Breast cancer research and treatment · 2026
Diagnostic accuracy of tumor bed biopsy for predicting pathological complete response in breast cancer patients achieving clinical complete response after neoadjuvant chemotherapy: a meta-analysis.
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Garg Garvit, Bharath S, Krishna Abhishek, Sethi Shivank, Agrawal Vishesh, Johri Goonj, Yadav Sanjay Kumar, Sharma Dhananjaya
Аннотация
PURPOSE: With growing interest in surgical de-escalation for breast cancer, tumor bed biopsy (TBB) after neoadjuvant chemotherapy (NACT) has been proposed as a tool to predict pathological complete response (pCR). This meta-analysis assessed the diagnostic accuracy and clinical applicability of TBB in breast cancer patients achieving complete clinical response (cCR) post-NACT.
METHODS: PubMed, Embase, and online clinical trial registries were systematically searched up to April 2025 for studies evaluating TBB in cCR patients after NACT. Pooled sensitivity, specificity and false-negative rate (FNR) were calculated using a random-effects model. Heterogeneity was quantified using the I2 statistic.
RESULTS: Eight studies met inclusion criteria. Pooled sensitivity was 0.58 (95% CI 0.51-0.65), specificity was 1.00 (95% CI 0.99-1.00) and the pooled false-negative rate was (42%, 95% CI 35-49%) with I2 values (65.8% for sensitivity; 0% for specificity).
CONCLUSION: In this meta-analysis limited to patients achieving clinical complete response after neoadjuvant chemotherapy, tumor bed biopsy demonstrated excellent specificity but suboptimal sensitivity with an unacceptably high false-negative rate. These findings indicate that a negative tumor bed biopsy cannot reliably confirm pathological complete response and therefore cannot replace standard surgical excision at present. While tumor bed biopsy may help identify residual disease, its current diagnostic performance does not support its use as a standalone tool for surgical de-escalation, underscoring the need for further refinement and prospective validation before clinical adoption.
METHODS: PubMed, Embase, and online clinical trial registries were systematically searched up to April 2025 for studies evaluating TBB in cCR patients after NACT. Pooled sensitivity, specificity and false-negative rate (FNR) were calculated using a random-effects model. Heterogeneity was quantified using the I2 statistic.
RESULTS: Eight studies met inclusion criteria. Pooled sensitivity was 0.58 (95% CI 0.51-0.65), specificity was 1.00 (95% CI 0.99-1.00) and the pooled false-negative rate was (42%, 95% CI 35-49%) with I2 values (65.8% for sensitivity; 0% for specificity).
CONCLUSION: In this meta-analysis limited to patients achieving clinical complete response after neoadjuvant chemotherapy, tumor bed biopsy demonstrated excellent specificity but suboptimal sensitivity with an unacceptably high false-negative rate. These findings indicate that a negative tumor bed biopsy cannot reliably confirm pathological complete response and therefore cannot replace standard surgical excision at present. While tumor bed biopsy may help identify residual disease, its current diagnostic performance does not support its use as a standalone tool for surgical de-escalation, underscoring the need for further refinement and prospective validation before clinical adoption.