Evolving Real-world Trends in Biomarker Testing for Bladder Cancer: A Comprehensive Retrospective Analysis from the US Community Oncology Setting (2015-2024)

Author(s)

Lisa Herms, PhD, Helen Latimer, MPH, Zhaohui Su, PhD, Jessica K. Paulus, ScD, Robert L. Reid, MD, FACP;
Ontada, Boston, MA, USA

Presentation Documents

OBJECTIVES: Knowledge of the molecular pathogenesis of bladder cancer (BC) has identified new therapeutic targets, leading to the development of drugs targeting PD-L1, FGFR2/3, and HER2. Molecular profiling is now recommended for all patients with metastatic BC. However, barriers like access, cost, and variable testing protocols persist, particularly in diverse community settings. This study examined real-world trends in biomarker testing for BC within a US community oncology network over the past decade.
METHODS: This retrospective observational study utilized structured data from oncology-specific electronic health records within The US Oncology Network and non-Network practices for adult patients diagnosed with metastatic BC between January 2015 and December 2024. Testing for FGFR2/3, HER2, and PDL-1 was assessed within 30 days of metastatic diagnosis.
RESULTS: The study included 5,797 patients, predominately male (75%) and Caucasian (90%), with a median age of 73 years. Most (61%) were de novo metastatic; 26% progressed from Stage I-III, and 13% progressed but an initial stage was unknown. Overall testing increased from <1% in 2015 to 72% in 2024, with a notable spike starting in 2019. PD-L1 testing drove overall rates. Testing for PD-L1 and HER2 substantially improved by 2024 (68% and 13%) and by 2021 (21%) and 2022 (20%) for FGFR2 and FGFR3, respectively. Testing rates were often higher for progressing than de novo patients.
CONCLUSIONS: Biomarker testing has significantly increased over the past decade. Gaps remain, especially for FGFR2/3 and HER2, although this may stem from data limitations, restricting to testing within 30 days, and including untreated patients who were never candidates for testing. Annual trends also suggest that testing rates may be influenced by the timing of regulatory approval for targeted companion therapies, the setting for these treatments, and subsequently evolving practice guidelines. This study highlights an encouraging trend towards more testing, which is promising as new BC treatments emerge.

Conference/Value in Health Info

2025-05, ISPOR 2025, Montréal, Quebec, CA

Value in Health, Volume 28, Issue S1

Code

RWD17

Topic

Real World Data & Information Systems

Topic Subcategory

Health & Insurance Records Systems

Disease

SDC: Oncology

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