CLL Support Association
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Best front-line treatment(non-chemo) for CLL with no 17p deleton/TP53?

Hi All,

I am reading through many innovative approaches and trials of treatment naive patients with non-chemo drugs.

Anyone doing well on therapies as Ventoclax/Ibrutinib etc?

Thank you!

Regards.

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How are you defining 'best'? Funded treatments or clinical trials? Long duration or cycled?

~chris

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If you read and view the many opinions from USA CLL experts, some would consider FCR Chemo for 13q Mutated or Tri 12 Mutated patients. If Chemo is excluded, and some like my CLL expert exclude all Chemo, I think most would suggest Ibrutinib mono-therapy first. See these CLL expert videos:

onclive.com/insights/cll-tr...

onclive.com/web-exclusives/...

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If the patient has markers for high risk of Richter's transformation - see:

onclive.com/peer-exchange/r...

onclive.com/insights/cll-tr...

Then a combination of Ibrutinib and Venetoclax might be used. But cost and insurance coverage would be a major part of the decision.

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Len

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Hi Paula I am in month 8 of ibrutinib and doing well.

Ann

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After 20 months on a trial of Ibrutinib + Venetoclax, I and 86% of my fellow trial patients in the first batch of 14 are MRD-. I had no real side effects and have maintained "CLL not detected" status in blood and marrow for the last few tests. It's still early days though and you might not be able to access this treatment at this stage.

The way things are going, in 5 years time we'll probably be talking about different "latest and greatest" treatments but the non-chemo options for first line treatment available now are pretty good.

Graham

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32 months on imbruvica. No side effects .. life is good ...

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12 months on ibrutinib. Doing very well. It corrected my cytopenias quite quickly, and I am not aware of any side effects. I was very ill from CLL when I started treatment, and had 95-99% bone marrow infiltration. For me, ibrutinib has been a miracle.

kim

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Hi everyone,

Thank you so much for the responses, they gave me so much courage!

I would not let the insurance determine the quality of my mom's treatment. I will do the impossible, but provide whatever is needed.

I saw her doctor today and he suggests FCR as first-line treatment, basically insist on it saying its his decision and other therapies are new and not proven for long remissions.

I am very upset, he should be there for support and respect the patients decision. He said that we are not starting immediately but he will wait for 3 weeks to see how the lymph nodes are growing. He mentioned she has prolymphocytic cells and the treatment won't be different than PLL, while in the report I shared here it shows clearly CLL.

I want to make sure I am doing the best for my mom and not fall for something just because it is cheaper option or easier for the doctor to implement.

I am reading many posts and I am seeing so many of you doing great on non-chemo therapies as first line. This gives me lots of hope.

I plan to insist on non-chemo during our next check up.

Thank you one more time <3

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Please help your Mom get to a CLL specialist. FCR can be a difficult go, particularly given a patient’s age, health, and CLL characteristics. Do you need help finding one?

I am currently on the Obinutuzumab arm of a clinical trial of Acalabrutinib, Obinutuzumqb, and Venetoclax. OThis is my first treatment ever. This weekend, I’m in a (disc) golf tournament. No side effects so far. Great results. I had a doc say to me early on “This is how I have decided to treat you.” We left immediately and never looked back. Saved my life.

Best to you and your mother.

Glenn

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Thanks Glenn! Well he is the best in UAE, most of the rest are just Indians...

He has incredible profile. But insists on FCR probably bc its the easiest and cheapest way...

30 years experience in haematology. He established the clinical haematology service in Dubai Health Authority which is involved in the management of both benign disorders (anaemias, bleeding disorders, thrombosis/thrombophilia) and malignant disorders (acute and chronic leukaemias, myeloma, myeloproliferative disorders, myelodysplastic syndrome). He runs both an undergraduate and postgraduate training in Haematology.

Prof. X did his undergraduate training in Andhra University, India. His haematology training was done in the UL at Heartlands Hospital, Birmingham, (formerly East Birmingham Hospital), The West Midlands Blood Transfusion Service, Edgbaston, Birmingham, The John Radcliffe Hospital and Chuchill Hospital in Oxford, UK.

Prof. X has been involved in medical education for over 20 years. He is a Professor of Medicine and Haematology and is the Head of the Academic Department of Medicine, Dubai Medical College / Dubai Health Authority. He is also an external examiner for the Royal College of Physicians of UK.

