Re: UK residents : Abiraterone

[Guest guest]

Is this statement correct:

<snip> The potential

to increase life by years. Not just 4 months. On the 9 month trail, nobody on the drug died. Men on the placebo arm of the trial started to die

after 5 months. Hence 4 months of extra life.<snip>

I haven’t hunted up the study but I

gained the impression that there was a four month difference in median survival

between the two arms. If that was so then half the men in the Abiraterone arm

died four months later than half the men in the placebo arm.

All the best

Terry

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Metcalf

Sent: Thursday, 2 February 2012

9:41 PM

To: Prostate Cancer Support

e-group

Subject: UK residents :

Abiraterone

Abiraterone

Dear

As you have probably heard already, Abiraterone has been

rejected by NICE. This is a very successful drug which is proven to work and we

all have to try to get this decision reversed. There is a consultation process

into which we can participate. Please contact all

of your members and urge them to log onto:

http://guidance.nice.org.uk/TA/Wave26/4/Consultation/DraftGuidance

This will take them to a form in which they can submit their

views. If we can produce thousands submissions,

NICE will have to take notice. This has to done by February 23rd 2012.

At the moment, Abiraterone is available until 2014, in England only,

under the EDF, for chemotherapy failed patients. We have to strive to make it

generally available on the NHS.

In your submissions, please try to stress the following

* The potential to increase life by

years. Not just 4 months. On the 9 month trail, nobody on the drug died. Men

on the placebo arm of the trial

started to die after 5 months. Hence 4 months of

extra life.

* The ability to help men to keep in

employment and not have to claim benefits because of ill heath

* Greatly increased quality of life

with much reduced pain

* Very easily administered, just 4

tablets per day, at home (or anywhere else you may be.)

* Very few side affects, (In my own

case none)

* No alternative treatments

available, the alternative is death.

This is very important for all of us, please try to give it

your best shot!

Very best wishes

Hugh

Hugh Gunn

Hon. Treasurer

Prostate Cancer Support Federation

[Guest guest]

Terry it is a matter of how you look at the stats.

It was 4 months than mitoxantrane i.e. 14.8 months in for Abiaterone.

Getting to be a bit more important for me now

B

Abiraterone

Dear

As you have probably heard already, Abiraterone has been rejected by NICE. This is a very successful drug which is proven to work and we all have to try to get this decision reversed. There is a consultation process into which we can participate. Please contact all of your members and urge them to log onto:

http://guidance.nice.org.uk/TA/Wave26/4/Consultation/DraftGuidance

This will take them to a form in which they can submit their views. If we can produce thousands submissions, NICE will have to take notice. This has to done by February 23rd 2012.

At the moment, Abiraterone is available until 2014, in England only, under the EDF, for chemotherapy failed patients. We have to strive to make it generally available on the NHS.

In your submissions, please try to stress the following

* The potential to increase life by years. Not just 4 months. On the 9 month trail, nobody on the drug died. Men on the placebo arm of the trial started to die after 5 months. Hence 4 months of extra life.

* The ability to help men to keep in employment and not have to claim benefits because of ill heath

* Greatly increased quality of life with much reduced pain

* Very easily administered, just 4 tablets per day, at home (or anywhere else you may be.)

* Very few side affects, (In my own case none)

* No alternative treatments available, the alternative is death.

This is very important for all of us, please try to give it your best shot!

Very best wishes

Hugh

Hugh Gunn

Hon. Treasurer

Prostate Cancer Support Federation

[Guest guest]

Folks: Criticise the NICE judgement. Write to your MP's. Keep the ball

rolling. [i think we need to look very closely at the text of the

research used by NICE to base their decision. What / where is it? I

have found numerous papers on PubMed, but the NICE specific one .. ?

Are they using a report format like Cochrane to asses numerous trials

or what ? ]

There are also other ways we can go to keep the 'kettle boiling' so to

speak, and help maintain an interest in abiraterone. The key is that

abiraterone is NOT just for the few at the very end of their prostate

cancer journey:

Here for instance, the Royal Marsden are looking at abiraterone in a *

pre-chemotherapy setting *[1] .

I think it will be shown that abiraterone works very well in this

setting - prolonging life, reducing symptoms of the cancer, and

enabling men to become more independent / not claiming benefit /

working & contributing to family & society at large. Much more so than

in a post-chemotherapy setting. Making the drug available 'up front'

will produce a greater market demand for abiraterone, and reduce

asking price from thousands to hundreds. [ A similar picture a few

years ago with inflated prices for Zoladex.]

It has often been a complaint that second line treatment is ' too

little and too late '. If abiraterone can be accessed before men reach

the stage they need chemotherapy, there is a good chance they will

never need the chemotherapy ! Because abiraterone induces a much more

powerful hormone block, there is a good chance many cancers will be

destroyed and the disease go into complete remission after a few

months treatment. Basically, it has already been shown that very early

hormone block can induce remission in a population [Labrie, F].

However, early detected prostate cancer does not always demand drastic

action such as hormone block: Abiraterone makes it easier to identify

those men who really need hormone block [Oliver, T], and not some

other long term intervention such as active surveillance or androgen

therapy.

Then there is the breast cancer angle:

http://cancerhelp.cancerresearchuk.org/trials/a-trial-of-abiraterone-acetate-for\

-breast-cancer-that-has-spread

If abiraterone shows (as it will) improved survival in women with

advanced breast cancer we have another market force that will lower

the price of the drug.

Sam.

~~~~~~~~~~~~~~~~

Refs

1. Drug Discov Today. 2011 Dec 19. [Epub ahead of print]

Abiraterone acetate: redefining hormone treatment for advanced prostate cancer.

Pezaro CJ, Mukherji D, De Bono JS.

Drug Development Unit and Academic Urology Unit, The Royal Marsden NHS

Foundation

Trust, Downs Road, Sutton, Surrey SM2 5PT, UK; The Institute of Cancer

Research,

Downs Road, Sutton, Surrey SM2 5PT, UK.

Prostate cancer has long since been recognised as being hormonally driven via

androgen receptor signalling. Abiraterone acetate (AA) is a rationally designed

CYP17 inhibitor that blocks the conversion of androgens from non-gonadal

precursors effectively, thus reducing testosterone to undetectable

levels. AA has

recently been proved to extend survival for men with metastatic

castration-resistant prostate cancer who have progressive disease after

first-line chemotherapy treatment. In addition, it is currently being

tested in a

Phase III trial in the pre-chemotherapy setting. This paper will review the

preclinical discovery and clinical development of AA and will outline the

strategy of parallel translational research.

Copyright © 2012. Published by Elsevier Ltd.

PMID: 22198164 [PubMed - as supplied by publisher]

2. Surg Oncol. 2009 Sep;18(3):275-82. Epub 2009 Mar 6.

Intermittent hormone therapy and its place in the contemporary endocrine

treatment of prostate cancer.

Shaw G, Oliver RT.

Department of Medical Oncology, St Bartholomew's Hospital, West field,

London EC1A 7BE, UK. gregshaw@...

Castration results in dangerous and disabling side effects. Deferred hormone

therapy has been shown to be associated with decreased survival. Intermittent

hormone therapy (IHT) was attempted initially to reduce morbidity of treating

metastatic prostate cancer with stilboestrol. Preclinical work using castrate

mice with hormone sensitive prostate tumours demonstrated that pulses of

testosterone delayed the onset of androgen independent growth and PSA

production

in these mice. This led to development of clinical treatment protocols

for use in

phase II trials by a number of centres in a variety of clinical

scenarios. These

phase II trials demonstrated apparent safety of this approach,

prompting several

large scale RCTs. Thus far no difference in survival has been demonstrated

between IHT and continuous hormone therapy despite large numbers and prolonged

follow-up. Quality of life has been proven to improve with stopping hormone

therapy. A recent meta-analysis and multivariate analysis of phase II studies

provides a unique opportunity to identify features of the various published IHT

protocols which engender treatment success and allow the following

recommendations to be made which may guide the clinician in devising their own

IHT protocol. A PSA nadir below 1 ng/ml has been shown to be the best

determinant

of when it is safe to stop treatment. It can be achieved after as

little as three

months in patients with local disease. Patients with metastatic

disease should be

treated for at least eight months. Restarting treatment when the PSA

rises to 15

ng/ml prolongs survival. MAB or LHRH monotherapy should be the standard of care

in all patients with possible exception of recurrent disease after radiotherapy

or prostatectomy where anti-androgen monotherapy may be appropriate.

Initial PSA

and the level of the PSA nadir achieved enable definition of prostate cancer

patients in whom this approach may define a subgroup of local disease

patients in

whom it may be safe to avoid radical therapy. Preclinical and clinical

data from

a phase II trial demonstrating that addition of finasteride prolongs the off

treatment period and provide the impetus for a randomized controlled

trial (RCT)

to prove this.

PMID: 19269165

>

>

>

> Terry it is a matter of how you look at the stats.

>

> It was 4 months  than mitoxantrane i.e. 14.8 months in for Abiaterone.

>

> Getting to be a bit more important for me now

>

> B

>

>

>

>

>

> Abiraterone

>

> Dear

>

> As you have probably heard already, Abiraterone has been rejected by NICE.

This is a very successful drug which is proven to work and we all have to try to

get this decision reversed. There is a consultation process into which we can

participate. Please contact all of your members and urge them to log onto:

>

> http://guidance.nice.org.uk/TA/Wave26/4/Consultation/DraftGuidance

>

> This will take them to a form in which they can submit their views. If we can

produce thousands submissions, NICE will have to take notice. This has to done

by February 23rd 2012.

>

> At the moment, Abiraterone is available until 2014, in England only, under the

EDF, for chemotherapy failed patients. We have to strive to make it generally

available on the NHS.

>

> In your submissions, please try to stress the following

>

> *    The potential to increase life by years. Not just 4 months. On the 9

month trail, nobody on the         drug died. Men on the placebo arm of the

trial started to die after 5 months. Hence 4 months of         extra life.

>

> *    The ability to help men to keep in employment and not have to claim

benefits because of ill heath

>

> *    Greatly increased quality of life with much reduced pain

>

> *    Very easily administered, just 4 tablets per day, at home (or anywhere

else you may be.)

>

> *    Very few side affects, (In my own case none)

>

> *    No alternative treatments available, the alternative is death.

>

> This is very important for all of us, please try to give it your best shot!

>

> Very best wishes

>

> Hugh

>

> Hugh Gunn

>

> Hon. Treasurer

>

> Prostate Cancer Support Federation

>

>