title: Increased frequency of venous thromboembolism with the combination of docetaxel and thalidomide in patients with metastatic androgen-independent prostate cancer.
abstract: OBJECTIVE
  To evaluate the frequency of venous thromboembolism (VTE) in patients with advanced androgen-independent prostate cancer who were treated with docetaxel alone or in combination with thalidomide.
  
  
  METHODS
  Retrospective analysis of a randomized phase II trial.
  
  
  METHODS
  National Institutes of Health clinical research center.
  
  
  METHODS
  Seventy men, aged 50-80 years, with advanced androgen-independent prostate cancer.
  
  
  METHODS
  Each patient received either intravenous docetaxel 30 mg/m2/week for 3 consecutive weeks, followed by 1 week off, or the combination of continuous oral thalidomide 200 mg every evening plus the same docetaxel regimen. This 4-week cycle was repeated until there was evidence of excessive toxicity or disease progression.
  
  
  RESULTS
  None of 23 patients who received docetaxel alone developed VTE, whereas 9 of 47 patients (19%) who received docetaxel plus thalidomide developed VTE (p=0.025).
  
  
  CONCLUSIONS
  The addition of thalidomide to docetaxel in the treatment of prostate cancer significantly increases the frequency of VTE. Clinicians should be aware of this potential complication when adding thalidomide to chemotherapeutic regimens.
authors.affiliation: Department of Laboratory Medicine, Hematology Service, W.G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892, USA.
authors.forename: McDonald K
authors.initials: MK
authors.lastname: Horne
authors.forename: William D
authors.initials: WD
authors.lastname: Figg
authors.forename: Phil
authors.initials: P
authors.lastname: Arlen
authors.forename: James
authors.initials: J
authors.lastname: Gulley
authors.forename: Catherine
authors.initials: C
authors.lastname: Parker
authors.forename: Nehal
authors.initials: N
authors.lastname: Lakhani
authors.forename: Howard
authors.initials: H
authors.lastname: Parnes
authors.forename: William L
authors.initials: WL
authors.lastname: Dahut
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D043823:Taxoids; D013792:Thalidomide / Q000009:adverse effects* / Q000627:therapeutic use; D020246:Venous Thrombosis / Q000139:chemically induced*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D013792:Thalidomide; D017239:Paclitaxel