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CLL Support Association
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Chemo-Free Treatment Best Option for CLL Patients Under 70

There is good news in the advancement of chemo-free approaches to managing chronic lymphocytic leukemia, and I am thrilled to share it with you.

Results of the phase III ECOG trial found that the combination of ibrutinib (Imbruvica) plus rituximab (Rituxan) came out superior to the chemotherapy and immunotherapy (chemoimmunotherapy) grouping of fludarabine, cyclophosphamide, and rituximab, known as FCR.

READ MORE: glennsabin.com/chemo-free-t...

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I was 13q and mutated. Had 3 cycles of FCR this summer...in remission. Had no major problems with it. I was 63. I didn't want pills the rest of my life. I am so glad my experts recommended FCR. Hopefully a long remission.

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Lucky u as FCR only gave me 20 months of remission yet I did 6 cycles

Hope it did not damage my internal organs .

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I am 4 months into remission. Gosh..sorry u only got 20 months of remission. That is frustrating. What were your markers?

Are you on Ibrutinib now? 💕

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All my markers are good!

Have the SLL variant.

Imbruvica almost 3 years now.

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Good news! Hope this will help shift treatment practices away from chemo and onto the newer and less toxic drugs. I admire your book n of 1 and your own personal journey through CLL.

kim

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Thank you, Kim.

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Hi Glenn, you were cured with EGCG? that's what i read in one of your vlogs.

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My marrow has been cleared for seven years now, and EGCG was one of the products I consumed. I do not like or use the word cure ... my published case can be found here: glennsabin.com/wp-content/u...

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You do not like the word CURE? That's exactly what we all want!

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I am happy as long as it’s under control. I don’t focus on the word “ cure”

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I'm not focused on the word cure, but it would be really nice to have one, well i think most people would agree.

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Only potential cure is FCR or a bone marrow transplant.

The other agents are mostly for relapsed patients although they look promising it’s to soon to know.

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I’m certain a cure will be available in our lifetime but what works for one won’t for all, so for now I think the aim is hit it hard and fast with minimal disruption or side effects to us and give us a durable remission and repeat until something more permanent is available...

Although it’s very hard for some people still, with all the therapy regimes the fear factor will be in decline dependant on those treatments being available to us all..

Stuart

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And i agree with you Stuart 100%. Thank you☺

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I think green tea is dangerous to drink if on treatments.

According to the ASH conference the cure may be FCR taken with imbruvica

Imbruvica /Rituxin has no known benefits

By the way I read your book. Congratulations!

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Supplemented EGCG at higher doses, such as the 4 gms daily used in the Mayo study, should be monitored for potential liver issues. A CMP shows liver enzymes. Not an expensive test. The ibrutinib + retuxin combo versus FCR (for folks under 70) was presented at ASH.

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You are correct there is a huge financial conflict of interest with local hematologist wanting to do FCR or BR. Unfortunately that was my experience where the hematologist was threatening bleeding in the brain with Imbruvica. Very sad.

Now there is clear evidence that doing FCR or BR violates the Hippocratic oath!!

Great book.

Be well,

Hoffy

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I did allude to financial benefits to the oncology clinic delivering systemic therapy versus prescribing pills (ex. ibrutinib) because it is important to put that out there. But for some cases - subsets of disease and various factors - FCR may still be the best option. For some it has resulted in 5+ year durable remissions. So best to work with CLL expert within a major academic center to get specific guidance. Does not mean you would ever need to necessarily be treated within that facility ... you might make the academic physician-investigator part of your team, but get treated by your local hematologist.

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isen't ibrutinib better then FCR now>

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FCR in combination with imbruvica is best

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If you have the right prognostic markers, (mutated IGHV, etc), FCR can give you a very good chance of a very long remission of 10 + years after just 6 months of treatment.

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My first hematologist said FCR would give me an infection and I would die.

I found another hematologist

Did FCR in 2014. Am alive and well

My friend in South Africa did B/R twice. She’s doing great!

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How does it violate the hippocratic oath?

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The Hippocratic oath is to do no harm to a patient I believe.

It’s clear now that FCR does more harm/side effects to patient’s from the recent studies.

For a small subset of mutated easy genetics people FCR does work well.

Maybe six cycles of FCR and you’re done for many many years. With that said FCR can cause other cancers and bone marrow issues much later on so that is a concern.

