Abstract
Addition of epirubicin to adjuvant chemotherapy can provide important benefits for patients with early breast cancer, but the optimal dose remains unclear. Further improvements can be achieved with dose-dense regimens, but densification of fluorouracil/epirubicin/cyclophosphamide (FEC) has proved difficult, with FEC(60) providing little benefit over standard chemotherapy and FEC(100) associated with toxicity. We investigated the feasibility of two intermediate dose-dense FEC regimens. Patients were randomised to six cycles of FEC(75) or FEC(90), with all three drugs given on day 1 of each 14-day cycle. Patients also received pegfilgrastim 6 mg as a single subcutaneous injection on day 2 of each cycle. The primary efficacy endpoint was the proportion of subjects receiving > or =85% relative dose intensity and was achieved by 96% and 88% of patients in the FEC(75) and FEC(90) arms, respectively. Of 147 FEC(75) infusions, 4.1% were delayed, while 9.8% of 143 FEC(90) infusions were delayed. The most common reasons for delay were adverse events and personal/logistical reasons. One dose reduction occurred during the study (FEC(90)), related to diarrhoea. Grade 3-4 haematological toxicities were reported in two patients in the FEC(90)...Continue Reading
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