Evaluating the Surrogacy of Pathological Complete Response at Radical Cystectomy in Neoadjuvant-based Muscle-invasive

Pietro Scilipoti1, Aleksander Ślusarczyk2, Constance Thibault3

  • 1Department of Experimental Oncology/Unit of Urology, Urological Research Institute (URI), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Summary

Pathological complete response (pCR) is not a validated surrogate for overall survival (OS) in muscle-invasive bladder cancer (MIBC) neoadjuvant trials. This study found pCR did not meet trial-level surrogacy criteria for OS, questioning its use in trial design.

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