Provenge

VascodaGama said:

Forum on Provenge
Cap

Not many report on provenge in this forum and not much is known about results from the treatment, except that it prolongs life to approximatly 2 years. Some posts have commented short periods of 4 months.
I think that the company providing the treatment should go public with the results at their hands. News are critical about the benefits and many like you deserve proper support on what to expect.
Some links are here;
http://www.health-forums.com/alt-support-cancer-prostate/provenge-vs-prostvac-178246.html
http://www.healingwell.com/community/default.aspx?f=35&m=2389603

Not to alarm you but Reuters has posted this in late March;
http://in.reuters.com/article/2012/03/30/us-provenge-idINBRE82T07420120330

I wish you success in the outcome.

Regards
VGama

Provenge...
I will tell you three things up front, and then, you can decide on the veracity of the information I will give you:
1. I hold three degress in the physical sciences and have been a biotech investor since 1980.
2. I have been a shareholder in Dendreon since 2006, and have followed Provenge through its Phase 3 pivotal trials and FDA approval process
3. I am a Seeking Alpha Gold Certified Contributor and have written extensively on Dendreon corporation and Provenge as well as on JNJ's Zytiga and Medivation's MDV3100. You will find my background information and list of articles here:

http://seekingalpha.com/author/theodore-cohen/articles

Provenge was approved by the FDA in April, 2010, for end stage prostate cancer. If you asked the company for a statement regarding their immunological treatment, they would tell you this (as they did me): "The FDA approval was based on a significant improvement in overall survival shown in three well-designed, randomized, double-blind, controlled clinical trials – including the pivotal IMPACT trial – with remarkably consistent results shown across the trials as well as in numerous patient subgroups.

"The Provenge clinical data have undergone a rigorous scientific review process that included FDA review process, a Center for Medicare and Medicaid Services national coverage determination, a Technology Assessment and the peer review of multiple publications. As evidenced by the FDA approval, CMS national coverage decision, and NCCN treatment guidelines, the PROVENGE data clearly demonstrated a significant patient survival benefit and support its use as a clinically meaningful treatment option for certain types of advanced prostate cancer."

Here are some facts. The MEDIAN life-extension benefit upon which approval was based is 4.1 months. That means that half the patients in the pivotal studies lived less than 4.1 months, and half lived longer. Confounding the analyses, however, was the fact that some patients in the placebo cohort crossed over and were given a frozen form of Provenge called Frovenge. When these patients are removed from the analyses, the MEDIAN survival benefit is estimated to be between 7.8 and 12.1 months (based on two studies presented at medical symposia).

JNJ, the maker of Zytiga, and Dendreon now are running trials to determine the proper sequencing of their two drugs. The concern, here, is that Zytiga must be coadministered with prednisone, and so, if Zytiga is given first (which is NOT recommended by the Journal of Clinical Oncology), the patient first must 'detox' for 60 days before Provenge can be administered. Details can be found here:

http://jco.ascopubs.org/content/29/27/3595.full?sid=a9e276db-0ac1-4ca1-8fd4-a16a19e7151f#sec-14

The Reuters article to which VGama referred discusses a Commentary published in the Journal of the National Cancer Institute. Understand, first, that the JNCI has NO relationship whatsoever with the US National Cancer Institute. None! The JNCI is published by Oxford University Press. The Commentary, written by Huber et al., discusses a controversal theory called 'immunodepletion' that earlier had been introduced at the CMS (Medicare) National Coverage Review of Provenge held in November, 2010. Few gave it credence. The theory continues to generate controversy, and I will not say more because it could cause the dialogue here to deteriorate rapidly.

If you are interested in learning more about Provenge, there are 1000 commercial and academic providers currently available in the Lower 48. You can find one near you, as well as other information on the treatment, here:

www.provenge.com

Finally, Provenge is covered by Medicare. At least 75% of all patients have incurred no or little out-of-pocket expenses. The treatment is administered in three parts, each 2 weeks apart.

I hope this has helped you.

Ted