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Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.

Publication ,  Journal Article
Francis, CW; Kessler, CM; Goldhaber, SZ; Kovacs, MJ; Monreal, M; Huisman, MV; Bergqvist, D; Turpie, AG; Ortel, TL; Spyropoulos, AC; Pabinger, I ...
Published in: J Thromb Haemost
June 2015

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. FINDINGS: 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. CONCLUSION: 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.

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Published In

J Thromb Haemost

DOI

EISSN

1538-7836

Publication Date

June 2015

Volume

13

Issue

6

Start / End Page

1028 / 1035

Location

England

Related Subject Headings

  • Venous Thromboembolism
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Recurrence
  • Prospective Studies
  • Neoplasms
  • Middle Aged
  • Male
 

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Francis, C. W., Kessler, C. M., Goldhaber, S. Z., Kovacs, M. J., Monreal, M., Huisman, M. V., … Kakkar, A. K. (2015). Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study. J Thromb Haemost, 13(6), 1028–1035. https://doi.org/10.1111/jth.12923
Francis, C. W., C. M. Kessler, S. Z. Goldhaber, M. J. Kovacs, M. Monreal, M. V. Huisman, D. Bergqvist, et al. “Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.J Thromb Haemost 13, no. 6 (June 2015): 1028–35. https://doi.org/10.1111/jth.12923.
Francis CW, Kessler CM, Goldhaber SZ, Kovacs MJ, Monreal M, Huisman MV, et al. Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study. J Thromb Haemost. 2015 Jun;13(6):1028–35.
Francis, C. W., et al. “Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.J Thromb Haemost, vol. 13, no. 6, June 2015, pp. 1028–35. Pubmed, doi:10.1111/jth.12923.
Francis CW, Kessler CM, Goldhaber SZ, Kovacs MJ, Monreal M, Huisman MV, Bergqvist D, Turpie AG, Ortel TL, Spyropoulos AC, Pabinger I, Kakkar AK. Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study. J Thromb Haemost. 2015 Jun;13(6):1028–1035.
Journal cover image

Published In

J Thromb Haemost

DOI

EISSN

1538-7836

Publication Date

June 2015

Volume

13

Issue

6

Start / End Page

1028 / 1035

Location

England

Related Subject Headings

  • Venous Thromboembolism
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Recurrence
  • Prospective Studies
  • Neoplasms
  • Middle Aged
  • Male