Need To Consider Strategies As Well As Treatments

Monitoring multiple outcomes simultaneously, ideally based on desirable trade-offs among these outcomes, is an example of a "multiplicity." A second type of multiplicity arises because a given patient with secondary AML/MDS (or cancer) typically receives multiple treatment regimens. Administration of one therapy may affect outcome with a subsequent therapy. For example, because "targeted therapies" may affect multiple targets, a therapy directed at target "X" may also "down (or up) regulate" target "Y," thereby influencing response to a future therapy aimed at Y. It is possible that patients of age 60 and above with high-risk MDS or secondary AML/MDS might have less TRM if given LI first, and HI only should LI fail. However the reverse approach might be preferable if HI's antileukemia effect is significantly greater than that of LI, outweighing any reduction in TRM with the LI first strategy. Thus, the issue is evaluation of a multicourse treatment strategy, rather than a particular treatment, with a goal of assessing which is the preferable sequence of

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