Neoadjuvant chemotherapy (NCT) using anthracycline - taxane based chemotherapy achieved better outcome and increase the rate of breast conservative surgery (BCS). This study evaluates the efficacy and safety profile of 4 cycles AC followed by 4 cycles of DC as NCT and detect pCR with its subsequent effect on BCS, OS, DFS and its correlation with molecular subtypes and other markers as ERCC1and Ki-67.
A prospective phase II study at the Medical Oncology Department of the National Cancer Institute (NCI), Cairo University, where 104 female patients with LABC were recruited during the period from March 2010 to July 2013 to receive eight cycles of NCT, 4 cycles of (AC) followed by 4 cycles of (DC), responding patients were referred to surgery then to radiotherapy for local control. All patients were assessable for toxicity. ER, PR, Her2neu, Ki-67 and ERCC1 were done.
Median age: 51yrs, postmenopausal: 48.1%, median tumour size at presentation: 8 cm, stage IIIB: 82.7%, ER/PR positive: 78.8% and 25% were Her2neu positive. The pCR after DC according to Miller and Payne system was 20.2%, with mean tumour size:4.15± S.D 2.703. Age and menopausal status showed statistical significant correlation with pathological response. The correlation between DFS in positive and negative ERCC1 was statistically significant; (p-value ≤ 0.01). The overall survival (OS)of the patients was 85.4% at 36 months while the disease free survival (DFS) was 85.3% at 24 months. Anaemia G2 & more was encountered in 27 patients (26%); neutropenia G2 & more was reported in 49 patients (47.1%), while Peripheral neuritis was observed in 103 patients (99%).
Adding Cisplatin to Docetaxel for 4 cycles after 4 cycles of Adriamycin – Cyclophosphamide improved the pCR, OS and rate of BCS. ERCC1 is a predictor marker of DFS.
Clinical trial identification
Legal entity responsible for the study
IRB Committee of the national cancer institute of Cairo University
National Cancer Institute - Cairo University
All authors have declared no conflicts of interest.