Despite the ongoing COVID-19 pandemic, breast cancer remains one of the leading health concerns for women. One in 8 American women will develop breast cancer during her lifetime. Women diagnosed may feel frightened and overwhelmed by the challenges of understanding their diagnosis and choosing the appropriate breast cancer treatment. While chemotherapy has been a standard treatment, it’s not always effective and beneficial for all patients. Now, a personalized test can predict whether this type of treatment will add substantial benefit for individual patients.
The Oncotype DX Breast Recurrence Score® test, developed by Genomic Health, Inc., and provided by Exact Sciences Corp., helps physicians tailor treatment with precision.
Intended to be used for women diagnosed with early-stage HR+, HER2- breast cancer with either node-negative or node-positive disease, the Oncotype DX Breast Recurrence Score test precisely identifies which patients will benefit from chemotherapy, the extent of the chemotherapy benefit and the chances of their cancer returning. This personalized approach can guide next steps for the patient and provider in making the right treatment decision.
“We used to give chemotherapy to pretty much every single patient with early stage breast cancer,” says Dr. Virginia Kaklamani, the leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center. “And now, thanks to the Oncotype DX® test, we can save up to 80 percent of those patients from receiving chemotherapy. That’s huge.”
After a routine mammogram, Laurie Levin was diagnosed with stage 2B breast cancer in 2005. She was nervous about having chemotherapy since she already had it 30 years earlier for a lymphoma diagnosis.
“The consequences of having had chemotherapy prior was that if I were to receive chemotherapy again, I was at high risk for cardiac toxicity and secondary cancers like leukemia,” says Levin, a non-fiction author and anthropologist who’ll be 72 this fall. “The whole idea of getting chemotherapy a second time was pretty daunting.”
Luckily, Levin’s doctor knew about the Oncotype DX test. Without this type of testing, Levin and her doctor would have had to make a treatment decision based on factors that can only estimate the chances of the cancer returning but are not predictive of treatment benefit. Test results showed Levin’s “magic number,” as she calls it, was 17, indicating chemo would not have provided a significant benefit over endocrine therapy alone. She was able to complete radiation and a five-year course of endocrine therapy.
She’s been cancer-free for 15 years. Levin gets diagnostic mammograms annually. She encourages other women to create a dialogue with their doctor and to know what tools are available to them to treat their cancer.
Speaking from experience, she says, “Trust the science and do your own research. The more informed you are, the less frightening your diagnosis and decision-making will be.”
Understanding the test
The Oncotype DX Breast Recurrence Score test, performed on a small amount of tumor tissue taken from a biopsy before or during the surgery procedure, measures the expression of 21 genes: 16 cancer-related genes and five reference genes.
The results, which are on a continuous scale from 0-100, show the individual patient’s tumor biology. The higher a patient’s Recurrence Score® result is, the higher the likelihood she will benefit from chemotherapy and the higher the risk of her cancer returning.
The TAILORx trial — the largest, independently-led, randomized adjuvant breast cancer treatment trial ever conducted — highlights the unique value of the Oncotype DX test in guiding chemotherapy treatment decisions for patients whose cancer has not spread to the lymph nodes. In the study, investigators enrolled more than 10,000 patients from over 1,000 sites across six countries and used the Oncotype DX Breast Recurrence Score test on every patient to assign or randomize treatment. Findings showed that, overall, patients with Recurrence Score® results 0-25 showed excellent outcomes when treated with endocrine therapy alone, while patients with results 26-100 are known to have significant chemotherapy benefit.2, These study results definitively demonstrate that the Oncotype DX test identifies the vast majority of women with node negative early-stage breast cancer who receive no significant benefit from chemotherapy (approximately 80 percent with Recurrence Score results 0-25) and the important minority for whom chemotherapy can be life-saving.
Standard of care
These days, the Oncotype DX test is the standard of care, says Dr. Kaklamani, who’s also a professor of medicine in the division of hematology/oncology at UT Health San Antonio.
“It’s a very personalized approach to how we treat these patients,” says Dr. Kaklamani. “And it’s easier to explain to them that the reason they’re not going to get chemotherapy is because the genes are showing that their cancer is less likely to respond to it, or, the reason they’re getting chemotherapy is because they have a higher likelihood of deriving substantial benefit from this type of treatment.”
Typically breast cancer patients who don’t receive chemo are treated with endocrine therapy, that adds, blocks, or removes hormones.
Dr. Kaklamani reminds women that early detection and getting the right treatment are critical in supporting the best possible outcomes for patients.
“I always tell my patients that they are their own best advocate,” she says.
If you or a loved one are diagnosed with breast cancer, visit MyBreastCancerTreatment.org to learn more about the Oncotype DX Breast Recurrence Score test.
American Cancer Society. How Common Is Breast Cancer? Jan. 2020. Available at: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html.
 Paik et al. J Clin Oncol. 2006.
 Sparano JA et al. N Engl J Med. 2018.
 Ballman et al. J Clin Oncol. 2015.
 Albain et al. Lancet Oncol. 2010.
 Geyer et al. NPJ Breast Cancer. 2018.