title: [Safety of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer].
abstract: OBJECTIVE
  To investigate the safety and tolerance of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer.
  
  
  METHODS
  From January 2004 to December 2006, 101 patients with high-risk breast cancer after surgical resection were enrolled into this study. The patients were divided into two groups: dose-dense and regular groups. Each patient received 6 cycles of chemotherapy with intravenous administration of paclitaxel (175 mg/m2, on D3) and epirubicin (60 mg/m2, on Dl and D2). The dose-dense group had repeated treatment every two weeks, while the regular group repeated it every three weeks. G-CSF was used in a dose of 3 microg/kg on D5-D9 during each cycle in the dose-dense group. While in the regular group, it was used only under the condition that grade II neutropenia occurred.
  
  
  RESULTS
  The toxicity could be evaluated in 101 patients. Major grade II-IV toxicities included: neutropenia, nausea, vomiting and alopecia. The incidence of grade III-IV neutropenia was 16.0% in the dose-dense group versus 54.9% in the regular group (P = 0.000); postponing of chemotherapy was 2.4% versus 6.0% (P = 0.027). Ninety-eight patients completed the chemotherapy as planed. After a median follow-up of 24 months, the median DFS and OS were not reached. The relapse-free rate and survival rate were 89.8% and 100% in the dose-dense group, which were 87.8% and 93.9% in the regular group. The relapse-free rate of the high-risk patients in the dose-dense group was 86.8% versus 81.3% in the regular group, and the corresponding survival rate was 100% versus 90.6%.
  
  
  CONCLUSIONS
  Adjuvant dose-dense chemotherapy with paclitaxel and epirubicin is safe, tolerable and promising for high-risk breast cancer.
authors.affiliation: Department of Medical Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Beijing 100021, China.
authors.forename: Wei-Hua
authors.initials: WH
authors.lastname: Wu
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.forename: Bing-He
authors.initials: BH
authors.lastname: Xu
authors.forename: Pin
authors.initials: P
authors.lastname: Zhang
authors.forename: Long-Mei
authors.initials: LM
authors.lastname: Zhao
authors.forename: Peng
authors.initials: P
authors.lastname: Yuan
authors.forename: Jia-Yu
authors.initials: JY
authors.lastname: Wang
authors.forename: Rui-Gang
authors.initials: RG
authors.lastname: Cai
authors.forename: Ai-Ping
authors.initials: AP
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008207:Lymphatic Metastasis; D008408:Mastectomy / Q000379:methods; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local; D009360:Neoplastic Cells, Circulating; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D017239:Paclitaxel