Updated TAILORx Results Confirm Women With Intermediate Recurrence Score Can Skip Chemotherapy
Women diagnosed with early-stage, estrogen receptor-positive breast cancer with an intermediate Oncotype DX Recurrence Score of 11-25 can safely skip chemotherapy, according to the latest results from the TAILORx study. There was no difference in the risk of recurrence (the cancer coming back) between women who received chemotherapy and women who didn’t.
The research, “Trial Assigning Individualized Options for Treatment (TAILORx): An Update Including 12-Year Event Rates,” was presented on Dec. 6 at the San Antonio Breast Cancer Symposium (SABCS).
About the Oncotype DX Breast Recurrence Score Test
The Oncotype DX Breast Recurrence Score Test analyzes a group of 21 genes from early-stage, estrogen receptor-positive, HER2-negative invasive breast cancer to figure out:
the risk of the cancer coming back in a part of the body away from the breast, called distant recurrence by doctors
the likelihood that a person diagnosed with this type of early-stage breast cancer might benefit from chemotherapy
The Oncotype DX Breast Recurrence Score Test assigns a Recurrence Score — a number between 0 and 100 — to the breast cancer. Based on your age, you and your doctor can use the following ranges to interpret your results.
For women older than 50:
Recurrence Score of 0-25: The cancer has a low risk of recurrence. The benefits of chemotherapy are not likely to outweigh the risk of side effects.
Recurrence Score of 26-100: The cancer has a high risk of recurrence. The benefits of chemotherapy are likely to be greater than the risk of side effects.
For women age 50 and younger:
Recurrence Score of 0-15: The cancer has a low risk of recurrence. The benefits of chemotherapy are not likely to outweigh the risk of side effects.
Recurrence Score of 16-20: The cancer has a low to medium risk of recurrence. The benefits of chemotherapy are not likely to outweigh the risk of side effects.
Recurrence Score of 21-25: The cancer has a medium risk of recurrence. The benefits of chemotherapy are likely to be greater than the risk of side effects.
Recurrence Score of 26-100: The cancer has a high risk of recurrence. The benefits of chemotherapy are likely to be greater than the risk of side effects.
People and their doctors consider the Recurrence Score in combination with other factors, such as the size and grade of the cancer and the number of hormone receptors the cancer cells have (many versus few) to make decisions about chemotherapy.
About the TAILORx study
The TAILORx study was designed to confirm decisions about chemotherapy based on Recurrence Scores.
The study’s 2018 results found that women with an intermediate Recurrence Score of 11-25 could safely skip chemotherapy and take hormonal therapy alone after breast cancer surgery. The researchers reported those findings after about eight years of follow-up.
This latest analysis includes 12 years of follow-up. We know that at least 50% of recurrences of hormone receptor-positive breast cancer happen more than five years after diagnosis. So the researchers plan to follow the women in the TAILORx study for up to 20 years to make sure we have as much information as possible about recurrence rates.
For these findings, the researchers analyzed information from 6,711 women ages 18 to 75 diagnosed with early-stage, estrogen receptor-positive, HER2-negative invasive breast cancer. All the women had a Recurrence Score of 11-25.
The researchers randomly assigned the women to one of two treatment groups after surgery:
3,399 women took hormonal therapy alone
3,312 women took hormonal therapy and also received chemotherapy
After 12 years of follow-up:
76.8% of the women who took hormonal therapy alone were alive with no recurrence
77.4% of the women who took hormonal therapy and received chemotherapy were alive with no recurrence
92.6% of the women who took hormonal therapy alone were alive with no distant recurrence
92.8% of the women who took hormonal therapy and received chemotherapy were alive with no distant recurrence
Joseph Sparano, MD, FACP, chief of the Division of Hematology and Medical Oncology for the Mount Sinai Health System and deputy director of the Tisch Cancer Institute, who presented the research, noted that the researchers saw more recurrences at 12 years of follow-up than at five years of follow-up. Researchers call recurrences that happen more than five years after diagnosis late recurrences. Still, these late recurrence rates were about the same whether or not the women received chemotherapy.
Overall survival rates at 12 years also were the same for the two treatment groups:
89.8% of women who took hormonal therapy alone were alive
89.8% of women who took hormonal therapy and received chemotherapy were alive
Overall survival is how long a person lives, whether or not the cancer comes back.
“The main study findings remain unchanged for women with a Recurrence Score of 11-25,” said Dr. Sparano, “indicating we can effectively spare chemotherapy in the majority of patients with early-stage breast cancer.”
“[These results] showed us that tests like the Oncotype DX Recurrence Score are really, really effective at predicting who does not need chemo, which is awesome,” Stephanie Graff, MD, told Breastcancer.org. “Because a bunch of patients don’t need chemo with hormone receptor-positive breast cancer.”
Dr. Graff is director of breast oncology at the Lifespan Cancer Institute at Brown University.
What this means for you
If you’ve been diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer and are weighing the pros and cons of adding chemotherapy to your treatment plan, the Oncotype DX Recurrence Score test may help you and your doctor make that decision. Besides any genomic test results, you and your doctor will consider other factors when developing your treatment plan, including:
your age
the size of the cancer
hormone-receptor protein levels
the grade of the cancer
any other health conditions you might have
your personal preferences
Together, you can make the best treatment decisions for your unique situation.
Learn more about the Oncotype DX tests.
— Last updated on February 16, 2023 at 9:14 PM