The model for drug development in solid tumor malignancies in general, and in colon cancer in particular, has been first to identify a new agent that is effective in patients with refractory disease, and then to use that agent (alone if it is active enough, or in combination with the older agent or regimen if it is not) for patients with metastatic disease and demonstrate improved overall survival, progression-free survival, or both in a randomized trial against the previous standard. That new agent or new agent-containing combination is then used in a randomized trial in the adjuvant setting with the hope of improving the cure rate after definitive surgery. This approach is time-honored and is based on rational expectations, an acceptable apportionment of risk tolerance among patients at various stages of their diseases, and even some positive test results. But what if this strategy is wrong?
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