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Bladder Cancer: More Questions Than Answers With pCR Endpoint

 
• By Derrick Gingery

Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

Bladder-cancer-cells
Validating pCR as a surrogate endpoint could help advance drug development in muscle-invasive bladder cancer. • Source: Shutterstock

Physicians and researchers laid out so many problems with using pathologic complete response in muscle-invasive bladder cancer that some attendees at a recent workshop co-sponsored by the US Food and Drug Administration may have thought it was not worth exploring as a potential surrogate endpoint.

But Evan Yu, medical director for clinical research support at the Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium,...

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