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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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SELECT-D: A randomised control trial of Xarelto vs dalteparin in patients with active cancer

Major Studies

 
Background

  • The risk of recurrent VTE is increased at least two-fold in patients with cancer compared to those without
  • For more than a decade, subcutaneous low-molecular weight heparin ( LMWH ) has been the standard of care

Objective

  • To assess if an oral factor Xa inhibitor, Xarelto, would offer an alternative treatment for VTE in patients with cancer

Study design

  • A multicentre, randomised, open-label, pilot trial in the United Kingdom to investigate patients with active cancer who had symptomatic PE , incidental PE or DVT . Patients were treated with either dalteparin or Xarelto

SELECT-D Study

Endpoints

Primary efficacy outcome

  •  VTE recurrence

Safety outcomes

  • Major bleeding

  • Clinically non-relevant bleeding

Key Findings

  • Over the course of 6 months fewer patients treated with Xarelto experienced a recurrent VTE compared to dalteparin (4% vs 11.0% respectively).

  • Only 54% of patients completed the 6-month duration of study with a median duration of treatment of 5.8 and 5.9 months for dalteparin and Xarelto respectively

  • 4% of patients receiving dalteparin had major bleeds compared with 6% of patients treated with Xarelto.

  • Incidence of fatal bleeding was the same in both groups (0.5%)

  • 7 patients receiving dalteparin experienced CRNMB compared with 25 patients receiving Xarelto (3-fold relative increase).

  • Overall survival at 6 months was 75% for Xarelto (95% CI 69%–81%) and 70% for dalteparin (95% CI 63%–76%).

     

     

 

BID, twice daily; ECOG PS, Eastern Cooperative Oncology Group performance status; LMWH , low-molecular weight heparin; OD, once daily; SC, subcutaneous ; VTE , venous thromboembolism;

*Active cancer was defined as a diagnosis of cancer (other than basal-cell or squamous-cell skin carcinoma) within the previous 6 months, recurrent or metastatic cancer, or cancer not in complete remission.

 

PP-XAR-ALL-1826-1

    • 1
      Young AM, et al. J Clin Oncol. 2018;36:2017–2023.
    • a
      Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism. 
    • b
      subcutaneous = Introduced beneath the skin.
    • c
      Low molecular weight heparin (= LMWH). An anticoagulant used to prevent new clots forming and existing clots from getting larger. It is injected subcutaneously.
    • d
      Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage. 
    • e
      Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal…