AUSTIN, Texas--(BUSINESS WIRE)--A pioneering new technique known as ‘delayed’ sentinel lymph node biopsy could spare as many as four in five Americans diagnosed with high-risk ductal carcinoma in-situ (DCIS) from an unnecessary additional underarm surgical procedure.1
Ductal carcinoma in-situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast, and accounts for one in every five new breast cancer diagnoses.2 It is considered the earliest form of breast cancer and is non-invasive, meaning that the cancer has not spread beyond the milk duct and has a low risk of becoming invasive. If left untreated, DCIS can break down and become invasive, where the cancer spreads through the lymphatic system.
A common treatment for DCIS is a mastectomy, where the patient will undergo surgery to remove the entire breast. Until now, doctors would also remove the majority of lymph nodes in the underarm on the side of the affected breast tissue during the mastectomy, to assess whether the cancer has spread. This procedure is known as a sentinel lymph node biopsy. Every year over 50,000 American women with the earliest form of breast cancer receive this node surgery.3 Yet, 70-80% of women diagnosed with DCIS do not have invasive cancer,3,4 rendering this additional surgery unnecessary.
The new procedure, known as a ‘delayed’ sentinel lymph node biopsy, involves the use of the Magtrace® lymphatic tracer, a magnetic lymphatic tracer used in axilla staging. It is the only tracer that will be retained long enough in the lymph nodes to enable this pioneering treatment. In the procedure:
- The Magtrace® lymphatic tracer is injected at the time of the mastectomy and DCIS surgery, naturally migrating to the nodes that the cancer is most likely to spread to, if the disease is invasive.
- It remains in place for up to 30 days after it has been injected and will provide a magnetic signal to help the surgeon return to the nodes, if they need to.
- This means that doctors can wait for pathologic analysis of the DCIS to confirm if it is invasive. This information can then determine whether a sentinel lymph node biopsy is necessary. In up to 80% of cases it will not be. 1
- If pathology confirms that the DCIS is invasive, the long-lasting signal of Magtrace allows for the sentinel lymph node biopsy to still be performed to understand the extent of cancer migration to the lymph nodes.
“The delayed sentinel lymph node biopsy has really revolutionized our ability to maintain lymphatic integrity in women who have DCIS”, explained Dr Kandace McGuire, Chief, Section of Breast Surgery Surgical Leader of the Multidisciplinary Breast Cancer Program at Massey Cancer Center, Virginia. “So, what we do is we inject the Magtrace® lymphatic tracer at the time of the initial mastectomy. The great thing about this is that the tracer will stay in the lymph nodes for up to six weeks so that we have time to get pathology back. If there’s no invasive cancer, there’s no need to do a sentinel lymph node biopsy.”
By preventing surgery, the new ‘delayed’ sentinel lymph node biopsy spares women’s lymph nodes and leaves the lymphatic system undamaged, reducing the risk of life-altering complications connected with lymph node surgery. One of these is lymphedema, a condition affecting over 10 million Americans,5 caused by a build-up of lymphatic fluid that escapes into the body when the system is disrupted. Lymphedema, while manageable, is largely incurable,6 and causes lifelong swelling, altered sensation, pain and limitations in range of motion.7
“It felt wonderful to know that I would only have a sentinel lymph node biopsy if I truly needed it,” explained Theresa Poon, who benefitted from the delayed Sentinel Lymph Node Biopsy procedure. “I was very scared of lymphedema. The swelling can just happen at any time, and even though it’s very rare, it’s always in the back of your mind. To be offered the possibility of not having any lymph nodes removed if I didn’t have invasive cancer was great.”
Research from Uppsala University Hospital in Sweden and University Hospitals Cleveland has shown that the delayed Sentinel Lymph Node Biopsy procedure has reduced surgical interventions in 78.3% and 87% of cases respectively, and reduced costs to the healthcare system by 24.5% for women without invasive breast cancer.1,7 In total, over 160,000 women across more than 700 hospitals in over 45 countries have already been able to access more precise and less invasive breast cancer treatment thanks to Magtrace® and Endomag’s other breast cancer treatment technologies.
"Women with breast cancer face so many difficult choices, so it’s gratifying to know that for high-risk DCIS patients, we can take one away without compromising their care and offer a real chance of avoiding unnecessary surgery,” said Mathew Stephens, Chief Marketing Officer at Endomag. “Our new campaign, #SaveOurNodes, seeks to ensure that all women with high-risk DCIS are aware of this new surgical option. With advice from expert breast surgical oncologists who offer the technique and other patients who have had the procedure, we hope this campaign helps to provide more clarity on the best treatment approach for them."
Find out more about the campaign and the ‘delayed’ sentinel lymph node biopsy technique by visiting www.saveournodes.com, which features more information and resources about the procedure. There is now an ever-growing number of hospitals across the US practicing ‘delayed’ sentinel lymph node biopsy and Endomag will continue to work to improve access for all breast cancer patients.
Endomag is a global medical technology company that believes everyone deserves a better standard of cancer care. Many of the world’s leading physicians and hospitals use the company’s technologies to help women with breast cancer avoid surgery when it isn’t needed, and experience better outcomes when it is.
At the heart of the company’s product platform is the Sentimag® localization system. The Sentimag® system features a probe which works like a metal detector, and when placed near the skin’s surface is used to detect Endomag’s magnetic seed (Magseed®) or liquid tracer (Magtrace®), for tissue localization and sentinel node biopsy procedures.
To date, Sentimag has been used in over 250,000 tissue localizations in over 45 countries and on all six continents that perform breast cancer surgery. The technology has allowed these patients, regardless of hospital setting, to access more precise and less invasive breast cancer treatment. The company’s technologies are also widely supported by extensive clinical data, with over 5,000 patients featured Magseed® marker studies, making it the world’s most studied non-radioactive seed technology.
Endomag is headquartered in Cambridge, UK, with an office in Austin, Texas.
1 Karakatsanis A, et al., P24: Superparamagnetic Iron Oxide Nanoparticles (SPIO): A Sentinel Node (SN) Tracer with Novel Applications. Presented at 2019 the Society of Surgical Oncology Annual Cancer Symposium. Available at: https://eventmobi.com/sso2019/agenda/a68d98c3-ec1d-4ac1-b81c-db45c027f559/d4ed4867-c0dd-4e02-9ed9-eaa65060587e Last Accessed August 2021.
2 Kerlikowske K. Epidemiology of ductal carcinoma in situ. J Natl Cancer Inst Monogr. 2010;2010(41):139-141.
3 Mitchell K, et al., DCIS and axillary nodal evaluation: compliance with national guidelines. BMC Surgery 2017.
3 Lyman GH, et al., American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. Journal of Clinical Oncology 2014; 32:1365-1383.
4 Senkus E, et al., ESMO Guidelines Committee. Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2015; 26(Suppl 5):v8-v30.
5 Cancer Research UK. Living with Lymphoedema After Treatment. Available at : https://www.cancerresearchuk.org/about-cancer/breast-cancer/living-with/lymphoedema-after-treatment Last Accessed, August 2021.
6 Anbari A, et al. Breast cancer-related lymphedema and quality of life: A qualitative analysis over years of survivorship. Chronic Illness. 2019:0(0):1-12.
7 Miller E, et al. SENTINOT: Utilization of a novel tracer for patients with ductal carcinoma in situ to avoid unnecessary sentinel lymph node biopsy. Presented at the ASBrS 22 Annual Meeting. Available at: https://virtual.oxfordabstracts.com/#/event/public/1705/submission/53 Last Accessed, August 2021.