Breast cancer survivors
Men with breast cancer
People with a genetic mutation linked to cancer risk
Women under 45
Women over 45
A research study named the “Trial Assigning Individualized Options for Treatment” (TAILORx) asked whether chemotherapy is beneficial for women who have mid-range Oncotype DX tumor recurrence scores. This trial — the largest breast cancer treatment trial ever conducted— showed that endocrine therapy alone was as effective as endocrine therapy plus chemotherapy in women with certain types of early-stage breast cancer. The results of this trial are expected to be immediately practice changing (7/20/18)
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Tailoring breast cancer treatment for women with mid-range Oncotype DX recurrence scores.
About half of all breast cancer cases diagnosed in the United States are hormone receptor-positive and node-negative — fed by hormones but not yet spread to the lymph nodes. Adjuvant chemotherapy, chemotherapy after tumor surgery, can reduce risk of recurrence, and the risk of dying from breast cancer in certain patients. But chemotherapy comes with side effects. Being able to determine which patients will or won’t receive benefit from chemotherapy is goal of prognostic tests such as Oncotype DX, Mammoprint, and others. XRAYS reviewed an earlier study by the same group of researchers that supported the clinical validity of Oncotype DX to identify patients who may be safely spared adjuvant chemotherapy. The TAILORx trial is a continuation of this research and asks whether some patients receive unnecessary chemotherapy.
For women with hormone receptor-positive, HER2-negative, node-negative early-stage breast cancer
This clinical trial suggests that women with intermediate, mid-range Oncotype DX scores (11-25) do not benefit from adjuvant chemotherapy. However, younger women (50 and under) with higher mid-range scores (16-25) may still benefit from adjuvant chemotherapy. There is a point on the recurrence scale at which chemotherapy is beneficial, but that point is not yet certain. Your doctor may use other factors to decide which treatment is right for you.
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The American Society of Clinical Oncology (ASCO) has published guidelines on the use of different biomarker tests to guide decisions on adjuvant chemoatherapy or hormone therapy in early-stage breast cancer. Among their recommendations. Strength of recommendation is noted in parentheses):
Additional information on other tumor types and biomarker tests can be found on the ASCO website.
The National Comprehensive Cancer Network (NCCN) has expert-developed guidelines for treating breast cancer. NCCN guidelins for node-negative, ER-positive, Her2-negative breast cancer includes the following recommendations.
NCCN notes that other prognostic tumor tests are available for treatment decision-making. The NCCN guidelines state that the Oncotype Dx 21-gene panel is preferred by the Breast Cancer Panel for node negative breast cancer.
These guidelins are up-to-date as of 09/28/19.
The following study is looking at tumor prognostic tests used for decision-making in early-stage breast cancer:
Global Health Newswire
US News and World Report
Oncotype DX is a test to predict whether chemotherapy will benefit a patient with hormone receptor-positive breast cancer. Recurrence scores are based on RNA expression of 21 genes. Recurrence scores range from 0 to 100. Scores of 31 and higher (or 26 and higher in some studies) are associated with chemotherapy benefit. Low recurrence scores (0-10) are associated with a very low risk of recurrence that chemotherapy is not likely to lower any further. While many experts recommend the use of the Oncotype DX tumor test as a predictor of recurrence and to guide chemotherapy recommendations, it was uncertain whether those who had mid-range recurrence scores would benefit from adjuvant chemotherapy.
Whether they could further tailor treatment of hormone receptor-positive breast cancer for patients with mid-range Oncotype DX recurrence scores.
The phase III, prospective study enrolled women who were 18 to 75 years of age, had hormone receptor-positive, HER2-negative, axillary node-negative breast cancer who met National Comprehensive Cancer Network guidelines for the consideration of adjuvant chemotherapy.
10,273 women registered for the study between October 6, 2010, and April 7, 2016.
There were 9,716 patients with follow-up information who were assigned therapy based on their Oncotype DX recurrence score:
Median length of endocrine therapy was 5.4 years. The most common chemotherapy regimens among patients were docetaxel-cyclophosphamide (56%) and anthracycline-containing regimens. Hormonal therapies among postmenopausal women most commonly included an aromatase inhibitor (91%) and among premenopausal women either tamoxifen alone or tamoxifen followed by an aromatase inhibitor (78%). Suppression of ovarian function was used in 13% of premenopausal women.
Results of the TAILORx trial were presented on June 3, 2018, at the annual American Society of Clinical Oncology meeting in Chicago, Illinois and published in the New England Journal of Medicine.
While chemotherapy had some benefit for women 50 years of age or younger with recurrence scores of 16 to 25, it is not clear why. It is possible that this observation is due a lowering of estrogen from chemo-induced menopause, but the researchers did not collect data on that. It remains unclear whether similar benefits could be achieved with ovarian suppression coupled with an aromatase inhibitor for these women.
In the early 2000s, most patients with breast cancer who were hormone receptor-positive and node-negative received chemotherapy, but most did not benefit from it. The results of the TAILORx trail, the largest breast cancer treatment trial ever conducted, suggest that the Oncotype DX tumor test could identify up to 85% of women with early breast cancer who can forego adjuvant chemotherapy, especially women older than 50 with a recurrence score of 25 or less and women 50 years of age or younger with a recurrence score of 15 or less. This trial, as well as other smaller trials, have generated new data that can guide adjuvant chemotherapy use for patients. More studies are needed to clarify those women who need more of some therapies and less of other therapies.
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