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Trials show that GeneSearch can eliminate post-surgery waits for lymph node testing.
Published Jul. 31, 2007

The last thing a woman who has just undergone surgery for breast cancer wants to hear is that the cancer has spread to her lymph nodes.

What's worse, many have to wait days after their initial surgery to find out if the cancer has indeed spread.

"It is agonizing because it's the whole question of, 'Where has it gone?' " said Genevieve Riley, 54, who underwent a lumpectomy on her right breast last year and waited almost two weeks to hear if the cancer was in her nodes. "You're just sitting there not knowing what you're going to have to incorporate into the rest of your life. You want to get in there and get it done and move on."

A test recently approved by the FDA aims to reduce that uncertainty by more accurately diagnosing cancer in the lymph nodes during a patient's initial mastectomy or lumpectomy.

The thinking is, "Let's get an answer while we're in the operating room," said Dr. Peter W. Blumencranz, a surgical oncologist at Morton Plant Hospital in Clearwater, who led research on the new test. "Going back involves a lot of emotional and psychological turmoil. To boot, it adds cost to the medical system."

GeneSearch, a molecular-based lab test, samples more of the lymph node more thoroughly than previous tests. And it's all done during the patient's first surgery. If the test reveals cancer, a patient can have her lymph nodes removed then, instead of waiting days for a second pathology test.

"As a breast cancer surgeon, I'd rather be able to tell the patient with a lot more accuracy that her nodes are clear or not," said Blumencranz, who is also medical director for breast health services for Morton Plant Mease Health Care.

Lymph nodes are a part of the body that help protect against infection. The presence or absence of cancerous cells in the nodes is essential in staging breast cancer treatment and developing a plan. So, it's important to know as soon as possible if and to what degree the cancer has spread to those nodes.

Now it takes weeks

There are an estimated 180,000 new cases of breast cancer nationwide each year. Aside from non-melanoma skin cancer, breast cancer is the most common form of cancer in women, according to the Centers for Disease Control and Prevention.

When a breast cancer patient undergoes a mastectomy or lumpectomy, the surgeon removes some of the patient's lymph nodes to look for cancer cells under a microscope. A portion of the node is tested immediately and another portion is sent away for a more microscopic examination. Final results can take days or weeks.

Sometimes the initial test doesn't catch the cancer. That's because it only looks at 10 to 15 percent of the nodes. However, the longer range test might still come back positive. Patients then return for a second surgery.

GeneSearch allows doctors to analyze about 50 percent of the node during that initial test, compared to 15 percent. If GeneSearch detects cancerous cells, the patient can have the nodes removed right there. The test analyzes more of the node because it studies it on a molecular, rather than a microscopic, level.

Patients still have to undergo a second test of their lymph nodes, but scanning more the first time should reduce the frequency of second surgeries.

Results are immediate

In the emotional minefield that is cancer, positive outcomes are treasured.

Last September, Jeanene Andrews was reveling in such success. After being diagnosed with breast cancer a month before, she had undergone surgery to have the tumor removed from her left breast.

Days later, while recovering at home, she got the call. An additional test showed that the cancer had spread to her nodes. She'd have to undergo another surgery.

"It was like someone slammed the brakes on my life again," said Andrews, 40, a mother of three young daughters. "I had to figure out, 'Am I going to die, and how do I get through this one?' "

GeneSearch strives to reduce the number of cases like hers.

"Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

700 patients in trial

GeneSearch is manufactured by Veridex, a Johnson & Johnson Co. of Warren, N.J.

In the clinical trial, GeneSearch correctly predicted breast cancer had spread nearly 88 percent of the time in women with metastasis. Patients who didn't have cancer in their lymph nodes were identified accurately 94 percent of the time, according to the FDA.

More than 700 patients participated. Dr. Blumencranz did 185 of those procedures at Morton Plant Mease. The hospital was selected as the lead test site because of Blumencranz's history researching lymphatic mapping.

Because the hospital was a trial site, it will be among the first in the nation to use GeneSearch. Hospital officials expect to begin using the new method in a few weeks.

Nicole Hutcheson can be reached at or (727)445-4162.