title: [A randomized phase II trial of docetaxel and doxorubicin in treatment for patients with non-small-cell lung cancer who have failed previous platinum-based chemotherapy].
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy, toxicity and safety of doxorubicin combined with domestically produced docetaxel versus with taxotere, and to investigate whether these two regimens result in similar outcomes in the treatment for non-small-cell lung cancer (NSCLC) patients who failed previous platinum-based chemotherapy.
  
  
  METHODS
  Eighty-eight NSCLC patients were enrolled into this clinical phase II trial. The patients randomly received either domestic docetaxel (study arm) or taxotere (control arm) at a dose of 70 mg/m2 on D2, while doxorubicin at a dose of 40 mg/m2 on D1 was administered in both groups. It was repeated every 3 weeks, totally for three cycles. No granulocyte colony-stimulating factor was used to prevent granulocytopenia. The response rate and toxicity were evaluated using World Health Organization toxicity scale and Karnofsky performance status scale.
  
  
  RESULTS
  Of the 88 patients, 81 were evaluable in terms of efficacy. There was no complete responder in this series. The response rate (RR) was 17.1% in the study arm versus 7.5% in the control arm, and the clinical benefit rate (CBR) was 80.5% in the study group versus 72.5% in the control group. The most frequent grade 3 or 4 toxicities were neutropenia, leucopenia and gastrointestinal symptoms. Other toxicities such as alopecia and vomiting were mild and generally well tolerated. No fluid retention was noticed.
  
  
  CONCLUSIONS
  The administration of doxorubicin 40 mg/m2 on D1 combined with domestic docetaxel 70 mg/m2 on D2 is proved to be as effective and tolerable as with taxotere. The domestic drug docetaxel may be considered as an alternative for patients with non-small-cell lung cancer who failed previous platinum-based chemotherapy.
authors.affiliation: Department of Medical Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Beijing 100021, China. pingziwang@yahoo.com
authors.forename: Zi-ping
authors.initials: ZP
authors.lastname: Wang
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.forename: Xiang-ru
authors.initials: XR
authors.lastname: Zhang
authors.forename: Mao-hong
authors.initials: MH
authors.lastname: Zhang
authors.forename: Xiu-wen
authors.initials: XW
authors.lastname: Wang
authors.forename: Xue-jun
authors.initials: XJ
authors.lastname: Yu
authors.forename: Ke-jun
authors.initials: KJ
authors.lastname: Nan
authors.forename: En-xiao
authors.initials: EX
authors.lastname: Li
authors.forename: Ji-wei
authors.initials: JW
authors.lastname: Liu
authors.forename: Ya-jie
authors.initials: YJ
authors.lastname: Gao
authors.forename: Xiao-qian
authors.initials: XQ
authors.lastname: Guan
authors.forename: Shu-ping
authors.initials: SP
authors.lastname: Song
authors.forename: Li-jun
authors.initials: LJ
authors.lastname: Sheng
authors.forename: Dong-lin
authors.initials: DL
authors.lastname: Wang
authors.forename: Zhi-xin
authors.initials: ZX
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage; D017211:Treatment Failure; D014839:Vomiting / Q000139:chemically induced
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin