Edoxaban for treatment of venous thromboembolism in patient groups with different types of cancer: Results from the Hokusai VTE Cancer study

Mulder, Frits I.; Es, Nick van; Kraaijpoel, Noémie; Nisio, Marcello Di; Carrier, Marc; Duggal, Anil; Gaddh, Manila; García, David; Grosso, Michael; Kakkar, Ajay K.; Mercuri, Michele; Middeldorp, Saskia; Royle, Gordon; Segers, Annelise; Shivakumar, S; Verhamme, Peter; Wang, T.; Weitz, Jeffrey I.; Zhang, G.; Büller, Harry R.; Raskob, Gary E.

doi:10.1016/j.thromres.2019.11.007

Cited by 59 publications

(60 citation statements)

References 13 publications

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“…After exclusion of 716 records based on information drawn from title and abstract, 39 records were selected for full‐text assessment. Of those, we identified 4 clinical trials contributing to 9 different publications, including 5 publications on specific subgroups or post hoc analysis or on outcomes during extended treatment beyond 6 months 12‐15,22‐26 . Figure 1 shows a Preferred Reporting Items for Systematic Reviews and Meta‐Analyses flow diagram, which summarizes the process of study identification and selection 27 …”

Section: Resultsmentioning

confidence: 99%

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Direct oral anticoagulants compared to low‐molecular‐weight heparin for the treatment of cancer‐associated thrombosis: Updated systematic review and meta‐analysis of randomized controlled trials

Moik

Posch

Zielinski

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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Background Low‐molecular‐weight‐heparins (LMWHs) have been established for the treatment of cancer‐associated venous thromboembolism (VTE). Recently published randomized controlled trials (RCTs) have compared direct oral anticoagulants (DOACs) with LMWHs. The aim of this systematic review and meta‐analysis was to evaluate efficacy and safety of DOACs versus LMWHs and update the evidence for treatment of VTE in cancer. Methods Biomedical databases were screened for RCTs evaluating DOACs for cancer‐associated VTE. Primary efficacy and safety outcomes of this meta‐analysis were recurrent VTE and major bleeding at 6 months. Secondary outcomes comprised clinically relevant nonmajor bleeding (CRNMB), major gastrointestinal (GI) and genitourinary bleeding, mortality, fatal bleeding/pulmonary embolism, and treatment discontinuation rate. We performed prespecified subgroup analyses. Pooled relative risk (RR) and 95% confidence intervals (CIs) were obtained by the Mantel‐Haenszel method within a random‐effect model. Results We screened 759 articles and included 4 RCTs (n = 2894). DOACs significantly reduced recurrent VTEs compared to LMWHs (5.2% vs 8.2%; RR, 0.62 [95% CI, 0.43‐0.91]), but were associated with a nonsignificant increase in major bleedings (4.3% vs 3.3%; RR, 1.31 [95% CI, 0.83‐2.08]) and a significant increase in CRNMB (10.4% vs 6.4%; RR, 1.65 [95% CI, 1.19‐2.28]). Mortality risks were comparable between groups (RR, 0.99 [95% CI, 0.83‐1.18]). Preterm treatment discontinuation was less common with DOACs (RR, 0.88 [95% CI, 0.81‐0.96]). Major bleeding was more frequent in patients with GI cancer treated with DOACs (RR, 2.30 [95% CI, 1.08‐4.88]). Conclusion In patients with cancer‐associated VTE, DOACs are more effective in preventing recurrent VTE compared to LMWH. However, risk of bleeding is increased with DOACs, especially in patients with GI cancer.

