Acceptance

My wife and I took the dog for a walk this morning (Lake Wintergreen, one of our favorite walking places). Spring is very slowly making its way to Connecticut, and green buds are just barely popping out on the trees.

Still, the morning sun on the water was just stunning.

We walk around our neighborhood every morning, at least 2 miles. It's pleasant enough, but every now and then, a "forest bath" is good for us. It makes us think a little differently, maybe a little clearer. It helps us make connections that we hadn't seen before.

I made one of those connections this morning.

As we got near the end of our walk, we both saw the same thing -- a small evergreen. 

Now, as you can see from the photos, there are lots of big, beautiful evergreens around the lake, but most of them are on the opposite side from where we were. Near where we were, there are lots of tall grasses, with swifts and red-winged blackbirds perched and diving. 

So this little evergreen kind of stood out, sitting there all by itself.

 

If you've been reading for a while, you might remember that I get this kind of feeling every year around this time. There's a particular daffodil that pops up every year in my thorny blackberry patch (I've written about it a few times in the past). It always gives me hope to see something so beautiful thrive among the difficulties that thorns represent.

That little evergreen gave me some similar feelings this morning. 

It's not surrounded by thorns, or anything dangerous. It's just the opposite -- on one side is a gravel path, and on the other is a bunch of rocks leading down to the water.

As my wife and I looked out onto the lake from that spot, I said, "That little evergreen looks like it doesn't belong her."

And my wife said, "Yeah, but at the same time, it seems to be making the best of where it is."

And that was the connection.

The evergreen seems to have accepted its place. Probably not what it would have chosen, if it had a choice, but it's doing its best with where it is.

Accepting something doesn't mean liking it. It's OK to wish for something else, to ask "Why Me?" and wonder how things might have been different. 

But it's possible to do those things and accept where you are, too. 

I'm not trying to be overly optimistic here. I'm not saying cancer patients need to always smile and see the good in it. I've heard people say that getting cancer was a gift, and it changed their lives for the better. If that's the case, that's great. It's probably easier to feel that way after it's al over. Harder to think of cancer a s a gift when you're in the middle of it.

But I do think that acceptance is important. As some point, if anything is going to change, you need to acknowledge where you are. Maybe that helps you see what's around you, and see where you want to be instead. Standing firmly in one place, even for a short time, can help you figure all of that out. That's acceptance. 

That doesn't mean wanting to stay in that place. Maybe your next move is to kick and scream and do whatever you can to be somewhere else. That's OK, too.

And probably easier for us to move somewhere else, physically or emotionally, than it is for that little evergreen.

I hope you're all able to enjoy some beautiful weather, wherever you are. I recommend a change of scenery when you're able. 

It's a nice way to recognize where you are , and to see where you might be able to go.
 

Some Follicular Lymphoma News

I've had a lot of stuff piling up in my Drafts folder, so instead of giving you a full post for each, I'm going to give you some short comments on a bunch of them.  

• First, my Instagram Live session last Thursday went well. As I told my host Yolanda afterwards, it was as much as you can have talking about cancer. If you'd like to watch it on YouTube, you can see it here. We talked a lot about some of the emotional parts of having Follicular Lymphoma. It was my first IG Live experience, and while I've made a few videos for other folks, I may try to get more into sharing my story in this way. (Watch until the end for a special guest appearance!)
• As expected, last week the FDA recommended some changes to the way PI3K Inhibitors are approved for blood cancers. As I said in my last post, there were some concerns about Overall Survival and safety. Some patients has severe side effects from the treatments -- severe enough to affect the Overall Survival statistics. The FDA really didn't have much choice but to change the way they have been treating PI3K Inhibitors and their approval. As one of the members of the committee that voted (Dr. Christopher Lieu of the University of Colorado Cancer Center) said, "The bottom line is, if we aren’t improving length of life with any therapy but exposing patients to toxicity and therefore decreasing their quality of life, are we truly helping our patients? I don’t believe so.” Just to be clear: the FDA isn't saying that these treatments can't be used anymore, and they aren't saying that they won't approve them. But they do want to see more data before approval to make sure they are safe and effective. They will basically have to follow the same process as every other treatment, rather than being able to get approval earlier than usual. Now it will be up to the makers of the inhibitors to decide if it is worth the time and money to bring the treatment to patients. A couple of links, if you're interested: a nice write-up about the meeting from OBR Oncology, with some quotes from committee members; and a video of the 4 hour meeting where it was all discussed. 
• Good news from Europe! The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended that the bi-specific treatment Mosunetuzumab be approved for Follicular Lymphoma. Final approval should come soon, which is great news.  

I'm reading about a few more interesting FL issues, but I'll write about them more soon.

 

Updates: Instagram, plus PI3K Inhibitors

Just a couple of quick notes today:

First, a final reminder that I'll be on Instagram Live tonight with @MyelomaChick at 7:00pm ETA. We're going to talk about what life is like as a blood cancer patient. If you can, tune in. Feel free to leave comments while we're on. And if you can't make it tonight, I'll send a link where you can watch the recording on YouTube.

Hope you can make it.