My point is the doctor needs to be very open and give both sides to the story not try to say that FCR is the gold standard and bleeding in the brain is a problem with Imbruvica. That is a very uncommon side effect.

He current disadvantage of single therapy Imbruvica is you have to stay on it for many years many times.

What is coming now are combos with Imbruvica plus Venetoclax that get people to MRD negative in the bone marrow after about eight months to a year many times without any long term side effects. Provide if you don’t die from Afib.

The times they are a changing!

We are lucky that there are so many new agents out there.

Be well,

Hoffy

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So which one causes more/worse side effects inbruvica or FCR?

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Varies by patient... most CLL treatments are relatively side effect mild, compared to treatments for other lymphomas etc.

Imbruvica (ibrutinib) has some serious side effects like A.fib and bleeds, but they are relatively rare...

~chris

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Hi Hoffy,

I take it you’re not from the U.K. because here FCR is still the first line treatment on offer on the NHS for people without 17p/TP53 deletions. Unless patients are eligible for a trial, the choice is no choice.

In that context, statements suggesting doctors are breaching their Hippocratic Oath is extreme, unfair and yes, rather sensationalist.

On the basis of that assertion, maybe a class action should be taken out against the British Government and their agents NICE for ‘governmental abuse’ for enforcing this treatment practice and placing medics in breach of their professional code?

Please be aware that these statements are alarmist for many of us who presently have little choice. We are not all so lucky and this is an international site with very different levels of treatment access including countries with less developed health care systems.

Some of your statements have the potential to terrify a newly diagnosed CLL’er and clearly have!

Regards,

Newdawn

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Hi Newdawn,

Or is it Dawn? Anyway, I think Hoffy was simply making a general statement about the medical community being forced by politicians follow certain protocols.

In the US, his statement would be only partially true. There are many valid reasons for FCR treatment over Ibrutinib - and not just cost or availability. Many patients do not want to be held to taking a pill every day. Ibrutinib resistance does pose a problem for some also. I could go on and on, but FCR vs Ibrutinib is not a black and white situation. Many people have taken FCR, done extremely well, and it will continue to be a "choice" among treatments.

In the UK, I am not sure that Hoffy's statement is valid at all. It is extremely unfortunate however, that physicians in the UK have to follow government guidelines precisely. Then again, a lot of other countries do the same thing. As someone from the US, I feel terrible that others like me in different countries do not have the treatment options that I do. Then again, my options are as of 2018. Options could change as we (in the US) cut back on health spending. The new targeted therapies for many cancers are depleting funds for medical care rapidly.

It is a good thing that a major medical statement was made at ASH regarding non-chemo treatments. The fact that we have gotten to the point where data can be shown and a good number of physicians agree with these findings, perhaps some governments (like the UK), will see this as a major prompting to change their policies. You can't argue with data!

One thing that is looking good for the future is the use of Ibrutinib and Venetoclax - and treatments that emerge like it. If a good number or remissions can be achieved, then oral targeted therapy has a finite time of use when it can be totally stopped. These data are quickly emerging too. Even an overzealous bureaucratic bean counter will realize that this dramatically lowers the price of targeted therapy. That can be incredibly assuring to those who look at their future treating CLL. Isn't I-V one of the "arms" of the FLAIR trial too? A good swift "kick in the pants" to pharmaceutical companies wouldn't hurt either.

I think things will turn out well in the end. Right now, we are in a state of flux regarding treatments for CLL - and basically ALL cancers. You can't stop progress, so these new agents will have to be clinically available too. Research is not just done for the researchers to write journal articles.

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Yes indeed Jonquiljo, I&V is part of the remaining 3 arms of the Flair trial. It is still possible however to be randomised to FCR. I’m soon to be considered for this trial and have no fear of being allocated to FCR if my biomarkers are right. As you say, it can offer some benefits and offers an evidenced strong, durable remission for the right candidates.

We are all caught up in the medico-political system I’m afraid but my point was the unfairness in blaming doctors for using the only methods open to them in certain health systems. I’m sure it causes many great angst and consternation.

My name isn’t Dawn incidentally. I use the site name Newdawn to represent renewal and ‘a new day, a new dawn, a new life for me’...you know the rest 😊

Regards,

Newdawn

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Sorry, was just joking about "Dawn"! The names behind the posts intrigue me.

