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)

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 di...

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Published in:	Breast cancer research and treatment Vol. 112; no. 3; pp. 557 - 563
Main Authors:	Kahán, Zsuzsanna, Spanik, Stanislav, Wagnerova, Maria, Skacel, Tomas, Planko, Barbara, Fitzthum, Elisabeth, Lindner, Elisabeth, Soldatenkova, Victoria, Zielinski, Christoph C., Brodowicz, Thomas
Format:	Journal Article
Language:	English
Published:	Boston Springer US 01-12-2008 Springer Springer Nature B.V
Subjects:	Adolescent Adult Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast cancer Breast Neoplasms - therapy Cancer research Cancer therapies Chemotherapy Chemotherapy, Adjuvant - methods Clinical Trial Clinical trials Cyclophosphamide - therapeutic use Dose-Response Relationship, Drug Drug dosages Epirubicin - therapeutic use Female Filgrastim Fluorouracil - therapeutic use Granulocyte Colony-Stimulating Factor - administration & dosage Granulocyte Colony-Stimulating Factor - metabolism Humans Medical Oncology - methods Medicine Medicine & Public Health Middle Aged Oncology Polyethylene Glycols Recombinant Proteins Side effects Treatment Outcome Dose densification Chemotherapy Cyclophosphamide Pegfilgrastim Granulocyte colony-stimulating factor Breast cancer Epirubicin Fluorouracil
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Summary:	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 ≥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.
ISSN:	0167-6806 1573-7217
DOI:	10.1007/s10549-008-9894-7