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Methods for assessment of cancer drug activity.
The clinical benefits of new cancer chemotherapies can be reliably measured, more accurately than with conventional cytotoxic agents, by using biologic end points such as reduction in tumor size, changes in tumor cell proliferation and changes in tumor angiogenesis. Improvement of clinical outcome and a reduction of the incidence of morbidity and mortality will depend on implementation of these methods in clinical practice. By using a variety of animal models, we have sought to analyze the activity of new antimetabolites and alkylating agents, new antitumor antibiotics and antimetabolic agents and newer DNA synthesis inhibitors. Our approach is to test these agents against a variety of xenografts in a tumor-model system, starting with sensitive human tumors and progressing to more resistant tumors. This is relevant in that the former should predict activity in humans, while the latter serve as surrogates for tumor resistance mechanisms to the agents being evaluated. We have also used similar approaches in a variety of animal models, some of which are pharmacologically and physiologically more predictive than subcutaneous tumor models. Our intent is to assess multiple aspects of drug action in each tumor type, in each animal model, and in both single-agent and combination-therapy regimens. Tumor growth, angiogenesis, apoptosis, as well as drug uptake, metabolism and disposition, including pharmacologic and pharmacodynamic considerations relevant to tumor activity and normal tissue toxicity are all being analyzed. Correlative studies will assess the relevance of these measurements to the clinical situation.The majority of CSAs are growing vegetables that are consumed by individuals

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