In this final report, adding enzalutamide tablets to hormone therapy in men with metastatic prostate cancer that still responded to hormone therapy reduced the risk of death by about one third, even though some patients in the placebo group later took enzalutamide.
mHSPC regardless of disease volume; prior docetaxel (up to 6 cycles) allowed; ECOG 0 to 1
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Enzalutamide | 160 mg once daily | Oral, with or without food | Daily |
| ADT (GnRH agonist or antagonist, or prior orchiectomy) | Per formulation | — | Continuous |
Dose per the FDA label and the trial. Seizures occurred in 0.6% of patients.
On the page “Prostate cancer” · Metastatic hormone-sensitive disease (mHSPC)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Enzalutamide 160 mg orally once daily with ADT (LHRH agonist or antagonist or orchiectomy), until radiographic progression or unacceptable toxicity; median treatment duration 40.2 months.
Placebo with ADT (median treatment duration 13.8 months); after unblinding, 180 patients (31.3%) without progression crossed over to open-label enzalutamide (median time to crossover 21.5 months).
Source of the regimen details: Full text of the paper (PMC9113211) and ClinicalTrials.gov NCT02677896
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
1150 men with metastatic hormone-sensitive prostate cancer with ECOG performance status 0 or 1; short-term prior ADT and up to 6 cycles of prior docetaxel without progression were allowed. Stratified by disease volume and prior docetaxel.
Prespecified final analysis of overall survival (key secondary endpoint); update of radiographic progression-free survival, other secondary endpoints and safety.
With a median follow-up of 44.6 months, the incidence of adverse events was consistent with the primary analysis and no new safety signals were seen. In the primary analysis, grade 3 or higher adverse events were 24.3% versus 25.6%.
This analysis established the survival benefit of enzalutamide with ADT in mHSPC and confirmed it, alongside abiraterone, as one of the standard ARPIs in this setting.
Median survival was not reached in either group; crossover after unblinding may underestimate the size of the benefit. Subgroup details are not given in the abstract.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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