Response rate with weekly epirubicin and docetaxel as neoadjuvant chemotherapy (NAC) for locally-advanced breast cancer (BC)

Abstract

885 Background: In a previous phase II study of patients (pts) with locally-advanced BC, we showed that NAC with epirubicin (E) 35mg/m2 and paclitaxel 80mg/m2 administered on days 1 and 8 every 3 wks, resulted in a high clinical complete response (cCR) rate and a pathological complete response (pCR) rate of 11.4%, with acceptable toxicity (Proc. ASCO, 2003; abst. 231). Methods: Pts with large (>4cm) tumors were treated with E 45 mg/m2 and docetaxel (D) 35mg/m2, both days 1 and 8, every 3 wks for 3 cycles before BC surgery. No prophylactic G-CSF or antibiotics were allowed. All pts had surgery 3 wks after NAC. Following surgery, pts were treated with 6 cycles of CEF (cyclophosphamide 500mg/m2, E 70 mg/m2, 5-fluorouracil 500mg/m2, q3 wks) Results: A total of 42 pts were enrolled between 2003 and 2004; 32 are evaluable. Median age was 47 years (range, 26–69), 63% of pts were estrogen receptor negative, and 28% overexpressed HER-2/neu. Mean tumor size before NAC was 6.5cm. After NAC, mean tumor size decreased to 2.1cm and 12 pts (38%) had negative axillary lymph nodes. Four pts had breast-conserving surgery (BCS), although 10 were candidates for BCS on clinical evaluation. The cCR and clinical partial response rates were 41% and 50%, respectively, and no pts had disease progression. A pCR was found in 7 pts (22%) including 3 with focal intraductal carcinoma only. Grade 3–4 leukopenia was reported in 3 pts (9%) and one pt developed febrile neutropenia. Nonhematologic toxicities included grade 1–2 nausea and vomiting in 28 (88%) and 5 (16 %) pts, respectively, and grade 1–2 arthralgia and grade 2 alopecia in 13 pts (41%).Conclusions: Neoadjuvant chemotherapy with 3 cycles of E 45mg/m2 and D 35mg/m2 (days 1 and 8, every 3 wks) is feasible with acceptable toxicity for most pts, resulting in a pCR rate of 22%. No significant financial relationships to disclose.