Presentation (CTI)

OBJECTIVES: Despite the 2023 German CLL guidelines emphasizing TP53 aberrant and IGHV unmutated status testing for treatment decisions, many patients remain untested. This research examines molecular testing frequency in clinical practice in Germany and explores physician-reported barriers to implementation.
METHODS: A retrospective data collection across 30 institutions using a structured eCRF was conducted on incident or prevalent CLL patients with causal treatment between 2021 and 2023 in Germany. Institutions with low molecular testing rates were identified, and qualitative clinician feedback was analyzed using thematic analysis. Barriers were categorized by patient characteristics, clinical workflows, and systemic factors.
RESULTS: The 2023 German CLL guidelines emphasize molecular testing for treatment decisions. However, real-world adherence is around 80%, below the expected near 100%. Approximately 46% of untested patients received BTK inhibitors (BTKi). Among 30 centers, 27 (90%) had documented patients with no testing performed, with 18 (67%) providing rationale for non-adherence to the guidelines. Five barriers to molecular testing adherence were identified: Perceived Relevance: Testing was deemed unnecessary for older patients on long-term therapies or those with pre-determined treatment plans. Practice Patterns: Testing was viewed as prognostic rather than predictive, especially for BTKi treatments in older patients. Cost and Resources: High costs and insufficient sample availability discouraged testing, with additional testing deemed unnecessary. Historical Practices: Inconsistent testing for older patients or those with pre-planned BTKi regimens led to gaps in molecular data in later lines. Referral Issues: Patients from private practices or with outdated diagnostics lacked molecular data due to insufficient testing at initial diagnosis.
CONCLUSIONS: These findings expose gaps in molecular testing, driven by perceptions of limited clinical relevance, logistical barriers, and systemic issues. Addressing these challenges through education, streamlined workflows, and strategies to mitigate cost together with material constraints is crucial for aligning real-world practice with treatment guidelines.