Efficacy and safety of docetaxel combined with oxaliplatin as a neoadjuvant chemotherapy regimen for Chinese triple-negative local advanced breast cancer patients : A prospective, open, and unicentric phase II clinical trial

摘要

Background and Aims: To determine the efficacy and toxicity of an oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple-negative local advanced breast cancer (TNLABC) patients. Methods: Patients with stage IIIb or IIIc, chemotherapy-naive TNLABC receive docetaxel 75 mg/m2 day 1 and oxaliplatin 130 mg/m2 day 2, every 21 days for up to 4 cycles. The primary end point is pathologic complete response (CR), and the secondary end points are clinical response (including CR and partial response), disease-free survival, overall survival, and safety. Results: Twenty-nine TNLABC patients were treated: 17(58.62%) had stage IIIB disease and 12 (41.38%) had stage IIIC disease. After neoadjuvant chemotherapy, there were 10 patients (34.48%) with pathologic CR (95% confidence interval, 21.51%-48.70%). Twenty patients responded (7 CR and 13 partial response) with a 68.97% total clinical response rate (95% confidence interval 57.51%-88.02%). Nearly 27.59% patients (8 patients) had disease progression after at least 2 cycles of chemotherapy, and only 1 patient (3.45%) had the disease stable, respectively. In the 29 treated patients, there were no unusual or unexpected adverse events in a total of 91 cycles for the chemotherapy setting. Common grade 3 or 4 hematologic toxicities were leukocytopenia, which occured in 4 TNLABC patients (13.79%), and thrombocytopenia in 1 patient (3.45%). Grade 3 or 4 transaminase elevation occured in 5 (17.24%) patients and grade 3 vomiting occured in 1(3.45%) patient. One patient experienced grade 3 neurosensory toxicities. There are 5 reports (17.24%) of grade 3 fatigue. Conclusions: The results of this phase II clinical study suggest that docetaxel combined with oxaliplatin as a neoadjuvant chemotherapy regimen in TNLABC patients is active and well tolerated, and should be further investigated as a favorable treatment alternative for TNLABC patients. A large randomized prospective clinical study is warranted to confirm the results.