Docetaxel and mitoxantrone, versus docetaxel mitoxantrone and letrozole as first-line therapy in advanced breast cancer: A randomized study

722 Background: Doxetaxel (DCT) and mitoxantrone (MX) are highly active and potentially synergistic agents in the treatment of metastatic breast cancer (MBC). Letrozole, a nonsteroidal, third-generation aromatase inhibitor has shown efficacy in the treatment of postmenopausal women with advanced disease, producing objective tumor response rates of approximately 25% after failure of previous therapy. This study evaluates the combination of DCT and MX with or without letrozole in patients with MBC to determine the efficacy and toxicity of this therapy. Methods: One hundred and eleven (median age 62 yrs), postmenopausal previously untreated patients with MBC were studied. The patients were randomly assigned to receive the combination of Docetaxel 80 mg/m2, Mitoxantrone 12 mg/m2 every three weeks and Letrozole 2.5 mg daily (group A, n=56 pts), or Docetaxel 80 mg/m2 and Mitoxantrone 12 mg/m2, every three weeks (group B, n=55 pts). Response was assessed according to UICC criteria at 12 and 24 weeks. Results: Th...