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Related Experiment Video

Updated: Jan 18, 2026

Minimally Invasive Establishment of Murine Orthotopic Bladder Xenografts
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End Points for the Next-Generation Bladder-Sparing Perioperative Trials for Patients With Muscle-Invasive Bladder

Andrea Necchi1,2, Matthew D Galsky3, Nazli Dizman4

  • 1Vita-Salute San Raffaele University, Milan, Italy.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|September 11, 2025
PubMed

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Summary

Standardized outcome measures for muscle-invasive bladder cancer (MIBC) bladder preservation strategies were established. Clinical complete response (cCR) and event-free survival (EFS) are key endpoints for evaluating bladder-sparing treatments.

Area of Science:

  • Oncology
  • Urology
  • Clinical Trial Design

Background:

  • Muscle-invasive bladder cancer (MIBC) treatment is evolving, necessitating new trial designs for bladder preservation.
  • Evaluating organ preservation strategies requires standardized outcome measures.

Purpose of the Study:

  • To establish standardized outcome measures for evaluating organ preservation strategies in MIBC.
  • To develop a framework for risk-adapted bladder-sparing treatment approaches for MIBC.

Main Methods:

  • Convened an international, multidisciplinary consensus panel including experts and patient advocates.
  • Reviewed literature and developed draft recommendations.
  • Utilized a modified Delphi process with voting to achieve consensus.

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Last Updated: Jan 18, 2026

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Main Results:

  • Defined clinical complete response (cCR) encompassing absence of malignancy on pathology, cytology, and imaging.
  • Recommended event-free survival (EFS) as the preferred primary endpoint for durability.
  • Emphasized prespecification of events, intention-to-treat analysis, and continuous patient preference assessment.

Conclusions:

  • The consensus definition of cCR and the presented framework provide a foundation for testing bladder-sparing treatments in MIBC.
  • Risk-adapted bladder-sparing paradigms require thorough evaluation using standardized endpoints.