Low-molecular-weight heparin in patients with advanced cancer: A phase 3 clinical trial

Kostandinos Sideras, Paul L. Schaefer, Scott Heitaka Okuno, Jeff A Sloan, Leila Kutteh, Tom R. Fitch, Shaker R. Dakhil, Ralph Levitt, Steven Robert Alberts, Roscoe F. Morton, Kendrtth M. Rowland, Paul J. Novotny, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

130 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)758-767
Number of pages10
JournalMayo Clinic Proceedings
Volume81
Issue number6
DOIs
StatePublished - 2006

Fingerprint

Phase III Clinical Trials
Low Molecular Weight Heparin
Survival
Neoplasms
Placebos
Injections
Confidence Intervals
Venous Thromboembolism
Standard of Care
Randomized Controlled Trials
Hemorrhage

Keywords

  • CI = confidence Interval
  • LMWH = low-molecular-weight heparin
  • NCCTG = North Central Cancer Treatment Group
  • QOL = quality of life
  • SDS = symptom distress scale
  • UFH = unfractionated heparin
  • ULN = upper limit of normal

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Low-molecular-weight heparin in patients with advanced cancer : A phase 3 clinical trial. / Sideras, Kostandinos; Schaefer, Paul L.; Okuno, Scott Heitaka; Sloan, Jeff A; Kutteh, Leila; Fitch, Tom R.; Dakhil, Shaker R.; Levitt, Ralph; Alberts, Steven Robert; Morton, Roscoe F.; Rowland, Kendrtth M.; Novotny, Paul J.; Loprinzi, Charles Lawrence.

In: Mayo Clinic Proceedings, Vol. 81, No. 6, 2006, p. 758-767.

Research output: Contribution to journalArticle

Sideras, K, Schaefer, PL, Okuno, SH, Sloan, JA, Kutteh, L, Fitch, TR, Dakhil, SR, Levitt, R, Alberts, SR, Morton, RF, Rowland, KM, Novotny, PJ & Loprinzi, CL 2006, 'Low-molecular-weight heparin in patients with advanced cancer: A phase 3 clinical trial', Mayo Clinic Proceedings, vol. 81, no. 6, pp. 758-767. https://doi.org/10.4065/81.6.758
Sideras, Kostandinos ; Schaefer, Paul L. ; Okuno, Scott Heitaka ; Sloan, Jeff A ; Kutteh, Leila ; Fitch, Tom R. ; Dakhil, Shaker R. ; Levitt, Ralph ; Alberts, Steven Robert ; Morton, Roscoe F. ; Rowland, Kendrtth M. ; Novotny, Paul J. ; Loprinzi, Charles Lawrence. / Low-molecular-weight heparin in patients with advanced cancer : A phase 3 clinical trial. In: Mayo Clinic Proceedings. 2006 ; Vol. 81, No. 6. pp. 758-767.
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abstract = "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.",
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AU - Sloan, Jeff A

AU - Kutteh, Leila

AU - Fitch, Tom R.

AU - Dakhil, Shaker R.

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AU - Alberts, Steven Robert

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AU - Novotny, Paul J.

AU - Loprinzi, Charles Lawrence

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KW - ULN = upper limit of normal

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