Saturday, July 26, 2014

I'm Back!

My two vacation is over. I got back just in time to hear the news about the FDA approving Idelalisib/Zydelig for Follicular Lymphoma, and to post something quick on Thursday morning, but it's mostly been recovery and catching up for a couple of days since then.

My wife, kids, and I went to the United Kingdom for two weeks -- 5 days in London, 4 in Cornwall in Southwest England, and then 5 days up north in Edinburgh, Scotland. It was a great trip for all of us. My Doctor Who fan daughter got to see the TARDIS in Earls Court; my middle child, who has embraced his Scottish heritage, got to eat real haggis in Scotland; and my oldest, the jazz musician, got to see Bill Evans and Mike Stern, who played with Miles Davis in the 80's, in concert as part of the Edinburgh Jazz and Blues Festival.

It was the first visit to England for me and the kids, though my wife had been there before we were married. So this was also her way of keeping her promise to show me England some day. I still need to keep my promise to show her Italy, where I lived for 10 months years ago.

It was a great trip, and a much-needed one. We had a really tough spring. My shoulder surgery and recovery was only a part of it, and I won't get into the rest of it here. But it seemed like someone was just piling more and more tests on us as the spring went on. We passed those tests, and we're all better for it. And the trip to England and Scotland became, in some ways, a celebration of getting through the spring, a way of re-setting our lives and starting over, but also a way of remembering someone we love.

And while it seemed like I had been writing from the UK every few days, to be honest, I had actually written most of that stuff before I left, and posted it as I went along. That meant that I took a chance on writing a post about missing our dog, but it worked out OK, because we really did miss her. And she missed us, too. She didn't pass out when she saw us, like this other schnauzer did (in a video conveniently posted on YouTube yesterday), but she was happy to see us anyway.

It's funny, though, how it's almost impossible to take a vacation from cancer. It seemed like there was always a reminder. One museum we visited showed artifacts from vikings who had lived on the British Isles, including a quiver full of arrows -- anyone who has read this blog knows the specialist I saw long ago called the available lymphoma treatments the "arrows in your quiver." And it seemed like every major street in every town we visited had a few "charity shops," what we in the U.S. know as Goodwill or Salvation Army stores. And a whole bunch of those shops supported Cancer Research UK. And then outside Edinburgh Castle, a man dressed as William Wallace from Braveheart (as opposed to the real William Wallace) posed for pictures with tourists, accepting donations in a box, with a sign that said "All Donations to Support Leukemia Research."

I think we all probably knew already that there's no vacation from cancer. And that's OK. I wasn't looking for one. Six and a half years, and I still check in with the support group every day. I still read your comments on the blog every day. I still look around the net to see what's new for Follicular Lymphoma every day. Every day. And I still welcome new experiences, and ways to share the world with my family, and opportunities to live my life. Every day. Cancer is only one part of those days -- as small a part as I decide it's going to be.

It's good to be back.

Thursday, July 24, 2014

Idelalisib Approved for Follicular Lymphoma

The FDA announced yesterday that Idelalisib has been approved for treatment of three types of indolent NHL, including Follicular Lymphoma.

Also, it seems like the name is now being changed to Zydelig, to conform to the rule that all newly approved drugs have to have a Z or an X in their name, preferably both. Which stinks, because I finally learned how to spell Idelalisib without having to look it up every time.

This is excellent news. Idelalisib/Zydelig received Accelerated Approval for Follicular Lymphoma, for patients who have had at least two previous treatments. Accelerated Approval means that the approval was based on results of a phase 2 clinical trial, rather than a larger phase 3 trial (though the manufacturer will still need to conduct another trial to confirm the phase 2 results).The trial that resulted in the approval involved 123 patients with either FL or SLL (another indolent lymphoma) who were no longer being helped by Rituxan or traditional chemotherapy. The study found that 54% of Follicular Lymphoma patients responded to Idelalisib/Zydelig.

Idelalisib/Zydelig is an oral treatment, taken in pill form. It is a kinase inhibitor, targeting and stopping a protein that is responsible for cancer cells thriving and growing.

The FDA's announcement, however, makes very clear that there are some side effects associated with Idelalisib/Zydelig (there are always side effects). So while the treatment looks promising, it's still something that needs to be discussed seriously with an oncologist.

Two big take-aways from this, I think:

The first and most obvious is that we have another arrow in the quiver. Options are good, especially options that seem to work when Rituxan and chemo stop working.

