FCR, WHAT IS THE AGE LIMIT FOR FCR OR IS IT MORE ABOUT FITNESS

[BasTel]

I am 71 years of age and was diagnosed with MGUS 22 years ago, this progressed to CLL in July this year. I have had a FISH test and have been recommended for the FLAIR trail. FCR is one Arm of the trial so am I right to assume that my age is not an issue? I am pretty fit and do not have any co-morbidity.

[Cllcanada Top Poster CURE Hero]

It's about body age and comorbidities... not chronological age. In other words being fit... with adequate renal, liver and cardio function...

FLAIR is a wonderful trial... wish you all the best

~chris

[Yuck in reply to Cllcanada]

Hi Chris,

Right on with your comment as usual. Last month this topic came up in our support group and a knowledgeable person explained how age 65 came about in the early research. A number needed to be chosen, as I recall; seemed arbitrary, as I recall.

At Dana Farber, my fit husband got FCR at age 66 in 2010.

A 68-year-old in the support group is about to start FCR at a neighboring Boston hospital. The hospital also allowed him to choose to have Ibrutinib at the same time as FCR, if he wanted, which made him annoyed. He felt they should decide as the experts, so he picked one.

Take care!

~ Yuck

[GMa27]

Just had FCR and in remission. I am 63, 13q and mutated. It was my last chance for FCR. It is not recommended for 65 and older. Had 2 CLL experts. They both agreed no FCR over 65.

Has nothing to do with how fit you are. I don't remember what their explanation was cuz I was happy I was under 65. I only needed 3 cycles. Got BMB and blood work and achieved remission.

Had no problems during chemo. Port was great. Kept my hands free and veins healthy. Good to get second opinion. Good luck! 💞

[AdrianUK in reply to GMa27]

It just shows how much different experts differ in their advice regarding our disease. The flair trial on line inclusion criteria doesn’t have the an upper age limit you mention (hence for FCR) but below 75 leaves it to the discretion of the consultant where it’s about the perception of clinical fitness.

[Cllcanada Top Poster CURE Hero in reply to AdrianUK]

What scoring system did FLAIR use? CIRS?

[AdrianUK in reply to Cllcanada]

They are much more clinical judgement based chris. The inclusion criteria talks about the presence of certain specific criteria and says “any other medical condition...” seee cancerresearchuk.org/about-...

[BasTel in reply to AdrianUK]

Thanks for that Adrian but I do believe that the age range, according to Cancer.co.uk, is 18-75!

[Cllcanada Top Poster CURE Hero in reply to BasTel]

Yes... 18-75 years old... chronologically

[AdrianUK in reply to BasTel]

I read that before my answer and somehow missed it. You are right so have edited my answer to point out that below 75 it’s clinical discretion see cancerresearchuk.org/about-...

[Cllcanada Top Poster CURE Hero in reply to AdrianUK]

That's what CIRS Or CIRS-G is... a rating system of 13 major system functions... also ECOG or Karnowski for QOL

oncologypro.esmo.org/Oncolo...

Table 1 has the full criteria for FLAIR, could have changed with new arms..,

ncbi.nlm.nih.gov/pmc/articl...

[starsafta]

You don't mentioned whether the FISH test showed you are mutated or unmutated. It is my understanding that FCR is not as effective for those who are unmutated. Hopefully, your doctors are taking that into consideration.

[BasTel in reply to starsafta]

Unmutated

[AdrianUK in reply to BasTel]

In the UK unmutated status does not confer any special privileges re treatment. Ibrutinib is only available first line for those who have 17p /TP53 issues outside of a clinical trial.

[starsafta]

So sorry the UK hasn't stepped up to the plate. Makes me even more firm that we in the US have to fight socialized medicine to the hilt.

If those running the FLAIR trial have any compassion at all, they will put all with potential for limited benefit from FCR in one of the Ibrutinib arms, even if they can't admit it. Hope that will be so for you. You have a 3 to 1 chance for an effective response. Sounds like participating in the trial is a hopeful option for you.

My first treatment was in an Idelalisib trial, and I can tell you that it takes faith and trust. There is some comfort in knowing there are all sorts of controls to constantly monitor and evaluate progress. In the long run, the gathering of data leads to being better taken care of than when in standard treatment on these new oral drugs.

May you find faith and trust. Good luck!

[cajunjeff in reply to starsafta]

All countries have different versions of their own “fda” and protocols to get drugs approved. There will always be the debate over private pay and social systems. I don’t think ibrutinib not being approved in the UK yet for frontline is an indictment of social medicine. I now get my ibrutinib front line through Medicare, which is socialized medicine. Private pay or socialized, however anyone does it is fine with me, so long as we make sure everyone has access, just not the few.

As to the OP, my doctor has been credited with being one of the founders of fcr and he doesn’t put any arbitrary age cut off for taking it. When you think about it, it’s silly to think you are good to go at age 65 and not one day older. It is absolutely a function of your relative fitness. Some 60 yr olds might not be fit enough for fcr, some 70 year olds are. It’s the same thing for transplants by the way. 65 is the recommended cut off, but fit 70 yr olds can still benefit.

[starsafta in reply to cajunjeff]

I agree with you about arbitrary age limits. However, data does show less effective FCR results for unmutated status.

I am ever grateful for access to Ibrutinib, which I began taking the week after it was approved as standard treatment, and for grants that cover my copays. I pray that people continue to contribute to these organizations despite new tax laws that disallow donation deductions. You're right. Access to life-saving drugs should be available to all who would benefit from them.

Be well.

