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Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery.

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Pegulicianine fluorescence-guided surgery (pFGS) helped remove residual breast cancer in some patients, avoiding repeat surgeries. However, its sensitivity for detecting all remaining cancer needs improvement for optimal clinical use.

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Area of Science:

  • Oncology
  • Surgical Innovation
  • Medical Imaging

Background:

  • Breast-conserving surgery (lumpectomy) offers survival rates comparable to mastectomy.
  • Local recurrence after lumpectomy is a significant factor in breast cancer mortality.
  • Positive surgical margins, indicating incomplete tumor removal, are a primary driver of local recurrence and often necessitate reoperation.

Purpose of the Study:

  • To evaluate the effectiveness of pegulicianine fluorescence-guided surgery (pFGS) in identifying and removing residual breast cancer at positive margins.
  • To assess the impact of pFGS on reducing the need for reoperation in breast cancer patients.

Main Methods:

  • A prospective trial involving 406 patients with stages 0-3 breast cancer undergoing lumpectomy.
  • Patients received intravenous pegulicianine, with pFGS used to guide the excision of additional margins at sites of fluorescence signal.
  • The study evaluated pFGS-guided margin status, sensitivity, and specificity as coprimary endpoints.

Main Results:

  • pFGS-guided margins successfully removed residual tumor in 27 of 357 patients, including 22 cases where initial margins were deemed clear.
  • The technology helped avoid second surgeries in 9 of 62 patients with initially positive margins.
  • The specificity of pFGS was 85.2%, while its sensitivity was 49.3%.
  • Six patients experienced adverse events, with two serious grade 3 events related to pegulicianine.

Conclusions:

  • Pegulicianine fluorescence-guided surgery met its primary endpoints for residual tumor removal and specificity.
  • The study did not meet the prespecified threshold for sensitivity in detecting all positive margins.
  • Further refinement may be needed to enhance the sensitivity of pFGS for comprehensive margin assessment in breast cancer surgery.