) 1.00 1.00 1.00 1.00
   1–3 1.31 (0.87–1.96); 0.19 1.59 (1.03–2.47); 0.04 1.21 (0.77–1.91); 0.40 1.69 (1.03–2.77); 0.04
   ≥ 4 2.33 (1.49–3.64); < 0.001 2.81 (1.75–4.52); < 0.001 2.03 (1.25–3.29); 0.004 2.70 (1.58–4.52); < 0.001
  Tumour size (mm)
   ≤ 20 (Ref.) 1.00 1.00 1.00 1.00
   > 20 1.04 (0.75–1.45); 0.80 0.92 (0.66–1.29); 0.63 1.23 (0.86–1.76); 0.25 1.04 (0.72–1.51); 0.84
  Histological grade (NHG)
   1 (Ref.) 1.00 1.00 1.00 1.00
   2 1.51 (0.84–2.72); 0.17 1.34 (0.73–2.45); 0.35 1.36 (0.74–2.48); 0.32 1.13 (0.60–2.11); 0.71
   3 1.82 (1.03–3.23); 0.04 1.96 (1.09–3.54); 0.03 2.70 (1.36–5.33); 0.004 2.25 (1.08–4.66); 0.03
  ER
   Negative (Ref.) 1.00 1.00 1.00 1.00
   Positive 0.94 (0.66–1.34); 0.74 0.69 (0.49–0.99); 0.04 0.41 (0.12–1.36); 0.15 0.37 (0.11–1.27); 0.11
  PR
   Negative (Ref.) 1.00 1.00 1.00 1.00
   Positive 1.06 (0.75–1.49); 0.75 0.80 (0.57–1.14); 0.21 2.38 (0.77–7.30); 0.13 1.76 (0.57–5.48); 0.33
  HER2
   Negative (Ref.) 1.00 1.00 1.00 1.00
   Positive 1.10 (0.72–1.69); 0.65 1.26 (0.81–1.94); 0.30 1.05 (0.66–1.67); 0.85 1.11 (0.68–1.82); 0.67
  LVI
   Absent (Ref.) 1.00 1.00 1.00 1.00
   Present 1.49 (1.08–2.05); 0.02 1.26 (0.90–1.76); 0.18 1.39 (0.99–1.95); 0.06 1.05 (0.73–1.51); 0.78
  1. All analyses were stratified by study region
  2. Abbreviations: BCFi breast cancer free-interval, CI confidence interval, ER oestrogen receptor, HER2 human epidermal growth factor receptor 2, HR hazard ratio, LVI lymphovascular invasion, NHG Nottingham histological grade, OS overall survival, PR progesterone receptor, TILs tumour-infiltrating lymphocytes, TNBC triple-negative breast cancer
  3. aThe following variables were included in multivariable analysis: age (≥ 40 vs. < 40 years), nodal status (0 vs.1–3 vs. ≥ 4), tumour size (> 20 mm vs. ≤ 20 mm), histological grade (1 vs. 2 vs. 3), ER (positive vs. negative), PR (positive vs. negative), HER2 (positive vs. negative), LVI (present vs. absent) and TILs (high vs. intermediate vs. low)
  4. bTILs were categorised as low: < 10%, intermediate: 10–49% and high: ≥ 50%
  5. cA series of multivariable analyses including TILs and only one additional prognostic variable at a time revealed that the univariable effect of intermediate vs. low TILs on outcome was mainly confounded by NHG. In the prognostic cohort, 65% of the patients with intermediate TILs had NHG 3 tumours