Understanding and deciding on appropriate treatments for men with advanced prostate cancer can be confusing. All the treatments come with side effects and one never knows what the benefits might be for an individual. Even with good clinical trials, men with advanced prostate cancer still need to navigate a most unclear path.
Provenge, ever since is introduction has attracted nothing but controversy. The first rumblings go all the way back to its initial FDA hearing and just continues all the way to today. I cannot think of many drugs or treatments that can boast of such a rocky history. When will it end, I have no idea.
Issues around its survival advantage to its costs have been raised again and again. Te controversies once even became so hot that some of the FDA’s Advisory Committee members were threatened, requiring that they move around with body guards. It certainly has been a very weird roller coaster ride that continues to shock and surprise all of us.
At the upcoming American Society of Clinical Oncologists (ASCO) meeting there will be two posters that will probably continue the buzz about Provenge, but these posters should not inflame the issues, instead they should add to our understanding of the potential survival advantage that Provenge does offer men with advanced, castrate resistant prostate cancer.
The first poster is:
An analysis to quantify the overall survival (OS) benefit of sipuleucel-T accounting for the crossover in the control arm of the IMPACT study at:
The second poster is:
Post-progression treatment with APC8015F may have prolonged survival of subjects in the control arm of sipuleucel-T phase III studies at:
These 2 posters examine the issue I have often raised about the true statistical survival benefit that Provenge supplies. The IMPACT Trial, which was the trial used to obtain the FDA approval, showed that the treatment offered a median survival advantage of 4.2 months. However, it did not take into consideration that members of the control group were offered a frozen version of Provenge (APC8015F ) at the completion of the trial.
Many of us question the effect that APC8015F might have had in extending the survival of members of the control group. Finally, with these two studies, we have some insight into this question.
These two analyses showed about APC8015F did extend the survival of members of the control group, by as much as 3.7 months. Provenge was initially thought to extend survival by a median of 4.1 months; the actual life extension is really a median of 7.8 months, almost doubling the 4.1 number.
Remember, these numbers are median numbers and can not predict what benefit you might receive.
Joel T Nowak, M.A., M.S.W.
My husband will be beginning Provenge in the coming week. How will we know the drug is working?
That’s a great question. Few prostate cancer patients on Provenge are told how they should measure success of their treatment. It is an individual thing, so, the best answer I can give is that you ask your urologist. Call your urologist today…no need to wait and wonder.