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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) 21670447 | Henke/2011 | 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. | a multicenter, double-blind, randomized, placebo-controlled trial | | Key results | Severe 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) 21670453 | Le/2011 | Total of 188 patients divided in half. Palifermin (n = 94) and placebo (n = 94) arms were well balanced. | Randomized, placebo-controlled, double-blind study | | Key results | The 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) (Dental Hygiene) |
| Keywords |
Head and Neck Caner, Radiochemotherapy, Palifermin, Fibroblast Growth Factor 7, Oral Mucositis (Grade 2,3,4)
|
| ID# |
2284 |
| Date of submission: |
04/19/2012 |
| E-mail |
simmonsm@livemail.uthscsa.edu |
| Author |
Matthew Simmons |
| Co-author(s) |
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| Co-author(s) e-mail |
|
| Faculty mentor/Co-author |
Michaell Huber, DDS |
| Faculty mentor/Co-author e-mail |
HuberM@uthscsa.edu |
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?) |
post a rationale |
| None available | |
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Comments and Evidence-Based Updates on the CAT
(FOR PRACTICING DENTISTS', FACULTY, RESIDENTS and/or STUDENTS COMMENTS ON PUBLISHED CATs) |
post a comment |
| None available | |
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