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

Kazumi Kawase; Kazuhiko Yoshida; Keigo Hara; Suguru Hidaka; Hiroshi Takeyama

doi:10.52845/CMI/2023-4-2-1

Authors

Kazumi Kawase a:1:{s:5:"en_US";s:65:"The Jikei University School of Medicine Katsushika Medical Center";}
Kazuhiko Yoshida The Jikei University School of Medicine Katsushika Medical Center
Keigo Hara The Jikei University School of Medicine Katsushika Medical Center
Suguru Hidaka
Hiroshi Takeyama The Jikei University School of Medicine

DOI:

https://doi.org/10.52845/CMI/2023-4-2-1

Keywords:

albumin-bound paclitaxel, human epidermal growth factor receptor 2, neoadjuvant chemotherapy, breast cancer, peripheral neuropathy

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.