Efficacy of palifermin (keratinocyte growth factor-1) in the amelioration of oral mucositis.

Core Evidence Pub Date : 2010-06-15 DOI:10.2147/ce.s5995
Stephen T Sonis
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引用次数: 51

Abstract

Purpose: Oral mucositis is a significant toxicity of cytotoxic chemo- and radiation-therapy used to treat cancer. Palifermin is the first pharmaceutical/biological agent approved for the intervention of oral mucositis. The major objective of this review is to evaluate the evidence supporting the use of palifermin.

Methods: A literature search was performed using an appropriate keyword search in MEDLINE and PubMed databases.

Results: Of 100 full papers and 4 abstracts identified, 12 papers and 3 abstracts were appropriate for analysis. Level 2 evidence supporting palifermin use in patients with hematologic malignancies being treated with autologous hematopoietic stem cell transplantation (HSCT) is clear. Level 2 evidence also exists for the use of palifermin in the prevention of oral mucositis in patients with solid tumors (colorectal cancer, head and neck cancer), but is incomplete. Level >/= 3 data support the use of palifermin in allogeneic HSCT recipients and cycled chemotherapy. A single health economic study concluded that palifermin is essentially cost neutral in the autologous HSCT population.

Conclusion: Data supporting the use of palifermin in autologous HSCT recipients with hematologic malignancies is clear. Some data exist demonstrating its efficacy in other oncologic indications. Additional studies are needed to broaden the potential applications of palifermin and to ascertain its economic, but not symptomatic, effectiveness.

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角化细胞生长因子-1 (palifermin)对口腔黏膜炎的改善作用。
目的:口腔黏膜炎是细胞毒性化疗和放射治疗的重要毒副作用。Palifermin是第一个被批准用于干预口腔黏膜炎的药物/生物制剂。本综述的主要目的是评价支持palifermin使用的证据。方法:在MEDLINE和PubMed数据库中选择合适的关键词进行文献检索。结果:100篇全文和4篇摘要中,有12篇论文和3篇摘要适合分析。2级证据明确支持palifermin用于接受自体造血干细胞移植(HSCT)治疗的血液系统恶性肿瘤患者。palifermin在预防实体肿瘤(结直肠癌、头颈癌)患者口腔黏膜炎方面也有2级证据,但尚不完整。水平>/= 3的数据支持palifermin在异基因HSCT接受者和循环化疗中的使用。一项单一的健康经济学研究得出结论,palifermin在自体造血干细胞移植人群中基本上是成本中性的。结论:支持palifermin用于血液学恶性肿瘤自体造血干细胞移植患者的数据是明确的。一些数据显示其对其他肿瘤适应症的疗效。需要进一步的研究来扩大palifermin的潜在应用,并确定其经济效益,但不是症状性的有效性。
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Core Evidence
Core Evidence PHARMACOLOGY & PHARMACY-
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期刊介绍: Core Evidence evaluates the evidence underlying the potential place in therapy of drugs throughout their development lifecycle from preclinical to postlaunch. The focus of each review is to evaluate the case for a new drug or class in outcome terms in specific indications and patient groups The emerging evidence on new drugs is reviewed at key stages of development and evaluated against unmet needs
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