(012) Characterization of Novel Longitudinal Oncology Real World Datasets in Germany and UK

Background: Real world oncology data with the clinical depth and recency to conduct rigorous pharmacoepidemiology studies in Europe is limited.

Objectives: Our objective was to identify cohorts of patients with cancer in Germany and UK for prospective longitudinal observational studies, define curation of variables and outcomes for harmonization across countries, and to describe the prevalence rates for positive biomarker test results here.

Methods: Patients were eligible if they had a diagnosis of breast cancer or non-small cell lung cancer (NSCLC) after 1 Jan 2016 and excluded if age < 18 years at time of diagnosis. The source was Flatiron Health Datascapes generated from HorizonDB, which includes 3.8 million patients electronic health record (EHR)-derived data from around the globe including the US, Germany, UK, and Japan. This study included Germany and UK patients. Prospective longitudinal follow-up began on 1 Jan 2024 after pre-specification of variable definitions. New relevant information is re-abstracted with 90-day recency by recurring EHR access from sites. Key variables include diagnosis date, stage, histology, drug dosage/units, ECOG performance status, biomarker test results, and mortality. For interim characterisation of the initial population, the prevalence of biomarker positivity is defined as the percentage of people whose most recent test result was positive among those who were tested.

Results: The cohort included 1,132 patients. Among patients with NSCLC in Germany (n = 151) and the UK (n = 579), the distribution of clinical staging was, respectively: Stages I-III (60%, 66%), Stage IV (40%, 34%). At least one biomarker test was recorded for 83% of patients in Germany and 64% in the UK. Pooling countries together, the prevalence rate of biomarker positive results (as a % of those tested) in NSCLC was: EGFR+ 10%, PDL1+ 54%, KRAS+ 37%. Results for BRAF, HER2, MET, ALK, NTRK, ROS1 and RET cannot be reported yet due to small sample size and will be reported as the cohorts grow. Among patients with breast cancer in Germany (n = 118) and the UK (n = 284), the distribution of clinical staging was, respectively, Stages I-III (79%, 84%) and Stage IV (21%, 16%). Most patients were tested for any biomarker in Germany (95%) and all were in the UK. The prevalence of biomarker positivity in Germany and UK breast cancer was: HER2+ 14%, ER+ 79%, and PR+ 65%.

Conclusions: The results were consistent with expectations, clinical practice, or previously published EU findings. These ongoing, growing, ambispective (retrospective and prospective) datasets were designed to be fit-for-purpose for oncology treatment comparative-effectiveness research and pooling across countries.