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The status of tumor-infiltrating lymphocytes (TILs) has been recently proposed to predict clinical outcome of patients with breast cancer. We therefore studied the prognostic significance of CD8 +  TILs and FOXP3 +  TILs in residual tumors after neoadjuvant chemotherapy (NAC) and the alterations in these parameters before and after NAC in patients with triple-negative breast cancer (TNBC).    Methods  One hundred thirty-one TNBC patients who received NAC at three institutions were examined. CD8 +  TIL and FOXP3 +  TIL in residual tumors and biopsy specimens were evaluated by double-staining immunohistochemistry. The CD8 +  TIL and FOXP3 +  TIL status of the residual tumors was assessed, and the rates of their changes before and after NAC were calculated.    Results  TNBC patients with high CD8 +  TIL levels or a high CD8/FOXP3 ratio in residual tumors had significantly better recurrence-free survival (RFS) and breast cancer-specific survival (BCSS) than patients with low values of these parameters. In multivariate analyses, CD8 +  TIL exhibited strong prognostic significance for RFS, with a hazard ratio (HR) of 3.09 (95 % confidence interval (CI) 1.537–6.614,  P =0.0013). The CD8/FOXP3 ratio was also significantly correlated with RFS (HR=2.07, 95 % CI 1.029–4.436,  P =0.0412). TNBC with larger residual tumor size and positive lymph node status, which are known prognostic factors, was independently associated with worse RFS ( P =0.0064 and  P =0.0015, respectively). High CD8 +  TIL levels were a markedly powerful indicator of improved BCSS, with an HR of 3.59 (95 % CI 1.499–9.581,  P =0.0036). Nodal status was also associated with BCSS ( P =0.0024). TNBC with a high rate of CD8 +  TIL changes was associated with significantly better RFS compared with the low group ( P =0.011). Higher rates of changes in the CD8/FOXP3 ratio were significantly correlated with both better RFS and BCSS compared with lower rates ( P =0.011 and  P =0.023, respectively).    Conclusions  This is the first study to demonstrate that high CD8 +  TIL and a high CD8/FOXP3 ratio in residual tumors and increment of these parameters following NAC and accurately predict improved prognosis in TNBC patients with non-pathological complete response following NAC. These parameters could serve as a surrogate one for adjuvant treatment in patients with residual disease in the neoadjuvant setting.    Electronic supplementary material  The online version of this article (doi:10.1186/s13058-015-0632-x) contains supplementary material, which is available to authorized users.

breast cancer research

Prognostic significance of tumor-infiltrating CD8+ and FOXP3+ lymphocytes in residual tumors and alterations in these parameters after neoadjuvant chemotherapy in triple-negative breast cancer: a retrospective multicenter study