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[Clinical experiences with UFD-1].

H Furue

    Gan to Kagaku Ryoho. Cancer & Chemotherapy
    |April 1, 1982
    PubMed
    Summary
    This summary is machine-generated.

    The anticancer drug FD-1, a 5-fluorouracil derivative, showed initial promise but caused central nervous system toxicities. Combining FD-1 with uracil (UFD-1) did not improve efficacy in advanced cancer patients and led to gastrointestinal toxicities.

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    Area of Science:

    • Oncology
    • Pharmacology
    • Drug Development

    Context:

    • FD-1 (1,3-bis(tetrahydro-2-furanyl)-5-fluorouracil) is a novel anticancer agent developed in Japan, functioning as a prodrug of 5-fluorouracil.
    • Preclinical studies suggested that uracil could enhance the antitumor activity of FD-1.
    • FD-1 administration can lead to central nervous system toxicities, necessitating further investigation into its therapeutic index.

    Purpose:

    • To evaluate the efficacy and safety of UFD-1, a combination of FD-1 and uracil, in patients with advanced cancer.
    • To determine if uracil enhances the antitumor activity of FD-1 in a clinical setting.
    • To assess the toxicity profile of UFD-1 in advanced cancer patients.

    Summary:

    • A clinical trial administered UFD-1 (FD-1 and uracil in a 1:20 molar ratio) at a daily dose of 300 mg FD-1 to fifteen advanced cancer patients.

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  • No tumor regression was observed in any patient.
  • Five patients experienced toxicities, primarily mild gastrointestinal issues, with one case of ataxia.

    • Impact:

    • The clinical study found UFD-1 to be ineffective for treating advanced adenocarcinoma.
    • The combination therapy did not demonstrate improved efficacy over FD-1 alone and introduced additional toxicities.
    • Further research is needed to optimize 5-fluorouracil prodrug strategies and manage associated toxicities.