Prevention of Cancer-Associated Thrombosis

Prevention of cancer-associated thrombosis and ongoing studies

In this section:

Hospitalized patients

Guidelines recommend prophylaxis for most hospitalized patients with cancer and patients undergoing major surgical intervention.

  • The recommended choices include UFH, LMWH, fondaparinux and warfarin depending on the guidelines and circumstances
  • Despite recommendations, underuse of prophylaxis in hospitalized patients with cancer has been reported

Ambulatory patients

Guidelines do not recommend the use of routine thromboprophylaxis in ambulatory cancer patients with solid malignancies, but state that it may be considered in selected high-risk patients.

  • Patients with myeloma (who have the highest risk of thrombosis) are the only patient group with well-defined recommendations for outpatient thromboprophylaxis
  • However, clinical studies have shown a reduction in the incidence of VTE with thromboprophylaxis in several different cancer types (i.e. pancreatic, lung, gastrointestinal)

Summary of guideline recommendations on the management of anticoagulation for the primary prevention of CAT

American Society of Clinical Oncology National Comprehensive Cancer Network European Society for Medical Oncology International Initiative on Thrombosis and Cancer
Hospitalized patients Inpatient: Pharmacological thromboprophylaxis recommended in the absence of bleeding or other contraindications

Perioperative: UFH or LMWH unless contraindicated because of active bleeding or high bleeding risk
Inpatient: LMWH, fondaparinux, UFH or warfarin

Surgery: LMWH, fondaparinux, UFH or warfarin
Inpatient: UFH, LMWH or fondaparinux in hospitalized patients confined to bed

Surgery: LMWH, UFH or fondaparinux
Inpatient: LMWH, UFH or fondaparinux

Surgery: LMWH or UFH

Insufficient evidence to support the use of fondaparinux
Ambulatory patients Routine: Thromboprophylaxis is not recommended, but may be considered for very select high-risk patients

Chemotherapy:
  • LMWH in highly selected outpatients with solid tumours receiving chemotherapy
  • For patients with myeloma, ASA or LMWH (low-risk patients) and LMWH (high-risk patients) in patients receiving thalidomide- or lenalidomide-based regimens with chemotherapy and/or dexamethasone
Routine: VTE prophylaxis not recommended outside of clinical trial settings

Chemotherapy: For patients with myeloma receiving thalidomide, lenalidomide or pomalidomide, ASA (low-risk patients) and LMWH or warfarin (high-risk patients)
Routine: Thromboprophylaxis is not recommended in patients receiving chemotherapy, but may be considered in high-risk patients

Chemotherapy: For patients with myeloma, LMWH or warfarin in patients receiving thalidomide plus dexamethasone or thalidomide plus chemotherapy
Routine: Thromboprophylaxis is not routinely recommended

Chemotherapy:
  • LMWH in patients with locally advanced or metastatic pancreatic or lung cancer treated with systemic anticancer therapy and who have a low bleeding risk
  • VKA, LMWH or ASA in patients treated with thalidomide and lenalidomide combined with steroids and/or other systemic anticancer therapies

To identify high-risk patients who would benefit from thromboprophylaxis, guidelines recommend the use of a validated risk assessment tool, such as the Khorana score.

Khorana score for predicting risk of chemotherapy-associated VTE in patients with cancer

Patient characteristic Score
Site of cancer
Very high risk (stomach, pancreas)
High risk (lung, lymphoma, gynaecological, bladder and testicular)

2
1
Pre-chemotherapy platelet count ≥350,000/mm3 1
Haemoglobin <10 g/dl or use of erythropoiesis-stimulating agents 1
Pre-chemotherapy leukocyte count >11,000/mm3 1
Body mass index ≥35 kg/m2 1

Ongoing studies

Research is ongoing into the prophylactic use of NOACs in CAT (currently an off-label indication) because of some of the limitations associated with LMWH and VKA therapies that can be overcome with NOAC use. Ongoing studies assessing the safety and efficacy of NOACs in primary prevention for ambulatory patients with cancer include the following randomized, double-blind, placebo-controlled studies:

  • AVERT (apixaban): a phase II study with an aim to recruit 574 patients from five centres in Canada
  • CASSINI (rivaroxaban): a phase III, multinational study with an aim to enrol ~700 patients (part of the Cancer Associated thrombosis – expLoring soLutions for patients through Treatment and Prevention with RivarOxaban [CALLISTO] programme)

Ongoing studies for the prevention of VTE with NOACs in patients with cancer

Study drug Clinical study title Study design (estimated enrolment) Primary efficacy endpoint Development status
Apixaban Apixaban for the prevention of VTE in high-risk ambulatory cancer patients (AVERT, NCT02048865) Randomized, placebo-controlled, double-blind (N=574) First episode of objectively confirmed symptomatic or asymptomatic VTE at 7 months Phase II
Rivaroxaban Efficacy and safety of rivaroxaban prophylaxis compared with placebo in ambulatory cancer patients initiating systemic cancer therapy and at high risk for venous thromboembolism (CASSINI, NCT02555878) Randomized, placebo-controlled, double-blind, parallel-group (N≈700) Time from randomization to first occurrence of objectively confirmed symptomatic and asymptomatic VTE at day 180 Phase III

Approval No.: G.COM.GM.XA.12.2017.2017

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