Drug intelligence / Profile preview

FEC100 + docetaxel + paclitaxel regimen

Development stage
Unknown
Lead developer
Sanofi
Modality
Nucleic Acid-Directed Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Intravenous
01

Overview

FEC100 + docetaxel + paclitaxel is a combination chemotherapy regimen used primarily in breast cancer treatment. This regimen consists of three distinct components: FEC100 (a combination of fluorouracil, epirubicin at 100 mg/m², and cyclophosphamide) followed by taxanes (docetaxel and paclitaxel). ## Composition and Dosing The FEC100 component typically consists of: - Fluorouracil (5-FU): 500 mg/m² - Epirubicin: 100 mg/m² (the "100" in FEC100 refers to this specific dosage) - Cyclophosphamide: 500 mg/m² This is usually administered intravenously every 21 days for 3-4 cycles, followed by either docetaxel or paclitaxel for additional cycles[4][6]. The search results don't specifically mention a regimen that includes both docetaxel and paclitaxel sequentially, but rather indicates that different protocols might use one or the other taxane after FEC100. ## Clinical Use and Efficacy This combination regimen is primarily used in: - Neoadjuvant setting (before surgery) for primary operable breast cancer - Adjuvant setting (after surgery) for node-positive and high-risk node-negative breast cancer patients[2][4] Studies have shown that FEC100 followed by taxanes demonstrates significant clinical efficacy: - The addition of docetaxel to FEC100 has shown a five-year disease-free survival (DFS) gain of 5% and overall survival (OS) gain of 4% compared to FEC100 alone[7] - In neoadjuvant settings, FEC100 followed by docetaxel has shown clinical response rates of 93% after the FEC component, with 24% complete responses after the addition of docetaxel[4] - Pathologic complete response rates of 15-25% have been reported with FEC100 regimens[3][4] ## Toxicity Profile The main adverse effects include: - Myelosuppression (bone marrow suppression), with 51.3% of patients developing grade 3/4 neutropenia with FEC100[3] - Universal alopecia (hair loss) - Granulocyte toxicity (grade 3-4 in 81% of patients during FEC vs 62% under docetaxel)[4] - Other less common toxicities include nausea, vomiting, diarrhea (3.8%), and cutaneous toxicity (5.8% with docetaxel)[4] ## Development Status This regimen is considered evidence-informed and is part of standard care for breast cancer patients. It meaningfully improves outcomes including survival, quality of life, and tolerability compared to alternatives[2]. It has evolved from earlier generation chemotherapy regimens and is now considered a second or third-generation chemotherapy option for breast cancer treatment[6]. The regimen appears to be most beneficial in high-risk patients, particularly those with node-positive disease, where it has shown significant improvements in disease-free and overall survival compared to less intensive regimens[7].

02

Targets

TOP2A (DNA topoisomerase II)TUBB (Tubulin (alpha and beta subunits))DNATS (Thymidylate synthase)

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