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[FO-152].

H Furue, H Niitani, M Kurihara

    Gan to Kagaku Ryoho. Cancer & Chemotherapy
    |July 1, 1987
    PubMed
    Summary
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    5'-O-(L-valyl)-5-fluorouridine hydrochloride (FO-152), a 5-fluorouridine derivative, shows improved antitumor effects and reduced toxicity in advanced cancer patients. Phase I trials established a safe dosage for further clinical investigation.

    Area of Science:

    • Oncology
    • Pharmacology
    • Drug Development

    Context:

    • 5'-O-(L-valyl)-5-fluorouridine hydrochloride (FO-152) is a novel derivative of 5-fluorouridine.
    • Preclinical studies indicated superior antitumor efficacy and a better therapeutic index for FO-152 compared to 5-fluorouridine.

    Purpose:

    • To evaluate the safety, tolerability, and preliminary efficacy of FO-152 in patients with advanced cancer.
    • To determine the dose-limiting toxicity and establish recommended Phase II doses for FO-152.

    Summary:

    • A Phase I study involving 38 advanced cancer patients assessed FO-152.
    • Myelosuppression (leukopenia) was the dose-limiting toxicity. Other side effects included mild flushing and gastrointestinal toxicities.
    • Clinical responses were observed in patients with gastric and lung adenocarcinoma, among others.

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    Impact:

    • FO-152 demonstrated significant advantages over 5-fluorouridine, primarily reduced toxicity.
    • Recommended Phase II doses for solid tumors are 250 mg/m2 once or 35 mg/m2 for 5 consecutive days, with a 4-week rest period and myelosuppression reversal.