TUESDAY, May 23, 2023 (HealthDay News) -- For patients with stages 0 to 3 breast cancers, pegulicianine fluorescence-guided surgery (pFGS) can enhance the efficacy of lumpectomy surgery, according to a study published online April 27 in NEJM Evidence.
Barbara L. Smith, M.D., Ph.D., from Massachusetts General Hospital in Boston, and colleagues conducted 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 lumpectomies in anticipation of pFGS assistance. In patients undergoing pFGS, at sites of pegulicianine signal, 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 end points.
Four hundred six 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 researchers found that pFGS-guided margins removed tumor left behind after standard lumpectomy in 27 of 357 patients undergoing pFGS, 22 from cavity orientations deemed negative on standard margin evaluation. In nine of 62 patients with positive margins, second surgeries were avoided by pFGS. PFGS specificity was 85.2 percent on per-margin analysis, and sensitivity was 49.3 percent. In six patients, pegulicianine administration was stopped for adverse events.
"We found that pFGS removed tumor missed by standard lumpectomy and reduced the need for second surgeries for positive margins," Smith said in a statement. "Given its potential, pFGS merits evaluation in future trials and studies."
Several authors disclosed ties to biopharmaceutical companies, including Lumicell, which funded the study.