A Phase II Neoadjuvant Trial of Sequential Nanoparticle Albumin-Bound Paclitaxel Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide in Locally Advanced Breast Cancer
A Phase II Neoadjuvant Trial of Sequential Nanoparticle Albumin-Bound Paclitaxel Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide in Locally Advanced Breast Cancer
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DOI：
10.3816/cbc.2010.n.011
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发表时间：
2010-02-01
影响因子：
3.1
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
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作者：
Robidoux, Andre;Buzdar, Aman U.;Wolmark, Norman
背景：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。各种治疗方案都探索了添加新药物以确定安全性和有效性。这项 II 期研究的目的是将白蛋白结合紫杉醇与基于蒽环类药物的序贯治疗相结合。专利和方法：纳入了 66 名患有 LABC 但未经治疗且无论激素受体或 HER2 状态如何的女性。所有患者每周接受白蛋白结合紫杉醇治疗，持续 12 周，然后每 3 周接受一次 5-氟尿嘧啶/表阿霉素/环磷酰胺 (FEC)，持续 4 个周期。曲妥珠单抗被允许用于 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的 pCR、临床 CR、2 年无进展生存期和总生存期。结果：65 名患者接受了至少 1 剂化疗，并纳入本次分析。 63 名患者完成了 4 个周期的白蛋白结合紫杉醇治疗。 62 名患者接受了至少 1 剂 FEC，其中 58 名患者完成了 4 个周期。 19 名 HER2(+) 女性中有 17 名接受了曲妥珠单抗治疗。乳腺的 pCR 为 29%（65 例中的 19 例）。对于 HER2(+) 子集，pCR 为 58%（19 例中的 11 例）。白蛋白结合型紫杉醇和 FEC 均具有良好的耐受性。最显着的毒性是白蛋白结合紫杉醇引起的 2/3 级神经病变 (16%) 和 FEC 引起的 3/4 级发热性中性粒细胞减少症 (7%)。结论：给予 12 周以上的白蛋白结合型紫杉醇耐受性良好。白蛋白结合紫杉醇应在辅助和新辅助试验的随机环境中进一步评估。
Background: 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. Patents and Methods: 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. Results: 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. Conclusion: 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.