Real‐world study: Impact of multidisciplinary management of apalutamide‐associated adverse events in prostate cancer

Author:

Córdoba Sánchez Julián1,Monge‐Escartín Inés2,Gil Javier3,Carrera Cristina3ORCID,Sáez‐Peñataro Joaquín4,Ferrer Laura5,Aversa Caterina5,Mellado Begoña5,Mases Joel6,Ribal Maria Jose1,Alcaraz Antonio1,Vilaseca Antoni1ORCID

Affiliation:

1. Uro‐Oncology Unit, Hospital Clínic de Barcelona Spain

2. Pharmacy Department Hospital Clínic de Barcelona Spain

3. Dermatology Department Hospital Clínic de Barcelona Spain

4. Clinical Pharmacology Department Hospital Clínic de Barcelona Spain

5. Medical Oncology Department Hospital Clínic de Barcelona Spain

6. Radiotherapy Oncology Department Hospital Clínic de Barcelona Spain

Abstract

AbstractObjectiveTo analyse the adverse events (AEs) associated with apalutamide and the impact of a multidisciplinary team (MDT) protocol on its management at a tertiary care hospital in a real‐world setting.MethodsThis was an observational, prospective, cohort study based on real‐world evidence at the Hospital Clínic de Barcelona. Includes patients diagnosed with metastatic hormone‐sensitive prostate cancer (mHSPC) or high‐risk nonmetastatic castration‐resistant prostate cancer (nmCRPC) and who started treatment with apalutamide between May 2019 and March 2023 in a real‐world clinical setting.ResultsOf the 121 patients treated with apalutamide, 52.1% experienced an AE, 19.8% experienced temporarily interruption or a reduction in the dose of apalutamide, and 13.2% discontinued treatment due to AEs. Without MDT protocol (49 patients), 24.5% of patients had to temporarily interrupt or reduce the dose of apalutamide due to AEs, with a median time from the start of treatment of 10.1 months, and 24.5% discontinued apalutamide due to AEs, with a median time from the start of treatment of 3.1 months. Meanwhile, whit MDT protocol (72 patients), 16.7% of patients had to temporarily interrupt or reduce the dose of apalutamide due to AEs, with a median time from the start of treatment of 1.6 months, and 5.6% discontinued apalutamide due to AEs, with a median time from the start of treatment of 4 months. The risk reduction associated with treatment discontinuation was statistically significant (p‐value = 0.003).ConclusionsThis study highlights the importance of MDT management of AEs associated with apalutamide to reduce treatment discontinuation.

Publisher

Wiley

Reference40 articles.

1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

2. Agencia Española de medicamentos y productos sanitarios.Informe de Posicionamiento Terapéutico de apalutamida (Erleada®) en combinación con tratamiento de privación de andrógenos en cáncer de próstata hormonosensible metastásico.2021. Available from:https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_4-2021-Erleada.pdf

3. Agencia Española de medicamentos y productos sanitarios.Informe de Posicionamiento Terapéutico de apalutamida (Erleada®) en combinación con tratamiento de privación de andrógenos en cáncer de próstata resistente a la castración no metastásico.2021. Available from:https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_5-2021-Erleada2.pdf

4. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

5. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer

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