Transcript:
Jorge Cortes, MD: So, David, Harry explained something that I merely hope to ask you to tell us a little bit a lot more about, adherence. This is a chronic treatment. Patients take a pill and it goes on for a long time, indefinitely, we’re starting to assess discontinuation, yet at least for a very, quite long time. Exactly how relevant is assessing adherence? Does it matter? Exactly how do we do it?
David Snyder, MD, FACP: No, I believe it is quite important. As Harry said, there are studies showing somewhat intuitive, perhaps, that patients that don’t take their drugs don’t do also as those that take it. There’s likewise data showing a quite large proportion of patients, I believe it’s something enjoy 85% of patients along with CML are not consistently adherent. And I believe that’s an vital issue we should be aware of.
I believe there are two sides of it. One is the patient that is feeling well, their illness is fully controlled, they’re not having edge effects from the drugs. It’s almost enjoy they don’t have actually a reminder that, aah, there’s something wrong here, I should make certain I take my drug to remind them every day. And so people, busy along with their everyday lives, they tend to forget. Especially if it’s a drug that they have actually to take a lot more compared to once a day, there’s more possibility that they’ll miss out on a dose here and there. So I believe that’s one portion of it.
The various other portion is concerning a few of the complications that Harry explained concerning the ongoing sort of nagging edge effects. For most of the patients, the edge effects that occur, which are common, tend to be reduced grade, grade 1 or 2, and they tend to be transient. However, we already know that a few of the patients have actually ongoing reduced grade toxicity that’s sort of constantly there. That could be a demand for them to say, oh, I should take a break; I requirement a little holiday. So, it’s vital to be aware of that.
We do have actually selections of various other TKIs. If there’s an issue concerning this sort of nagging ongoing edge effects, that’s something to address, and potentially think about a modification to permit them to be a lot more adherent.
Jorge Cortes, MD: I believe one of perhaps the most telling studies, these from David Marin, that showed among these patients that had been on treatment for a long time, and they measured adherence by this device in the cap and he showed that patients that had at least 10% of the dose, the probability of achieving these deeper responses, MR 4.5 was 0%. So it doesn’t take as well numerous doses to miss out on and that’s why a few of these tips actually tell us that as soon as the patient is not reaching these endpoints, the very first thing you do is examine adherence and exactly what is maybe interfering along with adherence since it’s quite important.
David Snyder, MD, FACP: I echo exactly what Harry said concerning meeting on an ongoing basis along with the patient. My patients already know that I’m going to be checking the PCR and they frequently sort of confess to me. “Oh, I took that journey from the country and I left my drug at home. Do you believe that’s going to prove to up?” And most likely it will certainly and I believe it’s vital to emphasize that.
Jorge Cortes, MD: Okay. A great deal of exactly what we’ll be discussing has actually to do along with monitoring the patient and all these aspects that are so important for assessing the response. Exactly how do you monitor patients, Kevin, in the clinic? I’m talking concerning enjoy a newly diagnosed patient. Exactly how do you do the monitoring?
Kevin Kelly, MD, PhD: Yes, certainly. I tend to follow the NCCN Guidelines. For safety considerations, I examine CBC and chemistry every two weeks for the very first two months, then I pay close focus to the three months BCR-ABL time point. This is a essential milestone, as we alluded to earlier, since patients that achieve BCR-ABL, much less compared to 10% at three months have actually a much better overall survival. Of course, we don’t necessarily should act immediately if they’re slightly above 10%. So we have actually that six-month time point, too, where we can easily make a change, particularly if they’re still above 10% at the six- month time point. then I keep on to examine BCR-ABL every three months until the patient achieves a significant molecular response.
You do have actually the option after that to maybe extend it out to every 6 months, but, as Harry said, we enjoy to see these patients on a frequent basis. So, typically, if they’re coming to the office anyhow, we keep on to examine their BCR-ABL, so every three months.
Then as soon as the patient reaches BCR-ABL much less compared to 1%, which we said was sort of equivalent to a finish cytogenetic response, we frequently times do a bone marrow biopsy to confirm the presence of a finish cytogenetic response. So we’ve moved away from doing A great deal of bone marrow biopsies and I believe A great deal of patients are quite grateful for that as soon as we can easily examine BCR-ABL. yet there still is a role for bone marrow biopsies, particularly as soon as the BCR-ABL is hovering above the 1% mark, and we hope to confirm that they’ve lost a finish cytogenetic response.
