Measuring postirradiation subcutaneous soft-tissue fibrosis: state-of-the-art and future directions.

Clinician-based rating scales and quantitative instruments used to quantify the severity of soft-tissue fibrosis were reviewed to determine if they were reliable and valid measures for clinical and research use. Existing clinician-based measures, the Medical Research Council (MRC) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG), have preliminary testing of reliability and validity such that they provided a basis for the development of a revised measure. The revised measure, designed for use in National Cancer Institute-Common Toxicity Criteria for Adverse Events v3.0, evaluates subcutaneous and deep-tissue fibrosis separately and each is graded on a 5-point scale. The revised measure needs to be tested for reliability and validity, and it is recommended that it be used in concert with the MRC and/or EORTC/RTOG scales until such evidence is available and its utility can be determined. Quantitative measures, although attractive from a research perspective, will have limited clinical and multisite utility because of the apparatus required and the associated costs. Finally, a framework for evaluating fibrosis and the consequences of fibrosis is presented.