Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism (VTE) in patients with active cancer

Cohen, Alexander T.; Maraveyas, Anthony; Beyer‐Westendorf, Jan; Lee, A.Y.Y.; Mantovani, LG; Folkerts, Kerstin; Bach, Miriam; Sanctis, Yoriko De; Abdelgawad, K.

doi:10.1093/annonc/mdz265.020

Cited by 3 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The COSIMO study previously demonstrated that patients with CAT who change their VTE treatment from LMWH, fondaparinux, or a VKA to rivaroxaban in everyday clinical practice experience an improvement in treatment satisfaction. 22 In the current analysis, this study also provided insights into the types of patients selected for and who chose rivaroxaban treatment in routine clinical practice, and associated clinical outcomes. Patients were recruited sequentially, and inclusion and exclusion criteria were minimal; this allowed for insights into the benefit‐risk profile of rivaroxaban across a range of patients with active cancer who have been considered suitable for rivaroxaban by treating physicians, including patients differing from those enrolled in previous RCTs.…”

Section: Discussionmentioning

confidence: 99%

“…Limitations of the COSIMO study have been previously described. 21 , 22 COSIMO was a single‐arm study, and although a comparator intervention might have provided further clinical perspective, a two‐armed noninterventional study would have required propensity score adjustment to address the high levels of heterogeneity in populations of patients with CAT; the larger sample size required for this may have been complicated by recruitment and retention challenges. 33 Because the study was limited to patients switching to rivaroxaban, the possibility of bias according to DOAC selection cannot be excluded.…”

Section: Discussionmentioning

confidence: 99%

Section: All-cause Mortalitymentioning

confidence: 99%

See 2 more Smart Citations

Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

Maraveyas

Beyer‐Westendorf

Lee

et al. 2021

Research and Practice in Thrombosis and Haemostasis

View full text Add to dashboard Cite

Background Patients with cancer‐associated thrombosis (CAT) have a high risk of recurrent venous thromboembolic events, which contribute to significant morbidity and mortality. Direct oral anticoagulants may provide a convenient treatment option for these patients. Objectives To assess clinical characteristics and outcomes of patients with active cancer changing to rivaroxaban after ≥4 weeks of standard therapy for the treatment of venous thromboembolism (VTE) in clinical practice. This analysis focused on secondary outcomes of Cancer‐associated thrOmboSIs – Patient‐reported outcoMes with rivarOxaban (COSIMO). Patients COSIMO was a multinational, prospective, noninterventional, single‐arm cohort study. Overall, 505 patients received at least one dose of rivaroxaban; 96.6% changing from low‐molecular‐weight heparin, 1.6% from a vitamin K antagonist, and 1.8% from fondaparinux. Results Most patients had solid tumors (n = 449; 88.9%) and approximately half of these patients had metastases. The qualifying venous thromboembolic event was deep vein thrombosis (DVT) in 45.3% of patients, pulmonary embolism (PE) in 37.2% of patients, DVT with PE in 9.7% of patients, and catheter‐associated DVT in 7.5% of patients. Approximately 75.1% of patients received rivaroxaban for at least 3 months; 150 (29.7%) patients received concomitant chemotherapy during the study. VTE recurrence, major bleeding, nonmajor bleeding, and major adverse cardiovascular events occurred in 18 (3.6%), 18 (3.6%), 81 (16.0%), and 12 (2.4%) patients, respectively. Conclusions In patients with CAT who changed to rivaroxaban treatment after ≥4 weeks of standard therapy, the observed incidence proportions of recurrent VTE and bleeding events were in keeping with the recognized effectiveness and safety profile of rivaroxaban for the treatment of CAT.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: All-cause Mortalitymentioning

confidence: 99%

See 1 more Smart Citation

Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

Maraveyas

Beyer‐Westendorf

Lee

et al. 2021

Research and Practice in Thrombosis and Haemostasis

View full text Add to dashboard Cite

show abstract

“…5 Direct oral anticoagulants (DOACs) are used for the prevention and treatment of thromboembolic events across several indications, including VTE. The direct factor Xa inhibitors apixaban, edoxaban, and rivaroxaban (and to a lesser extent the direct thrombin inhibitor dabigatran) have been investigated in studies of the prevention [6][7][8] and treatment [9][10][11][12][13][14][15] of VTE in patients with cancer; results from many of these studies are now published. 6,7,[9][10][11] This review details the rationale, study designs, and results (where applicable) of completed and ongoing investigations of DOACs in CAT, with a focus on rivaroxaban and the studies in the CALLISTO (Cancer Associated thrombosis-expLoring soLutions for patients through Treatment and Prevention with RivarOxaban) program (Tables 1 and 2).…”

