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Revisiting OPTIMIST trial imaging criteria for pathologic complete response to neoadjuvant therapy
Ji-Jung Jung1, Jayme Natasha K Paggao2, Na Hye Han3
1Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Surgery, Samsung Medical Center, Seoul, Republic of Korea.
Summary
Omission of breast surgery after neoadjuvant systemic therapy (NST) is not yet feasible based on imaging criteria alone. Pathologic confirmation via biopsy remains essential for accurate assessment of complete response.
Area of Science:
- Oncology
- Radiology
- Breast Cancer Research
Background:
- Neoadjuvant systemic therapy (NST) can induce pathologic complete response (pCR) in some breast cancer patients.
- Omitting surgery after NST could reduce treatment burden for exceptional responders.
- Reliable prediction of pCR is crucial for safe surgical omission strategies.
Purpose of the Study:
- To assess the performance of OPTIMIST imaging criteria in predicting pCR after NST.
- To explore if refined imaging thresholds can improve clinical applicability for surgical omission.
- To evaluate the negative predictive value (NPV) of imaging criteria for pCR.
Main Methods:
- Retrospective review of 499 eligible breast cancer patients treated with NST and surgery.
- Evaluation of OPTIMIST criteria: post-NST tumor size, lesion-to-background signal enhancement ratio (L-to-B SER), and residual calcifications.
- Comparison of original OPTIMIST criteria with modified tumor size thresholds for predicting pCR.
Main Results:
- Original OPTIMIST criteria (tumor size ≤1 cm, L-to-B SER ≤1.6, calcifications ≤2 cm) showed a 69.3% NPV and 16.1% false-negative rate for pCR.
- Residual tumor size and SER were predictive of pCR, while calcifications indicated residual disease.
- Expanding tumor size threshold to ≤2 cm maintained NPV (67.5%) and increased patient eligibility by 19%.
Conclusions:
- Current imaging criteria alone are insufficient to guide omission of breast surgery post-NST.
- Pathologic confirmation through image-guided biopsy remains necessary for assessing pCR.
- Refined imaging thresholds may enhance clinical utility without sacrificing predictive accuracy.