- Paper Report
- Open Access
Primary chemotherapy with CEF-infu
- Fatima Cardoso1
© Biomed Central Ltd 2002
- Received: 8 January 2002
- Accepted: 9 January 2002
- Published: 1 December 2002
- Breast cancer, CEF-infu, phase I, primary chemotherapy
Neoadjuvant chemotherapy for large operable (LO) or locally advanced (LA) breast cancer (BC) has been shown to increase the rate of conserving breast surgery, without compromising overall survival. However, the optimal regimen remains unknown. Previous studies using infusional 5-FU (5-FU-infu) in association with epirubicin and cisplatin/carboplatin (ECisF) for LO and/or LABC have shown high response rates and good tolerability. The dose of epirubicin used in those studies was 50 mg/m2, q3w. As there is a well-known dose-response effect for anthracyclines, the aim of this study was to identify the maximum tolerated dose of epirubicin, when given in association with the other two drugs.
A total of 21 patients (11 LO, 8 LABC) were treated, with a median of 5 cycles per patient. An interim analysis showed that grade 3 palmar-plantar erythrodysesthesia (PPE) occurred in 5/16 patients at the 3 dose levels. Accordingly, the protocol was amended to limit the duration of 5-FU-infu from 4 to 3 weeks. Dose limiting toxicities were grade 3 febrile neutropenia (FN), grade 3 mucositis, and grade 3 infection. Epirubicin 60 mg/m2, day 1 & 8, q4w was considered the recommended dose. Objective responses were seen in 75% (15/20) of evaluable patients.
Phase I clinical trial, dose escalation
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