In another (perhaps more positive) article in today’s issue of the New England Journal of Medicine is a full publication of the data from the AFFIRM trial of enzalutamide (MDV3100) in the treatment of men with metastatic, castration-resistant prostate cancer who had already received docetaxel-based chemotherapy.
The article by Scher et al. offers no surprises compared to the data previously reported at the Genitourinary Cancer meeting in San Francisco earlier this year, but readers will be pleased to see that the full text of this article is available on line, complete with full details of the side effects associated with enzalutamide therapy compared to the side effects seen in men on a placebo.
We will read the article in detail before making any further comment (if any further comment is even necessary).
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment
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Thanks for the link. I was waiting for this article to appear as I was not clear why this trial had a longer median overall survival for the placebo group compared to the placebo group in the abiraterone trial, even though the hazard ratios in both trials were about the same.
In the MDV3100 trial: The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) among patients receiving enzalutamide and 13.6 months (95% CI, 11.3 to 15.8) among patients receiving placebo
In the abiraterone trial: Overall survival was longer in the abiraterone acetate + prednisone group than in the placebo + prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001).
As I can’t see anything immediate in the patient baseline characteristics, do you think the agents used post therapy made the 2.7-month difference? (Abiraterone was used in ~25% of patients and cabazitaxel in ~15%.)
Thanks again
Dear Summer:
I don’t think there is any way to tell whether the difference between the outcomes of the enzalutamide trial and the abiraterone trial was due to the active drug being, small differences in the patient populations in the trials, or anything else. It is very dangerous to compare data from two trials like this because small differences in the trial protocols can introduce significant differences in the results.
In an ideal world, the developers of enzalutamide would “bite the bullet” and carry out a head-to-head randomized trial of enzalutamide against abiraterone acetate + prednisone. Do I think that will happen? Possibly … but it’s pretty unlikely. The risk would be very high.
My personal “take” on the data from these two trials is that the two drugs seem to have “comparable” effects on survival, but enzalutamide seems to have a better side effect profile; you don’t have to take it with prednisone; and you can take it with food. That looks like a +3 score for enzalutamide to me, regardless of any other data.