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Poster Discussion session - Breast cancer, early stage

2553 - 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio


20 Oct 2018


Poster Discussion session - Breast cancer, early stage


Bioethical Principles and GCP;  Targeted Therapy

Tumour Site

Breast Cancer


Pier Franco Conte


P.F. Conte1, V. Guarneri1, G. Bisagni2, F. Piacentini3, A.A. Brandes4, L. Cavanna5, F. Giotta6, M. Aieta7, V. Gebbia8, A. Frassoldati9, A. Musolino10, O. Garrone11, C. Taverniti12, A. Rimanti13, S. Sarti14, D. Rubino15, A. Bologna2, R. Vicini16, S. Balduzzi16, R. D'Amico16

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 Department Of Medical And Surgical Sciences For Children & Adults, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41122 - Modena/IT
  • 4 Department Of Medical Oncology, Ospedale Bellaria, 40139 - Bologna/IT
  • 5 Oncology Department, Azienda Ospedaliera Piacenza, 29121 - Piacenza/IT
  • 6 Medical Oncology, Istituto Oncologico Bari, 70126 - Bari/IT
  • 7 Medical Oncology, Centro di Riferimento Oncologico Basilicata IRCCS, 85020 - Rionero in Vulture/IT
  • 8 Medical Oncology, Ospedale La Maddalena, 90100 - Palermo/IT
  • 9 Department Of Morphology, Surgery And Experimental Medicine, Azienda Ospedaliera di Ferrara St. Anna, 44100 - Ferrara/IT
  • 10 Medical Oncology, Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 11 Medical Oncology, Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 12 Oncologia Medica Senologica, AOU città della salute e della scienza di Torino, Torino/IT
  • 13 Oncology, Azienda Ospedaliera di Mantova, 43126 - Mantova/IT
  • 14 Medical Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 15 Medical Oncology, AOU Policlinico Sant'Orsola Malpighi, 40138 - Bologna/IT
  • 16 Department Of Diagnostic And Clinical Medicine And Public Health, University Hospital of Modena and Reggio Emilia, Modena/IT


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Abstract 2553


In the ShortHER trial, 1254 HER2+ early breast cancer patients were randomized to 9 weeks versus 1 year trastuzumab. At 6 years median follow up, non inferiority could not be claimed according to the frequentistic approach (HR 1.13; 90% CI 0.89;1.42) with the upper limit of CI crossing the non inferiority margin set at 1.29. However, based on the pre-planned Bayesian analysis, the probability that the short arm is not inferior to the long one was 80%. Moreover, G >/= 2 cardiac events were 82 in the long and 27 in the short arm (RR 0.33, 95% CI 0.22 to 0.55). It is therefore of interest to identify subgroups of patients for whom, based on the risk/benefit ratio, a shorter treatment might be an option


At multivariate analysis, pathologic tumor size and nodal status were independent prognostic parameter for Disease-Free Survival (DFS) and three prognostic groups could be identified: low risk (pT 2cm and N 0-3) and high risk (pT > 2cm and N 4+).


The low, intermediate and high risk groups included 37.5%, 51.9% and 10.5% of the patient population, respectively. The 5 year DFS and G>/=2 cardiac events in the long and short arms according to the prognostic group are summarized below:

5 year DFS

Hazard Ratio(95% CI)
Long arm Short arm
Low risk 91% 92% 0.96 (0.56-1.66)
Intermediate risk 87% 86% 1.05 (0.71-1.54)
High risk 80% 60% 1.94 (1.07-3.53)
G>/=2 cardiac events Relative Risk (95% CI)
Low risk 14.6% 5.1% 2.85 (1.51-5.36)
Intermediate risk 11.6% 3.9% 2.9 (1.57-5.35)
High risk 14.1 3.3 4.22 (0.96-18.5)


Subgroups analysis of the ShortHER trial allows to identify patients at low and intermediate risk of relapse. This population includes 89% of the patients and the 5 year DFS is not different in the two treatment arms (89% long, 88% short; HR 1.02, 95% CI 0.78-1.33); on the contrary, the risk of cardiac events is significantly higher in the long arm (12.8% vs 4.5%; RR 2.88, 95% CI 1.85-4.47). These results may contribute to better define the risk/benefit ratio of 1 year adjuvant trastuzumab.

Clinical trial identification

EUDRACT number: 2007-004326-25

NCI ClinicalTrials.gov number: NCT00629278

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