Revolution of Therapy in Acute Lymphoblastic Leukemia - Episode 23
Max S. Topp, MD: The inotuzumab trial was published by Hacop Kantarjian, MD, in the New England Journal of Medicine. The trial was just in patients in the first and second salvage setting, being treated with inotuzumab. And it was focusing on 2 endpoints: The primary endpoint was reaching remissions, and their secondary endpoint was OS [overall survival]. The first endpoint was met, but the secondary endpoint was not met, which was a surprise because the response rates were 80%. Everyone thought, Well if you’ve got an 80% response rate, that has to correspond with a chemotherapy, which was a 30% response rate, and that will translate in overall survival. But it didn’t.
So that’s really quite a surprise. Despite having a very effective agent initially, in a reasonably long-term setting, it didn’t show as being very beneficial. So in the field, I’m a little hesitant about those results, personally, and how to interpret it out of caution. Whereas in the blinatumomab trial, with a much more advanced disease-stage setting—because those patients were in the third and fourth salvage setting—there was still an OS benefit between the 2 drugs that they tested: the experimental arm being blinatumomab, and the other arm being chemotherapy. Both were balanced, were all there, and that is more meaningful.
I would use inotuzumab in a more elderly patient population because of the compliancy issues of actually following through a protocol in patients with hyperleukocytosis and in patients with a huge extramedullary disease burden. That’s on a personal level, where I’ve seen that in patients and the circumstances just don’t do too well with blinatumomab. I usually prefer to use inotuzumab in those patients.
The VOD [veno-occulusive disease] is the biggest problem. So we do initial assessment of liver function. And then periodically we’ll look for signs of VOD. It’s difficult to detect, and it’s difficult to treat. There are ID [indentification] problems that can occur. This is chemotherapy, and you deliver it in a smarter way. And there’s the hematoxicities, so we would follow guidance that we usually use when we do regular chemotherapy using growth factors and antibiotic prophylaxis. So it’s very similar to that. It’s not really immunotherapy. It’s just a smarter way of delivering chemotherapy.
Transcript Edited for Clarity