Prognostic value of tumor-infiltrating lymphocytes in patients with early-stage triple-negative breast cancers (TNBC) who did not receive adjuvant chemotherapy: Annals of Oncology

J.H. Park, S.F. Jonas, G. Bataillon, C. Criscitiello, R. Salgado, S. Loi, G. Viale, H.J. Lee, M.V. Dieci, S.-B. Kim, A. Vincent-Salomon, G. Curigliano, F. André, S. Michiels

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Background: Although stromal tumor-infiltrating lymphocytes (sTILs) have been considered an important prognostic factor in early-stage triple-negative breast cancer (TNBC), there have been limited data on their prognostic value in the absence of adjuvant chemotherapy. Patients and methods: A pooled analysis was carried out using four cohorts of TNBC patients not treated with chemotherapy. sTILs were evaluated in the most representative tumoral block of surgical specimens. Cox proportional hazards regression models were used for invasive disease-free survival (iDFS), distant disease-free survival (D-DFS), and overall survival (OS), fitting sTILs as a continuous variable adjusted for clinicopathologic factors. Results: We analyzed individual data of 476 patients from 4 centers diagnosed between 1989 and 2015. Their median age was 64 years. The median tumor size was 1.6 cm and 83% were node-negative. The median level of sTILs was 10% (Q1-Q3, 4%-30%). Higher grade was associated with higher sTILs (P < 10-3). During follow-up, 107 deaths, and 173 and 118 events for iDFS and D-DFS were observed, respectively. In the multivariable analysis, sTILs obtained an independent prognostic value for all end points (likelihood ratio χ2 = 7.14 for iDFS; P < 10-2; χ2 = 9.63 for D-DFS, P < 10-2; χ2 = 5.96 for OS, P = 0.015). Each 10% increment in sTILs corresponded to a hazard ratio of 0.90 [95% confidence interval (CI) 0.82 - 0.97] for iDFS, 0.86 (95% CI 0.77 - 0.95) for D-DFS, and 0.88 (95% CI 0.79 - 0.98) for OS, respectively. In patients with pathological stage I tumors with sTILs ≥30% (n = 74), 5-year iDFS was 91% (95% CI 84% to 96%), D-DFS was 97% (95% CI 93% to 100%), and OS was 98% (95% CI 95% to 100%). Conclusion: sTILs add important prognostic information in systemically untreated early-stage TNBC patients. Notably, sTILs can identify a subset of stage I TNBC patients with an excellent prognosis without adjuvant chemotherapy. © 2019 The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Original languageEnglish
Pages (from-to)1941-1949
Number of pages9
JournalAnn. Oncol.
Issue number12
Publication statusPublished - 2019


  • adjuvant chemotherapy
  • prognosis
  • triple-negative breast cancer
  • tumor-infiltrating lymphocytes
  • doxifluridine
  • adult
  • age
  • aged
  • Article
  • cancer adjuvant therapy
  • cancer grading
  • cancer mortality
  • cancer patient
  • cancer prognosis
  • cancer radiotherapy
  • cancer size
  • cancer staging
  • cancer survival
  • cancer tissue
  • clinical feature
  • cohort analysis
  • confidence interval
  • controlled study
  • data analysis
  • diagnostic value
  • disease association
  • disease free survival
  • distant disease free survival
  • early cancer
  • female
  • follow up
  • hazard ratio
  • histopathology
  • human
  • human tissue
  • major clinical study
  • middle aged
  • multivariate analysis
  • overall survival
  • pooled analysis
  • priority journal
  • prognostic value
  • proportional hazards model
  • regression analysis
  • triple negative breast cancer
  • tumor associated leukocyte


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