title: Weekly taxane-anthracycline combination regimen versus tri-weekly anthracycline-based regimen for the treatment of locally advanced breast cancer: a randomized controlled trial.
abstract: BACKGROUND
  Extensive studies have confirmed the efficacy of taxanes in combination with anthracycline-based chemotherapy on breast cancer. However, few studies have assessed the efficacy of weekly taxane-anthracycline regimens on locally advanced breast cancer. This study was to compare the efficacy and safety of a weekly taxane-anthracycline regimen with those of tri-weekly anthracycline-based regimen in patients with locally advanced breast cancer.
  
  
  METHODS
  Patients with locally advanced breast cancer were randomized to receive 4-6 cycles of neoadjuvant chemotherapy with tri-weekly 5-fluorouracil-epirubicin-cyclophosphamide (FEC) regimen or weekly paclitaxel-epirubicin (PE) regimen. The primary endpoint was the pathologic complete response (pCR) rate. Other endpoints included the clinical tumor response, breast-conserving surgery rate, and adverse events.
  
  
  RESULTS
  Between March 2010 and September 2013, 293 patients were randomized to the FEC (n = 151) and PE (n = 142) arms. The overall clinical response rate was significantly higher in the PE arm than in the FEC arm (76.06% vs. 59.95%, P = 0.001). Consistently, the post-chemotherapy pathologic T and N stages were significantly lower in the PE arm than in the FEC arm (P < 0.001). However, the pCR rate was similar in the two arms (10.61% vs. 12.31%, P = 0.665). Overall, 36 (27.27%) patients in the FEC arm and 6 (35.28%) in the PE arm were qualified for breast-conserving surgery. Most adverse events were comparable in both arms, with more severe neutropenia in the PE arm than in the FEC arm (11.97% vs. 5.96%, P = 0.031).
  
  
  CONCLUSIONS
  In patients with locally advanced breast cancer, weekly PE was not superior to FEC in terms of pCR. However, weekly PE has a higher response rate and superior down-staging effects. On this account, the PE regimen may be considered an alternative option for locally advanced breast cancer. Long-term follow-up data are needed to confirm the efficacy of this regimen on locally advanced breast cancer. Trial registration Chinese clinical trial registry, ChiCTR-TRC-10001043, September 21, 2014.
authors.affiliation: Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Qiu-Wen
authors.initials: QW
authors.lastname: Tan
authors.affiliation: Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Ting
authors.initials: T
authors.lastname: Luo
authors.affiliation: Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Ting-Lun
authors.initials: TL
authors.lastname: Tian
authors.affiliation: Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Ping
authors.initials: P
authors.lastname: He
authors.affiliation: Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: Jie
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China.
authors.forename: He-Lin
authors.initials: HL
authors.lastname: Zeng
authors.affiliation: Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, P. R. China. lvqingwestchina@163.com.
authors.forename: Qing
authors.initials: Q
authors.lastname: Lv
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil
keywords: Anthracycline; Chemotherapy; Locally advanced breast cancer; Neoadjuvant; Randomized clinical trial; Taxanes