New Tool Improves Accurate Excision of Previously Positive Axillary Lymph Nodes After Neoadjuvant Chemo in Breast Cancer

For patients with breast cancer whose disease has spread to the axillary lymph nodes, the use of a new reflector device technology in the early neoadjuvant chemotherapy setting can help to more accurately pinpoint cancerous nodes for resection, and potentially improve outcomes, according to Leslie L. Montgomery, MD, and Tara M. Balija, MD.

The reflector device, which can serve as an alternative to wire localization for identifying cancerous tumors prior to resection, was approved by the FDA in 2018 for use in the axillary lymph nodes in patients with breast cancer and has been utilized at Hackensack University Medical Center.¹ A study conducted by surgeons at the institution, and published in Breast Cancer Research and Treatment, examined the efficacy of the device compared with wire localization in patients with node-positive breast cancer.

Of the 99 patients enrolled to the study, 42 underwent wire localization and 57 underwent localization with the reflector device. Results showed that the wire and reflector-device approaches yielded similar efficacy in identifying positive axillary lymph nodes overall, at 83.3% and 84.2%, respectively.

Notably, in 22 patients who had the reflector device placed 8 weeks or more before surgery, or in the early- to mid-neoadjuvant chemotherapy setting, that efficacy increased to 100%. Conversely, among patients who had the device placed within 8 weeks of surgery, the efficacy was just 79.2% (P =.02).²

Due to these results, Montgomery and Balija have hypothesized that the device could have potential use beyond breast cancer.

“I am hopeful that people are aware of this technology because this can be used to find lymph nodes in head and neck surgery, or lymph nodes in melanoma surgery,” Montgomery said. “As we investigate more and more types of cancer that receive neoadjuvant treatment, seeing whether disease is still persistent in [certain] areas is important. This is a technology that I am sure [we will see] approval for [use] in other areas of the body and in other types of cancer.”

In an interview with OncLive^®, Montgomery and Balija discussed the benefits of a novel reflector device in patients with breast cancer, its efficacy in identifying clipped axillary lymph nodes, and the potential future use of this device in other cancer types.

Montgomery is the director of the Hackensack University Medical Center Division of Breast Surgery, and the co-director of the Breast Cancer Service at John Theurer Cancer Center. Balija is an assistant professor of surgery at the Hackensack Meridian School of Medicine at Seton Hall University, and director of the Breast Cancer Assessment & Risk Evaluation program.

OncLive^®: What unmet need does this tool address? Why might this approach be better to use vs wire localization?

Montgomery: When a woman has breast cancer, [often] the cancer will go to the axillary lymph nodes. If a patient presents with axillary metastases, the standard of care is neoadjuvant chemotherapy. We do that for many reasons, [one of which] is that we have found that chemotherapy is capable of sterilizing that axillary basin. [As such,] maybe by the time that patient goes to surgery, if we check that lymph node and the sentinel lymph node, and that is indeed sterilized, then we do not have to do a complete lymph node dissection, and we do not have to subject the patient to that morbidity.

Finding that lymph node can be difficult. As we know, [there are] many axillary lymph nodes, and after chemotherapy that lymph node will hopefully be smaller and could be completely obliterated. We need to be able to get it out, and we need to be accurate about whether that is the lymph node that was positive for metastatic disease. The standard is to mark that lymph node with a clip, which does not help us in the operating room. [We need] something else to find the lymph node for us at the time of the operation. Classically, that was a wire, but the wire is difficult for radiologists to get into the angle of the axillary lymph nodes. It is [also] difficult on the patient to be crammed into the machines to have that done, and it is [especially] difficult for them to have an additional procedure on the [same] day of operation. It can be very difficult for the surgeon, as well, because the wire often comes out the back.

For many reasons, the wire, even though that has been our workhorse of localization in the breast for years, was not a great localization tool for the axillary lymph nodes. That is why we, and many other surgeons, are looking at different modalities to find the axillary lymph nodes.

How do you decide which patients you should use this device on? Should all patients be considered, or do they need to meet certain criteria?

Balija: The reflector device is a very tiny, 1.2-cm, device that is placed in tissue, and can either be placed in the breast or the axillary lymph nodes. [The device] works off radar technology and is placed via a needle. Later, in the operating room, we can use a probe to locate the device.

The device can be used in almost any patient because it can be used either in the breast, or if the patient has a positive node, in the axilla. The only contraindications would be if a patient has stage IV disease and is not going to be moving forward with surgery, or if they have a nipple allergy. That is an important thing to keep in mind.

You recently conducted a study that was published in Breast Cancer Research and Treatment. Could you speak to this study and some of the key takeaways from this research?

Balija: Since we were early adopters of this reflector device technology, we wanted to compare outcomes [with this approach] vs outcomes with the wire. [To do this,] we looked at women at our practice who had breast cancer, a positive axillary lymph node, and who were going to undergo neoadjuvant chemotherapy. Those women went on to receive neoadjuvant chemotherapy and when they came back, especially if they had a good response in the axilla, we signed them up to do a sentinel node biopsy. Of course, [we used] either the wire or the reflector [to find] the sentinel lymph nodes, especially for the clipped lymph node.

We identified 99 women in our practice, and a little more than half of them had the reflector device placed; the other half had a wire placed. We found that the reflector device was just as successful as a wire at identifying that marked lymph node.

However, one interesting point was that when we looked at women who did not have successful identification of the clipped lymph node, usually these were women who had the device placed closer to the time of surgery. Either it was a wire that was [placed] on the day of surgery, or the reflector that was placed within proximity to the day of surgery.

In our study, we used 8 weeks as our dividing time point, but 22 women had their reflectors placed in the early- to mid-chemotherapy period. All those women had successful identification of that lymph node in the operating room.

What is the clinical significance of these data?

Montgomery: The take-home point for us is that we can put this device into a patient’s lymph node before chemotherapy, and thereby be much more confident that this is the lymph node that has cancer in it. That is very important. We were only able to do that once the FDA approved that we were allowed to put it in the axilla, as well as [leave it] in for months at a time. It is important to [to put that device in] as early as possible, with the greatest burden of disease.

This has been very helpful for patients, and for the radiologists trying to find that lymph node again after everything has been altered. It certainly [has also been helpful] for the surgeons, to have the ability to accurately get those lymph nodes out and feel confident that [the lymph node they are considering] is, indeed, the lymph node that was involved. This is a very good technology, and not many technologies are out there that can be put in [like this].

References

1. Hackensack University Medical Center breast surgeons demonstrate accuracy of new technology for marking location of cancerous lymph nodes. News release. Hackensack University Medical Center. June 24, 2021. Accessed July 27, 2021. https://bit.ly/3i9MLvY 
2. Balija TM, Braz D, Montgomery L. Early reflector localization improves the accuracy of localization and excision of a previously positive axillary lymph node following neoadjuvant chemotherapy in patients with breast cancer. Breast Cancer Res Treat. 2021;189(1):121–130. doi:10.1007/s10549-021-06281-w