A follow-up to my last post on Tazemetostat, an newly approved EZH2 inhibitor:
At the same time it was approved by the FDA, a new test to detect EZH2 mutations was also approved. The test takes a DNA sample (the mutation is to a gene that is part of the DNA) and is able to find the mutation very quickly -- results will come in less than a day. If a mutation is detected, the patient would be eligible for Tazemetostat, and may benefit from it.
Another piece of FDA news: The makers of Umbralisib have submitted a Rolling New Drug Application for previously treated Follicular Lymphoma (and Marginal Zone Lymphoma, another indolent blood cancer).
A "Rolling Submission" for the FDA means the makers can submit parts of the application one at a time, rather than all at once. As you might guess, an FDA application is pretty large. Being able to submit parts of it, and get feedback tat can help with the other parts still to come, is a great advantage.
Umbralisib is a dual inhibitor of PI3 kinase-delta and CK1-epsilon
proteins, both of which are necessary for cancer cells to grow. The application to the FDA is based on results from the phase 2b UNITY-NHL trial, which looked at Umbralisib in combination with some other agents, in a few different types of Non Hodgkin's Lymphoma, including Follicular Lymphoma.
As always, we'll keep an eye on this one.
Saturday, June 27, 2020
Tuesday, June 23, 2020
FDA Approval: Tazemetostat for Follicular Lymphoma
Some FDA Approval News in the last week: Tazemetostat, also known as Tazverik. Tazemetostat is an EZH2 inhibitor.
EZH2 is short for "Enhancer of Zeste Homolog 2." I'm not sure how much it's worth breaking this down, but basically, EZH2 is an enzyme that is controlled by the EZH2 gene. It's job is to regulate tumor growth, so when there is a problem with it, tumors grow.
Tazemetostat is an inhibitor, which means it stops something from happening. In this case, it stops the EZH2 that isn't doing its job. So: cancer cells grow because EZH2 is letting them. Tazemetostat comes in and tells EZH2 to get back to work and stop those cancer cells.
The approval is for Follicular Lymphoma patients who are dealing with one of two situations: 1) a test shows that that they have an EZH2 gene mutation, and they have already had at lest two treatments already, or 2) the patient has no satisfactory treatment alternative.
That first one sounds great. There were two groups in the trial that led to the approval. One involved 42 patients with EZH2 mutation. The Overall Response Rate was 69%, with 12% getting a Complete Response and 57% getting a Partial Response. The second trial involved 53 patients with Wild-Type EZH2 mutation (a different type of mutation). In this group, there was a 34% Response Rate, with 4% getting a Complete Response and 30% Partial. About 30% of patients in the trial had serious side effects, and 8% of patients had to stop the trial because of it.
Tazemetostat is the first FDA approved treatment for patients with an EZH2 mutation. That mutation can affect a whole bunch of cancers. Having a treatment That targets it is important.
I'll be honest -- I'm having a hard time getting excited about this one. (And I say this while reminding everyone that I am not a doctor or a cancer researcher -- I'm just a cancer patient who reads a lot.) Part of my muted excitement comes from this affecting a fairly small group of FL patients. Not all of us have it; one study put it at "more than 25%" of us (I assume it's not much more than 25% or they'd have said so). And while EZH2 mutation is very serious, and this will help those who have that mutation, the numbers are very good, but the Complete Responses are kind of low.
And that's what concerns me about the second approval -- patients who have no satisfactory treatment alternative. That's going to give oncologists some room to use this. It will probably be their decision when it comes to figuring out whether or not there are alternatives.
The FDA gave this an Accelerated Approval. This means that, essentially, clinical trials will continue to make sure Tazemetostat is as effective and safe as the early trials seem to show. That's a good thing. It will give doctors more data to help determine which patients this could be useful for.
In general, I think that more treatments are a great thing. More arrows in the quiver, as an oncologist told me years ago. More choices to go to, when the ones we've tried have stopped working.
And this one is no different. Another choice is good, especially for patients with the EZH2 mutations. It will be interesting to see what happens as clinical trials continue.
EZH2 is short for "Enhancer of Zeste Homolog 2." I'm not sure how much it's worth breaking this down, but basically, EZH2 is an enzyme that is controlled by the EZH2 gene. It's job is to regulate tumor growth, so when there is a problem with it, tumors grow.
Tazemetostat is an inhibitor, which means it stops something from happening. In this case, it stops the EZH2 that isn't doing its job. So: cancer cells grow because EZH2 is letting them. Tazemetostat comes in and tells EZH2 to get back to work and stop those cancer cells.
The approval is for Follicular Lymphoma patients who are dealing with one of two situations: 1) a test shows that that they have an EZH2 gene mutation, and they have already had at lest two treatments already, or 2) the patient has no satisfactory treatment alternative.
