Breast Cancer: New Diagnostic Tools

New Diagnostic Tools Propel Targeted Medicine

Though it didn't seem so at the time, Donna Henagin is lucky. She was 37 years old four years ago when she became one of the 200,000 women annually diagnosed with breast cancer. It was a cancer her doctor missed, and it had spread aggressively to 19 lymph nodes. Fortunately, it had not spread further.

But because Donna was diagnosed in this millennium, she had the newest diagnostic tests at her disposal. These told her doctors that her cancer was the type that would respond to a promising new drug called Herceptin; indeed, the early definition of her type of cancer and use of Herceptin most likely saved her life.

Herceptin is one of the hottest entries in the new frontier called “personalized medicine”. Using gene-related technologies, companies create targeted therapies that are safer and more effective. More than 40 percent of cancer drugs in early- to mid-phase clinical trials are expected to emerge as targeted therapies.

Targeting the Problem

The nucleus of a human cell contains more than 30,000 genes; one of these is called HER-2. It is a gene that helps control how cells grow, divide and repair themselves. In about a quarter of all breast cancers, the cells contain extra copies of the HER-2 gene. This amplification of HER-2 makes the cancer cells grow and spread faster. Women with this type of breast cancer do not respond to other therapies and tend to have a worse chance of survival. But Herceptin targets HER-2 to block the cell growth stimulated by it and shrink the tumor. It is also reported to have a positive effect in preventing recurrence.

Herceptin has a significantly higher success rate in HER-2 positive patients. Unfortunately, it is prohibitively expensive and has not shown promise in other forms of breast cancer. When treating aggressive cancers, time is a critical factor. Patients may try several different therapeutic options before finding the one that works, at a dear cost in dollars, disease progression and angst. Most patients are willing to face the bad side effects if they can believe they will be cured, or at least have a few more years with a good quality of life. So targeted therapies like Herceptin are bringing new hope to all types of patients, and that is why new diagnostic tests, which help identify the target, are critical.

In the late 1990s, the first tests to determine HER-2 positive cancers emerged, giving the medical community much-needed ammunition against these aggressive cancers. Immunohistochemistry (IHC) testing detects excessive HER-2 proteins on the surface of the cell. 1 “These tests are now considered mandatory and routine on all breast tumors,” said Andrew Seidman, MD, medical oncologist and an attending physician on the breast cancer medicine service at Memorial Sloan Kettering in New York. These diagnostic tools prevent wasting valuable time and miserable illness on treatments that will not work. They also save money by getting the treatment option right the first time, and getting patients out of the hospital more quickly.

While these tests have provided a huge leap in managing the treatment of these types of breast cancers, advances in technology are bringing more accurate diagnostics to physicians seeking to prescribe the most effective treatments for their individual patients.   One such test is fluorescence in situ hybridization (FISH), which detects an amplification of the HER-2 gene, an earlier stage than the IHC test.

“ Given that so much is at stake here, with the dramatic therapeutic benefits of new cancer treatments like Herceptin, it is crucial to get it right the first time. Diagnostic tests such as fluorescent in-situ hybridization, are a critical tool as we learn how best to fight these diseases.”

Ensuring Patient Access

The Lewin Group report that “Medicare reimbursement for new clinical laboratory tests is “archaic, impractical and severely flawed” and discourages the use and development of new tests. The authors found that Medicare often pays the same or less for a new test than an existing test, despite the fact that the new test may offer greater benefits to patients and physicians.

According to The Lewin Group, “Tests that can predict how a patient will respond to particular drug therapies exemplify how reimbursement may fail to keep up with improvements in diagnostic technology.” It states that FISH was “assigned to a reimbursement code developed in 1989 that does not sufficiently capture the increased resources needed for the new FISH testing method.”

Congress must take action now to modernize the 20-year-old Medicare Clinical Laboratory Fee Schedule before patients and the health care system suffer.

Sources:

1. Study Suggests That Treatment for Women with Late-Stage Breast Cancer is More Effective and Less Costly When Fish Diagnostic Technology is Used —Abbott Press Release regarding Journal of Clinical Oncology report, March 22, 2004