Monday, August 28, 2017

FDA Priority Review for Obinutuzumab

The FDA announced today that  it will grant Priority Review for Obinutuzumab for patients with untreated Follicular Lymphoma. It's good news.

Let's break this down.

First, "Priority Review" is one of the categories that the FDA (which approved cancer treatments and other things in the United States) developed to try to speed up approvals. A Priority Review is given for a treatment that make provide a significant improvement over what is already available, and it means that a decision will be made within 6 months. For Obinutuzumab (also known as Gazyva), the approval should come before the end of the year.

So what is Obinutuzumab improving on? Why, Our Old Pal Rituxan. They are both Monoclonal Antibodies (which is why "mab" is at the end of the name, like it's at the end of the name Rituxumab and the beginning of Mabthera -- other names for Rituxan).

Like Rituxan, Obinutuzumab targets the CD20 protein on B Lymphocytes (the white blood cells that cause Follicular Lymphoma). What makes it different is that it is humanized (Rituxan was developed from mouse cells) and in theory, that should cut down on some of the allergic reactions that people have to Rituxan (like the one I experienced).

Obinutuzumab is also glycoengineered. That means that sugar molecules are added to them in a way that makes them better at their job (which is to call out to the immune system to attack the cancer cells). The company that makes Obinutuzumab has a cute video that explains it all.

The FDA granted Priority Review based on the results of the GALLIUM trial, which compared Obinutuzumab + chemotherapy with Obinutuzumab maintenance to Rituxan + chemotherapy with Rituxan maintenance. In the trial, after 41 months, the Obinutuzumab patients had a 32% less chance of the disease getting worse.

It will be interesting to see what happens. I think there's a good chance that Obinutuzumab gets approved after the review. (Obinutuzumab is already approved for Follicular Lymphoma as a second line treatment -- for use by people who had taken Rituxan, but had it stop working within 6 months.)

I'm curious what happens after that. Will oncologists start using it in place of Rituxan? There are going to be a bunch of choices in that area soon -- biosimilars might be used in place of Rituxan, too. I have no idea where Obinutuzumab comes in as far as cost goes, and if the cost will make it worth choosing it over Rituxan, even if Obinutuzumab might work slightly better. old habits die hard -- lots of oncologists still go with CHOP, just because that's what they've always done.

As always, it's going to come down to an honest discussion with your doctor.

The important thing, though, is that we might have another choice when it comes to treatment.  And that's good news.

Friday, August 25, 2017

Follicular Lymphoma Videos: The Evolving Landscape for Treatment

We're in that slow period for Follicular Lymphoma news. After the big conferences in June and July, when all of the really interesting research gets shared, everyone seems to go on vacation for the month of August. I'm guessing we will see some more new FL material in a couple of weeks.

In the meantime, though, here are two things to keep you going.

First, OncLive has another video series on Follicular Lymphoma. I've linked to these before -- they post a series of short videos on a topic, putting up a new one every few days, so they form a series when they're all done.

This series is on the topic "The Evolving Landscape of Therapy for Follicular Lymphoma," and it features two of my favorite Lymphoma Rock Stars -- Dr. Bruce Cheson and Dr. Anas Younes. There are four videos in the series so far. I'm guessing there will be a few more.

It starts off with a short video on Diagnosing and Staging FL. At the end, Dr. Cheson mentions the Ann Arbor staging system vs. the Lugano system (named after the conference that takes place every year in Lugano). As he says, the Lugano system is very recent -- from 2016. The Lugano system involves using a PET-CT scan to help with staging. I don't know if it is used "officially" yet, though there are probably lots of people using it.

Other videos in the series (so far) look at Risk Stratifying (figuring out which patients are low, medium, or high risk), and figuring out the best treatments for those risks; and Triggers for Therapies (figuring out when to actually give treatments), something we all worry about, especially those who have watched and waited. There might be some more videos added to the series, so check back there in a few days.

It's all good stuff from two great Lymphoma experts. Not necessarily anything new, but always nice to see something that shows the up-to-date thinking of people in the lymphoma community.

