Additional Excision of Margin Tissue Did Not Alter Satisfaction in Breast Cancer

LumiSystem prompted the removal of a median of 10.5cc extra tumor margin tissue in patients with breast cancer and did not significantly affect satisfaction outcomes.

The use of LumiSystem to perform an additional intraoperative margin assessment of the lumpectomy cavity was found to not significantly alter the satisfaction outcomes of patients with breast cancer, according to results from a prospective, multicenter trial (NCT04440982) presented in a poster at the 2024 San Antonio Breast Cancer Symposium (SABCS).¹

LumiSystem is made up of LUMISIGHT an imaging agent that uses a fluorescent dye to enhance suspected cancerous tissue, and Lumicell Direct Visualization System to help with fluorescence guidance.² Patients were randomly assigned to either the LumiSystem-assed device arm or the standard lumpectomy arm. If indicated, those who received a standard lumpectomy could complete additional Lumi-System-guided cavity margins.

From the data of a post-operative breast satisfaction survey completed 6 to 12 months after surgery, 70.6% of surveyed patients strongly preferred or preferred avoiding a second breast surgery as opposed to optimizing cosmetic outcomes. Additionally, there was not a significant difference with regards to mean post-operative breast satisfaction per BREAST-Q surveys: 79.8 (range, 33-100) in the LumiSystem arm to 78.2 (range, 35-100) in the control arm (P = .359). The mean change in breast satisfaction score (post-operative score minus pre-operative score), showed a gain of 10.8 for patients in the LumiSystem group and 14.4 for patients in the control group.

Per the post-operative patient preference information (PPI) scale (1 being to maximize cosmetic outcome and 5 being to avoid second surgical procedure), both the LumiSystem and control arm had similar means: 4.24 and 4.08, respectively (P = .652).

Of the patients who took the survey, extra margin tissue excision prompted by LumiSystem occurred in 25 (51%) patients in the LumiSystem arm; a median of 10.5cc tissue was excised.

For patients who didn’t have any LumiSystem shaves taken, post-operative breast satisfaction was 73.8 (range, 33-100) compared with 80.3 (range, 45-100) for patients who did have LumiSystem shaves taken (P = .256). The mean change in breast satisfaction, was a gain of 14.7 for the group that didn’t have any LumiSystem shaves taken and a gain of 7.7 for the group that did have LumiSystem shaves taken (P = .203).

“There was no decrease in breast satisfaction following use of LumiSystem for intraoperative margin assessment of the lumpectomy cavity, despite excision of additional margin tissue,” lead study author Barbara L. Smith, MD, PhD, an associate professor of surgery at Harvard Medical School and director of the Breast Program and co-director of the Woman’s Cancers Program at Massachusetts General Hospital, and coauthors wrote in the presentation.¹ “Most patients valued avoidance of a second surgery over optimizing cosmetic outcome.”

In this trial, patients with stage 0-3 breast cancer were randomly assigned, in a 3:1 ratio, to undergo either pegulicianine LumiSystem-aided lumpectomy surgery or standard lumpectomy surgery.

A total of 84 patients were enrolled and asked to take BREAST-Q surveys and PPI surveys. Surveys were given 6 to 12 months following survey, and 63 (75%) patients filled them out; 14 patients from the control arm and 49 patients from the LumiSystem arm.

Patients received 1.0 mg/kg of intravenous pegulicianine 2 to 6 hours before surgery. Following completion of the standard lumpectomy surgery, LumiSystem-identified cavity margins were removed at locations of positive pegulicianine fluorescence in the lumpectomy cavity walls.

In April 2024, LumiSystem—pegulicianine and Lumicell’s direct visualization system, in tandem—was approved by the FDA for fluorescence-based imaging in adult patients undergoing breast cancer surgery.³ The phase 3 INSITE trial that led to his decision showed that the margin-level specificity of pegulicianine fluorescence-guided surgery for breast cancer was 85.2% (95% CI, 33.7%-86.6%) with a sensitivity level of 49.3% (95% CI, 37.0%-61.6%).⁴

References

1. Smith BL, Daly AE, Anderman KJ, et al. Does additional margin excision during LumiSystem-guided lumpectomy surgery affect patient breast satisfaction? Presented at: 2024 San Antonio Breast Conference Symposium; December 10-13, 2024; San Antonio, TX. Abstract P3-09-04.
2. What is LumiSystem™? LumiSystem. Accessed December 20, 2024. https://tinyurl.com/4c3urs2a
3. Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer. News release. Lumicell, Inc. April 18, 2024. Accessed December 18, 2024. https://tinyurl.com/yc7t26f2
4. Smith BL, Hunt KK, Carr D, et al. Intraoperative fluorescence guidance for breast cancer lumpectomy surgery. NEJM Evid. 2023;2(7). doi:10.1056/EVIDoa2200333