麻豆传媒

At the virtual European Society for Medical Oncology meeting, researchers presented a from the STAMPEDE platform assessing androgen deprivation therapy (ADT) alone for high-risk non-metastatic prostate cancer versus ADT plus abiraterone acetate (Zytiga) and prednisolone (AAP), with or without enzalutamide.

In this exclusive 麻豆传媒 video, , chair of urology at the Keck School of Medicine at the University of Southern California in Los Angeles, explains why he believes the implications are practice changing.

Following is a transcript of his remarks:

So this is a seminal trial. This trial looked at the M0 population -- high-risk M0 population, metastatic. High risk being defined as either node positive, or high-risk node-negative, which means T3-4 disease, PSA 40 or greater, or Gleason 8-10 grade group 4, essentially, or relapsing.

And so this trial randomized men, almost 2,000 men, at 113 locations in the U.K. and Switzerland. The randomization was about 900 patients to ADT with or without abiraterone plus prednisolone, and 1,000-plus patients to ADT with or without abiraterone and enzalutamide. And the primary endpoint of this trial was metastasis-free survival. And the treatment effect was measured at 2 years.

The baseline of both these groups were well balanced. About 79% had grade group 4 disease in both groups, about 39% were node positive, median PSA was about 34, and median age was about 68 -- so the kind of patient that we would often see in clinic.

And so, upon analyzing the outcomes, metastasis-free survival events occurred significantly more in the control group -- 306 versus 180.

So the abiraterone-based therapy improved metastasis-free survival and also overall survival. For example, 6-year metastasis-free survival improved from 69% to 82%, and 6-year overall survival from 77% to 86%. And these were statistically significant.

And the authors concluded that 2 years of abiraterone-based therapy significantly improves the metastasis-free survival and overall survival in men with high-risk, non-metastatic prostate cancer. And when starting ADT, this study indicates that AAP-based therapy should be added to ADT, and indicates that this should now be considered the new standard of care.

So from my perspective, I want to compliment the authors. This is a lot of work, and a huge advance in the field. For men with non-metastatic high-risk prostate cancer, we all know that the chances of their relapsing, either biochemically or otherwise, are not insignificant, and this shows with clear data that at least at 2 years, the outcomes from the pertinent outcomes -- i.e., overall survival and metastasis-free survival -- were significantly superior.

These are convincing data that will change practice. And I just want to compliment the authors on this seminal study.

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