Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Le, QT; Kim, HE; Schneider, CJ; Murakozy, G; Skladowski, K; Reinisch, S; Chen, Y; Hickey, M; Mo, M; Chen, MG; Berger, D; Lizambri, R; Henke, M.
Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study.
J CLIN ONCOL. 2011; 29(20): 2808-2814.
Doi: 10.1200/JCO.2010.32.4095
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- Co-Autor*innen der Med Uni Graz
- Reinisch Sabine
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- Abstract:
- Purpose Oral mucositis (OM) is a debilitating toxicity of chemoradiotherapy for head and neck cancer (HNC). This randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of palifermin to reduce OM associated with definitive chemoradiotherapy for locally advanced HNC. Patients and Methods Patients receiving conventionally fractionated radiotherapy (2.0 Gy/d, 5 days/wk to 70 Gy) with cisplatin (100 mg/m(2) on days 1, 22, and 43) received palifermin (180 mu g/kg) or placebo before starting chemoradiotherapy and then once weekly for 7 weeks. The primary end point was the incidence of severe, observable, and functional OM (WHO grade 3 to 4). Results The palifermin (n = 94) and placebo (n = 94) arms were well balanced. The incidence of severe OM was significantly lower for palifermin than for placebo (54% v 69%; P = .041). In the palifermin arm, median time to severe OM was delayed (47 v 35 days), median duration of severe OM was shortened (5 v 26 days), and the incidence of xerostomia grade >= 2 was lower (67% v 80%), favoring palifermin; however, the differences were not significant after multiplicity adjustment. Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms. Adverse events were similar between arms (98%, palifermin; 93%, placebo). The most common study drug-related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between treatment arms. Conclusion Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemoradiotherapy remains to be elucidated.
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- Antineoplastic Agents - adverse effects
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- Drug Toxicity -
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- Fibroblast Growth Factor 7 - adverse effects Fibroblast Growth Factor 7 - therapeutic use
- Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - pathology Head and Neck Neoplasms - radiotherapy
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- Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use
- Stomatitis - etiology Stomatitis - prevention and control
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