Yes, FCR is great in the right circumstances. I suspect the key is to choose the right bio markers (not simple, I guess), and only going as many cycles as you need.

I get confused as I am 65, and the presentation this thread refers to us "under 70." I wonder, as I approach 70 - what am I supposed to do?

One thing that people often don't see is that the US medical system (especially Medicare) is getting seriously depleted from all these targeted therapies. I really wish that all countries would form an alliance and come down on the pharmaceutical companies. Unfortunately the US government is not of the sort to work with anyone as of late!

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Do they not exclude the unmutated IGVH from receiving FCR in the UK ?

I thought the literature was pretty clear that regardless of FISH the unmutated group didn’t respond well to FCR and therefore should go straight to IB with or without another drug ie Rituxan...

Even 13qdel won’t get FCR in Canada (or shouldn’t) if they are unmutated.

Maybe I’m wrong

The mutated 13qdel group has the best long term remission rates from FCR and it’s still the gold standard especially if the patient is “young” <70. There’s no question that targeted therapy is growing and growing but the long term results aren’t quite there yet. Hopefully in time they will be. I think even though some specialists CLL specialists would say avoid the chemo FCR if at all possible: FCR with good cytogenetics and mutated IVGH will very likely result in 10+ yrs of remission with low complications and side effects

I’m waiting for the evidence to show even in the mutated 13qdel group IB is better long term !!

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No they don’t exclude the unmutated IGVH from receiving FCR I’m afraid. In fact hyper-mutation isn’t always tested for on the standard NHS protocol. I understand it is for the Flair Trial but even then, the unmutated are not excluded from a trial that includes FCR as one of the arms. 17p/TP53 is the only deletion to drive treatment decisions presently regardless of the evidence relating to efficacy.

Cllcanada will be the best person to comment on your belief that even 13q who are unmutated wouldn't be given FCR in Canada. That isn’t my understanding.

Regards,

Newdawn

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Thank you kindly : the FLAIR trial should yield very interesting results

I just hope those of “us” in W&W will still be there to reap its benefits. But it’s good to know many others will.

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First.. there is no 'Canada' in medicine in Canada. It is provincial and drug availability varies, quite a bit and each province have their own protocols... so location matters...

In Ontario... the phrase for first line ibrutinib consideration..is a patient is 'not suitable for fludarabine', so this is a broad interpretation. Does IGHV unmutated fit in this catch phrase.. pretty much up to the doctor...

I know many unmutated 13q patients treated 10-12 years ago, when IGHV had no impact on treatment, that did extremely well on FCR.

IGHV mutation status, should only be a single consideration among others, when deciding the best treatment for a patient in my view...

~chris

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Thank you again Chris lol...I was trying to edit my post to be more specific and detailed and I couldn’t.

Here is the link to the funding and

cadth.ca/sites/default/file...

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I'm well aware of pCODR... we present input to them for all new CLL drug approvals for funding and have for about the last 10 years .

CLLPAG

cllpag.ca

You will note the statement for Ontario, is incorrect since it references a prior treatment... requirement for firstline use... 🤨

For patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy and are considered inappropriate for treatment or retreatment with a fludarabine-based regimen. Renewal criteria: Patient has experienced no disease progression while on Imbruvica therapy.

You need the actual EAP statement of and conditions for use.

~chris

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Hoffy -please provide documentation to support such an extreme statement. I have not seen clear evidence to support it. It smacks of the worst kind of sensationalism! Clearly treatment for many is moving away from chemo based approaches, but for some, treatments like FCR and BR still have advantages, and in many countries the treatments available are limited first line, and often beyond that.

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This recent study highlights this I think it is called EPOG. That is what Glenn posted about I believe. Also many top CLL doctors are very clear on this subject. Dr. Kipps and Dr. Furman, Dr. Byrd. Be well,

Hoffy

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Link? Using EPOG in a search I get information about economic studies.

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The study is E1912... NCI study actually...

clinicaltrials.gov/ct2/show...

ECOG ...Eastern Cooperative Oncology Group

I just posted here Dr. Shanafelt from the Mayo, giving the presentation... video

~chris

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This ASH gave clear evidence see this link. It is the ECOG trial.

The evidence is now very compelling.

