(HealthDay News) — Pegulicianine fluorescence-guided surgery (pFGS) can enhance the efficacy of lumpectomy in patients with stages 0 to 3 breast cancers, according to a study published in NEJM Evidence.
Researchers conducted a prospective trial of 406 patients to examine the use of pFGS for stages 0 to 3 breast cancers. All 406 patients received pegulicianine (1.0 mg/kg), followed by lumpectomy, and 392 patients underwent randomization. The patients were randomly assigned after lumpectomy to the pFGS group (n=357) or the control group (n=35).
“Randomization was not designed to provide a control group for analysis of device performance but rather to introduce uncertainty as to whether there would be pFGS assistance, thereby encouraging surgeons to perform their best standard lumpectomy before pFGS imaging,” the researchers explained.
Of the 392 patients who were randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. The researchers found that pFGS removed tumor left behind after standard lumpectomy in 27 of the 357 patients randomly assigned to pFGS, 22 from cavity orientations deemed negative on standard margin evaluation.
In 9 of 62 patients with positive margins, second surgeries were avoided by pFGS. PFGS specificity was 85.2% on per-margin analysis, and sensitivity was 49.3%. In 6 patients, pegulicianine administration was stopped due to adverse events.
“Our findings suggest potential benefits of the pFGS approach,” the researchers wrote. “In the 17% of patients who had positive margins after standard surgery, 9 of 62 avoided a second surgical procedure as a result of additional margins excised in real time, guided by pFGS signal. Perhaps more provocative is the discovery of additional tumor in 27 of 357 patients, where pFGS-guided margins removed tumor left behind by standard lumpectomy. This potential benefit merits evaluation in future trials.”
Several researchers disclosed ties to biopharmaceutical companies, including Lumicell, which funded the study.