DR SMITH: The study involved about 1,000 patients, randomized patients to abiraterone acetate plus prednisone versus prednisone. The study had coprimary endpoints of overall survival and progression-free survival.
And, as presented at ASCO, this was a positive trial with a marked improvement in PFS, with a hazard ratio, 0.43, and a trend toward improvement in overall survival, with a hazard ratio of about 0.75.
DR LOVE: What were you doing in your own practice before this paper? And is it going to be any different since you saw these data?
DR SMITH: So it’s a good question. So in my view, the constructive pre- and postdocetaxel is primarily a regulatory construct. There’s not a biologic construct. It’s an important framework for drug development. That landscape will now change with the approval of a variety of other agents. And there’s no biologic reason to believe that abiraterone would be less effective in patients who’d not had prior chemotherapy. And conversely, we don’t think chemotherapy confers sensitivity to abiraterone or other agents.
So I was using and do use abiraterone prior to chemotherapy in select patients. It’s an easy choice for many patients because of improved tolerability relative to chemotherapy. But this does raise lots of important questions about sequencing, for which there’s not high-level evidence.
DR LOVE: So Mario, what are your thoughts about this issue of moving agents up? And I’ll say: What about using, for example, these 2 new endocrine approved agents in PSA-only disease?
DR EISENBERGER: I think that we obviously need clinical trials to test that. I’d be a little concerned about using expensive drugs that have not been tested in that paradigm, in that space, in a standard way. It’s certainly logical to think that way, since so much appears to be making an impact that the other agents didn’t appear to make in a late-stage disease. That would probably work even better in the earlier-stage disease.
DR LOVE: So Bob, you’re an evidence-based kind of guy. What do you think of this concept? And were you using abiraterone before chemo before ASCO?
DR DREICER: I want to point out that Mario wrote an editorial with the first abi paper and basically made the point that the use of docetaxel was a regulatory issue, not a biological paradigm. I’ve been using abi prechemotherapy since about January of this year, mostly similar to Dan, just waiting for the reimbursement issue to not be an issue. And interestingly enough, early on we were sending in preapps, telling them that the patient hadn’t received chemotherapy in the check box, and they approved the drug anyway.
So I think going forward there’s a bit of biology and a lot of regulatory reimbursement issues. So I use abi prechemotherapy. I have no issues with it, but I also agree with Mario. In a biochemical failure setting, I think we need data.