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贝伐珠单抗治疗血管肉瘤和上皮样血管内皮瘤的开放性、多中心、二期研究。

An open-label, multicenter, phase II study of bevacizumab for the treatment of angiosarcoma and epithelioid hemangioendotheliomas.

机构信息

Division of Hematology/Oncology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago 60611, USA.

出版信息

Ann Oncol. 2013 Jan;24(1):257-63. doi: 10.1093/annonc/mds237. Epub 2012 Aug 21.

DOI:10.1093/annonc/mds237
PMID:22910841
Abstract

BACKGROUND

To determine efficacy and safety of bevacizumab, a recombinant humanized antibody against vascular endothelial growth factor (VEGF), in the treatment of metastatic or locally advanced angiosarcoma and epithelioid hemangioendotheliomas.

PATIENTS AND METHODS

In this single-arm phase II trial, 32 patients were enrolled and they received bevacizumab 15 mg/kg IV infusion in 21-day cycles. Patients had disease that was deemed not surgically resectable, Eastern Cooperative Oncology Group (ECOG) performance status of ≤1, adequate organ function and had not received any radiation treatment in the last 28 days.

RESULTS

Of the 30 patients evaluated for efficacy and toxic effect, four (two angiosarcoma and two epithelioid hemangioendothelioma; 17%) had a partial response. Fifteen patients (11 angiosarcoma and 4 epithelioid hemangioendothelioma; 50%) showed stable disease with a mean time to progression of 26 weeks. Bevacizumab was well tolerated with only one grade 4 adverse event. Expected known toxic effects of the drug were manageable.

CONCLUSION

Bevacizumab is an effective and well-tolerated treatment for metastatic or locally advanced angiosarcoma and epithelioid hemangioendotheliomas. Further phase III studies of bevacizumab in combination with other chemotherapeutic agents and/or radiation treatment are warranted.

摘要

背景

为了确定贝伐珠单抗(一种针对血管内皮生长因子[VEGF]的重组人源化抗体)在治疗转移性或局部晚期血管肉瘤和上皮样血管内皮细胞瘤中的疗效和安全性。

患者和方法

在这项单臂二期临床试验中,共纳入 32 例患者,他们接受贝伐珠单抗 15mg/kg 的静脉输注,每 21 天为一个周期。患者的疾病被认为无法通过手术切除,东部肿瘤协作组(ECOG)表现状态为≤1,器官功能良好,并且在过去 28 天内未接受任何放射治疗。

结果

在 30 例可评估疗效和毒性的患者中,4 例(2 例血管肉瘤和 2 例上皮样血管内皮细胞瘤;17%)有部分缓解。15 例(11 例血管肉瘤和 4 例上皮样血管内皮细胞瘤;50%)表现为稳定疾病,进展时间的平均为 26 周。贝伐珠单抗耐受性良好,仅有 1 例 4 级不良事件。药物的预期已知毒性反应是可以控制的。

结论

贝伐珠单抗是一种有效且耐受性良好的治疗转移性或局部晚期血管肉瘤和上皮样血管内皮细胞瘤的药物。需要进一步开展贝伐珠单抗联合其他化疗药物和/或放射治疗的三期研究。

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