How Long To Wait For Trials and Treatments ?

[Ernest2]

A question I’ve wanted to ask you all for a long time:

How long should we wait for trials and new treatments, and how to decide that the time is right to sign up, or not to wait any longer for what isn’t quite yet available?

As I’m at the end of round 6 FCR (more of that later) the penny drops that if things go well I am, under current best knowledge, hopefully returning to the status of a “Watch and Wait” patient. I’ll be very happy though if at some point I’m told “no, we think now with the improved tests we now have, that your FCR might be a cure”.

So that gets me back to the realisation that at some point I may well be a 2nd line patient looking at CLL treatments and trials again.

I now understand that the UK is a great centre for trials, so that is the likely way for those located here to access the best current treatments.

In turn that makes me consider with hindsight, was my decision to wait for FLAIR the right thing to do, and more significantly now, if I was faced with that sort of question again, how might I make a better job of deciding when the time is right to start treatment?

The snag is, there is always the temptation of a better trial or treatment around the corner, and we have to accept that predicted dates for such things are often going to be a moving target due to the complexity involved in setting up trials.

You can make a decision say that “I’ll wait for another couple of months but no more”, but that time soon goes by and it’s always just too tempting to try to hang on a little while longer, “just another month”.

We have to decide of course how urgent is our need for treatment, and assess the risks of waiting, and of course accept that we may not ever know if we made the right decision afterwards.

How do you classify how urgent you are?

- Critical, time to start treatment

- Very Urgent

- Urgent – is that too risky to wait any longer ?

- Ready for treatment

- Ready to think about treatment

etc.

It is just too easy to change your view on each of the above as you slide from one to the next (and I’m not a gambler, perhaps too careful if anything)

So some may say “Ah, you’re spoiled for choice then”, but that doesn’t seem to help much when you are in the thick of it.

I really hope that nothing changes to make me regret that I waited for FLAIR, when I ended up on FCR. The way I look at it with my prognostics, is that I’m going to need something like Ibrutinib or its successors in very approximately 5 or so years’ time, so thank you all for helping try out and understand these new therapies.

I hope I’ve got some time to think about all that, but it would be helpful (and very much appreciated) if anyone would share their decision making process on how long to wait for trials and new treatments.

Apologies I haven’t posted yet on the Round 6 FCR but I think there is a little way to go. The taking of the Chemotherapy and Immunotherapy are thankfully over, but remember it stays in your system for some while (6->8 weeks as best I know) and I’m still suffering from falling red blood cell count and Neutrophils, so I will hopefully be in for a red blood cell transfusion later this week.

Best wishes to all,

Ernest.

P.S. The above is a repeat of the question I raised in response to a great post "Treatment dilemmas - the waiting game" from Paula, and much following good discussion, all well worth a read:

healthunlocked.com/cllsuppo...

[Cllcanada Top Poster CURE Hero]

Love the photo...Great shot!

I can address two instances on your list...

Very urgent would be a transformation either Richter's or perhaps MDS/AML.

Urgent would be nodes threatening organs or infiltrations, for example to the bowel.

I hope you get the 9 year... FCR remission... that some MDAnderson doctors consider might be a cure!

Rituxan's effects can hang around for perhaps 6- 8 months, apparently... still working

~chris

[Ernest2 in reply to Cllcanada]

Thanks Chris.

I did start off with a larger list but realised I'm just not qualified, so if people fancy trying to make a full list that would be interesting. I did want people to think about how they change from one to another, and not always predictably, as we let time go by waiting for treatment. Perhaps opportunity for a poll or two.

Didn't realise at all about Rituximab lifetime. The impression I had was that it is an efficient killer of the CLL but only for as long as you keep taking it, and having stopped the CLL woukd return. Not sure if low dose long term would be possible, and any studies done on that (apologies for ignorance). Of course on FCR I can't be sure myself which symptoms due to FC and which to the Rituximab.

I do remember your post about subcutaneous Rituximab:

healthunlocked.com/cllsuppo....

There, I can cut and paste on a tablet computer.

Ernest

[70s-80s-overlander]

Your question was, "How long should WE wait for trials and new treatments?" The "we" is the problem. That is a statistical "we". Answering that "we" question might provide some guidance -- regarding, for example, that, overall, this treatment appears to be better than that treatment STATISTICALLY, given the average characteristics of the folks allowed into the particular study. Some trials are stopped because too many folks aren't doing well, but even in those trials there tends to a couple of folks who are doing just fine, possibly much to a certain degree of amazement.

The best you and your doc can do is to decide WHEN and WHY to start treatment -- and, upon reaching that starting point, to decide WHAT to use. The individual variables are many. In some situations in medicine there are fancy computer programs that can analyze a myriad of variables -- that can cone down the decision-making process a bit -- but generally it all still comes down to humans -- you and your doc -- making a judgment call. Folks would prefer to believe that there is ONE perfect answer, but usually a decision has to be made between the best of several possibly bad options.

