Clinical Trial Aims to Minimize Surgery for Patients with Breast Cancer

Historically, all patients with advanced breast cancer have had the lymph nodes in their underarm area removed as part of their surgical treatment.

Lymph nodes, also known as lymph glands, are pea-size lumps of tissue found throughout the body that help protect the body from infection and cancer. They are mostly in the neck, groin, underarm and behind the collarbone.

Removal of underarm lymph nodes was established as the standard of care at the end of the 19th century 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 underarm and greatly reduced cancer recurrence rates in that area.

In addition, the pathology information gained from the lymph node removal gave important prognostic information about the cancer in the breast(s) and provided the oncologist with vital information that helped to determine the need for chemotherapy.

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

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.

Minimally invasive procedure
In the 1990s, biopsy of the sentinel node(s) emerged as a minimally invasive, less-extensive procedure. The sentinel node is the first lymph node into which a breast tumor drains.

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

At that time, Stony Brook University Hospital 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.

Avoiding lymph node removal
More recently, 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 a multidisciplinary team, are taking the lead, 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 Cancer Institute clinical trial called Alliance A011202 – “A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy.”

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 cancerfree by preoperative chemotherapy, no further surgery is performed, and the patient is removed from the study group.

However, if it is determined that the lymph node still has cancer, patients are randomized to lymph node removal or not, and both groups would receive radiation.

The goal of the trial is to determine whether or not radiation without armpit 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.

For more information, call (631) 638-0709.

Photo of surgeons from the Carol M. Baldwin Breast Care Center (l to r): Patricia Farrelly, MD; Brian O'Hea, MD; and Anastasia Bakoulis, DO.