Combining drugs and extending treatment — a PFS end point is not sufficient

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Abstract

In studies investigating the combination of two or more anticancer drugs that are already approved for independent use, or ‘maintenance’ regimens, the use of progression-free survival as the end point for approval is inadequate; sequential treatment with the same agents or existing salvage therapies, respectively, might provide an equivalent survival benefit, with lower toxicity, cost, and treatment burden, therefore, the use of an overall survival end point is essential to justify such interventions.

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