Clinic Trail Decision: FCR vs. Ibrutinib/Rituximab

[FarmerGirl00]

I'm scheduled to start treatment for CLL in a few weeks. I live in the USA and have an opportunity to participate in a randomized clinic trail of FCR vs. Ibrutinib/Rituximab for treatment naive; < 65 years old subjects. The only health issue I have is CLL, (no blood pressure problem, Cholesterol, etc.) so I'm not on any prescription drugs. I have (a) no deletions, (b) the B-cells are negative for ZAP70 (18%), (c) IGH somatic hypermutation in B-CLL. The IGH V allele identified was 3-30*01 F. My WBC has gone from 140K to 240K in a year with a large tumor load.

What criteria have others used to decide whether to participate in a trial; and/or to go with the FCR course of treatment. The idea of taking pills (Ibrutinib) for an unknown amount of time is not very appealing. The study representative said that the very expensive medication would be supplied as long as I was responding to it (1 year or 10 years). That is very hard to believe that a drug company would agree to provide such an expensive medication indefinitely. Thanks for any response.

[Cammie]

I would investigate the side effects of each drug as a starting point for a decision.

After which you need to look at the results gained from each treatment.

Side effects for ibrutinib are being documented regularly as more usage becomes the norm and time moves on as experience is gained from patients.

Of course if you go for the trial you will be taking the pills indefinitely where,as you say, FCR is normally a six month or less treatment but with a chemotherapy and therefore a toxic drug combination.

Having had FCR myself last year I was asked to go on a trial here in the Uk for a maintenance therapy however, I find that my system reacts to drugs and decided that I would not take the risk .

Every drug even aspirin can cause side effects,of course, you just have to weigh up the size of the risk against the benefits gained.

Hope this helps

Geoff

[FarmerGirl00 in reply to Cammie]

Thanks so much for the reply. Would you share what your side effects were from the FCR?

[Cammie in reply to FarmerGirl00]

Nuetropenia, two bouts of nuetropenic sepsis due to Nuets dropping to 0.01 and getting high temperature, drug rash due to chemo reacting with other regular meds, Diarrhoea on third session.

You can search for side effects of FCR and Macmillan do a leaflet that explains possible problems.

[MartyR]

Hi FarmerGirl,

I've been on a Clinical Trial with Gilead Sciences for nearly three years now and whilst there have been some "ups & downs" over that time - overall the experience and results have been positive for me.

Obviously you can't necessarily assume that a new treatment is better than standard treatment. We don't know whether it is, which is why the new treatment is being tested in the first place. But there are advantages to taking part in a trial, including:-

A./ You may get a new treatment that works, that you could not get outside the trial

B./ You could be helping to improve cancer treatment for future patients

You will also be more closely monitored:-

Have more blood tests, CT scans or other cancer tests

Have check ups more often and for longer than usual with your doctor or research nurse

Many people find this reassuring. Some people find it makes them more nervous and preoccupied with cancer. Only you know how you feel about this. The tests and check ups you need to have are explained to you before you decide to enter the trial.

There is some risk that an experimental treatment could harm you. The research team may not know a great deal about the new treatment yet. They will keep a close eye on you, and will stop the treatment if necessary.

Remember that even in phase 1 or 2 trials, the treatment has been carefully researched in the laboratory before it is given to patients. With phase 3 trials, more is known about the new treatment so there is less risk that there could be a harmful side effect.

I know its a difficult decision - so may your God be with you..

2 Corinthians 1:4 Who comforts us in all our trials so that we may be able to comfort others in any sort of trial with the comfort that we receive from God.

Marty

[FarmerGirl00 in reply to MartyR]

Thank you for the helpful informtion. Lots to consider.