Thus the beauty of doing what you can to become as healthy as possible during the so-called "watch and wait" period. Efforts to help your body do what it needs to do generally are good efforts to recommend for everyone. These "good options" are closer to "perfect" answers. In contrast, chemotherapy and immunotherapy and radiation are NOT good efforts to recommend for everyone. These are NOT "perfect" one-size-fits-all answers at all. All you and you doc can do is, first, to make an educated guess (perhaps in advance) about WHEN and WHY -- and then, when the starting point comes, to make an educated guess about WHAT.

Whew! Good luck on sorting out your situation!

[Ernest2 in reply to 70s-80s-overlander]

Many thanks Overlander for a comprehensive answer.

I am thinking about the kind of decisions many of us have to make (statistics was never a strong area for me, but now much more interesting with the medical stuff we try to understand)

Sorry I'm not good with words. My list was not intended as definative, I just wanted to get the concept of a list (see above to Chris).

You are right about working with your clinical team, but such meetings will always be short compared to the total length of time we have to think about it, and consider that our situation may be changing, sometimes rapidly.

Anyhow I am hoping I've got more than a few years before I need to worry too much - time to get my brain in shape then for when the time comes.

Your para about getting in physical shape is spot on, and that is the thing we don't want to destroy by waiting too long.

Thank you,

Ernest

[PaulaS Volunteer]

Thanks for sharing, Ernest, and for identifying some of the issues. Great photo too. Lovely rich colours.

Yes, I think some people forget that even after FCR, they are still on "Watch and wait". I never thought it was a good phrase (W&W). For many reasons, but partly because people assume you stop watching and waiting after treatment, which isn't true.

You're right that the UK is a great centre for trials. We're very lucky, compared to some countries. But I agree that it can be confusing, and there's the temptation to wait too long, hoping for a new treatment or trial to become available. That's what I need to be careful about, at the moment. According to your classification, I reckon I'm wobbling between "Ready for Treatment" and "Urgent".

You ask people about their decision making processes... Well it was very complicated for me, and has dragged on rather a long time. It's late tonight but maybe I'll try and explain later... It was complicated by the delays in trials opening, and the "progression" of my illness. Sometimes we think we've done our research and made our decision, but then things change... Duh...

Anyway, going back to your situation... I do hope your blood counts pick up soon - even if it needs a transfusion to help you on your way.

Wishing you a good long remission,

Paula

[Ernest2]

Thanks Paula, hope things are ok with you.

I'm plumbed in now, and starting at Hb = 6.3 g/dL this morning, I'm already feeling miles better after 1st of three bags of blood.

So no excuses now for my Typos and confusing English.

I agree about the W + W terminology. It did seem unfortunate we got stuck on that, but I remember Nick explaining it was too hard to change being used as general medical terminology - shame though not to Improve on that.

Interesting where you place youself on the list. I think more levels need to be added (in the middle too) and of course it is a sliding scale, and in reality not just one dimensional (different factors driving treatment).

Anyhow I reckon you will be an expert in this question, and the very best in making your choices. I just realise I'm not very good at it.

I am truely humbled to be lucky enough to have treatment choices, thinking of those that didn't and those that yet don't.

Ernest.

[PaulaS Volunteer in reply to Ernest2]

I'm glad to hear you're "plumbed in now" Ernest! With an Hb of 6.3, you certainly needed some help. Great that you're feeling much better already, after your first bag of blood.

I guess I put myself between "ready for treatment" and "urgent", because the doctors sort of told me that. There is a list of criteria they use - boxes to tick, to help them define when treatment could start. But it's rarely "urgent" at that point (though sometimes it is).

I met the criteria for treatment several months ago, but was told it wasn't urgent. However, since then my Hb has dropped to 10.1, spleen and liver are even more enlarged, and I'm losing weight because my spleen is squashing my stomach. Those are all boxes that can be ticked..

I'm also very tired, and my WBC is 303, but tiredness and high WBC don't usually count as reasons for treatment. (My ALC is probably about 3 to 8 less than 303, but they're using an automatic machine and it isn't accurate at such high levels.)

But no, I'm not an expert in these things, and not very good at decision making. Especially when the situation keeps changing...

You're right - we are very lucky to have any choices at all.

I hope the rest of your transfusion goes well, and you continue to feel even more better after it.

Best wishes,

Paula

[Ernest2 in reply to PaulaS]

Many thanks Paula.

I'm onto bag number 3 now, so will be floating out of here on a wave of euphoria. Can't believe my thumping head from this morning is all gone.

I can really empathise with the enlarged spleen, and hope the treatment when started soon sorts that out. (Apologies I can't find the right words there)

I do also think given a little more time you will be an expert on advising on this decision making process.

For me I think you can now call it ALC = 300.

And please keep trying to drink and look after yourself as best you can.

Wishing you the best in your choices. 

Best Regards,

Ernest