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Henke, M; Alfonsi, M; Foa, P; Giralt, J; Bardet, E; Cerezo, L; Salzwimmer, M; Lizambri, R; Emmerson, L; Chen, MG; Berger, D.
Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial.
J CLIN ONCOL. 2011; 29(20): 2815-2820. Doi: 10.1200/JCO.2010.32.4103 [OPEN ACCESS]
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Friedrich Michaela

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Purpose Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela. Methods We conducted a multicenter, double-blind, randomized, placebo-controlled trial in 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received 60 or 66 Gy after complete (R0) or incomplete resection (R1), respectively, at 2 Gy/fraction and five fractions per week. Cisplatin 100 mg/m(2) was administered on days 1 and 22 (and on day 43 with R1). Patients were randomly assigned to receive weekly palifermin 120 mu g/kg or placebo from 3 days before and continuing throughout radiochemotherapy. Trained evaluators performed oral assessments twice weekly. The primary end point was the incidence of severe oral mucositis (WHO grades 3 to 4). Overall survival and time to locoregional progression were also assessed. Analysis was by intention to treat. Results Severe oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). Palifermin decreased the duration (median, 4.5 v 22.0 days) and prolonged the time to develop (median, 45 v 32 days) severe mucositis. Neither patient-reported mouth and throat soreness scores nor treatment breaks differed between treatment arms. After median follow-up of 32.8 months, 23 deaths (25%) had occurred in both treatment arms, and disease had recurred in 25 (27%) and 22 (24%) of palifermin- and placebo-treated patients, respectively. Conclusion Palifermin reduced the occurrence of severe oral mucositis in patients with head and neck cancer undergoing postoperative radiochemotherapy. Additional clinical exploration of palifermin with postoperative radiochemotherapy would be useful.
Find related publications in this database (using NLM MeSH Indexing)
Antineoplastic Agents - adverse effects
Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology Carcinoma, Squamous Cell - radiotherapy
Chemotherapy, Adjuvant - adverse effects
Cisplatin - adverse effects
Double-Blind Method -
Drug Toxicity -
Female -
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
Humans -
Intention to Treat Analysis -
Male -
Middle Aged -
Radiotherapy, Adjuvant - adverse effects
Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use
Stomatitis - etiology Stomatitis - prevention and control
Survival Analysis -

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