Feasibility of two dose-dense FEC regimens with growth factor support for adjuvant therapy in patients with early breast cancer: results from a randomised study of the Central European Cooperative Oncology Group (CECOG)

Breast Cancer Research and Treatment
Zsuzsanna KahánThomas Brodowicz

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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Citations

Mar 2, 2010·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Matti AaproDidier Kamioner
Jun 18, 2011·Pathology Oncology Research : POR·Alíz NikolényiZsuzsanna Kahán
Jun 14, 2008·Expert Opinion on Biological Therapy·Mariko Morishita, Robert C Leonard
Oct 22, 2015·Expert Opinion on Biological Therapy·Matteo LambertiniPaolo Pronzato
Aug 27, 2013·PloS One·Julie A WallaceMichael C Ostrowski
Jul 19, 2013·PloS One·Rebecca LambRobert B Clarke
Jan 7, 2014·PloS One·Mohammed AlshalalfaReda Alhajj
Jan 5, 2014·PloS One·Emer CaffreyGrace Callagy

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