MSI or MSS

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stu
Posts: 901
Joined: Sat Aug 17, 2013 5:46 pm

Re: MSI or MSS

Postby stu » Wed Sep 26, 2018 12:55 pm

Hi Sandkeeper ,
Thanks for that information . How interesting . Not so good when they got mixed up though!!!
I understand anyone can approach NICE for information so I thought I would and see what happens !! I am in Scotland so quite a small health department to annoy !!
Hope you are keeping well and I will take a note of the other reference names . Never heard of them either .
I help out at a cancer charity and it pains me to see people running out of treatment options yet when I start to ask about it , all I see is total confusion .
Hope you keep well ,
Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

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O Stoma Mia
Posts: 1450
Joined: Sat Jun 22, 2013 6:29 am

Re: MSI or MSS

Postby O Stoma Mia » Wed Sep 26, 2018 2:11 pm

stu wrote:Hi .
Avastin is not coming back any time soon for Colorectal patients ...

Hi Stu -

Thank you for mentioning the UK's NICE committee (National Institute for Health and Care Excellence). I just now finished reading a Wikipedia review of it, and now I understand better what you are trying to do.

And I also just read the December 2010 NICE guideline on colorectal cancer [TA212], and I see that this is where your comment on the phase-out and demise of Avastin is explained in Paragraph 1.1:

https://www.nice.org.uk/guidance/ta212/chapter/1-Guidance

It seems to me that the most recent NICE guidelines on colorectal cancer are quite a bit out-of-date and are in need of serious updating. Your efforts will be greatly rewarded if somehow you can encourage them to start working on an update, especially one that covers recent advances in immunotherapy.

Another question: In the UK do you have any kind of CRC advocacy program equivalent to the "Call on Congress" program that exixts in the US? i.e., something that might be called "Call on Parliament"?

WarriorSpouse
Posts: 159
Joined: Tue Aug 16, 2016 9:02 pm

Re: MSI or MSS

Postby WarriorSpouse » Wed Sep 26, 2018 7:42 pm

https://www.ncbi.nlm.nih.gov/pubmed/25862517

"Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group...
BACKGROUND:
The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation."

This study is more recent than the 2010 findings in the UK.
WS
Spouse of wife 47 years old
10/2014, Stage IV Metastatic CC
Lymph node involvement 12/15, w/ positive PET on para-aortic lymph nodes.
5 cm sigmoid tumor resection as well as positive Virchow lymph node.
KRAS mut, Highly Differentiated, Lynch Negative
Folfox and Avastin 1 YR (Oxi for 5 months) NED 05/2015
Zeloda and Avastin since 01/2016
Chemo break 03/2017, back on Zeloda and Avastin 04/2017.

"...Perseverance is not a long race; it is many short races one after the other."
-Walter Elliot

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O Stoma Mia
Posts: 1450
Joined: Sat Jun 22, 2013 6:29 am

Re: MSI or MSS

Postby O Stoma Mia » Thu Sep 27, 2018 12:18 am

I think the link posted by WarriorSpouse is very important.

It shows that Avastin does indeed have a positive effect. In addition, this Phase 3, randomised controlled trial was published in 2015 in The Lancet (a British journal !!!)

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O Stoma Mia
Posts: 1450
Joined: Sat Jun 22, 2013 6:29 am

Re: MSI or MSS

Postby O Stoma Mia » Fri Sep 28, 2018 1:31 am

As already noted by others above, the mandate of UK's NICE Committee (National Institute for Health and Care Excellence) is two-fold, (1) efficacy and (2) cost-effectiveness:

"... [The NICE] appraisals are based primarily on evaluations of efficacy and cost-effectiveness in various circumstances..."
Reference: https://en.m.wikipedia.org/wiki/National_Institute_for_Health_and_Care_Excellence

I think that this can help explain why Keytruda and Avastin are not well supported for colorectal cancer indications in the UK - - they cost far too much, and the Committee is applying its mandated cost-management principles.

Keytruda is an expensive drug:
"Keytruda will be an expensive treatment option ... Merck has disclosed that its new PD-1 inhibitor will cost payers $12,500 per month or about $150,000 per year.... . Keytruda now looks set to become a blockbuster drug for Merck and a leading drug within the PD-1 inhibitor class..."

