Weekly carboplatin and nab-paclitaxel plus trastuzumab, or plus or minus bevacizumab: Clinical response in patients with breast cancer

Abstract

10699 Background: We previously reported a high, complete pathological remission rate in the neoadjuvant setting using carboplatin and metronomic paclitaxel plus or minus trastuzumab (TC ± H) following anthracycline therapy in patients with HER2+ and triple negative (ER-, PR- and HER2-) breast cancer, respectively. [SABCS 2004 abstract #1110 & SABCS 2005 # 5056] . We now report the clinical outcome of patients with breast cancer who were treated with carboplatin and a 130-nm, albumin-bound form of paclitaxel (nab-paclitaxel) plus trastuzumab (nab-TCH) in HER2+ patients, or plus or minus bevacizumab (nab-TC ± B) in HER2- patients or trastuzumab-exposed HER2+ patients. Methods: Twelve consecutive patients with performance status of 0–2 were treated in the neoadjuvant or metastatic setting from April 2005 to December 2005. Of the 12 patients, 10 received prior anthracycline therapy, 10 received prior taxane therapy, 4 received prior carboplatin therapy, and 4 received prior trastuzumab therapy. Patients received carboplatin calculated at an area under the concentration-time curve (AUC) of 2 and nab-paclitaxel at 80–100 mg/m2 weekly for 3 weeks followed by 1 week of rest. Either concurrent trastuzumab therapy was administered at 4 mg/kg loading dose, followed by maintenance dose of 2 mg/kg/wk (3 patients) or concurrent bevacizumab therapy was administered at 10mg/kg every 2 weeks (8 patients). One patient received carboplatin and nab-paclitaxel alone. Results: At this point, 9 pts are evaluable. Eight of the first 9 patients achieved a major clinical response (89%, 95% CI: 52%−100%), with 2 of the 8 responders obtaining a documented complete clinical response. Of the 3 remaining patients, 1 had clinical resolution of malignant ascites, 1 had normalization of tumor marker, and 1 had resolution of pain at early follow up. None of the patients had neutropenic fever or grade 3/4 neuropathy or arthralgia. Conclusions: The above combinations (nab-TCH or nab-TC ± B demonstrated promising antitumor activity in patients with breast cancer in the neoadjuvant and metastatic breast cancer. We have initiated a phase II study exploring nab-TCH and nab-TCB (sequenced after doxorubicin and cyclophosphamide) in the neoadjuvant setting. [Table: see text]