He is a member of The European Haematology Association, The International Society of Thrombosis and Haemostasis. He is a regular participant at the Annual Congress organized by these organizations, as well as other haematology organizations.

Present posts:

Consultant Haematologist at Dubai Health Authority.

CBS Consultant Haematologist, Mediclinic City Hospital.

Vice President, Emirates Society of Haematology.

Professor of Medicine & Haematology, Dubai Medical College/Dubai Health Authority.

Head, Academic Department of Medicine, Dubai Medical College, Dubai Health Authority.

Memberships:

Emirates Society of Haematology (Vice President).

European Haematology Association.

International Society of Haemostasis and Thrombosis.

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I like him I trust his expertise, I am only afraid he might be considering my financial difficulties in the choice of treatment, while Im ready to do the impossible to fund the right one.

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Hi Paula. Here’s the thing. FCR may be the best treatment for your mum! How old is she? Do you have her IGVH mutation status also? For some people with those markers FCR is for all intents and purposes a cure (with Remissions lasting twelve years and up and in some cases still counting). Ibrutinib is very good when FCR fails and some people do get it first line. However it’s more like a break on the disease rather than an attempt to get rid of it and you have to take it for maybe ten years until it stops working which it will at some point. So one school of thought (and this is used a lot in the uk) is to “bank” your FCR remission then when you relapse move to ibrutinib etc. If you click my name theres a post I did on pros and cons of the different treatments. In the end I decided to go for a trial which randomised people between three option and I’ve got FCR and am happy to take it even tho private insurance would pay for ibrutinib. I would have taken whatever the computer gave me. I’m betting my life on FCR followed by ibrutinib if needed working for me and don’t really think that reversing the order would probably make a huge difference. And we sure don’t have data to make that

Clear. If you want the most studied treatment with the largest amount of data behind it FCR is your choice even tho the new treatments are exciting.

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Thank you for the reply. Did you have any side effects or consequent issues after FCR?

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I’m about to start FCR a week today. If you click my name you can see some

Posts I’ve written and comments others made on them. It’s very complicated. And the new kids on the block may eventually displace FCR especially when we figure out how to give them in combo. But FCR is well known and the doctors know really well how to use it... I’ve heard of USA doctors who now feel chemo isn’t the best for anyone. But I’ve also heard other USA specialist CLL doctors say they stilll think FCR is the best for some patients. Spent ages trying to figure out what was best and then realized I just didn’t know what was best and really nobody did. For many of us we will need more than one treatment in our lifetime anyway.

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Adrian,

where did you find the evidence for your comments - "However it’s more like a break on the disease rather than an attempt to get rid of it and you have to take it for maybe ten years until it stops working which it will at some point. So one school of thought (and this is used a lot in the uk) is to “bank” your FCR remission"

Adrian, you are over generalising the treatment of CLL and Ibrutinib/FCR therapy. Please provide some references for your statement, particularly the parts that I have emphasised in bold. If it's only your opinion, please say that and make it clear.

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OK, I am oversimplifying but if you look at the published data (and I have gone through that in more detail in my previous posts) ibrutinib rarely gets you to the point of MRD -ve status. That is what I mean when I say it is very effective as a "break" on the disease.

Clearly the numbers and nodes do come down. But nobody is suggesting that it very often gives anything that could even really be considered a "functional" cure (Ie a remission that is so deep and so long it may as well be a cure and accompanying MRD-ve status).

Ibrutnib therefore has to be taken ongoingly since if you stop it then the CLL cells simply start dividing again). People often say you will need to take it for the rest of your life. But we know that it is unlikely to keep working for ever, that is a mainstream view.

There is a figure of ten years sometimes banded around but of course nobody has even taken it for that long yet as it is so new.

What we do know is that very few people get to be able to stop taking it confident that the CLL has essentially gone away for now due to a very deep remission.

Thus Ibrutinib it is not time limited therapy like FCR which is given for six months. Since CLL is still considered to be an incurable disease and ibrunib resistance is a thing and the assumption is that if you keep taking it for long enough eventually it will happen and it stop working. Nobody really knows how long.

