National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA Centre Hospitalier, de l'Université de Montreal (CHUM), Montreal, Quebec, Canada.
Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.
Neoadjuvant chemotherapy has become standard treatment for women with locally advanced breast cancer (LABC). Various regimens have explored the addition of newer agents to determine safety and efficacy. The aim of this phase II study was to incorporate albumin-bound paclitaxel with sequential anthracycline-based therapy.
Sixty-six women with LABC but without prior treatment and regardless of hormone receptor or HER2 status were enrolled. All patients were to receive albumin-bound paclitaxel weekly for 12 weeks followed by 5-fluorouracil/ epirubicin/cyclophosphamide (FEC) every 3 weeks for 4 cycles. Trastuzumab was allowed in HER2-positive (HER2+) patients. Primary endpoint was pathologic complete response (pCR; CR) in breast. Secondary endpoints included pCR in breast and nodes, clinical CR, 2-year progression-free survival, and overall survival.
Sixty-five patients received at least 1 dose of chemotherapy and were included in this analysis. Sixty-three patients completed 4 cycles of albumin-bound paclitaxel. Sixty-two patients received at least 1 dose of FEC, and 58 completed 4 cycles. Seventeen of 19 HER2+ women received trastuzumab. The pCR in breast was 29% (19 of 65). For the HER2+ subset, the pCR was 58% (11 of 19). Both albumin-bound paclitaxel and FEC were well tolerated. The most significant toxicities were grade 2/3 neuropathy (16%) with albumin-bound paclitaxel and grade 3/4 febrile neutropenia (7%) with FEC.
Albumin-bound paclitaxel given over 12 weeks is well tolerated. Albumin-bound paclitaxel should be further evaluated in a randomized setting in both adjuvant and neoadjuvant trials.
新辅助化疗已成为局部晚期乳腺癌（LABC）女性的标准治疗方法。各种方案都在探索添加新型药物，以确定其安全性和有效性。本Ⅱ期研究的目的是将白蛋白结合型紫杉醇与序贯蒽环类药物联合使用。
共纳入 66 例未经治疗的局部晚期乳腺癌且不论激素受体或 HER2 状态的患者。所有患者均接受白蛋白结合型紫杉醇每周 1 次，共 12 周，随后每 3 周接受氟尿嘧啶/表柔比星/环磷酰胺（FEC）治疗 4 个周期。曲妥珠单抗可用于 HER2 阳性（HER2+）患者。主要终点是乳腺病理完全缓解（pCR；CR）。次要终点包括乳腺和淋巴结 pCR、临床完全缓解（CR）、2 年无进展生存率和总生存率。
65 例患者至少接受了 1 剂化疗，并纳入本分析。63 例患者完成了 4 个周期的白蛋白结合型紫杉醇治疗。62 例患者至少接受了 1 剂 FEC，58 例患者完成了 4 个周期。19 例 HER2+患者中有 17 例接受了曲妥珠单抗治疗。乳腺 pCR 为 29%（19/65）。HER2+亚组的 pCR 为 58%（11/19）。白蛋白结合型紫杉醇和 FEC 均具有良好的耐受性。最常见的毒性反应是 2/3 级神经病变（16%，白蛋白结合型紫杉醇）和 3/4 级发热性中性粒细胞减少症（7%，FEC）。
12 周内给予白蛋白结合型紫杉醇具有良好的耐受性。白蛋白结合型紫杉醇应在辅助和新辅助试验中进一步进行随机评估。
