Table 2.
Clinical trials evaluating the accuracy of sentinel lymph node dissection in clinically node-positive patients. Summary of trials designed to evaluate the accuracy of sentinel lymph node dissection to assess axillary nodal response to therapy in clinically node-positive patients who receive neoadjuvant chemotherapy
| Trial | ACOSOG Z1071 [7, 33] | SENTINA (Arm C) [9] | SN FNAC [10] |
|---|---|---|---|
| Nodal eligibility criteria | cN1-2 | cN1-2 | cN1-2 |
| Endpoints reported for cN1 a | |||
| Biopsy required to confirm metastases? | Yes | No | Yes |
| Number of patients | cN1 = 603 | 592 | 153 |
| cN2 = 34 | |||
| Overall FNR (No IHC) | 12.6 % a | 14.2 % | 13.4 % |
| FNR with IHC | 8.7 % a | Not reported | 8.4 % |
| FNR depending on mapping agents | |||
| One agent | 20.3 % | 16 % | 16 % |
| Dual agents | 10.8 % | 8.6 % | 5.2 % |
| FNR by number of SLNs | |||
| One SLN | 31 % | 24.3 % | 18.2 % |
| Two SLNs | 21.1 % | 18.5 % | ≥2 SLNs = 4.9 % |
| Three or more SLNs | 9.1 % | 4.9 % |
aLimited to patients classified as cN1 with ≥2 sentinel lymph nodes removed
FNR, False negative rate; IHC, Immunohistochemistry; SLN, Sentinel lymph node