WP6 focuses on creating a new set of response monitoring criteria for metastatic breast cancer, known as the PREMIO criteria (PET/CT Response Monitoring in Oncology). These criteria guide clinicians in determining whether a patient’s current therapy is effective or if disease progression requires switching to a new treatment. The goal is to identify progression at the optimal time point—not too early and not too late—minimizing unnecessary side effects and ensuring timely access to more effective therapies.
Building on the widely used PERCIST framework, WP6 adapted key elements to suit the longer monitoring periods typical in metastatic breast cancer. For example, the PREMIO criteria introduce the nadir scan (the scan showing the best response so far) as the reference point for declaring progression, improving sensitivity and accuracy. Additionally, a classification system for new lesions was developed to reduce false positives and ensure that declared progression truly reflects disease advancement.
Validated through extensive analysis of FDG-PET/CT scans from a large patient dataset, the PREMIO criteria are now ready for application in the MONITOR-RCT study, providing a robust and clinically relevant approach to response monitoring in metastatic breast cancer.