Hello. I am David Kerr, professor of cancer medicine from the University of Oxford, in England. I want to talk about a study published in the February 15 edition of the New England Journal of Medicine.[1] This was a beautifully well-designed and conducted randomized trial that compared edoxaban, a novel oral anticoagulant, with dalteparin in patients with cancer who had a venous thromboembolism (VTE).
The trials group calls itself the Hokusai Group. For those of you who don’t know Hokusai, he was an important Japanese painter who created many woodblock prints and was a member of the school of ukiyo-e, painters of passing, or everyday, life. There is something about the ephemerality of their art that has always attracted me. Among the more famous paintings are different views of Mount Fuji. My apologies if I am being a smarty pants, a clever clogs. But some of these paintings, particularly The Great Wave, are absolutely beautiful.
This trials group randomly assigned just over 1000 patients to receive oral edoxaban (after 5 days of low-molecular-weight heparin) or subcutaneous dalteparin. It was a noninferiority trial; treatment was given for a minimum of 6 months and a maximum of 12 months after the initial venothrombotic or embolic event. The composite endpoint, which is being used more and more in these trials of novel oral anticoagulants, was the recurrence rates of VTE and major bleeding incidents. The trial showed that edoxaban is not inferior to subcutaneous dalteparin.
Within the composite endpoint, there were fewer further thromboembolic events in the edoxaban arm but more bleeding events in the edoxaban arm. They evened each other out in terms of the noninferiority.
This was quite a useful study. It is an important first step in being able to show that we can substitute useful oral treatment for daily subcutaneous dalteparin. Patients don’t like dalteparin. We’ve all had patients who self-administer dalteparin during chemotherapy, and they are covered in bruises; they are sore. It’s a nuisance and it’s necessary, but if we find that we can substitute edoxaban, which is given orally and is well tolerated, then this is quite an important landmark study.
The major bleeds were predominantly in the upper gastrointestinal (GI) area. Quite a number of the patients who had GI bleeding had previously undergone GI surgery of some sort. Interpret that as you will.
This is an important study—well designed, well conducted, well reported—that tells us that we have a possible alternative to discuss with patients, offering them edoxaban instead of subcutaneous dalteparin.
Thank you for listening. Thank you for allowing me to segue into stories about Hokusai and the painters of ukiyo-e. Think about the passing life, the ephemerality. W.H. Auden called life the gallop to the grave; there’s some truth in that.
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