Androgen Deprivation Therapy Plus Enzalutamide for Hormone-Sensitive Prostate Cancer
Dr. Haffizulla: So let’s talk a little bit about the phase III ARCHES study that will be presented at the ASCO GU conference in San Francisco this year. What question was this particular study designed to answer?
Dr. Dorff: ARCHES was asking the question of intensification in metastatic hormone-sensitive prostate cancer, which has been a trend in the field of prostate cancer over the last few years, starting with docetaxel and the CHAARTED and the STAMPEDE studies, and then followed by abiraterone in the LATITUDE and STAMPEDE studies. So this was asking whether enzalutamide might improve outcomes when used at the start of androgen-deprivation therapy for a newly diagnosed metastatic prostate cancer patient compared to reserving that for castration-resistant setting.
Dr. Haffizulla: Can you tell us more about the design of the study?
Dr. Dorff: So it was a randomized, placebo-controlled trial. One important aspect of the design is that both low volume and high volume patients were included. So that becomes important because of all the talk on subset analysis with this MHSPC group. Also, because the CHAARTED and STAMPEDE docetaxel became available, in this study, unlike LATITUDE, some of the patients got the up-front docetaxel. It was felt that, you know, we had to offer patients standard of care. So about 18% in each arm had received docetaxel in addition to the study therapy of the enzalutamide or placebo.
Dr. Haffizulla: Well, how effective did this combination appear to be, the androgen-deprivation therapy and enzalutamide in this setting?
Dr. Dorff: So the data are definitely positive for the primary endpoint that radiographic progression-free survival was significantly prolonged, but it’s an early look, so that median follow-up right now is just a little over 14 months, and so the overall survival data are not mature. In this patient population, the studies have really used overall survival. So it may be that we need a little bit more follow-up before everyone’s fully comfortable, but certainly, there’s efficacy. There was good safety. No new safety signals identified, and so it was a positive study.
Dr. Haffizulla: Well, and based on your expert opinion, I know that we still have a lot of data ahead to review and to garner and to interrogate. Do you envision that enzalutamide will eventually have a place in the management of these patients?
Dr. Dorff: I definitely think so. It seems to me that these very effective treatments in the castration-resistant setting are beneficial to patients earlier, so I believe these data will continue to expand on the benefit as they mature, and eventually, we’ll have multiple options in the hormone-sensitive intensification setting.
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