ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Fibroblast Growth Factor, Palifermin, May Reduce Incidence Of Oral Mucositis In Head And Neck Cancer Patients Undergoing Radiochemotherapy Treatment
Clinical Question In a head and neck cancer patient receiving radiochemotherapy, does growth factor Palifermin reduce the incidence of oral mucositis compared to those patients who receive a placebo? (See Comments on the CAT below)
Clinical Bottom Line Introducing a head and neck cancer patient to a single dose of palifermin before each cycle of radiochemotherapy reduces the incidence and severity of oral mucositis. However there are questions pertaining to the actual clinical relevance of the drug that require future study.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 21670447Henke/2011186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.a multicenter, double-blind, randomized, placebo-controlled trial
Key resultsSevere oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). It did reduce the occurrence of severe oral mucositis in patients, but could not definitely prove the clinical relevance of this observation. Palifermin-treated patients did not experience fewer treatment breaks or lower average MTS scores. These MTS scores were assessed using the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer.
#2) 21670453Le/2011Total of 188 patients divided in half. Palifermin (n = 94) and placebo (n = 94) arms were well balanced.Randomized, placebo-controlled, double-blind study
Key resultsThe incidence of severe OM was significantly lower for palifermin than for placebo (54% v 69%; P = .041). After multiplicity adjustment the differences in results were not significant enough to declare palifermin as successful. After median follow-up of 2 years, overall survival was similar between the two treatments.
Evidence Search (("Fibroblast Growth Factor 7" AND "Stomatitis"
Comments on
The Evidence
A systematic review with meta-analysis is the strongest evidence to obtain. Both of these articles used Placebo-Controlled Randomized Controlled Trials; producing a relatively small sample size but with a strong form of Evidence Based Research. Both articles made oral assessment of mucositis by using World Health Organization (WHO) oral toxicity scale (grades 0 to 4). If the patient received a grade of 3 or 4 from a trained evaluator, he or she was considered suffering from functioning OM. Both studies had evidence that palifermin not only reduced the incidence of OM, but also delayed appearance and shortened the duration of severe OM. However, palifermin did not alter mouth and throat soreness (MTS) scores significantly in either study, nor did it reduce the occurrence of treatment breaks.
Applicability The evidence is applicable to head and neck cancer patients undergoing radiochemotherapy who are at risk for oral mucositis. However there remains debate as to the clinical value of using palifermin in this cancer patient cohort and further study is necessary.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (Periodontics)
Keywords Head and Neck Caner, Radiochemotherapy, Palifermin, Fibroblast Growth Factor 7, Oral Mucositis (Grade 2,3,4)
ID# 2284
Date of submission: 04/19/2012spacer
E-mail simmonsm@livemail.uthscsa.edu
Author Matthew Simmons
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Michaell Huber, DDS
Faculty mentor/Co-author e-mail HuberM@uthscsa.edu
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