That first one sounds great. There were two groups in the trial that led to the approval. One involved 42 patients with EZH2 mutation. The Overall Response Rate was 69%, with 12% getting a Complete Response and 57% getting a Partial Response. The second trial involved 53 patients with Wild-Type EZH2 mutation (a different type of mutation). In this group, there was a 34% Response Rate, with 4% getting a Complete Response and 30% Partial. About 30% of patients in the trial had serious side effects, and 8% of patients had to stop the trial because of it.
Tazemetostat is the first FDA approved treatment for patients with an EZH2 mutation. That mutation can affect a whole bunch of cancers. Having a treatment That targets it is important.
I'll be honest -- I'm having a hard time getting excited about this one. (And I say this while reminding everyone that I am not a doctor or a cancer researcher -- I'm just a cancer patient who reads a lot.) Part of my muted excitement comes from this affecting a fairly small group of FL patients. Not all of us have it; one study put it at "more than 25%" of us (I assume it's not much more than 25% or they'd have said so). And while EZH2 mutation is very serious, and this will help those who have that mutation, the numbers are very good, but the Complete Responses are kind of low.
And that's what concerns me about the second approval -- patients who have no satisfactory treatment alternative. That's going to give oncologists some room to use this. It will probably be their decision when it comes to figuring out whether or not there are alternatives.
The FDA gave this an Accelerated Approval. This means that, essentially, clinical trials will continue to make sure Tazemetostat is as effective and safe as the early trials seem to show. That's a good thing. It will give doctors more data to help determine which patients this could be useful for.
In general, I think that more treatments are a great thing. More arrows in the quiver, as an oncologist told me years ago. More choices to go to, when the ones we've tried have stopped working.
And this one is no different. Another choice is good, especially for patients with the EZH2 mutations. It will be interesting to see what happens as clinical trials continue.
Thursday, June 18, 2020
ASCO Review: PET Scans as Predictors
As promised, here's the other interesting ASCO presentation about the GALLIUM trial:
"First-line immunochemotherapy for Follicular Lymphoma in the GALLIUM study: Prognostic value of PET-CT status after long-term follow-up."
It's especially interesting to me after I saw the response to the Bone Marrow Biopsy research that I posted about a few days ago. Sometimes I'm surprised at what people respond to so passionately, and the BMB post was one of those things. I think, as patients, we are interested in testing, since it's something we all have in common. We haven't all had the same treatments -- I can't tell you anything about what it feels like to get CHOP. But we all know how it feels to have a really good phlebotomist, don't we? One that takes a blood sample and does it so smoothly that we can barely feel it happening? Same for something like a BMB or PET scans. We've almost all been through them. And if you're like me, you have strong opinions about them.
Back to this ASCO presentation:
The GALLIUM trial was created to compare Rituxan with Obinutuzumab by looking a large sample (about 1200 Follicular Lymphoma patients) and comparing how they responded to R+ chemo + R Maintenance versus O + chemo + O maintenance. Look here for more on the long-term results.
The trial has been great because it's so large, and because they have been able to track all those patients over a long term (over 6 years, and still going), and look at things besides just the R versus O stuff. For example, for this study, they looked at whether or not PET scans could predict Progression Free Survival and Overall Survival.
The quick answer is: yes, it seems like they can.
The researchers gave PET scans to some of the patients (a total of 595) before they had treatment, and then right after treatments. The scans measured for Complete Metabolic Response. A Metabolic Response is a more accurate way of measuring than a Morphological Response. With a Morphological response, the patient might have clear blood tests, a tumor that has visibly shrunk in size, etc. Could be great news, but could also be hiding something. A PET scan can measure for Metabolic Response, and even though everything looks great on the surface, the scan is sensitive enough to show that there is still some cancer lurking about.
The question is, how sensitive is it? And how useful could it be in predicting a long response?
What the researchers found was that a Complete Metabolic Response -- where the cancer was wiped out completely, according to a PET scan -- was a good way to predict PFS and OS. 63% of patients who had a CMR right after treatment had a 6 year PFS -- the cancer hadn't progressed. Only 23% of patients with a CMR had a 6 year PFS. As for Overall Survival, the 6 year OS for the CMR group was 91%, versus abou 79% for the non-CMR group.
Why does this matter?
If a patient does not have a Complete Metabolic Response, as measured by a PET scan, right after treatment, then chances are good that the cancer will come back at some point. Those patients might need to be checked on more frequently. They might have had a Complete Morphological Response, one that made it seem like everything was all clear, but the PET said otherwise.
Of course, there's no guarantee that someone with a CMR will have a long PFS (as 37% of these patients fund out), and no guarantee that a non-CMR will not have a long PFS (as was my own experience -- my PET right after Rituxan showed some disease remained, and that was over 12 years ago).