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My second item is about the WEGO Health Awards. As I wrote in July, I have been nominated for two awards from WEGO Health -- Best in Show: Blog and Best Kept Secret. A whole bunch of you endorsed me for these awards, and I am so very grateful. The endorsement period ends on September 1, so if you are inclined, please consider endorsing me if you haven't already done so. You can endorse me by clicking here; they will ask for an email address to make sure people don't vote more than once.

After the Endorsement period ends, the three health advocates with the most endorsements in each category will move on to the finals, along with two others who are chosen by a panel of judges. Overall winners will be announced in October.

Thank you all once again for reading. As I've said before, I would write this blog even if no one but my family actually read it (and for a few years, that was true). But it's even better when I have such great readers who don't feel obligated to send me birthday cards and make conversation with me at Thanksgving dinner.

Monday, August 21, 2017

Not Knowing What to Say

Someone I care about a lot was diagnosed with cancer a few weeks ago.

I remember those first few weeks myself. It was a very tough time. For me, the first 10 days or so was such a whirlwind -- getting the diagnosis, telling my young children, getting a bone marrow biopsy, seeing a specialist -- there was no time to think about it all, even as I was in the middle of it all. Once things slowed down a little, that's when things got real. That's when the fear really kicked in. That's when I held it all inside and fell into a deep, black well. It was not a good time.

My wife also remembers all of that, and, being a wonderful person, has been buying and mailing cards to our loved one since her diagnosis.

I bought a card, too, a few weeks ago. I felt like I should send one just myself, not one from our whole family.

But I haven't sent it. I just didn't know what to say.

Which is so strange. I mean, if anyone should know what to say, it should be me, right? I've heard the words "You have cancer." I've been through the testing, and some treatment, and the deep, dark well. I know.

But I've also been through all of that other stuff that comes with a cancer diagnosis -- the people saying nothing, or saying dumb things, or saying the exact wrong thing on the day that you really didn't need to hear it, and it throws you into another deep, dark well.

Fortunately, I saw my loved one yesterday. We don't live near each other (which is why we've been sending cards). And I got a chance to give a big hug (which often works better than any words can) and at least get a sense of how things are going (without coming out and asking, because we all get that question more then we want to hear).

Fortunately, my loved one is blessed with a what I think of as an Irish Outlook on the world -- knowing that life is hard sometimes, absurd most of the time, and best met with a big dose of humor. And an understanding that sometimes people say stupid things when they don't know what else to say, and that they mean well. Face-to-face, it was an easy conversation. My loved one is handling things.

But it still bothers me that sometimes I don't know what to say. Not just because I've been through this, but also because I've written a few thousand words about cancer every week for almost 10 years.  I learned that lesson, too, long ago -- sometimes people don't now what to say, but they say nothing, or they say something stupid. But in the end, they're saying what they think is the right thing to say.

Not many of complain about the words I use here, so I'm happy about that. But just in case, I'm sending a big hug to all of you, just in case. Sometimes that's better than words, anyway.

Thursday, August 17, 2017

Oncologist Appointment

Saw my oncologist today. Everything looks good.

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Before I get to that, I want to give myself a plug for another article that I had published on The Mighty.  It's called "Monetizing My Cancer (Or, How I Almost Became a Kardashian)," and it tells the tale of how I tried to make some money off of this blog (and failed). Please take a look if you get a chance.

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As for my oncologist appointment:

I was pleased that I was able to see Dr. V again. You might remember my recent history with oncologists. I saw Dr. R for a long time, since I'd been diagnosed, and then he moved away. I was given an appointment with another doctor, a general oncologist who didn't listen to me  at all and talked to me like I was a child. I was getting ready to leave him when he retired. Dr. V was his "temporary" replacement, coming into the office only once a week, and teaching and seeing patients at a medical school for the rest of his time. He is still coming once a week. When we met last time, he and I talked about some of the treatments for Follicular Lymphoma that were being studied and were close to approval. We both got very excited about it all. I really liked him.

So I was happy to see him again. We didn't talk about treatments this time -- it was enough to know that I could if I needed or wanted to.

As always, the exam consisted of three parts: blood work, physical exam, and asking me questions. My blood work looked good (he said there was one number that was borderline high, but he wasn't worried about it). No new lumps or bumps. I had nothing to report as far as chills or fevers or night sweats.