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Section: Resultsmentioning

confidence: 99%

“…We conducted a subgroup analysis of risk of major bleeding in patients with GI cancer, including colorectal, gastric, gastroesophageal, pancreatic, and hepatobiliary cancer. Detailed data for a 6‐month observation period were available for Hokusai VTE Cancer and SELECT‐D (aggregated n = 1452; 33% GI cancer) 12,13,22 …”

Section: Resultsmentioning

confidence: 99%

Direct oral anticoagulants compared to low‐molecular‐weight heparin for the treatment of cancer‐associated thrombosis: Updated systematic review and meta‐analysis of randomized controlled trials

Moik

Posch

Zielinski

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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“…The DOAC edoxaban was not inferior to LWMH. In a recent subgroup analysis, data for 111 patients with hematological malignancies including the 40 patients with lymphoma were presented, and no difference in the primary outcome during the 12-month observation period between edoxaban and dalteparin was observed (8.9% and 10.9%) [58].…”

Section: Treatment and Prophylaxis Of Vte In Lymphomasmentioning

confidence: 99%

Venous Thromboembolism in Lymphoma: Risk Stratification and Antithrombotic Prophylaxis

Hohaus

Bartolomei

Cuccaro

et al. 2020

Cancers

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Lymphoma is listed among the neoplasias with a high risk of venous thromboembolism (VTE). Risk factors for VTE appear to differ from risk factors in solid tumors. We review the literature of the last 20 years for reports identifying these risk factors in cohorts consisting exclusively of lymphoma patients. We selected 25 publications. The most frequent studies were analyses of retrospective single-center cohorts. We also included two reports of pooled analyses of clinical trials, two meta-analyses, two analyses of patient registries, and three analyses of population-based databases. The VTE risk is the highest upfront during the first two months after lymphoma diagnosis and decreases over time. This upfront risk may be related to tumor burden and the start of chemotherapy as contributing factors. Factors consistently reported as VTE risk factors are aggressive histology, a performance status ECOG ≥ 2 leading to increased immobility, more extensive disease, and localization to particular sites, such as central nervous system (CNS) and mediastinal mass. Association between laboratory values that are part of risk assessment models in solid tumors and VTE risk in lymphomas are very inconsistent. Recently, VTE risk scores for lymphoma were developed that need further validation, before they can be used for risk stratification and primary prophylaxis. Knowledge of VTE risk factors in lymphomas may help in the evaluation of the individual risk-benefit ratio of prophylaxis and help to design prospective studies on primary prophylaxis in lymphoma.

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“…Furthermore, a pan-cancer score should ideally have a similar benefit-risk trade-off of the treatment regimen for all cancer types. It has been acknowledged, however, that the efficacy and safety of DOACs in treatment of VTE may vary across cancer types [41,42,75,76]. For example, a substantial difference in the risk of VTE was observed between pancreatic and non-pancreatic cancer patients in the CASSINI trial.…”

Section: Where Do We Standmentioning

confidence: 99%

Primary Thromboprophylaxis in Ambulatory Cancer Patients: Where Do We Stand?

Mulder

Bosch

2020

Cancers

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Venous thromboembolism (VTE), comprising deep-vein thrombosis and pulmonary embolism, is a frequent complication in ambulatory cancer patients. Despite the high risk, routine thromboprophylaxis is not recommended because of the high number needed to treat and the risk of bleeding. Two recent trials demonstrated that the number needed to treat can be reduced by selecting cancer patients at high risk for VTE with prediction scores, leading the latest guidelines to suggest such an approach in clinical practice. Yet, the interpretation of these trial results and the translation of the guideline recommendations to clinical practice may be less straightforward. In this clinically-oriented review, some of the controversies are addressed by focusing on the burden of VTE in cancer patients, discussing the performance of available risk assessment scores, and summarizing the findings of recent trials. This overview can help oncologists, hematologists, and vascular medicine specialists decide about thromboprophylaxis in ambulatory cancer patients.

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Edoxaban for treatment of venous thromboembolism in patient groups with different types of cancer: Results from the Hokusai VTE Cancer study

Cited by 59 publications

References 13 publications

Direct oral anticoagulants compared to low‐molecular‐weight heparin for the treatment of cancer‐associated thrombosis: Updated systematic review and meta‐analysis of randomized controlled trials

Direct oral anticoagulants compared to low‐molecular‐weight heparin for the treatment of cancer‐associated thrombosis: Updated systematic review and meta‐analysis of randomized controlled trials

Venous Thromboembolism in Lymphoma: Risk Stratification and Antithrombotic Prophylaxis

Primary Thromboprophylaxis in Ambulatory Cancer Patients: Where Do We Stand?

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