TY - JOUR
T1 - Low-molecular-weight heparin in patients with advanced cancer
T2 - A phase 3 clinical trial
AU - Sideras, Kostandinos
AU - Schaefer, Paul L.
AU - Okuno, Scott H.
AU - Sloan, Jeff A.
AU - Kutteh, Leila
AU - Fitch, Tom R.
AU - Dakhil, Shaker R.
AU - Levitt, Ralph
AU - Alberts, Steven R.
AU - Morton, Roscoe F.
AU - Rowland, Kendrtth M.
AU - Novotny, Paul J.
AU - Loprinzi, Charles L.
N1 - Funding Information:
This study was conducted as a trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-63826, CA-52352, CA-60276, CA-35431, CA-37417, CA-35101, and CA-35195 from the National Cancer Institute, Department of Health and Human Services .
PY - 2006/6
Y1 - 2006/6
N2 - OBJECTIVE: To prospectively assess whether low-molecular-weight heparin (LMWH) provides a survival benefit in patients with advanced cancer. PATIENTS AND METHODS: Between December 1998 and June 2001, we performed a randomized controlled study of patients with advanced cancer. Initially, the study was double blinded and placebo controlled, with the patients receiving daily injections of 5000 U of LMWH or saline. However, because of low accrual midway through the study, the placebo Injection arm was eliminated, and the study became open labeled, with patients receiving either LMWH injections plus standard clinical care or standard clinical care alone. The primary study end point was overall survival. RESULTS: Of 141 patients randomized to this clinical trial, 3 dropped out, leaving 138 patients. The median survival time was 10.5 months (95% confidence interval, 7.6-12.2 months) for the combined standard care and placebo groups. The median survival time for the combined LMWH arms was 7.3 months (95% confidence interval, 4.8-12.2 months). These median survival times were not significantly different (log-rank P=.46). The median survival times for the blinded and unblinded LMWH groups were 6.2 months and 3.0 months, respectively. The median survival times were 10.3 months for the blinded placebo arm and 10.5 months for the standard care arm. The rate of severe or life-threatening venous thromboembolism was 6% in the LMWH arms and 7% in the control arms. The rate of severe or life-threatening bleeding was 3% in the LMWH arms and 7% in the control arms. CONCLUSION: This trial was unable to demonstrate any survival benefit for LMWH In patients with advanced cancer.
AB - OBJECTIVE: To prospectively assess whether low-molecular-weight heparin (LMWH) provides a survival benefit in patients with advanced cancer. PATIENTS AND METHODS: Between December 1998 and June 2001, we performed a randomized controlled study of patients with advanced cancer. Initially, the study was double blinded and placebo controlled, with the patients receiving daily injections of 5000 U of LMWH or saline. However, because of low accrual midway through the study, the placebo Injection arm was eliminated, and the study became open labeled, with patients receiving either LMWH injections plus standard clinical care or standard clinical care alone. The primary study end point was overall survival. RESULTS: Of 141 patients randomized to this clinical trial, 3 dropped out, leaving 138 patients. The median survival time was 10.5 months (95% confidence interval, 7.6-12.2 months) for the combined standard care and placebo groups. The median survival time for the combined LMWH arms was 7.3 months (95% confidence interval, 4.8-12.2 months). These median survival times were not significantly different (log-rank P=.46). The median survival times for the blinded and unblinded LMWH groups were 6.2 months and 3.0 months, respectively. The median survival times were 10.3 months for the blinded placebo arm and 10.5 months for the standard care arm. The rate of severe or life-threatening venous thromboembolism was 6% in the LMWH arms and 7% in the control arms. The rate of severe or life-threatening bleeding was 3% in the LMWH arms and 7% in the control arms. CONCLUSION: This trial was unable to demonstrate any survival benefit for LMWH In patients with advanced cancer.
KW - CI = confidence Interval
KW - LMWH = low-molecular-weight heparin
KW - NCCTG = North Central Cancer Treatment Group
KW - QOL = quality of life
KW - SDS = symptom distress scale
KW - UFH = unfractionated heparin
KW - ULN = upper limit of normal
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UR - http://www.scopus.com/inward/citedby.url?scp=33744823500&partnerID=8YFLogxK
U2 - 10.4065/81.6.758
DO - 10.4065/81.6.758
M3 - Article
C2 - 16770976
AN - SCOPUS:33744823500
SN - 0025-6196
VL - 81
SP - 758
EP - 767
JO - Mayo Clinic proceedings
JF - Mayo Clinic proceedings
IS - 6
ER -