Wednesday, December 13, 2017

CAR-T Follow-Up

Well, ASH is over, and that means it's time for the press releases from researchers and analyses from experts about what mattered most. I'll keep an eye on it and report back on the good stuff.

One of the outcomes from ASH that has gotten some attention was the updated numbers on CAR-T therapy.

If you've been reading the blog for a while, you are familiar with CAR-T, or Chimeric Antigen Receptor T cell therapy. It's a very recent, very promising treatment that involves removing T cells (a kind of immune cell that usually attacks invaders) from a patient, changing them in a way that makes them recognize cancer cells as invaders, putting them back into the patient, and allowing them to do their job. CAR-T has shown some real promise for Follicular Lymphoma.

You can read more about CAR-T from two readers, Ben and Bill, who run the CAR-T and Follicular Non-Hodgkin's Lymphoma blog. Bill sent me a couple of emails with links (thanks, Bill) -- for a presentation at ASH, and a publication in the New England Journal of Medicine, with updated data on CAR-T treatments in lymphoma, including Follicular Lymphoma. (Ben is a CAR-T patient, as is Bill's wife.)

The NEJM article looks at 111 patients with "refractory large B-cell lymphoma after the failure of conventional therapy." Basically, they haven't been able to get a response with the things they have tried. And that group of large B-cell Lymphoma patients includes patients with Transformed Follicular Lymphoma.

Of the 111 patients, 110 were able to have T cells changed, and 101 of them were able to have them administered.

The Overall Response Rate was 82%, with a Complete Response of 54%. With a Median Follow-Up of 15.4 months, 42% of patients who had a response continued to have one, and 40% of patients who had a Complete Response continued to have one.

Out of this larger group, 16 patients had Transformed Follicular Lymphoma. They were analyzed as part of a slightly larger group of 24 patients (the rest had another type of Lymphoma). In that group of 24, 20 of them had a Response (17 had a Complete Response), and 2 more had Stable Disease.

One of the concerns about CAR-T treatments are the side effects, which can be especially harsh. In the NEJM study, every patient had at least one adverse event. These included neurologic problems and Cytokine Release Syndrome, though they seemed to be controlled, and the treatments to control the symptoms did not seem to have an impact on the treatment. (I get the sense that CAR-T researchers are better prepared for these problems, though I don't want to downplay how serious they are.)

The most important thing to come out of the study is the treatment's durability -- it lasts a while. People who had a response right away continue to have a response.

It seems like CAR-T treatments remain as promising as we had hoped (so far). It will be interesting to see the next long-term follow-up to see if the responses remain as durable as they have been.

Sunday, December 10, 2017

ASH Preview: Quality of Life

The ASH conference is going on this weekend, but I have one more preview. It's a presentation scheduled for tomorrow (Monday, Dec 11): "Changes in Quality of Life in Indolent Non-Hodgkin Lymphoma 3 Years after Diagnosis." Since it hasn't happened yet, it's still technically a preview.

I am indebted to Dr. John Leonard for pointing this one out to me. When I searched for ASH abstracts for FL, this one didn't show up, since it covers "indolent lymphomas," which, of course, includes Follicular.

Dr. Leonard is active on Twitter, and in the days leading up to ASH, he tweets "Leonard's List" -- the 10 presentations he is most excited about. This one is #1 on The List. His comment on Twitter when he named this one as his #1 was this (I'm translating a little bit from Twitter-ese -- I know many FL patients are on the older side, and this kind of this is difficult for you to understand):

Since a large percentage/most indolent NHL patients will live a normal lifespan, here Quality of Life is a key issue/goal in long-term management. The study has important insights for Quality of Life course, reassures patients that Quality of Life likely won't deteriorate despite diagnosis, and patients seem to have psycho-social adaptation.

(Actually, I know most of you could have figured it out, even at your age. I was more concerned with how it would translate for my non-English-speaking friends.)

I appreciate his giving the top spot on his influential list to something that focuses on Quality of Life. As much as we all appreciate research that moves toward a cure (or at least a longer Overall Survival), we need to live with the disease, and the quality of that life can be an afterthought.

So QOL becomes an important factor. There are two approaches to FL research these days. One school of thought says we should go for a cure. But the other approach is to treat FL like a chronic disease, something that will always be with us, but can be managed through medication. I personally am open to either approach. But if I am going to treat FL like a chronic disease, then whatever treatment I receive must take Quality of Life into account.. There's no point in staying alive as long as the general population if I'm going to be miserable doing it.

For this presentation, the researchers acknowledge that Quality of Life can be affected by the disease itself, by side effects from treatments, and from the "psychosocial effects of living with an incurable cancer." (I'll say it again -- Follicular Lymphoma is an emotional disease as much as a physical one.)

Patients with Indolent (slow-growing) Non-Hodgkins Lymphoma (including Follicular) were included in the study. Their QOL was measured at Baseline (from what I can tell, within 9 months of diagnosis) and then 3 years later. QOL was measured using a survey called Functional Assessment of Cancer Therapy-General scale (FACT-G). You can see the survey here. It asks patients to measure their responses to fairly simple statements in 4 areas: physical, social/family, emotional, and functional well-being. So statements for "emotional well-being," for example, include things like "I feel sad" and "I am losing hope in the fight against my illness." Patients respond with how they have felt in the last 7 days.They were also asked to complete a "a single item Linear Analogue Self-Assessment (LASA) for measuring overall QOL."

1050 patients were included in the research (32% of them had grade 1 or 2 FL). At the 3 year follow-up, 577 patients (55%) had received treatment, 42 (4%) transformed, and 53 had an event (progression of disease, re-treatment, or death).

Interesting results:
Emotional Well-being significantly improved over 3 years.
Social/family Well-being  significantly decreased.
Functional Well-being, physical Well-being, and overall Quality of Life were not significantly different. 
The results were similar whether patients got treatment, or they watched-and-waited. 

In patients with an event during the 3 years, emotional Well-being had a significant improvement, but overall QOL decreased.

In patients without an event, improvements were reported in functional Well-being, physical Well-being, emotional Well-being, and overall QOL, but social/family Well-being went down.  

In their conclusion, the researchers say that the increase in emotional Well-being is a sign of "psychosocial adaptation by the patient." In other words, we learn how to deal with it.

I think that's probably true. We don't have much choice to adapt, so we adapt. We are, on the whole, very strong people. Sure, we have our bad days, but we get out of bed and get stuff done. That's just the way it is.  

It's hard to think back to where I was 3 years after I was diagnosed. I was a year past Rituxan treatments. I think I felt pretty good. It always helps to get a pretty clean scan. I was still running, so my physical Well-being was great.  I had support from family and friends. My day-to-day life was OK -- I was still working and playing with my kids. It all matches up for me.

What I found kind of surprising (though as I think about it, it shouldn't be surprising) is that the Social/family Well-being went down. 

As I think about it, this, sadly, makes sense. I hear lots of stories from people whose relationships were changed by cancer. family and friends stopped calling, probably because they didn't know what to say. That happens a lot, no matter what kind of cancer.

But people with FL and other indolent blood cancers face a different set of challenges, I think. 

When we get a diagnosis, lots of people come to our side. They want to help. And then -- nothing happens. Many of us watch and wait. The heat from the diagnosis starts to die down. Some people might feel a little betrayed. That cancer diagnosis had everyone worried, and now you don't even need treatment? Even worse than the people who don't know what to say are the ones who went on the emotional roller coaster ride with you, and got off before the ride started up again.

Are think there are two big lessons here.

The first is for patients. For many of us, we learn how to deal with the emotions that come with the diagnosis. We are, as I said, a strong group of people. We find ways to deal with it, and we do our best. For some us, though, we don't get the social help that we'd like. The lesson is that it's really important to find a social outlet. If family and friends can't help, then some group that understands what you are going through is crucial. Maybe that's a support group at the hospital you are being treated at. Or an online group (which is what worked for me). A Facebook group. Some bunch of people who can hear what you have to say and respond with "Yeah, I felt that way, too." 

The second lesson is for doctors. The physical check-up should be easy. The emotional check-up doesn't always come with the office visit, but it's just as important. And maybe doctors aren't comfortable with that, or aren't trained in that. But having some kind of resources available at hand would be helpful. Just a quick, "How are you feeling, emotionally?" might bring great results. Sometimes just being asked is a wonderful thing.

But the biggest take-away here is that researchers are paying attention to Quality of Life. That's a great thing. Certainly worthy of being #1 on any list.

Tuesday, December 5, 2017

More on Rituxan Maintenance

I had planned on writing about something else today, but Mylegacy left a comment with questions last night on my last post. I put the comment off to the side and got back to writing, but the Cancer Nerd got the best of me and I started doing some research, and I found the whole thing fascinating, so I'm just going to answer it here.

At least, I'm going to try to answer it. This is a good time to remind everyone that I am not an oncologist or a cancer researcher or a biologist. I'm just a patient who reads a lot.


Here is Mylegacy's comment:

What follows is/are a/several convoluted question(s). I do not know enough to say what follows as a statement of fact. IF I've missed the boat - PLEASE give me the smack down I'll deserve!

I understand that most of us who die with our "incurable" guest will do so from "infection." Most likely pneumonia or other respiratory illnesses. We will not succumb to FL, as such, but to the failure of our - by the time we're near dying - badly damaged white B cells being unable to guide the T cells to the pneumonia in great enough numbers, and in a short enough time frame, for our immune system to save us. Is what I have just written there correct(ish)?

IF SO: Then that is why I'm opposed to R maintenance. R is an indiscriminate killer of white B cells (is it not?). Cancer, or no cancer, R kills them. The ONLY reason it is safe(ish) is because it DOES NOT kill white B STEM cells. These "Baby B cell factories" continue to produce new B cells in our bone marrow.

However - over time IF you use R maintenance - who are reducing B cells and you end up with mostly new(ish) immature B cells. Our immune systems suffer - those of us who will die, will do so from the infections our mostly "baby/immature" B cells can not destroy. Our adult, mature, effective B cells have been decimated over time.

I've only had one 6 month R/B dance so far but just now (6 months after my final 2 day adventure) I'm in the 19th day of a cold. I'm 71, had a few colds in my time, but NEVER have I had one last this long. I'm beginning to think I understand what my future might look like. To make this journey even more interesting - I've already had pneumonia once about 15 years ago.

Intuitively, why wouldn't B maintenance (just killing Cancer cells) make more sense than reducing generations of adult B cells and diminish our bodies immune system being able to find and identify the bad guys for or T cells to kill? 


OK, lots to respond to. (And it's just a response. I don't think I've given anyone a "smack down" since I was on the wrestling team in high school....)

We'll start with how we die -- that's the thing that caught my eye first.

I'm not a big fan of talking about death (I'm sure not too many of us are), though it's certainly in the back of our minds as cancer patients (and maybe the front).

I think the description of FL patients dying of infection is accurate for some patients, but I'm not sure I'd commit to "most" patients.

And before we go any farther, I want to remind everyone about what I wrote a couple of weeks ago about Overall Survival. Death is always part of the equation for cancer, but the median OS for FL patients is close to 20 years, and statistics don't say anything about individuals. Keep reminding yourself of that.

There has actually not been a lot of research on how FL patients die, though earlier in the year, there was a presentation at the Lugano Conference called "Cause of Death in Follicular Lymphoma in the Rituximab Era: A Pooled Analysis of French and US Cohorts." There were 1643 patients in the study, who were diagnosed from 2001 onward. The median OS for the patients was about 80% at 10 years.

The median follow-up for the patients was about 85 months, or about 7 years. In that time, the OS was about 83% -- 283 of 1643 patients had died.

(Let's repeat that, since we're talking about death here -- 83% of the FL patients in this study lived.)

Of those 283 patients, 49% of them died of Lymphoma. Another 15% died of treatment-related causes, including infection, heart problems, and Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) -- basically side effects of the treatment, whatever the treatment was. Another 12% developed and died from a different cancer, and a final 12% didn't have a cause of death listed for the study.

Of that 49% (about 140 of the 1643 patients) who died of Lymphoma, about 55% of them died from Transformed FL.

Now, even though "infection" is listed as part of that 15% treatment-related cause, Mylegacy's comment seems to be including "infection" in a broader way, one that would make it part of the "Lymphoma" cause. It certainly is the case that for some cancer patients, a weakened immune system leads to infection, including pneumonia. But that's not the case for everyone.

I think the important thing here is to understand that 1) Follicular Lymphoma doesn't kill everyone who has it -- it's a fairly small percentage, and 2) the cause of death varies.

That's important to make clear, given the second part of the comment.

Rituxan Maintenance does indeed kill mature B cells. But I don't think the immune system works in such a way that we end up with only immature B cells as our only defense. For one thing, not all B cells express CD20. And for those that do, not all of them are killed by Rituxan.

Stepping back a little -- Follicular Lymphoma is a B cell lymphoma. It affects a particular type of white blood cell called a B cell. B cells go through a a series of steps before they are "mature" -- able to do their job of finding invaders in the blood. If you want an explanation of how B cells develop, this video does a decent job of explaining. B cells start out in the bone marrow, and over time become differentiated -- the body sends signals that let the stem cell know which type of blood cells they need to develop into. So they develop into a form of B cell that is able to accept an antigen -- the thing that lets them fight a specific type of invader.

In the scenario described in the comment, Rituxan would wipe out all of those later-stage B cells that are able to accept an antigen, leaving only B cells that can't fight off invaders.

I don't think it works that way. Bone marrow produces new stem cells all the time. (I read somewhere that it is several million every day, but I can't find that source again.) Some of those cells will move on down the chain that eventually leads them to develop into mature B cells. The point is, the body has a supply of them ready to go when signals come that an invader needs to be fought. It's an ongoing process.

Rituxan goes after those B cells -- they have a protein on their surface called CD20 that Rituxan attaches to. It goes after them whether they are cancerous or not. That is certainly true. And while people are taking Rituxan, they are, for that reason, more susceptible to infection.Their B cell counts are lowered. But it's important to note that Rituxan doesn't wipe out the entire immune system. Some B cells remain in the blood, and stem cells go untouched, and they keep differentiating into B cells. 

The next question is, how long is the patient affected by this?

Well, Rituxan works slowly. It can take a couple of months for it to really start to bring the size of tumors down. And then Rituxan's effects can go for up to 6 months. It could be a full year before the immune system is back to "normal" again.

(By the way, I'm getting a  lot of what I'm giving here from the page on Rituxan. They're my go-to for all things Lymphoma-related.)

With Rituxan Maintenance, that period could extend for up to a year after the maintenance is finished (so if we're talking about the standard 2 year maintenance, then you'd have a good 3 years before the Rituxan's effects were finished.)

Next important question: are there any long-term negative effects from Rituxan?

Yes, for some patients. Again, helps us here, citing some studies that show that "Late Onset Neutropenia" is a side effect for 5% to 27% of patients who received Rituxan. For as much as a year after treatment, patients can have abnormally low levels of neutraphils, a type of white blood cell. I haven't seen anything to suggest that it's a chronic condition brought on by Rituxan. My understanding is that it is treatable.

So, again, the important point here is, Rituxan does a good job of taking out cancerous B cells, and does result in some side effects, including making patients more prone to infection. But those don't seem to be long-term. The idea that Rituxan Maintenance might have a negative effect on our immune systems over the long term just doesn't seem to be the case.

And further evidence about a lack of long-term side effects comes from the study that Mylegacy was commenting on. Both the maintenance group and the non-maintenance group in that study had about the same median Overall Survival rate -- about 80% after 10 years. If there was a negative long-term result from Ritiuxan Maintenance, I assume we would see a difference there, with a lower OS for the maintenance group.


So let's sum all of this up.

Rituxan Maintenance is controversial. Given how it works -- finding and killing off B cells, whether they are cancerous or not, and lasting for up to a year -- it makes sense that it prolongs Progression Free Survival, when compared to patients who had a similar initial treatment but no Maintenance. 

However, while it does increase the risk for infection (given that it weakens the immune system), there does not seem to be a long-term negative affect. Patients who had maintenance after immunochemotherapy had the same Overall Survival rate as those who didn't have maintenance. The controversy comes when you ask whether the short-term risks are worth it, given the same long-term result in OS. Lots of different answers to that question.

Now, as far as causes of death, there's no question that infection (in some form) is a cause of death for some FL patients (as it is for other cancers). Many different treatments affect our immune systems -- including Rituxan.

But long term? The evidence that I found does not suggest that Rituxan or Rituxan Maintenance plays a role in long-term infections. If anything, experts agree that Rituxan has extended Overall Survival. Since the beginning of the "Rituxan Era" in the late 1990's, OS for Follicular Lymphoma has about doubled. 

And as for the last question in the comment -- why wouldn't Bendamustine Maintenance work better? Well, Bendamustine is a chemotherapy, and its side effects would probably cause much more damage through repeated use over the long term than Rituxan would. But the point is well-taken -- treatments that target the cancer cells, and not healthy cells as well, make a lot more sense.

