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Background: Deep prostate-specific antigen (PSA) response (≥90% reduction in PSA [PSA90]) is an important early response indicator of radiographic progression-free survival and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC). This study compared PSA90 responses by 6 months between patients with mCSPC at first use of apalutamide or abiraterone acetate, both androgen receptor signaling inhibitors.
Methods: Clinical data from 77 community urology practices in the United States were analyzed. Patients with mCSPC were classified into treatment cohorts based on their first filled prescription (index date) for apalutamide or abiraterone acetate on or after September 17, 2019 (approval date of apalutamide for mCSPC). Patients were followed from the index date until the earliest of index treatment discontinuation, treatment switch, end of clinical activity, or end of data availability (September 17, 2021). Inverse probability of treatment weighting (IPTW) was used to ensure similarity in distribution of baseline characteristics between cohorts. PSA90 was defined as the earliest attainment of ≥90% reduction in PSA relative to baseline (most recent value within 13 weeks pre-index). Time to PSA90 between cohorts was compared by weighted Kaplan-Meier analysis and with Cox proportional hazards models.
Results: A total of 364 patients treated with apalutamide and 147 treated with abiraterone acetate met the study criteria. Patient characteristics were well balanced after IPTW. By 6 months post-index, patients initiated on apalutamide were 53% more likely to achieve PSA90 than those initiated on abiraterone acetate (P = 0.016). Similar results were observed by 9 and 12 months post-index (both P ≤ 0.019). The median time to PSA90 was 3.5 months for the apalutamide cohort and not reached for the abiraterone acetate cohort.
Conclusions: In real-world patients with mCSPC, significantly more patients achieved PSA90 with apalutamide than with abiraterone acetate, and this response was achieved earlier with apalutamide.
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http://dx.doi.org/10.1016/j.urolonc.2023.03.013 | DOI Listing |
Eur J Pharm Biopharm
September 2025
Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, China. Electronic address:
Prodrugs with enzymatic activation requirements, such as the weakly basic biopharmaceutical classification system (BCS) class IV compound abiraterone acetate (ABA), face considerable bioequivalence (BE) risks owing to their pH-dependent solubility, food effects, and variable intestinal hydrolysis. This study established clinically relevant dissolution specifications for ABA using biorelevant dissolution and physiologically based biopharmaceutics modelling (PBBM). Two dissolution methods, two-stage (gastrointestinal transfer simulation) and single-phase (biorelevant media), were evaluated under fasted and fed conditions.
View Article and Find Full Text PDFJCO Glob Oncol
August 2025
Division of Medical Oncology and Hematology, Department of Medicine, University of Florida, Gainesville, FL.
Purpose: Abiraterone acetate (AA) is approved for prostate cancer at a standard dose of 1,000 mg fasting. Because of a significant food effect, a lower dose (250 mg with food-AA low dose [AALD]) shows similar efficacy at 75% lower cost. In Brazil, 80% of patients rely on the public health care system, which does not cover the standard dose.
View Article and Find Full Text PDFInt J Clin Oncol
August 2025
Department of Pharmacy Practice, Faculty of Pharmacy, M. S. Ramaiah University of Applied Sciences, Bangalore, 560054, India.
Background: Novel hormonal agents (NHAs), including enzalutamide, abiraterone acetate, apalutamide, and darolutamide, have improved survival in advanced prostate cancer (PCa). However, their potential neurological adverse effects (AEs)-notably cognitive impairment, seizures, and falls-raise safety concerns, particularly in older adults. This study aimed to compare the neurological safety profiles of NHAs in men with advanced PCa using a Bayesian network meta-analysis (NMA).
View Article and Find Full Text PDFJAMA Health Forum
August 2025
Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.
Importance: Brand-name drugs in the US are sold at high prices during market exclusivity periods defined by their patents, before prices are lowered by generic competition. Drug manufacturers use several strategies to extend these market exclusivity periods and delay generic competition, including obtaining overlapping thickets of patents.
Objective: To estimate excess US spending associated with delays in generic competition due to extended market exclusivity for 4 top-selling drugs.
World J Urol
August 2025
Dr. D.Y. Patil Vidyapeeth, Deemed to be University, Pimpri, Pune, Maharashtra, India.