Palifermin Reduces Severe Mucositis in Definitive Chemoradiotherapy of Locally Advanced Head and Neck Cancer: A Randomized, Placebo-Controlled Study
| العنوان: | Palifermin Reduces Severe Mucositis in Definitive Chemoradiotherapy of Locally Advanced Head and Neck Cancer: A Randomized, Placebo-Controlled Study |
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| المؤلفون: | Sabine Reinisch, Györgyi Muraközy, Dietmar Berger, Quynh-Thu Le, Harold Kim, Michael Henke, Charles J. Schneider, May Mo, Krzysztof Składowski, Richard Lizambri, Yuhchyau Chen, Mon Gy Chen, Michael Hickey |
| المصدر: | Journal of Clinical Oncology. 29:2808-2814 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Cancer Research, medicine.medical_specialty, Randomization, Intention-to-treat analysis, business.industry, Head and neck cancer, Placebo-controlled study, medicine.disease, Placebo, Gastroenterology, Surgery, Oncology, Palifermin, Internal medicine, medicine, Mucositis, business, Chemoradiotherapy, medicine.drug |
| الوصف: | 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/m2 on days 1, 22, and 43) received palifermin (180 μg/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. |
| تدمد: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2010.32.4095 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::0959ae7433539affb2e34a32fef4e0d8 https://doi.org/10.1200/jco.2010.32.4095 |
| رقم الانضمام: | edsair.doi...........0959ae7433539affb2e34a32fef4e0d8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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| DOI: | 10.1200/jco.2010.32.4095 |