Table 1.
Studies on predicting pCR by VAB after NAC
| Study | Type | Inclusion | n | Means of prediction | FNR and NPV |
|---|---|---|---|---|---|
| Heil 2015 [44] | prospective | cCR after NAC | 164 | 116 CCs; | mammographically guided VABs: NPV 100%, FNR 0%; |
| 46 VABs | ultrasound-guided VABs: NPV 53.3% | ||||
| CCs: NPV 70.2%; FNR 60.9% | |||||
| The existence of a clip marker tended to improve the NPV (odds ratio 1.98) | |||||
| Heil 2016 [45] | prospective | clinical/imaging partial or complete response, lesion visible in ultrasound | 50 | Ultrasound-guided VAB | NPV: 76.7% FNR: 25.9% |
| Given a histopathologically representative VAB sample (n =38), the NPV was 94.4%, and the FNR was 4.8% | |||||
| Heil 2020 [46] | prospective | T1-3 | 398 | Image-guided VAB | FNR 17.8% |
| If no residual lesions were found in imaging and VAB, the FNR could be reduced to 6.2%, or the FNR could be reduced to 0% by performing VAB with the giant needle by volume (7-gauge) | |||||
| Kuerer et al. [47] | prospective | T1-3, N0-3 TNBC or HER2-positive | 40 | ultrasound-guided or mammography-guided FNA and VAB | VAB alone was more accurate than FNA alone |
| Combined FNA/VAB demonstrated an accuracy of 98%, FNR was 5%, and NPV was 95% | |||||
| If the admission criteria are stringent, FNR could be further reduced to 3.2% | |||||
| MICRA study [48] | prospective | N0, radiologic partial or complete response on MRI | 525 | Ultrasound-guided 14 G biopsies targeted around pre-NAC-placed marker (four central; four peripheral) | The FNR was 37%. Sensitivity was 63%, specificity was 100%, PPV was 100%, and NPV was 75% |
| NOSTRA PRELIM study [51] | prospective | ER-negative or HER2-positive; lesion size >1 cm; cN+ | 150 | Ultrasound-directed biopsy | FNR < 10% |
| Sutton [52] | prospective | IA to IIIC; cCR on MRI | 20 | MRI-guided biopsy | NPV was 92.8%, accuracy was 95%, sensitivity was 85.8%, PPV was 100%, and specificity was 100% |
| Tasoulis MK [50] | pooled analysis | - | 166 | Image-guided biopsy | The FNR was 3.2%, NPV was 97.4%, overall accuracy was 89.5% |
| Lee [53] | prospective | cCR on MRI | 20 | Ultrasound-guided biopsy | NPV, accuracy, and FNR was 87.1%, 90.0%, and 30.8% |
Abbreviations: NAC, neoadjuvant chemotherapy; pCR, complete pathological response; cCR, clinical complete response; CCs, Core-cut-MIB; VAB, Vacuum-assisted-MIB; TAD: targeted axillary dissection; FNR, false-negative rate, PPV, positive predictive values; NPV, negative predictive values; MRI, magnetic resonance imaging.