ASCO - 2012 - Zytiga Off Label Usage

The data coming out of ASCO 2012 for Zytiga is not good. Early use of Zytiga was no better than placebo for 18 months. The Kaplan-Meier curves for Zytiga show that there was no survival trend seen until 18 months after the 14 month long treatment began.

That is, the placebo group and Zytiga group were basically the same in terms of deaths for 18 months.

Zytiga is not doing any good for you folks using it for early / off label use.

Don't believe the hype given by the news press. Go directly to the trial data.

Best Wishes

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Unless I am mistaken, the trial referenced is for chemo naive patients and shows excellent results.

I would not agree with the conclusions above and encourage all readers to review the results of the clinical trial: Abiraterone Acetate (Zytiga) in chemotherapy-naive mCRPC — Phase III trial outcome; this double-blind trial was unblinded because the outcomes were so favorable. A summary can be found on the New Prostate Cancer International website at http://prostatecancerinfolink.net/2012/06/01/abiraterone-acetate-in-chemoth erapy-naive-mcrpc-phase-iii-trial-outcome. The ASCO abstract can be found at http://abstract.asco.org/AbstView_114_95300.html As i noted on the website, the results need clarifying since it is not clear exactly how the "Not Reached' result comes about.

In terms of onset of pain, starting chemo, need for more radiation, survival and more, the Zytiga arm was superior. Inspired45 needs to be specific as to where he believes the Zytiga arm failed to show superiority.

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Can't recall where I read just the opposite.
There is always data that contadicts each other, how is one to know what to do?

Also read one should become HT refractory before starting Zytiga?

BOOGEE

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Inspired is talking about the Zytiga survival data being unspectacular, Otis is talking about Progression Free Survival that was proven in the trial. Both of you are right, but about different things.

The survival chart that Inspired is talking about is the second chart on the following page. As you see the survival curves don't separate until 18 months. So you need to take the drug for 18 months before you see survival benefit. That's a long time to be on prednisone which is a steroid. In the pre-chemo space you can take other drugs that work after 6 months. So if you want to extend survival you would take other faster acting drugs before Zytiga. So Zytiga will probably be approved for pre-chemo, but its important that docs and patients get the correct sequencing of the drugs.

Survival chart:
http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx?et_cid=29383386&et_r id=463641288&linkid=http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx% 23.T8uyPFGiDy9.twitter

More detailed explanation of what I was trying to say:
http://www.prostate.net/2012/prostate-cancer/provenge-vs-zytiga-what-you-sh ould-know/

Stopping the trial was controversial:
www.forbes.com/sites/matthewherper/2012/06/04/new-cancer-data-shine-spotlig ht-on-the-secret-committees-that-make-medicines-toughest-decisions/

From the article:
But that decision to stop the trial early is questionable, because the drug hasn’t shown a statistically significant survival advantage. Now because the study was stopped early, it will be much more difficult to say whether this drug actually extends lives.
http://www.xconomy.com/national/2012/06/03/jj-prostate-cancer-trial-shouldn t-have-been-stopped-early/

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I keep hearing survival rates of 4 months, 6 months, etc. And a lot of talk about trial results and all I know is that Zytega gave me back my life. I am that almost a 20 year veteran of PC treatments. After a radical prostatecemony (1994) I have been on Lupron, Casodex, Kontkonisole, Provenge and so much radiation I don't know why I don't glow in the dark. I thought the end was near, pain was horrible (morphine and other narcotic type pain) and than I was given Zytega. Within days the pain was gone and the PSA dropped to 7. That was 12 months ago. I am now starting my second year. In 1994 My initial prognosis was one year to live, Gleason score of nine and it had left the prostate (which was almost 100% cancer). Since than I have asked if the Doctors prognosis was wrong and other Doctors have confirmed the prognosis. I am very grateful to all of my Doctors, both Urologists, Oncologists and Radiologists for their professionalism and patience. I must also acknowledge the pharmaceutical firm for their continuing effort to provide relief if not yet a cure. I follow some discussions about what treatment to pursue, be grateful that you have a choice. In 1994 we had very few options! I am hoping to get another year or two out of Zytega, but my PSA is going up and I am having some pain. So we will see. My next treatment will be chemo, which I have always thought of as the court of last resort. My Doctors reassure me that it is much better than it used to be. We will live, we will see. God love you all, we are indeed a band of brothers in the worse fight of our life. Stand tall and hold your head erect, you are still a man. Semper Fi

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Jimmy,

I'm glad to hear your story. I hope what I wrote didn't offend you. I think you make a good point that there are lots of different treatments now. Most of them have different mechanisms of action, so taking them all should be beneficial. Some people respond to a treatment more than others. The only way to know how you'd do on a drug is to actually take it.

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Study demonstrated that the activity of docetaxel in patients with mCRPC who first received treatment with abiraterone was lower than expected
"
The activity of abiraterone(Zytiga) may differ according to its sequencing with docetaxel. A retrospective study of patients with metastatic castrate-resistant prostate cancer who received abiraterone (Zytiga) followed by docetaxel may have uncovered concerns about cross-resistance."

http://www.oncologystat.com/journals/journal_scans/Antitumour_Activity_of_D ocetaxel_Following_Treat
ment_With_the_CYP17A1_Inhibitor_Abiraterone_Clinical_Evidence_for_Cross_Res istance.html

CONCLUSION:
"
The activity of docetaxel post-abiraterone (Zytiga) appears lower than anticipated and no responses to docetaxel were observed in abiraterone-refractory patients. "

http://annonc.oxfordjournals.org/content/early/2012/07/05/annonc.mds119.abs tract

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I started with Zytiga in Sept. 2011. My PSA began to drop from 62.010 As of today PSA is 0.030. The pain is much less, with less fatigue. Two scans since I started show no new areas and no expansion of the old areas. My PSA as been at 0 or undetected until 2 months ago when its started to move up. I can only say Zytiga is working for me.
Joe

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