Efficacy and safety of neoadjuvant chemotherapy with dose de-escalation tri-weekly nanoparticle albumin-bound paclitaxel and FEC for human epidermal growth factor receptor 2-positive breast cancer

Abstract

Introduction: Neoadjuvant chemotherapy (NAC) is widely used for human epidermal growth factor receptor 2-positive (HER2⁺) breast cancer. The standard NAC regimen for HER2⁺ breast cancer is an anthracycline, followed by taxane in combination with anti-HER2 drugs. However, the risk of toxicities such as cardiac dysfunction and peripheral neuropathy occasionally requires dose reduction. Nanoparticle albumin-bound paclitaxel (nab-PTX) is a new taxane used in NAC. The aim of this study was to examine the effects of tri-weekly low-dose nab-PTX with anti-HER2 drugs followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) as NAC in patients with HER2⁺ breast cancer.

Methods: Patients with operable primary HER2⁺ breast cancer in clinical stages I–III were enrolled in this study. The NAC regimen included four courses of nab-PTX (220 mg/m²) concurrently with trastuzumab (6 mg/kg) tri-weekly, followed by four courses of FEC75 (5-fluorouracil: 500 mg/m², epirubicin: 75 mg/m², and cyclophosphamide: 500 mg/m²). Pathological responses, adverse events, and follow-up data at 36 months were evaluated.

Results: Among the 20 patients enrolled, 15 completed the treatment protocol. The pathological complete response (pCR) rates were 60.0% overall and 85.7% in hormone receptor-negative/HER2⁺ patients. At 36 months, one secondary malignancy was observed. The most frequent adverse event was peripheral sensory neuropathy (25/42, 59.5%), which persisted in four (16%) patients at 36-month follow-up.

Conclusions: NAC with low-dose tri-weekly nab-PTX followed by FEC demonstrated favorable pCR and disease-free survival. Peripheral sensory neuropathy remains a concerning long-term adverse effect in some patients, even after reducing the nab-PTX dosage.