BACKGROUND Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin's efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity. METHODS An observational study was conducted in a series of HER2-negative ABC patients treated from January'14-December'17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated. RESULTS Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33-83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2-5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2-4.9) and 11.1 months (CI95% 9.5-14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites. CONCLUSION In everyday clinical practice, eribulin's efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found.

中文翻译：

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艾日布林在西班牙综合癌症中心治疗晚期和经过治疗的 HER2 阴性乳腺癌的真实疗效和安全性。


背景艾日布林可改善已接受治疗的 HER2 阴性晚期乳腺癌 (ABC) 的生存率。然而，关于合并症和中枢神经系统（CNS）疗效的数据有限。本研究的目的是回顾艾日布林在日常临床实践中的有效性和安全性，特别关注年龄、体重指数 (BMI) 和中枢神经系统 (CNS) 活动。方法 对 2017 年 1 月 14 日至 2017 年 12 月期间在临床试验之外接受治疗的一系列 HER2 阴性 ABC 患者进行了一项观察性研究。评估客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）以及临床和病理变量与结果的关联。结果 95 名女性接受了至少一个周期的艾日布林治疗。中位年龄为 57 岁 (33-83)，18% 肥胖。 ABC 既往化疗次数中位数为 3 (2-5) 次，76% 的患者出现内脏转移，其中 21% 累及中枢神经系统。大多数肿瘤呈雌激素受体阳性（79%）。 6 个月时的 ORR 和疾病稳定 (SD) 分别为 26.2% 和 37.5%。值得注意的是，艾日布林观察到了相关的中枢神经系统疗效：20% 的患者获得部分缓解，25% 的标准差 (SD)。治疗通常具有良好的耐受性和可控性，3 级毒性为 29%，4 级毒性为 10.9%。中位 PFS 和 OS 分别为 4.1 个月 (CI95% 3.2-4.9) 和 11.1 个月 (CI95% 9.5-14.7)。在多变量分析中，三阴性疾病、> 2 个器官受累以及年龄小于 70 岁是 OS 较差的独立预后因素。大多数患者（75%）在已有的转移部位出现进展。结论 在日常临床实践中，艾日布林的疗效似乎与关键试验相似。观察中枢神经系统功效。 TNBC、> 2 个器官受累以及年龄小于 70 岁是 OS 较差的独立预后因素。值得注意的是，与之前的研究相比，4 级毒性的发生率较低。