Idarubicin: an evaluation of cardiac toxicity in 77 patients with solid tumors.

Idarubicin (4-demethoxydaunorubicin) is a daunorubicin analog that has shown comparable activity and less cardiotoxicity than daunorubicin and doxorubicin in preclinical studies. Phase I and II studies appear to confirm its safety but no definitive conclusion about cardiotoxicity was possible due to the small number of patients in each study. We evaluated 77 patients with advanced solid tumors treated with oral single agent (idarubicin 15 mg/m2 for three days every 4 weeks). Physical examinations and ECGs were performed before every course of treatment and at discontinuation. Eighteen patients also received sequential radionuclide angiocardiographies for evaluation of LVEF. After the administration of a median of 135 mg/m2 of idarubicin (range 45-540), no clinical sign of cardiotoxicity was observed: in three patients minor and transient ECG changes occurred. No significant reduction in mean LVEF values was observed during treatment.