Prospective performance of an MRI algorithm for early re-direction of breast cancer neoadjuvant treatment

Motivation: In our preliminary study of breast cancer patients undergoing neoadjuvant treatment in the I-SPY 2 TRIAL, functional tumor volume (FTV)-based algorithm using 3-week and 6-week MRI successfully identified sub-optimal responders as potential candidates for early treatment re-direction. Goal(s): We aimed to evaluate the performance of the algorithm using data collected after the requirement for 6-week MRI based on 3-week response was officially added. Approach: We tested PPV and sensitivity of the algorithm in 146 patients enrolled in I-SPY 2 between October 2021 and June 2022. Results: The combined 3-week and 6-week MRI algorithm showed high PPV and high sensitivity in identifying sub-optimal responders. Impact: In the I-SPY 2 neoadjuvant breast cancer trial, an MRI-based algorithm demonstrated its ability to identify sub-optimal responders at 6 weeks of treatment. This will impact response-based personalization of treatment in future clinical trials and ultimately treatment in the clinic.