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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=20244376337&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/15699479
U2 - https://doi.org/10.1200/JCO.2005.03.134
DO - https://doi.org/10.1200/JCO.2005.03.134
M3 - Article
C2 - 15699479
SN - 0732-183X
VL - 23
SP - 2130
EP - 2135
JO - Journal of clinical oncology
JF - Journal of clinical oncology
IS - 10
ER -