The effect of low molecular weight heparin on survival in patients with advanced malignancy

Clara P. W. Klerk, Susanne M. Smorenburg, Hans-Martin Otten, Anthonie W. A. Lensing, Martin H. Prins, Franco Piovella, Paolo Prandoni, Monique M. E. M. Bos, Dick J. Richel, Geertjan van Tienhoven, Harry R. Büller

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Purpose: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1 %) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). Concjusion: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation. © 2005 by American Society of Clinical Oncology.
Original languageEnglish
Pages (from-to)2130-2135
JournalJournal of Clinical Oncology
Volume23
Issue number10
DOIs
Publication statusPublished - 2005
Externally publishedYes

Cite this

Klerk, C. P. W., Smorenburg, S. M., Otten, H-M., Lensing, A. W. A., Prins, M. H., Piovella, F., ... Büller, H. R. (2005). The effect of low molecular weight heparin on survival in patients with advanced malignancy. Journal of Clinical Oncology, 23(10), 2130-2135. https://doi.org/10.1200/JCO.2005.03.134
Klerk, Clara P. W. ; Smorenburg, Susanne M. ; Otten, Hans-Martin ; Lensing, Anthonie W. A. ; Prins, Martin H. ; Piovella, Franco ; Prandoni, Paolo ; Bos, Monique M. E. M. ; Richel, Dick J. ; van Tienhoven, Geertjan ; Büller, Harry R. / The effect of low molecular weight heparin on survival in patients with advanced malignancy. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 10. pp. 2130-2135.
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title = "The effect of low molecular weight heparin on survival in patients with advanced malignancy",
abstract = "Purpose: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95{\%} CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3{\%}) of nadroparin-treated patients and in one (1 {\%}) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95{\%} CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95{\%} CI, 0.62 to 1.25). Concjusion: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation. {\circledC} 2005 by American Society of Clinical Oncology.",
author = "Klerk, {Clara P. W.} and Smorenburg, {Susanne M.} and Hans-Martin Otten and Lensing, {Anthonie W. A.} and Prins, {Martin H.} and Franco Piovella and Paolo Prandoni and Bos, {Monique M. E. M.} and Richel, {Dick J.} and {van Tienhoven}, Geertjan and B{\"u}ller, {Harry R.}",
year = "2005",
doi = "10.1200/JCO.2005.03.134",
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pages = "2130--2135",
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Klerk, CPW, Smorenburg, SM, Otten, H-M, Lensing, AWA, Prins, MH, Piovella, F, Prandoni, P, Bos, MMEM, Richel, DJ, van Tienhoven, G & Büller, HR 2005, 'The effect of low molecular weight heparin on survival in patients with advanced malignancy' Journal of Clinical Oncology, vol. 23, no. 10, pp. 2130-2135. https://doi.org/10.1200/JCO.2005.03.134

The effect of low molecular weight heparin on survival in patients with advanced malignancy. / Klerk, Clara P. W.; Smorenburg, Susanne M.; Otten, Hans-Martin; Lensing, Anthonie W. A.; Prins, Martin H.; Piovella, Franco; Prandoni, Paolo; Bos, Monique M. E. M.; Richel, Dick J.; van Tienhoven, Geertjan; Büller, Harry R.

In: Journal of Clinical Oncology, Vol. 23, No. 10, 2005, p. 2130-2135.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - The effect of low molecular weight heparin on survival in patients with advanced malignancy

AU - Klerk, Clara P. W.

AU - Smorenburg, Susanne M.

AU - Otten, Hans-Martin

AU - Lensing, Anthonie W. A.

AU - Prins, Martin H.

AU - Piovella, Franco

AU - Prandoni, Paolo

AU - Bos, Monique M. E. M.

AU - Richel, Dick J.

AU - van Tienhoven, Geertjan

AU - Büller, Harry R.

PY - 2005

Y1 - 2005

N2 - Purpose: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1 %) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). Concjusion: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation. © 2005 by American Society of Clinical Oncology.

AB - Purpose: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1 %) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). Concjusion: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation. © 2005 by American Society of Clinical Oncology.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/15699479

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JO - Journal of Clinical Oncology

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