A newer report of this study has been published: Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer (2022)
In this study, men with prostate cancer that had spread but still responded to hormone treatment were given, in addition to their usual hormone treatment, either a drug called enzalutamide or a placebo. Adding enzalutamide markedly reduced the risk of the disease growing on scans or of death. The rate of serious side effects was about the same in the two groups, and patients' quality of life was maintained.
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 continued ADT (LHRH agonist or antagonist or bilateral orchiectomy), until radiographic progression or unacceptable toxicity (574 patients).
Matching oral placebo once daily with ADT (576 patients).
Source of the regimen details: Full text of the paper (PMC6839905) 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 (metastases on bone scan or CT/MRI; disease confined to the pelvic lymph nodes was not eligible), ECOG performance status 0 or 1. Short-term prior ADT (up to 3 months) and up to 6 cycles of prior docetaxel without progression were allowed; 63.2% had high-volume disease and 17.9% prior docetaxel. Stratified by disease volume and prior docetaxel.
Primary endpoint: radiographic progression-free survival. Secondary endpoints included PSA progression, start of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, pain progression, achievement of an undetectable PSA level and/or objective response, and quality of life.
Grade 3 or higher adverse events were reported in 24.3% of patients in the enzalutamide + ADT group versus 25.6% in the placebo + ADT group, and no unexpected adverse events were seen; serious adverse events and adverse events leading to discontinuation were similar in the two groups.
According to the abstract, adding enzalutamide to ADT significantly reduces the risk of radiographic progression or death in patients with mHSPC, including those with low-volume disease or prior docetaxel. The status of drug approvals and clinical guideline recommendations should be checked separately, as they are not mentioned in the abstract.
The abstract does not mention the study's limitations. At the time of this analysis, median radiographic progression-free survival in the enzalutamide group had not yet been reached, and overall survival data are not reported 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.
Who are you reading this site as?
Your choice applies to every page; change it any time from the bottom of the page.
Type to search...