Abstract

BackgroundAbout 40 % of women with breast cancer achieve a pathologic complete response in the breast after neoadjuvant systemic treatment (NST). To identify these women, vacuum-assisted biopsy (VAB) was evaluated to facilitate risk-adaptive surgery. In confirmatory trials, the rates of missed residual cancer [false-negative rates (FNRs)] were unacceptably high (> 10%). This analysis aimed to improve the ability of VAB to exclude residual cancer in the breast reliably by identifying key characteristics of false-negative cases.MethodsUni- and multivariable logistic regressions were performed using data of a prospective multicenter trial (n = 398) to identify patient and VAB characteristics associated with false-negative cases (no residual cancer in the VAB but in the surgical specimen). Based on these findings FNR was exploratively re-calculated.ResultsIn the multivariable analysis, a false-negative VAB result was significantly associated with accompanying ductal carcinoma in situ (DCIS) in the initial diagnostic biopsy [odds ratio (OR), 3.94; p < 0.001], multicentric disease on imaging before NST (OR, 2.74; p = 0.066), and age (OR, 1.03; p = 0.034). Exclusion of women with DCIS or multicentric disease (n = 114) and classication of VABs that did not remove the clip marker as uncertain representative VABs decreased the FNR to 2.9% (3/104).ConclusionFor patients without accompanying DCIS or multicentric disease, performing a distinct representative VAB (i.e., removing a well-placed clip marker) after NST suggests that VAB might reliably exclude residual cancer in the breast without surgery. This evidence will inform the design of future trials evaluating risk-adaptive surgery for exceptional responders to NST.

Highlights

  • About 40 % of women with breast cancer achieve a pathologic complete response in the breast after neoadjuvant systemic treatment (NST)

  • For patients without accompanying ductal carcinoma in situ (DCIS) or multicentric disease, performing a distinct representative vacuum-assisted biopsy (VAB) after NST suggests that VAB might reliably exclude residual cancer in the breast without surgery

  • This evidence will inform the design of future trials evaluating risk-adaptive surgery for exceptional responders to NST

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Summary

Introduction

About 40 % of women with breast cancer achieve a pathologic complete response in the breast after neoadjuvant systemic treatment (NST) To identify these women, vacuum-assisted biopsy (VAB) was evaluated to facilitate risk-adaptive surgery. Uni- and multivariable logistic regressions were performed using data of a prospective multicenter trial (n = 398) to identify patient and VAB characteristics associated with false-negative cases (no residual cancer in the VAB but in the surgical specimen). Based on these findings FNR was exploratively re-calculated. A false-negative VAB result was significantly associated with accompanying ductal carcinoma in situ (DCIS) in the initial diagnostic

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