Biweekly nonpegylated liposomal doxorubicin (M) and docetaxel (T) as neoadjuvant treatment in patients with stage II-III breast cancer

Abstract

11049 Background: We have previously reported (ASCO 2006) the efficacy and toxicity of 4 courses of M (75mg/m2) and T (75mg/m2) with G-CSF support in a 21 day schedule as neoadjuvant treatment in patients with resectable breast cancer. Aim: To evaluate the clinical and pathological response rate (RR) and toxicity of biweekly M and T given prior to surgery in patients with breast cancer. Methods: Patients with histological confirmation of breast cancer (stage II-III and inflammatory), age >18 years, left ventricular ejection fraction > 45% and adequate bone marrow, renal and hepatic function were included in the study. Prior systemic therapy, radiotherapy or surgery for breast cancer were not allowed. The treatment was: M (60 mg/m2) and T (60mg/m2) each in 1 hour infusion, with subcutaneous G-CSF (5 mcg/kg) support on days 4–9. Courses were repeated every 14 days. Patients received 6 courses prior to surgery. Results: To date 45 patients have been enrolled; 20 who have completed therapy and underwent surgery (except for patients with progression) were included in this interim analysis. Median age: 48 years (38–63), ECOG PS 0: 90%, ECOG PS1: 10%, postmenopausal: 35%. Histology was infiltrating ductal carcinoma in 80%. Patients received a total of 110 courses (median 6, range 2–6). Efficacy: Of 19 evaluable patients, 4 achieved a clinical complete response (cCR) (21%), 12 partial response (cPR) (63%), 1 stable disease (cSD) (5%) and 2 progressive disease (cPD) (10%), resulting in a clinical response rate (cRR) of 84%. Surgery was performed in 17 (85%) patients, 4 (23%) of them had pathological complete response (pCR), 12 (70%) partial response (pPR), 1 (6%) stable disease (pSD), resulting in a pathological RR of 93%. Median time to progression and overall survival have not been reached. Toxicity: Hematological grade III/IV toxicities per patient were neutropenia (10%), febrile neutropenia (10%) and thrombocytopenia (5%). Non-hematological grade III/IV toxicities per patient were mucositis (10%), nausea/vomiting (10%) and epigastralgia (10%) Conclusions: Six courses of T and M every 14 days with G- CSF support as induction treatment in stage II and III breast cancer are active and well tolerated. No significant financial relationships to disclose.