Oncologist Laila Agrawal, M.D., talks about what new research means for patients and care practices

Published: June 5, 2018 | Updated: September 28, 2022

The average person may have only limited interest in news from a professional medical conference for oncologists. That changes quickly, however, when the news sparks a shift in medical treatment that could affect tens of thousands of women every year. Now, many early-stage breast cancer patients may avoid needing chemotherapy.

At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers presented results from the TAILORx study. This 12-year clinical trial looked at whether “recurrence scores” from a special molecular test called the Oncotype DX breast cancer assay can be used to assign patients to the most appropriate and effective treatment.

Thousands of patients with an Oncotype DX score of 11 to 25 were randomized to hormone-blocking treatment alone or chemotherapy and hormone-blocking treatment. Results showed that patients whose scores fell in a low to intermediate range did not need chemotherapy to improve their prognosis. The study’s authors noted, however, that some women under age 50 may still benefit from chemotherapy.

Laila Agrawal, M.D., an oncologist and breast cancer specialist with Norton Cancer Institute, was at the ASCO meeting when this new information was presented. She is not surprised the results would generate keen interest since, after skin cancer, breast cancer is the most common cancer in women in the United States.

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“This is a very significant, practice-changing study that will allow more patients with early-stage breast cancer to avoid chemotherapy,” Dr. Agrawal said. “This gives us powerful new information in the age of precision medicine to be able to provide patients with the right therapy at the right time.”

Dr. Agrawal shared some insights about what this important news means for breast cancer patients.

Q: Can you explain the Oncotype DX breast cancer assay and what it has to do with this new recommendation?

A: This is a genomic test that can be performed on certain breast cancers that are estrogen receptor positive and HER2 negative to help us understand the prognosis and the benefit of chemotherapy. This test was used as the tool in this study to help determine which patients may be able to safely avoid chemotherapy.

Q: Before this study, were some patients already able to skip chemo?

A:  The Oncotype DX test has been used for many years to help identify low-risk patients who could omit chemotherapy and high-risk patients who would benefit from chemotherapy. However, cancers with an intermediate-range score fell into a “gray zone,” and there was uncertainty about whether or not chemotherapy would reduce the risk of cancer recurrence.

Q: Why is it better to avoid chemotherapy?

A: Chemotherapy is still a lifesaving part of treatment for many breast cancer patients. However, it comes with short- and long-term side effects, including fatigue, nausea, diarrhea, hair loss, and chance of infertility or early menopause. Some chemotherapy agents have a very small, but serious, risk for heart failure or leukemia. We are motivated to try to spare patients from this toxicity whenever it would be safe to do so.

Q: What situations will still call for chemotherapy?

A: Chemotherapy is still a critical part of treatment for most triple negative breast cancer and HER2 positive breast cancers. Patients with hormone receptor-positive breast cancer and a high-risk Oncotype score will still be offered chemotherapy. This study did not include patients with tumors larger than 5 centimeters or with lymph nodes involved with cancer.

It also is important to note that this study did find that women younger than age 50 with an Oncotype recurrence score of 16 to 25 still have some benefit from chemotherapy. These patients will have a discussion with their doctors about balancing the risks and benefits of chemotherapy.

Q: How many women will be impacted by this new information?

A: Breast cancer that is estrogen receptor-positive, HER2 negative and node negative is the most common type of breast cancer. About two-thirds of these women would have an Oncotype score of less than 26 and be able to avoid chemotherapy based on the results of this study.

Q: How quickly will this information change how patients are treated?

A:  This is a practice-changing study, and the impact of this will be immediate. This is a phase III, prospective, randomized study and provides the highest level of evidence to confidently recommend avoiding chemotherapy in appropriate patients.