Great news for patients with advanced prostate cancer. A new investigational agent, abiraterone acetate, was shown to significantly improved survival in men with metastatic castration-resistant prostate cancer.
Abiraterone acetate is an investigational agent being developed by Ortho Biotech. It acts by blocking CYP17 and potently inhibits persistent androgen synthesis from adrenal and intratumoral sources.
In the study, investigators randomly assigned 1,195 patients with castration-resistant metastatic prostate cancer and who had been previously treated with docetaxel to 1 of 2 study groups: abiraterone 1000 mg plus prednisone 5 mg twice daily (n = 797) or placebo plus prednisone (n = 398).
Patients who received abiraterone acetate plus prednisone had a median overall survival of 14.8 months, compared with 10.9 months for patients assigned to receive corticosteroid prednisone plus placebo.
The most commonly observed adverse effects in the abiraterone group were fluid retention (30.5% vs 22.3%) and hypokalemia (17.1% vs 8.4%). Grade 3/4 hypokalemia (3.8% vs 0.8%) and grade 3/4 hypertension (1.3% vs 0.3%) were infrequent.
While 3.9 months may not seem like much in the history of prostate cancer, only 4 drugs have ever shown a survival benefit. Furthermore, it is an oral that does not have the toxicity of chemotherapy.
It is anticipated that this new drug will change the way doctors treat advanced prostate cancer in the future.
Source: 35th European Society for Medical Oncology Congress: Abstract LBA5. Presented October 11, 2010.
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