In the INSITE study reported in JAMA Surgery, E. Shelley Hwang, MD, MPH, and colleagues found that use of an intraoperative imaging agent with a pegulicianine fluorescence–guided system (pFGS) was effective in detecting residual cancer in the tumor bed of women with breast cancer undergoing breast-conserving surgery. Use of the novel system allowed avoidance of reexcision in some patients.
E. Shelley Hwang, MD, MPH
Study Details
The U.S. multicenter study included 234 women (safety population) with newly diagnosed primary invasive breast cancer or ductal carcinoma in situ undergoing breast-conserving surgery. They were enrolled between February 2018 and April 2020, and received a pegulicianine injection of 1 mg/kg at a mean of 3.2 hours prior to surgery.
After completion of standard-of-care excision, pFGS was used to scan the lumpectomy cavity to guide the removal of additional shave margins. Patients were monitored over a 30-day follow-up period.
Key Findings
A total of 230 patients completed the trial and were evaluable for efficacy. In per-margin analysis (n = 1,522 margins), correlation of pFGS with final margin status showed a sizable improvement in sensitivity vs standard pathology findings in the main lumpectomy specimen (69.4% vs 38.2%). The false-negative rate for pFGS was 1.2%.
Overall, 138 (60%) of 230 patients had additional excisions guided by pFGS, with residual tumor identified in 26 (19%). In per-patient analysis, the false-negative rate of pFGS was 23.7% (9 of 38 patients) and sensitivity was 76.3% (29 of 38 patients). Among 32 patients who underwent excision of pFGS-guided shaves, pFGS findings avoided the need for re-excision in 6 (19%).
One patient with a history of allergy to contrast agents had an anaphylactic reaction, recovered without sequelae, and underwent planned surgery. Three additional adverse events considered likely associated with the study intervention consisted of superficial thrombophlebitis, transient transaminitis, and posttraumatic stress disorder (in the patient with anaphylaxis).
The investigators concluded, “In this pilot feasibility study, the safety profile of pegulicianine was consistent with other imaging agents used in breast-conserving surgery, and was associated with a reduced need for second surgery in patients who underwent intraoperative additional excision of pFGS-guided shaves. These findings support further development and clinical performance assessment of pFGS in a prospective randomized trial.”
Dr. Hwang, of the Duke Cancer Institute and Duke University Health System, is the corresponding author for the JAMA Surgery article.
Disclosure: This study was funded by a grant from the National Institutes of Health and by Lumicell. For full disclosures of the study authors, visit jamanetwork.com.
