Specialized Intraoperative Specimen Radiography in Breast-Conserving Breast Cancer Surgery

Researchers investigated whether intraoperative specimen radiography (SR) with a system designed for precise localization was able to reduce the positive margin rate (PMR) in breast-conserving surgery (BCS). They found that the radiopaque tissue transfer and X-ray system device was not superior to standard specimen radiography. However, they noted that SR and immediate re-excision did appear to improve PMR reduction. The findings were presented in BJS Open.

The randomized controlled trial enrolled 122 patients with microcalcification-associated breast cancer who were scheduled to undergo BCS. The participants were randomly assigned either SR with a radiopaque tissue transfer and X-ray system (KliniTray^TM) or the institutional standard procedure (ISO). Patients who had a radiological margin under 5 mm received an immediate re-excision. The primary measure was PMR and secondary measures included risk factors for positive margins and the impact of immediate re-excision.

Improving Positive Margin Reduction in Breast-Conserving Breast Cancer Surgery

A total of 117 patients were eligible for the final analysis. Reportedly, final histopathology identified a PMR of 31.7% for the KliniTray^TM group and 26.3% for the ISO group (P=.127). Additionally, histological tumor size over 30 mm (adjusted odds ratio [aOR], 10.73; 95% CI, 3.14-36.75; P<.001) and specimen size over 50 mm (aOR, 6.65; 95% CI, 2.00-22.08; P=.002) were independent risk factors for positive margins after BCS. Finally, immediate re-excision due to positive SR yielded an absolute risk reduction in positive margins of 13.6%, from 42.7% to 29.1%, the researchers noted.

The article reported a major limitation in a false-estimated reduction of PMR within the intervention group given that the control group also had a lower PMR than expected after BCS. Additionally, unequal distribution of tumor size between the groups may have introduced bias—though the authors noted that stratification by tumor size is challenging in a randomized trial as sizes estimated by mammography are not precise. Moreover, outcomes including recurrence and survival were not assessed due to the study’s short follow-up period.

Ultimately, the authors suggested their prospective findings supported the “limited use of SR for intraoperative margin assessment to reduce the PMR in BCS of breast cancer predominantly associated with microcalcifications,” though they acknowledged that there was no evidence that the special orientation system was advanced compared to standard procedure.

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