In this study, men with advanced prostate cancer who had not yet had chemotherapy received either abiraterone with prednisone or a placebo (dummy drug) with prednisone. Abiraterone nearly doubled the time before the disease got worse on scans and delayed the start of chemotherapy and the need for opioid painkillers. On the other hand, side effects such as problems with the body's salt and water balance and changes in liver tests were more common in the abiraterone group, so the doctor needs to monitor these.
mCRPC with no prior ARPI, before or after docetaxel; in COU-AA-302, asymptomatic or mildly symptomatic, ECOG 0 to 1, no visceral metastases
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Abiraterone acetate | 1000 mg once daily | Oral, on an empty stomach | Daily |
| Prednisone | 5 mg twice daily | Oral | Daily |
| ADT (GnRH agonist or antagonist, or prior orchiectomy) | Per formulation | — | Continuous |
Dose per the FDA label and the trial. In mCRPC, prednisone 5 mg is given twice daily (once daily in mCSPC).
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.
Abiraterone acetate 1000 mg (4 × 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily, until disease progression; castration continued (546 patients).
Placebo (4 tablets once daily) with prednisone 5 mg twice daily (542 patients).
Source of the regimen details: ClinicalTrials.gov NCT00887198 and the FDA label for ZYTIGA (DailyMed)
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.
1088 men with metastatic castration-resistant prostate cancer, without previous chemotherapy, asymptomatic or mildly symptomatic (no opioid use for cancer pain), ECOG performance status 0 or 1, testosterone below 50 ng/dL, progression after antiandrogen withdrawal; patients with visceral or brain metastases and previous ketoconazole use were excluded.
Coprimary endpoints: radiographic progression-free survival and overall survival. The abstract also reports the superiority of abiraterone-prednisone for time to initiation of cytotoxic chemotherapy, opioid use for cancer-related pain, PSA progression and decline in performance status.
According to the FDA label (median duration of treatment 13.8 months): hypertension 22% (grade 3–4: 3.9%) versus 13% (3.0%); oedema 25% versus 21%; fatigue 39% versus 34%. In the paper, grade 3 or 4 mineralocorticoid-related adverse events and liver function test abnormalities were more common with abiraterone.
This study showed that abiraterone with prednisone in metastatic castration-resistant prostate cancer before chemotherapy improves radiographic progression-free survival and delays the start of chemotherapy. The improvement in overall survival did not cross the efficacy boundary at this interim analysis. Drug approval status and guideline recommendations should be checked separately, as they are not given in the abstract.
The study was unblinded after the interim analysis (after 43% of expected deaths), and overall survival did not cross the prespecified efficacy boundary, so the overall survival result was reported as a "trend towards improvement". Mineralocorticoid-related adverse events and liver function abnormalities were more frequent with abiraterone.
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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