Standard-dose eribulin mesylate (1.4 mg/m d1 + 8) achieves clinical benefit rates of 26%–52% in patients with metastatic breast cancer (mBC). <10% of patients in the registration trial were ≥ 70 years old; dose reductions were common in these older patients. This single-arm phase II trial explored the efficacy of reduced starting dosing of first-line eribulin at 1 mg/m d1 + 8 q3 weeks in patients with mBC aged ≥70 years. The primary endpoint was a disease control rate (DCR) ≥55%. The secondary endpoints were objective response (OR), progression-free survival (PFS), overall survival (OS), and patient-reported neurotoxicity. Overall, 77 patients were accrued; their median age was 76 years and Eastern Cooperative Oncology Group performance status was 0–1 in 90%. The DCR was 40% (90% confidence interval [CI]: 31–50); therefore, the primary endpoint was not reached. The overall response rate was 22% (95%CI: 13–33), median PFS 5.4 months (95%CI: 4.5–7.7), and median OS 16.1 months (95%CI: 13.5–26.9). Dose modifications were necessary in 35% of patients. In nine patients, more than fifteen cycles were given; 48 patients (62%) experienced at least one grade 3 toxicity. Median patient-reported neurotoxicity scores remained stable for at least fifteen cycles. The main reason for treatment discontinuation was disease progression (57%). We report the first prospective data on first-line eribulin in older patients. The reduced starting dose of 1.1 mg/m was safe, with prolonged treatment and DC achieved in a considerable proportion of patients (but less than the 55% assumed), without cumulative neurotoxicity. The reduced dose was apparently within the range of the minimal effective dose, as shown by the efficacy lack in patients requiring further dose reductions. Thus, our results do not support the approach of a reduced starting dose for older patients.

中文翻译：

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艾日布林作为老年晚期乳腺癌患者的一线治疗：一项多中心 II 期试验 [SAKK 25/14]


标准剂量甲磺酸艾日布林 (1.4 mg/m·d1 + 8) 在转移性乳腺癌 (mBC) 患者中实现了 26%–52% 的临床获益率。注册试验中<10%的患者年龄≥70岁；在这些老年患者中，剂量减少很常见。这项单组 II 期试验探讨了对于年龄≥70 岁的 mBC 患者，一线艾日布林起始剂量减少为 1 mg/m d1 + 8 q3 周的疗效。主要终点是疾病控制率（DCR）≥55%。次要终点是客观缓解（OR）、无进展生存期（PFS）、总生存期（OS）和患者报告的神经毒性。总共有 77 名患者；他们的中位年龄为 76 岁，东部肿瘤合作组的 90% 表现状态为 0-1。 DCR 为 40%（90% 置信区间 [CI]：31–50）；因此，未达到主要终点。总体缓解率为 22%（95%CI：13-33），中位 PFS 5.4 个月（95%CI：4.5-7.7），中位 OS 16.1 个月（95%CI：13.5-26.9）。 35% 的患者需要调整剂量。 9 名患者接受了超过 15 个周期的治疗； 48 名患者 (62%) 经历了至少一种 3 级毒性。患者报告的中位神经毒性评分在至少十五个周期内保持稳定。停止治疗的主要原因是疾病进展（57%）。我们报告了老年患者一线艾日布林的第一个前瞻性数据。减少的起始剂量为 1.1 mg/m2 是安全的，经过长期治疗，相当大比例的患者（但低于假设的 55%）实现了 DC，且没有累积神经毒性。减少的剂量显然在最小有效剂量的范围内，如需要进一步减少剂量的患者缺乏疗效所表明的那样。 因此，我们的结果不支持减少老年患者起始剂量的方法。