Today’s big news is about a media release made yesterday by Centocor Ortho Biotech with the official and final results of the Phase III clinical trial of abiraterone acetate (Zytiga™) plus prednisone vs. prednisone alone in men with metastatic, castration-resistant prostate cancer (mCRPC) who have already received at least one course of a docetaxel based chemotherapy (taxotere or cabazitaxel). The actual texts of the results are published in today’s issue of the New England Journal of Medicine.
Of course, there were no surprises, but it is good to see them in black and white. To sum up the results:
• The most important was that the overall survival of men in the abiraterone plus prednisone arm of the trial (14.8 months) was longer than that of men in the placebo plus prednisone arm (10.9 months) (hazard ratio
• They also found that the time to PSA progression was longer in the abiraterone plus prednisone arm of the study (10.2 vs. 6.6 months; P < 0.001). • Progression-free survival was also longer in the abiraterone plus prednisone arm of the study (5.6 vs. 3.6 months; P < 0.001). • PSA response rate was superior for the men receiving abiraterone plus prednisone (29% vs. 6%, P < 0.001). • They found that the most common adverse events were mostly grade 1 or grade 2 and they occurred in both groups of men. These side effects included back pain, nausea, constipation, bone pain and arthralgia (joint pain). • However, there were some other mostly grade 1 and grade 2 adverse reactions more common in the investigational group. These additional side effects included urinary tract infections, cardiac events, fluid retention, hypertension and hypokalemia (life threatening drop of potassium in the blood). • Abiraterone acetate treatment was also associated with an increased risk for a serious elevation in aminotransferase levels (a liver enzyme) which required frequent liver functions monitoring, especially during the first 12 weeks of treatment. • The median follow-up time was 12.8 months.Abiraterone acetate is a hormonal drug that when combined with the more traditional ADT drugs clearly demonstrated the ability to extend life, even after the failure of chemotherapy.Joel T Nowak, M.A., M.S.W. [/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]