New Hormone Therapy Boosts Non-Metastatic Survival in Prostate Cancer Patients
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New Hormone Therapy Boosts Non-Metastatic Survival in Prostate Cancer Patients
New Generation Hormone Therapy Significantly Improves Prostate Cancer Patient Outcomes with a Near 90% Non-Metastatic Survival Rate.
Prostate cancer, one of the most common malignancies in the urinary system, ranks as the second most prevalent malignancy in men worldwide, severely impacting the health of middle-aged and elderly men.
Past studies have shown that within ten years after the final treatment for prostate cancer, approximately 20% to 50% of patients experience biochemical recurrence, characterized by an elevation in prostate-specific antigen (PSA) levels.
Elevated PSA levels may indicate the presence of micro-metastases, local, or distant diseases, increasing the likelihood of prostate cancer-related illnesses and death.
The new generation hormone therapy enzalutamide is a androgen receptor signaling inhibitor. It not only hinders the binding of androgens to their receptors but also inhibits the translocation of the receptor into the cell nucleus and the binding of the androgen receptor to DNA.
A recent study published in the New England Journal of Medicine (NEJM), known as the EMBARK trial, evaluated the efficacy and safety of enzalutamide in combination with androgen deprivation therapy (ADT) or enzalutamide monotherapy compared to ADT alone in patients with high-risk biochemical recurrence of prostate cancer, where the PSA doubling time was less than or equal to 9 months.
The study showed that in patients with high-risk biochemical recurrence of prostate cancer, enzalutamide combined with leuprolide (a luteinizing hormone-releasing hormone agonist) was superior to leuprolide monotherapy in terms of non-metastatic survival. Enzalutamide monotherapy also outperformed leuprolide monotherapy.
This international, randomized, phase 3 trial took place from January 2015 to August 2018, involving 1,068 patients with high-risk biochemical recurrence of prostate cancer from 17 countries and 244 sites. Patients were randomly assigned in a 1:1:1 ratio to receive either enzalutamide (160 mg) once daily plus leuprolide every 12 weeks (combination therapy group, n=355, double-blind), placebo plus leuprolide (leuprolide monotherapy group, n=358, double-blind), or enzalutamide monotherapy (n=355, open-label).
The data was collected until January 31, 2023, with a median age of 69 years, a median PSA doubling time of 4.9 months, and a median follow-up period of 60.7 months. The primary endpoint of the study, assessed by a blinded independent central review, was non-metastatic survival comparing the combination therapy group with the leuprolide monotherapy group.
The results showed that, according to the blinded independent central review, 45 patients (12.7%) in the combination therapy group, 92 patients (25.7%) in the leuprolide monotherapy group, and 63 patients (17.7%) in the enzalutamide monotherapy group experienced disease progression or death.
The 5-year non-metastatic survival rate was 87.3% (95% CI, 83.0% to 90.6%) in the combination therapy group, 71.4% (95% CI, 65.7% to 76.3%) in the leuprolide monotherapy group, and 80.0% (95% CI, 75.0% to 84.1%) in the enzalutamide monotherapy group.
The combination therapy group had a 57.6% lower risk of metastasis or death compared to the leuprolide monotherapy group, which was statistically significant (hazard ratio [HR], 0.42; 95% CI, 0.30 to 0.61; P<0.001). The enzalutamide monotherapy group had a 36.9% lower risk of metastasis or death compared to the leuprolide monotherapy group, which was also statistically significant (HR, 0.63; 95% CI, 0.46 to 0.87; P=0.005).
In terms of safety, no new safety signals were observed, and there were no significant differences in quality of life indicators among the groups.
In summary, in patients with high-risk biochemical recurrence of prostate cancer, enzalutamide combined with leuprolide was superior to leuprolide monotherapy in terms of non-metastatic survival, and enzalutamide monotherapy also outperformed leuprolide monotherapy. Enzalutamide’s safety profile was consistent with previous clinical studies and did not have a significant adverse impact on quality of life.
New Hormone Therapy Boosts Non-Metastatic Survival in Prostate Cancer Patients
Reference:
[1] Freedland SJ, et al., (2023). Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med, doi:10.1056/NEJMoa2303974.
(source:internet, reference only)
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