title: [A randomized trial of irinotecan plus fuorouracil and leucovorin with thalidomide versus without thalidomide in the treatment for advanced colorectal cancer].
abstract: OBJECTIVE
  To evaluate the efficacy, side-effects and quality of life in the advanced colorectal cancer patients treated by irinotecan plus fuorouracil and leucovorin with thalidomide or without thalidomide.
  
  
  METHODS
  Eligible patients were randomly assigned to the treatment group and control group in a 1:1 ratio. In the treatment group, 32 evaluable patients were treated with irinotecan 180 mg/m2 i. v. on day 2, fuorouracil 400 mg/m2 bolus on day 1, 2 at a dose of 1200 mg/m2 civ. for 43 hours; leucovorin 200 mg/m2 i. v. on day 1, 2; thalidomide 300 mg, orally on day 1 - 14, two weeks as a cycle. In the control group, the regimen was the same as in the treatment group except oral intake of thalidomide.
  
  
  RESULTS
  The response rate was 28.1% in the treatment group vs. 15.2% in the control group (P = 0.2034) with a median TTP of 3.8 months vs. 2. 5 months (P = 0.1312). Furthermore, there was no statistically difference either between two groups regarding to adverse effects.
  
  
  CONCLUSIONS
  Irinotecan plus fuorouracil and leucovorin without oral intake of thalidomide is as effective and tolerable as irinotecan plus fuorouracil and leucovorin combined with oral thalidomide for advanced colorectal cancer.
authors.affiliation: Department of Medical Ocology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China.
authors.forename: Hong-gang
authors.initials: HG
authors.lastname: Zhang
authors.forename: Jin
authors.initials: J
authors.lastname: Li
authors.forename: Shu-kui
authors.initials: SK
authors.lastname: Qin
authors.forename: Yan-jun
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Shu-ping
authors.initials: SP
authors.lastname: Song
authors.forename: Da-tong
authors.initials: DT
authors.lastname: Chu
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin