ASH Preview: Rituxan Maintenance

Here we go -- time to start looking at some of the Follicular Lymphoma abstracts from this year's ASH conference.

Before I get into the first one, a couple of important reminders.

First, I don't think there's anything really ground-breaking at ASH this year, in terms of Follicular Lymphoma. Occasionally, there's some big news that everyone is talking about before the conference begins (on December 11), I'm just not seeing anything online. Maybe something will show up on this year's Leonard's List, but so far, I'm not hearing about anything major. And that's OK. It means there will be lots of interesting articles about existing treatments and other FL-related topics that help us better understand our disease and our options for treatment. That's usually how science works, anyway -- baby steps.

Second, even the presentations that I do excited about are not necessarily all that exciting. A lot of what I see are results from phase 1 and phase 2 clinical studies. That means they are still pretty early in the process, and there is plenty of time for things to go wrong (the treatments being studied are not as effective or as safe as they seemed). Looking back at my old ASH and ASCO previews, there are lots of things that got me excited that never made it to the clinic. Remember that. My excitement is about hope for the future, not reality in the present. It's kind of like looking through the Sears Wish Book as a kid -- I knew I was never going to get most of the stuff that got me excited, but it was fun anyway. 

(And if you don't understand that reference, sorry. If you do understand it, you'll know why I still have happy memories of a purple Chuck Foreman #44 Minnesota Vikings jersey from Christmas 1976.)  

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So which one are we looking at first?

Let's go with "3544 Rituximab Maintenance Benefits Less for Follicular Lymphoma Patients with Low Risk of the Follicular Lymphoma International Index."

Some background for this one: As many of you know, Rituxan Maintenance (RM) is a common practice. After receiving immunochemotherapy (like R-B or R-CHOP), some FL patients are then given Rituxan every 3 months for 2 years. (There are other possibilities for how often and how long the patient might get RM, but every 3 months for 2 years is most common.) Research has shown that RM can increase Progression-Free Survival (PFS) is many patients. 

The other important part of this study has to do with the Follicular Lymphoma International Prognostic Index, or FLIPI. The FLIPI is kind of a misunderstood thing. It uses information about a patient like age, disease stage, and how many places in the body the disease is found. Using that information, the index classifies a patient as low, intermediate, or high risk. It was created to help classify patients in clinical trials, not to tell an individual patient what their future is, which is now many use it. 

All of that said, the study has some interesting things to say about Maintenance.

The study involved 203 patients who were diagnosed with FL between 2003 and 2020. Of those patients, 192 received immunochemotherapy and had either a Complete Response or Partial Response. 96 of those patients then had RM (every 3 months for 2 years). The other 96 received no Maintenance, or had fewer than 4 rounds of Maintenance (less than a year). Follow up was a little over 3 years. The 5 Year Overall Survival rate for the whole study was 95%, and the PFS was 83%. Both excellent numbers. But FL patients who received RM, the numbers were even better for the PFS -- 92%, instead of the 70% for patients who did not have RM. Clearly, the study confirms what we've known -- Maintenance helps prolong PFS. It keeps the disease from coming back, at least for a while.

However, when the patients were looked at again according to their FLIPI score, the PFS was a little different, when compared to those who didn't have RM. Patients classified as low-risk had a 95% PFS, intermediate had an 84% PFS, and high risk had a 67% PFS. The conclusion here? Maintenance works well for intermediate and high risk patients, but there is no difference for low-risk patients between those who had RM and those who didn't.

It's a small study that involves a small percentage of FL patients (not all of us have immunochemotherapy, and not every oncologist recommends RM). But I think it brings up the bigger issue of just how much treatment we need. RM is clearly an effective strategy for a lot of patients. But as with any treatment option, it has risks. Rituxan destroys B cells, and those are an important part of the immune system (as we're all being reminded of lately). Lots of patients put off RM because of the effects it has on the immune system during the pandemic. I think those patients, especially those who were low-risk, can feel better about that decision.

The study also highlights some important issues related to our treatment choices. At my oncologist appointment this week, Dr. H again pointed out how pleased he was that Rituxan did such a good job for me. He said maybe 10-20% of FL patients get the long-term results I got with Rituxan, and he kind of imagined how different things would have been if I had been given R-CHOP instead. Probably the same result, but with much more toxicity and the possibility of more long-term side effects. I was fortunate to have an oncologist back then who was willing to try something less aggressive as a first treatment.

So that's the larger lesson for me, though it might not be obvious. No one is lucky to get cancer, and no cancer is "the good kind," even though you may have heard someone use that language. But one upside to having FL is that we usually have a little more time than people with a more aggressive cancer have, and we can use that time to get a second opinion from a Lymphoma specialist who can hep us think through our options. Even small bits of research like this might be something that a specialist can use to say "Maybe RM isn't the best choice. It will bring side effects without adding much effectiveness. Let's skip it and see how you do." That's the value of a lot of the research at ASH, I think.

I'll keep reading and reporting, and keeping an eye out for other commentaries from experts. More to come soon. 

Oncologist Appointment

I had a six month oncologist appointment today. Everything continues to look good. 

As usual, I went to the hospital early to get my blood taken. Phlebotomists tell me that I have good veins, and it seems to be true. I almost never have any problems getting a blood sample taken from my arm, or getting an IV line put in. Of course, today was different. The oncologist's office never sent my paperwork over to the blood draw office, so I had to wait a while for that. And then the phlebotomist completely missed my very large, inviting vein. She apologized a lot, but it was fine. We got it done, and I went to the oncologist's office for my exam.

Before I saw Dr. H, I saw another doctor, one who is receiving specialized training in blood cancer. He did the initial exam, asking all of the questions and feeling around. He seemed nice enough. It's not the first time I've had one of these trainees, and I always ask them the same question before they leave: Why oncology? Of all the specializations in medicine, why focus on cancer?

He said he had received some training already to be an internist -- a general practitioner or family medicine specialist. He thought he'd like to specialize in something, though, and he liked the idea of being able to possibly cure someone. A good answer. But he added a little more information. More on that below.

Dr. H came in next. As usual, we chatted away while he did his physical exam. He asked me questions about work. Asked about some other health issues I've been dealing with. Asked about any movies I've seen lately. I haven't been to a movie theater in 2 years. He hasn't been to one in 6 years. (His kids are small.) He said he's asking about movies because there really isn't much more for us to talk about. Everything looks good for me.

I always ask him what he's excited about in the world of Follicular Lymphoma. He's excited about CAR-T, which he thinks will ultimately cure FL, at least for a lot of patients. And he's excited about bispecifics, which he thinks will be approved for FL within the next year. (I'm still looking for any sessions at ASH this year that look at bispecifics -- if he thinks they are that close to approval, there will likely be some reports at ASH.)

And then he told me I was doing great, and that I should enjoy life. I told him that HE should enjoy life -- get a babysitter and go see a movie sometime. 

I go back in six months.

Now, back to that doctor who is training in oncology. He reflected a little bit on his choice of specialty, and said something that I've been thinking about since then: "I was concerned that I wouldn't be able to disassociate myself. But I think I'm able to."

What he meant was, he wasn't sure if he'd be able to not let his emotions get the best of him. I completely understand -- it's why I ask the question. Why would anyone go into oncology when there's so much possibility of things not going well for your patients?

But it also made me think -- how much do I really want an oncologist that is able to disassociate himself? How much do I want an oncologist that can cut off his emotions? And when does that process start? Is it only after the patient gets bad news? Is that when a doctor starts to distance himself? Because it seems like that's when I would need him most. So is it sooner, when things are going well? Does that mean no more discussions about movies, or how work is going, or where to get the best hot dog in the area (a discussion I have also had with Dr. H)? No sense in making connections like that if you ust need to cut them off later, right?

It can't be an easy job, and I don't know I there's an easy answer to that that question -- how much of an emotional connection to patients should an oncologist have?  I'm curious about how all of you feel about this, and how much of a connection you have with your oncologist.

The bottom line, though -- things look good. It's happy news as we are just a few days from Thanksgiving.

ASH Abstracts are Here!

It's that time of year again -- the ASH conference is coming up soon, and the abstracts are now online.

ASH is the American Society of Hematology, the organization for doctors and other healthcare professionals who deal with blood diseases, including Follicular Lymphoma. Every December, they hold their annual meeting (this year, it runs December 11-14), where researchers present the results of their work. Along with the ASCO conference in the spring, it's a conference I pay close attention to -- it's often where researchers choose to reveal their biggest, happiest results. 

