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

Table 3 Predictive value of TILs for TAM response with respect to breast cancer-free interval (ER-positive cohort)

	Univariable (n = 321)		Multivariable^a (n = 277)
Variable	HR (95% CI)	P value	HR (95% CI)	P value
TAM vs. control in TILs < 50%	0.63 (0.47–0.84)	0.002	0.60 (0.43–0.83)	0.002
TAM vs. control in TILs ≥ 50%	0.84 (0.24–2.86)	0.77	0.90 (0.22–3.64)	0.88
Interaction TILs × TAM (HR ratio)	0.75 (0.21–2.65)	0.65	0.67 (0.16–2.83)	0.59

Separate effects of tamoxifen in the two TIL groups were estimated by changing the reference group for TILs in the Cox model with main effects for treatment and TILs and an interaction effect. The HR for interaction (0.75) is the ratio between the tamoxifen effects in low and high TILs, i.e. 0.63/0.84. All analyses were stratified by study region
Abbreviations: ER oestrogen receptor, CI confidence interval, HR hazard ratio, TAM tamoxifen, TILs tumour-infiltrating lymphocytes
^aThe following variables were included in the 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) and LVI (present vs. absent)

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