Alan Holtzman felt that an angel was on his shoulder when a chance meeting with another CLL patient directed him to a leading specialist. Watch his story.
Why do I have lung cancer if I’ve never smoked? Dianne Stewart, a stage IV cancer patient, asked herself this question following her diagnosis. Hear about her initial stage of shock and denial and her advice for others.
July 9, 2012
Jeffrey Lipton discusses news from ASCO 2012 about how Tasigna could bring faster and deeper responses, taking some newly diagnosed patients all the way to Complete Molecular Response (CMR) well within the first year of therapy. Dr. Lipton explains that the focus in Chronic Myelogenous Leukemia (CML) is moving away from simply keeping patients alive and toward the possibility of a cure and being able to discontinue treatment.
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most appropriate for you.
Welcome to Patient Power.
I’m Andrew Schorr.
In our continuing series on CML, we wanted to connect you with
another expert, this time from Canada.
Dr. Jeffrey Lipton is the head of the CML program at the Princess
Margaret Hospital in Toronto and the Ontario Cancer Institute. Dr. Lipton, thank you so much for being
Dr. Lipton, recently you were a lead investigator and
there were data presented at the American Society of Clinical Oncology (ASCO)
meeting with physicians from all over the world, and you were a lead in the
ENEST-cmr trial. What was that trial
about? What is its significance for
patients with CML?
Well, I think with the success of treatment with drugs like Gleevec
(imatinib) and second-generation drugs over the last number of years we’re no
longer looking at--patients’ are no longer looking at just surviving as an end
point in the disease. Many of us are
looking at the possibility that some patients may be cured. And by “cure” I mean treating their CML and
being able to stop treatment. At this
point in time it’s generally thought that people are on their drugs for life,
but this may not necessarily be the case.
With ENEST-cmr we looked at patients who had not got the type of
response, something called a Complete Molecular Remission, or CMR, that is
necessary to be eligible for a trial in stopping treatment. These are individuals who had had a partial
response, something called a complete cytogenetic remission, and the goal was
to see if we could move more patients into the CMR group and hence be eligible
down the line for a stopping study. So
this was a randomized study of taking patients who had had a complete cytogenetic
response and randomizing them either to stay on their Gleevec (imatinib) or to
switch into a second-generation drug called Tasigna (nilotinib) and see if we
could convert more of them to a better degree of response.
And, how did it work out?
Well, it worked out extremely well. In fact we did get a lot more people moved
into the CMR response, but in fact we got--we had a lot more people respond
regardless of what their baseline response was so that they improved
significantly even with just one year of follow-up, the point where twice as
many people were now in the CMR group as in the Gleevec (imatinib) group and
hence would be eligible for some form of stopping study in the future.
You were getting faster, deeper remissions as people were on Tasigna
(nilotinib) versus Gleevec (imatinib) if I have that right.
That’s correct. In fact Tasigna
(nilotinib) is now approved in many countries including Canada and the United
States for treatment of newly diagnosed patients. This is because in a study called the ENESTnd
it was shown in fact that patients got faster responses and deeper responses
and less progression if they were on the Tasigna (nilotinib) arm than the Gleevec
(imatinib) arm. This study was to take
patients who had been on Gleevec (imatinib) for a period of time before Tasigna
(nilotinib) became available but had not maxed out the type of response we
would like to see and see if we can improve the response by switching them to
what we think is a more powerful drug, and that’s what happened.
So where are we headed, do you think? Could you start a patient on Tasigna
(nilotinib), measure the rapidity and the depth of their response, getting them
to this deep response and then identify them versus someone who didn’t have
such a fast response and say, at this point we now have data to suggest that
you can stop taking medicine, go on with your life?
I think that’s a little more than we would say. We would say that patients with a complete
molecular response are eligible for a study where they can stop treatment. Part of the whole issue of stopping treatment
is monitoring has to be very careful of these individuals because about 60 or
70 percent of them will recur within six months after stopping treatment. But if you monitor them closely, which means
taking what we would normally recommend to be three-monthly monitoring, take it
down to one-monthly monitoring, we can put them all back into remission if we
restart their medication. So it’s important
that this is not the kind of thing that gets done outside of the guidelines of
a study with very close monitoring.
We also know that people who do not have a complete molecular
remission or near-complete molecular remission at the time when they do stop,
their chances of recurrence of the disease is very high. So you really have to get a minimal complete
molecular response in order to be eligible.
So we hope we now have more patients who will be eligible for doing this
under a study, not just off the cuff.
Okay. So people can
discuss whether there might be a study they could participate in, but it’s not
something you do on your own.
Looking ahead though, and I know we’re talking about evidence-based
medicine, do you have a gut feeling about where we may be headed? You’ve been at this a long time. Do you have a feeling that we really could be
at a time where patients who have certain types of responses could be deemed
Well, I guess if you want a cynical definition of cure, it’s
you keep people alive with no chronic myeloid leukemia so that they obviously
at some point in their life are going to die from something else. Really a cure in my mind is you can take a
person with CML and take them off all treatment and have them live a normal
life with no evidence of the CML or side effects of the CML or anything, and I
think that’s where we’re heading. I
think this is fantastic for a lot of people is it now takes the whole concept
of just being worried that you’re going to survive to now saying, well, geez, I
can live a life span the same as anybody else my age with my other health
conditions and I don’t have to worry. I
think that is possible.
We know from the preliminary trials that have gone on around
the world that if you’re a real good risk patient, perhaps 70 percent of these
individuals may be able to stop, and at least with a couple of years of follow-up
that they have not shown any evidence of the CML, even in the whole group
overall this may be as much as a third of patients. So I think that’s important for a number of
different reasons, both the mental state of a patient, the well-being of a
patient, things like patients being able to get on with normal aspects of their
life, such as having children if they’re a woman. I think that makes a big difference in the
quality of life for patients.
Absolutely. Doctor, one
last question, and that is you mentioned about monitoring, but in many areas of
medicine there are prognostic factors or tests right up front. Do you think that could be achieved, where a
patient right at the time of diagnosis there will be some analysis to say, we
believe you will have this sort of response and after this amount of time if
that happens as we expect and we believe based on this up-front test it would,
that you would be able to go on with your life without medicine? That kind of up-front testing, do you think
that might happen?
Well, the only up-front testing that was shown at least in the
preliminary stopping studies were that patients had what is called a low Sokal
score. Sokal score is a way of
classifying patients as either low-, intermediate- or high-risk and that they
had been on Gleevec (imatinib) for a period of time of at least two or three
years. That was really the only thing
that is predictive. It is not related to
the degree of response. We know--now
know that there are some other tests you can do with molecular monitoring that
the response at three months will tell whether some people will get a good
response down the line. It is not at
this point known to be predictive for an ability to stop.
And just tying it all together, as you were saying a minute
ago, it sounds like you are very encouraged.
I’m really encouraged by this.
The results seem very good, and hopefully we will see more patients with
time be able to stop study--go on a stop study and actually stop the drug and
get on with their lives.
Dr. Jeffrey Lipton, head of the CML program at Princess
Margaret Hospital in Toronto, Canada and at the Ontario Cancer Institute, thank
you so much for being with us today.
I’m Andrew Schorr. We’ll
continue to give you updates on the latest in CML.
Thank you for joining us.
Remember, knowledge can be the best medicine of all.
By Andrew Schorr