Sarah Cannon Research Institute, Nashville, TN, USA.
Tennessee Oncology, PLLC, Nashville, TN, USA.
Breast Cancer Res Treat. 2020 Apr;180(3):647-655. doi: 10.1007/s10549-020-05563-z. Epub 2020 Feb 14.
Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancer patients who did not achieve a pCR following standard neoadjuvant chemotherapy.
Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2- (Cohort B), and HER2+ (Cohort C).
One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%).
Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.
新辅助化疗后原发部位或腋窝淋巴结残留浸润性乳腺癌的女性复发风险较高。表柔比星和多西他赛治疗进展后的转移性乳腺癌患者，艾日布林可改善其生存。本Ⅱ期试验评估了标准新辅助化疗后未达到 pCR 的乳腺癌患者术后使用艾日布林的疗效。
局部乳腺癌患者在完成≥4 周期标准蒽环类和/或紫杉烷类新辅助化疗后残留侵袭性癌，接受辅助艾日布林治疗。HER2 阳性患者还接受曲妥珠单抗治疗 1 年。辅助激素治疗和局部区域放疗按照机构指南进行。主要终点是 2 年无病生存率。分析了 3 个患者队列：三阴性乳腺癌（队列 A）、激素受体阳性/HER2 阴性（队列 B）和 HER2 阳性（队列 C）。
共纳入 126 例患者（队列 A-53 例，队列 B-42 例，队列 C-31 例）。新辅助化疗中 70%的患者接受了紫杉烷和蒽环类药物治疗。艾日布林耐受性良好；84%的患者接受了计划的 6 个周期治疗。中位随访 28 个月后，队列 A、B 和 C 的 24 个月无病生存率分别为 56%（95%CI 42，69）、83%（95%CI 67，91）和 73%（95%CI 53，86）。最常见的 3/4 级治疗相关不良事件为中性粒细胞减少症（26%）、白细胞减少症（13%）和周围神经病变（7%）。
新辅助化疗后给予辅助艾日布林是可行且耐受良好的。在任何队列中，24 个月无病生存率均未达到研究目标水平，且与这些队列中单独新辅助化疗后的无病生存率相似。
