Journal
ANNALS OF SURGERY
Volume 275, Issue 3, Pages 576-581Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/SLA.0000000000004246
Keywords
breast cancer surgery; complete response; individualized treatment; neoadjuvant systemic treatment; surgical de-escalation; vacuum-assisted biopsy
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Funding
- Deutsche Forschungsgemeinschaft'' (German Research Group) [GZ:HE 6824/5-1]
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This study evaluated the ability of minimally invasive, image-guided vacuum-assisted biopsy (VAB) to diagnose a pathologic complete response in the breast. The results showed a higher false-negative rate than expected, suggesting the need for improvements in procedure and patient selection before considering omitting breast surgery.
Objective:We evaluated the ability of minimally invasive, image-guided vacuum-assisted biopsy (VAB) to reliably diagnose a pathologic complete response in the breast (pCR-B).Summary Background Data:Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in up to 80% of women with breast cancer. In such cases, breast surgery, the gold standard for confirming pCR-B, may be considered overtreatment.Methods:This multicenter, prospective trial enrolled 452 women presenting with initial stage 1-3 breast cancer of all biological subtypes. Fifty-four women dropped out; 398 were included in the full analysis. All participants had an imaging-confirmed partial or complete response to NST and underwent study-specific image-guided VAB before guideline-adherent breast surgery. The primary endpoint was the false-negative rate (FNR) of VAB-confirmed pCR-B.Results:Image-guided VAB alone did not detect surgically confirmed residual tumor in 37 of 208 women [FNR, 17.8%; 95% confidence interval (CI), 12.8-23.7%]. Of these 37 women, 12 (32.4%) had residual DCIS only, 20 (54.1%) had minimal residual tumor (<5mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of 10%. In 19 of the 37 cases (51.4%), the false-negative result was potentially avoidable. Exploratory analysis showed that performing VAB with the largest needle by volume (7-gauge) resulted in no false-negative results and that combining imaging and image-guided VAB into a single diagnostic test lowered the FNR to 6.2% (95% CI, 3.4%-10.5%).Conclusions:Image-guided VAB missed residual disease more often than expected. Refinements in procedure and patient selection seem possible and necessary before omitting breast surgery.
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