USE OF BODY SURFACE AREA AS A DETERMINANT OF DOSE IN CANCER STUDIES
Author(s)
Trappe RU1, Cooke C2, Heatley R2, Johnson KI2, Wiesner C31Universitätsklinikum Schleswig-Holstein, Kiel, Germany, 2Complete Clarity, Macclesfield, Cheshire, United Kingdom, 3F. Hoffmann-La Roche Ltd., Basel, Switzerland
OBJECTIVES: With the lack of alternative strategies for calculating the dose of cytotoxic drugs in chemotherapy regimens, body surface area (BSA), despite well-documented limitations, remains the most frequently used measure for dosing guidelines. This is based on the assumption that physiological variables related to drug metabolism and elimination, such as basal metabolic rate, renal and hepatic function, vary between individuals according to BSA. BSA has traditionally been calculated using a formula derived from Du Bois and Du Bois and published in 1916. It is recognised this is probably not the most accurate method of calculating chemotherapy doses, since the formula was derived from metabolic studies using a small number of subjects. The practice of calculating chemotherapy dose adjusted to BSA has drawn attention due to its lack of clear scientific basis, and lack of applicability to different genders, disease states, and culture. METHODS: A systematic literature review was conducted using CRD methodology to establish the average BSA in cancer patients in Europe and the variability between genders, tumour types, and cultures. RESULTS: Meta-analysis of the findings showed significant differences between genders overall (females 1.72m2 vs males 1.88m2), between different tumour types (range 1.68m2 to 1.93m2) and between different European countries (range 1.74m2 to 1.83m2). However, statistical modelling showed that a BSA of 1.80m2 approximated the population mean and identified the dispersion to be 1.72-1.87m2and was therefore a valid approximation for the majority of cancer patients in Europe. CONCLUSIONS: Establishing a patient’s BSA is important in determining the appropriate dosage regimen, but the population norm serves as a useful basis for drugs administered in a fixed dose formulation.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PRM142
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Oncology