Everolimus Through Plasmatic Concentrations in Cancer Patients: Prospective Longitudinal Observational Multicentric...

Area of Science:

• Oncology
• Pharmacology
• Translational Medicine

Background:

• Everolimus, an mTOR inhibitor, treats various cancers but shows significant pharmacokinetic variability.
• Routine therapeutic drug monitoring (TDM) for everolimus in oncology is not standard practice.
• Understanding drug concentration variability is crucial for optimizing cancer therapy.

Purpose of the Study:

• To determine the prevalence of everolimus minimum steady-state concentrations (Cminss) outside the therapeutic range (10-26.3 ng/mL).
• To explore correlations between non-therapeutic everolimus levels and patient/treatment-specific factors.
• To provide insights for personalized dosing strategies in cancer treatment.

Main Methods:

• Multicenter, prospective observational cohort study.
• Inclusion of 60 patients with metastatic breast, neuroendocrine, or renal cancers undergoing everolimus treatment.
• Regular blood sample collection (every 4-6 weeks) for Cminss monitoring and correlation analysis with clinical data.

Main Results:

• Hypothesizes that 30-50% of patients will have everolimus levels outside the target therapeutic range.
• Aims to identify demographic, clinical, laboratory, and genetic factors associated with variable drug concentrations.
• Will quantify the incidence of suboptimal everolimus exposure in a real-world oncology setting.

Conclusions:

• Findings may guide the implementation of routine TDM for everolimus in cancer care.
• Results can inform personalized dosing strategies to improve treatment efficacy and safety.
• Contributes to optimizing everolimus therapy and potentially other targeted anticancer agents.