Epirubicin/taxane combinations in breast cancer: Experience from several Italian trials

Doxorubicin/paclitaxel (Taxol) combinations are very active in advanced bre ast cancer, with objective response rates up to 90%, but have shown a high incidence of cardiotoxicity. A phase I/II trial replacing doxorubicin with epirubicin (Ellence), a less cardiotoxic analog, produced an objective resp onse rate of 84%, but,vith a low rate of cardiotoxicity. A careful cardiac monitoring in more than 100 patients treated with this combination has demo nstrated that the risk of congestive heart failure is below 10% up to a cum ulative epirubicin dose of 990 mg/m(2). To examine the possibility that the pharmacokinetic and pharmacodynamic interactions that occur when anthracyc line and paclitaxel are administered together might result in subadditive a ntitumor activity, a phase III study is comparing concomitant vs sequential administration of epirubicin and paclitaxel in patients with advanced brea st cancer. A phase I/II study of epirubicin plus docetaxel as first-line ch emotherapy for advanced breast cancer patients evaluated the maximum tolera ted doses and for subsequent studies recommended epirubicin at 75 mg/m(2) p lus docetaxel at 80 mg/m(2). In the adjuvant setting, an ongoing phase III trial is comparing epirubicin plus paclitaxel vs FEC (fluorouracil, epirubi cin, and cyclophosphamide [Cytoxan, Neosar]) in node-positive patients, pre liminary data confirm the cardiac safety of these treatments.