From staging to changing strategy: [18F]FDG PET/MRI's impact on treatment planning in early breast cancer.
Abstract
INTRODUCTION Accurate staging at diagnosis is essential for optimizing treatment strategies and prognosis in early breast cancer (EBC). [18F]FDG positron emission tomography/magnetic resonance imaging (PET/MRI) is a hybrid imaging modality that enables simultaneous evaluation of locoregional disease and metastatic spread. This study assessed the impact of [18F]FDG PET/MRI on treatment planning in patients with EBC.
Methods
This unplanned sub-study derives from a prospective, interventional, single-arm clinical trial (SNB vs PET/MRI 2) conducted at San Raffaele University Hospital (Milan) between July 2020 and April 2024 (NCT04829643). Patients with EBC scheduled for primary surgery underwent additional preoperative [18F]FDG PET/MRI. The primary objective was the proportion of patients whose treatment strategy was modified following [18F]FDG PET/MRI findings and multidisciplinary discussion. The secondary objective was the performance of [18F]FDG PET/MRI in detecting multifocal breast cancer compared with standard imaging.
Results
A total of 264 patients were analyzed. [18F]FDG PET/MRI led to treatment plan modifications 30.7% (81/264, 95% CI: 25.4%-36.5%) of patients. Surgical approach was altered in 23.9% (63/264), while 4.9% (13/264) received primary systemic therapy and 1.9% (5/264) were referred for systemic therapy alone. [18F]FDG PET/MRI showed a sensitivity of 61.7%, specificity of 84.9%, positive predictive value (PPV) of 49.2%, and negative predictive value (NPV) of 90.4% for multifocal disease detection. When combined with standard imaging, PPV increased to 63.6%; sensitivity was 29.8%.
Conclusions
[18F]FDG PET/MRI substantially influences treatment decisions in EBC, modifying management in nearly one-third of patients. MRI was highly informative for detecting multifocal disease, whereas the potential added value of [18F]FDG PET/MRI may primarily relate to integrated axillary and distant staging. However, its moderate diagnostic accuracy warrants caution to prevent overtreatment.