THURSDAY, Feb. 8, 2018 (HealthDay News) — For men with non-metastatic castration-resistant prostate cancer, apalutamide is associated with prolonged metastasis-free survival, according to a study published online Feb. 8 in the New England Journal of Medicine to coincide with the American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, held from Feb. 8 to 10 in San Francisco.
Matthew R. Smith, M.D., Ph.D., from the Massachusetts General Hospital Cancer Center in Boston, and colleagues randomized men with non-metastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less to receive apalutamide (806 men) or placebo (401 men). All patients continued to receive androgen-deprivation therapy.
The researchers found that the median metastasis-free survival was 40.5 months in the apalutamide group and 16.2 months in the placebo group in the planned primary analysis performed after 378 events had occurred (hazard ratio for metastasis or death, 0.28). Significantly longer time to symptomatic progression was seen with apalutamide versus placebo (hazard ratio, 0.45). The rate of adverse events leading to discontinuation of the trial regimen was 10.6 and 7.0 percent in the apalutamide and placebo groups, respectively. Adverse events that were considered related to the trial regimen and that occurred at a higher rate with apalutamide included rash, hypothyroidism, and fracture.
“These results show that apalutamide made a significant difference in prolonging the time before the development of metastasis,” a coauthor said in a statement.
The study was funded by Janssen, the manufacturer of apalutamide.
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