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SSO 2022 Press Release – The Clinical Impact of Intraoperative Margin Assessment in Breast Cancer Surgery

(Dallas—March 11, 2022, 10:11 a.m.) — The use of pegulicianine fluorescence guided surgery (pFGS) for identifying residual cancer in the tumor bed of patients undergoing breast conserving surgery has an excellent safety profile and merits continued study, according to research presented at the Society of Surgical Oncology 2022 International Conference on Surgical Care. Fluorescence-guided surgery can be used to define tumor location and margins during the procedure.

Shelley Hwang MD MPHLed by Shelley Hwang, MD, MPH, from Duke University, Durham, N.C., researchers set up a prospective, single arm, open-label feasibility study at 16 US sites that enrolled 234 female patients aged 18 years and older with newly diagnosed invasive or intraductal cancer undergoing breast conserving surgery. The patients were injected intravenously with pegulicianine prior to surgery at a dose of 1.0 mg/kg. After tumor excision per standard of care, pFGS was used for identification and removal of residual cancer.

Of the patients enrolled, 234 patients received pegulicianine and 230 completed pFGS. One patient experienced anaphylaxis during the administration of pegulicianine and pFGS prompted additional margin excisions in 138 patients while residual tumor was found in 26 patients (19%). Negative margins after breast conservation surgery were achieved in 192/230 (83.5%) patients.

Dr. Hwang found that pFGS guided excision of residual tumor in 14/192 (7.3%) patients with negative standard of care margins. In these 14 patients, pFGS guided removal of residual tumor that would have otherwise remained in the patient. Among the 38 patients with positive margins after breast conserving surgery, 23 had pFGS shaves; 6 of these patients (15.8%) were converted to negative margins on final pathology. In three additional patients with positive margins, pFGS recommended further excision, but these were not performed based upon surgeon judgement. The overall final positive margin rate after pFGS was 15% (35/230). The overall sensitivity, specificity, and negative predictive value of pFGS were 69.4%, 70.4% and 98.3% respectively.

Residual tumor was removed after breast conservation surgery in 19% of patients who underwent an additional margin excision for a positive pFGS signal. The safety profile of pegulicianine was excellent and consistent with other imaging agents used in BCS.

“These findings, including a notably high negative predictive value, support further clinical assessment of pFGS which is currently being conducted in the prospective randomized trial INSITE,” Dr. Hwang reported.

About the Society of Surgical Oncology

The Society of Surgical Oncology is a dynamic global community of cancer surgeons shaping advancements in the profession to deliver the highest quality surgical care for cancer patients. SSO promotes leading-edge research, quality standards and knowledge exchange, connecting cancer surgeons worldwide to continuously improve cancer outcomes. Our highly regarded educational resources, the Society’s clinical journal, Annals of Surgical Oncology and events, including SSO 2022 – International Conference on Surgical Cancer Care, inspire members and spur each cancer surgeon to grow, improve and thrive.

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