Real-world incidence and burden of adverse events among non-metastatic prostate cancer patients treated with secondary hormonal therapies following androgen deprivation therapy

Abstract

Aims:To describe the incidence and identify prognostic factors of central nervous system (CNS) adverse events (AEs) and any AEs (CNS, skin rash, or fracture) and evaluate the healthcare resource utilization (HCRU), direct medical costs, and therapy discontinuation associated with these AEs among non-metastatic prostate cancer (nmPC) patients who received secondary hormone therapies. Methods and results: nmPC patients who had initiated secondary hormonal therapy with enzalutamide, bicalutamide, or abiraterone 1 year after androgen deprivation therapy (ADT) were identified in the MarketScan database. Survival analyses were used to describe the incidence of CNS or any AEs. Annual HCRU and costs were compared across patient groups (CNS AE vs no CNS AE; any AE vs no AE) using propensity score weighted generalized linear models. Multivariate Cox proportional hazards models were used to identify AE predictors and compare risks of discontinuation. Results: The analysis included 532 patients who initiated secondary hormonal therapies, among whom 201 (38%) and 244 (46%) experienced a CNS AE and any AE, respectively. Median times to CNS AE and any AE from therapy initiation were 17.90 and 11.00 months, respectively. Predictors of any AE were any AE in the baseline period (6 months before starting therapy), Charlson Comorbidity Index (CCI) score (1 vs 0), surgical castration, and older age. Predictors of CNS AEs were CNS AE in the baseline period and CCI score (1 vs 0). CNS and any AEs were associated with significantly higher HCRU. CNS AEs were associated with significantly higher incremental total medical costs ($18,522). CNS AEs and any AEs significantly increased therapy discontinuation risk by 48% and 38%, respectively. Conclusions: AEs increase the economic burden and therapy discontinuation among nmPC patients receiving secondary hormonal therapies subsequent to ADTs. These patients should be carefully evaluated for AEs to reduce therapy discontinuation, HCRU, and direct medical costs. ARTICLE HISTORY

Economic Outcomes in Patients with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide or Abiraterone Acetate Plus Prednisone

“…An administrative claims study, looking at mCRPC patients without differentiating between chemotherapy-naïve and post-chemotherapy patients, showed that there was a higher likelihood of having a broadly defined central nervous system (CNS) event with enzalutamide compared with abiraterone [33]. In a separate administrative claims study in a nonmetastatic prostate cancer population, CNS-related adverse events were associated with higher per patient per year HCRU with respect to inpatient and emergency department visits versus patients without CNS adverse events; however, no direct association with different drug treatment was reported as most patients were treated with bicalutamide (n = 477) and only a few patients on abiraterone or enzalutamide (n = 55) were included [34]. Other adverse event-related costs with second-generation androgen therapy, such as for cardiac disorder, infection, pneumonia, renal impairment, skeletal-related events, urinary tract infection, etc., have to our knowledge not been studied.…”

Gonadorelins adherence in prostate cancer: A time‐series analysis of England’s national prescriptions during the COVID‐19 pandemic (from Jan 2019 to Oct 2020)

“…The “English Prescribing Dataset” (EPD) 20 contains public sector information licensed under the Open Government Licence V2.0, which provides anonymized prescription data in England 24 . The EPD contains detailed information on community‐issued prescriptions (not hospital) issued in England but which were dispensed across the UK (England, Wales, Scotland, Guernsey, Alderney, Jersey, and the Isle of Man).…”

“…However, at some time patients usually stop responding to ADT and experience rising PSA levels despite castrate levels of serum testosterone (castrate resistant PCa or castrate‐resistant prostate cancer). 20 However, due to the variable recovery of the HPA, natural testosterone levels sometimes never recover and discontinuation of therapy (intermittent ADT) is feasible. For younger patients, if timely administration is missed, rising testosterone levels may cause further disease progression.…”

“…Due to the variable recovery of the HPA, natural testosterone levels recover slowly and so in patients exhibiting a good response to treatment discontinuation of therapy (intermittent ADT) is feasible. However, at some time patients usually stop responding to ADT and experience rising PSA levels despite castrate levels of serum testosterone (castrate resistant PCa or castrate‐resistant prostate cancer) 20 . However, due to the variable recovery of the HPA, natural testosterone levels sometimes never recover and discontinuation of therapy (intermittent ADT) is feasible.…”

Utilization of Poly(ADP-Ribose) Polymerase Inhibitors in Ovarian Cancer: A Retrospective Cohort Study of US Healthcare Claims Data

“…Use of claims data is well established in research examining tolerability and HCRU in several diseases, including a range of cancers [42][43][44][45]. Nevertheless, this study has some limitations, including biases inherent to observational studies and use of healthcare claims data, which are recorded for billing rather than research purposes and do not include a review of medical records.…”