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Breast Cancer

A Reprieve from Chemo

Upon being told you have breast cancer, your blood turns arctic-cold. A fierce terror grasps you in a strangle-hold. You are certain you will die, and very soon. Your medical caretakers assure you that such is not the case, there are therapies and treatments, and you will surely make it through the process just fine. You want to believe, but you are dubious. Your mind takes off again, zeroing in on the dreaded chemotherapy. The terror tightens its grip.
Isn’t the uncertainty of a cancer diagnosis enough to bear without the indignities of chemo?
It’s quite possible. Tens of thousands of breast cancer patients, mostly women, have gotten a reprieve in recent years. Their early-stage, estrogen receptor-positive cancer qualified them for an innovative diagnostic laboratory test, the OncotypeDX Breast Cancer Assay. This test measures the likelihood of both the cancer’s return within 10 years and the patient benefitting from chemotherapy in addition to anti-hormonal drug therapy.
Lori Lockridge, 45, of Smithville, Mo., considers herself one of “the lucky ones.” She was diagnosed in mid-April and has been commuting to Cancer Treatment Centers of America at Midwestern Regional Medical Center in Zion for her care. After a mastectomy in May, her OncotypeDX score showed no need to undergo chemotherapy. “I have been blessed,” she said. “The doctors say there’s no more cancer.”
OncotypeDX was developed by Genomic Health in Redwood City, Calif., and first made available in 2004. It works by examining a small sample of the cancer, taken during a biopsy or surgery and preserved in a paraffin block, and measuring the activity level of 21 relevant genes. The result is expressed as a number between 0 and 100, called a Recurrence Score. The lower the score, the less risk of recurrence and less beneficial the chemotherapy. Scores below 18 are low, from 18 to 31 are intermediate, and above 31 are high.
By providing deeper insight into the cancer’s molecular biology, which varies greatly from patient to patient, recurrence scores help doctors make treatment recommendations. The scores are considered in combination with other factors such as the patient’s age, tumor size and grade, whether the cancer has spread to the lymph nodes and if so, how far.
“The more we know about the particular disease and the patient, the more we can tailor treatment to her situation,” said Cancer Treatment Centers of America medical oncologist Dennis Citrin, M.D., PhD., who is treating Lockridge. “Very subtle differences in the disease can have a profound effect on our prognosis and treatment recommendations. Two patients can have the same size tumor, the same node status, and one has an Oncotype score of 6 and one has a score of 37. They will be treated entirely differently.”
Although the major benefit of the test is that many women can confidently forgo chemotherapy, high scores are valuable as well, by providing confirmation that chemotherapy is necessary, he added.
Cindy Kleidon of Oak Park also was able to avoid chemotherapy. Three years ago she underwent two lumpectomies followed by 10 sessions—twice daily for five days—of balloon catheter radiation at Loyola University Medical Center in Maywood. Her OncotypeDX score was low enough that the radiation and drug therapy were sufficient to stave off her cancer.
“I know it’s not a guarantee, but it’s an indicator you can use wisely,” said Kleidon, 65. “It was reassurance that we were heading in the right direction. I’ve seen people really suffer from the side effects of chemo. To me, it was a big relief not to have to go there.”
More than 200,000 new cases of breast cancer are diagnosed each year in the United States. The most common form of the disease is estrogen receptor-positive, which means the cancer cells are fueled by estrogen. OncotypeDX is not the only multi-gene assay on the market, but it is the mostly widely used. Others are Mammostrat Breast Cancer Test by Clarient and MammaPrint by Agendia. The cost, far cheaper than chemotherapy, is generally covered by insurance companies.
Not every patient is a good candidate for the test. And for some patients, the test is more informative than for others. Those who score in the intermediate range, for example, may not find the test particularly helpful, perhaps raising more questions than it answers.
“There are those who will never accept chemotherapy, regardless of a score, and so for them, the test should not be done,” said Kathy D. Albain, M.D., professor of medicine at Loyola University Chicago Stritch School of Medicine, and director of the Breast and Thoracic Oncology Programs at Cardinal Bernardin Cancer Center in Maywood. “And vice versa—some women want chemotherapy even if its benefit would be marginal, so the test will have no added meaning.”
Patients also must understand that their scores assume they will receive at least five years of drug therapy, she added.
“It is absolutely critical they take it for the full five years,” said Dr. Citrin, whose research into patient compliance shows that of those who relapsed, more than half prematurely stopped taking the medication. “It wasn’t the only reason for the relapse, but it is an important factor.”
For the future, more and more is being learned about cancer behavior. Genomic Health and other companies are refining and enlarging their capabilities to include more cancer types and increasingly aggressive forms of cancer. Initially only patients with no lymph node involvement were eligible for OncotypeDX. The test has since become available to select cases of node-positive cancers and ductal cancers in situ.
“Of every 100 women who receive chemotherapy for early-stage breast cancer, only four will benefit,” said Emily Faucette, senior director of corporate communications and spokesperson for Genomic Health. “Yet the majority is treated with chemotherapy because there is no way to identify who those four are. We haven’t precisely identified the four, but we are getting closer.”
Now is an exciting time in breast cancer
biology research, said Dr. Albain, whose research focus is women with positive lymph nodes and their treatment.
“In node-positive breast cancer, the risk of relapse is generally much greater, and all these women have been offered chemotherapy based on its benefit to survival,” she said. “We may have been over-treating some of these women.”
Genomic Health has also developed an OncotypeDX Colon Cancer Assay and is working on tests for prostate cancer.
“We believe there will be a day when there will be a test for all cancers,” said Faucette.
As for those patients who must endure chemotherapy, Dr. Citrin has comforting news: It may not be as bad as you fear. Thanks to new medications, the serious side effects such as nausea, vomiting and infections, which were once inevitable and often debilitating, are far less common today.
“Naturally, she should be apprehensive, but the fact is it is much easier and better tolerated than it used to be,” he said.

Published: October 13, 2012
Issue: November 2012 Issue