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Annals of Oncology Advance Access originally published online on August 22, 2007
Annals of Oncology 2007 18(10):1646-1651; doi:10.1093/annonc/mdm277
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© 2007 European Society for Medical Oncology

breast cancer

A dose escalation trial of adjuvant cyclophosphamide and epirubicin in combination with 5-fluorouracil using G-CSF support for premenopausal women with breast cancer involving four or more positive nodes

B. Findlay1,*, K. Tonkin2, M. Crump3, B. Norris4, M. Trudeau5, M. Blackstein6, M. Burnell7, J. Skillings8, D. Bowman9, D. Walde10, M. Levine11, K. I. Pritchard5, M. J. Palmer12, D. Tu12 and L. Shepherd12

1 Hotel Dieu Hospital, St Catharines
2 Cross Cancer Institute, Edmonton
3 OCI/Princess Margaret Hospital, Toronto
4 BC Cancer Agency–Fraser Valley Centre, Surrey
5 Toronto Sunnybrook Regional Cancer Centre, Toronto
6 Mount Sinai Hospital, Toronto
7 Saint John Regional Hospital, Saint John
8 (Not yet determined)
9 BCCA Vancouver Island Cancer Centre, Vancouver
10 Algoma Regional Cancer Program, Sault Area Hospital, Sault Ste Marie
11 Henderson Hospital, Hamilton
12 National Cancer Institute of Canada Clinical Trials Group, Kingston, Canada

* Correspondence to: Dr B. Findlay, Hotel Dieu Hospital, St Catharines, 155 Ontario Street, St Catharines, Ontario L2R 5K3, Canada. Tel: 905-682-6451; Fax: 905-685-1201; E-mail: brian.findlay{at}hdhsc.org

Background: Dose-dense and dose-intensive regimens have improved the outcome of breast cancer in high-risk women with operable disease.

Patients and methods: Sixty-three premenopausal women with Stage 2, 3 breast cancer and ≥4 positive axillary nodes were treated in three successive cohorts with 70 mg/m2 of epirubicin, 500 mg/m2 of 5-fluorouracil and G-CSF every 14 days for 12 cycles. Cyclophosphamide (C) was given at 700 mg/m2, 900 mg/m2, and 1100 mg/m2 doses. Patients were evaluated for dose-limiting toxicities (DLTs) in the first four cycles, the primary endpoint of the trial.

Results: No DLTs were seen at C 700 mg/m2; at C 900 mg/m2 two of 16 patients experienced febrile neutropenia and poor performance status; at C 1100 mg/m2, 1 of 31 patients experienced poor performance status. Over 6 months, febrile neutropenia, grade 4 thrombocytopenia, grade 3 anemia and severe fatigue were observed. Clinical congestive heart failure occurred in three patients over 4 years.

Conclusion: A dose-intense and dose-dense regimen of cyclophosphamide, epirubicin and 5-fluorouracil was delivered with G-CSF without apparent increase in acute toxicity. Cyclophosphamide could be increased to more than twice the standard dose at the cost of more anemia and fatigue.

Key words: breast cancer, adjuvant chemotherapy, premenopausal

Received for publication October 20, 2006. Revision received March 15, 2007. Accepted for publication April 30, 2007.


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