In this large study, men with advanced prostate cancer who had not yet had chemotherapy took either enzalutamide tablets or a dummy pill (placebo). Enzalutamide lowered the risk of the disease growing on scans and the risk of death, and delayed the start of chemotherapy. The most common important side effects of this drug were tiredness and high blood pressure.
mCRPC with no prior ARPI, before or after docetaxel; visceral metastases allowed; a history of seizures was an exclusion criterion in the trial
| 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.
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 (4 × 40 mg capsules) orally once daily with continued ADT, until disease progression (radiographic, skeletal event or clinical) and initiation of chemotherapy, or unacceptable toxicity (872 patients).
Placebo (4 capsules once daily) with ADT (845 patients).
Source of the regimen details: Full text of the paper (PMC4418931) and ClinicalTrials.gov NCT01212991
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.
1717 men with metastatic prostate cancer with PSA or radiographic progression despite ADT (testosterone 50 ng/dL or less), without prior chemotherapy and asymptomatic or mildly symptomatic. Patients with visceral metastases (lung or liver) and class I–II heart failure were eligible; a history of seizure or a condition predisposing to seizure was an exclusion criterion.
Coprimary endpoints: radiographic progression-free survival and overall survival. Secondary endpoints included time to initiation of cytotoxic chemotherapy, time to first skeletal-related event, complete or partial soft-tissue response, time to PSA progression and a PSA decline of at least 50%.
Grade 3 or higher adverse events 43% versus 37% (median time to first grade 3 or higher event 22.3 versus 13.3 months); the most common grade 3 or higher event with enzalutamide was hypertension (7%); hypertension overall 13% versus 4%. Discontinuation due to adverse events 6% in both groups. One seizure in each group.
Based on the abstract, enzalutamide is an effective option for men with metastatic prostate cancer that has progressed despite androgen-deprivation therapy and who have not yet received chemotherapy, improving radiographic progression-free survival and overall survival. The status of approvals and current guideline recommendations should be checked separately.
The abstract does not mention the study's limitations. The study was stopped after the interim analysis, so this report contains no longer-term data. The study was funded by Medivation and Astellas Pharma.
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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