Fluorescence-Guided Breast Cancer Surgery Tool May Be Gamechanger

Fluorescence-guided surgery for patients with breast cancer using pegulicianine (Lumisight) in combination with the LumicellTM Direct Visualization System may be “game-changing” for this population, according to Barbara Smith, MD, PhD.

Smith, director of the Breast Program and co-director of the Women’s Cancers Program at Massachusetts General Hospital, and professor of surgery at Harvard Medical School, spoke with CancerNetwork^® during the Society of Surgical Oncology (SSO) 2024 Annual Meeting about how a potential FDA approval of pegulicianine-guided surgery for patients with breast cancer may impact best practices in this field.

She highlighted that this tool could allow surgeons to assess an entire surgical cavity for residual tumor, which may help patients omit the need for a second operation. Additionally, being able to remove more residual disease with this fluorescence-based imaging agent may allow for the de-escalation of subsequent treatments such as radiotherapy.

In March 2024, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of pegulicianine-based imaging in patients with breast cancer undergoing breast-conserving surgery.

Transcript:

One of the things all this work has made me realize is how imperfect our current margin assessment or tissue assessment is. Our pathologists are limited by the fact that we give them a piece of tissue that maybe [starts as one] size in the patient and changes shape completely once during screening. They’re only able to look at a tiny fraction of the surface of a specimen; less than 1%. Tools like [pegulicianine] that let you look at the entire cavity, instead of less than 1%, to find residual tumor is just game-changing. The fact that it happens during that first surgery for that patient and not a situation where we get the information week later and must go back and do a second operation on the second day would be a total game changer. The idea that you’re removing more tumor is going to also potentially let us deescalate other treatments that patients [must] have right now. Right now, in lumpectomy surgery, almost everyone has to have radiation afterward because we know we’re leaving tumor behind; we had no way to find it. It may be that you can have patients have lesser treatments from other modalities than they do now because we’re able to do a better job surgically.

Reference

Lumicell announces FDA Advisory Committee’s positive recommendation on the benefit-risk profile of LUMISIGHT in the detection of cancerous tissue during breast conserving surgery. News release. Lumicell Inc. March 6, 2024. Accessed March 26, 2024. https://tinyurl.com/mucd64en