To evaluate an MRI-based radiomic texture classifier alone and combined with radiologist qualitative assessment in predicting pathological complete response (pCR) using restaging MRI with internal training and external validation. Consecutive patients with locally advanced rectal cancer (LARC) who underwent neoadjuvant therapy followed by total mesorectal excision from March 2012 to February 2016 (Memorial Sloan Kettering Cancer Center/internal dataset, n = 114, 41% female, median age = 55) and July 2014 to October 2015 (Instituto do Câncer do Estado de São Paulo/external dataset, n = 50, 52% female, median age = 64.5) were retrospectively included. Two radiologists (R1, senior; R2, junior) independently evaluated restaging MRI, classifying patients (radiological complete response vs radiological partial response). Model A (n = 33 texture features), model B (n = 91 features including texture, shape, and edge features), and two combination models (model A + B + R1, model A + B + R2) were constructed. Pathology served as the reference standard for neoadjuvant treatment response. Comparison of the classifiers' AUCs on the external set was done using DeLong's test. Models A and B had similar discriminative ability (P = 0.3; Model B AUC = 83%, 95% CI 70%-97%). Combined models increased inter-reader agreement compared with radiologist-only interpretation (κ = 0.82, 95% CI 0.70-0.89 vs k = 0.25, 95% CI 0.11-0.61). The combined model slightly increased junior radiologist specificity, positive predictive value, and negative predictive values (93% vs 90%, 57% vs 50%, and 91% vs 90%, respectively). We developed and externally validated a combined model using radiomics and radiologist qualitative assessment, which improved inter-reader agreement and slightly increased the diagnostic performance of the junior radiologist in predicting pCR after neoadjuvant treatment in patients with LARC.
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