But knowing that possibility is greater, that some disease remains, might mean that the oncologist and patient decide that more frequent appointments might be useful, or that maintenance might be a good idea, or that some other kind of salvage treatment (something different to "clean up" what is left) would be useful. It's a good tool to have.
And it confirms that PET scans are useful in some situations, like right after treatment, and right before treatment. In between treatments, when things are going well? Those are less helpful, according to research.
PET scans aren't fun (I dread drinking whatever liquid they ask me to drink), but they don't suck as bad as BMBs, and they have their place. There's a cost -- lots of radiation -- but research like this that helps us understand when they are indeed useful might make the benefits worth the cost.
"First-line immunochemotherapy for Follicular Lymphoma in the GALLIUM study: Prognostic value of PET-CT status after long-term follow-up."
It's especially interesting to me after I saw the response to the Bone Marrow Biopsy research that I posted about a few days ago. Sometimes I'm surprised at what people respond to so passionately, and the BMB post was one of those things. I think, as patients, we are interested in testing, since it's something we all have in common. We haven't all had the same treatments -- I can't tell you anything about what it feels like to get CHOP. But we all know how it feels to have a really good phlebotomist, don't we? One that takes a blood sample and does it so smoothly that we can barely feel it happening? Same for something like a BMB or PET scans. We've almost all been through them. And if you're like me, you have strong opinions about them.
Back to this ASCO presentation:
The GALLIUM trial was created to compare Rituxan with Obinutuzumab by looking a large sample (about 1200 Follicular Lymphoma patients) and comparing how they responded to R+ chemo + R Maintenance versus O + chemo + O maintenance. Look here for more on the long-term results.
The trial has been great because it's so large, and because they have been able to track all those patients over a long term (over 6 years, and still going), and look at things besides just the R versus O stuff. For example, for this study, they looked at whether or not PET scans could predict Progression Free Survival and Overall Survival.
The quick answer is: yes, it seems like they can.
The researchers gave PET scans to some of the patients (a total of 595) before they had treatment, and then right after treatments. The scans measured for Complete Metabolic Response. A Metabolic Response is a more accurate way of measuring than a Morphological Response. With a Morphological response, the patient might have clear blood tests, a tumor that has visibly shrunk in size, etc. Could be great news, but could also be hiding something. A PET scan can measure for Metabolic Response, and even though everything looks great on the surface, the scan is sensitive enough to show that there is still some cancer lurking about.
The question is, how sensitive is it? And how useful could it be in predicting a long response?
What the researchers found was that a Complete Metabolic Response -- where the cancer was wiped out completely, according to a PET scan -- was a good way to predict PFS and OS. 63% of patients who had a CMR right after treatment had a 6 year PFS -- the cancer hadn't progressed. Only 23% of patients with a CMR had a 6 year PFS. As for Overall Survival, the 6 year OS for the CMR group was 91%, versus abou 79% for the non-CMR group.
Why does this matter?
If a patient does not have a Complete Metabolic Response, as measured by a PET scan, right after treatment, then chances are good that the cancer will come back at some point. Those patients might need to be checked on more frequently. They might have had a Complete Morphological Response, one that made it seem like everything was all clear, but the PET said otherwise.
Of course, there's no guarantee that someone with a CMR will have a long PFS (as 37% of these patients fund out), and no guarantee that a non-CMR will not have a long PFS (as was my own experience -- my PET right after Rituxan showed some disease remained, and that was over 12 years ago).
But knowing that possibility is greater, that some disease remains, might mean that the oncologist and patient decide that more frequent appointments might be useful, or that maintenance might be a good idea, or that some other kind of salvage treatment (something different to "clean up" what is left) would be useful. It's a good tool to have.
And it confirms that PET scans are useful in some situations, like right after treatment, and right before treatment. In between treatments, when things are going well? Those are less helpful, according to research.
PET scans aren't fun (I dread drinking whatever liquid they ask me to drink), but they don't suck as bad as BMBs, and they have their place. There's a cost -- lots of radiation -- but research like this that helps us understand when they are indeed useful might make the benefits worth the cost.
Sunday, June 14, 2020
ASCO Review: The GALLIUM Trial
Some more post-game analysis of the ASCO 2020 virtual conference.
There were two presentations on data from the GALLIUM trial. This trial has been really important for Follicular Lymphoma. It was really well designed, and it has looked at a lot of different aspects of FL treatment. On the surface, it's a comparison between Rituxan, the monoclonal antibody that has been around since 1997, and Obinutuzumab, a monoclonal antibody that was created to improve on Rituxan.
What makes it such a great study is that 1) it involves a large number of patients (1202 of them, all getting their first treatment after being diagnoses with FL), and the fact that it is a direct comparison between tow treatments, where half of the participants receive one treatment, and half receive the other. (Some trials give everyone the same treatment, and then compare the results to a study that took place sometime in the past). A large, well-designed study can tell us a lot.