Of course if you are say 75 the chances that it might last long enough for you to see out a natural lifespan are much higher than if you are 47.

To be clear NOBODY knows what will happen beyond a few years of ibrutniib and how quickly mutations and hence resistance will arise.

But it would be unreal of anyone to think that if they were say 47 like me that this drug will work in mono-therapy for the next 40+ years.

FCR is an attempt to eradicate the disease. And for some people it is just possible that it has worked. We don't know for sure whether those who have had 12 years+ remissions after FCR are actually cured or not and its certainly probable that many/some/all of them will eventually relapse if they live long enough not to die from another cause.

And of course FCR is associated with relapses in most people eventually (and that may turn into everyone).

The overall data is widely available and I have done previous posts reviewing what is known about if people click on my name. Sorry if my oversimplification sounded misleading in any way it isn't meant to be.

The whole point is there is a LOT that we don't know even about FCR and certainly about the newer drugs, especially about the long term. I am convinced however that FCR or Ibrutinib are both reasonable first choice treatments.

I am just realistic that as a young man who is also unmutated they are highly unlikely to be the last treatment for me.

I am fully ready to take both which is why I volunteered for FLAIR and allowed a computer to decide which one I would have. I would not have been disappointed to have Ibrutinib, and would have been happy to have had Ibrutinib plus venetoclax.

I fully expect to take all of these drugs and others one after the other unless I have a long remission from FCR and something else new and better comes along first....

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Well said adrian.some people think they know it all well theyyyyy dooooont...

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Adrian, you have massively oversimplified things.

With new developments and data reported recently, I would seriously challenge much of what you have said as it shows ignorance of many of the issues.

Please make sure that statements that are only your assumptions/supposition state that it's your opinion only or please quote your references. Your own previous posts that you reference are not the full picture. You also mix up the data for treatment niave and R/R patients which is important.

Phrases such as 'what we do know' and 'to be clear' imply that what you are saying is undisputed fact and that is not the case. In particular, the absence of MRD negativity with Ibrutinib treatment is NOT associated with poorer PFS and 95% of treatment niave patients have not progressed after 60 months of treatment. FCR can cause DNA bone marrow damage that results in cytopenias which have a significant impact on survival.

I'll leave the last word to Dr. Rick Furman. Please read his article from 2017:

cllsociety.org/2017/12/one-...

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We just don’t know how long ibrutinib will continue to work for. Five years data does look great. But I think most experts would agree that to ask ibrutinib to last for twenty years or more before resistance is developed is most likely a bit of an ask.

To be absolutely clear I am NOT saying ibrutinib isn’t a great treatment it clearly is.

And you are right that the absense of MRD-ve didn’t seem to make a difference in terms of progression so far with ibrutinib. But it does mean you have to keep taking it.

Really nobody knows which would be best over twenty years. We will gradually find out. And in the meantime many of us will probably end up taking both treatments or at least multiple treatments and the question is going to be which order should we take them in.

I just want those of us who have had to take FCR to realize that it is not necessarily the short straw especially if we are able to get ibrutinib or maybe venetoclax plus rituximab as a second line treatment.

There’s a philosophical difference between the two treatments as I outline elsewhere

FCR hit it hard for six months then hopefully be able to forget about it for a while.

Ibrutinib more gentle on the body in general and more slow in terms of what it does to the cancer cells, and needing to keep treading it.

Both treatments have a great chance of causing a response. Both treatments seem to last a long time for many people if they do work. But we should be under no illusions that for most of us either treatment would hold us for say 20 years or more. It may for some. But probably not for most. But again we don’t KNOW a lot about all this.

And if my previous posts are not the full picture perhaps you could show us how and provide references.

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I was under the impression Ibrutinib worked for life?

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Because of the cancerous nature of CLL, when CLL cells clone, some of the inevitable DNA copy errors that occur are not corrected. (The DNA copy process is a marvel of engineering - 6 billion proteins or around 200 million atoms duplicated in about an hour, with error detection and correction a built in part of the process in healthy cells). These DNA copy errors sometimes lead to CLL sub-clones that are not inhibited by the newer drugs such as Ibrutinib and venetoclax, so these sub-clones become dominant and resistance develops, so the CLL becomes refractory to treatment. That resistance is countered by switching to a different inhibitor drug. We are fortunate that so many new drugs with different inhibitory mechanisms are being developed, that we should be able to keep ahead of resistance developing.