Unlike ASCO, ASH doesn't allow for free registration for independent cancer advocates like me. So I won't get access to a lot of the data that would be most interesting. But that's OK -- I'll do as I always do, and look at some of the abstracts (the summaries of the presentations that the researchers will make at the conference) and share some thoughts about the ones that seem most interesting. Because the abstracts are already available, I'll do some "ASH preview" posts over the next few weeks, and keep an eye out during and after the conference for any news in the Lymphoma World with some expert opinions about the conference. (Expert opinions are good. Better than Cancer Nerd opinions, which is what you'll get from me.)

I've taken a quick look at the abstracts, and there are 269 presentations related to Follicular Lymphoma. From what I can tell, none of them are the kind of "blockbuster" presentations that we sometimes get, the kind that will change the way people think about FL. Most seem to about research that helps us better understand what we already know about FL and its treatments -- and those are certainly valuable.

One thing I did notice, though (and again, this is just on my quick scanning of the abstracts), is that there are a lot of presentations involving Lenalidomide (also known as Revlimid). This makes a lot of sense. Lenalidomide is half of the treatment combination known as R-squared (Revlimid + Rituxin). The combination was the first non-chemotherapy treatment to be shown to be as effective as chemo like R-CHOP and R-Bendamustine. Researchers are going to want to build on that, and find new combinations that are even more effective. I plan to report on some of that.

There is some research on CAR-T as well, though not as much as I expected. It seems like CAR-T research doesn't wait for conferences to be announced. There's plenty of good stuff out there on CAR-T, even without ASH. I'll share some of that, too.

I'm also seeing some of the broader "Here's Where We Are" type of research. By this I mean, every year some researchers look at our assumptions about Follicular Lymphoma (who gets it, why they get it, how it is commonly treated), and does some research that shows whether or not those assumptions still hold up. For example, for many years (including when I was first diagnosed), the assumption was that the Overall Survival for FL was 8-10 years. Researchers keep challenging that by looking at different sets of data, so now we know that the OS for FL is closer to 18-20 years. So I've seen a few of those "here's Where We Are" studies, and I'll share those, too.

I'm looking forward to presenting some good news to you all. If there's bad news, I'll present that, too. But here's hoping there's much more good news than bad.

More soon.

Cancer Research Grant Reviewer Experience

Today is Veterans Day in the United States. It's a day set aside to honor those who served in the U.S. military. It was originally Armistace Day, which I think is still celebrated in some other countries, marking the end of fighting in World War 1 (the 11th hour of the 11th day of the 11th month).

Enough history. It's a day that makes me think of my father, who died a few years ago from lung cancer. (My mom died from ovarian cancer. I was diagnosed a few years before either of them.) My father served in the U.S. Navy for a few years, then in the Naval Reserves. He joined when he was very young, at a time when his family was going through some difficult times. He said it helped him grow up quickly, and as he got older, he seemed to realize more and more how much of an influence the experience had on him. I like to think for the better.

I've been thinking about him, and his service, this week because a few days ago, I served again as a Consumer reviewer for the  Congressionally Directed Medical Research Programs’ (CDMRP), Peer Reviewed Cancer Research Program (PRCRP). In this program, $115 million is set aside by the U.S. Congress to fund research into cancer that affects active military members, veterans, and their families, and of course can help the rest of the world if they result in treatments. 

As a Consumer Reviewer, my role was to represent cancer patients. I was part of a panel that included cancer researchers and oncologists, and had an equal vote when we looked at proposals and decided how to rate them. That's a pretty cool and unusual thing -- mostly it's cancer "experts" like researchers who decide these things. The CDMRP recognizes that cancer patients and survivors have a special kind of expertise, too. A scientist can comment on how important the science is. But only a patient can really speak to how a research project might affect the lives of cancer patients -- how it will affect quality of life, our emotions, etc.

It was a good experience to do this last year, and a very good experience this year. It feels like a way of honoring my father. I don't get to honor him in such a meaningful way very often.

And, of course, it's way of helping all of you. It could be years before the research that gets funded by this program actually has any impact of cancer patients. 

And that's OK. I can wait.

 I'm used to it.

Fear of Recurrence

The organization Lymphoma Canada hosted a really great webinar recently called "Fear of Recurrence for Lymphoma Patients." The webinar features Dr. Sophie Lebel, a clinical psychologist and professor at the University of Ottawa. Dr. Lebel does research on cancer survivors and their families, and fear of recurrence is one of her special interests.

