ABSTRACT

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Despite the inherent methodologic difficulties to be discussed in this chapter, analyses that have attempted to relate the intensity of cytotoxic chemotherapy to its effectiveness have had substantial influence both on the interpretation of data from cancer clinical trials and on recommendations for practice in oncology. Prior to a discussion of analytic pitfalls, a brief description of the evolution of the concept of dose intensity and its impact on the design and analysis of trials will be presented. It should be noted from the outset that although most discussions of these issues involve the term dose intensity, this term has been used in many ways. In fact, precisely how the amount of treatment given over time is quantified is an important problem in itself.