Of course, this is Follicular Lymphoma, the "No Straight Answer Cancer," so even the best studies can be frustrating.
The first presentation from the GALLIUM study was a 5-year follow-up of patients in the study ("Comparison of efficacy and safety with Obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: Updated results from the phase III Gallium Study"). Every trial needs to look at efficacy -- how many patients had a good result from the treatment -- and safety -- what kind of side effects they dealt with.
The GALLIUM study compared Rituxan + chemotherapy, followed by Rituxan maintenance, versus Obinutuzumab + chemotherapy, followed by Obinutuzumab maintenance. There were an equal number of patients getting each treatment, and none of them had received any treatment before the trial. (In the ASCO abstract, Obinutuzumab is known as "G," not "O," for its trade name Gazyva.)
It's interesting to look back at a blog post I wrote in 2007 about the trial. The 5 years results from ASCO are pretty much the same story as in 2017. The Obinutuzumab group had a better Progression Free Survival than the Rituxan group: 70.5% of the O patients had their disease remain stable, vs 63.2% for the R group. Also, patients whose disease progressed within 2 years was lower in the O group than the R group (this group is known as POD24, progression of disease within 24 months, and they often have worse prognosis than other FL patients). The percentage of POD24 patients in the O group was 9.2%, versus 16.3% in the R group.
On the other hand, patients in the O group had a higher rate of serious side effects that the R group (19.7% versus 16.8%), mostly related to neutropenia, a low level of neutrophils, a type of white blood cell. This can lead to increased risk of infections.
Also, there was virtually no difference in Overall Survival between the two groups. 90.2% of patients on the O group were alive at the 5 year mark, versus 89.4% of the R group. Both are considered high by the researchers.
So after 5 years, there's not much change than what we saw after 2 years. Better PFS for Obinutuzumab + chemo + O maintenance, but slightly worse side effects, and no difference in OS.
What's the practical outcome of all of this? The researchers say Obinutuzumab should be considered the better choice for first treatments with immunochemotherapy.
Will that actually happen? Hard to say. I've certainly seen more talk online from patients who are getting O as part of their treatment, but there are still plenty getting Rituxan, too. My guess (and this is only a guess) is that some doctors will continue to g with Rituxan out of habit, since there isn't (in their opinion) enough of a difference to make them switch. Speaking from my own experience, when I talked to my oncologist about possible treatments (if and when I need treatment again), he mentioned trying Rituxan again, since it worked well the first time, but didn't bring up Obinutuzumab at all. Maybe that would come up if Rituxan stopped working?
I don't think Rituxan is a bad choice at all, so don't be worried if that's the one you've been going with. They both result in excellent Overall Survival, which is really the important thing.
But if the choice is a possibility, it's worth talking about with your doctor.
I'll get to that other GALLIUM trial presentation next time.
There were two presentations on data from the GALLIUM trial. This trial has been really important for Follicular Lymphoma. It was really well designed, and it has looked at a lot of different aspects of FL treatment. On the surface, it's a comparison between Rituxan, the monoclonal antibody that has been around since 1997, and Obinutuzumab, a monoclonal antibody that was created to improve on Rituxan.
What makes it such a great study is that 1) it involves a large number of patients (1202 of them, all getting their first treatment after being diagnoses with FL), and the fact that it is a direct comparison between tow treatments, where half of the participants receive one treatment, and half receive the other. (Some trials give everyone the same treatment, and then compare the results to a study that took place sometime in the past). A large, well-designed study can tell us a lot.
Of course, this is Follicular Lymphoma, the "No Straight Answer Cancer," so even the best studies can be frustrating.
The first presentation from the GALLIUM study was a 5-year follow-up of patients in the study ("Comparison of efficacy and safety with Obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: Updated results from the phase III Gallium Study"). Every trial needs to look at efficacy -- how many patients had a good result from the treatment -- and safety -- what kind of side effects they dealt with.
The GALLIUM study compared Rituxan + chemotherapy, followed by Rituxan maintenance, versus Obinutuzumab + chemotherapy, followed by Obinutuzumab maintenance. There were an equal number of patients getting each treatment, and none of them had received any treatment before the trial. (In the ASCO abstract, Obinutuzumab is known as "G," not "O," for its trade name Gazyva.)
It's interesting to look back at a blog post I wrote in 2007 about the trial. The 5 years results from ASCO are pretty much the same story as in 2017. The Obinutuzumab group had a better Progression Free Survival than the Rituxan group: 70.5% of the O patients had their disease remain stable, vs 63.2% for the R group. Also, patients whose disease progressed within 2 years was lower in the O group than the R group (this group is known as POD24, progression of disease within 24 months, and they often have worse prognosis than other FL patients). The percentage of POD24 patients in the O group was 9.2%, versus 16.3% in the R group.
