Eribulin Monotherapy in Patients Aged 70 Years and Older With Metastatic Breast Cancer
Eribulin Monotherapy in Patients Aged 70 Years and Older With Metastatic Breast Cancer
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DOI：
10.1634/theoncologist.2013-0282
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发表时间：
2014-04-01
期刊：
影响因子：
5.8
通讯作者：
O'Shaughnessy, Joyce
中科院分区：
文献类型：
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作者：
Muss, Hyman;Cortes, Javier;O'Shaughnessy, Joyce
目的.在证实了甲磺酸艾日布林在重度预治疗的转移性乳腺癌患者中的有效性和安全性后，进行了一项探索性分析，以研究年龄对这些患者的影响。数据来自两项单组II期研究和一项开放标签随机III期研究，其中患者在21天周期的第1天和第8天接受甲磺酸艾日布林1.4 mg/m2静脉输注2- 5分钟。计算4个年龄组（≥ 70岁）的年龄对中位总生存期（OS）、无进展生存期（PFS）、总缓解率（ORR）、临床获益率（CBR）和不良事件（AE）发生率的影响。总体而言，827例患者纳入分析（≥ 70岁，n = 79）。年龄对OS无显著影响（分别为11.8个月、12.3个月、11.7个月和12.5个月; p = 0.82），PFS（分别为3.5个月、2.9个月、3.8个月、4.0个月）; p = 0.42）、ORR（分别为12.7%、12.5%、6.3%和10.1%）或CBR（分别为20.2%、20.8%、20.4%和21.5%）。尽管一些AE在最年轻或最年长的亚组中发生率较高，但年龄对AE（包括神经病变、中性粒细胞减少和白细胞减少）的发生率没有总体影响。在这些选定的具有良好基线体能状态的老年患者中，艾日布林单药治疗导致的OS、PFS、ORR、CBR和耐受性与患有转移性乳腺癌的年轻患者相似。艾日布林的益处和风险在不同年龄组似乎相似。
Purpose. Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer, an exploratory analysis was performed to investigate the effect of age in these patients.Methods. Data were pooled from two single-arm phase II studiesandoneopen-label randomizedphase III study inwhich patients received eribulin mesylate at 1.4 mg/m(2) as 2- to 5-minute intravenous infusions on days 1 and 8 of a 21-day cycle. The effect of age on median overall survival (OS), progression-free survival (PFS), overall response rate (ORR), clinical benefit rate (CBR), and incidence of adverse events (AEs) was calculated for four age groups (= 70 years).Results. Overall, 827 patients were included in the analysis (= 70 years, n = 79). Age had no significant impact on OS (11.8 months, 12.3 months, 11.7 months, and 12.5 months, respectively; p = .82), PFS (3.5months, 2.9months, 3.8months, and 4.0 months, respectively; p = .42), ORR (12.7%, 12.5%, 6.3%, and 10.1%, respectively), or CBR (20.2%, 20.8%, 20.4%, and 21.5%, respectively). Although some AEs had higher incidence in either the youngest or the oldest subgroup, there was no overall effect of age on the incidence of AEs (including neuropathy, neutropenia, and leukopenia).Conclusion. Eribulin monotherapy in these selected older patients with good baseline performance status led to OS, PFS, ORR, CBR, and tolerability similar to those of younger patients with metastatic breast cancer. The benefits and risks of eribulin appear to be similar across age groups.