There is ongoing research into how this resistance develops and the mechanisms are gradually becoming understood. Some patients who are more at risk of it can be identified in research labs by looking for prognostic markers - or you just wait and see if resistance develops.

We don't know if developing resistance is inevitable. Many patients who started on the early Ibrutinib trials over 5 years ago are still going fine on Ibrutinib. However, this risk of becoming refractory to treatment is another driver for the search of combination treatments. The theory is that a CLL subclone is unlikely to spontaneously become resistant to two differently acting inhibitors. Combination treatment is anticipated to provide long periods of remission after a limited treatment period and perhaps that cure.

Neil

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And it may well be true that if we treat with a combination of two inhibitors and maybe even an antibody, get to MRD negative status then stop the treatment that the chances of that combo working second time round are high. The idea of two or three drugs being less likely to introduce resistant disease is what is behind FCR. In a few years we will no doubt have an agreed new combo. VR has a license now for second line. VI has shown a lot of promise but is as yet unlicensed. Other combos will be considered too.

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Well put Neil.

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That’s a common misconception. People have developed resistance to it we just don’t know yet how long it’s going to last as it does last very well for the first few years. The assumption is that a low percentage of people will get resistant to it each year meaning that eventually everyone will. But we don’t know yet. Of course for some people that might be after twenty years of treatment which if you were a lucky one and started it affect 60, well you might pass on from something else before you got resistant!

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The right treatment may well be FCR. We have 15 years of data on that so called gold standard combination, compared to 5 or less years on non chemo treatments.

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I know..but what about the consequences... I am so afraid that she is 68 years old, i dont want to cause a damage she cannot live with.

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Paula, there are always going to be risks with any treatment (and that is one reason why we do watch and wait for long as it seems sensible to do it) but there are also benefits. Some people suggest that older people are better off not taking FCR and maybe taking a different from of chemo or specific treatments, but a lot depends on their state of health. Some 70 year olds are definitely fitter and healthier than me at 47! This is why you need to have a doctor who you can trust who can explain the pros and cons of all the options and then help the patient decide what is best. None of us on here can let you know what to do for your specific situation. Even if there was a clear answer about what is best in general there may be factors in your situation that make that different. This article may be of some interest as it shows what British doctors think is the way forward for treatment onlinelibrary.wiley.com/doi...

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When we have CLL, there are unfortunately adverse consequences no matter what we do. Specialists think we are around the point now with treatments where early treatment (as is normally the case with cancer) may prolong life more than Watch and Wait and only treating when necessary, but we don't yet have studies to confirm that.

When it comes to the choice between chemo and non-chemo, we also don't have the long term studies to say which is best for a given patient group. Specialists also talk about "Financial Toxicity", the financial impact of paying unsustainable amounts for continuing treatment with the newer, non-chemo maintenance treatments. Paying around US$160,000 per year indefinitely is beyond nearly all of us.

The long term consequences of FCR and other well established chemo based treatments are well known. For the early non-chemo treatments, we don't know what happens after about 5 years. What we do know may be of concern to you regarding your mother's future, because a significant proportion of patients on Ibrutinib stop taking it because they just can't cope with the side effects. If they haven't been able to get to MRD- status (and only about 10% do after 5 years), they generally need to switch quickly to an alternative non-chemo treatment.

I think that there's a newer paper about what happens long term with Ibrutinib treatment, which I can't find, but these papers from a few years ago give you some idea of the consequences we know about :

cancernetwork.com/chronic-l...

bloodjournal.org/content/13...

Read up on them and explore with your mother's specialist the reasons behind his treatment recommendation for your mother to see if you agree.

Neil

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Here's the paper I was looking for on the first five years of experience with Ibrutinib: ncbi.nlm.nih.gov/pmc/articl...

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You might check the CLL Society to see if they know of any CLL specialists in the UAE. His credentials are most impressive, to be certain, and could it be that even one of the Indian practitioners might have spent the past ten years specializing in this most complex and of disorders with a quickly evolving treatment landscape? Please understand I mean no disrespect. For context, I went from being totally mishandled locally to being, as I type this, at Dana-Farber in Boston where I only just now learned that after one month on Acalabrutinib and one full dose of Obinutuzumab (split over two days) that my blood counts have already *returned to normal!* I would probably have only a few years and options left had I not gone to docs who specialize in this.

