Do FCR trials ever end early when the results are very favorable?

Hi

I am new to this community but not new to CLL. Was diagnosed in 9/2009 with a WBC of 28.5k after a routine physical and was totally asymptomatic. Just turned 50 also at the time a few months before which was a little ironic. Anyway, other prognosticators like Del 13q, IGVH mutated, low Bm2, and 1 reputable clinic had me Zap 70 negative and another famous facility said positive. Anyway, after 5.5 years and watching the count rise to 208k this past January, swollen lymph nodes in neck, armpit, and groin and slightly enlarged spleen I was encouraged to go on a US NCI clinical trial of FCR vs Ibrutinib/Rituxan trial. 2/3 get the Ibrutinib/R and the other 3rd get FCR. I was really hoping to get into the former arm but ended up on FCR arm. Now I am very healthy mid 50 male and regularly execercise and eat pretty healthy (my sister-in-law is vegan but I am not quite that extreme as I still love fish and chicken in moderation) so the idea of putting these chemicals in me was very scary because of all the potential side effects and unknown side effects. But I knew it was time to see something and I know clonal evolution is always a possibility. Anyway, I ask a lot of questions and gained a lot of my knowledge through CLLtopics.org (although it;s no longer current but still has a lot of great info. I do miss it) and I wanted to know if FCR ever ends earlier than the US standard of 6 cycles of FCR for 6 months if all the numbers both metabolic and blood look good. My first round was amazing. WBC went to 7.5 and other than a creatinine creeping up to 1.6 (it went down to 1.3 after a week but we are watching for TLS) and a 1 day fever of 100.9 I never felt better and the nodes have shrunk down to nothing. When I asked my clinic doctor why it's 6 cycles vs. 2, 4, 6 or 8 (I think France does 8) she stated that there is no standard actually for CLL. It's generally assumed 4 does the trick and if you tolerate FCR well the second two are sort of a just to make sure (Gravy). But the clinical trial protocol states 6. Generally they stop early if a person is having issues or the WBC drops under 5500 along with platelets or the hemo. But in my mind, If everything looks great after 4 cycles, why go through the 2 additional rounds of more chemicals since there is no trial evidence that demonstrates 6 is more responsive than 4 cycles for CLL)? I really have a concern of long term effects with especially FC and given I am healthy (relatively) with no other health issues other than my daily statin. So has anyone stopped earlier when things are good?

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  • My husband had exactly this conversation with his haematologist this week.

    He is at the end of the 3rd cycle of FCR. He has had good results (with just a few issues on the way). His consultant had disussed it with colleagues in the light of an article in blood journal which had suggested that more research should be done on reduced number of cycles. He said there is definite evidence for 6 cycles giving excellent results but no trials or definitive evidence yet on a reduced number of cycles. The issue seems to be whether doing less cycles will reduce the length of remission, and basically nobody knows yet.

    They have however agreed that he will do the 'lite' version (ie 3 days rather than 5 days) for the remaining cycles to try and reduce the side effects.

  • I had only 4 cycles of FCR, finishing in December, 2013. I have been in remission since. A CT scan three months after completing FCR showed all my lymph nodes and spleen back to normal size. My serum lymphocyte count has only recently come back into normal range (it dropped very low during treatment). My haematologist didn't want to give me more chemo than necessary. I am in my fifties and weigh 58 kgs which might have some baring.

    Kay

  • I had only 3 rounds of C and R instead of 6 or 8 after 10 years of W&W. Results normal. I was told I could stop after my questioning. If CLL returned it was no problem to start again. At the moment: about a year everything o.k. untill now. So I am happy I didnot get all the extra chemo! All the best to you!

  • Thanks. Yes if the lymphocyte count drops below the range like 3500 or so they will stop treatments. Glad things a back to normal.

  • Hi CClaver

    I am just waiting for my 4th round of FCR.

    My Nuets have been slow to recover after round 3 and at week five they were still 0.75

    I had already had a conversation with my consultant in respect of the number of sessions and he had already stated he did not believe in giving more chemo than necessary.

    I am now into week 6 and waiting for a blood test next Tuesday hoping that Nuets are back up to 1 plus. It is likely that round 4 will be my last session.

    I understand that it is not uncommon for sessions less than 6 to be administered. It depends on results and the reaction patients have to the chemo. Not sure about clinical trials although I am aware having seen a presentation just recently that on one of the UK trials patients on FCR arm were swapped over to the other drugs after several sessions.

    Hope this info helps in your discussions?

    Wishing you all the best.

    Geoff

  • You might find this interview interesting. It brings up the issue of reduced cycles: patientpower.info/video/is-...

  • Hi I agree that there doesn't seem to be any reliable research into the number of cycles. In my own case as I was on a trial I completed the 6 cycles but had the last two at 75 0/0. In view of the complications from chemotherapy I wish I had stopped at 4. Having said that four years later I am still minimal residual disease negative. How are patients to decide when the experts don't know?

  • Im new to cll jargon . Is this FCR avalable in Australia? Im 2 years on W&W with 1 WBC increasing every 2 mounth in blood testing.

  • FCR is approved for CLL treatment in Australia and is what you are most likely to be offered unless you are fortunate enough to qualify for a clinical trial. Your best chances for joining in a clinical trial are if you can access treatment in Sydney or Melbourne and have already had prior treatment for your CLL...

    Neil

  • I'm in the same trial. I am in the same arm. Doing quite well. Starting my 5th cycle next week. They won't tell you much but I would do all 6 cycles if you can tolerate them. My doctor said they can reduce dosage of F and C if they have too. Good luck. IML

  • You would have to ask the trial coordinators about protocol for stopping early if in a trial.

  • I only had 4 cycles and have had an amazing response to the treatment. The consultant told me that my counts had returned to an acceptable level and that after 4 rounds you need to weigh up the damage the FCR will wreak on the body versus the benefit it will have. I had better results after 4 than some of my group did after 6. Plus my consultant was very keen that younger people will have more, less toxic alternatives very soon so we had done enough to keep the monster at bay for long enough. I think you need to be guided by the team treating you and listen to what they know. I doubt there are 2 of us on this site with the same blood results so how could we ever think theres a" 1 size fits all" treatment ?

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