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

Abstract

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 (range 32–59) in group B1 and 64 years (range 60–72) in group B2. All seven cycles were administered in 95% (A1), 100% (A2), 99% (B1) and 89% (B2) of patients. A dose reduction was made only in 1% (A1), 2% (A2), 1% (B1) and 1% (B2) of the cycles. In comparing these four groups, delays in administering cycles were more frequent in the dose-intensified group of older patients (6% in A1 vs. 17% in A2; 6% in B1 vs. 11% in B2). The hematological toxicity data are shown in Table 1. NCI-CTC grade 3–4 non-hematological toxicities were rare and revealed no differences between the groups. Conclusions: The administration of a dose-dense regimen with epirubicin and paclitaxel followed by CMF with G-CSF support is feasible in elderly patients with a tolerable safety profile. Referring to the analysed data, a decreased hematopoetic potency must be considered in older patients. No significant financial relationships to disclose.