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Breast cancer, early stage

4748 - Tumor-infiltrating lymphocytes (TILs) in HER2-positive (HER2+) early breast cancer treated with neoadjuvant lapatinib and trastuzumab without chemotherapy in the PAMELA Trial


09 Sep 2017


Breast cancer, early stage


Cytotoxic Therapy;  Breast Cancer


Paolo Nuciforo


Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362


P. Nuciforo1, A. Prat2, A. Llombart3, R. Fasani1, L. Paré4, T. Pascual4, M. Oliveira5, N. Martínez Jañez6, B. Bermejo De Las Heras7, M. Vidal5, S. Pernas Simon8, R. López9, M. Muñoz10, I. Garau11, L. Manso12, J. Alarcon Company13, E. Martinez de Dueñas14, P. Villagrasa Gonzalez15, J. Cortes Castan16, E. Holgado16

Author affiliations

  • 1 Molecular Oncology Group, Vall d´Hebron Institute of Oncology, 08035 - Barcelona/ES
  • 2 Medical Oncology  , Hospital Clínic de Barcelona  , 8036 - Barcelona/ES
  • 3 Medical Oncology  , Hospital Universitario Arnau Vilanova de Lleida, 25198 - Lerida/ES
  • 4 Medical Oncology, IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer, 8036 - Barcelona/ES
  • 5 Medical Oncology Department, Vall d’Hebron University Hospital Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 6 Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 7 Medical Oncology  , Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 8 Medical Oncology, Institut Català d'Oncologia (ICO)-Hospitalet, 08908 - Barcelona/ES
  • 9 Medical Oncology Department, Hospital Clínico de Santiago, Santiago de Compostela/ES
  • 10 Clinical Oncology, Hospital Clinic i Provincial de Barcelona, Barcelona/ES
  • 11 Medical Oncology  , Hospital de Son Llàtzer, Palma de Mallorca/ES
  • 12 Clinical Oncologist, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 13 Medical Oncology  , Hospital Universitario Son Espases, 7010 - Palma de Mallorca/ES
  • 14 Medical Oncology, Hospital Provincial de Castellón, Castellon/ES
  • 15 Scientific Department, SOLTI Breast Cancer Research Group, Barcelona/ES
  • 16 Oncology Service, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES


Abstract 4748


Increased number of TILs at baseline is associated with pathological complete response (pCR) and improved outcomes in HER2+ early breast cancer (BC) treated with anti-HER2-based chemotherapy. The associations in the neoadjuvant setting in the absence of chemotherapy and the effect of on-treatment TILs changes on pCR in the breast (pCRB) are unknown.


PAMELA is a prospective study in HER2+ BC designed to evaluate the ability of the PAM50 intrinsic subtypes (IS) to predict pCRB following neoadjuvant lapatinib and trastuzumab (with hormonal therapy if hormone receptor-positive[HR+]). Levels of TILs as continuous and categorical (TILs-low = 50%) variables and their changes were correlated with pCRB.


TILs evaluation was available for 148 baseline (BS) and 134 Day-15 (D15) samples of 151 recruited patients. At BS, the median (interquartile range) levels of TILs were 10% (5-20). Median TILs distribution according to IS was: HER2-E (10%), Luminal (Lum) A (7.5%), LumB (5%), Basal-like (5%) (p = 0.02). Levels of TILs were higher in HR- (10%, 1-20) vs HR + (5%, 1-20) tumors, although not statistically significant (p = 0.07). pCRB rates were 58.3% (7/12) for TILs-high and 27.2% (37/136) for TILs-low (p = 0.03). At baseline, TILs were significantly associated with pCR in univariate analysis. At D15, median levels of TILs were 15% (5-30) with an increase across all the different IS (p 


The presence of TILs at D15 is an independent predictive marker of pCRB in HER2+ early BC treated with neoadjuvant anti-HER2 agents without chemotherapy.

Clinical trial identification


Legal entity responsible for the study

SOLTI Breast Cancer Research Group


GlaxoSmithKline (now Novartis)


All authors have declared no conflicts of interest.

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