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Trial Explores Eliminating Breast Cancer Surgery in Exceptional Responders to Neoadjuvant Therapy

Gina Columbus and Angelica Welch
Published: Thursday, Feb 02, 2017

Henry Kuerer, MD, PhD

Henry Kuerer, MD, PhD

A prospective study is investigating whether breast cancer surgery can be eliminated in patients who respond well to neoadjuvant systemic therapy.

The phase II single-center trial, conducted out of The University of Texas MD Anderson Cancer Center (NCT02945579), aims to determine how often breast cancer recurs in patients who previously received chemotherapy and follow-up radiation therapy, but not surgery, and have no evidence of disease. Forty patients with early-stage, triple-negative or HER2-positive breast cancer care underwent image-guided biopsy after completing chemotherapy and before beginning radiation therapy to see if surgery is necessary.

With follow-up, explains lead author Henry M. Kuerer, MD, PhD, researchers will be able to determine whether surgery can, indeed, be avoided in these patients. A concern among many with breast cancer, he adds, is overtreatment.

Kuerer, a professor of Surgery at The University of Texas MD Anderson Cancer Center, lectured on surgical advancements in the field of breast cancer during the 2017 OncLive® State of the Science Summit on Treatment of Metastatic Breast Cancer. In an interview, he discussed the goals of the prospective trial and how it could impact these exceptional responders.

OncLive: Could you give an overview of your discussion on surgical management in breast cancer?

Kuerer: We are very excited about a new trial at The University of Texas MD Anderson Cancer Center that is just about to open. It is potentially groundbreaking for patients, in that we are going to try to eliminate breast cancer surgery for those who have an exceptional response to neoadjuvant therapy. We've known for quite some time that there are some patients with exceptional responses, even after a few cycles.

However, we particularly know for triple-negative breast cancer (TNBC) and HER2-neu–positive breast cancer that these patients overall, with standard therapies, have about a 50% chance of having no residual breast cancer at all. We have an obligation to test whether or not surgery is essential in those patients. The problem has been breast imaging; even the best and most advanced techniques cannot predict, with any accuracy acceptable to clinicians, who has no residual disease, and whether moving on to radiotherapy without surgery could be potentially dangerous.

The new trial is open to women with tumors that are less than 5 centimeters, are triple-negative, and HER2-neu. Patients who are responding and, in which we can sample with extensive vacuum-assisted biopsies at the end—just like we do at the beginning of therapy to make a diagnosis—and those patients without residual disease will go on to receive standard radiation without surgery.

We have moved to this point only with the completion of our feasibility clinical trial to assess whether or not we can accurately identify patients using biopsy with imaging to select patients without residual disease. Of course, safety is prime in our mind on testing this, so our completed clinical trial was for the same patient population of TNBC and HER2-neu. We had an endpoint of vacuum-assisted core biopsy along with fine-needle aspiration (FNA) to see the correlation of our ability to take that biopsy and to do our standard surgery and find out whether it is accurate.

Essentially, this trial met its endpoints with a very high accuracy that combines those techniques. Their accuracy was nearly 98% with a false-negative rate of 5% and a predictive value of about 95%.

With that data, we can be confident that when we sample extensively, it will likely be safe to just move on and have radiotherapy without the surgery. Of course, when you have 1 patient in whom you missed the residual disease, you focus on that particular patient. We learned a lot from the trial in that, on average, there were 12 vacuum-assisted core biopsies—which is very good sampling.

The 1 patient where the core biopsy and the FNA did not show any residual disease, but actually did have residual disease, was a limited sampling with only 4 core biopsies. We learned from that trial that we are going to need to do extensive vacuum-assisted biopsy for the clinical trial where we eliminate the surgery.

What does surgery look like to you in the next 5 to 10 years?

What has changed so much over the years is the integration of neoadjuvant systemic therapy with surgery. Even for patients who present lymph node¬–positive disease, we now have a new technique called targeted axillary lymph node dissection. Here, we test the lymph node that had cancer prior to neoadjuvant therapy along with what we call the sentinel lymph nodes. We found that to be a very accurate method. We are eliminating more extensive surgery and lymph node surgery as well in probably 40% to 50% of cases.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: How Do We Leverage PARP Inhibition Strategies in the Contemporary Treatment of Breast Cancer?May 31, 20191.5
Community Practice Connections™: A Better Way to Stop Pain: Paths Toward Responsible Postsurgical Pain Management for Patients With Breast CancerMay 31, 20191.5
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