Ziel/Aim: As the PERCIST criteria have been originally developed for the assessment of drug
trials with a strongly generalized and study-centric approach, their application in
clinical response monitoring is not fully suitable. We propose a further development
of PERCIST with a more personalized and patient-centric focus for response monitoring
aiming for a better individual assessment: the PREMIO (Personalised Response Monitoring
In Oncology) criteria.
Methodik/Methods: Evolving from the one-lesion PERCIST, we further develop the criteria based on a
prospectively acquired dataset of [18F]-FDG-PET/CT response monitoring cases of 87
metastatic breast cancer patients with a median of 6 follow-up scans [1] without change of therapy. For the determination of the suitable SULpeak increase
for progression in the PREMIO criteria, the probability for false positive progression
was minimized based on a regression analysis of the SULpeak values in stable periods
of the patients. Ideal ground truth time point of progression has been determined
by consent of two nuclear medicine physicians after validating the progression in
the follow-up scans.
Ergebnisse/Results: Major changes in PREMIO with respect to PERCIST are: the introduction of the nadir
scan with the lowest SULpeak as the reference scan for progression; the definition
of measurability and comparability on scan level and between current scan and reference
scan; a 50% SULpeak increase criterium for progression in comparison to nadir; the
integration of a molecular imaging RADS for the assessment of new lesion (submitted
to NuklearMedizin 25); and definitions for the progression based on anatomic increase
and visual assessment. PREMIO is better suitable for clinical response monitoring
than PERCIST with a PPV of 94% vs. 84% and a NPV of 100% vs. 63%.
Ergebnisse/Conclusion The new PREMIO criteria fill the gap for an objective and patient-centric response
monitoring system of solid tumors PET/CT scans. The modular approach with possible
different molecular imaging RADS also suggests the application in other tumor entities
and other tracers than [18F]-FDG, which is to be further evaluated.