Adult multicenter trials using dexrazoxane to protect against cardiac toxicity
Swain, S.M.
Seminars in Oncology 25(4 Suppl 10: 43-47
1998
ISSN/ISBN: 0093-7754 PMID: 9768823 Document Number: 494320
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.