And that's exactly what more recently-developed treatments are trying to do. We know so much more about the genetics of cancer cells now than we ever did, enough to know how to find particular biomarkers -- clues that let us know which cells need to be killed and which can be left alone, and which treatments can find distinguish between them. 

That's the future. And partly the present. Lots of treatments in different stages of development that will find cancer cells and get rid of them as needed. Researchers are still working on those.

But until that's all perfected, we could do a lot worse than Rituxan.

Thanks for the comment, Mylegacy. I hope that answered your questions. And I'll close out by saying, once again, that I'm not an oncologist or other expert in this area. I'm confident in the numbers I give, and what they have to say, but I know I oversimplified the biology. If anyone has a better explanation for all of this, please let us know.

Thursday, November 30, 2017

ASH Preview: Rituxan Maintenance

Another ASH preview: This one is for "Long Term Follow-up of the PRIMA Study: Half of Patients Receiving Rituximab Maintenance Remain Progression Free at 10 Years."

The PRIMA Study has been looking at the long-term effects of Rituxan Maintenance on Follicular Lymphoma for a while now, and this presentation will look at how patients have been doing after 10 years.

Rituxan Maintenance has been fairly controversial in the Follicular Lymphoma community. It's one of those topics where enthusiasm kind of flip-flops with every new study. One study will find a benefit to it, and then another will show that the benefit wasn't as great as it seemed, or that there were new drawbacks. But neither side has shown enough evidence to make everyone agree on a definite Yes or No to Maintenance.

The PRIMA study looked at FL patients who were given Rituxan + chemo (mostly CHOP, but some CVP or Fludarabine) as an initial treatment, between 2004 and 2007. This was followed by half of the patients (505 of them) being given Rituxan Maintenance (every 8 weeks for 2 years), and the rest (513) getting no Maintenance. There have been follow-up studies of the patients at 3 years and 6 years, and now at 10 years.

The results certainly back up a benefit for R-Maintenance. Those who received it had a median Progression Free Survival of over 10 years. For those who didn't get it, the median PFS was just over 4 years. At the 10 year follow-up mark, 51% of the Maintenance patients had not had their disease progress, while only 35% of the non-Maintenance patients had no progression. The median time to a new treatment was just over 6 years for the non-Maintenance group (that is, it took that long for half of them to need treatment), while the Maintenance group hadn't yet reached the median.

One of the arguments against R-Maintenance is that it means patients are being treated for a long time when they haven't necessarily shown a need to be treated. They might have a clean scan, but continue to get Rituxan anyway. Some argue that this could result in over-treatment, with unnecessary side effects and potential long-term problems. 

The argument that the researchers make here for the value of R-Maintenance is that, because Follicular Lymphoma patients are living longer, it's worth the risk of giving Rituxan for two extra years. If it means patients will then not need treatment for another 8 years (at least), it frees them from the side effects (including developing secondary cancers) that might come if they had to go through another round of chemotherapy or other treatment. It's a compelling argument.

On the other hand, despite the longer PFS, there is no Overall Survival benefit to Maintenance. Both groups had a median OS of about 80% at 10 years. There is a group of people in the FL community that says, while extended PFS is nice, Maintenance doesn't make anybody live longer, and that's really the ultimate goal. So maybe the extra cost, time, and potential side effects of the Maintenance aren't worth it.

I'm still on the fence about it, for what it's worth. I do think that OS is ultimately what we are all aiming for. But as someone who has managed, with just Rituxan, to go almost 8 years without further treatment, I can say that it's pretty nice to not have to stress out about going to the treatment room. There's certainly a Quality of Life argument to be made here. Patients who can go for years without further treatment? That's a worthy goal, too.

The ASH conference is always followed up with commentary from experts, and I'll be very interested to see what the experts have to say about this. Will some of those anti-Maintenance folks come around and change their minds? Will they point out something in the data that we can't see right now by just looking at the abstract? I have a feeling this is going to be one those presentations that gets lots of attention.

ASH is coming up very soon -- it starts next week. We won't have to wait for long to hear from real experts (and not just Cancer Nerds).

Sunday, November 26, 2017

ASH Preview: Progression of Disease in 24 Months for FL

A few posts ago, I looked briefly at an upcoming ASH session called "Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study."

