Extract

Grochow et al. (1) questioned the use of body surface area in dose normalization more than a decade ago in this Journal. In this issue, Baker et al. (2) retrospectively assessed the pharmacokinetics of 33 investigational agents tested in phase I trials during the past decade as a function of body surface area in 1650 adult cancer patients. Based on their findings, they recommend that the practice of calculating starting doses on the basis of body surface area in phase I trials should be abandoned. Historically, we have initiated phase I dosing based on body surface area and then retained the practice, carrying it forward through phase II and III studies and ultimately to Food and Drug Administration labeling. Should we accept the recommendation by Baker et al. and abandon the use of body surface area for dose determination? To answer this question it may be useful to put body surface area-based dosing of anticancer agents into perspective.

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