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Personalized medicine (also referred to as individualized treatment) is a model of the way medicine will evolve through the use of specific treatments and therapeutics best suited to an individual's genotype. There has been much discussion of the scientific, social, economic, and ethical considerations of personalized medicine.1,2Cancer therapy presents a unique example of personalized medicine in which an individual's genotype is important in so far as it determines not only the therapeutic and toxic responses to a drug (the pharmacogenotype), but also the genotype of the tumor. Cancer therapy stands today at a confluence of two movements, one toward personalized medicine and the other toward the use of new molecularly targeted cancer drugs that exploit the tumor's molecular signature. This commentary focuses on the unique challenges of achieving the goal of personalized medicine for cancer. This encompasses both the prevention of preneoplastic or early cancer and the therapy of advanced cancer.
To achieve the goal of personalized medicine, it is necessary to develop drugs with defined molecular specificities and to have biomarker and imaging tests, preferably noninvasive to identify the molecular targets in a patient's tumor and the patient's pharmacogenotype. A related and sometimes linked objective of the same tests is to have a way to measure the effect of a drug on its molecular target. Clearly, an important question is how much drug is required to inhibit the molecular target in a tumor and whether there is a benefit to giving more drug. Alternatively, will such maneuvers only increase the chances of toxicity?3It is also desirable to have a test to assess early response so that a nonresponding patient can be spared unnecessary treatment and be moved to alternate therapies. If a noninvasive test is not available, there may be reluctance to take solid tumor …
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