The presentation looked at 1202 patients in the GALLIUM clinical trial, which compared two immunochemoptherapy regimens.  In one, patients had Obinutuzumab + chemo, followed by Obinutuzumab maintenance. In the other, patients had Rituxan + chemo, followed by Rituxan maintenance. As I said in the post last week, the results from this trial helped get the Obinutuzumab regimen approved for untreated Follicular Lymphoma.

Because the study dealt with untreated patients who were getting immunochemotherapy (the chemo was CHOP, CVP, or Bendamustine), it was a convenient place to also look at POD24.

POD24 stands for Progression of Disease at 24 months -- for patients who had received  immunochemotherapy and then had their disease get worse, their Overall Survival was lower than those who did not have Progression of Disease in that time.

I know some of you are in this group, or have had immunochemotherapy and haven't made it to 24 months yet, and the numbers worry you. I'm not going to tell you not to worry. I've been in your shoes -- the diagnosis is still raw, and it might not matter what anyone tells you. The worry is going to be there.

But it might be helpful to look more closely at the numbers.

Of the 1202 patients in the trial, after 24 months, 155 were POD24, and 916 did not progress.  So, first off, if you've had immunochemo and you haven't gotten to 24 months yet, the numbers show that the treatment worked well for a whole bunch of people -- about 87% of them. Of the 155 patients who were POD24, 56 died. Of those 56, only 40 died due to Proogression of Disease; the other 16 died of other causes (remember, Overall Survival measures death by any cause).

So 40 of 1202 patients who received immunochemotherapy died from their disease -- that's about 3%. As for those who were POD24, that's about 26%.

It's easy to focus on words like "lower Overall Survival," and it's easy to get caught up in numbers. But it's also important to remember that those numbers look at trends, not at individual patients. What happened to 40 people in a large trial doesn't say anything about you individually. And if you want to look at numbers, look at this: 40 of 155 POD24 patients died, but 115 of 155 didn't. That's a 74% survival rate. Pretty good odds, really.

To me, you can look at POD24 as being bad or good. Most who are in the situation will think of it as bad, and that's an understandable reaction. While the idea of POD24 is only a few years old, POD24 patients have been around for as long as Follicular Lymphoma -- we just hadn't identified that group yet. So being able to identify POD24 patients is a good thing. Researchers know they exist, and can start finding ways to help them.

There are a few other POD24-related presentations at ASH.

Like the GALLIUM presentation, another one confirms that POD24 is a valid thing: "Validation of POD24 As a Robust Early Clinical Endpoint of Poor Survival in Follicular Lymphoma: Results from the Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) Investigation Using Individual Data from 5,453 Patients on 13 Clinical Trials"

The good thing about this one is, besides confirming that there are POD24 patients, they also found some other factors that could help build a prognostic model. In other words, they might be able to identify trends that could allow oncologists to identify patients as being at higher risk for POD24, and find other ways to treat them.

Another presentation, "The Tumor Microenvironment Is Independently Prognostic of Conventional and Clinicogenetic Risk Models in Follicular Lymphoma," also confirms that POD24 is real, and goes a step farther by identifying some Tumor Microenvironment markers that could help researchers figure out who is at higher risk.

Yet another presentation, "Impact of PET Staging of Follicular Lymphoma on Treatment Outcomes and Prognosis," looked at the effect of CT and PET scans on EFS24 (Event-Free Survival at 24 months, similar to POD24). Researchers found that patients who had PET scans had a higher OS than those who had CT scans, indicating that PET might be useful in predicting EFS24.

All of this research points to the same thing. While there isn't yet a way to predict POD24 patients, or a way to treat them that is guaranteed to work, a bunch of teams of researchers are working on it. In the last couple of years, I've seen many Follicular Lymphoma experts give summaries of where they think research is headed, and almost all of them said that it was important to work on the POD24 issue -- finding ways to identify them, and finding ways to treat them. Clearly, that work is happening.

In the meantime, the best thing we can do is what we've always done -- pay attention to you body, stay informed, and insist on honest and open communication so you can get the best care possible.

Thursday, November 23, 2017

Being Thankful

Today is Thanksgiving in the United States (I know some of you are from other countries). It's a day we're supposed to stop and think about what we are thankful for.

I say "supposed to" because I think the "being thankful" part of the day is kind of automatic for a lot of people. Many families have a tradition of going around the table and having everyone say something they are thankful for. It's a nice tradition, though I think it's easy for people to joke about, or say something obvious.

