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| Assessment of Oral Mucositis |
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There is little consistency in the terminology applied to oral mucositis. For example,
the terms stomatitis and mucositis have been used interchangeably when describing inflammatory
oral conditions.
Accurate assessment of oral mucositis is of fundamental
importance to the development
of effective new therapeutic agents.1 Assessment scales must precisely describe mucosal damage,
reproducibly measure severity, objectively classify changes, and link
underlying molecular
mechanisms to clinically relevant outcomes
such as improvement in ulceration or degree of pain reduction.1
A number of assessment scales are commonly used, which are
described below.
The assessment scales used in the Kepivance®
(palifermin) phase 3 clinical trial are described in Table 1.
Table 1. Comparison of Oral Mucositis Assessment Scales2-5
| WHO |
None |
Soreness
± erythema |
Erythema,
ulcers, and
patient can
swallow
solid food |
Ulcers with
extensive
erythema
and patient
cannot
swallow
solid food |
Mucositis
to the extent
that alimentation
is not possible |
| RTOG |
None |
Erythema
of the
mucosa |
Patchy
reaction
< 1.5 cm,
noncontiguous |
Confluent
reaction
> 1.5 cm,
contiguous |
Necrosis or
deep
ulceration,
± bleeding |
| WCCNR |
Lesions:
none
Color:
pink
Bleeding:
none |
Lesions:
1-4
Color:
slight red
Bleeding:
N/A |
Lesions:
> 4
Color:
moderate red
Bleeding:
spontaneous |
Lesions:
coalescing
Color:
very red
Bleeding:
spontaneous |
N/A |
|
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Adapted from the WHO, RTOG, and WCCNR scales.
WHO = World Health Organization; RTOG = Radiation Therapy Oncology Group;
WCCNR = Western Consortium for Cancer Nursing Research
The World Health Organization (WHO) Oral Toxicity Scale measures anatomical, symptomatic, and functional
components of oral mucositis.2 The severity of the condition is graded from 0 (no oral mucositis) to 4 (alimentation
not possible and the patient needs TPN) (Table 1). By contrast, the Radiation Therapy Oncology Group (RTOG) Acute
Radiation Morbidity Scoring Criteria for mucous membranes and the revised oral mucositis staging system of the Western
Consortium for Cancer Nursing Research (WCCNR) measure only the anatomical changes associated with oral mucositis.3,5
The WCCNR scale is a 4-grade assessment tool (Table 1).
In 1982, the National Cancer Institute (NCI) created the Common Toxicity Criteria (NCI-CTC) for the evaluation
of CT-related effects, and the RTOG developed the Acute Radiation Morbidity Scoring Criteria for the evaluation of RT
effects (separate criteria were also developed for the late effects of RT).4 In 1997, the NCI revised the original CTC.
The RTOG appointed a panel to revise the RTOG scoring criteria and the revised RTOG was incorporated into the NCI-CTC
to produce version 2.0, which has been used in all NCI-sponsored clinical trials since March 1998.4,5 The latest available
revision of the NCI-CTC version 2.0 is dated as April 30, 1999. Although an updated NCI-CTC scale was released in December 2003,
widespread implementation will take time.6
The RTOG assessment scale utilized in the Kepivance® phase 3 trial consists of 5 grades (Table 1) and has been shown
to provide an effective measure of the mucosal toxicity of anticancer therapeutic regimens. Severity of oral mucositis is graded
from 0 (no oral mucositis) to 4 (necrosis or deep ulceration present, with or without bleeding). This RTOG scale is an integral part
of the NCI-CTC version 2.0.5
The Oral Mucositis Assessment Scale (OMAS) has been shown to be
highly reproducible between observers, responsive over time, and accurate
in recording elements associated with mucositis.1 The OMAS provides an objective
assessment of oral mucositis based on scoring of the presence and size
of ulcerations or pseudomembranes (score 0 to 3: 0 = no lesion; 1 = lesion < 1cm2;
2 = lesion of 1cm2 to 3cm2; 3 = lesion > 3cm2)
and erythema (score 0 to 2: 0 = none; 1 = not severe; 2 = severe) on the
upper and lower lips, right and left cheeks, right and left ventral and
lateral tongue, floor of the mouth, soft palate/fauces, and hard palate.1,7
The Oral Mucositis Index (OMI) assesses the severity of oral mucositis
in terms of erythema, ulceration, atrophy, and edema (each graded on a scale of 0 to 3,
where 0 = none and 3 = severe). The OMI has been shown to be internally consistent with
high test-retest and inter-rater reliability and exhibits strong evidence of construct validity.8
These validated scales are essential for assessing the efficacy of new treatments for oral mucositis.
| 1 |
Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Mucositis Study Group. Cancer. 1999;85:2103-2113. |
| 2 |
World Health Organization. Handbook for reporting results of cancer treatment. Geneva, Switzerland: World Health Organization; 1979:15-22. |
| 3 |
WCCNR: Assessing stomatitis: refinement of the Western Consortium for Cancer Nursing Research (WCCNR) stomatitis staging system. Can Oncol Nurs J. 1998;8:160-165. |
| 4 |
Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys. 2000;47:13-47. |
| 5 |
National Cancer Institute Common Toxicity Criteria. Version 2.0, June 1, 1999. Available at: http://ctep.info.nih.gov. Accessed January 20, 2005. |
| 6 |
National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Cancer Therapy Evaluation Program. Released December 2003. Available at: http://ctep.info.nih.gov. Accessed January 20, 2005. |
| 7 |
Sonis ST, Oster G, Fuchs F, et al. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol. 2001;19:2201-2205. |
| 8 |
McGuire DB, Peterson DE, Muller S, et al. The 20 item oral mucositis index: reliability and validity in bone marrow and stem cell transplant patients. Cancer Invest. 2002;20:893-903. |
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ABOUT ORAL MUCOSITIS
ABOUT KEPIVANCE®
TOOLS AND RESOURCES
FOR NURSES
FOR PHARMACISTS
IMPORTANT PRODUCT SAFETY INFORMATION
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