WEDNESDAY, Oct. 18, 2023 (HealthDay News) — For patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide is best for metastasis-free survival, according to a study published in the Oct. 19 issue of the New England Journal of Medicine.
Stephen J. Freedland, M.D., from the Cedars-Sinai Medical Center in Los Angeles, and colleagues enrolled patients with prostate cancer with high-risk biochemical recurrence with a prostate-specific antigen doubling time of nine months or less. Patients were randomly assigned to receive enzalutamide daily plus leuprolide every 12 weeks, placebo plus leuprolide, or enzalutamide monotherapy (355, 358, and 355 patients, respectively).
The researchers found that metastasis-free survival was 87.3, 71.4, and 80.0 percent in the combination group, leuprolide-alone group, and monotherapy group, respectively. Enzalutamide plus leuprolide was superior to leuprolide alone with respect to metastasis-free survival (hazard ratio for metastasis or death, 0.42); enzalutamide monotherapy was also superior to leuprolide alone (hazard ratio for metastasis or death, 0.63). There were no new safety signals noted; quality-of-life measures did not differ substantially between the groups.
“The data from this trial confirm findings in previous phase 3 trials, in which patients treated with the androgen-receptor inhibitor enzalutamide and androgen-deprivation therapy derived clinically meaningful benefit relative to androgen-deprivation therapy alone,” the authors write.
The study was supported by Pfizer and Astellas Pharma, which manufacture enzalutamide.
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