Ted Simons: Researchers have found a way to use an old chemotherapy treatment to extend the life of prostate cancer patients. Clinical trials of the drug study were conducted in part at the Mayo Clinic here in Arizona. Dr. Alan Bryce is here now to discuss the treatment. Good to have you here. New life it sounds like for an old chemo drug?
Dr. Alan Bryce: Indeed. Very exciting development that was just announced earlier this month at looking at using one of our old standards in prostate cancer in a new way that has made it dramatically more effective than before.
Ted Simons: What is the name of the drug? How was it used before, how could it now be used to help people?
Dr. Alan Bryce: The drug is called Docetaxel. It was previously used very late in the course of prostate cancer; it was really reserved for patients far down the line. In that setting it was approved in 2006 with a survival advantage that is a life extension of only about two months. That was modest, clearly, it's not that much to get excited about, but it was the best we had at the time. What happened in the intervening years, in the last four years there's been a revolution in prostate cancer. Five new drugs have come on the market, hormone drugs, immune drugs, further chemotherapy drugs. They have also provided life extension on the order of two to five months and the old drug, Docetaxel, was pushed further back down the line. But there's a variety of scientific reasons why many of us who do research in this field felt that was a mistake that Docetaxel it really ought to be early in the disease course, so this study was designed to test that hypothesis.
Ted Simons: Why wasn't it early in the disease course earlier?
Dr. Alan Bryce: Part of it is the fairly natural bias people have against chemotherapy. We certainly understand it causes side effects; it's hard on the patient. It also required a change in therapy, mostly these patients would be managed by their surgeons and this required sending the patient to the oncologist. That transition is a certain barrier to entry certainly.
Ted Simons: You were talking before the program that in many cases prostate cancer patients never get to see the oncologist.
Dr. Alan Bryce: We find about 40% of prostate cancer patients who die of prostate cancer in the U.S. never receive this drug at all. In many cases it's because the conversation never really came up. So what happened now with this study is the chemotherapy was given at the beginning rather than at the end. What it ended up showing was that it extended life by over a year, just over 13 months.
Ted Simons: As far as trials are concerned, explain what was done, what was looked at and what was found.
Dr. Alan Bryce: So the study looked at taking this well established chemotherapy drug and giving it right in the beginning of treatment for metastatic prostate cancer in a setting where previously the standard of care was just do hormones. Take away a man's testosterone and that would usually work for a year or two. But what we did was we gave six cycles of this chemotherapy over a course of 18 weeks in combination with the hormone therapy, and then the chemo would end and hormones would continue. In doing that, the survival of all the patients was extended by over a year, but in the highest risk patients with the most metastatic disease the survival advantage was over 17 months.
Ted Simons: Was that a surprise?
Dr. Alan Bryce: It was tremendous. It was actually one of the key lectures of the oncology conference of the year. We were stunned by how dramatic it was, truly.
Ted Simons: This now is old enough to be a generic drug, correct?
Dr. Alan Bryce: Yes.
Ted Simons: Talk about how -- obviously industry wants the next biggest, the brightest so they will test the biggest and the brightest. You got some of these old generic drugs sitting out there doing a clinical trial on something that old, is that unusual?
Dr. Alan Bryce: That's another part of the challenge and an important piece of the story. Because this is a generic drug the only way a clinical trial of this size and this expense could be done is through the national clinical trials networks run by the national cancer institute. That whole system is under strain now because of budget cuts at the federal level, and so the biggest cooperative group in the country that Mayo Clinic is part of called the alliance has seen its 2014 budget cut by 40%, really threatening our ability to do these studies. In terms of the drug being generic, the course of treatment only costs about $9,000. The competing drugs are all somewhere in the range of to $60-100,000 for a course of treatment. So economically and in terms of benefit to the patient there is no comparison.
Ted Simons: With that in mind is there any attempt now to look at any other older cancer drugs and see, not only for the price but also for the results, there's something else out there?
Dr. Alan Bryce: Absolutely. We are always looking at newer ways to use old drugs. Repurpose or reposition them in the course of care. But there again, it really requires robust national clinical trial system to do that.
Ted Simons: Do you think this just -- your thoughts here, do you think that there are generic drugs just sitting out there waiting to be reborn, as it were?
Dr. Alan Bryce: Absolutely. We don't usually get drugs that provide--- or studies that provide this kind of dramatic response. But we constantly have studies of older drugs that are showing uses that they previously had not been established for.
Ted Simons: Reaction to this clinical trial and this study. What are you hearing?
Dr. Alan Bryce: Very positive. No question that this changes the standard of care in the United States. There's going to be an education process in terms of getting the news out so that physicians know about it and patients hear about it. But it's absolutely paradigm changing.
Ted Simons: Do you think, and again this calls for a little bit of opinion, do you think physicians are hesitant sometimes go back whether there's all the new stuff that's supposed to be newer and better?
Dr. Alan Bryce: There's always excitement in doing the new thing. And there's always more support in terms of funding to do studies with new drugs. So it's more challenging, frankly, to do studies with old drugs. I think there's a bias built into the system.
Ted Simons: You said it's an exciting time regarding treatment of prostate cancer. You said the last four, five years we have seen a lot of advancement. What have we seen?
Dr. Alan Bryce: Two new oral pills which act through hormones. We have seen a new immunotherapy drug. We can call it a vaccine like approach to attack prostate cancer. There's a new chemotherapy drug that comes after the one we're talking about here, and there's a new I.V. radiation drug that is injectable and that gets into the bones and attacks the cancer there. By comparison, from the 80's up until 2006, we had a total of five drugs approved. Now we have had five in four years. Really, the pace of change is tremendous in prostate cancer.
Ted Simons: That’s for folks -- are we talking prevention or just treatment once diagnoseD?
Dr. Alan Bryce: This is advanced disease, so men who have had the diagnosis and who have had the disease spread beyond the prostate.
Ted Simons: Interesting. All right, very encouraging results there. It's nice to see that something that's been around for a while has a new life.
Dr. Alan Bryce: Yes.
Ted Simons: Thank you so much. We appreciate it.
Dr. Alan Bryce: Thank you.