New technology makes excisions more precise, second operations less frequent
PROVIDENCE — Led by Dr. Jennifer Gass, director of Care New England’s Breast Health Center, a recent clinical trial at centers in the U.S., Canada, the United Kingdom and Austria has brought new hope to women diagnosed with breast cancer.
The trial involved a pioneering procedure known as the Breast Cancer Locator System, or BCL.
“Breast cancers commonly have an irregular shape, and this study was designed to determine if giving the surgeon a more precise image of the tumor size and shape using a customized guidance device might enable more successful surgeries,” Gass said in a Care New England press release. “The BCL technology enabled us to define the precise location and boundaries of even the most difficult tumors, and to view tumors in 3D before and during surgery. This detailed tumor guidance is information that has been missing with other methods until now.”
Gass elaborated in an interview with Ocean State Stories.
“Most breast cancers are not palpable, not ‘feelable,’ and so therefore we women go for mammograms on a regular schedule,” the surgeon said. “When a breast cancer is found, ‘multi -modality’ or ‘multi -disciplinary’ treatment is needed to render the patient cancer-free and keep the patient cancer-free.
“That usually involves a surgical procedure to remove the cancer from the breast. And when we remove the cancer from the breast, particularly when it’s breast-conserving surgery, we need to demonstrate in the final analysis of the tissue that there is no tumor in proximity of the cut surface. That is what we call the surgical margin. And achieving clear surgical margins has long been an issue for breast surgeons.”
She noted, however, that “when women attend mammograms regularly, particularly if they go every year, most cancer are found before they are palpable.”
Until BCL, Gass said, “we had no way to mark the borders of the cancer edge as demonstrated by breast MRI.” With no way to confirm that the surgeon had excised the entire tumor, a remnant could continue to grow and later surgery would be required.
In the U.S., participants in the BCL trial included Care New England’s Women & Infants Hospital and CNE’s Kent Hospital, plus centers in Arizona, Florida, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Texas and Vermont. More than 400 women from all locations were enrolled.
Results of the trial were announced at a May meeting of the American Society of Breast Surgeons in Seattle. Gass led the discussion.
“The BCL System provided patient-specific information regarding the unique size, shape and location of each tumor, derived from supine [magnetic resonance imaging],” Gass stated “Having detailed information about each tumor gave us information we could consider before and during each breast cancer surgery.”
According to Care New England, “the foundation of the Breast Cancer Locator (BCL) System is an MRI taken with the patient lying face-up, in the same position as surgery, to obtain the most accurate view of the tumor shape, size, and location. The Breast Cancer Locator (BCL) System is then 3D-printed using the MRI imaging data to create a customized, breast-shaped device matching the unique shape of a patient’s breast and the unique location and shape of the tumor. At the start of surgery [after the patient is anesthetized], the BCL is placed on a patient’s breast, and a surgeon uses ports in the device to guide them to the precise tumor margins during excision. The tumor is also viewable in 3D before and during surgery.”
Lebanon, New Hampshire-based Cairn Surgical, sponsor of the BCL trial, stated that “positive margins (tumor at the edge of the lumpectomy specimen, requiring additional surgery to completely remove the tumor) occur following breast-conserving surgery in about 20% of all patients and in 30-40% of patients with DCIS or invasive lobular cancer. More than 80% of tumors are irregularly-shaped, making their margins difficult to precisely define by today’s conventional means.
“The BCL System is intended to provide intraoperative guidance to surgeons regarding tumor shape, size, and location while the patient is in the supine (face-up) position for surgery. In the pivotal trial, the following observations were made in comparing the BCL System to conventional wire localization: 32% reduction in [positive margin rates] across all patients, 34% reduction in re-excision rate (second surgeries) across all patients [and a] comparable safety profile.”
Gass received her medical degree from the University of Maryland, then completed a residency at Temple University in Philadelphia. She began her career as a general surgeon and was a trauma critical care surgeon at DMC Detroit Receiving Hospital in Michigan while her husband, now retired, finished a cardiac surgery fellowship. Gass practiced general surgery when the couple moved to Rhode Island in 1993. Eight years later, she began to specialize in breast cancer surgery.
“When women face a cancer diagnosis, they’re so frightened,” said Gass, who is also a professor at The Warren Alpert Medical School of Brown University. “To be able to paint the pathway for them to becoming cancer-free and cancer survivors is a true privilege. It makes you feel better every day. We all know that we don’t cure every breast cancer, and there are times where we have to stand beside a woman when she looks at cancer recurrence. But when you witness the strength and courage of women as they face these challenges, it’s so inspiring.
“I think I’m the lucky one just to watch these women because they inspire me every day, whether it’s someone postmenopausal or what we might call elderly — a mature woman — or a 30-something-year-old who shouldn’t even be facing this diagnosis. They come in and how they stand up with their resolve and get through the treatment — I feel like it makes me a better person.”
Looking to the future, Gass told Ocean State Stories that she is optimistic the federal Food and Drug Administration, the FDA, will approved the new technology for widespread use.
“The FDA approved the trial and the process now is you go back to ask the FDA to approve the device. So the FDA will look at these study results and they will determine if they will approve the device. But with a statistically significant and clinically meaningful reduction in positive margins, it seems as certain as one could be that the FDA will approve it.”
Gass believes women receiving BCL System treatment will benefit emotionally.
“A hard thing to do as a surgeon is to take someone to surgery to remove their cancer and then see them one week after their surgery and say, ‘well, the results are in, but your margins aren’t clear, you need a second operation,’ ” she said. “That’s a powerful way to take the wind out of a woman’s sails, to dispirit an individual to think that they have to return for an additional procedure. “This trial gives us another strategy of how we can more carefully and skillfully identify the borders of the cancer and get those clear margins.
