Non-metastatic castration-resistant prostate cancer (nmCRPC): Meta-analysis of efficacy and safety with novel hormonal agents apalutamide and enzalutamide

Almeida, Daniel Vargas Pivato de; Oliveira, Cleyton Zanardo de; Mariano, Rodrigo; Kater, Fabio; Souza, M.C.L.A.; Ruiz-Schutz, V.C.; Yamamura, Rosely; Carvalho, Ricardo Saraiva de; Maluf, Fernando C.; Morgans, Alicia K.; Srinivas, Sandy; Gupta, Shilpa; Dorff, Tanya B.; Yu, Evan Y.; Schütz, Fábio Augusto Barros

doi:10.1093/annonc/mdy284.017

Cited by 2 publications

(1 citation statement)

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“…3,13,14 Individual trial data also suggest an improvement in OS, but these data are not fully mature; however, a recent meta-analysis including data from both trials found a significant increase in OS (HR = 0.76; 95% confidence interval = 0.59-0.76). 29 As add-on therapies to ADT, the availability of enzalutamide and apalutamide will increase treatment costs, but the resulting delays in progression to mCRPC include some associated offsets in cost. Given the strong clinical outcomes and evidence supporting treatment in this patient population, it will be important for payers to understand the potential health economic implications of their utilization.…”

Section: ■■ Discussionmentioning

confidence: 99%

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Schultz

O’Day²,

Sugarman³

et al. 2020

JMCP

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BACKGROUND: Prostate cancer is the most common cancer and secondleading cause of cancer death among men in the United States. Prostate cancer poses a large economic burden, which increases with progression from localized to metastatic disease. Newly approved treatments for nonmetastatic castration-resistant prostate cancer (nmCRPC) delay disease progression and reduce the risk of metastatic disease. Quantifying the potential budget impact of these new treatments is of interest to health care decision makers. OBJECTIVE: To estimate the budget impact of enzalutamide for the treatment of patients with nmCRPC in the United States over a 3-year time horizon.METHODS: An Excel-based model was developed to estimate the budget impact to a U.S. health plan of enzalutamide, a second-generation antiandrogen, as an add-on to androgen deprivation therapy (ADT) for the treatment of high-risk nmCRPC patients (prostate-specific antigen doubling time of ≤ 10 months). Comparators include apalutamide + ADT, bicalutamide + ADT, and ADT only. The analysis includes treatment costs for nmCRPC and for treatment after progression to metastatic castration-resistant prostate cancer (mCRPC). The treated population size was estimated from epidemiological data and literature. Dosing, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. RED BOOK, Centers for Medicare & Medicaid Services fee schedules, and literature were used to obtain costs of drugs, adverse events, and health care visits. Market shares were estimated for each comparator before and after enzalutamide adoption. A 1-way sensitivity analysis was performed to quantify the impact of parameter uncertainty. RESULTS: In a hypothetical 1-million-member plan with 3% annual growth, it was estimated that there would be approximately 19 eligible incident nmCRPC patients in year 1, increasing to 20 eligible incident patients in year 3.

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Section: ■■ Discussionmentioning

confidence: 99%

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Schultz

O’Day²,

Sugarman³

et al. 2020

JMCP

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A Multi-Disciplinary Review of the Evidence Supporting Metastasis-Free Survival (MFS) and the Benefit of Delaying Metastasis in High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

Оудард

Soto

2019

EMJ Urol

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Until recently, men diagnosed with high-risk non-metastatic castrate-resistant prostate cancer (nmCRPC) were faced with the prospect of a relatively short reprieve from symptomatic progression before the onset of metastatic disease. Crossing this red line represents a turning point in the disease, characterised by debilitating pain, greater functional and emotional impairment, a need for additional treatments, and, eventually, death. Delaying time to metastatic progression has the potential to limit symptomatic progression, reduce morbidity and mortality, and maintain quality of life in nmCRPC, and efforts have been made to establish the validity of metastatic-free survival (MFS) as a valid and meaningful clinical endpoint in this setting. The approval in Europe of apalutamide and enzalutamide based on the Phase III SPARTAN (NCT01946204) and PROSPER (NCT02003924) trials, respectively, with MFS as a primary endpoint (defined as time from randomisation to first radiographic detection of distant metastases, or death) sets a new precedent for future trials in nmCRPC. Although median overall survival (OS) has not yet been reached in either trial, meta-analyses of the two studies suggest a significant improvement in OS alongside a confirmed improvement in MFS for novel anti-androgens versus placebo. A third drug, darolutamide, has also been submitted for regulatory approval to treat nmCRPC. This review aims to summarise the evidence supporting the use of MFS as a clinical endpoint and the benefit of delaying metastasis in men with high-risk nmCRPC, and to discuss the influence of next-generation imaging on prostate cancer staging.

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Non-metastatic castration-resistant prostate cancer (nmCRPC): Meta-analysis of efficacy and safety with novel hormonal agents apalutamide and enzalutamide

Cited by 2 publications

References 0 publications

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

A Multi-Disciplinary Review of the Evidence Supporting Metastasis-Free Survival (MFS) and the Benefit of Delaying Metastasis in High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

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