The webinar describes some of the research she has done -- how common it is for patients to have great fear that our cancer will come back -- and more importantly, how we can manage that fear.

Interestingly, Dr. Lebel says that about 49% of cancer patients experience fear of recurrence, and it is the most common response when cancer patients are asked what need they have that wasn't met by their oncologist. I don't doubt the research, but 49% seems really low to me. If half of you out there have had successful treatment and feel great, I'm very happy to hear it.

(Dr. Lebel also acknowledges that for those of us with a disease like Follicular Lymphoma, it might be a little tougher to get past that fear, since FL is considered incurable.)

Dr. Lebel also thinks it's important that we understand that there is a continuum for this fear. It's normal for us to feel some fear occasionally (especially when we have a scan r doctor's appointment coming up) and we usually can manage that. However, some of us might sometimes experience more extreme fear, to the point where it interferes with living our lives, and we can't manage it ourselves. Interestingly, research shows that young people and women are more likely to experience this kind of problematic fear. The same goes fo those with multiple physical symptoms and side effects.

There is also no connection between statistical risk of recurrence and level of fear. In other words, you might be told that after treatment, 15% of people will relapse. However, you might feel that there is a 100% chance that the cancer will come back. This makes perfect sense to me. Statistics are rational; fear is emotional. I've certainly been in a situation where numbers did nothing to make me feel better. I was convinced that whatever small number there might have been that was negative, that's where my mind would go.

Most importantly, Dr. Lebel gives some strategies for managing the fear. One of the biggest pieces of advice she gives is to talk. We often keeps things inside, because we don't want to burden others of increase their fears. But all this does is make the fear grow. Talking helps. I found that early on.

Self-care helps, too. Exercise, meditate, do yoga. Moving around helps release tension and increase some feel-good hormones. 

And if those things don't work, it's OK to seek help. That's a big lesson to take away.

There's more to this excellent webinar, and I hope you'll watch/listen to the whole thing. The webinar recording is at the bottom of this page (the video at the top is interesting, too, but it's not the webinar).

If you've been reading for a while, you know how often I say this: Follicular Lymphoma is an emotional disease as much as it is a physical disease, because for many of us, we aren't experiencing physical symptoms all the time. All cancers have emotional components, but FL is special in that way. Pay attention to things like fear. Help yourself, and get help from others when you need it.

 

CAR-T Given Priority Review for Follicular Lymphoma

Busy week last week, so I had a hard time posting. I was attending a (virtual) medical writing conference. Unlike something like ASCO, I don't have much to report, unless some of you want to know how to become a regulatory writer and create materials for clinical trials, or how to create infographics for drug pamphlets. Fascinating stuff, for me, anyway. 

The big news last week -- and it is pretty big news -- is that the FDA is granting Priority review for Tisagenlecleucel (also known as Kymriah), one of the different types of CAR-T treatment, for adult patients with relapsed or refractory Follicular Lymphoma who have already had at least two types of treatment that have stopped working.

This is major news. Right now, CAR-T treatments are approved for aggressive Follicular Lymphomas, like those that have transformed. There are several clinical trials looking at CAR-T and indolent FL, the slower-growing types that most of us have. An approval for Kymriah would mean a big expansion in who can receive the treatment.

The Priority Review is based on results of the phase 2 ELARA trial, which involves FL patients from 30 countries. The results were presented at ASCO last June, as I described here. There were 94 patients evaluated in the trial, with an 86% Overall Response, and a 66% Complete Response rate. Safety was also very good, with just under half having some kind of Cytokine Release Syndrome, but none having a serious CRS reaction.

Priority Review by the FDA means the goal is make a decision on approval within 6 months, rather than the usual 10 months. So if all goes well, this could be approved by next spring (though, of course, there is no guarantee that it will be approved). 

This is great news, and I'm sure it will potentially be an option for many of you. There's nothing great about having had at least two treatments for FL, and needing another, but in this case, perhaps something good is in the future.

I've written many times before about CAR-T. I know a lot of patients see it as The Answer for FL, and maybe some day it will be. For now, it's not perfect, with a very high cost, some potentially severe side effects, and good response that don't always last for very long. But from everything I've read, researchers are improving it all the time. I hope it ends up as a successful option for some of us some day.