I think it is probably a similar situation with Avastin.

stu
Posts: 901
Joined: Sat Aug 17, 2013 5:46 pm

Re: MSI or MSS

Postby stu » Fri Sep 28, 2018 3:09 am

Hi ,
That’s exactly the issue with our system . Everything is cost/ benefit analysis before its sanctioned. Avastin has larger useage whereas Keytrunda would be a much smaller subset of patients reducing the bill . I really doubt Avastin for stage 4 bowel cancer will get funding . Breast cancer patients seem to have better access to it. They do fund expensive drugs but the evidence of benefit has to be strong .
Avastin is largely funded privately now by “ gofund me “ campaigns . So sad for people already up against it . A lot of people also have private medicine here through work so they can still access it that way .
I will go back and read all the links again . Someone is getting me the address of the committee.
Thank you so much for all your help ,
Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

WarriorSpouse
Posts: 159
Joined: Tue Aug 16, 2016 9:02 pm

Re: MSI or MSS

Postby WarriorSpouse » Fri Sep 28, 2018 6:07 am

Stu,
Thank you for drawing attention to this issue both in the UK and around the world on this forum.

Many in the world can not put a face on the consequence of the State deciding who they will support with best treatment practices based on a cost a benefit analysis matrix. It may be a good fiscal approach, but deceased victims of said poor practices do not testify before politicians and never complain to the free press when they allow the State to dictate their shortened lifespans through State run approved treatment plans.

Your conversation here has shown a light on this very important issue. Research and development of new and improving drugs, and treatment practices, requires the use of what is medically approved. The free market will allow for movement forward in research and development, while financially assisting the indigent in the process. A State run system removes an important portion of the engine that allows and creates the potential successes of our future. Both State and Private systems need to work together in allowing the use of better treatments to make best practices available for everyone, without prejudice.

Thank you for taking this issue on Stu. It will be good advocacy for those not only in the UK, but around the world who participate through this forum. Everyone here needs to be an advocate for what Stu is discussing. Every person you influence along the way matters. Thank you Stu and Colon Talk for providing this international discussion.
WS
Spouse of wife 47 years old
10/2014, Stage IV Metastatic CC
Lymph node involvement 12/15, w/ positive PET on para-aortic lymph nodes.
5 cm sigmoid tumor resection as well as positive Virchow lymph node.
KRAS mut, Highly Differentiated, Lynch Negative
Folfox and Avastin 1 YR (Oxi for 5 months) NED 05/2015
Zeloda and Avastin since 01/2016
Chemo break 03/2017, back on Zeloda and Avastin 04/2017.

"...Perseverance is not a long race; it is many short races one after the other."
-Walter Elliot

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O Stoma Mia
Posts: 1450
Joined: Sat Jun 22, 2013 6:29 am

Re: MSI or MSS

Postby O Stoma Mia » Fri Sep 28, 2018 6:12 am

Hi stu,

You mentioned earlier that you had access to a cancer charity's campaign section. Is there someone there that could help you write your letter and check that the letter is accurate and convincing? Does the charity have access to any doctors or medical scientists who could give technical advice on appropriate content for your letter?

One thing I noticed in the NICE documentation is that they tend to use the generic name for a drug, not the commercial trade name. You might need to have someone with a technical background check the text of your letter before you send it off to make sure that it is in a professionally acceptable format.

Another thing you might do is to have a look at some of the materials and arguments prepared by the U.S. organization FightCRC in their requests or petitions that are sent off to the U.S. Congress. This might give you some ideas on how to formulate a good, effective argument:

http://action.fightcrc.org

https://fightcolorectalcancer.org/advocacy/hill/legislative-goals/

stu
Posts: 901
Joined: Sat Aug 17, 2013 5:46 pm

Re: MSI or MSS

Postby stu » Sat Sep 29, 2018 6:52 am

Hi WarriorSpouse ,
You are correct . It takes surely must take influence from many quarters to bring about change . If we all do our bit !!
I totally agree that there needs to be more collaborative working between sectors.
Just to encourage you I am now actively using your link over here to explain to people what they need to be discussing with their oncologist. Such a great explanation. So a big thank you for it .
Take care,
Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

stu
Posts: 901
Joined: Sat Aug 17, 2013 5:46 pm

Re: MSI or MSS

Postby stu » Sat Sep 29, 2018 6:59 am

Hi O stoma Mia ,
Thank you for the suggestions . That is such a great idea . I will contact them to see if they can offer guidance .
I will see if the campaigns section have any guidance to offer also. Getting them to polish it a bit would be of considerable benefit .
I shall get to work and see what happens .
Thank you once again ,
Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

WarriorSpouse
Posts: 159
Joined: Tue Aug 16, 2016 9:02 pm

Re: MSI or MSS

Postby WarriorSpouse » Sat Sep 29, 2018 7:16 am

Thank you for the kind words Stu.
Here are more links on the Cairo3 CRC Study.

https://www.karger.com/Article/FullText/453027
2016 article

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844763/
2018 article

Keep moving FORWARD! :)
WS
Spouse of wife 47 years old
10/2014, Stage IV Metastatic CC
Lymph node involvement 12/15, w/ positive PET on para-aortic lymph nodes.
5 cm sigmoid tumor resection as well as positive Virchow lymph node.
KRAS mut, Highly Differentiated, Lynch Negative
Folfox and Avastin 1 YR (Oxi for 5 months) NED 05/2015
Zeloda and Avastin since 01/2016
Chemo break 03/2017, back on Zeloda and Avastin 04/2017.

"...Perseverance is not a long race; it is many short races one after the other."
-Walter Elliot

User avatar
O Stoma Mia
Posts: 1450
Joined: Sat Jun 22, 2013 6:29 am

Re: MSI or MSS

Postby O Stoma Mia » Sat Sep 29, 2018 3:33 pm

Hi Stu -

Good luck on drafting your letter! Actually, what I would suggest is for you to treat the Avastin and Keytruda requests separately, in two different letters/requests.

This is because the two issues are very different and would require two different kinds of logical reasoning.

Avastin has been approved for colorectal cancer by the European Medicines Agency for a long, long time, with the most recent approval update dated August 31, 2018.

Keytruda, however, has been approved only for melanoma, NSCLC lung cancer, Hodgkin lymphoma, and urothelial cancer by the European Medicines Agency, and has never ever been approved by them for use with colorectal cancer.

(see the documents in the two links below)

https://www.ema.europa.eu/medicines/human/EPAR/avastin

https://www.ema.europa.eu/medicines/human/EPAR/keytruda

In the case of Avastin, you would be requesting to have the NICE Committee reinstate the earlier status authorizing Avastin's use in the NHS system.

In the case of Keytruda, however, you would probably have to deal with a different agency in order to first of all get Keytruda exceptionally approved for use with colorectal cancer, then deal with the NICE Committee afterwards. I think that the NICE Committee ordinarily only deals with drugs that have already been approved for a specific use by the EMA.

According to information given in the link below, it appears that the agency that can grant such exceptional regulatory approval in the UK is the MHRA (Medicines and Healthcare-products Regulatory Agency)

https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/access-to-treatment/how-are-drugs-licensed-in-the-uk

stu
Posts: 901
Joined: Sat Aug 17, 2013 5:46 pm

Re: MSI or MSS

Postby stu » Tue Oct 09, 2018 3:25 am

Hi ,
Just a little update .

A clinical trial has opened up . It will allow some access to immunotherapy . So pleased about that .

Had a little fright about the European aspect of drug control but other cancer types have managed it so hopefully colon cancer will get some options too .

Will keep you updated .

Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

User avatar
bitchslapped
Posts: 1523
Joined: Tue Sep 09, 2014 3:23 pm
Location: PNW/USA

Re: MSI or MSS

Postby bitchslapped » Sat Oct 13, 2018 4:32 pm

stu wrote:I help out at a cancer charity and it pains me to see people running out of treatment options yet when I start to ask about it , all I see is total confusion .


Bully for you Stu! That would be so hard. Good input from our O Stoma Mia & others. It might be uphill, but changes do take place beginning @ the grass roots.

Best Wishes
BS
DSS,35YO,unresect mCRC DX 7/'14,lvr,LN,peri,rib
FOLFOX+Avstn 4 Rnds d/c 10/'14
Stent 9/'14
FOLFIRI+Avstn 10/'14
Gone From My Sight 2/20/15
Me:garden variety polyps + precancerous polyp, diverticulitis
Carergver x2 DH,DM dbl occupancy,'03-'10
DH dx 47YO mCRC,'04-'07 fried x HAI
DM dx CC 85YO,CC,CHF,stroke,dementia,aphasia

henry123
Posts: 149
Joined: Sun Oct 08, 2017 3:25 am

Re: MSI or MSS

Postby henry123 » Wed Oct 31, 2018 10:24 pm

Stu
You are doing great work there.
Does anyone know of any advocacy group for approval of Keytruda / Nivolumab for CRC in Canada.
Health Canada seems to be sleeping in this regards.
46yo M
5/16 lap AR 14/21 L nodes +ve
T4N2M1
7/16 Capox 9 cyc
9/16 cea 2
1/17 550
PET CT mets in lung & peri
iri+ avast fail
3/17 10577
msi-h Lynch
4/17 regro fail
5/17 cea 28800
5/17 CT inc in size of mes nodes ,onset of multi nodules in liver.
6/17 Opdivo start
7/17 26754
8/17 5623
9/17 497
10/17 52
11/17 12
CT all clear exc a nodule in Lung. liver norm
1/18 3.6
2/18 2.3
4/18 2.0
Aspirin start
6/18 1.5 CT clear
8/18 1.3
10/18 1.2
12/18 1.1 CT Clear NED
Vegan yoga juicing apricot
Still on opdivo


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