Many CLL docs might consider your Mom, at 68, to be just a few years over the ideal range for FCR. How is her health/fitness, otherwise?

Others here have asked about her IVGH mutational status, 17p, and 13q. All of these factor into treatment decisions. Perhaps your doc knows these things and that they are all consistent with the use of FCR and has just not shared them with you? Could there be cultural factors at play, where the male doc simply says “Here is what I am going to do” to the female patient?

Glenn

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Will you need any further chemo? Or was only one dose enough?

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No chemo. The three drugs are Acalabrutinib, Obinutuzumab, and Venetoclax. I have started the first two. After five days on the Acalabrutinib (a pill) I noticed a decrease in the size of all palpable nodes. After a month, I can barely see the biggest of the most visible ones. It was on my neck, and about the size of a half a golf ball. After the "test" dose of Obinutuzumab (infusion), my white blood count went from 72,000 down to 17,000. The test dose was 1/10th of a full dose. I was infused with the other 9/10ths the following day. I went in a week later for my second infusion. My WBC had dropped from 17,000 down to 7,000, which is in the normal range. I have three more infusions. Then, the Venetoclax (another pill) starts on the 19th of November. I will then stay on both the Acalabrutinib and Venetoclax until no more CLL can be detected. If they can still detect it, they'll keep me on those two pills as maintenance.

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God bless! Wish you lots of health.

This sounds so encouraging! I hope to find a doctor who can implement such treatment for mom.

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God bless you and your mother, as well. You sound like a fine daughter. You honor her here. If I can be of any help or encouragement, please do not hesitate to message me.

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Make sure you and your mom are going to a CLL specialist - not just a general hematologist or general oncologist. So much is going on right now with advances in CLL treatments and knowledge that only a CLL specialist is going to be on top of the best options an opportunities for your mom, not to mention the correct time to start treatment. Other doctors might start her too soon.

kim

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I am on month 8 of the Ibrutinib/Venetoclax trial. Results are better every time I get tested; blood all normal, most nodes are gone. Can't wait to see the bone marrow biopsy results in 1 month. I would say that 70% of the progress happened within the first 2 months of treatment. Side effects are minimal. I highly recommend the trial.

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Glad to hear your are doing well! Which markers you had when you started? Did you have any prolymphocytic cells?

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Thank you! trisomy 12 & 19 and mutated...medium risk, diagnosed 5 years earlier. Wishing you well too.

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I think AdrianUK and AussieNeil are spot on. I finished FCR treatment 3 years ago this month and feel great and I'm still in remission with no lingering effects. I'm in my late 50's so age can be a factor only in how the overall health is to tolerate the drugs. Similar to AdrianUK, I was offered the trial on a random computer choice of getting FCR (33% of the participants) or Ibrutinib (66% participants). It was definitely time for me to get treated given my spleen size, my WBC (over 210k) and some enlarged Lymph nodes. I was very disappointed initially to learn that I ended up in the FCR bucket as the thought of putting "poison" into my otherwise "healthy?" body was a non-starter for me. A friend of my sister in Massachusetts who is a top Leukemia specialist gave me the advice you a getting as well. FCR has a lot of proven data behind it from many years. It works pretty well (depending on all the other prognosticators) and as mentioned could keep me in remission a very long time (like maybe forever!). The newer drugs (they are still drugs) for frontline treatment while very promising can come with side effects for some people and like the statin pill I take daily for my high cholesterol is right now forever. The long term effects of Ibrutinib and other BTK inhibitors is just unknown right now. That's not to say there is a danger, its just an unknown is all compared to the years of data for FCR. While going through my 6 cycles of treatment, it was a battle after each cycle. I went in 3 days in a row (Wednesday through Friday) for a few hours each day. Saturday and Sunday were recovery days as steroids wore off and the drugs ran through the body. Exercise (I started working out with a trainer) and drinking lots of water were key and each cycle became more difficult to recover from initially which took several days. After the 4th cycle I wanted to quit (numbers go down immediately and lymph and spleen were normal as the CLL cells get flushed out of the nodes) as the recovery can best be described as simply feeling like crap. But each time my loving wife helped me move forward and with support from others I finished the other two cycles. By the way, I was able to also go to work after each treatment and resume all normal activities. So, I will not know if FCR is the best long term solution for first line treatment or if Ibrutinib or something similar is a better choice, but it has worked for me for now and I don't think I'm all that worse off for it with no lingering side effects. Good luck.