We had a pleasant chat about my kids.

Nothing too exciting.

Which is something I appreciate in an appointment with an oncologist.

He again offered to make the next appointment for a full year from now, but said I could come back earlier if I wanted to. I took him up on the 6 month appointment offer.

So I guess you're stuck with me for a while longer.

Thanks for reading.

Sunday, August 13, 2017

Video Journal of Hematological Oncology

A few days ago, I posted some videos from the Video Journal of Hematological Oncology. This morning, I tried to watch a video that they had posted on Twitter, and I got this message:



I'm not a healthcare professional, so I didn't click. Which is too bad, because the video looked interesting.

I don't understand the logic of this apparently very new policy. It shows a deep misunderstanding of what it means to be a blood cancer patient in 2017. We have access to information -- lots of information. And a lot of it is crap. The VJHO has the opportunity to give patients (and not just healthcare professionals) access to that information in a way that is very easy to find and understand. Videos like theirs provide information that makes it easier for us to talk to our doctors about our conditions.

There are plenty of medical journals that are subscription-based; you can see an abstract, but not the full article, unless you pay. I completely understand that. But that's not what the VJHO is doing -- they are keeping it available for free, just telling patients that they can't come in.

That's really discouraging.

Their YouTube channel is still wide open, though. I won't post anything from it, but you might be able to find something interesting on there. (For now.)

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Update (Tuesday, Aug 15):
I wrote to the VJHO, and received a reply from their editor. He explained that contributors to the journal, and the editorial board, are concerned about non-healthcare professionals misinterpreting what they see in the videos, which has some legal implications, especially for things that involve prescription medications. I understand the legal issues, though I disagree with some of the other reasoning. Still, I respect their decision. More importantly, he said that they were planning another video channel aimed at patients and caregivers, with some input from patients. I applaud them for that, and I hope their plans for the patient-focused video channel actually happen. I'll update you when I hear more.
Bob

Friday, August 11, 2017

Alternative Therapies & Follicular Lymphoma: It's Complicated

Yesterday, the Journal of the National Cancer Institute published an article called "Use of Alternative Medicine for Cancer and Its Impact on Survival." It looks at the use of Alternative Thrapies, and the news isn't good for people who make that choice. And while Lymphoma, especially Follicular Lymphoma, wasn't a cancer that was studied, it's important to think about this topic as it relates to that cancer that effects our lives.

The study looked at 840 patients with several types of cancer -- breast, prostate, lung, and colorectal.Two-thirds of the patients received Conventional Cancer Therapies, which the researchers define as Chemotherapy, Radiotherapy, Surgery, or Hormone Therapy. The rest took Alternative Therapies, by themselves, without Conventional Cancer Therapies. The main finding of the study is that those who took only Alternative Therapies had a lower survival rate than those who took Conventional Cancer Therapies.

There are a couple things that should be pointed out here. While they don't get into what the Alternative Therapies are exactly, they do see the problem with them as being that they are "ineffective and unproven." So while something like Rituxan doesn't exactly fall into any of their categories, it has been around for 20 years and saved and extended thousands of lives, so that doesn't qualify as either "ineffective" or "unproven." They mean treatments that have not been through a rigorous clinical trial process.

And it's also important to note that they are looking at Alternative Therapies on their own, not those that are combined with Conventional Cancer Therapy. That combination approach is sometimes called using a "Complimentary Therapy," since it is used as a compliment to traditional medicine, not as an alternative to it.

Lymphomation.org does a nice job describing these three different approaches. Alternative Practice (they don't call it "medicine," and I agree with that choice) is unproven. Complimentary practices, as they say, help you work through Conventional Therapies: "Yoga for pain or stress relief is an example.  Exercise to help manage fatigue is another.  Such activities are sometimes called integrative medicine when used by medical doctors."  They refer to Conventional Cancer Therapies as "Evidence-Based Medicine," since those treatments have gone through trials to back up the science that created them. I think they do a really nice job of distinguishing between those three things.