On the other hand, patients in the O group had a higher rate of serious side effects that the R group (19.7% versus 16.8%), mostly related to neutropenia, a low level of neutrophils, a type of white blood cell. This can lead to increased risk of infections.
Also, there was virtually no difference in Overall Survival between the two groups. 90.2% of patients on the O group were alive at the 5 year mark, versus 89.4% of the R group. Both are considered high by the researchers.
So after 5 years, there's not much change than what we saw after 2 years. Better PFS for Obinutuzumab + chemo + O maintenance, but slightly worse side effects, and no difference in OS.
What's the practical outcome of all of this? The researchers say Obinutuzumab should be considered the better choice for first treatments with immunochemotherapy.
Will that actually happen? Hard to say. I've certainly seen more talk online from patients who are getting O as part of their treatment, but there are still plenty getting Rituxan, too. My guess (and this is only a guess) is that some doctors will continue to g with Rituxan out of habit, since there isn't (in their opinion) enough of a difference to make them switch. Speaking from my own experience, when I talked to my oncologist about possible treatments (if and when I need treatment again), he mentioned trying Rituxan again, since it worked well the first time, but didn't bring up Obinutuzumab at all. Maybe that would come up if Rituxan stopped working?
I don't think Rituxan is a bad choice at all, so don't be worried if that's the one you've been going with. They both result in excellent Overall Survival, which is really the important thing.
But if the choice is a possibility, it's worth talking about with your doctor.
I'll get to that other GALLIUM trial presentation next time.
Wednesday, June 10, 2020
ASCO Review: Bone Marrow Biopsies Still Suck
I'm at that point now where I'm going back to ASCO presentations and describing the ones that I find interesting. Not necessarily the most ground-breaking or important, but interesting (even if it's just interesting to me).
This one caught my eye, because it immediately made me think about something I saw on Twitter about two months ago that made me laugh.
The ASCO presentation is called "Relevance of bone marrow biopsies for response assessment in National Clinical Trials Network follicular lymphoma clinical trials."
The tweet that made me laugh came as Covid-19 testing was really getting started. If you're unaware, Covid-19 tests (at least the ones that I have seen) involve having a long swab put up your nose so it can get a sample from your sinus. A friend described it to me as "having someone poke your brain for 20 seconds." What made me laugh was seeing someone complain about how unpleasant the test was. Another cancer patient commented, "Unpleasant? These people have obviously never had a bone marrow biopsy. Suck it up, Buttercup."
(I really do enjoy hearing other cancer patients describe experiences that I can relate to.)
If you or a loved one were lucky enough not to have a BMB, it's one of the diagnostic tools that doctors use to stage a patient's lymphoma. By taking a sample of bone marrow (which involves getting into a patient's bone), the doctor can tell if the lymphoma cells have gone beyond the lymph nodes, which would make the patient stage 4.
But here's the problem -- stage doesn't really impact treatment as much as grade does. In other words, stage 3 and stage 4 are usually treated the same; the treatment will get to the cancer cells no matter where they are. Grade, however, is often a measure of how aggressive the cancer is. More aggressive lymphoma can mean more aggressive treatment.
This ASCO presentation looked at whether bone marrow biopsies had any impact on treatment. Did having the results of a BMB change things for the patient?
The short answer is, No.
Researchers looked at 580 Follicular Lymphoma patients from 7 clinical trials, who had BMBs before treatment. Some also had a BMB treatment. They also had scans before and after treatment. By comparing those patients who had the post-treatment BMB with those who didn't, and then tracking their progress, the researchers found that there was no difference in either Progression Free Survival or Overall Survival. In other words, having the BMBs didn't help researchers predict how well they would do. That only happened in 5 of the 580 patients -- less than 1%. The scans did a better job of helping doctors understand how well patients were doing.
If that's the case, then why bother with Bone Marrow Biopsies? At the very least, a post-treatment BMB seems unnecessary, since it doesn't tell the doctors anything useful, it costs time and money, and it might discourage patients from being art of clinical trials (something the researchers are especially concerned about).
I don't think BMBs are going away as part of the first tests that patients get right after diagnosis. But I'm all for doing away with unnecessary pain and expense after that.
It's a fairly small point, affecting a fairly small group of patients (no one mentioned a second BMB to me after treatment, though they might be a more common practice in clinical trials). But it is a nice study in getting the lymphoma community to think more about Quality of Life -- how the need for information has to be balanced with the needs of patients -- our time, money, and physical comfort.
There's been a lot happening in the last few years on testing and over-testing, and I'm happy to see a little more like this. It's another reason to think BMBs suck.
This one caught my eye, because it immediately made me think about something I saw on Twitter about two months ago that made me laugh.
