Verana Health, San Francisco, CA
Shannon Gallagher , Alyshah Abdul Sultan , Kathryn Sands , Iris Chin , Sarah Cote , Samuel Spigelman , Simona Baculea , Jennifer Bepple
Background: Bladder cancer ranks among the most common cancers globally. At diagnosis, 75% of patients have non-muscle-invasive bladder cancer (NMIBC). However, there is limited evidence on the real-world burden of NMIBC by risk categories specified by the International Bladder Cancer Group (IBCG). Large routinely collected data lack reliable granular information on tumor size, multiplicity, grade, and recurrence history and can lead to misclassification. Methods: Electronic health record data from the American Urological Association (AUA) Quality (AQUA) Registry, which is a national Qualified Clinical Data Registry was leveraged within the de-identified NMIBC Qdata module to identify and risk stratify patients based on the updated IBCG guidance. This EHR-derived module was linked to Komodo Health claims to increase capture of procedures. A random sample (n=2,500) from approximately 54,000 study-eligible NMIBC patients within the overall database was identified between 2015 and 2022 with a valid T-stage reading anytime in their medical record. Information on relevant parameters (e.g., tumor size, multifocality, stage, grade) were manually abstracted based on a standard protocol and summarized. Abstraction quality was ensured through a comprehensive disease and study training and test cases in which the clinical abstractor met ³85% agreement with the gold standard. Audits were also performed on ³10% of cases. Results: Of the 501 records initially abstracted, 96% of patients had information on relevant parameters to classify them by risk based on the IBCG guidelines. At first presentation during the study period, the majority of patients were Ta (65%), whereas 8% and 27% presented as Tis and T1, respectively. During the observation period, 291 (65%) patients were classified as high-risk whereas 114 (24%) and 135 (28%) were ever classified as low and intermediate risk, respectively. For patients with intermediate risk NMIBC, the proportion of newly diagnosed versus recurrence was similar (50%). Conclusions: This study leveraged one of the largest US-created NMIBC databases to provide contemporary, real-world distribution of NMIBC risk founded on the updated IBCG guidance. The study demonstrates that a high proportion of NMIBC patients that have explicit tumor characteristics documented are classified as high risk followed by intermediate risk, warranting the need for innovative therapies in these patient groups.
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