Abiraterone acetate plus prednisone efficacious, safe in castration-resistant disease
Monday, May 16, 2011 (Last Updated: 05/17/2011)
MONDAY, May 16 (HealthDay News) -- Individuals with castration-resistant prostate cancer progressing after docetaxel-based chemotherapy benefit from abiraterone acetate (AA) with low-dose prednisone (P), according to research presented at the annual meeting of the American Urological Association, held from May 14 to 19 in Washington, D.C.
Fred Saad, M.D., of the University of Montreal Hospital Centers, and colleagues randomized 1,195 patients with castration-resistant prostate cancer who had previously undergone chemotherapy with docetaxel to receive 1,000 mg AA plus 5 mg P twice daily, or placebo. The primary end point was overall survival.
The investigators found that overall survival was increased by a median 14.8 months with AA plus P as compared with 10.9 months with placebo. AA plus P reduced the risk of death by 35 percent compared with placebo. Patients who received AA plus P experienced less fatigue (8 versus 10 percent), back pain (6 versus 10 percent), and spinal cord compression (3 versus 5 percent) as compared to patients who received placebo. The most common grade 3/4 adverse events were decreased lymphocyte levels (21 percent in those who received AA plus P versus 23 percent in the placebo group), fluid retention (2.3 versus 1 percent), hypokalemia (3.8 versus 0.8 percent), liver function test abnormalities (3.5 versus 3.0 percent), hypertension (1.3 versus 0.3 percent), and cardiac disorders (4.1 versus 2.3 percent).
"In men with metastatic prostate cancer, hormone therapy typically slows disease progression for a substantial time. Chemotherapy becomes an option when the disease no longer responds to standard hormone therapy," Christopher Amling, M.D., of the Oregon Health and Science University in Portland, who moderated a press conference on the research, said in a statement. "But what happens when prostate cancer progresses after chemotherapy? By targeting persistent androgen synthesis, these data suggest that abiraterone, combined with low-dose prednisone, may be an option."
The study was funded by Cougar Biotechnology.
Hematology & Oncology
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