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

Prostate. 2024 Sep;84(13):1198-1208. doi: 10.1002/pros.24755. Epub 2024 Jun 18.

Abstract

Objective: To 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.

Methods: This 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.

Results: Of 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).

Conclusions: This study highlights the importance of MDT management of AEs associated with apalutamide to reduce treatment discontinuation.

Keywords: adverse events; apalutamide; drug‐drug interactions; multidisciplinary team management; prostate cancer; real‐world evidence.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Cohort Studies
  • Humans
  • Male
  • Middle Aged
  • Patient Care Team
  • Prospective Studies
  • Prostatic Neoplasms* / drug therapy
  • Prostatic Neoplasms, Castration-Resistant* / drug therapy
  • Prostatic Neoplasms, Castration-Resistant* / pathology
  • Thiohydantoins* / administration & dosage
  • Thiohydantoins* / adverse effects
  • Thiohydantoins* / therapeutic use

Substances

  • apalutamide
  • Thiohydantoins
  • Antineoplastic Agents