The ASCO presentation is called "Relevance of bone marrow biopsies for response assessment in National Clinical Trials Network follicular lymphoma clinical trials."
The tweet that made me laugh came as Covid-19 testing was really getting started. If you're unaware, Covid-19 tests (at least the ones that I have seen) involve having a long swab put up your nose so it can get a sample from your sinus. A friend described it to me as "having someone poke your brain for 20 seconds." What made me laugh was seeing someone complain about how unpleasant the test was. Another cancer patient commented, "Unpleasant? These people have obviously never had a bone marrow biopsy. Suck it up, Buttercup."
(I really do enjoy hearing other cancer patients describe experiences that I can relate to.)
If you or a loved one were lucky enough not to have a BMB, it's one of the diagnostic tools that doctors use to stage a patient's lymphoma. By taking a sample of bone marrow (which involves getting into a patient's bone), the doctor can tell if the lymphoma cells have gone beyond the lymph nodes, which would make the patient stage 4.
But here's the problem -- stage doesn't really impact treatment as much as grade does. In other words, stage 3 and stage 4 are usually treated the same; the treatment will get to the cancer cells no matter where they are. Grade, however, is often a measure of how aggressive the cancer is. More aggressive lymphoma can mean more aggressive treatment.
This ASCO presentation looked at whether bone marrow biopsies had any impact on treatment. Did having the results of a BMB change things for the patient?
The short answer is, No.
Researchers looked at 580 Follicular Lymphoma patients from 7 clinical trials, who had BMBs before treatment. Some also had a BMB treatment. They also had scans before and after treatment. By comparing those patients who had the post-treatment BMB with those who didn't, and then tracking their progress, the researchers found that there was no difference in either Progression Free Survival or Overall Survival. In other words, having the BMBs didn't help researchers predict how well they would do. That only happened in 5 of the 580 patients -- less than 1%. The scans did a better job of helping doctors understand how well patients were doing.
If that's the case, then why bother with Bone Marrow Biopsies? At the very least, a post-treatment BMB seems unnecessary, since it doesn't tell the doctors anything useful, it costs time and money, and it might discourage patients from being art of clinical trials (something the researchers are especially concerned about).
I don't think BMBs are going away as part of the first tests that patients get right after diagnosis. But I'm all for doing away with unnecessary pain and expense after that.
It's a fairly small point, affecting a fairly small group of patients (no one mentioned a second BMB to me after treatment, though they might be a more common practice in clinical trials). But it is a nice study in getting the lymphoma community to think more about Quality of Life -- how the need for information has to be balanced with the needs of patients -- our time, money, and physical comfort.
There's been a lot happening in the last few years on testing and over-testing, and I'm happy to see a little more like this. It's another reason to think BMBs suck.
Sunday, June 7, 2020
ASCO: Survivorship (Happy Survivors Day)
Today is National Cancer Survivors Day in the U.S. Not sure if that's a thing in other countries, but here, it's a chance to celebrate surviving.
(And as much as I try not to, every time I see the Survivors Day logo, I can't help but think of the figure skater Katarina Witt and the massive crush I had on her when I was a teenager.)
The folks who organize the day define a survivor as anyone who has received a cancer diagnosis, and is still living. You don't need to be in remission. You don't need to be 5 years out from hearing the news. If you were diagnosed yesterday, and you're reading this today, then you're a survivor.
I like that definition. In the 12+ years since I was diagnosed with Follicular Lymphoma, I have kind of wrestled with what other people should call me. Or what I should call myself. But I like that I can be a "survivor" while I still consider myself (and call myself) a "cancer patient."
Twelve and a half years. I've done some surviving.
It's interesting, looking at the ASCO presentations this year, that they don't always look at it that way, at least officially. They organize their presentations by cancer type -- breast, colon, blood, etc. But they also have a category called "Symptoms and Survivorship." As if half of that group is about having cancer, the symptoms, and the other half is about what to do when the symptoms are gone, the surviving.
I guess it's just easier to think about things in those terms. I mean, when you're dealing with the symptoms, you're not really thinking about what to do after they're gone. And when they're gone, you want to think about anything but the symptoms, right?
That might be a little harder for us with Follicular Lymphoma. I know I've spent a lot of time thinking about both things -- even when there are no symptoms, they're always in the back of my head. That little bump on my neck might be a mosquito bite. But it might not be.
I think there's some recognition of this in oncology, not just in FL circles. Palliative care is an example. If you know the term, you probably associate it with end-of-life care. Palliative care involves "making the patient comfortable" when there are no more treatment options. But even though that's what we often think of when we hear those words, Palliative Care is offered at all levels of a disease. The idea is to not just make someone comfortable in their last days, but to help with Quality of Life in all of their time as a patient.
