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VP-16-213. A phase II trial using a weekly schedule

G Karp, K Antman, G Canellos

    Cancer Clinical Trials
    |January 1, 1981
    PubMed
    Summary
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    This study found that weekly etoposide phosphate (VP-16-213) showed limited efficacy in patients with refractory malignancies. A novel side effect of soft-tissue ulceration was observed with perivenous infiltration.

    Area of Science:

    • Oncology
    • Pharmacology
    • Cancer Chemotherapy

    Background:

    • Malignancies refractory to standard chemotherapy pose a significant treatment challenge.
    • Etoposide phosphate (VP-16-213) is an established chemotherapeutic agent.
    • Investigating alternative dosing schedules for refractory cancers is crucial.

    Purpose of the Study:

    • To evaluate the efficacy and safety of a weekly schedule of etoposide phosphate (VP-16-213) in patients with advanced malignancies resistant to conventional chemotherapy.
    • To identify potential adverse events associated with this specific regimen.

    Main Methods:

    • Forty-six patients with various malignancies refractory to standard chemotherapy were enrolled.
    • Treatment consisted of etoposide phosphate (VP-16-213) administered on a weekly schedule.

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  • Patient responses and adverse events were closely monitored.

    • Main Results:

    • Only one out of forty-six patients (approximately 2%) demonstrated a response to the weekly VP-16-213 regimen.
    • Perivenous infiltration of VP-16-213 led to soft-tissue ulceration, a previously unreported side effect.
    • The overall efficacy of this weekly schedule was found to be minimal.

    Conclusions:

    • Weekly administration of etoposide phosphate (VP-16-213) demonstrates limited utility in patients with previously treated, refractory malignancies.
    • The occurrence of soft-tissue ulceration from perivenous infiltration highlights a specific safety concern.
    • Further research into optimal dosing and administration of VP-16-213 may be warranted for different patient populations or disease types.