Now, my guess is that anyone who has been reading Lympho Bob for a while knows that I am a strong advocate for Evidence-Based Medicine, and not so much into Alternative Therapies. So I will assume that you feel the same way.

Still, it's worth talking about why Alternative Therapies are tricky when it comes to Follicular Lymphoma.

As you know, Follicular Lymphoma is often slow-growing. And sometimes, it "waxes and wanes" -- gets better on its own, and then gets worse on its own, often while we are watching and waiting. So while we might be watching our FL, trying to be healthy, doing yoga three times a week and eating broccoli with every meal, it's tempting to think that it's the yoga and broccoli are the reason we  haven't needed treatment yet. But they probably aren't the reason -- it's just the nature of our disease.

Not that there is anything wrong with yoga and broccoli. They are both great. And if they make you feel good, that's even better. But they probably won't cure your cancer.

And I "probably" because maybe someday we might find out that yoga and broccoli, in some way, do have an effect on cancer. But that would only be after some very rigorous, scientifically-designed, evidence-based testing. And not because you saw on a message board that they might, or that a friend of a friend swears that they do.

As someone who watched and waited for two years before initial treatment, and then who has waited for almost 8 years since then, I know how easy it would be to think that there was something that I was doing that put me in the good position that I am in. But, off the top of my head, if I had to think about something I've done consistently in all that time, that might explain why I haven't needed treatment, it's probably been blogging. Writing about cancer has certainly been helpful for me, emotionally, anyway, but probably not physically. And there are lots of cancer bloggers who have unfortunately not survived for as long as I have.

Also, I have a hamburger and fries about once a week. I don't think that's helped either. Also, I drink Scotch, which probably hasn't helped, either. (Although I'm willing to sign up for a trial for that one.)

The point, of course, is that Follicular Lymphoma is a complicated disease. It acts all weird, and that makes it hard to know what has been helping and what hasn't. The only real way to tell is to trust science.

Monday, August 7, 2017

Follicular Lymphoma Videos

The Video Journal of Hematological Oncology just published a couple of videos on Follicular Lymphoma, featuring Lymphoma Rock Star Dr. Nathan Fowler of MD Anderson.

(I think one of you loyal readers is a patient of his, though I might be thinking of someone in the support group.)

The videos were posted a couple of days ago, though they were recorded at the ASCO conference in June. Dr. Fowler reports on some of the Follicular Lymphoma research that was highlighted at the conference.

The first video is called "Novel Therapies for the Treatment of CLL, MCL, and FL," so he discusses some of the research for a couple of other slow-growing lymphomas as well. But he has a lot to say about FL in particular. He focuses on the long-term follow-up data for the BRIGHT study and the STiL study. Both involved some FL patients who ad not received treatment.

The BRIGHT study looked at Bendamustine + Rituxan, compared to R-CHOP and R-CVP, and the STiL study looked at B+R vs. R-CHOP.. After a follow-up of 7-10 years, the Overall Survival was not different for the treatments, in both studies. It also found that there was not an excessive death rate. This is important, because, as Dr. Fowler points out, a study at ASH involving Bendamustine seemed to point to increased risk of death. Good to have some evidence that goes against that.

The second video is called "Ibrutinib in Combination with Rituximab -- The Future of Treating FL." In this video, Dr. Fowler discusses a trial that he reported on at ASCO.  He discusses the combination of Ibrutinib (a BTK inhibitor) and Rituxan, and points out that the Response Rate (around 80%) is higher than it is for either of those two treatments by themselves. The focus was especially on patients who wouldn't be able to tolerate chemotherapy (either because they were elderly or had other health problems), and they will start a phase III trial looking especially at those populations.

The idea in the title of Ibrutinib and Rituxan being "the future of treating FL" might be a little over-enthusiastic (Dr. Fowler doesn't really say that), but it does highlight the trend toward more targeted treatments, and away from traditional chemotherapy (though, as the BRIGHT and STiL trials show, there is still a place for that.)

I want to put in a small plug for The Video Journal of Hematological Oncology. They post mostly short videos (under 5 minutes) from experts in their fields. I sometimes use them as starting points -- they usually give a good summary of research, and then I can look into it for more detail somewhere else. Plus, it's always fun to see videos of researchers who are obviously excited about the work they are doing.

