Oncology · Surgery · 3 h ago
MRI-Based Breast Locator Noninferior to Wire Localization in Randomized Trial
In an international prospective randomized trial of 418 patients undergoing breast-conserving surgery for nonpalpable, MRI-visible breast cancer, the Breast Cancer Locator (BCL) was noninferior to wire localization for positive-margin rates. The primary analysis did not meet the prespecified threshold for superiority, although re-excision and margin rates were numerically lower with BCL.
- Randomized trial included 418 patients undergoing breast-conserving surgery.
- BCL met noninferiority criteria versus wire localization.
- Primary analysis did not establish superiority.
- Re-excision rates were 12.9% with BCL and 19.6% with wire.
The international prospective randomized trial compared the supine MRI-based Breast Cancer Locator (BCL) with wire localization in patients undergoing breast-conserving surgery for nonpalpable, MRI-visible invasive breast cancer or ductal carcinoma in situ. A total of 418 patients underwent surgery, with 209 in each group. The primary endpoint was the positive-margin rate (PMR).
PMR was 14.4% with BCL and 21.1% with wire localization. The primary analysis demonstrated noninferiority (treatment difference −7.1%; 95.4% CI −14.3 to 0.1; p=0.011), but the one-sided p-value for superiority (0.025) narrowly missed the prespecified significance threshold of 0.023. In a prespecified analysis stratified by final tumor type, PMR was significantly lower with BCL (p=0.019). Re-excision rates were 12.9% and 19.6%, respectively; adverse-event rates were similar.
The findings support BCL as a noninferior alternative in the studied population, with lower observed margin and re-excision rates. However, superiority was not established in the primary analysis; the favorable stratified result and tumor-subtype comparisons should be interpreted in that context.
In practice
For patients with nonpalpable, MRI-visible invasive breast cancer or ductal carcinoma in situ undergoing breast-conserving surgery, BCL was noninferior to wire localization for positive-margin rates in this randomized trial. Observed positive-margin and re-excision rates were lower with BCL, but the primary analysis did not meet the prespecified threshold for superiority. The results do not establish that BCL should replace wire localization; applicability is limited to the population and setting studied.
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Annals of Surgical Oncology: An International Randomized Prospective Trial Comparing a Supine MRI-based Guidance System, The Breast Cancer LocatorTM, to Wire Localization for Breast-Conserving Surgery for Non-palpable Breast Cancer ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.