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ASCO 2021 | Results from PEACE-1: abiraterone in mCSPC

Karim Fizazi, MD, PhD, Institut Gustave Roussy, Villejuif, France, provides an overview of the results from the Phase III PEACE-1 trial (NCT01957436) of abiraterone and/or local radiotherapy in men with metastatic castration-sensitive prostate cancer (mCSPC). Combining androgen deprivation therapy (ADT) and docetaxel, the current standard of care (SOC), with abiraterone and local radiotherapy resulted in a radiographic progression-free survival (rPFS) rate of 2.5 years. Prof. Fizazi additionally discusses the safety profile of abiraterone and suggests the triple treatment regimen should replace the current SOC. This interview took place at the American Society of Clinical Oncology (ASCO) 2021 Virtual Meeting.

Transcript (edited for clarity)

The median follow-up is approximately 3.5 years. What we found was that abiraterone very significantly improves the co-primary endpoint of radiographic progression-free survival when added on top of androgen deprivation therapy, plus docetaxel. The risk of progression or death was reduced by half. Regarding the medians, what we saw was an rPFS rate, a median rate, of two years in the control arm with ADT plus docetaxel, which was what we expected it to be...

The median follow-up is approximately 3.5 years. What we found was that abiraterone very significantly improves the co-primary endpoint of radiographic progression-free survival when added on top of androgen deprivation therapy, plus docetaxel. The risk of progression or death was reduced by half. Regarding the medians, what we saw was an rPFS rate, a median rate, of two years in the control arm with ADT plus docetaxel, which was what we expected it to be. And this compares to four years and a half in the abiraterone arm. So a big difference of two years and a half of additional time without radiographic progression or death for men receiving abiraterone on top of chemo-hormonal treatment, which is big.

Actually, when we looked at other means of measuring progression-free survival, for example, time to castration resistance, we saw pretty much the same difference, so at least two years of additional benefit on top of ADT plus docetaxel. And the same was true when we also looked at symptom-defined PFS, again, more than two years of additional time without symptoms for these men, when they received abiraterone on top of ADT plus docetaxel.

Now you might ask, of course, whether there is a cost to pay from the patient perspective in terms of safety, in terms of toxicity, and actually data were very reassuring. For example, the rate of neutropenic fever was exactly the same in the two arms, with or without abiraterone, just 5% incidence. Other side effects related to docetaxel were actually seen with lower incidence in the abiraterone arm. For example, fatigue or GI side effects were lower with abiraterone. And regarding the abiraterone-related side effects, they were exactly as we were expecting them to be. For example, hypertension, approximately 12% versus approximately 8% in the control arm. So nothing big, if you will.

So this really questions whether we should just change all the standard of care based on this data, and move to a triplet treatment for men with de novo metastatic prostate cancer. Of course, overall survival data are not mature as I’m speaking, we’re expecting them to mature probably this year.

But regardless of what they are, if you are adding two years and a half of additional time without progression, and I’m talking about serious progression measured in a hard way, radiographic progression or even symptoms. If you’re adding two years and a half of additional PFS, on top of what already ADT plus docetaxel provides, does this mean that we should change the standard of care? My personal answer is yes, but of course, I will be curious to hear what others think.

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