A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in...

Area of Science:

• Oncology
• Clinical Trials
• Breast Cancer Research

Background:

• Neoadjuvant systemic therapy is standard for locally advanced operable breast cancer.
• This study investigated if eribulin improves pathological complete response (pCR) rates compared to paclitaxel.

Purpose of the Study:

• To compare the efficacy and toxicity of neoadjuvant eribulin versus paclitaxel followed by FAC/FEC in operable HER2-negative breast cancer.
• To assess pathological complete response (pCR) rates and serious adverse events (SAEs).

Main Methods:

• A 1:1 randomized open-label phase II study.
• Patients received either weekly paclitaxel or eribulin, followed by 5-fluorouracil, doxorubicin/epirubicin, and cyclophosphamide (FAC/FEC).
• pCR and toxicity were compared between treatment arms.

Main Results:

• Only 5% of patients in the eribulin group achieved pCR versus 27% in the paclitaxel group, leading to study discontinuation due to futility.
• Eribulin was associated with significantly higher neutropenia-related serious adverse events (39% vs 11%), including one death from neutropenic sepsis.
• Five-year event-free survival was 74.0% for eribulin vs 81.8% for paclitaxel; overall survival was 84.4% vs 100%.

Conclusions:

• Eribulin followed by FAC/FEC is not superior to paclitaxel followed by FAC/FEC as neoadjuvant therapy for operable HER2-negative breast cancer.
• The eribulin regimen is associated with greater hematologic toxicity, including neutropenia-related SAEs.
• Eribulin is not recommended as a standard neoadjuvant therapy in this patient population.