1. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study
- Author
-
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., Russo, A., Pronzato, P., Giovanardi, F., Moretti, G., Lombardo, L., Schirone, A., Beano, A., Amaducci, L., Bajardi, E. A., Vicini, R., Balduzzi, S., D'Amico, R., Guarneri, Falci C, V., Giarratano, T, Mcmahon, L, De Salvo GL, Dieci, Mv, Maiorana, A, Ficarra, G, Caggia, F, Grisolia, D, Bartolini, S, Lorusso, V, Ardito, R, Tartarone, A, Vanella, P, Taverniti, C, Porpiglia, M, Spanu, Pg, Biglia, N, Andreis, D, Piancastelli, A, Fedeli, A, Parra, Hs, Gambaro, Ar, Romito, S, Malossi, A, Gori, S, Miglietta, L, Del Mastro, L, Amoroso, D, Mansutti, M, Generali, D, Prati, G, Bertolini, A, Berardi, R, Zanni, A, Cottafavi, L, Bologna, A, Naso, G, Pancotti, A, Farci, D, Zoboli, A, Silva, R, Laudadio, L, Bordonaro, R, Marenco, D, Dongiovanni, V, Baldini, E, Saggia, C, Gorzegno, G, Cariello, A, Biganzoli, L, Rampello, E., 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., Russo A., Pronzato P., Giovanardi F., Moretti G., Lombardo L., Schirone A., Beano A., Amaducci L., Bajardi E.A., Vicini R., Balduzzi S., D'Amico R., and Guarneri V.
- Subjects
Oncology ,Time Factors ,Adjuvant, Breast cancer, Cardiac safety, De-escalated treatment, Trastuzumab ,Settore MED/06 - Oncologia Medica ,Receptor, ErbB-2 ,medicine.medical_treatment ,Anthracycline ,030204 cardiovascular system & hematology ,Breast cancer ,Antineoplastic Agents, Immunological ,ErbB-2 ,0302 clinical medicine ,Trastuzumab ,Antineoplastic Combined Chemotherapy Protocols ,Clinical endpoint ,Anthracyclines ,skin and connective tissue diseases ,Adjuvant ,Mastectomy ,Cardiac safety ,De-escalated treatment ,Hazard ratio ,Hematology ,Middle Aged ,Chemotherapy regimen ,Bridged-Ring Compound ,Immunological ,Local ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,Taxoids ,Trastuzumab, adjuvant, breast cancer, cardiac safety, de-escalated treatment ,Breast Neoplasm ,Human ,Receptor ,medicine.drug ,Adult ,Bridged-Ring Compounds ,medicine.medical_specialty ,Time Factor ,Socio-culturale ,Breast Neoplasms ,Antineoplastic Agents ,Disease-Free Survival ,Drug Administration Schedule ,03 medical and health sciences ,Taxoid ,Internal medicine ,medicine ,Humans ,Chemotherapy ,Risk factor ,Aged ,Neoplasm Staging ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,medicine.disease ,Cardiotoxicity ,Neoplasm Recurrence ,Neoplasm Recurrence, Local ,business - 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)
- Published
- 2018