e11590 Background: Primary systemic therapy (PST) has become a standard therapy for locally advanced breast cancer (LABC). The aim of this study was to evaluate the activity and toxicity of EC (epirubicin/cyclophosphamide) followed by weekly paclitaxel with/without trastuzumab as PST in LABC. Methods: Primary endpoint was pathologic complete response (pCR) rate in the breast and axilla, and secondary endpoints were breast conserving rate and toxicities. Patients with histologically diagnosed invasive breast cancer by core needle biopsy of the T2–4 (>3 cm) or N1–3 were included in this study. Eligible patients were age >20 years, had a performance status of 0 to 1, and had adequate organ functions. It was determined that the expected rate of pCR in the trial was 25%, and the sample size was calculated using the Simon method, with a type I error of 5% and a study power of 80%. The target enrollment was estimated to be 40 evaluable patients. Treatment: Patients received epirubicin (100 mg/m2) and cyclophosphamide (600mg/m2 ) every 3 weeks for four cycles followed by paclitaxel (80 mg/m2 ) every week for 12 cycles. Trastuzumab (2mg/kg) was added to paclitaxel in HER2-positive patients. Results: Forty-three patients were enrolled into this study and 3 patients withdrew. pCR were observed in 8 patients and pCR rate was 20.0% (95% confidence interval, 7.6- 32.4). Twenty-four patients (60.0%) underwent breast conserving surgery. In particular, patients with HER2 positive tumor had significantly higher rate of pCR than the others (62.5% vs. 8.6%; p=0.0014). Grade 4 neutropenia was recorded in 27.5% of the patients, and febrile neutropenia occurred in 4 patients (10.0%). No heart failure was seen. Conclusions: EC followed by weekly paclitaxel with/without trastuzumab was an active and well-tolerated treatment for LABC. No significant financial relationships to disclose.
Effect of Primary Systemic Therapy on PD-1, PD-L1, and PD-L2 mRNA Expression in Advanced Breast Cancer
