This retrospective study analyzed data from 600 patients with node-positive breast cancer (clinical stage cT1–4 and cN1-3) who received neoadjuvant therapy between January 2011 and January 2024. The primary objective was to assess a multimodal nomogram that integrated ultrasonography, magnetic resonance imaging, and clinicopathological features to predict axillary pathological complete response (pCR). No comparator group was reported for this predictive modeling exercise.
The analysis identified independent predictors of axillary lymph node pCR after neoadjuvant therapy. These included ypT2 (p < 0.001), ypT3 (p = 0.007), HER2 status (p < 0.001), response PR (p = 0.007), efficacy evaluation showing SD/PD (p = 0.010), and the presence of the Hilum of the lymph gland on ultrasonography after neoadjuvant therapy (p < 0.001). The nomogram achieved an area under the curve (AUC) of 0.934 (95% CI: 0.913-0.960) in the training set and 0.908 (95% CI: 0.867-0.950) in the validation set. Sensitivity was 82.0% and specificity was 89.1% in the training set.
Safety data, including adverse events, discontinuations, or tolerability, were not reported for this study. Key limitations include the retrospective nature of the data collection, the absence of a comparator group, and the lack of reported follow-up duration. Additionally, the study phase and publication type were not reported. The model's performance relies on specific imaging and pathological features that must be available in the clinical setting.
In practice, this model may help accurately identify patients with axillary lymph node pCR after neoadjuvant therapy. Such identification could potentially prevent unnecessary axillary lymph node dissection in selected patients. However, clinicians should interpret these results cautiously given the observational design and the absence of external validation data beyond the internal validation set.
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ObjectivesThis study aims to create a model that combines ultrasonography (US), magnetic resonance imaging (MRI) examination, and clinicopathological features to predict the axillary pathological complete response (pCR) of patients with breast cancer (BC) who receive neoadjuvant therapy (NAT).MethodsThis retrospective study included 600 patients with node-positive breast cancer who were eligible for enrollment (clinical stage cT1–4 and cN1-3) and received neoadjuvant therapy from January 2011 to January 2024. Before biopsy and neoadjuvant therapy, these patients underwent ultrasound (US) and MRI imaging of breast lesions and axillary lymph nodes (ALNs), and clinicopathological features were recorded before and after NAT. All imaging evaluations were independently performed by two experienced breast radiologists (with >10 years of experience), and discrepancies were resolved by consensus. Independent risk factors for predicting ALN status after NAT were identified by univariate and multivariate analyses. These independent risk factors were used for nomogram construction.ResultsUnivariate logistic regression analysis revealed that the maximum diameter of the breast lesions on MRI after NAT (p < 0.001), MRI ADC-value after NAT (p < 0.001), maximum and minimum diameter of the ALN on US after NAT (p < 0.001), the Ki67 level (p < 0.001), tumor grade 3 (p = 0.017), primary ALN stage cN 2 (p = 0.022), efficacy evaluation of the neoadjuvant therapy, pT stage, MP classification, HR, HER2, and the presence of the Hilum of the lymph gland were significantly associated with ALN pCR after NAT (p < 0.05). In the multivariate logistic regression analysis, ypT2 (p < 0.001), ypT3 (p = 0.007), HER2 (p < 0.001), response PR (p = 0.007), efficacy evaluation (SD/PD) (p = 0.010), and the presence of the Hilum of the lymph gland on US after NAT(p < 0.001) were considered independent predictors of ALN pCR after NAT. The area under the curve (AUC) of the nomogram was 0.934(95% CI: 0.913-0.960) in the training set and 0.908 (95% CI: 0.867-0.950) in the validation set, with a sensitivity of 82.0% and a specificity of 89.1% in the training set.ConclusionOur noninvasive model based on US, MRI, and clinicopathological features can help accurately identify patients with ALN pCR after NAT and prevent unnecessary axillary lymph node dissection (ALND).