Early Study Data Supports the Value of MarginProbe® in Getting all the Cancer in the First Lumpectomy Surgery
Dr. Jeffrey Falk is a surgical oncologist focusing primarily on breast cancer since starting his practice in 2001. He performs 200-350 breast cancer surgeries annually and has a special interest in research and clinical trials for breast cancer treatments. One area Dr. Falk has recently conducted an evaluation of his own has been in the use of the MarginProbe system to identify safe margins when removing both ductal carcinoma in situ (DCIS) and invasive breast cancers.
Traditionally, margin identification falls to the pathologist during breast cancer surgery. “We know that when a pathologist looks at a surgical specimen and they’re looking at the margins they’re only looking at a very small percentage,” stated Dr. Falk. “They can’t possibly look at all the margins on a microscopic level and look at 100% of the surface area—it’s impossible.”
When he first heard of MarginProbe, Dr. Falk admitted he was skeptical. But when he heard that the device had received FDA approval and he was approached to conduct an evaluation of the system, he was very interested. Dr. Falk and his partner recently completed the evaluation, comparing 120 cases using MarginProbe to a 120 cases prior to using the new technology.
“After looking at our preliminary data we’ve found MarginProbe has significantly reduced our incidence of a positive margin. That means that I’m taking patients much less frequently back to the operating room for re-excisions now. In fact, with our first 36 cases using MarginProbe, we looked at our data and, our re-excision rate was 2.8%, which is far, far less than what you’d expect.”
“In order to make the data reproducible and valid, we didn’t exclude any patients except ones that had had neoadjuvant chemotherapy or anti-estrogen therapy prior to surgery,” he continued. “MarginProbe would not be used in those settings, as a fair percentage of those patients will have no residual tumor, so it’s not needed. But we used MarginProbe for pure DCIS, we used it for invasive lobular cancers, as well as invasive ductal cancers on any woman that was having a lumpectomy. We didn’t exclude any patients based upon age or breast density. We used the MarginProbe in every single one of those cases while we’re doing this study and probably will continue to use it with most of these types of patients.”
Why use MarginProbe
Why is Dr. Falk relying on the MarginProbe system so regularly? “When I’m talking about it before we go to the operating room, I tell patients that it’s just another tool to really help reduce their chance that we have to take them for a second operation,” he explained. “With an additional surgery, there’s an increased risk of infection and it emotionally drags out their care. The worst phone call to make is when you have to say to the patient, ‘Look, I know you thought we were done, but actually we have to go back to the operating room to take more tissue.’ It is a big deal. Even if it just cuts our re-excision rate by a little bit, it’s something worth considering, But we think in our practice it’s probably cut our re-excision rate in half, maybe even a little more than that.”
“I still do all the other standard things I was doing before, including specimen x-rays, serial sectioning of specimens, and use all that information in addition to the MarginProbe to really decide on whether I need to take more tissue and which margins should be addressed while we’re still in the operating room,” said Dr. Falk. “But MarginProbe is very simple to use and the way I view it is that it’s just another way to try to make sure you don’t have to bring a patient back to the operating room.”
MarginProbe finds hard-to-identify cancers
Beyond avoiding additional surgeries, MarginProbe is also very effective at identifying additional cancer that might have been missed using previous techniques. “It’s very common that you end up in the operating room taking an additional margin or two that you otherwise, based upon standard practice prior to MarginProbe, you wouldn’t have taken,” said Dr. Falk. “For example, we have a non-palpable lesion and we do a wire localization and then take the lesion out. Then we do a specimen x-ray. The lesion might look like it is right in the center of the specimen, and then you use MarginProbe, and it says you got a positive signal at the inferior margin or the superior margin, and you take extra tissue then and there. Then you get that report back and find out, had you not taken that margin you would be going back to the operating room. MarginProbe is picking up disease that you have no other way to know about.”
“Let me provide a specific example,” he continued. “I had a 44-year-old female who had genetic testing that was negative. She had an MRI which showed unifocal small cancer. She wanted to do a lumpectomy, which is very appropriate considering the information up to that point. She has fairly dense tissue and a smaller breast. I thought this is a great case use MarginProbe, it may help us to get a free margin and not have to take this young patient back to the operating room. On the primary specimen, MarginProbe told me to take an additional lateral margin. On the final pathology, all the margins on the primary specimen were negative, but there was a 3-mm focus of cancer in the additional lateral margin, with the new margin being negative. That cancer would have been left behind. I would never have taken an extra margin had I not used the MarginProbe. The MarginProbe said, ‘Hey, there’s something here,’ and it picked up some microscopic DCIS.”
“I’m even to the point now where I’m even doing a little bit smaller lumpectomies, trusting that the MarginProbe and my specimen x-ray will tell me if I need to take more tissue,” concluded Dr. Falk. “I think MarginProbe impacts cosmetic outcomes as well, and it really doesn’t add much time as far as surgery goes. I don’t think I’d like to go back to doing lumpectomies without it. It’s been that helpful.”
Dr. Jeffrey Falk
Saint John Providence