Tab. 1 – Characteristics of patients NON-PEGYLATED LIPOSOMAL DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY WEEKLY PACLITAXEL WITH (HER2+) OR WITHOUT (HER2-) TRASTUZUMAB AS PRIMARY SISTEMIC THERAPY IN OPERABLE AND LOCALLY-ADVANCED BREAST CANCER. PRELIMINARY RESULTS. D. Rossi 1. B. Pistilli 2, AM Baldelli 1, V. Casadei 1, G. Benedetti 2, V. Catalano 1, P. Alessandroni 1, S. Luzi Fedeli 1, P. Giordani 1, F. Graziano 1, L. Latini 2, G. Fiorentini 1 1. Oncology Unit, Ospedali Riuniti Marche Nord – Presidio San Salvatore di Pesaro; 2 Oncology Unit, Ospedale Civile Macerata E 53 Background Patients and methods Results Conclusions Schedules with anthracyclines and taxanes are one of the best options for neoadjuvant chemotherapy in breast cancer. Non-pegylated liposomal doxorubicin (NLD) in combination with cyclophosphamide is active and safe as first line treatment in metastatic breast cancer (1) but we have only few data as primary chemotherapy, especially with concomitant administration of trastuzumab (2, 3). The aims of our study were activity, in term of pathological complete response, and safety of a sequential schedule of NLD/cyclophosphamide followed by weekly paclitaxel with or without trastuzumab To date, 31 patients entered the study (13 pts stage IIIA and IIIB, 18 pts stage IIA and IIB). 25 pts are evaluable for clinical and pathological responses (10 pts with stage IIIA and IIIB). Median age was 55, 5 years (range 37 – 71). EgR positive in 23 pts (78% of evaluable pts). High/intermediate Ki 67 in 23 pts. 21 patients without Her2 overexpression (or FISH not amplified) were treated with NLD 60 mg/m² in combination with cyclophosphamide 600 mg/m² every three weeks for 4 cycles followed by weekly paclitaxel 80 mg/m² for 12 courses; 10 patients with Her2 overexpression (or FISH amplified) were treated with the same schedule plus trastuzumab (8 mg/kg for the first administration then 6 mg/kg for the other 3 cycles with NLD and cyclophosphamide; 2 mg/kg/weekly for the following 12 administrations with paclitaxel). Table 1. Pathological complete responses were documented in 6 pts (24%): 4 out of 7 evaluable pts with Her2 overexpression (57%) and 2 out of 18 evaluable pts without Her2 overexpression (11%). Overall clinical responses were 91,7%: complete 54,2% (78% in Her2 pts), partial 37,5% Conservative surgery was performed in 9 pts (36%) and mastectomy in 16 pts (64%). Table 2. Toxicity was mild: febrile neutropenia in 2 pts (gr. 3 – 4 neutropenia in 1 pt); gr. 3 vomiting in 1 pt; gr. 3 paresthesia in 1 pt. Only 1 patient experienced an asymptomatic decrease of ejection fraction lower than 50%. This new sequential schedule with the combination of NLD/cyclophosphamide followed by weekly paclitaxel with trastuzumab seems to be very active despite of the significantly higher rate of patients with ER+ positive disease and 42% of pts with locally advanced cancer. Consistently with previous data, pCR was higher in pts with Her2-overexpression.. The study is ongoing to achieve the planned accrual of 43 pts. Overall Complete Pathological Responses (pts) 6 (24%) Pathological Complete Responses in HER2+ pts 4 out of 7 evaluable pts (57%) Pathological Complete Responses in HER2- pts 2 out of 18 evaluable pts (11%) Overall Clinical Responses 91,70% Complete 54,20% Partial 37,50% Conservative surgery 9 (36%) Mastectomy 16 (64% References N° pts 31 Stage IIA – IIB 18 Stage IIIA – IIIB 13 Evaluable for clinical and pathogical response 25 Median Age 55,5 years (range 37 - 71) EgR positive 23 N° of pts treated without Trastuzumab 21 N° of pts treated with Trastuzumab 10 1. Batist G et al. J Clin Oncol 2001; 19 (5): 1444-54 2. Theodolou M et al. Clin Breast Cancer 2009; 9 (2): 101 - 7 3. Cortes J et al. Clin Cancer Res 2009; 15 (1): 307-14 Table 2. Results Tab. 1 – Characteristics of patients