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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).

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) arm. There were no incidences of febrile neutropenia during the study. The most common adverse events were increases in liver enzymes and gastrointestinal events; no event resulted in discontinuation. Only one patient (FEC(90)) experienced serious adverse events (vomiting and throat oedema). In conclusion, dose-dense FEC(75 )and FEC(90) are feasible with pegfilgrastim support. These regimens are associated with a very low risk of Grade 3-4 toxicity.

journal_name

Breast Cancer Res Treat

journal_title

Breast cancer research and treatment

authors

Kahán Z,Spanik S,Wagnerova M,Skacel T,Planko B,Fitzthum E,Lindner E,Soldatenkova V,Zielinski CC,Brodowicz T

doi

10.1007/s10549-008-9894-7

subject

Has Abstract

pub_date

2008-12-01 00:00:00

pages

557-63

issue

eissn

0167-6806

issn

1573-7217

journal_volume

112

pub_type

杂志文章,随机对照试验

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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).