10678 Background: Previous studies suggest that combined treatment of chemotherapy + surgery + radiotherapy has a high survival rate in pts with locally advanced or inflammatory breast cancer. Primary objective was evaluate response rate. Secondary objectives were time to progression and toxicity profile of neoadjuvant chemotherapy T, A and X in pts with LABC. Methods: Eligibility criteria: Pts with histological confirmation of LABC, ECOG PS ≤ 2, age ≤ 75 years, LVEF > 50%, and adequate bone marrow, renal and hepatic function. Prior systemic therapy, surgery or radiotherapy for breast cancer was not allowed. Pts with invasive bilateral breast cancer were not included. Treatment: T (30 mg/m2) iv day 1, 8 and 15, A (50 mg/m2) iv day 1 and X (1500 mg/m2 o.d.) days 1–14, in a 4 weeks course. This scheme was repeated up to 4 cycles followed by surgery. According to investigator criteria pts receive a maximum of six cycles. Radiotherapy and hormonal treatment are allowed depending on molecular markers. Expression of markers was performed by inmunohistochemistry before chemotherapy. Results: 36 pts were included in this analysis, with a median age of 48 years (25–69). ECOG PS was 0 in 32% of pts and 1 in 68%. Hormonal receptor status was ER+ 43%, PR+ 34% and C-erb2+ 52%. A total of 131 cycles (median 4, range 1–4) were administered. Median relative dose intensity was 86% for T, 91% for A and 93% for X. Two patients are still undergoing treatment; of 34 evaluable pts for efficacy, 11 achieved CR, 22 PR and 1 PD resulting in an ORR of 97% (CI 95%: 92–100). Surgery was performed in 34 pts: 3 (9%) of them achieved pathological CR and one additional patient had non invasive carcinoma. Grade III/IV toxicity per patient was neutropenia (69%), leucopenia (53%), febrile neutropenia (8%), mucositis (14%), diarrhea (11%), nausea/vomiting (6%), dysgeusia (3%) and asthenia (3%). Median follow up time was 8.8 months. Conclusions: T, A and X every 28 days administered during 4 cycles as neoadjuvant chemotherapy in LABC is an active regimen with a manageable toxicity profile before surgery. No significant financial relationships to disclose.
A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Malate in Combination with Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer
