Stromal Tumor-infiltrating Lymphocytes in NRG Oncology/NSABP B-31 Adjuvant Trial for Early-Stage HER2-Positive Breast Cancer

Rim S. Kim, Nan Song, Patrick G. Gavin, Roberto Salgado, Hanna Bandos, Zuzana Kos, Giuseppe Floris, Gert G.G.M.Van Den Eynden, Sunil Badve, Sandra Demaria, Priya Rastogi, Louis Fehrenbacher, Eleftherios P. Mamounas, Sandra M. Swain, D. Lawrence Wickerham, Joseph P. Costantino, Soonmyung Paik, Norman Wolmark, Charles E. Geyer, Peter C. LucasKatherine L. Pogue-Geile

Research output: Contribution to journalArticlepeer-review

27 Scopus citations


We retrospectively assessed association of stromal tumor-infiltrating lymphocytes (sTILs) with clinical outcomes and molecular variables reportedly predictive of trastuzumab-benefit in National Surgical Adjuvant Breast and Bowel Project B-31 (N = 2130). sTILs were assessed in 1581 eligible B-31 cases utilizing all available hematoxylin and eosin slides. Mean concordance between main reviewer and six other pathologists was 90.8% in 100 cases. Cox regressions were used to calculate hazard ratios (HRs). In chemotherapy and trastuzumab added to chemotherapy arms, increases in sTILs, as a semicontinuous variable (combined arms HR = 0.42, 95% confidence interval = 0.27 to 0.64, two-sided P <. 001) or as lymphocyte-predominant breast cancer with more than 50% sTILs (combined arms HR = 0.65, 95% confidence interval = 0.49 to 0.86, two-sided P =. 003) were statistically significantly associated with improved disease-free survival. There was no association of sTILs with trastuzumab benefit. However, higher sTILs were statistically significantly associated with higher trastuzumab benefit groups by 8-gene prediction model (two-sided P <. 001). Neither PIK3CA mutations nor Fc-gamma-receptor polymorphisms were associated with sTILs. sTILs may have utility as a prognostic biomarker identifying HER2-positive early breast cancer at low recurrence risk.

Original languageEnglish (US)
Pages (from-to)867-871
Number of pages5
JournalJournal of the National Cancer Institute
Issue number8
StatePublished - Aug 1 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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