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Immunocology

Impact of the concomitant medication on immune-related adverse events in checkpoint inhibitor therapy

In this translational research project, the hospital pharmacy and the Department of Medicine II (Hematology and Oncology) of the University Hospital Augsburg are collaborating to systematically investigate how non-oncological concomitant medication influence the occurrence of immune-related adverse events (irAEs) and treatment outcomes in cancer patients receiving checkpoint inhibitor therapy.

Checkpoint inhibitors have significantly transformed oncological treatment strategies. However, irAEs are a common and potentially therapy-limiting complication. This project aims to identify patient-specific risk factors—particularly those related to concomitant medication—to better understand their impact on irAE development and treatment response. The findings are intended to inform clinical decision-making and support preventive and supportive care strategies.

Dr. Mareike Mannewitz (left) und Dr. Mathias Lutz (right)

In a retrospective part of the study, data from approximately 500 patients with solid tumors will be analyzed. This includes evaluation of medication records, immune status, and a broad range of clinical parameters. A molecular subanalysis is being conducted in a subgroup of patients with lung cancer: in cooperation with the Department of Pathology of the University Hospital Augsburg, tumor tissue is being examined using immunohistochemistry to explore potential associations between specific drug classes (e.g., proton pump inhibitors, biguanides, AT₁ blockers), immune cell infiltration in the tumor microenvironment, and clinical outcomes.

A prospective part of the study focuses on extended and standardized medication assessments of the medication history through structured interviews conducted by clinical pharmacists. Drug-related problems are identified and documented. The prospective cohort enables the collection of high-quality clinical and medication-related data. The resulting improvement in data quality - particularly with regard to concomitant medications - allows for a more targeted analysis of potential influences on the immune profile and treatment response. In addition, we secured an intramural research grant from the University of Augsburg, which will enable further molecular and immunological analyses within this cohort, thereby expanding the translational scope of the project. A description is available at https://www.uni-augsburg.de/de/fakultaet/med/forschung/forschungsfoerderung/bewilligungen/.

For patient care, knowledge of individual risk factors for irAEs has direct implications for risk-adapted treatment strategies, including the adjustment of concomitant medications to prevent irAEs and improve treatment efficacy. Looking ahead, the project also paves the way for targeted pharmaceutical counselling and patient education strategies to enhance adverse event management.

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