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帕尼单抗:一种对转移性结直肠癌有活性的全人源单克隆抗体。

Panitumumab: a fully human monoclonal antibody with activity in metastatic colorectal cancer.

作者信息

Saadeh Claire E, Lee H Stephen

机构信息

Pharmacy Practice, Ferris State University, Big Rapids, MI, USA.

出版信息

Ann Pharmacother. 2007 Apr;41(4):606-13. doi: 10.1345/aph.1H492. Epub 2007 Mar 13.

Abstract

OBJECTIVE

To review the pharmacology, pharmacokinetics, clinical trials, adverse effects, and drug interactions of panitumumab.

DATA SOURCES

A MEDLINE search was conducted (1966-February 2007) using the search terms panitumumab, ABX-EGF, E7.6.3, monoclonal antibody, colorectal neoplasm, epidermal growth factor receptor, EGFr, and epidermal growth factor receptor signal transduction. Articles and abstracts were further identified from the American Society of Clinical Oncology and the National Comprehensive Cancer Network.

STUDY SELECTION AND DATA EXTRACTION

Clinical trials evaluating panitumumab for solid tumors were selected from the data sources. All published relevant abstracts were included.

DATA SYNTHESIS

The most recent developments in the treatment of metastatic colorectal cancer include the monoclonal antibodies targeted against vascular endothelial growth factor and the epidermal growth factor receptor (EGFr). Panitumumab is the first fully human monoclonal antibody that binds to EGFr. Clinical activity has been demonstrated, most notably in patients with EGFr-positive metastatic colorectal cancer who have failed prior therapy. Phase III study results indicate a 46% reduction in the rate of tumor progression in treated patients compared with those who received best supportive care alone. Panitumumab is well tolerated, with acneiform rash the most common dose-dependent adverse effect. Studies thus far indicate a low rate of infusion-related reactions (1%, grade 3-4).

CONCLUSIONS

Panitumumab is a fully human monoclonal antibody with promising activity in treatment of patients with metastatic colorectal cancer who have failed previous therapy, offering a favorable safety profile.

摘要

目的

综述帕尼单抗的药理学、药代动力学、临床试验、不良反应及药物相互作用。

数据来源

利用搜索词“帕尼单抗”“ABX-EGF”“E7.6.3”“单克隆抗体”“结肠直肠肿瘤”“表皮生长因子受体”“EGFr”及“表皮生长因子受体信号转导”对MEDLINE进行检索(1966年至2007年2月)。从美国临床肿瘤学会及国家综合癌症网络进一步识别相关文章及摘要。

研究选择与数据提取

从数据来源中选取评估帕尼单抗治疗实体瘤的临床试验。纳入所有已发表的相关摘要。

数据综合

转移性结直肠癌治疗的最新进展包括针对血管内皮生长因子及表皮生长因子受体(EGFr)的单克隆抗体。帕尼单抗是首个与EGFr结合的全人源单克隆抗体。已证实其具有临床活性,在既往治疗失败的EGFr阳性转移性结直肠癌患者中表现尤为明显。III期研究结果表明,与仅接受最佳支持治疗的患者相比,接受治疗的患者肿瘤进展率降低了46%。帕尼单抗耐受性良好,最常见的剂量依赖性不良反应为痤疮样皮疹。迄今为止的研究表明,输注相关反应发生率较低(1%,3-4级)。

结论

帕尼单抗是一种全人源单克隆抗体,在治疗既往治疗失败的转移性结直肠癌患者中具有良好活性,安全性良好。

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