title: 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.
abstract: OBJECTIVE
  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/m day 1 and oxaliplatin 130 mg/m 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 occurred in 4 TNLABC patients (13.79%), and thrombocytopenia in 1 patient (3.45%). Grade 3 or 4 transaminase elevation occurred in 5 (17.24%) patients and grade 3 vomiting occurred 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.
authors.affiliation: *Department of Breast Surgery, Fudan University Shanghai Cancer Center †Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
authors.forename: Fei
authors.initials: F
authors.lastname: Fei
authors.forename: Canming
authors.initials: C
authors.lastname: Chen
authors.forename: Jingyan
authors.initials: J
authors.lastname: Xue
authors.forename: Gen-Hong
authors.initials: GH
authors.lastname: Di
authors.forename: Jin-Song
authors.initials: JS
authors.lastname: Lu
authors.forename: Guang-Yu
authors.initials: GY
authors.lastname: Liu
authors.forename: Zhi-Ming
authors.initials: ZM
authors.lastname: Shao
authors.forename: Jiong
authors.initials: J
authors.lastname: Wu
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D000077150:Oxaliplatin; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*; D000637:Transaminases / Q000378:metabolism; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D000637:Transaminases