Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study‡

P. Conte, A. Frassoldati, G. Bisagni, A.A. Brandes, M. Donadio, O. Garrone, F. Piacentini, L. Cavanna, F. Giotta, M. Aieta, V. Gebbia, A. Molino, A. Musolino, A. Ferro, R. Maltoni, S. Danese, C. Zamagni, A. Rimanti, K. Cagossi, A. RussoP. Pronzato, F. Giovanardi, G. Moretti, L. Lombardo, A. Schirone, A. Beano, L. Amaducci, E.A. Bajardi, R. Vicini, S. Balduzzi, R. D'Amico, V. Guarneri, Reader study level-I, level-II Groups

Research output: Contribution to journalArticle

Abstract

Background: Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment of HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The short-HER study was aimed to assess the non-inferiority of 9 weeks versus 1 year of adjuvant trastuzumab combined with chemotherapy. Patients and methods: HER2-positive breast cancer patients with node-positive or, if node negative, with at least one risk factor (pT>2 cm, G3, lympho-vascular invasion, Ki-67 > 20%, age ≤35 years, or hormone receptor negativity) were randomly assigned to receive sequential anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or plus 9 weeks trastuzumab (arm B, short). This study was designed as a non-inferiority trial with disease-free survival (DFS) as primary end point. A DFS hazard ratio (HR)
Original languageEnglish
Pages (from-to)2328-2333
Number of pages6
JournalAnnals of oncology : official journal of the European Society for Medical Oncology
Volume29
Issue number12
DOIs
Publication statusPublished - Dec 2018

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    Conte, P., Frassoldati, A., Bisagni, G., Brandes, A. A., Donadio, M., Garrone, O., Piacentini, F., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Molino, A., Musolino, A., Ferro, A., Maltoni, R., Danese, S., Zamagni, C., Rimanti, A., Cagossi, K., ... Groups, L-II. (2018). Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study‡. Annals of oncology : official journal of the European Society for Medical Oncology, 29(12), 2328-2333. https://doi.org/10.1093/annonc/mdy414