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Proffered paper session - Breast cancer, early stage

1728 - Tumor-infiltrating lymphocytes (TILs) as an independent prognostic factor for early HER2+ breast cancer patients treated with adjuvant chemotherapy and trastuzumab in the randomized ShortHER trial.


19 Oct 2018


Proffered paper session - Breast cancer, early stage


Cytotoxic Therapy

Tumour Site

Breast Cancer


Maria Vittoria Dieci


Annals of Oncology (2018) 29 (suppl_8): viii58-viii86. 10.1093/annonc/mdy270


M.V. Dieci1, P.F. Conte1, G. Bisagni2, A.A. Brandes3, A. Frassoldati4, L. Cavanna5, A. Musolino6, F. Giotta7, A. Rimanti8, O. Garrone9, E. Bertone10, K. Cagossi11, S. Sarti12, A. Ferro13, C. Omarini14, A. Maiorana15, E. Orvieto16, M. Sanders17, R. D'Amico18, V. Guarneri1

Author affiliations

  • 1 Department Of Surgery, Oncology And Gastroenterology, University of Padova, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 2 Medical Oncology, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
  • 3 Medical Oncology, Ospedale Bellaria, 40139 - Bologna/IT
  • 4 Clinical Oncology, Azienda Ospedaliera di Ferrara St. Anna, 44100 - Ferrara/IT
  • 5 Oncology Department, Azienda Ospedaliera Piacenza, 29121 - Piacenza/IT
  • 6 Medical Oncology, Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 7 Medical Oncology, Istituto Oncologico Bari, 70126 - Bari/IT
  • 8 Oncology, Azienda Ospedaliera di Mantova, 43126 - Mantova/IT
  • 9 Medical Oncology, Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 10 Medical Oncology, S. Anna Hospital, Torino/IT
  • 11 Medical Oncology, Ramazzini Hospital, Carpi/IT
  • 12 Medical Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 13 Medical Oncology, Ospedale Santa Chiara, 38122 - Trento/IT
  • 14 Medical And Surgical Sciences For Children & Adults, Università degli studi di Modena e Reggio Emilia, 41124 - Modena/IT
  • 15 Diagnostic And Clinical Medicine And Of Public Health, University of Modena and Reggio Emilia, Modena/IT
  • 16 Pathology, Ulss 5 Polesana, Rovigo/IT
  • 17 Pathology, Microbiology, And Immunology, Vanderbilt University Medical Center, Nashville/US
  • 18 Department Of Diagnostic And Clinical Medicine And Public Health, University Hospital of Modena and Reggio Emilia, Modena/IT


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Abstract 1728


TILs are an established prognostic factor for triple negative breast cancer. We investigated the prognostic role of TILs for HER2+ early breast cancer patients enrolled in the prospective ShortHER trial.


The ShortHER study randomized 1254 patients with HER2+ early breast cancer to receive 9 weeks vs 1 year of adjuvant trastuzumab combined with chemotherapy (Conte, ASCO 2017). TILs were assessed for 855 cases on centralized HES slides according to recommendations (Salgado, Ann Oncol 2015). Metastasis-free survival (MFS) was calculated from randomization to distant disease recurrence or death. Median follow up was 72 months.


Median TILs was 5% (Q1-Q3 1%-15%). Higher TILs were associated with hormone receptor-negative status (p < 0.001) and age <60 years (p = 0.008). There was no association with stage and PIK3CA mutation. Increased TILs were associated with better MFS (HR 0.69, 95%CI 0.54-0.88 for each 10% TILs increment, p = 0.003). 5-yrs MFS rates were 91%, 94% and 100% for TILs<20%, TILs > =20% & <50% and TILs > =50% (p = 0.013). Multivariable cox models confirmed TILs as independent prognostic factor (Table).Table: 186O

FactorsAll patientsHormone Receptor negHormone Receptor pos
HR (95% CI)pHR (95% CI)pHR (95% CI)p
TILs 10% increase0.67 (0.52-0.86)0.0010.72 (0.53-0.97)0.0310.57 (0.36-0.91)0.017
HR pos vs neg0.63 (0.39-1.00)0.049----
Stage I-II vs III0.31 (0.20-0.50)<0.0010.27 (0.13-0.59)0.0010.33 (0.19-0.60)<0.001
Age >60 vs < 601.02 (0.65-1.60)0.9361.44 (0.69-3.02)0.3370.82 (0.45-1.47)0.501

The association between 10% TILs increments and MFS was significant in the short (HR 0.49, 95%CI 0.29-0.82, p = 0.006) but not in the long arm (HR 0.84, 95%CI 0.65-1.10, p = 0.212). Patients with TILs <20% benefitted from long treatment (HR 0.76, 95%CI 0.60-0.97, p = 0.024), whereas for patients with TILs > =20% the HR favored the short arm (HR 2.79, 95%CI 0.98-7.96, p = 0.055; 8 events only). Interaction test showed p = 0.064 (arm*10% TILs increase) and p = 0.019 (arm*TILs binary variable with 20% cutoff).


TILs are an independent prognostic factor for HER2+ early breast cancer patients treated with adjuvant chemotherapy and trastuzumab. Integration of TILs in prognostic algorithms can help refining risk stratification and guiding therapeutic de-escalation.

Clinical trial identification

EudraCT 2007-004326-25 Start date: 2007-11-15.

Legal entity responsible for the study

University of Modena and Reggio Emilia; University of Padova.


Agenzia Italiana del Farmaco (AIFA).

Editorial Acknowledgement


P.F. Conte: Speaker's bureau: Roche Genentech; Research funding (Institution): Roche. V. Guarneri: Research funding (Institution): Roche. All other authors have declared no conflicts of interest.

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