I was asked if there was one item that was a real game changer at the American Society of Clinical Oncologists (ASCO) meeting for men with advanced prostate cancer. The answer is yes, at this meeting it was formally shown by a study that starting chemotherapy (docetaxel) along with androgen deprivation therapy (ADT) in some men newly diagnosed with metastatic prostate cancer (mPCa) improved median overall survival by more than 13 months.
The PI, Christopher J. Sweeney, MBBS, of the Dana-Farber Cancer Institute in Boston noted, “This is one of the biggest improvements in survival we have seen in a trial involving patients with an adult metastatic solid tumor.”
In his study that 790 men were randomized to receive ADT alone (393 men) or ADT along with docetaxel chemotherapy (397 men). The men had a median age of 63 years. A planned interim analysis showed that the median overall survival (OS) was 44 months in the ADT-only arm compared with 57.6 months in the ADT plus docetaxel arm, a difference that translated into a significant 39% decreased risk of death.
In a subgroup analysis it was determined that this survival advantage was not experienced equally by all of the men in the combination arm of the trial. They found that the men with high-volume disease, the median OS in the ADT-only and combination arms was 32.2 months and 49.2 months, respectively, a 17-month difference that translated into a significant 40% decreased risk of death. In men with low-volume disease, median OS had not been reached at the time of the analysis, according to investigators.
NEXT STEPS
What this study does not ask and creates an urgent need for a follow up study to evaluate if men who are not newly diagnosed and have already been on ADT should also add early chemotherapy to their treatment protocol even while they remain castrate sensitive.
Joel T. Nowak, M.A., M.S.W.
Dan, I agree. Hopefully with this finding insurance companies will change their attitude. – Joel
The NY Times in reporting this opened the article with: “Many men with prostate cancer put off using chemotherapy as long as possible, fearing its side effects.” It’s a shame when they can’t get the facts straight. Here implying a disregard for treatments that could be both life extending and life saving. The reason we don’t get chemo early in the process is because the insurance companies don’t cover it because it isn’t considered the standard of care NOT because we’re afraid of the side effects! Thanks for reporting this.
So as of right now insurance companies are NOT paying for docetaxel for prostate cancer correct?
Kim, Insurance companies are paying for men with castrate resistant prostate cancer which is how it was approved by the FDA. The question is now how will they respond when asked to pay for a man with with aggressive disease who is still hormone responsive. Given this study, if they refuse we now have a great piece of data to use to appeal this decision. Also, different insurance companies will probably respond differently. – Joel