For patients with stages 0 to 3 breast cancers, pegulicianine fluorescence-guided surgery (pFGS) can
enhance the efficacy of lumpec- tomy surgery, according to a study published in NEJM Evidence.
Barbara L. Smith, MD, PhD, and colleagues con- ducted a prospective trial to examine margin status
with or without intraoperative pFGS for stages 0 to 3 breast cancers. Patients were randomly
assigned 10:1 to pFGS or control groups to prevent surgeons from performing smaller-than-standard
lumpecto- mies in anticipation of pFGS assistance. In patients undergoing pFGS, at sites of
pegulicianine sig- nal, additional pFGS-guided cavity margins were excised. The percentage of
patients for whom pFGS- guided margins contained cancer, sensitivity, and specificity were examined
as coprimary endpoints. A total of 406 patients received 1.0 mg/kg intravenous pegulicianine
followed by lumpectomy. Of 392 patients randomly assigned, 316 and 76 had invasive cancers and in
situ cancers, respectively. The re- searchers found that pFGS-guided margins removed tumor left
behind after standard lumpectomy in 27 of 357 patients undergoing pFGS and 22 from cavity
orientations deemed negative on standard mar- gin evaluation. In nine of 62 patients with positive
margins, second surgeries were avoided by pFGS.
