Key Points
Question
How does the efficacy and safety of treatment with enzalutamide monotherapy compare with active surveillance in patients with clinically localized low-risk or intermediate-risk prostate cancer?
Findings
In this phase 2, open-label, randomized clinical trial of 227 patients with low-risk or intermediate-risk localized prostate cancer, treatment with enzalutamide was well tolerated. Compared with active surveillance alone, enzalutamide significantly reduced the risk of pathological or therapeutic prostate cancer progression by 46%.
Meaning
The trial results suggest that enzalutamide monotherapy may offer a potential treatment option for this patient population.
We found significant disagreement between needle EMG and VCUG for a positive diagnosis of DESD. A combination of EMG and VCUG may identify more cases of DESD than either modality alone and underscores the need for more strict criteria when defining this entity from a urodynamic standpoint.
Objectives
This analysis from the PERSPECTIVE (a Prospective, Non‐interventional Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder) study evaluated treatment persistence with mirabegron or antimuscarinics over a 12‐month period.
Methods
Participants were adults diagnosed with overactive bladder (OAB) by their health care provider (HCP), who were initiating mirabegron or antimuscarinic treatment. The HCP made all treatment decisions, and patients were followed for 12 months with no mandatory scheduled visits. Information requests were sent to patients at baseline and months 1, 3, 6, and 12. Patients were nonpersistent if they switched, discontinued, or added OAB medications/therapies to their initial treatment. Reasons for discontinuation and switching patterns were investigated.
Results
Overall, 1514 patients were included (613 mirabegron and 901 antimuscarinic initiators). Persistence rates decreased steadily over time in both groups. A low proportion of patients added or switched medication at each time point. Unadjusted Kaplan‐Meier analysis showed similar persistence rates for both groups. When the data were adjusted for patient characteristics (age, sex, and OAB treatment status), mirabegron initiators had higher persistence rates. No significant differences were noted in unadjusted median time to end of persistence. However, end of treatment persistence by any cause was longer with mirabegron (median: 9.5 vs 6.7 months for antimuscarinics). HCPs stated that the most common reasons for nonpersistence were no symptomatic improvement and side effect aversion.
Conclusions
Treatment persistence was longer for mirabegron compared with antimuscarinic initiators after controlling for patient characteristics. End of treatment persistence by any cause was also longer with mirabegron.
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