The second is a little less direct, but just as important: the FDA is making serious attempts to get treatments to patients through "Breakthrough Status" and "Accelerated Approval" processes. Traditional approval for Idelalisib/Zydelig would have meant months or years of developing, recruiting, conducting, and reporting on a phase 3 study. I think the Accelerated Approval is as important as the approval itself. My guess is it won't be the last one we see in the next few years.

PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells - See more at: http://www.gilead.com/news/press-releases/2014/7/us-food-and-drug-administration-approves-gileads-zydelig-idelalisib-for-relapsed-chronic-lymphocytic-leukemia-follicular-lymphoma-and-small-lymphocytic-lymphoma#sthash.VDHyLFWM.dpuf
PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells - See more at: http://www.gilead.com/news/press-releases/2014/7/us-food-and-drug-administration-approves-gileads-zydelig-idelalisib-for-relapsed-chronic-lymphocytic-leukemia-follicular-lymphoma-and-small-lymphocytic-lymphoma#sthash.VDHyLFWM.dpuf

Tuesday, July 22, 2014

Zevalin Update for Follicular Lymphoma

From a couple of weeks ago, and early publication from The Annals of Hematology reporting on the long-term success of some Follicular Lymphoma patients who had received Zevalin.

A quick explanation if you don't know what Zevalin is:

Zevalin is a type of RadioImmuno Therapy, or RIT. Traditional radiation had limited use on most types of blood cancers, since radiation can't usually hit a moving target, like a circulating blood cell. RIT takes something that tracks down blood cells (think Rituxan) and attaches a small dose of radiation to it, so it can be delivered directly to the affected blood cells.

Zevalin, and other RITs, have had some success, but for a whole bunch of reasons, are not used very often on Follicular Lymphoma patients. Read more on RIT at Lymphomation.org.

So this study looked at 37 Follicular Lymphoma patients who had received Zevalin. As I said, Zevalin works: 34 of the 37 had a Complete Response. Long term, it did its job for most of the patients, though it certainly wasn't a cure. Patients reported decent Quality of Life results, too. I'll let you look at the numbers yourselves.

I think, even with a small study like this which is "outside of a clinical trial," it's clear that Zevalin is effective long-term. I'm not sure this adds anything new to what we've known about Zevalin, and since it's outside of a clinical trial, there are lots of questions about how representative the patients are.

But it's nice to see at least some evidence that Zevalin is still a valid option for us.

I'm not sure this study will result in increased use, but it keeps it at the front of everyone's minds, anyway, which might be about the best we can hope for. Good to remember that arrow is in the quiver.

Saturday, July 19, 2014

Stem Cell Transplants....For Dogs

As I mentioned a week or so ago, I've been away for a little while. Couldn't bring the dog. I miss her, even though she's useless to me as a cancer-sniffing dog. (Really, she's kind of useless as a dog in general. But she's sweet and she looks great, so we go with that. here's the little princess:


We assume she misses us, too.)

Anyway, I've been thinking about her, and it reminded me of an article from last month on dogs with lymphoma. I'd never wish lymphoma on any creature, two- or four-legged, but it's pretty cool to hear about how work on human lymphoma at the Fred Hutchinson Cancer Center in Seattle is being used to help dogs.

Also, there's some good news about cancer vaccines for dogs, too.


Obviously, dogs aren't people, but maybe the things we learn from dogs can be translated in some way to what we know about people cancer. Even indirectly.

I still miss my dog. We'll be home soon, baby.  And I know you're in great hands, and probably having a much better time than you would with us, anyway. You'd just be sitting at my feet while I read cancer journals, rather than playing with your friends.

Hope everyone is staying healthy.


Tuesday, July 15, 2014

Bendamustine: An Overview

The July issue of the Leukemia and Lymphoma journal features an article written by Dr. Enrico Derenzini, Dr. Pier Luigi Zinzani, and Lymphoma Rock star Dr. Bruce Cheson, called "Bendamustine: Role and Evidence in Lymphoma Therapy, An Overview."

The article is written for oncologists who want to know more about Bendamustine and how it might be used for a number of lymphomas and other blood cancers, including Follicular Lymphoma, of course.

The article gives some history on how Bendamustine was developed, how and why it works on lymphoma cells, how it might best be used, and what clinical trials have told us about its effectiveness.

