Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study.

Area of Science:

• Oncology
• Urology
• Pharmacology

Background:

• Metastatic castration-sensitive prostate cancer (mCSPC) requires effective treatment options.
• Apalutamide (APA) is an androgen receptor inhibitor used for mCSPC.

Purpose of the Study:

• To evaluate the real-world effectiveness and tolerability of apalutamide in patients with mCSPC.
• To assess clinical outcomes including overall survival and prostate-specific antigen (PSA) response rates.

Main Methods:

• Retrospective analysis of 531 patients with mCSPC treated with apalutamide in the ARON-3 study.
• Outcomes assessed included overall survival (OS), PSA90 (≥90% PSA decline), and PSA0.2 (PSA ≤0.2 ng/ml).
• Adverse events were collected and categorized using Common Terminology Criteria for Adverse Events v5.0.

Main Results:

• Median OS was not reached. High rates of PSA90 (87%) and PSA0.2 (69%) were observed.
• Significantly longer median OS was associated with achieving PSA90 or PSA0.2 (p < 0.001).
• Grade 3-4 fatigue was more common in elderly patients (≥80 years), but other adverse events were comparable across age groups.

Conclusions:

• Apalutamide demonstrates effectiveness in achieving PSA response and is well-tolerated in the real-world mCSPC population.
• Real-world data from the ARON-3 study support the efficacy and safety of apalutamide, consistent with clinical trial findings.