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TAILORx Clinical Trial Finds Many Breast Cancer Patients Don't Need Chemotherapy

July 18, 2018

An international clinical trial recently confirmed that many patients with early-stage breast cancer may not need chemotherapy. Breast cancer medical oncologists Qamar Khan, MD, and Priyanka Sharma, MD, discuss the effect of these results.

The TAILORx trial, which The University of Kansas Cancer Center took part in, involved 10,200 women with the most common form of breast cancer   Ì¶   hormone-receptor-positive, HER2-negative, lymph node-negative. Worldwide, about 50 percent of all women diagnosed with breast cancer have this form of the disease.

The study evaluated the reliability of an established genomic test to assess risk of cancer recurrence, based on expression of 21 genes that drive breast cancer recurrence. The findings showed that about 70 percent of women diagnosed with this type of breast cancer don’t need chemotherapy and could be spared of its side effects.

Q. Were you surprised at the TAILORx trial findings?

A.No, we were not surprised. The genetic test (used in the study) is one we use to determine how aggressive a cancer is and whether chemotherapy will benefit the patient. We knew a low score meant no chemotherapy was needed, and a high score indicated chemotherapy was needed. This study clarified how to treat patients with scores in the middle, between high and low. Knowing this is important because chemotherapy can cause life-changing side effects, including heart disease and leukemia. Chemotherapy should only be provided to those who truly need it. One caveat to the study is that women under 35 have more biologically aggressive cancers. There were not a lot of women in this trial under age 35 so this test should be used with some caution in these very young women. Overall, these findings must be considered and discussed thoroughly with patients, along with other clinical factors, to determine cancer treatment.

Q. How important are these findings?

A. We were anticipating the results of the trial and changed our practice the day they were confirmed. As a National Cancer Institute-designated cancer center, and the leader in the region, we can implement treatment protocol changes immediately. Because we are part of an academic medical center, we already develop treatment around the biology of the tumor and its aspects. Still, the study’s findings provide clear guidance for practitioners and mean less chemotherapy for patients.

Q. How is this changing the way we treat cancer?

A. One goal of cancer treatment is to cure the cancer but not over-treat the patient. With the knowledge from this study, we will be giving chemotherapy to far fewer women than we would have otherwise. By reducing the amount of harmful and unnecessary treatment, we de-escalate cancer treatment. This paradigm shift is also being realized in pediatric oncology, where in the past we treated children with adult-level intensive therapies that resulted in serious side effects as they grew into adults. There are many clinical trials taking place, including here at The University of Kansas Cancer Center, to de-escalate treatments and save patients from unnecessary side effects.

Q. Why are clinical trials so important to cancer care?

A. Through clinical trials, we advance the science of cancer care. All discoveries are made through clinical trials. Breast cancer treatment has advanced dramatically in recent decades, and it’s because of clinical trials. Clinical trials give patients an opportunity to receive testing and treatments of the future. Ultimately, more patients benefit from the advances clinical trials provide.

As an NCI-designated cancer center, we are an extension of the National Cancer Institute, striving to achieve the goal of curing cancer. This means we have a fully developed research infrastructure that meets NCI standards, which are at the highest level. At The University of Kansas Cancer Center, we develop our own ideas for clinical trials and conduct the trials based on research we perform.

To learn more about investigator-initiated clinical trials at The University of Kansas Cancer Center, visit

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