A phase III randomised trial comparing the tolerability of dose-dense chemotherapy in older to that in younger breast cancer patients with four or more positive lymph nodes

589 Background: Recently published data showed older patients to have similar dose-related benefits in reducing breast cancer-related relapse and mortality to those of younger women. This analysis was performed to assess the feasibility of a prospective randomised dose-dense regimen in the treatment of women over the age of 60. Methods: From June 1996 to November 2000, 211 primary breast cancer patients with four or more positive lymph nodes were prospectively randomised to either four cycles of epirubicin and paclitaxel (ET) at two-week intervals followed by three cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF) with G-CSF support (Group A) [age < 60 years (A1), n = 79; age ≥ 60 years (A2), n = 25] –or four cycles of epirubicin and cyclophosphamide (EC) at three-week intervals followed by three cycles of CMF (Group B) [age < 60 years (B1), n = 80; age ≥ 60 years (B2), n = 27]. Results: The median age was 52 years (range 26–59) in group A1, 64 years (range 60–71) in group A2, 48.5 years (...