It's harder to really think about, and answer to honestly.

Harder still when you're a cancer patient.

And maybe even harder than that when you have a cancer that is considered incurable.

It kind of takes one of those automatic answers off the list -- "I'm thankful for my health."

But I really am thankful for my health.

I'm healthy enough to be able to spend the day with my family. I'm healthy enough to wrap my arms around my wife and tell her I love her. My kids are all home, together under one roof, for the first time in months. I spent yesterday afternoon making pies, and today I'm going to eat way more than I should. I can do that. Not everyone can.

I'm healthy enough to continue working. I like my job -- a lot -- and even on bad days, I can get things done and look back at the end of the day and see what I accomplished. Maybe not everything I'd hoped, but something. Not everyone can.

I'm healthy enough to help others. As many of you know, since last spring, I've tried to expand my advocacy work, writing more than just the blog, and sharing all those years of experience with others. I'm healthy enough to do that. Most nights, I have enough energy left to do some reading and writing. Not everyone can.

Like most people, I can look back at my life and think of the people who haven't been able to do the things that I'm healthy enough to do.

I know people who haven't been healthy enough for receive the hugs I wanted to give them. I can remember a Thanksgiving dinner in a hospital room, visiting a loved one. I know folks who really want to help with the dishes, but who just need to lie down, and not because the big meal made them sleepy.

I'm not trying to make Thanksgiving about guilt. It should be a joyful time, focusing on the blessings we have.

But I also know how easy it is to focus on the things are not so joyful. So maybe focusing on what we are not -- completely healthy -- can be a way of helping us see what we are -- healthy enough.

That's what I'm focusing on today.

I hope you all enjoy the day, wherever you are, and that you're healthy enough to do something special, that makes you feel good, whatever it is.

Sunday, November 19, 2017

FDA Approval for Obinutuzumab (plus more ASH stuff)

The FDA announced on Friday that it had approved an Obinutuzumab combination for untreated Follicular Lymphoma.

Specifically, the approval is for Obinutuzumab plus chemotherapy (CHOP, CVP, or Bendamustine), followed by Obinutuzumab Maintenance. A similar combination with maintenance was already approved for FL patients who could no longer take a Rituxan-based treatment.

The approval came because of results from the GALLIUM trial, which compared the Obinutuzumab + chemo + maintenance to Rituxan + chemo + maintenance. In the trial, Obinutuzumab showed better Progression Free Survival than Rituxan. Overall Response rate was slightly better as well.

Given the results, it seems appropriate that Obinutuzumab gained FDA approval. The numbers do show that, in the circumstances tested, Obinutuzumab outperformed Rituxan. It's another option for us.

At the same time, though, when the results of the trial were published about a month ago, some experts questioned whether or not Obinutuzumab really was superior. The doses of the two treatments weren't same (Obinutuzumab's was higher), and the adverse events (bad side effects) were higher for Obinutuzumab as well. Lots of experts thought this meant there was not as clear a reason to switch from Obinutuzumab to Rituxan as it might seem at first.

But the approval is there now. Time will tell if oncologists make the switch.


Updated results from the GALLIUM trial will be presented at ASH next month.

It looks like there are several presentations about data from the GALLIUM trial.

One that really stands out to me is called "Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study."As part of the analysis of the GALLIUM data, researchers looked at POD24 -- patients who had Progression of Disease within 24 months after receiving immunochemotherapy (which would include patients in both the Obinutuzumab and Rituxan arms of the GALLIUM trial). It's been known for a few years now that this particular group of patients (about 20% of those with FL) has a lower Overall Survival that other Follicular Lymphoma patients.

The researchers found that the Obinutuzumab patients had a better chance of not being in the POD24 group (about a 33% better chance). However, overall, the study confirmed the idea that POD24 was an issue -- patients who have had immunochemotherapy whose disease returns or gets worse within 24 months have a lower Overall Survival rate.

While the whole idea of POD24 concerned FL experts, it also gave them some hope. Identifying this group of patients meant that they could start working on identifying them early and finding treatments that would be effective.

I'm working my way through those abstracts and trying to find a way to make sense of them all.

If you're in that group, stay hopeful -- a greater chance of something doesn't mean it's guaranteed. And some of the ASH research of POD24 seems to provide more reasons to be hopeful. That problem isn't solved, but it's clear that there are a lot of smart people who are looking into it.

More ASH stuff soon.