CML News at ASH 2018: Data on Treatment-Free Remission Studies | Transcript | Chronic Myeloid Leukemia (CML) | Patient Power


CML News at ASH 2018: Data From Treatment-Free Remission Studies

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Lee Swanson:

Welcome to Patient Power. I'm Lee Swanson at the American Society of Hematology conference. We're in San Diego, and right now I'm talking with Dr. Michael Savona from Vanderbilt in Nashville. And so, CML, chronic myeloid leukemia, number of different treatments and therapies available. What's going on?

Dr. Savona:

Yeah, well, this meeting at ASH, there has been a lot of new developments in lymphoma and acute myeloid leukemia, which we've been waiting for a long time. And luckily, patients with CML have a lot of therapies available to them, but what we're learning over the past several years is that there are right and wrong ways to administer these therapies.

And there are ways we can keep track of benchmarks the patients are hitting, and we're getting closer to understanding how the immune system can regulate low levels of disease. Specifically, people who are on TKIs, Gleevec or imatinib, dasatinib (Sprycel) or nilotinib (Tasigna), bosutinib (Bosulif), patients can get very, very low disease, low levels of disease with these drugs, with sometimes some very controlled low-level side effects, and then they can even go off the therapy. And we're learning how patients can best prepare to go off of therapy, and at that point, when they're off therapy, how their immune system can best learn to keep the disease away.

So, I can tell you a little bit more about some of the specifics with that. So, we have conducted a variety of treatment-free remission studies, and these TFR studies are looking at how we best position patients before they go off treatment.

Most treatment-free remission studies require patients to be in a deep remission, at least an MMR or a three-log reduction of their BCR-ABL on RT-PCR. And that's the lab value that most CML patients are following when they go to their doctor or their molecular test. If patients can get into a deep 4.5 remission, or between an MMR and a 4.5 remission, and be in that remission for a year, then we know that about half the patients who go off drug can remain off drug and stay in remission. And that's a remarkable finding.

If patients do go off drug, they have to be very careful, and this is one message that we'd like to get out to patients. Because now with these treatment-free remission trial data being available, a lot of patients are just stopping their therapy, and that's dangerous. We do know that if we stop the therapy, and we monitor very closely the molecular level of the BCR-ABL, then it can be safe. And 99 percent of the time, they can restart on the same drug and achieve the remission that they had.

Importantly, the relapses that we have in patients who try this approach, they usually occur in the first six months after stopping their TKI. So, we advise that patients get monthly BCR-ABL checks during that period. And as long as it doesn’t go up, and the discussions with their physician can be watched at intervals farther and farther apart. And this is important, for example, in my area, where I have patients who travel for six hours to come to see me, who just can't come once every three to four weeks. They have to come less frequently.

Lee Swanson:

Absolutely, and so, the patient who may be a candidate to go off therapy has to go through a regimen to do that.

Dr. Savona:

That's right. So, I try to outline that, but to be more specific, this is not something patients should expect when they first go on therapy. But the idea of this is that if patients reach their goal, their benchmarks, and their doctors can—each doctor is taking care of a CML patient should know—we've published through the National Comprehensive Cancer Network and also in the European Leukemia Network, specific benchmark goals that we're supposed to achieve. And if we're hitting those goals at three months, at six months, at 12 months, and we maintain those deep remissions for a long period of time, we know historically that if people maintain those remissions, their chance of doing well with treatment-free remission is quite good.

Lee Swanson:

And that's really encouraging, because leukemia cells have a way of finding their way around treatment and coming back and making the treatment, if they go back on it, not effective again.

Dr. Savona:

Well, that's right, and a few years ago, this would be heretical to give this kind of advice. So, it just goes to show how far we've come, and it gives patients something to look forward to, that possibility of not having to take a pill a day, not having the potential side effects that come with each of these therapies. And they're wonderful therapies, but they do have side effects. And there are some patients who truly suffer with these side effects, so I think any way we can mitigate this is an important strategy. It's important to remember though that these treatment-free remission strategies only are applied in certain circumstances, as I've defined them.

And for patients who are concerned about the disease coming back, of course this is—there are no guarantees. If you stop the medicine, the disease can come back and it could be resistant to the drug, but our clinical trials that we've done, the resistance of the CML when it returns, when it does, it's rarely resistant at all. So, for some patients, especially those with high side effect burdens, toxicity burdens, this is an easy decision to make.

Lee Swanson:

Well, that's great news. And anything else that's come out of the conference or that is going on in your practice you think patients should know about?

Dr. Savona:

Right, right. So, I think that understanding how we can best use TKIs has been our primary concern, since we've developed TKIs in CML in the past decade. The next thing is choosing TKIs, both in resistance and at new diagnosis, choosing the right TKI for patients. Some TKIs have different side effects than others, and some patients have specific risks, if they were to develop a side effect, that it's just not worth taking that drug, for whatever comorbidities that patient may have.

I think the next thing is starting to think about how we make the disease go away and stay away. And what's very encouraging at this conference is, how far the science and molecular biology has come, where we're starting to understand more about the mysteries of the immune system, and how we can manipulate the immune system to learn to keep that tumor in check. And in fact, when patients are in treatment-free remission, there are patients who—for years, there are patients who maintain very low level of disease, and it's thought that the immune system has now the capacity to control that disease. So, just as many times, in the history of CML in the past 20 years, this disease has taught us many lessons that we can apply to taking care of other cancers.

Lee Swanson:

So, you touched on patients you have who travel a long distance to get to you. It's important—I mean, there are a lot of people who don't have access to Vanderbilt or a cancer center, yet they should have some way of being in touch, in one way or another, with a specialist. Just tell me, how do they go about that?

Dr. Savona:

Yeah, I think that we have wonderful relationships with some of the oncology colleagues that we have in the community. Unfortunately, oncology's more and more complex, so those folks are tasked with taking care of breast cancer, anemia, CML, and you can't keep up with all these diseases. And what we try to do is partner with them. So, we might see a new CML patient in a consultation and see them annually or every six months, if they're having difficulties, and communicate with that physician at home. So, of course, tandem healthcare is one approach.

Another approach is using Patient Power and groups like this to take advantage of the Internet, and social media, and capacity to tap into information that, without leaving your home. There's a lot more information available now than there was 15, 20 years ago, where patients really didn’t have too much choice. And of course, there's grassroots societies, like The Leukemia & Lymphoma Society, the MDS Foundation, which have done a wonderful job in patient outreach. And all of us in academic medicine who practice in very specialized areas make some efforts to get out in the community, with these grassroots organizations and to provide some advice.

Lee Swanson:

Well, I appreciate it very much, and I'd like to thank you for taking the time this afternoon.

Dr. Savona:

Oh, it's my pleasure. It was nice meeting you.

Lee Swanson:

Glad to meet you. I'm Lee Swanson. This is the American Society of Hematology conference in San Diego.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Advertisement
Rejoignez notre communauté S'inscrire aux événements Lisez notre dernier blog
Advertisement

Page last updated on January 18, 2019