Deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively known as venous thromboembolism (VTE), occurs frequently in patients with cancer and contributes to elevated morbidity and mortality. In cancer patients VTE is an important and increasingly frequent clinical challenge.
Roughly one in five cancer patients experiencing venous thromboembolism. Blood clots in the deep veins of the leg may travel to the lungs causing a pulmonary embolism. These two conditions, affect approximately 10 million patients worldwide.
Current international treatment guidelines recommend that cancer patients are injected with an anticoagulant, a low molecular weight heparin, to treat and prevent recurrence of VTE. However, new results from a large, prospective, randomised, open label, multi-center pilot trial run at the University’s Warwick Medical School called ‘select-d’ suggest that a daily tablet could be a beneficial alternative for treating VTE in selected patients. The trial included cancer patients with VTE [symptomatic or incidental pulmonary embolism (iPE) or symptomatic lower extremity proximal deep vein thrombosis (DVT)].
Research led by Professor Annie Young, Ph.D, of Warwick Medical School found that prescribing the oral drug rivaroxaban (Xarelto®; Janssen Pharmaceuticals | licensed from Bayer HealthCare) significantly reduced venous thromboembolism recurrence among patients with cancer and VTE.
“Clinicians were already adopting the oral drug into practice for non-cancer patients and now they have data from this study to indicate that this form of treatment is an alternative option for many cancer patients who have a clot,” Young said.
Results from the study, supported by an unrestricted educational grant from Bayer AG, were published this earlier this month in published in the May 10, 2018 edition of Journal of Clinical Oncology.
Although there are many causes and risk factors for VTE, cancer patients are particularly at risk due to a combination of factors such as immobility (if in bed poorly), pancreatic and gastric tumours, and chemotherapy. Because VTE can be life-threatening, blood thinners are used to shrink existing clots and prevent others from forming.
The ‘select-d’ trial enrolled a total of 406 patients who had cancer and VTE. Most patients (69%) were receiving cancer treatment (typically chemotherapy) at the time of their VTE. Half were randomly assigned to receive low-molecular-weight heparin (dalteparin; 200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6) and half were given the oral drug rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for a total of 6 months).
After six months of treatment, the VTE recurrence rate was 4% (95% CI, 2% to 9%) among those taking a daily tablet of rivaroxaban (hazard ratio [HR], 0.43; 95% CI, 0.19 to 0.99) and 11% in those receiving dalteparin (95% CI, 7% to 16%).
The results for secondary outcomes were mixed.
In patients receiving rivaroxaban, there were around the same percentage of major bleeding events (6%; (95% CI, 3% to 11%) as those receiving dalteparin (4%; 95% CI, 2% to 8%) but a marked and significant increase in clinically relevant non-major bleeds (13%) with rivaroxaban (HR, 1.83; 95% CI, 0.68 to 4.96) compared to those having low molecular weight heparin (4%). The reason for increased bleeding is not known, however, the researchers believe this may be because rivaroxaban is more ‘potent’ than the comparative drug.
“We now need to be sitting down with each one of our cancer patients with VTE, discussing their preference alongside looking at all their clinical details including whether the cancer lesion is still there, what other medications are being taken and what other conditions the patient has so that we can choose the optimal VTE treatment for each patient,” Young concluded.
Last Editorial Review: May 11, 2018
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