Adult multicenter trials using dexrazoxane to protect against cardiac toxicity.
Two large multicenter placebo controlled trials (088001 and 088006) in metastatic breast cancer found a significant cardioprotective effect of dexrazoxane when administered with doxorubicin. A delayed dose analysis found a protective effect even after a cumulative dose of doxorubicin of 300 mg/m2. Exploratory analysis combing the arms on the two studies found a cardioprotective effect of dexrazoxane either initially or after 300 mg/m2 when administered in patients older than 65 years, compared to patients receiving only placebo. Also, patients with an ejection fraction within 10% above the lower limit of normal were protected with dexrazoxane. Objective response rates were borderline significantly lower for patients receiving dexrazoxane. Recommendations are to administer dexrazoxane after 300 mg/m2.
Comprehensive Breast Center, Greater Washington Area, A Salick Health Care Affiliate, Washington, DC 20015-2034, USA.
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D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced* / Q000517:prevention & control; D006801:Humans; D015337:Multicenter Studies as Topic; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D011929:Razoxane / Q000008:administration & dosage / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D002317:Cardiovascular Agents; D011929:Razoxane; D004317:Doxorubicin