Lucia Del Mastro Gruppo Italiano Mammella - GIM Napoli 10 marzo 2017 Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2X2 factorial, randomised phase III study. Lucia Del Mastro Gruppo Italiano Mammella - GIM Napoli 10 marzo 2017 IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro

W. Hryniuk

L. Norton

Istituto Nazionale per la Ricerca sul Cancro IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro M. Venturini P. Bruzzi

Dose-density Project Metastatic setting GM-CSF allows acceleration of standard CEF (16 vs. 20 days) - GM-CSF allows intensification (1000/80/600) & acceleration of CEF Randomized trial of intensified accelerated CEF vs standard: no benefit Dose-dense was an other main research field at our institute both in metastatic and adjuvant setting

Dose-density Project Adjuvant setting G-CSF allows acceleration of standard CEF (14 days) Dose-dense adjuvant chemotherapy in early breast cancer patients: results from a randomized trial HER2 expression and efficacy of dose-dense anthracycline-containing adjuvant chemotherapy in breast cancer patients Dose-dense was an other main research field at our institute both in metastatic and adjuvant setting

Overall survival

GRUPPO ITALIANO MAMMELLA -GIM

CLINICAL TRIALS CARRIED OUT BY the Gruppo Italiano Mammella (GIM) Type of study ACCRUAL TIME N° PATIENTS STATUS OF STUDY ENROLLEMENT GIM-1 Phase III Adjuvant CT, N- 25/11/2003 - 16/06/2010 1636 COMPLETED GIM-2 Adjuvant CT, N+ 24/04/2003 - 03/07/2006 2091 GIM-3 Adjuvant HT, postmenopausal 09/03/2007 – 31/07/2012 3707 GIM-4 01/08/2005 - 24/05/2010 2056 GIM-5 Traslational , HT postmenopausal 12/08/2005 – 13/05/2008 488 GIM-6 Phase III, Fertility preservation 24/10/2003 – 01/02/2008 282 GIM-7 Targeted therapy metastatic disease 13/06/2008 – 21/12/2011 31 EARLY STOP GIM-8 Phase III, HT + targeted therapy metastatic disease 24/09/2008 30/04/2013 348 GIM-9 Phase II, neoadjuvant 09/12/2008 – 07/12/2010 47 GIM-10 Phase III, adjuvant, postmenopausal 12/11/ 2013 455 ONGOING

a q3 EC-P arm b q3 FEC-P arm Therapy every 3 weeks Therapy every 3 weeks c d q2 EC-P arm q2 FEC-P arm Therapy every 2 weeks Therapy every 2 weeks 5-fluorouracil 600 mg/m2 i.v. Cyclophosphamide 600 mg/m2 i.v. Epirubicin 90mg/m2 i.v. Paclitaxel 175 mg/m2 i.v. over 3 hours

ER+ ER-

2016

GIM (Gruppo Italiano per il trattamento del carcinoma della Mammella) 140 Italian Oncologic Centers GOIRC GOL GONO GOCSI GOV GISCAD