INTRODUCTION: Despite being one of the most important clinical outcomes in NMIBC, there is currently no standard definition of disease progression.
Major clinical trials and meta-analyses have used varying definitions or have failed to define this endpoint altogether. A standard definition of NMIBC progression as determined by reproducible and reliable procedures is needed.
PURPOSE: To examine current definitions of NMIBC progression and propose a new definition that will be more clinically useful for determining patient prognosis and comparing treatment options.
MATERIALS AND METHODS: The IBCG analyzed published clinical trials and meta-analyses that examined NMIBC progression as of December 2012. The limitations of the definitions of progression used in these trials were considered, as were additional parameters associated with advancement of NMIBC.
RESULTS: The most commonly used definition of NMIBC progression is an increase in stage from non-muscle invasive to muscle invasive disease. Although this definition is clinically important, it fails to include other important parameters of advancing disease, such as progression to lamina propria invasion and increase in grade.
CONCLUSIONS: The IBCG proposes the following definition of NMIBC progression: an increase in T stage from CIS or Ta to T1 (lamina propria invasion); development of =T2 or lymph node (N+) disease or distant metastasis (M1); or an increase in grade from low to high. Investigators should consider the use of this new definition to help standardize protocols and improve the reporting of progression.
Written by:
Lamm D, Persad R, Brausi M, Buckley R, Witjes JA, Palou J, Böhle A, Kamat AM, Colombel M, Soloway M. Are you the author?
Department of Surgery, University of Arizona; BCG Oncology, Phoenix, Arizona, USA.
Reference: J Urol. 2013 Aug 22. pii: S0022-5347(13)05149-5.
doi: 10.1016/j.juro.2013.07.102
PubMed Abstract
PMID: 23973937
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