The issue with Imbruvica is the long term use and the cost but that will hopefully be solved by the combo treatments. Over 50% of People on Imbruvica with Venetoclax combo trials achieve MRD neg in the bone marrow after about 1 year.

hematology.org/Newsroom/Pre...

Late-Breaking Clinical Trials Advance Targeted Therapies for Patients with CLL

Results Are Expected to Prompt Changes in Practice, Improve Patient Outcomes

Published on: December 04, 2018

(San Diego, December 4, 2018) — Three studies being presented today during the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego offer more targeted solutions for managing CLL and multiple myeloma.

“The most important take home point is that all three of these late-breaking studies demonstrate how targeted therapies are improving outcomes for our patients,” said press briefing moderator Aaron Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Institute. “For both multiple myeloma and chronic lymphocytic leukemia, we’re rapidly shifting from cytotoxic to targeted treatments, which is exciting given the toxicities patients can experience with traditional chemotherapy.”

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"We're shifting" is a long way from using chemo based therapies is a violation of the Hippocratic Oath, and the studies presented help with decisions where these therapies are available, but that is not the case worldwide. There is a lot more that goes into this than the results of three studies presented at ASH. We don't live in a world that is that simple.

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Fortunately the evidence is becoming very clear. Before it was not. Hopefully the rest of the world will have access soon. If you have had FCR or BR I was told by Dr. Jennifer Brown of Dana Farber while at ASH that your bone Marrow can recover in about 3 years although there is the risk of secondary cancer such as MDS and AML.

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

Doctors need to clearly tell patients of this risk. Doctors need to provide all risks.

The Tait D. Shanafelt: Ibrutinib Vs. FCR Chemoimmunotherapy in CLL - YouTube Chris posted clearly discusses the latest data.

The Trial of the ECOG-ACRIN Cancer Research Group (E1912) paper:

ash.confex.com/ash/2018/web...

So with the imbruvica/R arm there is lower toxicity and better PS and OS. This usually does not happen.

For an older population this paper applies:

Results of Alliance North American Intergroup Study A041202Clinically Relevant Abstract

ash.confex.com/ash/2018/web...

This international phase 3 trial demonstrates that ibrutinib produces superior PFS to standard CIT in older pts with CLL and justifies it as a standard of care treatment for pts age 65 and older. The addition of rituximab does not prolong PFS with ibrutinib. While ibrutinib represents a major therapeutic advance, toxicities and also cost justify future efforts to reduce the need for long-term continuous treatment.

Many Doctors like Kipps, Byrd and Furman have been avoiding Chemo for years knowing from experience what these papers are showing.

I am very passionate about this subject because my first Hematologist at Scripps Clinic tried to push me into FCR telling me Imbruvica could cause bleeding in the brain with out every giving the negative side effects of FCR. Bleeding in he brain is a risk but it is rare and usually tied to people on blood thinner.

Fortunetly I left that doctor and went to UCSD and eventually on a clinical trial combining Imbruvica plus Ventoclax.

The down side of single imbruvica is one many times has to stay on it. With some of the new combos the treatment may go on for about a year then one can be off all drugs. This is happing with Imbruvica plus Venetoclax also with people of Venetoclax plus Rituximab. See the Murano Trial

ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL

ascopost.com/News/58358

At 2018 ASH:

184 MURANO Trial Establishes Feasibility of Time-Limited Venetoclax-Rituximab (VenR) Combination Therapy in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)

ash.confex.com/ash/2018/web...

Be well,

Hoffy

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Hi Glenn

Do you know your subset of disease.. what your ighv status was or if you had any chromosomes when diagnosed...

I haven’t read your book but I had a look at your blog a while back and noticed you altered your diet... did you suffer any intolerances or allergies to certain foods prior to diagnoses..

Stuart

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Just getting started w/ IR combo treatment - age 64 - my Doc is good and keeps up to date on new advances in the field - first rituxamab infusion tomorrow

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Very cool to find you here, as I have read your book! I am seeing a GREAT new Dr on 2/14, but am on W & W so far. Fatigue is MAJOR. Hate to take any drugs when counts are good and no other B symptoms. I wonder if a short trial of them could be considered to lower B cells and see if fatigue decrreased? Would hate to go on full treatment if all of fatigue was not CLL related. Time will tell.

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