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Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):637-648. doi: 10.1016/j.ijrobp.2019.06.2546. Epub 2019 Jul 8.

Clinical-Genomic Models of Node-Positive Breast Cancer: Training, Testing, and Validation.

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Department of Research, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.
Epidemiology and Preventive Medicine, Department of Public Health, National Taiwan University, Taiwan.
University of Mississippi Medical Center, Jackson, Mississippi.
Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan. Electronic address:



There is no useful model for predicting the risk of recurrence in node-positive patients regardless of breast cancer subtype. We developed and validated 2 clinical-genomic models (recurrence index [RI]-local recurrence [LR]) and RI-distant recurrence (RI-DR) for stratifying these patients into low- and high-risk groups.


The 4 data sets were (1) training group (n = 112); (2) testing group (n = 46); (3) validation group (n = 388); and (4) E-MTAB-365 data set (n = 426). Patients who had undergone mastectomy or breast-conserving surgery and mRNA microarray analysis of their primary tumor tissue and had a pathologic stage of I to III were enrolled in the training, testing, and validation groups. Using preset cut-offs obtained from the training group, the models were tested and validated in the 3 other independent groups.


In the validation data set, the RI-LR distinguished between low- and high-risk groups according to 10-year LR-free interval (100% vs 93.0%, P = .015) and relapse-free survival (RFS; 85.0% vs 76.9%, P = .032). The RI-DR distinguished the low-risk group from the high-risk group according to RFS (85.7% vs 77.4%, P = .025). RI-DR and RI-LR scores were independent prognostic factors in N1-N2 patients (hazard ratio [HR], 3.3; 95% confidence interval, 1.1-10.2; and HR, 2.7; 95% confidence interval, 1.1-6.7, respectively) by multivariate analysis. The RI-DR and RI-LR genetic models were tested similarly using the E-MTAB data set with HRs of 2.5 (P = .0048) and 2.7 (P = .0285), respectively, in node-positive patients.


Both RI-DR and RI-LR can partition N1-N2 patients into low- and high-risk groups for RFS; however, the latter is superior for predicting locoregional recurrence.

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