Phase â…¡ Study Of Neoadjuvant Carboplatin Plus Paclitaxel For Locally Advanced Triple-negative Breast Cancer

Objective To evaluate the efficacy, safety and survival of combination of carboplatin plus paclitaxel as neoadjuvant chemotherapy (NACT) for patients with locally advanced triple-negative breast cancer (TNBC) and explore the optimized regimen for TNBC.Methods Patients with core needle biopsy confirmed pathological diagnosis of ⅡA～ⅢC invasive breastcancer, negative for estrogen and progesterone receptors and HER2by immunohistochemistry, and with indication for NACT were eligible. Biopsied tumor tissue were tested of CK5/6, CK14, EGFR and Ki-67. Patients received neoadjuvant paclitaxel175mg/m2on day1, carboplatin at an area under the curve of5mg. min/ml on day2of every21days. The clinical response was evaluated every2cycles according to Standard RECIST1.0criteria and surgery was done after four to six cycles. Pathological complete remission (pCR) was defined as absence of invasive tumor in the breast and axillary lymph nodes samples or residual carcinoma in situ only.Results Overall41Patients were enrolled from January2008to April2012. The median age was51years and85.4%of patients were diagnosed of stage IIB to IIIC diseases.38Patients completed chemotherapy as planed while one patient changed regimen due to paclitaxel allergy and2were undergoing chemotherapy.36patients could be evaluated the clinical efficacy of which CR, PR, SD, PD were achieved in5,26,4and1women respectively. The objective response rate is86.1%. The expression rate of CK5/6, CK14and EGFR were79.4%(27/34)、61.8%(21/34)、68.6%(24/35). respectively. Among35patients who achieved modified radical mastectomy or breast-conserving surgery,15patients obtained pCR, with pCR rate42.8%(95%CI26.4%-59.2%). The pCR rate in CK5/6and CK14positive patients reached83.3%. All the41Patients could be evaluated toxicity according to the NCI-CTC v3.0. The major toxicity was neutropenia (87.8%)、vomiting (41.5%) and ALT/AST increase (26.8%), and grade3-4accounted for65.9%、2.4%、O respectively. Until April19th,2012, at a median follow-up of24.5months (range0.6-51.7),8patients developed recurrence including6patients died. Among15patients with pCR, one suffered lung metastasis at41months after surgery and survived with tumor until now, the other fourteen were alive and disease free.3-year DFS and OS were69.4%and71.7%, respectively.Conclusions As a neoadjuvant treatment for TNBC, TC regimen achieved notable higher objective response rate and pCR rate compared to anthracycline plus paclitaxel regimen reported by literatures, and was well tolerable. It is an optimized regimen for TNBC.