Lead Investigator: Leslie Padrnos, Mayo Clinic
Title of Proposal Research: Efficacy and safety of anticoagulants for the treatment of acute venous thromboembolism (VTE) in patients with hematologic malignancies a systematic review and individual patient level data meta-analysis
Vivli Data Request: 7503, 6635
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Venous thromboembolism (VTE) is a major cause of morbidity and mortality in patients with cancer. Although the relative risk of VTE in cancer patients is up to 50-fold higher than in patients without cancer, the absolute risk varies depending on the subtype of cancer and the cancer treatment, and patient-related factors. The risks of VTE recurrence and bleeding during antithrombotic treatment (also called “blood thinners”, medications that help treat blood clots) for cancer-associated VTE are also higher than in non-cancer patients but vary with each cancer subtype.
Patients with hematologic malignancies, cancers that arise from blood cells like lymphoma or leukemia, represent a diverse group with different thrombosis and bleeding risks. They are typically underrepresented in the few randomized controlled trials evaluating anticoagulant therapy in cancer patients. Consequently, management of blood clots in patients with blood cancers (hematologic malignancy) is typically extrapolated from results based largely on patients with solid tumors, but these populations have many differences including hospitalization rates, risk of infection, use of indwelling catheters, multi-drug treatments with potentially critical drug-drug interactions, and higher likelihood of severe cytopenias that may complicate blood clot management.
The restricted inclusion of hematologic malignancies in thrombosis treatment studies has led to a knowledge deficit regarding anticoagulant safety and efficacy, and thus, optimum management for these patients remains unknown. More precise risk estimates regarding efficacy and safety of anticoagulant modalities in patients with hematologic malignancies may provide valuable information to clinicians that have critical impact on patient outcomes. A systematic review with individual patient-level meta-analysis on treatment of acute VTE in patients with hematologic malignancies can help narrow this knowledge gap.
Requested Studies:
Lee AY et al. Low-molecular weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. NEJM. 2003. Description: patients with cancer and acute venous thromboembolism were randomized to low molecular weight heparin or coumarin.
Data Contributor: Pfizer Inc.
Study ID: Study 98-FRAG-069
DALTECAN Trial (Francis et al. Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study, J Thromb Haemost. 2015).
Data Contributor: Pfizer Inc.
Study ID: FRAG-A001-401
(Note: Additional studies added as part of Data Request 7503)
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00291330
Sponsor ID: 1160.53
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00329238
Sponsor ID: 1160.47
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
Data Contributor: Boehringer Ingelheim
Study ID: NCT00680186
Sponsor ID: 1160.46
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00558259
Sponsor ID: 1160.63
A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT02073682
Sponsor ID: DU176b-D-U311