ASH 2012 Interview: Dr Jeff Sharman "Why New CLL Treatments Supersede FCR"

ASH 2012 Interview: Dr Jeff Sharman "Why New CLL Treatments Supersede FCR"

Dr Sharman's blog cll-nhl.com, is well worth keeping an eye on for pertinent but easily understandable articles on lymphomas, with CLL getting plenty of attention lately.

In the video below, Andrew Schorr of Patient Power, asks Dr Sharman to discuss whether emerging therapies will replace FCR.

patientpower.info/video/an-...

Some quotes from the interview:

"We're in really a phenomenally exciting time for Chronic Lymphocytic Leukaemia. I think we're quickly transitioning from an era of chemotherapy to an era of targeted therapy."

and

"FCR was a wonderful regimen for its day. I think that day is passing."

Neil

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  • Thanks Neil it is good to read his posts and hope..

    I worry that our current "gold standard" firstline treatment for the fit is gaining such bad press as a consequence of the cumulative effect of clinical researchers singing the benefits of experimental treatments and testing in clinical trials that exclude the majority. I guess it helps fill trial quotas, but are people who may require treatment holding out because of a perceived understanding that less toxic alternatives will soon be available for them?

    Yes It is uplifting that experimental drug research and improved testing are showing promise, however IMHO they are still that; experimental, it is very early days. This was recently highlighted in the question thread cllsupport.healthunlocked.c... explaining how far off this change may be and what is involved.

    FCR and it's equivalents have not had their day here in the UK, that day cannot pass until an alternative is available? From what I understand that is a long way off for the majority.

  • Very good point! There's no sense in deferring needed treatment while waiting for something 'better'. Better may take at least 5 years to arrive and by then I expect we'll have more information on the particular problems these new treatments can have, so better may only apply to specific instances - and of course by then there will probably be in trial even 'better' combination treatments along with new drugs.

    It seems to me that one of the best ways we can improve both the quality and length of life for CLL patients that end up needing treatment, is by both working out what treatment will work best for the individual concerned and exactly when to treat. Too early and there's the risk of living longer with an immune system damaged by the treatment plus the risk of other permanent or long term repercussions from the treatment. Too late and you may not survive the hit to essential blood cell lines caused by the treatment.

    Here in Australia, FCR was only approved for use on the Health Pharmaceutical Benefits Scheme about a year ago after a long, drawn out approval process. Prior to that approval, I was wondering whether I'd be needing access to FCR and not being able to get it! Getting into a trial (assuming a suitable one is available where you live) may give you access to newer experimental treatments, but then you face the unknowns plus the higher risk from the likes of regular CT scans that are needed to monitor the effect of the trial regime - and which either aren't part of the final approved protocol or are used sparingly. I can appreciate the need for CT scans and admire those participating in trials, but I can also appreciate that radiation exposure needs to be minimised for patients at higher risk of developing secondary cancers. It is the old risk/reward trade-off.

    Neil

  • It is important to understand that what Dr. Sharman is talking about applies to the U.S. model of research, clinical trials and healthcare.

    For us in Canada, the UK and Australia and others, 'socialized medicine countries,' much of what is mentioned as to access to clinical trials, simply does not apply. While in some part it is economies of scale, it also is how clinical trials are funded. In a nutshell, we simply don't have the free enterprise engines driving things forward...

    I think CLL patients outside the U.S. must be very cautious about making any timeline to when these new targeted therapies will be available in our clinics... if ever.

    I saw what happened to Rituximab mono therapy when it entered major trials in 2000... nothing is certain... it STILL is not FDA approved for this use in CLL!

    Then there is the cost... how much do you think out healthcare systems will

    pay annual per patient for daily targeted treatments? $30,000? $40,000? ...I don't know...

    In Canada it is FCR or FR and it will be for the foreseeable future. There are no targeted therapy clinical trials announced yet, so that isn't even an option.

    ~chris

  • These are very sensible points to make as a counter weight to the noise and excitement around the new KIDs (kinase inhibitor drugs) on the block. However as someone with an incurable chronic disease, it is vitally important to have hope for the future. It can make such a difference, especially if that hope is based on non chemo treatments. This doubly applies to our children who might be inheritors of our CLL, not just ourselves.

  • I agree hope is important and we have plenty that encourages this, each time I read a bit I just end up with more questions.

    Looking up The UK trials picture I see it is fast changing. It's increasing complexity and range of options highlights why a CLL consultant with a special interest in CLL being on your team at treatment is becoming more important to understand and gain access to these . Although there are no trials using novel agents yet to replace FCR there are a growing number for the refractory or relapsed, a group who may be running out of options.

    I accept we have a cancer that may need treating and have to use what is available at the time of treatment. Let's hope in time these trials produce data to ethically trial the treatment naive UK population offering some choice of risk. Current publicity is emphasising the risk of FCR , but not giving access to the experimental less toxic agents. The risk/reward trade-off is made more difficult to consider knowing that you are excluded. I am nowhere near treatment under the current management paradigm. But know there is currently no standard of care for patients with CLL older than 70 years of age or patients with co-morbidities. So wonder if the UK will ever trial the younger group in this population?

    When Dr Anna Schuh talked at the Oxford CLLSA meeting last spring she was very excited by the novel treatments suggesting that they may have an application in very early CLL and be of use in providing a true management strategy, without chemotheraputic intervention. However, ethically it is going to be hard to trial this population and gain a sufficiently large cohort in a phase III trial to gain an approval. this is even before cost implications are considered or the complexities of the drugs action during treatment. Her recent paper; State-of-the-Art Management of Patients Suffering from Chronic Lymphocytic Leukemia gives a current treatment overview from the perspective of a leading UK CLL expert and clinical researcher: ncbi.nlm.nih.gov/pmc/articl...

    Kinase inhibitors behave differently to conventional treatment agents causing lymphocytosis as tumour cells are released to the blood from their tissue micro environments, creating very high blood counts that take a considerable time to reduce. I guess this can't help with data analysis and the approval process. Is this part of the reason for their combination with with Chemotheraputic Bendamustine and monoclonal antibody therapies in the current round of UK trials?

    Dr Sharman suggests that the next step will research how the new drug are strategically combined.

    I am curious will a patient who enters a combination trial involving a kinase inhibitor require ongoing maintenance with the drug? Will it remain a pill for life and who will pick up the tab for the ongoing medication?

    CURRENT - NCRN CLL Trials Portfolio Map

    ncrndev.org.uk/downloads/Tr...

    UKCTG - UK Clinical Trials Gateway

    ukctg.nihr.ac.uk/search?que...

    CLL Consultant Haematologists in the UK

    cllsupport.org.uk/experts.htm

  • I live in the US and am a "lab-rat" for phase Ib Ibrutinib now into my 33month of use. It is hard to describe the quality of life improvement and how quickly most of us experience it after a short time on Ibru. Even though kinase inhibitors are relatively new, good data with no outstanding serious side effects are showing up in over 4 years of use. The high cost will remain an issue even in the US and will be a tougher hurdle for more socialized medical societies. The "bean-counters" of all societies need to examine the total cost of CLL care per patient per year and take into consideration a comparison of hospitalizations for CLL associated illnesses due to immune dysfunction to assess whether the kinase inhibitors, when most effectively used, can reduce overall medical costs over a lifetime not to overlook the quality of life for the patient.

    WWW

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