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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, June 2, 2022
Implementing the pegulicianine fluorescence–guided system (FGS) while performing breast-conserving surgery appears to be a safe way to reduce the reexcision rate for these patients, according to findings from a nonrandomized controlled trial reported in JAMA Surgery. The safety profile of this novel imaging agent was consistent with other imaging agents used during breast-conserving surgery and reduced the need for a second surgery in patients who underwent intraoperative additional excision of pegulicianine FGS–guided shaves, concluded E. Shelley Hwang, MD, MPH, of the Duke Cancer Institute, Durham, North Carolina, and colleagues.
“These findings support further development and clinical performance assessment of pegulicianine FGS in a prospective randomized trial,” the authors concluded.
In this prospective, single-arm study, the authors enrolled 230 patients from 16 academic or community breast cancer centers in the United States. Patients were newly diagnosed with primary invasive breast cancer or ductal carcinoma in situ. Patients with previous breast cancer surgery or a history of dye allergies were not included in the study.
After a 30-day follow-up period, 229 patients completed the trial. (One patient with an allergy to contrast agents had an anaphylactic reaction and recovered without sequelae.) Using pegulicianine FGS resulted in a high sensitivity rate for residual tumor (69.4%), compared with standard pathology assessments of the main lumpectomy specimen (38.2%). The novel imaging approach also avoided the need for reexcision by 19% for patients who underwent excision of pegulicianine FGS–guided shaves. On a per-patient level, the false-negative rate of pegulicianine FGS was 23.7%, and the sensitivity rate was 76.3%.
“With its high negative predictive value, pegulicianine FGS is a promising intraoperative tool that has potential to detect residual disease and possibly reduce the rate of reexcision, thereby improving surgical and cosmetic outcomes in patients undergoing breast-conserving surgery for early-stage breast cancer,” the authors concluded.
Disclosure: For a full disclosure of the study authors, visit jamanetwork.com.
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