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Thats a very encouraging story. Cant say I am looking forward to biting the FCR bullet but I am looking forward to the sense I am fighting back against this disease and hopeful for a remission and improvement in my symptoms. Truth is BOTH Ibrtunib and FCR will cause some from of response in around 90% of people. The question is how deep a response (typically FCR will go deeper than ibrutnib) and how long a response (here we know less about ibrutinib because it has not been followed up for as long but something like 92% got to 5 years from first treatment without a relapse so this might turn out to be better than FCR. The other complication in all this is of course most people if they are in countries that fund it are likely to switch from I to FCR or from FCR to I down the line if they need further treatment so the real issue is not which is best first line but does it make any difference which one we use first. Personally I wouldn't want to use FCR twice, but am definitely prepared to use it once. As I have got used to the allocation I have received (and I will admit to being a bit disappointed at first) I am actually quite glad that I get this phase of my treatment over with and in six months time I will know I never have to do FCR again, but am likely to need ibrutinib at that point (unless of course venetoclax +R has its funding for second line use by then in which case there will be a choice between the two!

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I've been on Venetoclax monotherapy front line since December 2016 for 13q deletion mutated CLL. Normal CBC since the forth week on Venetoclax and labs have been normal since then. I'm feeling great, no side effects at all, lymph nodes gone after the first 1-2 months on treatment. Flow shows 0.02% CLL's. Plan is to stop treatment after two negative blood and two negative bone marrow flow cytometry tests.

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I believe that your mother's FISH test showed 13Q14 only. If you have to deal with a CLL diagnosis that's as good as it gets (my markers and I have done well for 16 1/2 years). It and could indicate that she could do well with FCR.

I don't know what else is available in the UAR for first and second line treatment. Treatment options vary greatly from country to country. Given your mother's markers, I don't think that there is a clear cut answer about which treatment is best - the "gold standard of FCR" - around for a long time, or the newer treatments which are very successful for many, but we don't know for how long.

Circlesaba Glenn) brings up a good point about cultural issues related to men dictating and women expected to just listen. I had Saudi neighbors for several years, and it was an education for me about this issue (I'm in the US). I could never, given my upbringing, deal with the restrictions placed on these women.

I took the wife to an emergency doctor's appointment and she shredded a box of kleenex in the car. I thought it was because she was worried about her health (actually that of her unborn child). It was because she had never been in a car with a woman driving! I can't even imagine that!

At your mother's appointment I would ask what other treatments are available there, first line, as opposed to cost. Also, whether there are any active clinical trials, and if so what they involve.

I would not rule out Indian doctors. Someone posted recently about CLL doctors in India. Someone there might have been trained by one of them. Your mother's doctor sounds very experienced with blood cancers, but if you can find someone who focuses on CLL for a second opinion, that would be even better. Hematology is a huge field. Is travel an option for a second opinion?

Think positive thoughts! CLL can be a very treatable disease.

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Hi Everyone,

Great replies and more than enough information! Thank you!

UPDATE: I definitely decided I dont wanna go for chemo and we are going to Turkey to explore other options. They have great specialized hospitals and all advanced treatments, I hope to get the best possible for mom!

Everyone here refers to FCR as "just a treatment" and noone really goes into the terrible details, so I was thinking its a normal procedure (like a flu shot). After I realized what we are dealing with and investigating more, I met several people who had done chemo in the past and it ruined them completely, others just refused it and decided to go in a peace.

I think to go for chemo or to go for pills is a no-brainer! At the end if the other treatment doesnt work you can always start chemo...

Excuse me if Im too harsh, I have infinite respect to everyone here and the ones who got the courage to go through the treatment. Im just too affected by stories about consequences from chemo and how easily this decision is taken by the doctors.

Regarding our visit in Istanbul, please share if you have a doctor to recommend.

Again lots of love and thanks to everyone.

Regards.

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