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Post by Tony Crispino on Feb 10, 2014 14:50:31 GMT -8
I saw this in Medpage and later that day posted on HealingWell. No Survival Benefit in CRPC With New Anti-Androgen
One key point was "Patients who received orteronel plus prednisone had a median overall survival (OS) of 17 months versus 15.2 months for patients treated with prednisone alone. Orteronel did lead to significantly better progression-free survival (PFS), a secondary endpoint of the trial." The overall survival was deemed insignificant. In our SWOG meeting today I raised the point of this article and there was a pretty big variation by region that basically killed this trial. Many patients in Europe were given Abiraterone prior to being accrued for the TAK-700 (orteronel) trial. The problem here is that both drugs use a similar mechanism, they are liase 17,20 inhibitors. So if the patient had failed abiraterone, then ortonel was not likely to help and the trial proved that. But because many patients who had failed abiraterone were accrued, there is no way to continue this trial and deliver the true effects of TAK700. S1216, a current SWOG trial, is testing men prior to the use of abiraterone. Which makes sense. Moving forward, S1216 is still a valid and viable trial option for men with metastatic disease. Tony
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Post by Tony Crispino on Feb 10, 2014 14:58:42 GMT -8
So I guess the best way to say it is that TAK700 failed after abiraterone. But that should be expected. The trial should have been changed to eliminate this conflict. But by no means is TAK700 eliminated as a viable option. In fact to the contrary, it is expected to be released in the US.
Tony
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Post by Allen on Feb 10, 2014 16:59:10 GMT -8
It should be tested against abiraterone.
- Allen
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Post by Tony Crispino on Feb 10, 2014 19:03:41 GMT -8
That's a reasonable thought. There's one side of that test that TAK700 would win ~ side effects. You do not need a cortical steroid unless a rare condition occurs during treatment. With abiraterone it's provided on label with prednisone and off label without it. Both drugs use the same oncological mechanism ~ they are CYP 17,20 lyase inhibitors. Abiraterone had similar challenges in trial. It was approved because of progression control not overall survival. But today there are several Abiraterone trials looking at it early such as this setting. I think we'll get a pretty good comparison soon.
I would imagine that Abiraterone with prednisone after TAK700 was ineffective would be an interesting trial. But I wouldn't sign up for that one. Knowing one CYP 17,20 inhibitor failed and trying another already failed in the reverse to prove an overall survival benefit.
Tony
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