title: [Randomized controlled trial of two kinds of home-produced docetaxel in China for advanced breast cancer].
abstract: OBJECTIVE
  Two kinds of home-produced docetaxel in China, injection Yiyoutasai and injection Aisu, have the same structure. Data from preclinical study had shown that injection Yiyoutasai has the same pharmacokinetics and toxicity as injection Aisu. This study was to evaluate the efficacy and toxicity of injection Yiyoutasai in treating advanced breast cancer.
  
  
  METHODS
  Eligible breast cancer patients were enrolled and randomly assigned to study group and control group, and received injection of 75 mg/m(2) Yiyoutasai or Aisu, respectively. The injections were repeated every 3 weeks. All patients received at least 2 cycles. The efficacy of Yiyoutasai and Aisu were evaluated after treatment.
  
  
  RESULTS
  A total of 67 patients were enrolled: 33 in study group, and 34 in control group. Of the 31 evaluable cases in study group, 1 achieved complete remission (CR), 9 achieved partial remission (PR), 11 had stable disease (SD), and 10 had progressive disease (PD); the total response rate was 22.22%. There were 1 CR, 5 PR, 19 SD, and 9 PD in control group; the total response rate was 15.15%. There was no significant difference between the 2 groups (P=0.662). The median follow-up was 16.5 months (8-28 months). In study group, the median progression-free survival time was 6.2 months (2-12 months), the 1-year survival rate was 68.51%, and the 2-year survival rate was 40.12%; in control group, the median progression-free survival time was 7.1 months (2.3-11 months), the 1-year survival rate was 65.23%, and the 2-year survival rate was 39.71%. There was no significant difference between the 2 groups (P=0.102, 0.098, 0.089, respectively). Common adverse events were myelosuppression, transient transaminase elevation, and alopecia. One patient in study group suffered from severe allergic reaction after infusion, 1 in control group suffered from whole body edema.
  
  
  CONCLUSIONS
  Yiyoutasai and Aisu have similar efficacy on and toxicity to advanced breast cancer patients.
authors.affiliation: State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.
authors.forename: Dong-Geng
authors.initials: DG
authors.lastname: Liu
authors.forename: Rou-Jun
authors.initials: RJ
authors.lastname: Peng
authors.forename: Feng-Yi
authors.initials: FY
authors.lastname: Feng
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Hu
authors.forename: Gui-Di
authors.initials: GD
authors.lastname: Tang
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Xiong
authors.forename: Hong-Yun
authors.initials: HY
authors.lastname: Zhao
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.forename: Zhong-Zhen
authors.initials: ZZ
authors.lastname: Guan
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D012074:Remission Induction; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel