Calling All Aussie Men (and Women!) - please help get Xtandi on the PBS BEFORE chemo!

This should be a clickable link...

www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form

Thanks for posting a clickable link gmoose2 - that is very kind of you.

And Chas, I gather, from reading JimJimJim's info, that while enzalutamide is not a miracle cure, some men who respond will have a much longer survival. Jim Marshall has personally met a man whose cancer has been kept at bay for 6 years so far on this drug.

But survival times pre-chemo and post-chemo are not different enough to convince the experts here apparently.

While many men report coping quite well with docetaxel, others have a terrible experience with the side effects. According to JimJimJim t's so bad for some men that they give up treatment.

On the other hand, enzalutamide has far fewer reported side effects, with fatigue and hypertension being the most common.

So, the first benefit of starting enzalutamide BEFORE chemotherapy is that a man can delay the start of chemo (from what I can gather).

Of course I understand everyone is different, and medication responses are different for everyone as well, however this would simply provide another option for men which is not currently available to them here - not fair!

I am so far from being any kind of expert on the subject it would be wrong for me to speculate any further, but someone like Tall Allen would almost certainly know and understand the ins and outs / pros and cons of this medication, along with all the other men on the forum who are currently prescribed it. I'm hoping perhaps one or two might come along to answer your questions, and perhaps even help us write a stronger and better-formed submission to the PBAC on behalf of all the Aussies here who might benefit from enzalutamide before chemo!

Post Edited (Jaybee&GG) : 1/20/2017 1:50:47 AM (GMT-7)

In 2014, the US FDA approved Xtandi as a firstline treatment for metastatic castration resistant prostate cancer; that is, without prior docetaxel use. It was first approved here in 2012 for use only after docetaxel. Here's the Astellas press release and details of the PREVAIL trial, which discusses the evidence for its approval for the new indication:

newsroom.astellas.us/news-releases?item=137065

An update on enzalutamide in the treatment of prostate cancer

The earlier AFFIRM trial of its use after docetaxel demonstrated a 4.8 month median survival improvement. When used before docetaxel, it improved median survival by 2.2 months.

NICE (the UK version version of PBS) approved Xtandi for this indication a year ago. They specify "Enzalutamide is recommended, within its marketing authorisation, as an option for treating metastatic hormone‑relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated; and only when the company provides it with the discount agreed in the patient access scheme."

This stuff is very expensive, so you can see why they'd hesitate to approve it with only a 2 month survival improvement. I think the important thing to remember is that docetaxel provides an 18 month survival improvement when used in men with multiple distant mets at the time ADT is initiated. But for men with just a few mets, early docetaxel provides no real benefit, and early Xtandi may be a better choice.