SOFIA

SOFIA - Sex- and Gender-Specific Organ Toxicity Following Fluoropyrimidine-Based
Chemotherapy: An Integrative Analysis of Clinical and Patient-Reported Data
Summary: Women and men may experience chemotherapy side effects differently, but the reasons for these differences are not well understood. This project investigates how biological sex and genderrelated
factors influence the occurrence, perception, and management of treatment-related toxicities
across cancer types, with a focus on gastrointestinal cancers receiving systemic chemotherapy
with fluoropyrimidines. By combining routine healthcare data, patient questionnaires, laboratory
results, and treatment information, we aim to identify factors associated with differences in toxicity
and treatment modifications. In a subgroup of patients, chemotherapy drug levels will be measured
to explore biological mechanisms underlying these differences. The interdisciplinary consortium
brings together expertise in oncology, gender-sensitive medicine, patient-reported outcomes,
pharmacology, and health data science. The findings will inform the development of a sex- and
gender-sensitive framework for toxicity assessment and treatment management, supporting safer,
more effective, and more personalized cancer care.