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Related Experiment Videos

Intravesical idarubicin: a dose-finding study

F Boccardo1, D Cannata, M Cussotto

  • 1Servizio di Oncologia Medica 2, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.

Cancer Chemotherapy and Pharmacology
|January 1, 1996
PubMed
Summary
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Intravesical idarubicin for recurrent bladder tumors showed significant local toxicity. Doses between 6.5-12.5 mg are recommended for Phase II studies, but may not offer superior efficacy over other anthracyclines.

Area of Science:

  • Urology
  • Medical Oncology
  • Pharmacology

Background:

  • Recurrent papillary bladder tumors require effective treatment options.
  • Anthracyclines like doxorubicin and daunorubicin are used in chemotherapy.
  • Idarubicin, a related anthracycline, demonstrates in vitro activity against bladder cancer cells.

Purpose of the Study:

  • To determine the appropriate dose of intravesical idarubicin for treating recurrent papillary bladder tumors.
  • To evaluate the safety and toxicity profile of intravesical idarubicin.
  • To assess the feasibility of idarubicin for further clinical investigation.

Main Methods:

  • A dose-finding study involving 12 patients with resected, recurrent papillary bladder tumors.
  • Weekly intravesical instillations of idarubicin at doses of 6.5, 12.5, and 20 mg in 50 ml saline.

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  • Dose escalation was not permitted within individual patients to assess cumulative toxicity.

    • Main Results:

    • Severe local toxicity (chemocystitis) led to the withdrawal of 4 patients.
    • 3 additional patients discontinued treatment due to mild to moderate toxicity.
    • The highest dose (20 mg) and some 12.5 mg doses resulted in toxicity, while no systemic toxicity was observed.

    Conclusions:

    • Intravesical idarubicin doses of 6.5 to 12.5 mg (0.125-0.250 mg/ml) are suggested for Phase II studies.
    • Higher doses may lead to unacceptable local toxicity.
    • Idarubicin's efficacy compared to doxorubicin or epirubicin at these doses is uncertain, and it may be more toxic.