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. 2020 Jul 7;25(11):e1621–e1627. doi: 10.1634/theoncologist.2020-0494
Title New assessment
Number of Patients Enrolled 14
Evaluation Method and Outcome Notes

The primary endpoint of FNR was calculated by correlating the pathological result of each clipped lymph node specimen (removed via SMART) with the patients’ ypN status. For clipped nodes that were not retrieved via SMART, the clip was specifically identified in the ALND specimen and analyzed for nodal pathological response.

For the secondary endpoint of identifying factors affecting nodal pCR, Fisher's exact test (p < .05) was used to compare categorical demographic, radiological and pathological variables between patients and clips with and without nodal pCR.

The sample size was small as this was a pilot study of a novel surgical approach. Fisher's exact test was used to compare categorical demographic, radiological and pathological variables between patient groups with and without nodal pCR. It was also used for comparison of various features between the individually clipped nodes with and without pCR. Statistical significance was set at p < .05. SAS V9.4 statistical software (SAS Inc, Cary, NC) was used to perform the analysis.

All 21 metastatic clipped nodes in 14 patients were removed but SMART failed to localize 3 clipped nodes and they were only retrieved from the ALND specimens. There was no surgical complications associated with SMART or ALND.

The first clipped node predicted the axillary status with a FNR of 7.1%. Based on this and another second clipped node, the FNR was 0%. ypT (p = .0390) and the first clipped node status (p = .0030) were statistically significant predictors for nodal pCR (Table 1). Table 2 shows detailed characteristics of the 21 clipped nodes.