Objective: To evaluate the efficacy and safety of the combination of pegylated liposomal doxorubicin and docetaxel as neoadjuvant therapy for breast cancer (BC) in patients with axillary lymph node metastasis.
Methods: In this single-arm study, 91 patients with clinical stage IIA-IIIc breast cancer received six cycles of pegylated liposomal doxorubicin plus docetaxel as neoadjuvant chemotherapy (NAC). Trastuzumab was allowed for patients with human epidermal growth factor receptor 2-positive tumors. The primary endpoint was pathologic complete response (pCR) in the breast after surgery. The overall response rate (ORR), Miller-Payne (MP) score of the primary tumors, and incidence of adverse events were also evaluated.
Results: In total, 88 patients completed all cycles of NAC. Fourteen patients (15.4%, 95% confidence interval [CI] = 7.8-22.9) achieved pCR. The ORR was 89% (95% CI = 82.5-95.6), and 72 lesions (79.1%) were rated as MP grade 3 or higher. The left ventricular ejection fraction (LVEF) was within the normal range, although four (4.4%) patients experienced an LVEF decline exceeding 10%. No symptomatic cardiac events were reported.
Conclusion: Preoperative NAC with pegylated liposomal doxorubicin and docetaxel appears effective and safe for treating BC with axillary lymph node metastasis.
Keywords: Pegylated liposomal doxorubicin; breast cancer; cardiovascular toxicity; docetaxel; lymph node metastasis; neoadjuvant chemotherapy.