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Background  Tumour-infiltrating lymphocytes (TILs) are of important prognostic and predictive value in human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) and triple-negative breast cancer (TNBC), but their clinical relevance in oestrogen receptor-positive/HER2-negative (ER+/HER2−) remains unknown. The primary study aim was to analyse the prognostic effect of TILs on the BC-free interval (BCFi) in premenopausal patients stratified by BC subtypes. The secondary aim was to investigate if TILs are predictive of tamoxifen (TAM) benefit.    Methods  Archival tissues from primary breast tumours were collected from patients from the SBII:2pre trial, in which 564 premenopausal women were randomised to 2 years of adjuvant TAM or no systemic treatment, regardless of hormone receptor status. TILs were scored on whole tissue sections from 447 patients with available ER status. Tumours were divided into ER+/HER2−, HER2+ and TNBC subtypes by immunohistochemistry and in situ hybridisation. The prognostic value of TILs was analysed in systemically untreated patients ( n  = 221); the predictive information was investigated in the ER+ subgroup ( n  = 321) by cumulative incidence curves and Cox regression analyses. The median follow-up was 28 years.    Results  High (≥ 50%) infiltration of TILs was a favourable prognostic factor in terms of BCFi (univariable analysis: hazard ratio BCFi  (HR BCFi ) 0.40; 95% confidence interval (CI) 0.22–0.71;  P  = 0.002). Similar effects were observed across all BC subtypes. The effect of adjuvant TAM was stronger in patients with ER+ tumours and TILs < 50% (HR BCFi  0.63; 95% CI 0.47–0.84;  P  = 0.002) than in patients with high immune infiltration (≥ 50%) (HR BCFi  0.84; 95% CI (0.24–2.86);  P  = 0.77). However, evidence for differential effects of TAM in categories of TILs, i.e. interaction, was weak.    Conclusions  We demonstrate a long-term favourable prognostic value of high infiltration of TILs in a cohort of premenopausal BC patients and the positive prognostic effect was extended to the ER+/HER2− subgroup. A beneficial effect of TAM in ER+ patients was observed in patients with tumours of low TIL infiltration, but evidence for a treatment predictive effect was weak.    Trial registration  This trial is registered in the ISRCTN database, trial ID:  ISRCTN12474687 .    Supplementary information  The online version contains supplementary material available at 10.1186/s13058-020-01364-w.

breast cancer research

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