[AdrianUK in reply to starsafta]

Firstly, the Uk has stepped up to the plate to ensue all the people they think need Ibrutinib will get it free of any co pay, irrespective of any financial status of the recipient, and not depending on having been under a health insurance scheme. Also now that once again people can be excluded pre existing health conditions by insurance companies in the USA (one of Trumps “wins” !) there will be many who simply won’t ever be able to get this treatment!

Secondly as we know most of the evidence for Ibrutinib is for second line. The USA have adopted it some would argue too quickly and too broadly whilst you might argue we have done it too slowly and too narrowly. But what is really needed is evidence to see what strategy has the best long term effect. And by long term I’m talking about the next 30 years plus for. Me.

Thirdly a clinical trial is a randomized endeavor so of course it has to be truly random to provide the gift of data 1500 of us UK patients are giving to the world.

Fourthly you simply cannot say that FCR won’t be effective for anyone who is unmutated that isn’t true. Some unmutated people may get a good response with around 50% of people not needing anything else for treatment by five years and if I remember the stats right something like 9% still not needing other treatment at twelve years.

In the UK if FCR doesn’t really work for me I can go straight to ibrutinib at that point. And before you say that “ah yes but it won’t Work as well at that point” know that they had hardly anyone in the Ibrutinib trials who had only had one FCR. I’ve written about the data in posts previously that you can find by clicking on my name.

Fifthly, FCR does have some advantages over Ibrutinib eg the ability to see a quick response and in some cases get to MRD negativity. It’s hard to argue with the extremely rapid drop of white count I’ve seen. You don’t typically get either thing with ibrutinib. Though of course we know it is a highly effective drug.

Finally, We are fortunate to have multiple good treatments. It’s not really right to dismiss one of them as ineffective. People are much better to take a treatment that is available to them than not take any treatment at all because we have scared them off! It’s not terribly helpful for someone who is fortunate enough to have health insurance in the USA that will fund ibrutinib to criticize a whole countries medical system when in the USA there are patients who don’t have insurance, or can’t get it to cover a pre existing condition. CLL is for life. Ibrutinib is for multiple years and if for example someone who’s insurance is though their job it’s going to be very difficult to keep that funding going.

So all in all let’s remember that all these drugs work. And whilst we may have some idea about where we think they may work better than each other we don’t actually fully know that with the exception of 17p/TP53.

Sorry for the slight rant. But I do think it’s important that we don’t imply to vulnerable patients needing treatment that the options available to them are terrible or ineffective. I would have been happy to take ibrutinib or FCR which is why I went into FLAIR. I got FCR and I intend to try and make the best of it knowing full well I will probably need ibrutinib at some point in the future.

[Benlewis in reply to AdrianUK]

Well said Adrian!

[misswoosie in reply to AdrianUK]

Spot on Adrian. I practised as a RN in the NHS and in the USA and wouldn't have their system if they paid me. The US FDA approves treatments based on flawed evidence due to pressure from poorly informed Americans and insurance companies. Bad medicine.

[thebigdipper in reply to starsafta]

You said:

/starts/

So sorry the UK hasn't stepped up to the plate. Makes me even more firm that we in the US have to fight socialized medicine to the hilt.

If those running the FLAIR trial have any compassion at all, they will put all with potential for limited benefit from FCR in one of the Ibrutinib arms, even if they can't admit it.

/ends/

It's only those with access to "paid for by the patient" medicine, through personal wealth, insurance, grants or charity who can afford to feel that "socialized medicine" is something to fight. The US has millions of people who cannot do any of that. In the UK, they'd be treated - and I'm proud to help pay for it.

The purpose of a trial is to run a controlled test - to provide scientific evidence. It is not a mechanism to provide new drugs to sick people who might otherwise not get them. Skewing the results by using anything other than random selection for each arm of the trial wouldn't do that. They have compassion, but they also understand what they're trying to achieve and how to go about it.

[Lola69]

I did FCR and regret it. It messed up my blood! presently on imbruvica

[thebigdipper in reply to Lola69]

Sorry to hear you regret going through FCR. You're unique, and no-one will be able to predict 100% how anyone will respond to anything. All the docs can go on is their expertise based on non-omnniprescent ability.

Hope you're doing better on Ibrutinib.

[noeagaman in reply to Lola69]

FCR messed me up too. After 4 treatment cycles it put me in the hospital for a week. Now seven months after that, I have a hard time going up stairs without losing my breath and my heart pounding. My platelets are still very low along with other blood counts as well so I get monthly IVIG's. It did put me into remission although my doc says that is with incomplete recovery and that I may never recover all the way. Oh well, some people have to get a bad reaction I guess. At least it did it's job. It just did it a little too well...

Hang in there Lola.

Chris

[BasTel in reply to noeagaman]

What is your age bracket?

[noeagaman in reply to BasTel]

I started FCR at 57. I just turned 58 a week ago.

[noeagaman in reply to noeagaman]

I forgot to metion that I am 13 Q as well...

[Big_Dee]

Hello Bas Tel

My CLL specialists in USA say no FCR over 65 and I will be 71 in a few days, just in time to start treatment. Baring my FISH test to make sure I have not become 17p, I will start on BR. I am un-mutated. I too was given choice between BR and Ibrutinib. after some arm wrestling, got the doctors to recommend doing the BR.

[Canuck901 in reply to Big_Dee]

What’s BR?

[Cllcanada Top Poster CURE Hero in reply to Canuck901]

Bendamustine/rituxan [BR] it a combination of a old East German drug called bendamustine, which is a nitrogen mustard like the C In FCR, and it has a ring of a purine analog attached like the F in FCR...

Rituxan is an antibody made of mouse and human cells in Chinese Hampster ovary cells...

So, BR a bit lighter version of FCR, often used in patients with other health issues and over 65 yo, but not always...

~chris