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Methotrexate: bioavailability and pharmacokinetics.

M A Campbell, D G Perrier, R T Dorr

    Cancer Treatment Reports
    |July 1, 1985
    PubMed
    Summary
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    This study on head and neck cancer patients found that oral methotrexate (MTX) has low bioavailability (36%) due to dose-dependent absorption. Intramuscular (IM) MTX showed higher bioavailability (93%), suggesting further research into optimal oral dosing strategies.

    Area of Science:

    • Pharmacology
    • Oncology
    • Clinical Pharmacy

    Background:

    • Squamous cell carcinoma of the head and neck is a significant health concern.
    • Methotrexate (MTX) is a chemotherapeutic agent used in cancer treatment.
    • Understanding MTX pharmacokinetics is crucial for optimizing treatment efficacy and minimizing toxicity.

    Purpose of the Study:

    • To evaluate the pharmacokinetics and bioavailability of single low doses of methotrexate (MTX) administered via intravenous (IV), intramuscular (IM), and oral routes in head and neck cancer patients.
    • To investigate the systemic absorption of oral MTX tablets and compare it with IM and IV administration.
    • To explore potential mechanisms for variable oral MTX absorption.

    Main Methods:

    • A randomized crossover study involving six adult patients with squamous cell carcinoma of the head and neck.

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  • Administration of single low doses of MTX (30 mg/m2) via IV, IM, and oral tablet routes.
  • Plasma MTX concentrations were quantified using a modified EMIT assay over 24 hours post-dose.
  • Pharmacokinetic parameters including total-body clearance, Vss, V lambda, and beta-half-life were calculated for IV MTX.
  • Absolute systemic bioavailability was determined for oral and IM routes relative to IV administration.

    • Main Results:

    • Mean pharmacokinetic parameters for IV MTX included: total-body clearance 124 mL/minute, Vss 0.56 L/kg, V lambda 0.69 L/kg, and beta-half-life 3.20 hours.
    • The absolute systemic bioavailability of oral MTX tablets was significantly low at 36% (+/- 10%).
    • Intramuscular MTX demonstrated a high absolute systemic bioavailability of 93% (+/- 14%).

    Conclusions:

    • Low systemic bioavailability of oral methotrexate tablets in head and neck cancer patients suggests dose-dependent gastrointestinal absorption.
    • Intramuscular administration of MTX offers significantly higher bioavailability compared to the oral route.
    • Further research is warranted to establish optimal oral dosing strategies for methotrexate to improve therapeutic outcomes.