Jorge Cortes, MD: Harry, Exactly how frequently do you do the BCR on your patients and does it modification over time or is it constant?
Harry Erba, MD, PhD: Well, the very first point I’d enjoy to make concerning that is I constantly do it at baseline and it’s not to get hold of a patient personal value. That’s not truly the importance, despite the fact that there is some data from Australia that Exactly how a lot it goes down by three months could be as vital as this 10% level. yet the genuine demand for doing it is that there will certainly be rare patients that will certainly have actually variant fusions of BCR and ABL where the commercially available PCR assays will certainly not detect it efficiently. And so the very best time to already know this is as soon as the patient shows up and they have actually a white count of 100,000 and you get hold of a BCR-ABL result of .1% or negative.
So I do every one of three assays at the beginning, chromosomes, FISH, and PCR since that’s the very best time to have actually your baseline. after that you already know the assay is informative, then I do it every three months starting at three months. And I do it to make certain they’re meeting their milestones and I constantly likewise do it as a method of checking adherence.
Let’s say the patient has actually gotten in to a significant molecular remission, yet one time they come in and it’s merely a little bit higher. So it went from .02 to .08 and hasn’t gone up 10-fold, they haven’t lost an MMR, we’re not so worried, your nurse calls the patient and the patient gets the result and they’re worried. And they could say, eeh, I didn’t tell Doc Erba that I was not taking the drug. I’m going to make certain I’m a little bit a lot more compliant. So I believe using it likewise as a method of ensuring compliance can easily be quite practical for our patients, so at baseline and every three months. And I keep on to do that. Patients that achieve a finish molecular remission that live far from our center, maybe every 6 months.
Transcript Edited for Clarity
Panelists:Jorge E. Cortes, MD, University of Texas MD Anderson Cancer Center; Harry P. Erba, MD, PhD, University of Alabama; Kevin Kelly, MD, PhD, University of Southern California; Javier Pinilla-Ibarz, MD, PhD, Moffitt Cancer Center; David S. Snyder, MD, FACP, City of Hope
Published Online: Tuesday, February 9, 2016
Transcript:
Jorge Cortes, MD: So, David, Harry explained something that I merely hope to ask you to tell us a little bit a lot more about, adherence. This is a chronic treatment. Patients take a pill and it goes on for a long time, indefinitely, we’re starting to assess discontinuation, yet at least for a very, quite long time. Exactly how relevant is assessing adherence? Does it matter? Exactly how do we do it?
David Snyder, MD, FACP: No, I believe it is quite important. As Harry said, there are studies showing somewhat intuitive, perhaps, that patients that don’t take their drugs don’t do also as those that take it. There’s likewise data showing a quite large proportion of patients, I believe it’s something enjoy 85% of patients along with CML are not consistently adherent. And I believe that’s an vital issue we should be aware of.
I believe there are two sides of it. One is the patient that is feeling well, their illness is fully controlled, they’re not having edge effects from the drugs. It’s almost enjoy they don’t have actually a reminder that, aah, there’s something wrong here, I should make certain I take my drug to remind them every day. And so people, busy along with their everyday lives, they tend to forget. Especially if it’s a drug that they have actually to take a lot more compared to once a day, there’s more possibility that they’ll miss out on a dose here and there. So I believe that’s one portion of it.
The various other portion is concerning a few of the complications that Harry explained concerning the ongoing sort of nagging edge effects. For most of the patients, the edge effects that occur, which are common, tend to be reduced grade, grade 1 or 2, and they tend to be transient. However, we already know that a few of the patients have actually ongoing reduced grade toxicity that’s sort of constantly there. That could be a demand for them to say, oh, I should take a break; I requirement a little holiday. So, it’s vital to be aware of that.
We do have actually selections of various other TKIs. If there’s an issue concerning this sort of nagging ongoing edge effects, that’s something to address, and potentially think about a modification to permit them to be a lot more adherent.