It's not just about dealing with symptoms. It's about living as a survivor, no matter how many days it's been since diagnosis.
There were 362 presentations on Palliative Care at ASCO this year. They run the whole range of thinking about what Palliative Care means. One study looked at 8636 patients with solid tumors in a large oncology practice. Patients had to be referred to an outside palliative care specialist before 2017. But after a Palliative Care specialist was added to the practice, the use of palliative care went up 600%. That's not end-of-life care. It's care at every stage of patients' time with cancer.
Another looked at the more common type of Palliative Care, and studied leukemia patients. When palliative care experts were involved with their end-of-life care, they were more likely to get hospice care and have a better quality of end-of-life care. But even there, the researchers suggested that there needs to be more exploration of palliative care much earlier, when patients are still being actively treated, and the effectiveness should be measured in how Quality of Life is improved.
The bigger point here is that oncology seems to be willing to think more carefully about what it means to be a patient vs. a survivor vs. someone at end-of-life. It might be easier to put someone with cancer into one of those three boxes, because it's just easier to think about that way. But easier isn't better.
And we need to remember to think about ourselves in those more complicated terms, too.
The things that survivors need -- mental and emotional support, a good diet and lots of exercise, palliative care for ongoing side effects of treatment -- we need those things no matter where we are with lymphoma. We need to learn to deal with where we are now, but also where we want to be in the future.
That's not always easy. But it's our life as FL patients. I remember, early on after diagnosis, saying No to a lot of things because it didn't make sense to do them when I didn't know what the future would bring. I stopped doing that after a while, and I'm glad I did. I learned to live in the in-between. I learned I could be a patient and a survivor at the same time.
You should do. Take care of yourself and be vigilant the way a patient does. But also live your life like it's all in the past. It might be for a long time.
(And as much as I try not to, every time I see the Survivors Day logo, I can't help but think of the figure skater Katarina Witt and the massive crush I had on her when I was a teenager.)
The folks who organize the day define a survivor as anyone who has received a cancer diagnosis, and is still living. You don't need to be in remission. You don't need to be 5 years out from hearing the news. If you were diagnosed yesterday, and you're reading this today, then you're a survivor.
I like that definition. In the 12+ years since I was diagnosed with Follicular Lymphoma, I have kind of wrestled with what other people should call me. Or what I should call myself. But I like that I can be a "survivor" while I still consider myself (and call myself) a "cancer patient."
Twelve and a half years. I've done some surviving.
It's interesting, looking at the ASCO presentations this year, that they don't always look at it that way, at least officially. They organize their presentations by cancer type -- breast, colon, blood, etc. But they also have a category called "Symptoms and Survivorship." As if half of that group is about having cancer, the symptoms, and the other half is about what to do when the symptoms are gone, the surviving.
I guess it's just easier to think about things in those terms. I mean, when you're dealing with the symptoms, you're not really thinking about what to do after they're gone. And when they're gone, you want to think about anything but the symptoms, right?
That might be a little harder for us with Follicular Lymphoma. I know I've spent a lot of time thinking about both things -- even when there are no symptoms, they're always in the back of my head. That little bump on my neck might be a mosquito bite. But it might not be.
I think there's some recognition of this in oncology, not just in FL circles. Palliative care is an example. If you know the term, you probably associate it with end-of-life care. Palliative care involves "making the patient comfortable" when there are no more treatment options. But even though that's what we often think of when we hear those words, Palliative Care is offered at all levels of a disease. The idea is to not just make someone comfortable in their last days, but to help with Quality of Life in all of their time as a patient.
It's not just about dealing with symptoms. It's about living as a survivor, no matter how many days it's been since diagnosis.
There were 362 presentations on Palliative Care at ASCO this year. They run the whole range of thinking about what Palliative Care means. One study looked at 8636 patients with solid tumors in a large oncology practice. Patients had to be referred to an outside palliative care specialist before 2017. But after a Palliative Care specialist was added to the practice, the use of palliative care went up 600%. That's not end-of-life care. It's care at every stage of patients' time with cancer.
Another looked at the more common type of Palliative Care, and studied leukemia patients. When palliative care experts were involved with their end-of-life care, they were more likely to get hospice care and have a better quality of end-of-life care. But even there, the researchers suggested that there needs to be more exploration of palliative care much earlier, when patients are still being actively treated, and the effectiveness should be measured in how Quality of Life is improved.
The bigger point here is that oncology seems to be willing to think more carefully about what it means to be a patient vs. a survivor vs. someone at end-of-life. It might be easier to put someone with cancer into one of those three boxes, because it's just easier to think about that way. But easier isn't better.
And we need to remember to think about ourselves in those more complicated terms, too.
The things that survivors need -- mental and emotional support, a good diet and lots of exercise, palliative care for ongoing side effects of treatment -- we need those things no matter where we are with lymphoma. We need to learn to deal with where we are now, but also where we want to be in the future.
