Ramaswami Ramya, O'Cathail Sean M, Brindley James H, Silcocks Paul, Mahmoud Sarah, Palmieri Carlo
Department of Medical Oncology, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.
Future Oncol. 2014 Feb;10(3):363-76. doi: 10.2217/fon.13.210. Epub 2013 Dec 24.
Eribulin mesylate is a synthetic analog of halichondrin B and is licensed for the treatment of patients with locally advanced or metastatic breast cancer that has progressed following treatment with anthracyclines and taxanes. It was not deemed to be cost effective based on a cost analysis by the National Institute for Health and Care Excellence in England and therefore it is not funded routinely by the National Health Service. The establishment of the Cancer Drugs Fund in England subsequently enabled access. As with any new chemotherapy drug that enters clinical practice for metastatic breast cancer (MBC) it is often used in heavily pretreated patients and the experience in a routine clinical setting can differ from that in a clinical study. We therefore present the experience of the first 25 cases treated at our institution via the Cancer Drugs Fund.
MATERIALS & METHODS: A total of 25 patients were treated and in the 22 assessable cases the objective response rate was 18% (four out of 22), with a clinical benefit rate of 41.0% (9 out of 22).
The median time-to-progression and overall survival were 4.08 months and 5.89 months, respectively. There was a significant difference in clinical benefit rate (odds ratio: 0.065; 95% CI: 0-0.529; p = 0.0055), as well as time-to-progression (hazard ratio: 9.18; 95% CI: 2.26-37.38; p = 0.002 adjusted for age at diagnosis and interval between initial MBC diagnosis and commencing eribulin) favoring those patients who had not been rechallenged. There was no significant difference in overall survival (hazard ratio: 1.16; 95% CI: 0.44-3.05; p = 0.770 adjusted for age at diagnosis and interval between initial diagnosis of MBC and commencing eribulin).
Eribulin mesylate shows clinical activity; however, there appears to be differences in terms of benefit in patients based on whether patients have been rechallenged with an anthracycline and/or a taxane. These data require confirmation in larger patient groups.
甲磺酸艾瑞布林是一种海兔毒素B的合成类似物，已被批准用于治疗蒽环类药物和紫杉烷类药物治疗后病情进展的局部晚期或转移性乳腺癌患者。根据英国国家卫生与临床优化研究所的成本分析，它被认为不具有成本效益，因此英国国家医疗服务体系通常不为其提供资金支持。英国癌症药物基金的设立随后使患者能够获得该药物。与任何进入转移性乳腺癌（MBC）临床实践的新型化疗药物一样，它常用于接受过大量治疗的患者，常规临床环境中的经验可能与临床研究中的经验有所不同。因此，我们介绍了我们机构通过癌症药物基金治疗的前25例患者的经验。
共治疗25例患者，在22例可评估病例中，客观缓解率为18%（22例中有4例），临床获益率为41.0%（22例中有9例）。
中位疾病进展时间和总生存期分别为4.08个月和5.89个月。临床获益率存在显著差异（优势比：0.065；95%置信区间：0 - 0.529；p = 0.0055），疾病进展时间也存在显著差异（风险比：9.18；95%置信区间：2.26 - 37.38；针对诊断时年龄以及初始MBC诊断与开始使用艾瑞布林之间的间隔进行调整后，p = 0.002），未再次接受蒽环类药物和/或紫杉烷类药物治疗的患者更具优势。总生存期无显著差异（风险比：1.16；95%置信区间：0.44 - 3.05；针对诊断时年龄以及初始MBC诊断与开始使用艾瑞布林之间的间隔进行调整后，p = 0.770）。
甲磺酸艾瑞布林显示出临床活性；然而，根据患者是否再次接受蒽环类药物和/或紫杉烷类药物治疗，患者在获益方面似乎存在差异。这些数据需要在更大的患者群体中得到证实。
