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COVID-19 - NCRI Recommendations for CML patients receiving TKI therapy

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The latest UK government updates are listed here:

https://www.nhs.uk/conditions/coronavirus-covid-19/  and https://www.gov.uk/government/publications/covid-19/guidance

According to the above links, you will be contacted (via letter) by the NHS by Sunday 29 March 2020. Please wait to be contacted.

Expert Opinion from the NCRI CML Subgroup 17th Mar 2020, updated 23rd March 2020

Please Note. Patients with CML will have received letters from their GP practice, stating that they are in the high-risk category. This will allow full access to government support services and patients are entitled to follow these recommendations. If patients have not received this notification by 29/03/20, they should contact their GP surgery and not their hospital.

For specific questions regarding your condition and treatment (outside of the NHS general guidance for high risk conditions) please contact your CNS or your CML specialist.

Are CML patients at higher risk for a more severe COVID-19 infection?

  • Patients with CML do not appear to be at a higher risk of getting COVID-19, although data are limited.
  • Having a diagnosis of CML or being treated with TKI therapy does not convincingly cause clinically significant immune suppression.
  • CML patients can be at a higher risk of COVID-19 infection if they are older (age over 70 years), have other medical conditions or are receiving other treatment which will suppress the immune system.
  • There are no published data on the course of the COVID-19 infection in CML patients treated with tyrosine kinase inhibitors (TKI) and reports are rare. Reassuringly, very few CML patients on TKI therapy were infected in the Hubei province in China, and the outcome was similar to the general population.
  • Self-isolation (self-quarantine) for 12 weeks is recommended for at-risk individuals, but in our specialist opinion, the diagnosis of CML or treatment for CML alone does not clearly fall in this category.
  • The life expectancy of CML patients is currently approaching that of the general population. The decision to place CML patients on TKI therapy in the high-risk category for COVID-19 infection must not have a negative impact on triage or other in-patient treatment related decisions, due to their excellent outcomes
  • Patients should not interrupt or reduce their TKI medication without the advice of their CML specialist team

 

NCRI CML Sub-group:

Dr Dragana Milojkovic (Chair); Prof Jane Apperley; Dr Jenny Byrne; Prof Richard Clark; Prof Mhairi Copland; Sandy Craine consumer representative; Prof Nick Cross; Dr Joanne Ewing; Prof Letizia Foroni; Dr Paolo Gallipoli; Dr Andrew Goringe; Prof Brian Huntly; Dr Hugues de Lavallade; Dr Andrew McGregor; Prof Adam Mead; Dr  Kate Rothwell; Prof Stephen O'Brien; Prof Oliver Ottman; Dr Seonaid Pye; Dr Anuparna Rao paediatric representative; Dr Graeme Smith; Richard Szydlo MSc,PhD; Dr Andres Virchis. Trainee members Dr Simone Claudiani; Dr Gillian Horne.

Sandy 

This is really appreciated as it is difficult to get any clarity at this time. 
 

Mark 

Yes, we have now entered a very difficult time. I am trying to get more clarity on the likely situation for CML patients - at least here in the UK - as we go on. The issue lies with CML being categorised as 'high risk' by NHE and PHE. I will update here as a when I know more.

Hi Sandy

thank you so much for doing all this research into CML and Covid-19.

There is a lot of conflicting information out there for us. I am currently social distancing and working from home, it is a worrying time for everyone.

Best wishes to you all and stay well.

Diane

 

Hospital check-up visits? My wife has to go for 3-monthly check-ups and her Imatinib will not be prescribed if she does not have a blood test for liver function at that check-up. Being over 75 and self-isolating, we would very much prefer not to be in the hospital at all, let alone sitting in  the airless and confined space in the Haematology waiting room at the Royal Devon & Exeter Hospital. Has anyone had advice about that? Should we contact the Consultant and see whether arrangements could be made to have the prescription without a hospital visit? Any views would be much appreciated.

David Cornes

Hospital check-up visits? My wife has to go for 3-monthly check-ups and her Imatinib will not be prescribed if she does not have a blood test for liver function at that check-up. Being over 75 and self-isolating, we would very much prefer not to be in the hospital at all, let alone sitting in  the airless and confined space in the Haematology waiting room at the Royal Devon & Exeter Hospital. Has anyone had advice about that? Should we contact the Consultant and see whether arrangements could be made to have the prescription without a hospital visit? Any views would be much appreciated.

David Cornes

Hi David,

If we interpret what we have read so far then GPs will be sending out letters urgently so as to protect 1.5 million people such as us, as we have been defined as High Risk.Ideally one would assume that your specialist would be contacting you as well.

If I were in your  wifes situation I would call the secretary to the consultant for clarification;as well I would be proactive to ask your GP if on an urgent basis they could do the bloods-if you were dissuaded from going to the surgery because of it being risky  then there should be a community nurse that would be able to come and take bloods at home.I presume a PCR test is needed as well but whether ther GP would be able to do this as well I am not sure.

With best wishes

John

Hi David,

All CML patients in England will be required to isolate for their own protection. As I have said in other posts over the last few days, this is because Public Health England have taken the cautious view that CML is a condition that puts patients at a higher risk of serious complications of a COVID-19 infection.

They have published a press release with the following statement:

  • Government urges up to 1.5 million people in England who face the highest risk of being hospitalised by the virus to shield themselves and stay at home
  • People with specific underlying health conditions, including some being treated for cancer, will be contacted by the NHS this week
  • Plans also unveiled to deliver groceries and medicines for those most at risk from the virus where needed
  • Up to 1.5 million people in England identified by the NHS as being at higher risk of severe illness if they contract coronavirus should stay home to protect themselves, the Government urged today (Sunday 22 March).

They will receive communication shortly with detailed advice on behalf of their GP practice or specialist on how best to protect themselves.

You can read the full press release here

and PH England Guidance Document below:

COVID-19: guidance on shielding and protecting people defined on medical grounds as extremely vulnerable

The relevant part of the above Guidance Document regarding hospital /clinic appointments is:

'We advise everyone to access medical assistance remotely, wherever possible. However, if you have a scheduled hospital or other medical appointment during this period, talk to your GP or specialist to ensure you continue to receive the care you need and determine which of these are absolutely essential.

It is possible that your hospital may need to cancel or postpone some clinics and appointments. You should contact your hospital or clinic to confirm appointments.'

Please read the Public Health England Guidance Document in full.

 

HI David

I am also treated at the RD and E in Exeter - since Sept 2009. My case is what my consultant calls "easy" and I am now in MR4 with very low PCR readings. For the past few years I get my phone appt from my consultant's secretary by post with the relevant blood forms every 3 months. I then make an appt with my local GP surgery for the phlebotomist 5 weeks before the phone appt to have my bloods taken in good time. 2-3 weeks later I get the results by email from the Genetics Lab via my consultant . He then phones on the pre-arranged day ( can be at any time as he is incredibly busy on clinic days) and we discuss my case. I only see him once  a year at the Uni as the Genetics students want to meet and talk to a real patient as well as a haematologist and the Genetics Prof.. I am well with no other health problems ( except osteoporosis) and I manage to avoid the hospital completely. I don't know who your wife's consultant is but maybe he/she would be willing to follow this routine - obviously depending on your wife's health. It may be that I can do it this way as I have been at MMR for nearly 10 years and my case is so straightforward.

I hope this helps both of you as I fully empathise with your feelings about the crowded waiting room.

Best wishes,

Chrissie

Hi

I also had an appointment booked for Monday 23rd march but my consultant phoned me to cancel it. I asked about the blood test and medication and he told me he had the authority to over ride the need for a blood test in certain circumstances. I have also been told that some hospitals are now posting medication.  Hopefully this will be your situation as well and it can be sorted with no fuss.

On top of the new restrictions it is a worrying time for us all with cml even those of us with low readings. Not looking forward to 12 weeks at home with no access to the outside world.

All the best.

X

 

 

To build on Sandy’s point, even if you accept that a CML patient in MMR or better may not have a significant immunodeficiency the interactions with TKIs COVI-19 are basically unknown. 

That’s bad for a CML patient who contracts C19.

If a CML patient is hospitalised, because of the above more resources will need to be used to treat them. They are taken from someone else who needed them. 

That’s bad for everyone else.

If things get extremely bad, and very difficult triage decisions are to be made they are made in mind of who would receive the most benefit from the scarce resource available - both human and equipment. 

That’s not good for any patient in a vulnerable group.

Though the Public Health advice may appear to be cautious, it’s not just for the benefit of the vulnerable. 

My wife's Consultant is Dr Veale at the RD&E but she rarely sees him - others deal with the appointments - it is a lottery who she sees - no continuity of care. Fortunately, she has been stable for many years with undetectable PCRs.

She is going to telephone Dr Veale's Secretary and discuss the best route during this coronavirus epidemic. I will post again if we have any answers.

Chrissie - we have never been told that telephone consultations are possible. It sounds like it might be a possible answer but GP bloods are a potential problem here where we live.

Sandy thanks for your post much appreciated,

Hi Sandy

Found this explanation of why we may be at risk on a US website

"At the moment in a normal situation, neither chronic phase CML per se nor tyrosine kinase inhibitors against CML appear to induce a state of clinically significant immune suppression. However, we really do not know if protection from COVID-19 requires a level of immune control that non optimally-controlled CML or TKI therapy may in part impair. Therefore, we recommend CML patients under TKI therapy to be extremely cautious and to strictly follow the restrictive measures suggested by health authorities of their respective countries, in order to avoid the risk of contamination and to prevent the spread of infection."

Hi again David,

David Veale has always struck me as a caring, sensible doctor and if your wife is undetectable he may well agree to phone appts. I forgot to continue in my post that after our phone chat, my haem, Paul Kerr, sends 3 months' prescriptions to the hospital pharmacy who send them on to Healthcare at Home. They deliver to my house every month and, in 5 years, have only let me down once when they lost the script. It has worked like clockwork 99.9% of the time.

Good luck - they surely want to avoid as many patients coming into the hospital as possible.

Best wishes, Chrissie

Hi Christine R,

Yes, this is taken from the guidance from iCMLf (international CML foundation) published earlier this month. 

Hi David

 

Hope you are keeping safe with your wife.

 

My mother is 82 and has CML.  We have been in contact with her Consultant as her PCR blood test was due this week.   I, like you would rather her not attend the hospital. Mum is also on Imatinib

The Consultant has agreed to give three months medication without the blood test.   It may well be because she also has heart disease and kidney disease.    I would email your wife's consultant and see what options there are.

Sadly, none of us know what to do for the best, the consultants advice was based on previous blood results.

I wish you both well.

 

Laura

Hi Sandy, I just wonder, the experts who believe anyone on any cancer medication isn’t a high risk candidate during this worrying time,  my concern is we, the world at this present time have no solid answers to Covid-19 apart from wash are hands, keep 2 metres distance from other people, and other lifestyle changes, Cml members need as much protection as possible and I personally won’t ever be persuaded to believe we should be moderate risk, not high risk, especially now, this kind of categorising isn’t going to boost my moral. Peter 

Thanks for that. My wife will be phoning the Consultant's secretary to find out if he will do a script without the blood test. She has had undetectable PCRs for many years so it seems to us the risk of not having a liver function test is a very low risk. I will post again when we know the answer. 

Hi Peter,

No one has said that people currently treated with 'cancer medication' - i.e chemotherapies, or other agents such as radio therapy, that specifically kill or suppress all cells both normal and malignant - should not be in the 'high risk' category.

What CML expert clinicians have said in their statement is that 'medically speaking' CML patients who are on TKI therapy, have a stable good molecular response and are not being treated with other therapies for other health issues that may impact their immune response to COVID -19 should be categorised as moderate, rather than high, risk - as their immune response is as close to, if not the same as, the normal population 

You may have not read all the responses, but Public Health England took a more cautious view and took the decision to include CML as 'high risk' along with all cancers, so you should be reassured by that. CML is still in the high risk category. 

Sandy 

 

Hi David,

given your wife's stable molecular response, which is and has been optimal for some time, you should be very confident that she is a low risk. Hopefully her consultant will be able to reassure her.

Sandy

Hi Sandy,

I'd like to share 2 interesting studies i found. One claims that in vitro both Imatinib and Dasatinib is somewhat useful against SARS and MERS. The other study is an in vivo (mice) experiment that determines that Imatinib has some real life antiviral activity against poxvirus, but Dasatinib is actually likely to suppress the immune system more than be helpful. Given that i'm also taking Dasatinib for the 3rd year now this makes me wonder if there are any human studies on possible immunosuppressive effects that may affect recovery outcomes negatively. 

https://researchgate.net/figure/Antiviral-activity-of-dasatinib-and-imat...

https://jvi.asm.org/content/85/1/21

This is the conclusion from the second study: "dasatinib treatment is unlikely to afford protection to lethally infected mice and indeed may have an immunosuppressive activity, likely due to inhibition of Src family kinases", and "The most likely explanation for the immunosuppressive effects of dasatinib is the inhibition of Src family kinases rather than Abl family kinases. In particular, Fyn and other Src family tyrosine kinases have been implicated in various aspects of the immune response, including innate and antigen signaling, phagocytosis, and T- and B-cell development". 

But the good news for those of you on Imatinib: "Previous work demonstrated that imatinib mesylate was capable of protecting mice from a lethal challenge when administered prophylactically".

Stay safe!

--Thomas

Hi Sandy,

I am very concerned about this statement.

On the whole it's very reassuring. It delivers the message that CMLers are at very little higher risk from Covid-19 than anyone else.

It also seems to deliver the message that the CML experts do not agree with the Government that we should be, or need to be in the Vulnerable Group and seems to suggest this may have consequences in the future should crucial decisions have to be made and these might not be to our benefit. 

At the moment having 2 trusted sources of information which, although meant to be supportive and compliment each other, appear to conflict and cause confusion. The Government's advice is clear - stay shielded at home. The experts appear to say we're not at that much risk. I appreciate their efforts and reassurance but people want clarity in a very scary situation. People's lives have been turned upside down. Does Hubby stay shielded at home or not? Are all the safeguards the family have put in place for him absolutely necessary? Does he really have to have all his own crockery, cutlery and towels? Do I have to keep my distance and sleep seperately? For me, that means the sofa! The Official Government Guidelines say yes. If that was the only advice to follow it would be clear, deliverable to him and the family, and much easier to live with. Without the statement from the experts I wouldn't even question my efforts to keep him safe. On the other hand, I don't want him selected for refusal of treatment if it came to the crunch.

I'm not trying to be contraversial I'm just confused and scared for us all.

They emphasise it is in their opinion, they have all the knowledge and expertise on this so this is reliable. Many will put their trust in this team over the Government especially as it's less restrictive day to day.

What prompted this statement to be issued in the first place? Was it their concern for their patients? Was it in response to a question raised by a patient?

Are they taking any action to get us removed from the Vulnerable list? If not, we should be following the Government's advice but be reassured we can fight this virus off as well as the next person.

 

Unfortunately there are no details, so at this point not sure about what to think, but there is a very unsettling forum entry from Giantonio Rosti here: 

https://www.cml-foundation.org/icmlf-forum/1501-should-i-stop-or-change-...

Apparently 2 patients on dasatinib passed away due to coronavirus. It is difficult to not drew premature conclusions, but probably would be important to learn more about the circumstances. 

Hi Lydia,

I have taken your main questions and tried to answer each as best I can. I hope this reassures you that you are doing everything you can with the information that you/we have available.

  • "They emphasise it is in their opinion, they have all the knowledge and expertise on this so this is reliable. Many will put their trust in this team over the Government especially as it's less restrictive day to day.

First thing I would say is that no one has all the knowledge on anything. So you need to continue to exercise your own judgment on this situation and how you respond to the official advice. I am confident that the expert CML clinicians who are part of the NCRI subgroup would not suggest for a moment that you should ignore the Government's communications or Public Health England's advice on how you can protect yourself or your family members from infections in general and COVID-19 in particular.

  • "What prompted this statement to be issued in the first place? Was it their concern for their patients? Was it in response to a question raised by a patient?"

I am sure they were, and still are, concerned for all CML patients. 

  • "Are they taking any action to get us removed from the Vulnerable list? 

No, not to my knowledge. If you refer to the statements made in the NCRI document, it is clear that PHEngland did not agree with the CML sub-group's that CML would better included in a moderate risk group. It is entirely clear to me that PHEng preferred to take a more cautious approach, which is entirely understandable why that would be.

  • If not, we should be following the Government's advice but be reassured we can fight this virus off as well as the next person."

I absolutely agree with you that we all need to follow official advice.

Personally I have confidence in my own ability to make sure, as far as I possibly can, that I - and my family - remain healthy throughout this really concerning time.

I hope your are reassured that whatever steps you have taken to protect yourself and your family are the right ones. 

Sandy

 

 

Many thanks for your reply. Sandy, 'it is clear that PHEngland did not agree with the CML sub-group's that CML would better included in a moderate risk group' is the missing part in my jigsaw and now it makes complete sense to me.