Clinical Trial Aims to Reduce Need for Lymph Node Removal in Breast Cancer Patients

Submitted by Stony Brook Surgery on Mon, 12/17/2018 - 14:09

By Brian J. O'Hea, MD, Chief of Breast Surgery and Director of the Carol M. Baldwin Breast Care Center

Our Breast Surgeons Are Participating in National Trial to Help Advance Patient Care

 

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Our breast surgeons, (l to r) Drs. Patricia A. Farrelly, Brian J. O'Hea, and Anastasia Bakoulis.

Historically, all patients with invasive breast cancer have had the lymph nodes in their axilla (armpit) area removed as part of their surgical treatment.

Lymph node removal was established as the standard of care at the end of the 19th century as part of radical mastectomy, and remained so for most of the 20th century until its therapeutic role was challenged by a clinical trial in the 1970s.

The operation typically removed two thirds of the lymph nodes in the axilla, and greatly reduced cancer recurrence rates in the axilla.

In addition, the pathology information gained from it gave important prognostic information about the cancer in the breast(s).

The pathology information — cancer in lymph nodes or not — provides the oncologist (cancer specialist) with vital information that helped to determine the need for chemotherapy.

For these reasons, the removal of axillary lymph nodes has been an important part of the surgical treatment of breast cancer.

 

Stony Brook breast surgeons were the first surgeons on Long Island
to offer the less invasive lymph node removal procedure.

While most patients recover very well from this procedure, some suffer long-term consequences such as pain, numbness, arm swelling (lymphedema), and even nerve damage.

In the 1990s, sentinel node biopsy emerged as a minimally invasive, less extensive armpit operation.

 

Breast and Adjacent Lymph Nodes
Breast and adjacent lymph nodes (illustration courtesy of National Cancer Institute).

Patients who had cancer-positive sentinel nodes continued to have complete removal of their axillary lymph nodes. However, patients who had negative sentinel nodes could be spared the full node removal, and the possible negative consequences associated with it.

At that time, Stony Brook University breast surgeons were the first surgeons on Long Island to offer sentinel node biopsy as a less invasive procedure, which then became widely accepted as standard of care.

More recently, randomized trials have confirmed the safety of avoiding lymph node removal in patients treated by lumpectomy, even if there are one or two positive sentinel nodes.

Once again, Stony Brook breast surgeons, in conjunction with our multidisciplinary team, are taking the lead on this, focusing on patients who have positive lymph nodes at the time of cancer diagnosis.

These patients, who require neoadjuvant (preoperative) chemotherapy, are given the opportunity to enroll in a large national clinical trial called Alliance A011202.

In this trial, after receiving preoperative chemotherapy, enrolled patients will have definitive surgery including sentinel node biopsy with simultaneous removal of the previously positive node.

If the previously positive lymph node has been rendered cancer-free by preoperative chemotherapy, no further surgery is performed, and the patient is removed from the study group.

However, if it is determined in the operating room that the lymph node still has cancer, patients are randomized to lymph node removal or not, expecting both groups would get radiation anyway.

The goal of the trial is to determine whether or not radiation without axillary lymph node removal is as effective as both together, as well as monitoring complication rates and arm problems (pain, swelling, functional disability, range of motion) in each treatment group.

 

We are committed to doing research to find new and better treatments for our patients. Our clinical trials enable us to use the most advanced treatments — long before they're available to other physicians. Participation in our clinical trials is always completely voluntary and never interferes with the normal standards for patient care. Our goal is to give patients the chance to be in trials of new treatments without long-distance travel. Patients participate in them only after they receive a complete explanation of their options from their surgeon.

 

Learn more about the Alliance A011202 trial. For more information about the trial at Stony Brook's Carol M. Baldwin Breast Care Center, please call 631-638-0709, and ask for our breast cancer navigator.