Enzalutamide Delays Metastasis in Castration Resistant Prostate Cancer
In the double-blind, phase 3 PROSPER trial (NCT02003924), were randomly assigned 1401 patients with a PSA doubling time of 10 months or less (median 3.7 months) on androgen deprivation therapy (ADT) to enzalutamide (160 mg) or placebo once daily. Over 3 years, nearly a quarter of enzalutamide-treated patients and half of the placebo recipients developed metastasis or died.
Investigators found that enzalutamide prolonged metastasis-free survival by almost 2 years compared with placebo (36.6 vs 14.7 months). Patients who received enzalutamide had a significant 71% lower risk for metastasis or death. In addition, enzalutamide significantly delayed subsequent antineoplastic therapy and PSA progression, with no decrease in quality of life.
Grade 3 or higher events occurred in 31% and 23% of the enzalutamide and placebo groups, respectively. Greater proportions of enzalutamide recipients experienced fatigue, hypertension, cardiovascular events, mental impairment, falls, and fractures.
The anticipated approval of enzalutamide represents important step forward for men with rising PSA levels during androgen deprivation therapy. The benefit-risk evaluation suggests that treatment is better than waiting until the appearance of metastases.
Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med 2018;378:2465-74. DOI: 10.1056/NEJMoa1800536 [Published online June 28, 2018]
Smith MR. Progress in nonmetastatic prostate cancer. N Engl J Med 2018;378:26. DOI: 10.1056/NEJMe1805733
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