1. Medical Oncology Unit ASL Frosinone, Frosinone, Italy;
2. Oncology Unit I, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy;
J Cancer. 2014 Mar 20;5(5):320-7. doi: 10.7150/jca.8748. eCollection 2014.
Eribulin was recently approved in patients progressing after being treated with anthracyclines and taxanes and after two or more chemotherapy lines for advanced disease.
This multicenter observational retrospective study was performed in order to evaluate activity and tolerability of eribulin in real-world patient population.
133 advanced breast cancer patients pretreated with ≥ 2 chemotherapy lines for metastatic disease were retrospectively enrolled in the observational trial in 11 italian cancer centres.
A median of 5 cycles of eribulin (range, 1-15) were administered. Twenty-eight partial responses were observed, for an overall response rate of 21.1% (95%CI,14.1-28.0). A stable disease was recorded in 57 patients (42.8%), and a clinical benefit (response or stable disease lasting ≥ six months) was observed in 51 patients (38.3%, 95%CI, 30.1-46.6). The subgroup analysis showed that a significant improvement in term of partial response and clinical benefit was achieved when eribulin was administered in HER-2 negative tumors (p=0.01 and p=0.004, respectively) and when it is given as third-line (p=0.09 and p=0.02, respectively). Toxicity was manageable; fatigue is the most common side effect observed, usually of low-grade, and clearly cumulative-dose related.
In this retrospective, observational analysis eribulin confirmed its efficacy and manageable tolerability even in real-world population and in heavily pretreated patients.
依立布林最近被批准用于在接受蒽环类药物和紫杉烷类药物治疗以及在晚期疾病中接受两种或更多种化疗方案后进展的患者。
这项多中心观察性回顾性研究旨在评估依立布林在真实世界患者人群中的疗效和耐受性。
在 11 家意大利癌症中心进行了这项观察性试验，共回顾性纳入了 133 名接受过两种或更多种化疗方案治疗转移性疾病的晚期乳腺癌患者。
中位接受了 5 个周期的依立布林（范围为 1-15）。观察到 28 例部分缓解，总缓解率为 21.1%（95%CI，14.1-28.0）。57 例患者（42.8%）病情稳定，51 例患者（38.3%，95%CI，30.1-46.6）有临床获益（缓解或稳定疾病持续≥6 个月）。亚组分析显示，依立布林在 HER-2 阴性肿瘤中的部分缓解和临床获益均有显著改善（p=0.01 和 p=0.004），而在三线治疗中（p=0.09 和 p=0.02）也有类似的改善。毒性可管理；疲劳是最常见的副作用，通常为低级别，且明显与累积剂量有关。
在这项回顾性、观察性分析中，依立布林在真实世界人群和接受过多线治疗的患者中证实了其疗效和可管理的耐受性。
