Wang Li, Hong Yang, Ma Jie, Han Meng, Zhang Shuo, Shan Baoen, Liu Yunjiang
Department of Breast Surgery, Xingtai People's Hospital, Xingtai, Hebei, China.
Department of Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
J Int Med Res. 2020 Aug;48(8):300060520944310. doi: 10.1177/0300060520944310.
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.
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.
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.
Preoperative NAC with pegylated liposomal doxorubicin and docetaxel appears effective and safe for treating BC with axillary lymph node metastasis.
评估聚乙二醇化脂质体阿霉素与多西他赛联合作为新辅助治疗对伴有腋窝淋巴结转移的乳腺癌（BC）患者的疗效和安全性。
在这项单臂研究中，91例临床IIA - IIIc期乳腺癌患者接受了六个周期的聚乙二醇化脂质体阿霉素加 多西他赛作为新辅助化疗（NAC）。人表皮生长因子受体2阳性肿瘤患者可使用曲妥珠单抗。主要终点是术后乳腺的病理完全缓解（pCR）。还评估了总缓解率（ORR）、原发肿瘤的米勒 - 佩恩（MP）评分以及不良事件的发生率。
总共88例患者完成了所有周期的NAC。14例患者（15.4%，95%置信区间[CI]=7.8 - 22.9）达到pCR。ORR为89%（95%CI = 82.5 - 95.6），72个病灶（79.1%）被评为MP 3级或更高。左心室射血分数（LVEF）在正常范围内，尽管有4例（4.4%）患者的LVEF下降超过10%。未报告有症状的心脏事件。
聚乙二醇化脂质体阿霉素与多西他赛术前NAC对治疗伴有腋窝淋巴结转移的BC似乎有效且安全。
