Over the last year or so we have seen a marked change in the treatment landscape for men with castrate resistant advanced prostate cancer. The FDA has approved sipuleucel-T (Provenge), cabazitaxel (Jevtana) and last week it also approved abiraterone (Zytiga).
This changed landscape of multiple treatment options creates new problems, of course good problems. Prostate cancer survivors along with their clinicians are now are going to have to make difficult decisions about which drugs to use and in what sequence. Some of these decisions will involve “off- label” uses, which in this climate, might not qualify for insurance reimbursement.
Making these decisions is going to be difficult as we do not have a lot of evidence about how some of these treatments stack up against each other and in what order (or perhaps even they should be mixed in a type of drug cocktail as is done in the treatment of HIV) they should be sequenced. Abiraterone and cabazitaxel haven’t been compared in a head-to-head trial; their pivotal clinical trials were against the then standard of care, docetaxel. Despite this, I can only assume that abiraterone which has fewer serious side effects and can be taken orally may make it the preferred first option.
To add to the dilemma, in a most unusual situation for advanced prostate cancer, there are still a number of other very promising drugs advancing in the pipeline. Both TAK-700 and MDV-3100 as well as a number of potential immunologic treatments are in phase III clinical trials in men with castrate resistant prostate cancer that no longer responds to docetaxel. If all of these drugs (treatments) also demonstrate life extension they too will be added to the same sequencing question.
Please do not interpret this as my complaining. I celebrate these recent advances. If we need a complication or a problem, what better one than this? Without additional clinical trials comparing these new treatments, how are we do know what will be best?
Despite this changed landscape we need to also remember that all three of these drugs, as well as docetaxel (chemotherapy) only extend survival time in relatively modest time increments measured in months. So, we still remain in the proverbial pickle.
– – If you have not yet written to your member of congress about having them sign on to the King-Jackson letter (see yesterday’s post), what are you waiting for?
Joel T Nowak, M.A., M.S.W.