In the article, you'll learn some fascinating tidbits, like:
  • Bendamustine was developed in East Germany in the early 1960s, but wasn't widely used or known about in Western Europe and the U.S. until the early 1990s, after things opened up over there.
  • It is related to the mustard has used in World War I.
  • It is generally better tolerated and more effective than CHOP, especially when combined with Rituxan.
  • It was named for Benedetto DaMustini, a young Italian immigrant who sold sausages from a small stand outside the East German hospital where it was developed. One night, after a long session of working on the compound, the lead researcher was about to give up on his efforts. He stopped for a sausage at the stand, and, refreshed by his snack, returned to work in the lab. A few hours later, he had his breakthrough. He went outside, thanked the boy for his sausage, asked the boy his name, and declared that he would name his new cancer treatment Bendamustine after young Benedetto DaMustini.
I actually made up that last fascinating tidbit. But I had so much fun thinking about writing a screenplay involving two monkeys named Johnny and Gonzalez who helped develop a Rituxan Biosimilar that I decided to work on a prequel that focuses on chemotherapy development.

Anyway, the stuff that you actually learn from the article is pretty interesting on its own, particularly given how much more common Bendamustine is becoming as a treatment for Follicular Lymphoma. As I have mentioned before, Dr. R and I have talked about it as a possible next treatment for me, when it becomes necessary to have one, so I have a special interest in learning more about it.

Friday, July 11, 2014

Battling and Beating Cancer

Charlene McMann and Scott Seaman are featured on the WGN Radio show hosted by Patti Vasquez, discussing their book Batting and Beating Cancer: The Cancer Survival Book.

I haven't read the book, so I can't speak to it directly, but their discussion of the book is interesting. I particularly like that they pay attention to issues for caregivers. We so often forget about the ones that take care of us, the patients, and what they go through. They deserve some recognition.

I've written about McMann and Seaman before. They are founders of the Chicago Blood Cancer Foundation, and have done lots to raise awareness of (and money for) blood cancer issues in Chicago and around the country. Scott is a lymphoma survivor himself.

Good stuff. Worth the 25 minutes to listen.



Tuesday, July 8, 2014

Rituxan Substitute?

More Rituxan in the news. (What is the deal with Rituxan these days? Two posts about Rituxan in a row? It's been around forever, but still manages to make news. It's becoming the Joan Rivers of cancer treatments, for crying out loud.)

Anyway, Rituxan is in the news because its patent expires in 2018, meaning other companies can make generic versions -- and sell them cheaper. (A big chunk of the cost of a drug comes from recovering all of the research and development that went into finding, creating, and testing the drug, which can take years. Generics don't have to do all of that work, so they don't have those costs to recover. So, we get cheaper drugs.)

The big issues with generics is that they need "biosimilarity." This is where things get complicated. Many generic drugs are made by recreating a chemical. (It's more complicated than that -- not many of us can make our own home version of ibuprofin or something like that -- but it's fairly straightforward.) Biosimilarity involves drugs or medical products that are produced by living organisms. This includes Rituxan, which is made from mice.

So creating a biosimilar of Rituxan is a lot harder. It's more than just mixing chemicals in a lab; it's trying to duplicate the entire process of creating something that is itself created from a living organism. And when you're dealing with stuff that is or used to be alive, you've got a whole bunch more factors to control that are potentially hard to control.

Of course, the original manufacturer of Rituxan isn't going to make this easy by offering any help.

An article in this month's Leukemia and Lymphoma describes a European attempt (successful) to create a biosimilar version of Rituxan. It's for a medical journal, so it's fairly thick reading, but I think a version aimed at a more popular audience would make for fascinating reading. There are deadlines to be met, with scientists frantically trying to copy things. There are "freshly purified human natural killer cells." And there are two monkeys. They don't have names, but when I write my screenplay based on this article, the monkeys will be called Johnny and Gonzalez. And nobody but my father will get that joke.

Anyway, it's pretty interesting reading, and maybe makes us appreciate how difficult it is to develop the original version of a treatment, let alone a generic version.

It will be interesting to see how the patent expiration plays out, and what we get as a result. Cheaper monoclonal antibodies? Maybe something just a tiny bit better? or a tiny bit worse?

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A quick note about the next couple of weeks:
I'm off on a vacation with the family, and unlike the vacations I usually take, this one will leave me with limited internet access. I plan to post to Lympho Bob every few days, because it's important to me to keep up with it. But the posts will definitely be shorter, and maybe have some longer stretches in between. My plan is to get back to my usual blogging habits when I get back near the end of the month.