ASH 2018: Apixaban for the Treatment of Cancer-Associated VTE
According to findings from the ADAM VTE trial, an oral drug, apixaban (Eliquis), is safe and effective in treating blood clots in patients undergoing cancer therapy. The drug was associated with fewer major bleeding events and fewer recurrent blood clots compared to low–molecular-weight. These findings were presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition by Robert McBane II, MD, a cardiologist at the Mayo Clinic (Abstract 421).
“Nearly 1 in 5 patients with cancer will develop a clot in the veins, referred to as either a deep vein thrombosis or pulmonary embolism,” said Dr. McBane in a statement. “Clotting events can be deadly, with pulmonary embolism being the second most common cause of death in [patients with] cancer.” While twice-daily injections of low–molecular-weight heparin has been the traditional treatment of choice for patients with cancer who suffer a venous clot, Dr. McBane notes that there are numerous limitations to this therapy. “These injections can be painful and cause considerable bruising at the injection site. Injections are expensive, at nearly $100 per day. And patients [with cancer] may experience low platelet counts and be at risk for a clotting disorder called heparin-induced thrombocytopenia.” Dr. McBane noted that cancer and cancer treatment can be associated with kidney injury, which can limit the drug’s use further. Finally, Dr. McBane says there isn’t is a good antidote for this medication should a bleeding problem arise.
“More recently, a number of new blood thinners called direct oral anticoagulants have become available,” says Dr. McBane. “As a class, these drugs have a number of advantages, including oral delivery, lack of interactions with foods or other medications, and the lack of a need for monitoring drug levels.” He says these qualities make this class of drug much easier to use than the traditional blood thinners. However, it was unclear whether these drugs could be used safely in patients with cancer until now.
Patients with cancer-associated acute VTE in the ADAM VTE trial were randomly assigned to receive either apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin (Fragmin; 200 IU/kg for 1 month followed by 150 IU/kg once daily) for 6 months.
The primary outcome was major bleeding.
Study Findings
Major bleeding occurred in 0 of the 142 patients (0%) in the apixaban group and in 3 of the 145 patients (2.1%) in the dalteparin group (P = .9956). Recurrent VTE occurred in 5 patients (3.4%) in the apixaban group and 20 patients (14.1%) in the dalteparin group (hazard ratio [HR] = 0.26, 95% confidence interval [CI] = 0.09 – 0.80, P = .0182). Major bleeding plus clinically relevant nonmajor bleeding were similar, at 9% for both groups.
Dr. McBane said quality-of-life surveys, which were taken monthly throughout the 6-month trial, showed that patients markedly preferred oral apixaban over injectable dalteparin when considering concern for excess bruising, stress, irritation, burden of delivery, and overall satisfaction with anticoagulant therapy.
“We are hopeful that this medication will also improve medication compliance in patients [with cancer] requiring blood thinner therapy,” concluded Dr. McBane.
Disclosure: See the study authors’ full disclosures at ash.confex.com.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