********************

Second, more bad news for PI3K Inhibitors. This week, the makers of Umbralisib decided to withdraw from the market -- in other words, Umbralisib won't be available anymore, and the company that makes it is likely to stop making treatments for cancer. 

The bigger picture for PI3K Inhibitors doesn't look good at all. Today, a meeting is scheduled for the FDA to talk about this type of inhibitor, and they are likely to announce some changes in the way they are approved. If you've been reading this blog for the last few months, you know that there have been issues. 

One big issue has been the way that PI3K inhibitors have been approved. They have received accelerated approval from the FDA. Usually, a treatment goes through steps -- developed in a lab, tested on animals, then on a small number of people in a phase 1 trial to figure out the most effective and safest dose, then a larger phase 2 trial to make sure it is as safe and effective as it seemed, and then a phase 3 trial where it can be compared to other treatments currently available to see if it offers something better than what we already have.

Accelerated approval was developed by the FDA to get treatments to patients more quickly. It can be several years between a phase 2 trial and a phase 3 trial, and if the phase 2 trial shows enough evidence that a treatment is safe and effective, then approval can be given -- the treatment can be offered to patients, as long as the maker agrees to run a phase 3 trial to confirm that the treatment really is safe an effective. The maker gets to start making money a few years sooner than it would have without the accelerated approval.

The potential issue with accelerated approval is that going through the full process, including a phase 3 trial, means more time to discover problems like long-term side effects that don't come out right after a phase 2 trial. 

And that's what has happened with PI3K inhibitors. The FDA issued a report before today's meeting that points out the problems that PI3K Inhibitors have shown. The big one -- even though PI3K Inhibitors improve Progression Free Survival in blood cancer patients, the data from six clinical trials actually shows a decrease in Overall Survival. In other words, compared to other treatments, patients who take these inhibitors have a better chance at going longer in between treatments, but also a better chance of dying sooner. That has never happened before with a cancer treatment, says the FDA.

Let me be very clear here -- this shouldn't be taken as meaning PI3K Inhibitors are going to kill you if you take them. It's more likely that a small number of patients had bad reactions to the treatment and the side effects caused premature death. That's going to mess up the statistics. I've been saying over the last few months that I have been very surprised to hear so little from oncologists about this situation. They're finally talking a little bit. One well-known blood cancer specialist, whom I respect very much, tweeted that he thought PI3K Inhibitors still had a place in blood cancer treatment for a lot of patients. He's probably right -- if anyone would know, it's him.

But the FDA has a responsibility to make sure patients are safe, which we should all be grateful for.They are probably going to make a few changes in the way approvals are made. First, no more accelerated approvals based on phase 2 trials. They will want phase 3 randomized trials. That means a large group of patients, all of them as similar as possible, in terms of their disease and the treatments they have had already, with half getting the new treatment and the other half getting a treatment that has already been approved. Direct comparison. It's the best way to run a trial, and to see if the new treatment is really safer and more effective than the older one. 

Second, the FDA is probably going to want more dosing experiments in phase 1 and phase 2a trials. That means having patients take different amounts of the treatment to see which amount is effective without causing too many harmful side effects. Do that in early phases of the process, and you have fewer problems in the later ones.

Finally, the FDA will probably put more emphasis on Overall Survival. There is a trend in using "surrogate endpoints" in trials -- basically saying, "If PFS is improved after 2 years, then Overall Survival must be improved after 5 years, since that's how it's always been." With the FDA saying this is the first time a cancer treatment has improved PFS but not OS, we'll probably see them asking for more OS data and not surrogate data that is a substitute. That just doesn't hold anymore.

The downside of all of this is that we have lost a bunch of treatment options. Not all of them -- Copanlisib is an effective PI3K Inhibitor, and still safe and effective, and still available. And Zandelisib is making its way through the trial process. They are likely to be told that they will need to do a randomized, phase 3 trial, instead of getting accelerated approval. I hope they decide to take that step -- they seem to have a good product that has taken steps cut down on side effects. But if they make the business decision to withdraw, then we will lost out on that option, too.

The upside, though, is that any treatments that do make it through the phase 3 process will be good treatments, with data that supports their safety and effectiveness. And that's better for us, in the end -- fewer treatments, but safe and effective ones.

(That was not nearly as brief as I had planned, but it's important to talk about. Hope to see some of you on Instagram tonight. Stay well.)

Join Me on Instagram This Thursday!

Hey everyone. 

Just a reminder that I will be a guest on the Instagram Live series "No Time Like the Present." I'll be talking about Follicular Lymphoma, my life as a patient, and anything else that comes up in this open conversation.

The host of the series is Yolanda Brunson, who goes my the Instagram handle @MyelomaChick. Yolanda is many things (as you can see from her biography on Blood-Cancer.com), including an advocate for patients with Multiple Myeloma, another type of blood cancer. She's great.

If you can't make it on Thursday at 7:00pm EST, you should be able to watch it afterwards on YouTube (I'll post a link after Thursday). But I hope you'll join us Thursday if you can. It's easy if you're on Instagram already -- just go to @MyelomaChick on Instagram and you'll see the two of us. As you are watching, feel free to ask questions by writing in the comments. I hope some of you can make it.