Enjoy.

Thursday, August 3, 2017

Keytruda and Rituxan for Follicular Lymphoma

We're back to looking at some recent research in Follicular Lymphoma treatments.

At the 2017 International Conference on Malignant Lymphoma biennial meeting in Lugano, Switzerland in June, researchers presented early results from a phase II clinical trial for Rituxan and Pembrolizumab, also known as Keytruda (and since that's easier to spell, it's what I'm going to use).

Keytruda is an interesting treatment -- it has been tried out on a bunch of different cancers, not just FL, or even blood cancers. It is perhaps most famously been used in treating former U.S. President Jimmy Carter's brain cancer. It is the first treatment approved by the FDA for a biomarker, rather than a body part. In other words, most cancer treatments are approved for a cancer in the blood, or the lungs, or the colon. But Keytruda targets a genetic abnormality that is present in lots of different types of cancer. There are some oncology experts who say that is the future of cancer treatment, focusing on genes and not body parts.

Keytruda is a humanized monoclonal antibody (which explain the "-mab" at the end of its harder-to-spell name), like Rituxan (also known as rituximab). Just like Rituxan targets a protein on the surface of an immune cell, Keytruda targets the PD-1 receptor on an immune cell. PD-1 stands for Programmed Cell Death -1. The PD-1 receptor is important because it tells the body not attack itself -- it is known as an "immune checkpoint."


So here's where the problem comes: the cells for many different types of cancer will attach to the PD-1 receptor and block it. That means that the immune system can't recognize the cancer cell as an invader. While it would normally kill off the cancer cell, now it doesn't even know it's there, and the cancer cells grows and grows.

Keytruda is a "checkpoint inhibitor." It attaches itself to the PD-1 receptor, so the cancer cells can't. This lets the immune cell see the cancer cells as invaders, and destroy them. It's a great example of Immunotherapy, where the treatment helps the immune system do it's job normally to kill of invaders like cancer cells.

The phase II clinical trial that combined Keytruda with Rituxan involved a small number of patients (only 30), but the results were very good, with an 80% Overall Response Rate. Keytruda seems to help out certain types of immune cells that kill invaders in a particular way (that particular way is called Antibody-Dependent Cellular Cytotoxicity, or ADCC, in case you want to look it up). Conveniently, Rituxan works through ADCC. So the thinking of the researchers was that combining Keytruda and Rituxan would work well for Follicular Lymphoma.

The patients in the study have all had treatments with Rituxan in the past. As I said, the Overall Response Rate was 80%, with 60% achieving a Complete Response, after a follow-up of 7 months. Pretty good numbers. There were some side effects, particularly related to immune system problems (which is expected when you give a treatment that blocks the things that keep immune cells from controlling themselves). But they were considered manageable.

There are lots of limitations to this study -- it's a small number of people (just 30), and it was done at just one institution (MD Anderson), and the follow-up time is pretty short (7 months). But the researchers argue that these numbers are good enough to expand, and that would seem to be the case.

Keytruda is an interesting treatment, and it has seen a lot of success in lots of different cancers that are affected by the PD-1 receptor. But it's not perfect, by any means. In fact, about a month ago, trials for a combination therapy that included Keytruda for patients with Multiple Myeloma (another blood cancer) had to be stopped because of several deaths. Again, this treatment can do a number on the immune system, and certain combinations will probably make that affect worse. It's important to note that the Keytruda/Rituxan trial reported no deaths, but it's a good reminder that every treatment carries some risk.

For now, though, this may represent yet another non-chemotherapy treatment that is worth keeping an eye on.

[I didn't include a direct link to the abstract for this presentation at the International Conference on Malignant Lymphoma, because the ICML doesn't have a search function for their abstracts, so I can't give a direct link to just this one. However, if you want to see the abstract for yourself, then follow this link to the Abstract Book, then scroll down to abstract #109, "HIGH RESPONSE RATES WITH PEMBROLIZUMAB IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA: INTERIM RESULTS OF AN ON OPEN‐LABEL, PHASE II STUDY.]