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甲磺酸艾瑞布林治疗转移性激素难治性和三阴性乳腺癌:一项关于疗效和安全性的多机构真实世界报告。

Eribulin Mesylate for the Treatment of Metastatic Hormone-refractory and Triple-negative Breast Cancer: A Multi-institutional Real-world Report on Efficacy and Safety.

机构信息

Medical Oncology Unit.

Medical Oncology Unit, La Maddalena Clinic for Cancer.

出版信息

Am J Clin Oncol. 2021 Mar 1;44(3):105-108. doi: 10.1097/COC.0000000000000790.

Abstract

OBJECTIVE

Eribulin mesylate (EM) is a fully synthetic macrocyclic ketone analogue of the marine natural product halichondrin. EM has been reported to be active in metastatic breast cancer. In this paper, we report efficacy and safety of data of EM in a retrospective, real-world series of patients with poor prognosis, hormone-refractory, or triple-negative metastatic breast cancer.

MATERIALS AND METHODS

The analysis was carried out at 4 interrelated oncology centers. EM was delivered at the dose of 1.4 mg/m2 in 100 mL of normal saline over 2 to 5 minutes on days 1 and 8 every 21 days. EM was continued until disease progression or unacceptable toxicity. Side effects were reported every cycle as per standard clinical practice and graded according to NCI-CTCAE, version 4.0. Time-to-progression and overall survival were reported.

RESULTS

In this series of 90 patients the overall response rate was 22%, and 21% and 23% in the hormonal-resistant group and the triple-negative one, respectively. Stable disease was recorded in 24%, 21%, and 27%, respectively, in the whole series, the hormonal-resistant group, and the triple-negative one, respectively. Time-to-progression was 3.5 months (range, 1 to 22 mo) in the whole series and 3.0 months (range, 1 to 14.7 mo) and 3.4 months (range, 2.2 to 16.2 mo) in the hormonal-resistant group and the triple-negative one, respectively. Overall survival reached a median of 11.4 months.

CONCLUSIONS

This multicenter study, albeit retrospective, demonstrates the activity of this combination as third-line chemotherapy option in a challenging clinical setting such as triple-negative or hormone-resistant patients with breast cancer progressing after several lines of hormonal manipulations.

摘要

目的

盐酸伊立替康甲磺酸盐(EM)是一种完全合成的海洋天然产物海鞘素的大环酮类似物。已有报道称 EM 对转移性乳腺癌具有活性。在本文中,我们报告了 EM 在一系列回顾性、真实世界的预后不良、激素难治或三阴性转移性乳腺癌患者中的疗效和安全性数据。

材料和方法

该分析在 4 个相关肿瘤学中心进行。EM 以 1.4mg/m2 的剂量在 100mL 生理盐水输注 2 至 5 分钟,每 21 天给药 1 天和 8 天。EM 持续给药直至疾病进展或出现不可接受的毒性。根据标准临床实践和 NCI-CTCAE(版本 4.0)报告每个周期的副作用。报告无进展生存期和总生存期。

结果

在这一系列 90 例患者中,总体缓解率为 22%,激素耐药组和三阴性组分别为 21%和 23%。整个系列、激素耐药组和三阴性组中稳定疾病的分别为 24%、21%和 27%。整个系列的无进展生存期为 3.5 个月(范围 1 至 22 个月),激素耐药组和三阴性组分别为 3.0 个月(范围 1 至 14.7 个月)和 3.4 个月(范围 2.2 至 16.2 个月)。总生存期达到了 11.4 个月的中位数。

结论

尽管本研究是回顾性的,但这项多中心研究表明,在激素耐药或三阴性乳腺癌患者中,在经过多线激素治疗后进展的情况下,EM 作为三线化疗方案在具有挑战性的临床环境中具有活性。

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