Gene Test Helps Some Breast-Cancer Patients Skip Chemo, Study Says

Gene Test Helps Some Breast-Cancer Patients Skip Chemo, Study Says

Oncotype DX can help women determine their treatment options

By Ron Winslow  Wall Street Journal

I remember this test being develop 30 years ago and released 10 years ago and like everyone else ( since breast cancer survival is best measured afar a treatment regimen for low risk patients in 5-10 year intervals , I was anxious to see long long term follow up. PLESE BE CLEAR ONY A VERY LOW SCORE GIVES YOU VERY VERY HIGH ODDS OF NOT NEEDED IV CHEMO AS DOES A HIGH SCORE WARN THAT YU PORBALY SHOULD WE DO NOT KNOW WHAT THE INTERMEDIATE SCORES MEN ALOS,THIS DOES NOT MEAN WE NOW HAVE SIMPLE TESTS FOR ALLOTHER CACERS TOPICK OUT WHO NEEDS FURHER THERAPY AND WHO DOES



A gene test used to guide treatment for early-stage breast cancer proved effective in enabling certain women to safely forgo chemotherapy, in a study that illustrates how genomic information is reshaping cancer care.

Researchers said the findings provide validation for the test, called Oncotype DX, which is already in use helping women decide whether chemotherapy should be part of their treatment. The test provides a score based on a tumor’s genetic signature that describes the risk that the cancer will recur.

In the study, less than 1% of women who skipped chemotherapy based on a low risk score had a recurrence of cancer beyond the breast five years later, researchers said. Just 1.3% had a recurrence of the original cancer anywhere.

“We knew these patients were going to do well, but we didn’t dream they would do this well,” said Joseph Sparano, associate chairman of medical oncology at Montefiore Medical Center and Albert Einstein College of Medicine in Bronx, N.Y., and lead author of the study. The results were to be presented Monday at the European Cancer Congress in Vienna and published online by the New England Journal of Medicine.

Oncotype DX, developed by Genomic Health Inc. GHDX -0.61 % in Redwood City, Calif., analyzes 21 genes in tumor tissue. More than half a million women have used the test since it was launched a decade ago, with about 175,000 changing their treatment as a result, the company said. The test lists for about $4,200 and is widely covered by insurance, but it hadn’t previously been validated in a large prospective trial.

The study enrolled 10,253 women with breast cancer that is fueled by the hormone estrogen and contained within the breast—a group representative of more than 100,000 of some 231,000 women diagnosed with the disease annually in the U.S. After surgery to remove the tumor, a combination of hormone therapy—either tamoxifen or one of a class of drugs called aromatase inhibitors—and chemotherapy is the main strategy for most such patients to prevent the cancer from returning and spreading.

Experts credit the combination for helping to reduce breast-cancer death rates by more than one-third over the past 25 years. So you sure as hell do not want to not take it if you are someone who can benefit. This test help single out those with a very low chance of any benefit IT IS NOT A GAURENTEE Dr Ryan

But research suggests that the addition of chemo extends lives for only a fraction of women—perhaps about 5%—meaning that most early-stage patients face bearing the cost and harsh side effects of the treatment without getting any benefit.

In the study, 1,626 or almost 16% of patients had a low Oncotype DX recurrence score—below 11 on a 100-point scale—and were assigned to hormone therapy without chemo. Another 6,897, or two-thirds of the participants, scored between 11 and 25 and were considered at intermediate risk; they received hormone therapy and were randomized to either chemo or no chemo. The other nearly 17% were in the high-risk category and assigned to hormone therapy plus chemo.

Jennifer Litton, a breast medical oncologist at University of Texas MD Anderson Cancer Center in Houston, who wasn’t a researcher on the study, said she is eager to see results for patients in the midrange, where earlier data are ambiguous. “That’s the tougher conversation with patients,” she said.

Longer follow-up of participants is necessary to make a determination on that point, which is the primary goal of the study, researchers said.

The current findings provide assurance for oncologists who already use the test to guide treatment of low-risk patients. “This is a group of patients that we are likely over-treating with chemotherapy,” Dr. Litton said. “Using this test we can spare these patients from chemotherapy.”

Lynda Neff, a 61-year-old office manager for a plumbing company from New Braunfels, Texas, said that after she was diagnosed with breast cancer in 2007, she knew “immediately” that she would have both breasts removed and have chemotherapy. She had three children, a grandchild and a strong marriage, she said. “I had everything to live for. From the beginning I made the most radical choice,” she said. In cases like hers, a double mastectomy is controversial, but she said precancerous tissue was in her other breast as well. After she healed from the surgery and breast reconstruction, her doctor urged her take the Oncotype DX test before deciding on chemotherapy. Her score was 5. “Once I got the result and it was a low number, it was a no-brainer for me,” she said. She skipped chemo. She continues to take an aromatase inhibitor.

Next month, Ms. Neff will celebrate eight years cancer-free. Her 10th grandchild is due in April. “I haven’t looked back,” she said.

The study was funded by the National Cancer Institute and run by the Eastern Cooperative Oncology Group without commercial support.

Corrections & Amplifications:
All 1,626 patients who had a low risk score from a gene test called Oncotype DX were assigned to a treatment without chemotherapy in major study of the test. A story in Monday’s editions incorrectly indicated they were randomized to get either chemo or no chemo. An earlier version of this article incorrectly stated (Sept. 29)



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