OBJECTIVES

The role of real‐world evidence (RWE) in healthcare decision‐making is constantly growing, acknowledged by recent FDA and EMA communications. Especially in oncology, a better understanding of the real-world treatment of patients is needed, both to compare RWE with clinical trial results and to identify unmet needs in the real-world (RW) treatment of patients. However, there is a lack of reliable data in this respect.

METHODS

We aimed to describe the RW treatment of patients included in a new electronic medical record databank targeting German oncology patients (INGRESS-Indivumed Liquid Biopsy RWE oncology database). The databank is built based on German outpatient oncology cases, it currently includes 14,145 oncology patients. It provides data on patient and disease characteristics, treatments, diagnostics including mutation/immunohistochemistry testing, and clinical outcomes; furthermore, for each patient blood draws for an ex-post mutation testing are available.

RESULTS

Most common cancer types in the database are breast cancer (BC), lung cancer (LC) and colon cancer (CC), with a proportion of 23.8%, 11.7% and 8.8%, respectively. The average age was 66.5 years in the overall sample (60.9/67.2/68.0 years in BC/LC/CC patients). Percentage of females was 56.3% (98.0%/40.6%/44.9%).

A mutation/immunohistochemistry test was conducted in 98.9% of the patients with BC (54.6% of patients with HER2+). Proportion of tested patients was 66.0%/55.9% in LC/CC. Most common mutation types in LC were PD-L1 and EGFR+ (53.0%/12.1% of tested LC patients) and KRAS in CC (42.5%).

The most frequently prescribed 1L treatment was paclitaxel in BC patients with/without HER2+, pembrolizumab in LC patients with PD-L1, carboplatin in non-PD-L1 LC patients, and irinotecan+folinic acid in KRAS+/non-KRAS CC patients.

CONCLUSIONS

The Indivumed Liquid Biopsy RWE oncology database has the potential to provide valuable insights into RW data on the treatment and treatment-associated outcomes of German oncology patients.