was FDA approved in 2010 for prostate cancer patients who were hormone refractory (castrate resistant), metastatic, and had little or no pain (symptoms). But because PROVENGE is an immunotherapy, it is different in many ways. It is different in the way it is administered (apheresis & a 1 month schedule). It is different in the way it addresses prostate cancer (kick-starting the immune system, not attacking the cancer cells), and different in the way we measure response (immediate PSA response not expected). So, it remains confusing for some people, but experts weigh in below…..
What the Experts are Saying:
Dr. Charles (Snuffy) Myers, Prostate Forum - "I am tantalized by the fact that pretreatment with PROVENGE might make subsequent therapies far more effective by bringing in the immune system in a more effective way..."
Dr. Charles Drake, Johns Hopkins Cancer Center - "...It turns out that if the PSA is low when you start, the magnitude of benefit seems to be larger. Whereas if you start with a high PSA (the highest quartile was greater than [approximately] 130 ng/mL), then you have less of a benefit..."
Dr. David Crawford, University of Colorado, Denver - "...people that benefit even more - people with PSA's of less than 2 - number of bone scan lesions less - these people have a very extended survival rate when you use this. It's not just the 4 months, but 18 months..."
Dr. Leonard Gomella, Jefferson Kimmel Cancer Center - on PROVENGE survival benefit - "From my viewpoint, actually the benefit of sipuleucel-T has actually been understated because many of the patients who received the frozen product were on the control [placebo] arm, actually enjoyed a longer survival, decreasing the difference between the control [placebo] arm and the treatment [sipuleucel-T] arm."
In addition, and especially noteworthy:
Although African American men only made up about 6% of the men in the phase 3 PROVENGE trial, their survival statistics were measured separately after PROVENGE was FDA approved. Instead of a 4.1 median overall survival benefit, the small group of African American men showed a surprising survival benefit of 30.7 months. There were only 33 men in the African American group, so it is impossible to draw valid scientific proof, but it is certainly noteworthy. Urology Times May 2012