That's not always easy. But it's our life as FL patients. I remember, early on after diagnosis, saying No to a lot of things because it didn't make sense to do them when I didn't know what the future would bring. I stopped doing that after a while, and I'm glad I did. I learned to live in the in-between. I learned I could be a patient and a survivor at the same time.
You should do. Take care of yourself and be vigilant the way a patient does. But also live your life like it's all in the past. It might be for a long time.
Wednesday, June 3, 2020
ASCO Review: Lots of CAR-T Stuff
I had hoped to write something about what I learned on Day 3 of the ASCO conference, but I've been busy with work and I've barely had a chance to think about it. I did learn a lot that day, it had a lot to do with the place that patients have in the oncology community. I'll get to it.
For now, a quick look at one of the hot topics of the ASCO conference: CAR-T. There were dozens of presentations about various CAR-T treatments. Not all were about Follicular Lymphoma. But it's clear that CAR-T treatments are one of those approaches that oncologists are excited about, and are putting a lot of hope into.
(And looking back at what I write about day 1 and day 2 of the conference, it seems like most cancer folks are going with the "we should be excited!" approach to CAR-T form day 1, rather than the "we need to learn a lot more!" approach of day 2, which is interesting.)
So here's a quick run down of some more of the CAR-T stuff that came out of the ASCO conference (and this is just some, not all, by any means):
For now, a quick look at one of the hot topics of the ASCO conference: CAR-T. There were dozens of presentations about various CAR-T treatments. Not all were about Follicular Lymphoma. But it's clear that CAR-T treatments are one of those approaches that oncologists are excited about, and are putting a lot of hope into.
(And looking back at what I write about day 1 and day 2 of the conference, it seems like most cancer folks are going with the "we should be excited!" approach to CAR-T form day 1, rather than the "we need to learn a lot more!" approach of day 2, which is interesting.)
So here's a quick run down of some more of the CAR-T stuff that came out of the ASCO conference (and this is just some, not all, by any means):
- One of the ways around the high expense of CAR-T is by developing an "off the shelf" version. In other words, instead of a treatment that is made for each individual patient, there could be a version that works for everyone who wants it. Results of a phase 1 study trying to do that: "First-in-human data of ALLO-501 and ALLO-647 in relapsed/refractory large B-cell or follicular lymphoma (R/R LBCL/FL): ALPHA study." In a very small study of DLBCL and aggressive FL patients, patients were first given a treatment to wipe out most of their existing T cells. Then they were give the "off the shelf" CAR-T. Like personalized CAR-T, this one targets lymphoma cells. But the pre-treatment makes sure that the patient's immune system doesn't get in the way of the new T cells as they go after cancer cells. The treatment was effective (9 patients were evaluated, with 3 Complete Responses and 4 Partial Responses, for a 78% response rate). As a phase 1 trial, safety is a primary concern, and it was shown to be safe, with expected side effects. 9 patients is very, very small, but the results are enough to continue on a larger group. Definitely worth watching.
- Most CAR-T treatments involve targeting of the CD19 protein on the cancer cells. Those kinds of targets are common -- Rituxan goes after the CD20 protein. While targeting CD19 seems effective, some researchers think it contributes to CAR-T being able to work well at first, but then stop working. One presentation, "Safety and efficacy of optimized tandem CD19/CD20 CAR-engineered T cells in patients with relapsed/refractory non-Hodgkin lymphoma," described a CAR-T treatment that targets both CD19 and CD20. Two targets might be better than one. The study described a combined phase 1/phase 2 trial with 99 patients with several different lymphomas, incuding some with FL and transformed FL. Overall, the early results look good, with 84% getting a response after a follow-up of 13.5 months, and the treatment being fairly safe. If the goal, though, is to produce longer responses than CAR-T with only one target, then longer-term follow up is going to be really important. Another one to keep an eye on.
- On the other hand, there was one study of long-term follow-up of CAR-T patients, called "Long-term follow-up of anti-CD19 CAR T-cell therapy for B-cell lymphoma and chronic lymphocytic leukemia." The study describes a group of patients who were given early versions of CAR-T treatment at the National Institute of Health between 2009 and 2015 -- 43 patients in all. They had a variety of lymphomas, including 5 with FL. The overall remission rate was 76%, with 54% complete remission and 22% partial. Long-term side-effects were minimal. Of the patients who had a CR, 15 of the 25 were still in remission. While the long-term effects for some patients were excellent (the FL patients did especially well), they were still limited -- close to the breakdown I have heard (1/3 of patients have a long remission, 1/3 have a shorter remission, and 1/3 have no remission). But these are also patients who had an early version of CAR-T, and the treatment does seem to be improving as researchers learn more from patients who have had some version of it.