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Knowledge of the association between isolated tumor cells (ITCs) in breast cancer patients and the outcome is very limited. We aimed to determine the prognostic value of axillary lymph node ITCs for T1N0M0 female breast cancer (FBC) patients.    Methods  Data for T1N0M0 FBC patients staged ITCs negative [pN0(i−)] and positive [pN0(i+)] were extracted from the Surveillance, Epidemiology, and End Results database from 2004 to 2015. Prognostic predictors were identified by Kaplan–Meier analysis, competing risk model, and Fine–Gray multivariable regression model.    Results  A total of 94,599 subjects were included, 88,632 of whom were staged at pN0(i−) and 5,967 were pN0(i+). Patients staged pN0(i+) had worse breast cancer-specific survival (BCSS) [hazard ratio (HR): 1.298, 95% CI = 1.069–1.576,  P  = 0.003] and higher breast cancer-specific death (BCSD) rate (Gray’s test,  P  = 0.002) than pN0(i−) group. In the Fine–Gray multivariable regression analysis, the pN0(i+) group had higher BCSD rate (HR: 1.321, 95% CI = 1.109–1.575,  P  = 0.002) than pN0(i−) group. In subgroup analyses, no significant difference in BCSD was shown between the chemotherapy and non-chemotherapy subgroup (Gray’s test,  P  = 0.069) or radiotherapy and non-radiotherapy subgroup (Gray’s test,  P  = 0.096).    Conclusion  ITC was independently related to the increase of the BCSD rate and could be identified as a reliable survival predictor for T1N0M0 FBC patients.

frontiers in oncology

A Competing Risk Analysis Model to Determine the Prognostic Value of Isolated Tumor Cells in Axillary Lymph Nodes for T1N0M0 Breast Cancer Patients Based on the Surveillance, Epidemiology, and End Results Database