title: Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.
abstract: BACKGROUND
  Treatment of venous thromboembolism (VTE) in patients with cancer has a high rate of recurrence and bleeding complications. Guidelines recommend low-molecular-weight heparin (LMWH) for at least 3-6 months and possibly indefinitely for patients with active malignancy. There are, however, few data supporting treatment with LMWH beyond 6 months. The primary aim of the DALTECAN study (NCT00942968) was to determine the safety of dalteparin between 6 and 12 months in cancer-associated VTE.
  
  
  METHODS
  Patients with active cancer and newly diagnosed VTE were enrolled in a prospective, multicenter study and received subcutaneous dalteparin for 12 months. The rates of bleeding and recurrent VTE were evaluated at months 1, 2-6 and 7-12.
  
  
  RESULTS
  Of 334 patients enrolled, 185 and 109 completed 6 and 12 months of therapy; 49.1% had deep vein thrombosis (DVT); 38.9% had pulmonary embolism (PE); and 12.0% had both on presentation. The overall frequency of major bleeding was 10.2% (34/334). Major bleeding occurred in 3.6% (12/334) in the first month, and 1.1% (14/1237) and 0.7% (8/1086) per patient-month during months 2-6 and 7-12, respectively. Recurrent VTE occurred in 11.1% (37/334); the incidence rate was 5.7% (19/334) for month 1, 3.4% (10/296) during months 2-6, and 4.1% (8/194) during months 7-12. One hundred and sixteen patients died, four due to recurrent VTE and two due to bleeding.
  
  
  CONCLUSIONS
  Major bleeding was less frequent during dalteparin therapy beyond 6 months. The risk of developing major bleeding complications or VTE recurrence was greatest in the first month of therapy and lower over the subsequent 11 months.
authors.affiliation: University of Rochester Medical Center, Rochester, NY, USA.
authors.forename: C W
authors.initials: CW
authors.lastname: Francis
authors.affiliation: Georgetown University Hospital, Washington, DC, USA.
authors.forename: C M
authors.initials: CM
authors.lastname: Kessler
authors.affiliation: Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: S Z
authors.initials: SZ
authors.lastname: Goldhaber
authors.affiliation: London Health Sciences Centre, London, Ontario, Canada.
authors.forename: M J
authors.initials: MJ
authors.lastname: Kovacs
authors.affiliation: Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Monreal
authors.affiliation: Leiden University Medical Center, Leiden, the Netherlands.
authors.forename: M V
authors.initials: MV
authors.lastname: Huisman
authors.affiliation: University Hospital, Uppsala, Sweden.
authors.forename: D
authors.initials: D
authors.lastname: Bergqvist
authors.affiliation: Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
authors.forename: A G
authors.initials: AG
authors.lastname: Turpie
authors.affiliation: Duke University Medical Center, Durham, NC, USA.
authors.forename: T L
authors.initials: TL
authors.lastname: Ortel
authors.affiliation: University of Rochester Medical Center, Rochester, NY, USA.
authors.forename: A C
authors.initials: AC
authors.lastname: Spyropoulos
authors.affiliation: Medical University of Vienna, Wien, Austria.
authors.forename: I
authors.initials: I
authors.lastname: Pabinger
authors.affiliation: Barts and The London Queen Mary's School of Medicine and Dentistry, London, UK.
authors.forename: A K
authors.initials: AK
authors.lastname: Kakkar
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D002170:Canada; D017985:Dalteparin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D054556:Venous Thromboembolism / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism
chemical_list: D000925:Anticoagulants; D017985:Dalteparin
keywords: cancer; dalteparin; deep vein thrombosis; low-molecular-weight heparin; pulmonary embolism; venous thromboembolism