title: [Randomized study of thalidomide combined with vinorelbine and cisplatin chemotherapy for the treatment of advanced non-small cell lung cancer].
abstract: OBJECTIVE
  To evaluate the efficacy, median time to progression (TTP), quality of life and toxicity in the patients with advanced non-small cell lung cancer (NSCLC), treated with thalidomide plus vinorelbine and cisplatin (NP) or NP alone.
  
  
  METHODS
  Sixty six patients with advanced NSCLC were divided randomly into two groups, the trial and control groups. The trial group was treated with vinorelbine 25 approximately 30 mg/m(2) i.v. on D1 and D8, cisplatin 70 approximately 80 mg/m(2) i.v. on D1 (NP regimen), and thalidomide 200 mg orally and daily from D1. The control group received vinorelbine and cisplatin as above described.
  
  
  RESULTS
  Of 66 assessable patients, the overall response rate was 51.5% in the trial group and 36.4% in the control group (P = 0.22). The median TTP was 6.0 months for the trial group, and 3.6 months for the control group (P < 0.001). The score of quality of life in trial group was higher than that in the control group, but no significant difference was observed between the two groups (P > 0.05). There were no significant differences in toxicities between the two groups (P > 0.05).
  
  
  CONCLUSIONS
  NP regimen combined with thalidomide can significantly prolong the median time to tumor progression in patients with advanced NSCLC. Thalidomide may have a synergic activity with NP regimen without increased toxicities.
authors.affiliation: Department of Pneumology, Shanghai Chest Hospital of Jiaotong Uniyersity, Shanghai 200030, China.
authors.forename: Ai-qin
authors.initials: AQ
authors.lastname: Gu
authors.forename: Bao-hui
authors.initials: BH
authors.lastname: Han
authors.forename: Xue-yan
authors.initials: XY
authors.lastname: Zhang
authors.forename: Jie
authors.initials: J
authors.lastname: Shen
authors.forename: Da-jiang
authors.initials: DJ
authors.lastname: Qi
authors.forename: Li-wen
authors.initials: LW
authors.lastname: Xiong
authors.forename: Yu
authors.initials: Y
authors.lastname: Xin
authors.forename: Yi-yi
authors.initials: YY
authors.lastname: Song
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; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D004357:Drug Synergism; D001068:Feeding and Eating Disorders / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D012074:Remission Induction; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D014839:Vomiting / Q000139:chemically induced
chemical_list: D013792:Thalidomide; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine