Phase II study of a novel neoadjuvant chemotherapy (NAC) for breast cancer (BC).
1060 Background: The goal of this NAC study was to improve the pathologic response of pts with localized BC. Methods: 51 pts with localized BC >1 cm were treated with this novel regimen consisting first of docetaxel 75 mg/m2, epirubicin 80 mg/m2, and cyclophosphamide 500 mg/m2 (TEC) and PEG Filgrastim for 4 cycles. Pretreament PET scan was done and repeated after course 1. Following the 4th course, ER+/HER2- patients received 4 additional TEC cycles if they achieved CR by MRI, or were switched to a non cross-resistant regimen (vinorelbine, bevacizumab, capecitabine) if they had < CR. HER2+ pts were given docetaxel + trastuzumab for 4 additional cycles, or were switched to a different regimen if < PR. MD Anderson residual cancer burden (MDARCB) score was used to measure pathologic response and correlation with several prognostic factors was studied. Results: Median age = 53; 27 were postmenopausal; 42 had invasive ductal carcinoma, 5 invasive lobular; 12 triple negative, 11 HER2+, and 28 ER+ or PR+/HER2-. MDARCB was significantly better in HER-2+ and triple negative tumors (table). ER+ or PR+/Her2- pts had the least favorable MDARCB with none achieving 0 and only 21% attaining MDARCB=1. 59% of pts with > 5% SUV drop attained MDARCB score 0-1 vs 13% with ≤ 5% drop. %Ki-67 correlated well with MDARCB (table). Ki-67 correlated well with receptor status: 85% of Triple Neg or Her2+ pts had Ki-67 >17 vs only 29% of ER+ or PR+/Her2-. Conclusions: a) This novel NAC regimen leads to markedly favorable MDARCB scores in triple negative and Her-2+ cases. b) Several factors may be useful in predicting response to chemotherapy, including receptor status, Ki-67, and PET scan response after 1st chemotherapy course. c) Ki-67 proliferative rate is closely correlated with receptor status. d) Early PET could be used to predict MDARCB. The challenge now is to improve response in ER+ or PR+/Her2- pts. [Table: see text]