Abstract
11559 Background: Tailoring neoadjuvant chemotherapy (NACT) ± trastuzumab (T) according to tumor/host features remains an open issue, with special reference to anthracycline omission in HER2+ cases. Methods: Patients (pts) with breast cancer (BC), NACT candidate, were eligible. HER2+ pts (n=12) received 24 wks of weekly T 4mg/kg loading dose d1 then 2mg/kg and Paclitaxel (P) 80 mg/m2 before surgery, followed by additional 12 wks of TP and T for 1 year. HER2- pts (n=21) received 8 cycles of epirubicin (E) and docetaxel (D) (90 and 75mg/m2 respectively, q3 wks) before surgery, followed by 3 CMF cycles. Hormone therapy was suggested in all hormone sensitive cases. The primary endpoint was pCR and its correlation with Topo2α expression and the extent of spontaneous T cell responses to HER2 and other BC-associated antigens. Results: The TP regimen gave a clinical response in all 8 evaluable pts (clinical complete remission (CR) in 3 pts, partial remission (PR) in 5). Radical mastectomy (RM and quadrantectomy (Q) were performed in 6 and 2 pts, respectively. Pathologic (p) response rate was 87% with 3 pCR. Nodal pCR occurred in 5/7 pts. The ED regimen gave a 79% clinical response rate in the 14 evaluable pts (CR in 7, PR in 4). RM and Q were performed in 8 and 6 pts, respectively. P response rate was 78.6% with 2 pCR. Nodal pCR occurred in 3/12 pts. Toxicity: onychopathy G3, alopecia G2, paresthesia G2 and mucositis G3 more frequent in the TP pts, neutropenia G3–4, febrile neutropenia, anemia G3 and alopecia G2 more frequent in ED. No cardiotoxicity was observed. Conclusions: This interim analysis suggests that the TP as NACT in HER2+ BC has a good efficacy and tolerability. Clinico-biological correlations are underway. No significant financial relationships to disclose.
Published Version
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