[ Inglês] CML Update From News at ASH 2017

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Topics include: Treatments and Understanding

What’s the latest in CML treatment news? Distinguished CML expert Dr. Michael Mauro from the Memorial Sloan Kettering Cancer Center, joins Patient Power to share the new developments in CML treatment and research released at the 2017 American Society of Hematology (ASH) annual meeting. Watch as he also provides updates on new drugs being investigated in CML clinical trials around the world.  

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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.

Andrew Schorr:

Hello and welcome to Patient Power.  I'm Andrew Schorr in Carlsbad, California, and joining us is one of our favorite experts certainly when it comes to chronic myelogenous leukemia, and that's Dr. Michael Mauro.  He's at Memorial Sloan Kettering Cancer Center in New York.  Welcome back to Patient Power, Dr. Mauro. 

Dr. Mauro:

Thank you, Andrew.  Thanks for having me. 

Andrew Schorr:

So recently we had the big American Society of Hematology meeting, the ASH meeting, and there were thousands of people from around the world, and certainly CML is not cured but many people are doing better with it.  What was the news from ASH related to CML? 

Dr. Mauro:

So right.  So a couple of exciting updates at ASH regarding CML.  Probably the one that also on the heels of the update came an approval was further information about the use of bosutinib (Bosulif) in the frontline setting.  So there's a trial called the BFORE trial where they've now had 18 months of follow-up for patients given either imatinib (Gleevec) or bosutinib in for frontline CML, and this trial as it matures is increasingly showing us that bosutinib has additional benefit just like nilotinib (Tasigna) and dasatinib (Sprycel) do for people with diagnosis, and that actually led to FDA approval right after ASH. 

The ASH meeting data was looking at again the 18-month data for major molecular response and deeper molecular response, and consistently we've seen improvements in the bosutinib arm versus the imatinib arm.  This study of course, like the others, needs to be followed a bit longer so we can look for any differences in toxicity, because that's the real question, the plus versus the minus. 

Imatinib is still is good drug and offers a very high response rate, and the other drugs do as well, but each with a distinct side effect profile.  There are more distinct side effects with bosutinib that are different than nilotinib and dasatinib, for example, GI side effects, liver enzyme elevations are things people need to be aware of.  I think this really—as I was asked about it I said, you know, the more options we have the better we can manage all patients with CML, so I thought this was a real—a real plus. 

There were additional other updates from ASH or reports I think were interesting.  I think when it comes to nilotinib I think a fairly intriguing report came out of France where a study looked at reducing the dose of nilotinib or really looking at response and the preservation of molecular response in people who had been on nilotinib and had that dose reduced for a number of different reasons.  Of course, the overarching question was whether that was to reduce cardiovascular side effects, but in the study called the NILO-RED Study we saw very nice preservation of major molecular response a year after people had dose reductions in nilotinib, and as you might expect probably improved side effects and hopefully improved risk of developing new side effects. 

Whether that should be the standard of care I don't know whether to say that, and there was some discussion in the room after that presentation, but I think that was intriguing and really showing us we are moving through these kind of detailed questions about the dose. 

Just to put in a word for dasatinib, we also had a nice report from a study called the DASFREE trial, which now is giving us more information about people who are on dasatinib and stopping therapy.  So this was an interesting study that it did have some patients who had both frontline and second-line dasatinib, but overall we see basically the same kind of preservation of deep molecular response in the right patients, meaning someone who had had a long and stable deep molecular remission on around 50 percent, 49 percent was the actual report.  So I think we're getting increasingly good data on treatment-free remission, and this report on dasatinib gives us a little bit more solidified data around that drug. 

Lastly, I would comment on a study that's been long running called the EURO-SKI trial, which—this is a very important large treatment-free remission trial.  I think that's probably one of the most exciting questions in CML.  And what this report at ASH on the EURO-SKI trial, what the author showed was analysis trying to answer the question about when is exactly the right time to think about treatment-free remission, is there an ideal time?  How long should someone be in a deep molecular remission?  How long should someone have had their TKI treatment ongoing? 

And given the large number of patients and the ability to look at people with different duration of treatment and different duration of deep molecular remission, they were able to identify what seemed to be a best cutoff of somewhere around five to six years of total TKI treatment and probably on or around three years of deep molecular remission.  And I think it's important to highlight this, because it's a little different than the NCCN guidelines in the U.S. say, so we might see some differences between Europe and the U.S. with regards to how conservative we are around treatment-free remission. 

The other nice thing is with a big study and a lot of data you can model and show, well, like getting interest on a bond in the bank.  What's the gain per year?  And there was a—they were able to demonstrate that there was an absolute increase of 3 percent improvement of being able to come off drug and maintain deep remission year to year for patients as they stayed in deep remission longer. 

So when I talk to people about this I try to share this data and really, hopefully—first off, as people have said, encourage that this is a choice, treatment-free remission, and second, that it's an individualized decision and that being conservative in the absence of ongoing or pressing toxicity questions I think makes sense.  So I think those were for me some of the big highlights. 

There were a few other reports on some things more in development.  Just to mention a few, one was on a drug that should affect the T25I mutation but may not have the risk of, called PF-114.  It's coming out of the Soviet Union, which is an area where you haven't seen primary CML research coming from, and I think that's encouraging.  We see global CML research really blossoming and more to come on that. 

And then a little bit more detail on what cytogenic changes in patients who have gone into remission and who don't have pH positive cells but what we call clonal evolution in cytogenic, the pH negative cells and what the implications of those are, some nice further research into that.  So those were the reports. 

Andrew Schorr:

That's a great report.  So just to summarize a couple things, I want to make sure we all understand.  So first of all, you have more medicines than you've ever had before. 

Dr. Mauro:

True. 

Andrew Schorr:

And you mentioned new approval.  You are having more evidence that some people, and this is a discussion, may be able to go off therapy, right? 

Dr. Mauro:

True. 

Andrew Schorr:

And trying to figure out when and how you measure that, and that's a decision.  I do have a question about that.  If somebody goes off therapy and then there are indications at some later time that they need therapy again, was there a penalty, if you will, for them going off therapy? 

Dr. Mauro:

I think that's probably one of the first and most important questions we had to answer, and I was remarked by the fact that if you look at the aggregate data in treatment-free remission a few facts have emerged.  First of all, when response loss happens it's generally clustered very early, which us kind of a crucial time when we know we need to watch.  And to answer your question, retreatment seems to be remarkably successful with the same drug at the same dose with a very rapid transition back to deep molecular remission.  I don't know if we could say it's absolutely perfect, but we basically put people right back where they were seamlessly. 

There have been—in one study from France someone who did unfortunately transform to a blast phase.  There was a patient in one of the nilotinib discontinuation trials who when they restarted treatment did have a mutation which was nilotinib resistant.  So these issues may arise, but they seem exceedingly rare.  So we can give people the hope that you're not gambling really very much between treatment-free remissions, but that's assuming everything is done under the right circumstances.  And that's I think where the NCCN guidelines in the U.S. are good and hopefully the European guidelines should be no less descriptive and robust.  They should probably be—or maybe even more.  But the burden is on us to make sure we choose properly, we monitor very carefully, and we don't expose people to risk because we're worried about that. 

Andrew Schorr:

Dr. Michael Mauro from Memorial Sloan Kettering Cancer Center in New York, thanks for being with us to give us an update on all the discussions related to CML at ASH.  Thank you. 

Dr. Mauro:

Thank you, Andrew. 

Andrew Schorr:

I'm Andrew Schorr keeping you informed about CML with a noted expert.  Remember, knowledge can be the best medicine of all. 

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.

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Page last updated on April 20, 2018