Abstract
Overall survival (OS) is a measure of efficacy for oncology therapies targeting metastatic disease. As science evolves, therapies are being developed to treat disease in the early-stage, non-metastatic setting where treatment intent is curative. Given the early setting, and prolonged survival, demonstrating OS within a clinical trial setting may not be feasible. In these cases, disease free survival (DFS) is a relevant regulatory endpoint. Our objective was to assess whether DFS was an acceptable endpoint for HTA decision-making purposes.
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