Mar 18, 2012 - 3:45 pm
Bad for Prostate cancer, and good for us!
According to a media release from Janssen Research & Development (a unit of Johnson & Johnson), an independent trial monitoring committee has advised the company to stop the randomized, Phase III clinical trial of abiraterone acetate + predisone compared to a placebo + prednisone in treatment of chemotherapy-naïve patients with metastatic, castration-resistant prostate cancer (mCRPC).
The phase III clinical studies on abiraterone (Zytiga) both in chemotherapy-treated and chemotherapy-untreated patients have been stopped early due to positive results, so that the patients in the placebo arm may also receive benefits of the drug.The first Phase III study was halted after a clear, median 4-month extended survival point had been reached. So all that be can said from this study is that it gave a median 4-month survival benefit, but this does not tell the real story of longer-term survivors on this drug.For long-term survival we need to look at the survivors from the initial trials. There is at least one 8-year survivor from the original Phase I trial and there are several 4-year survivors from the Phase II trials. There are also many 2-year survivors from the first enrollment of patients into the ongoing phase III studies. Although it is too early to tell the long-term benefits, these are positive signs. These are significant because the trials were carried out in the most difficult of prostate cancer cases, on the most resistant forms of prostate cancer that had failed all other therapies, including docetaxel chemotherapy. The typical average life expectancy of this cohort is about 14 months, so any life extension above that is good