Jorge Cortes, MD: I believe one of perhaps the most telling studies, these from David Marin, that showed among these patients that had been on treatment for a long time, and they measured adherence by this device in the cap and he showed that patients that had at least 10% of the dose, the probability of achieving these deeper responses, MR 4.5 was 0%. So it doesn’t take as well numerous doses to miss out on and that’s why a few of these tips actually tell us that as soon as the patient is not reaching these endpoints, the very first thing you do is examine adherence and exactly what is maybe interfering along with adherence since it’s quite important.
David Snyder, MD, FACP: I echo exactly what Harry said concerning meeting on an ongoing basis along with the patient. My patients already know that I’m going to be checking the PCR and they frequently sort of confess to me. “Oh, I took that journey from the country and I left my drug at home. Do you believe that’s going to prove to up?” And most likely it will certainly and I believe it’s vital to emphasize that.
Jorge Cortes, MD: Okay. A great deal of exactly what we’ll be discussing has actually to do along with monitoring the patient and all these aspects that are so important for assessing the response. Exactly how do you monitor patients, Kevin, in the clinic? I’m talking concerning enjoy a newly diagnosed patient. Exactly how do you do the monitoring?
Kevin Kelly, MD, PhD: Yes, certainly. I tend to follow the NCCN Guidelines. For safety considerations, I examine CBC and chemistry every two weeks for the very first two months, then I pay close focus to the three months BCR-ABL time point. This is a essential milestone, as we alluded to earlier, since patients that achieve BCR-ABL, much less compared to 10% at three months have actually a much better overall survival. Of course, we don’t necessarily should act immediately if they’re slightly above 10%. So we have actually that six-month time point, too, where we can easily make a change, particularly if they’re still above 10% at the six- month time point. then I keep on to examine BCR-ABL every three months until the patient achieves a significant molecular response.
You do have actually the option after that to maybe extend it out to every 6 months, but, as Harry said, we enjoy to see these patients on a frequent basis. So, typically, if they’re coming to the office anyhow, we keep on to examine their BCR-ABL, so every three months.
Then as soon as the patient reaches BCR-ABL much less compared to 1%, which we said was sort of equivalent to a finish cytogenetic response, we frequently times do a bone marrow biopsy to confirm the presence of a finish cytogenetic response. So we’ve moved away from doing A great deal of bone marrow biopsies and I believe A great deal of patients are quite grateful for that as soon as we can easily examine BCR-ABL. yet there still is a role for bone marrow biopsies, particularly as soon as the BCR-ABL is hovering above the 1% mark, and we hope to confirm that they’ve lost a finish cytogenetic response.
Jorge Cortes, MD: Harry, Exactly how frequently do you do the BCR on your patients and does it modification over time or is it constant?
Harry Erba, MD, PhD: Well, the very first point I’d enjoy to make concerning that is I constantly do it at baseline and it’s not to get hold of a patient personal value. That’s not truly the importance, despite the fact that there is some data from Australia that Exactly how a lot it goes down by three months could be as vital as this 10% level. yet the genuine demand for doing it is that there will certainly be rare patients that will certainly have actually variant fusions of BCR and ABL where the commercially available PCR assays will certainly not detect it efficiently. And so the very best time to already know this is as soon as the patient shows up and they have actually a white count of 100,000 and you get hold of a BCR-ABL result of .1% or negative.
So I do every one of three assays at the beginning, chromosomes, FISH, and PCR since that’s the very best time to have actually your baseline. after that you already know the assay is informative, then I do it every three months starting at three months. And I do it to make certain they’re meeting their milestones and I constantly likewise do it as a method of checking adherence.
Let’s say the patient has actually gotten in to a significant molecular remission, yet one time they come in and it’s merely a little bit higher. So it went from .02 to .08 and hasn’t gone up 10-fold, they haven’t lost an MMR, we’re not so worried, your nurse calls the patient and the patient gets the result and they’re worried. And they could say, eeh, I didn’t tell Doc Erba that I was not taking the drug. I’m going to make certain I’m a little bit a lot more compliant. So I believe using it likewise as a method of ensuring compliance can easily be quite practical for our patients, so at baseline and every three months. And I keep on to do that. Patients that achieve a finish molecular remission that live far from our center, maybe every 6 months.
Transcript Edited for Clarity
Latest Videos
$related_videos$