Section: Introductionmentioning

confidence: 99%

“…The primary outcome was a change in the ACTS Burdens score at week 4 compared with baseline. Patients with CAT reported a durable improvement in anticoagulation-associated treatment satisfaction, specifically a reduction in the perceived burdens of therapy, following the change to rivaroxaban 12. As part of this study, a discrete choice experiment was presented to patients, who were asked to decide between completely hypothetical treatment options based on a combination of different attributes (route of administration [injection/tablet], frequency of intake [once daily/ twice daily], need for regular assessment of international normalized ratio at least every 3-4 weeks [yes/no], and interactions with food/alcohol [yes/no]), regardless of efficacy or safety.…”

mentioning

confidence: 99%

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Bauersachs¹,

Khorana

Lee

et al. 2020

Research and Practice in Thrombosis and Haemostasis

View full text Add to dashboard Cite

Cancer‐associated venous thromboembolism (VTE) is a frequent, potentially life‐threatening event that complicates cancer management. Anticoagulants are the cornerstone of therapy for the treatment and prevention of cancer‐associated thrombosis (CAT); factor Xa–inhibiting direct oral anticoagulants (DOACs; apixaban, edoxaban, and rivaroxaban), which have long been recommended for the treatment of VTE in patients without cancer, have been investigated in this setting. The first randomized comparisons of DOACs against low‐molecular‐weight heparin for the treatment of CAT indicated that DOACs are efficacious in this setting, with findings reflected in recent updates to published guidance on CAT treatment. However, the higher risk of bleeding events (particularly in the gastrointestinal tract) with DOACs highlights the need for appropriate patient selection. Further insights will be gained from additional studies that are ongoing or awaiting publication. The efficacy and safety of DOAC thromboprophylaxis in ambulatory patients with cancer at a high risk of VTE have also been assessed in placebo‐controlled randomized controlled trials of apixaban and rivaroxaban. Both studies showed efficacy benefits with DOACs, but both studies also showed a nonsignificant increase in major bleeding events while on treatment. This review summarizes the evidence base for rivaroxaban use in CAT, the patient profile potentially most suited to DOAC use, and ongoing controversies under investigation. We also describe ongoing studies from the CALLISTO (Cancer Associated thrombosis—expLoring soLutions for patients through Treatment and Prevention with RivarOxaban) program, which comprises several randomized clinical trials and real‐world evidence studies, including investigator‐initiated research.

show abstract

Treatment of Venous Thromboembolism in Special Populations with Direct Oral Anticoagulants

2020

View full text Add to dashboard Cite

As a result of the successful completion of their respective phase III studies compared with vitamin K antagonists (VKAs), four direct oral anticoagulants (DOACs) have been approved for the treatment and secondary prevention of venous thromboembolism (VTE). These DOACs—apixaban, dabigatran, edoxaban, and rivaroxaban—have subsequently seen a steady uptake among clinicians since their approval. Despite the suitability of DOACs for a broad range of patients, they are not appropriate in certain situations, whereas in others they require additional considerations such as dose reductions. Subanalyses of phase III trials and studies on specific VTE patient populations have been conducted to evaluate the safety and efficacy of the DOACs in a broad range of settings, such as patients with renal impairment, patients with cancer, patients of childbearing potential, patients with multiple comorbidities and pediatric patients. Furthermore, many recent guidance documents from important hematological societies and other specialists have incorporated several of these developments. These documents also identify the patients for whom DOACs are not suitable and where traditional anticoagulation options such as heparins or VKAs should be considered instead. This review provides an overview of key VTE patient subgroups, the clinical evidence supporting the use of anticoagulation in these patients, and a discussion of the most appropriate approaches to their management, including considerations such as dosing, acute and extended treatment durations, and DOAC selection.

show abstract

Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism (VTE) in patients with active cancer

Cited by 3 publications

References 0 publications

Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Treatment of Venous Thromboembolism in Special Populations with Direct Oral Anticoagulants

Contact Info

Product

Resources

About