Eribulin is a preferred treatment for patients with advanced breast cancer (BC) following anthracyclines and taxanes. The final analysis of the IRENE study assessed the incidence and resolution of eribulin-induced peripheral neuropathy (EIPN), along with safety and quality of life (QoL), in patients with advanced/metastatic BC. IRENE was an observational, single-arm, prospective, multicenter cohort study. Patients aged ≥18 years with locally advanced/metastatic BC that progressed after 1–3 prior chemotherapeutic regimens received eribulin and were monitored for new-onset or worsening EIPN. Secondary endpoints included time to disease progression, safety, and health-related QoL. In total, 108 (32.2%) out of 335 patients experienced EIPN; 18 (5.4%) experienced grade ≥3 EIPN. Median time to EIPN resolution (EIPN ended or returned to baseline) was 78.7 weeks (95% CI 77.1—not estimable). Median time to disease progression was 4.5 months (95% CI 3.9–5.5). Treatment-emergent adverse events (TEAEs) occurred in 322 (96.1%) patients; serious TEAEs occurred in 185 (55.2%) patients. Incidence and resolution rates of EIPN were comparable with existing evidence from previous trials. TEAEs were consistent with the established eribulin safety profile, with no new safety signals. Eribulin treatment did not appear to affect QoL, as measured by EQ-5D-3L and EQ-VAS, or patient-reported neuropathy symptoms, as measured by the PNQ.
艾日布林是晚期乳腺癌患者在蒽环类和紫杉类药物治疗后的优选方案。IRENE研究的最终分析评估了晚期/转移性乳腺癌患者中艾日布林诱导的周围神经病变的发生率和缓解情况，同时考察了其安全性和生活质量。IRENE是一项观察性、单臂、前瞻性、多中心队列研究。年龄≥18岁、既往接受过1-3种化疗方案后进展的局部晚期/转移性乳腺癌患者接受艾日布林治疗，并监测新发或恶化的艾日布林诱导的周围神经病变。次要终点包括疾病进展时间、安全性和健康相关生活质量。在335例患者中，共有108例（32.2%）出现艾日布林诱导的周围神经病变；18例（5.4%）出现≥3级艾日布林诱导的周围神经病变。艾日布林诱导的周围神经病变缓解（病变结束或恢复至基线水平）的中位时间为78.7周（95% CI 77.1—不可估计）。疾病进展的中位时间为4.5个月（95% CI 3.9–5.5）。322例（96.1%）患者出现治疗期间不良事件；185例（55.2%）患者出现严重治疗期间不良事件。艾日布林诱导的周围神经病变的发生率和缓解率与既往试验的现有证据相当。治疗期间不良事件与已知的艾日布林安全性特征一致，未发现新的安全性信号。通过EQ-5D-3L和EQ-VAS评估，艾日布林治疗似乎未影响生活质量；通过患者报告的神经病变问卷评估，也未影响患者报告的神经病变症状。
肿瘤(癌症)患者之家