Author: By Lynda Williams, Senior medwireNews Reporter
medwireNews: For cancer patients with venous thromboembolism (VTE), study findings indicate that the oral factor Xa inhibitor apixaban is noninferior to the low molecular weight heparin dalteparin for the prevention of recurrent events and does not increase the risk of major bleeding.
The multinational open-label trial included patients with active cancer and symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism, the Caravaggio investigators explain in The New England Journal of Medicine.
Recurrent VTE occurred in 5.6% of the 576 patients who were randomly assigned to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily for 6 months, and 7.9% of the 579 patients who were instead treated with dalteparin at a once-daily dose of 200 IU/kg for 1 month, reduced to a dose of 150 IU/kg for the remaining 5 months.
This gave a hazard ratio of 0.63 in favour of apixaban use with confidence intervals within the prespecified margins for noninferiority compared with dalteparin, report Giancarlo Agnelli, from the University of Perugia in Italy, and co-workers.
The principal safety outcome of major bleeding occurred in a comparable 3.8% of apixaban-treated patients and 4.0% of those given dalteparin, and this was true for both major gastrointestinal (1.9 vs 1.7%) and non-gastrointestinal (1.9 vs 2.2%) bleeding events.
Secondary bleeding outcomes were also statistically comparable in the apixaban and dalteparin groups, such as the cumulative incidence of recurrent VTE or major bleeding (8.9 vs 11.4%) and clinically relevant nonmajor bleeding (9.0 vs 6.0%), although the researchers note that rates of the latter were “numerically higher” with apixaban, as previously reported for oral anticoagulants.
By day 210 of treatment, 23.4% of the apixaban-treated patients had died, as had 26.4% of those given dalteparin. The majority of deaths were attributed to cancer, but each group had four fatal VTE events and two bleeding-related deaths.
Noting that their findings are in line with those reported for VTE treatment in the general population, the Caravaggio investigators write that “[t]aken together, these findings may expand the proportion of patients with both cancer and venous thromboembolism who would be eligible for treatment with apixaban, including patients with gastrointestinal cancer.”
Agnes Lee, from the University of British Columbia in Vancouver, Canada, agrees in an accompanying editorial that the evidence from Caravaggio and the earlier ADAM VTE trial “makes a compelling case for adding apixaban as another anticoagulant option for the treatment of venous thromboembolism in patients with cancer.”
However, she cautions that “it is inappropriate to conclude that one direct oral anticoagulant is better than another without a head-to-head comparison”.
Agnes Lee concludes that clinicians must therefore choose anticoagulants carefully, using “a detailed clinical history, ascertaining the cancer type, status, and treatment, along with bleeding risk, concomitant medications, and the patient’s experiences and values.”
Agnelli G, Becattini C, Meyer G, et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med; Advance online publication 29 March 2020.
Lee AYY. Anticoagulant therapy for venous thromboembolism in cancer. N Engl J Med; Advance online publication 29 March 2020.
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