Positive news

system · 18 September 2012 18:52

Taken from a link I received today from breakthrough.org.uk xx

NEW ADVANCED BREAST CANCER DRUG

A new drug could give several extra months of good quality of life for patients with the most common type of advanced breast cancer. The news has been welcomed by Breakthrough Breast Cancer as “one of the biggest advances in breast cancer treatment in many years.”

18 Sep

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Afinitor® (everolimus) tablets, in combination with an aromatase inhibitor, has been approved for use by the European Commission.

Dr Rachel Greig, Senior Policy Officer at Breakthrough Breast Cancer, said: “Everolimus is one of the biggest advances in breast cancer treatment in many years. This drug could make a massive difference to thousands of patients with advanced breast cancer. While this is by no means a cure, it could give patients several extra months of good quality of life with their families.

“Everolimus needs to be assessed by Nice but we are strongly backing it to be made available for those who need it.”

In the UK, breast cancer is the most common form of cancer in women, accounting for approximately 31% of all new cancer cases. It is estimated that some 30,492 women have the advanced breast cancer form7, . In terms of the patient population in which everolimus is approved it is thought that up to 14,000 patients could benefit from the therapy.

Advanced breast cancer is an incurable disease and current estimated life expectancy for patients is approximately 18-36 months after diagnosis . The most common form of advanced breast cancer is the oestrogen receptor-positive type which accounts for approximately 75% of all breast cancers . The current cornerstone of treatment for women with advanced hormone breast cancer is endocrine therapy, but most will eventually develop treatment resistance to endocrine therapies such as aromatase inhibitors. Resistance to endocrine therapy is linked to disease progression.

“The benefit of endocrine therapy has always been limited by the eventual development of acquired resistance. For the first time clinical research has identified a therapeutic agent, everolimus, which in combination with exemestane can seemingly circumvent this treatment resistance and substantially reduce the risk of patients cancers worsening,” said Professor Stephen Johnston, Professor of Breast Cancer Medicine, The Royal Marsden NHS Foundation Trust. “Everolimus has the potential to redefine the way this common form of advanced breast cancer is treated and importantly offers women an effective alternative to a chemotherapy regime,” he added.

First mTOR inhibitor approved in HR+ breast cancer
mTOR (mammalian target of rapamycin) is a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism. When the mTOR pathway is overactivated resistance to endocrine therapy increases and tumours grow. Afinitor inhibits the mTOR protein thus slowing down cancer cell growth and boosts the efficacy of endocrine therapy.

“mTOR is an exciting new target protein in cancer management and seems to act as a ‘master switch’ because of its involvement in a number of cancers. Everolimus is the first licenced mTOR inhibitor in breast cancer and we have already seen the benefits of targeting this pathway in kidney and pancreatic neuroendocrine cancers. The potential for effectively targeting this pathway in breast cancer is very exciting,” said Dr Alison Jones, Consultant Medical Oncologist, Royal Free Hospital and University College London.

system · 19 September 2012 07:57

Thanks for posting this c1are_uk. See below for Breast Cancer Care’s response to this news:

Commenting on the UK availability of Afinitor® (everolimus) for secondary breast cancer patients, Jackie Harris, Clinical Nurse Specialist at Breast Cancer Care said:

“As the first mTOR inhibitor, the availability of Afinitor (everolimus) in the UK for treatment of oestrogen receptor positive (ER+) secondary breast cancer* is a promising step forward for a patient group whose treatment options are currently limited.

“By working with existing therapies, which some tumours can become resistant to, everolimus can extend the benefit of aromatose inhibitors and delay the need for possible chemotherapy. The side effects of everolimus are generally well tolerated, meaning the extra months of progression free survival can be accompanied by a valuable improvement in quality of life compared to other treatment options.

“We know from our work with people with secondary breast cancer that any drugs which delay the progression of breast cancer are extremely valuable. We therefore look forward to seeing further results from the BOLERO-2 trial and await the NICE decision in 2013 so that it may become widely available for eligible secondary breast cancer patients.

““For more information about secondary breast cancer, visit Secondary. Not Second Rate. | Breast Cancer Now or call Breast Cancer Care’s free, confidential, expert Helpline on 0808 800 6000.”

Haxted · 19 September 2012 07:59

Well - having just started Faslodex as “last chance saloon” treatment with all previous endocrine drugs havings become ineffective after a while, this is Good News!

Having got Faslodex through National Cancer Drugs fund, should I need this new one if/when that too becomes ineffective, I expect will have to apply for funding also as cant see NICE deciding it’s COST effective…

Hopefully - whilst I and those of us in same position are being kept going, a CURE will be invented!

system · 19 September 2012 08:56

This is good news but it’ll probably take forever to be approved in Scotland.

system · 21 September 2012 10:59

I really get fed up about this 18 to 36 months survival , we all know everyone is different and there are lots of people around for many years , I really gets up my mixes , there are so many factors !

system · 22 September 2012 22:01

Hello everybody

I intend to campaign that Everolimus is approved by NICE. It appears to me that secondary breast cancer and those of us who have the disease do not receive the treatment, support and drugs we deserve. In the last year NICE has rejected on QUALY Faslodex and Eribulin at the same time approving Caesarian Sections for those who choose them and IVF for same sex couples. Not that I totally understand the rationale behind these decisions but if it is financial I am sure that Caesarian by choice and IVF for same sex couples will be expensive and will not save or extend any lives. Both Eribulin and Faslodex have been approved and are available in Europe I just feel that perhaps if we all use our voices and campaign for NICE approval of Everolimus then maybe we may get a yes. I am initially writing to my MP and am also hoping to campaign through local and regional cancer link groups.

system · 22 September 2012 22:22

I think part of the excitment about this drug is that it is a new class of drug to be used in breast cancer sucessfully. My consultant told me he was excited that it may lead to the development of other similar and hopefully even more effective drugs in the future. NICE have published an initial appraisal document …Lets hope they assess it quickly and in a positive light cos similar to Scotland Welsh ladies do not have access to the drug fund. Pamx

chascat · 23 September 2012 08:44

agraham
I have only just finished treatment for primary BC but always fear the beast is never far away. This new drug is indeed very good news but like you also have my concerns re the NICE approval, if I can help with campaigning in anyway please let me know x

Lemongrove · 23 September 2012 11:37

Couple of comments:
(1) This is obviously good news for those whose cancer has become endocrine resistant. However, sometimes the reason that cancer ceases to respond to endocrine therapy is because it has simply changed it’s receptor and is no longer oestrogen receptive. Under those circumstances Everolimus would be pointless, because endocrine therapy would have no effect (as the cancer wouldn’t require oestrogen to grow). My hope is that NICE will change it’s guidelines, so that all patients who experience progression while receiving treatment are routinely biopsied to see if their receptors have changed (at the moment NICE advise that secondary tumours should not be biopsied unless the primary was never biopsied).
(2) Agraham, I’m really pleased to read that you intend to campaign. to get Everolimus funded. So many people sit on their hands, and then grumble when funding for life saving drugs and treatments is either refused or withdrawn. I understand your point about scarce funds going to what you regard as less deserving areas, but personally I don’t think that is the real issue. My feeling is that the NHS is simply under-resourced for the modern times. When the NHS first came into existance in 1948, we had full employment in Britain, and a fairly stable population - as there was hardly any immigration. So there were lots of people being taxed and making NI contributions to pay for the NHS, and the NHS could cope with the numbers coming through it’s doors. Between 1955 and 1965 full employment continued, and even though the number of people who came to Britain was approx 250,000, these people contributed to NHS funds by working (often for the NHS itself), and paying tax/NI. However, during the 1970’s everything went awry, unemployment hit the roof (so fewer people paid tax), and liberalization of the global economy meant that rich people could shift money around and avoid paying tax (and in later years, govts became reluctant to tax them anyway for fear they would move elsewhere). Also in later years Britain has become involved in various wars, and this has led to an influx of refugees (particularly from Iraq). This has meant that immigration is now running at 250,000 per year, instead of 250,000 over ten years (and that puts enormous pressure on the NHS).
The answer therefore in my view, is not to rob Peter of treatment so that Paul can have it, but to deal with the structural problems that prevent the NHS from being adequately funded. We desperately need to invest in science and technology so that we can create high tech manufacturing industry, with well paid jobs/tax payers. We also need to prevent rich people shifting money around to avoid paying tax, and stop getting involved in pointless wars, which generates so many refugees.

Angelfalls · 23 September 2012 12:58

AGraham - Good for you! And thank you for all your forthcoming efforts to get this drug approved by NICE. I wish you the very best of luck.

I know nothing about legal matters, but I often wonder whether there isn’t a case to be answered in the European Court of Human Rights when we in the UK are denied treatments that have been approved in Europe; surely we are being denied the most basic human right by not having access to life-extending drugs. Just a thought…

Pam - Even though we don’t have access to the drug fund in Wales, our oncs can apply for special funding on a case-by-case basis (although my onc has already told me she doesn’t know of many cases having actually been approved. Surprise, surprise!).

system · 26 September 2012 11:08

Hi all (and especially gail5 and herbgarden who mentioned the difference in Scotland and Wales)

I’ve had a clarification from the nursing team about the situation in Scotland and Wales, and thought you’d be interested to see it.

* * * * * *

Everolimus (Afinitor) is now licensed within the UK. This license means that doctors can prescribe it to patients who meet the “indications” of the license. In the case of everolimus, it can be prescribed in combination with the hormone therapy drug exemestane to postmenopausal women with estrogen receptor positive, HER2 negative secondary or advanced breast cancer. There are additional limitations: it cannot be prescribed if the woman has “symptomatic visceral disease” (cancer causing symptoms in the internal organs such as the lungs or liver) and the woman must have experienced a progression of her cancer whilst taking either anastrozole (Arimidex) or letrozole (Femara).

If you would like to know more about how drugs are licensed in the UK, you might like to visit this page from the Cancer Research UK website:

cancerhelp.cancerresearchuk.org/about-cancer/cancer-questions/how-are-drugs-licensed-in-the-uk

When a new drug receives a license, although doctors can, in theory, prescribe it, many hospital trusts will not fund it until it has been approved by NICE (National Institute of Health and Clinical Excellence) for England and Wales or the SMC (Scottish Medicines Consortium) in Scotland.

Everolimus is currently being assessed by NICE. It is not currently being assessed by the SMC, although my understanding is that there are plans to do so in the coming months.

When a drug is licensed but not approved, there are various steps that can be taken in order to try and access the drug. The first step for anyone would be to have a discussion with your cancer specialist about whether they feel the drug is appropriate for you. If this is the case, they will talk you through how funding might be applied for.

The Cancer Drugs Fund exists in England to provide a source of funding for drugs that haven’t been approved by NICE. The fund is divided between different Strategic Health Authorities. You can’t apply for drug funding yourself, the application is usually made by your specialist. Scotland, Wales and Northern Ireland do not have a similar fund so requests for “exceptional” funding are made on an individual case basis by your specialist.

I hope this makes things clearer but please contact the Helpline or Ask the Nurse email service if you would like to discuss everolimus in more detail.

Kind regards

Nursing Team

system · 26 September 2012 11:13

Thanks Leah, that’s very helpful. Do you know if it can be prescribed with Exemastane if Exemastane has failed as a hormonal on its own?

system · 26 September 2012 11:31

Hi LesleyLP - that’s probably a question best asked to our helpline as they’d be better placed to talk through all the ins and outs of it. You can call them on 0808 800 6000 or use the Ask the Nurse email service

system · 26 September 2012 12:42

Leah - thanks for the update on SMC approval.

system · 31 October 2012 22:59

Hi Lesley
Yes it can be prescribed with exemestane even if this has previously failed. This is my case. I also have liver and lung mets - though no symptoms, so just scrape in on the terms of the licence. I have started a separate thread on the treatment to keep people up to date on how it’s working for me, SEs etc as this seems to have the potential to be a really important drug for those of us who have had a good response to endocrine based treatment

system · 31 October 2012 23:04

Blast - have somehow managed to post this in triplicate!
Moderator dear - can you delete the extra versions
many thanks