Tinzaparin in cancer associated thrombosis beyond 6 months: TiCAT study

Jara‐Palomares, Luis; Solier-López, Aurora; Elías, Teresa; Asensio-Cruz, María Isabel; Blasco-Esquivias, Isabel; Marín-Barrera, Lucía; Borbolla-Artacho, Maria Rodriguez de la; Praena-Fernandez, Juan Manuel; Montero-Romero, Emilio; Navarro‐Herrero, Silvia; Serrano-Gotarredona, María Pilar; Sánchez-Díaz, José María; Palacios, Carlos; Otero, Remedios

doi:10.1016/j.thromres.2017.07.004

Cited by 118 publications

(96 citation statements)

References 26 publications

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“…Major bleeding occurred in 26 patients (7.8%) during months 1‐6 and in 8 of 192 patients (4.2%) during months 7‐12. Similar results were reported in the TiCAT study, which evaluated the safety of long‐term tinzaparin use in a prospective cohort of 247 cancer patients with VTE . The cumulative incidences of recurrent VTE at months 1‐6 and 7‐12 were 4.5% (95% CI, 2.2‐7.8) and 1.1% (95% CI, 0.1‐3.9), respectively.…”

Section: Discussionsupporting

confidence: 81%

See 1 more Smart Citation

Extended treatment with edoxaban in cancer patients with venous thromboembolism: A post‐hoc analysis of the Hokusai‐VTE Cancer study

Nisio

Carrier

et al. 2019

Journal of Thrombosis and Haemostasis

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Background Patients with active cancer and venous thromboembolism (VTE) are at high risk of recurrence. Therefore, continued anticoagulant therapy beyond the initial 6 months is suggested in this patient population, but evidence supporting this approach is limited. Methods The Hokusai VTE Cancer trial compared edoxaban with dalteparin for VTE treatment in patients with active cancer. This post hoc analysis focused on the follow‐up period from 6 to 12 months. The primary outcome was the composite of adjudicated first recurrent VTE or major bleeding. Secondary outcomes included recurrent VTE, major bleeding, and clinically relevant bleeding. Results Of the 522 and 524 patients randomized to edoxaban or dalteparin, 294 (56%) received edoxaban and 273 (52%) received dalteparin for more than 6 months (median duration of 318 and 211 days, respectively). Between 6 and 12 months, the primary outcome during study treatment occurred in seven patients (2.4%) in the edoxaban group and six patients (2.2%) in the dalteparin group (unadjusted hazard ratio 1.05; 95% confidence interval, 0.36‐3.05). Recurrent VTE occurred in two patients (0.7%) in the edoxaban group and in three patients (1.1%) in the dalteparin group, whereas major bleeding occurred in 5 (1.7%) and three patients (1.1%), respectively. Conclusions The rates of recurrent VTE or major bleeding are relatively low among patients with active cancer receiving extended anticoagulant therapy beyond 6 months. Extended treatment with oral edoxaban appears as effective and safe as subcutaneous dalteparin.

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Section: Discussionsupporting

confidence: 81%

“…Two prospective cohort studies have evaluated extended anticoagulant therapy beyond the initial 6 months for patients with cancer‐associated thrombosis . In the DALTECAN prospective cohort study, 55% of the 334 patients with VTE and active cancer who were treated with dalteparin completed 6 months and 33% completed 12 months of therapy .…”

Section: Discussionmentioning

confidence: 99%

Extended treatment with edoxaban in cancer patients with venous thromboembolism: A post‐hoc analysis of the Hokusai‐VTE Cancer study

Nisio

Carrier

et al. 2019

Journal of Thrombosis and Haemostasis

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“…These results have recently been confi rmed by data from the TiCAT study showing a favourable safety profi le of therapeutic tinzaparin continued beyond six months for the treatment of cancer-associated VTE [40]. Therefore, in patients with active cancer and a perceived high risk of VTE recurrence (e. g. locally advanced or metastatic disease or ongoing systemic chemotherapy), all guidelines recommend an individual assessment of the benefi t-to-risk ratio of extended (or even indefi nite) anticoagulation [7][8][9][10][11].…”

Section: How Long Should the Patient Be Anticoagulated?mentioning

confidence: 75%

Management of cancer-associated venous thromboembolism – a case-based practical approach

Voigtlaender

2018

Vasa

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Summary:In patients with solid tumours or haematological malignancies, venous thromboembolism (VTE) is a leading cause of death and signifi cantly contributes to morbidity and healthcare resource utilization. Current practice guidelines recommend long-term anticoagulation with low-molecular-weight heparin (LMWH) as the treatment of choice for cancer-associated VTE, based on clinical trial data showing an overall improved safety and effi cacy profi le of LMWH compared to vitamin K antagonists.However, several open questions remain, e. g. with regard to the intensity and duration of LMWH therapy; moreover, recent realworld evidence indicates that adherence to parenteral anticoagulation with LMWH over the course of treatment is poor in clinical practice. In this regard, the direct oral factor Xa or thrombin inhibitors (DOACs) have emerged as potential alternatives in the management of patients with cancer-associated VTE, albeit fi ndings from randomized controlled studies with a direct head-tohead comparison of DOACs with LMWH, the current standard of care, are still lacking. Based on the case of a lymphoma patient experiencing symptomatic pulmonary embolism during immunochemotherapy, this article aims at both highlighting the current state-of-the-art approach to cancer-associated VTE and pointing out some of the unresolved, controversial issues clinicians have to face when taking care of haematology and oncology patients with already established or with high risk of developing VTE. These issues include the management of patients with incidental pulmonary embolism or thrombocytopenia, the use of DOACs, and the initiation of pharmacological thromboprophylaxis in non-surgical cancer patients.

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“…Thirty‐nine patients (15.8%) died during the first 6 months and 30 (12.1%) died during the subsequent 12 months. In TiCAT, rates of clinically relevant bleeding (0.6%) and VTE recurrence (1.1%) during months 7 through 12 following the diagnosis of VTE were low; the event rates during months 1‐6 were 0.9% for clinically relevant bleeding and 4.5% for VTE recurrence . In the Hokusai‐VTE‐Cancer study, a total of 1050 patients were enrolled, with 354 (33.8%) of the 1046 patients included in the intention‐to‐treat analysis completing treatment for 12 months or until study closure (the overall median duration of treatment was 211 days for edoxaban and 184 days for dalteparin).…”

Section: Current Controversies In Catmentioning

confidence: 99%

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Bauersachs¹,

Khorana

Lee

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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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.

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Tinzaparin in cancer associated thrombosis beyond 6 months: TiCAT study

Abstract: Treatment with tinzaparin beyond 6months is safe in patients with CAT.

Cited by 118 publications

References 26 publications

Extended treatment with edoxaban in cancer patients with venous thromboembolism: A post‐hoc analysis of the Hokusai‐VTE Cancer study

Extended treatment with edoxaban in cancer patients with venous thromboembolism: A post‐hoc analysis of the Hokusai‐VTE Cancer study

Management of cancer-associated venous thromboembolism – a case-based practical approach

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

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