Epirubicin/Taxane Combinations in Breast Cancer: Experience From Several Italian Trials

ABSTRACT: Doxorubicin/paclitaxel (Taxol) combinations are very active inadvanced breast cancer, with objective response rates up to 90%, but have showna high incidence of cardiotoxicity. A phase I/II trial replacing doxorubicinwith epirubicin (Ellence), a less cardiotoxic analog, produced an objectiveresponse rate of 84%, but with a low rate of cardiotoxicity. A careful cardiacmonitoring in more than 100 patients treated with this combination hasdemonstrated that the risk of congestive heart failure is below 10% up to acumulative epirubicin dose of 990 mg/m2. To examine the possibility that thepharmacokinetic and pharmacodynamic interactions that occur when anthracyclineand paclitaxel are administered together might result in subadditive antitumoractivity, a phase III study is comparing concomitant vs sequentialadministration of epirubicin and paclitaxel in patients with advanced breastcancer. A phase I/II study of epirubicin plus docetaxel as first-linechemotherapy for advanced breast cancer patients evaluated the maximum tolerateddoses and for subsequent studies recommended epirubicin at 75 mg/m2 plusdocetaxel at 80 mg/m2. In the adjuvant setting, an ongoing phase III trial iscomparing epirubicin plus paclitaxel vs FEC (fluorouracil, epirubicin, andcyclophosphamide [Cytoxan, Neosar]) in node-positive patients. Preliminary dataconfirm the cardiac safety of these treatments. [ONCOLOGY 15(Suppl 7):21-23,2001]

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