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Oncotype DX Results Appear Less Accurate in Black Women Diagnosed With Certain Early-Stage Breast Cancers

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Black women diagnosed with stage I to stage III estrogen-receptor-positive, axillary node-negative breast cancer were more likely to die from breast cancer than white women with similar diagnoses and similar Oncotype DX Breast Recurrence test scores, according to a study.

The research was published online on Jan. 21, 2021, by the journal JAMA Oncology. Read the abstract of “Association of Race/Ethnicity and the 21-Gene Recurrence Score With Breast Cancer-Specific Mortality Among US Women.”

Stage I to stage III breast cancer is considered early-stage breast cancer.

Axillary node-negative breast cancer means that cancer was not found in the axillary lymph nodes, the lymph nodes in the underarm area.

About the Oncotype DX Breast Recurrence Score Test
About the study
What this means for you

About the Oncotype DX Breast Recurrence Score Test

The Oncotype DX Breast Recurrence Score test is a genomic test that analyzes the activity of a group of 21 genes from a breast cancer tissue sample that can affect how a specific type of early-stage breast cancer is likely to behave and respond to treatment.

Doctors use the Oncotype DX Breast Recurrence Score test to help figure out a person’s risk of early-stage, estrogen-receptor-positive, HER2-negative breast cancer coming back in a part of the body away from the breast (distant recurrence), as well as how likely a person is to benefit from chemotherapy to treat the cancer.

The Oncotype DX Breast Recurrence Score test results assign a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer. Based on your age, you and your doctor can use the following ranges to interpret your results.

For people older than 50 years of age:

  • Recurrence Score of 0-25: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks 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 risks of side effects.

For people age 50 and younger:

  • Recurrence Score of 0-15: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 16-20: The cancer has a low to medium risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks 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 risks 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 risks of side effects.

According to the researchers who did the study reviewed here, the Onctoype DX Breast Recurrence Score test is the most commonly ordered genomic test to figure out the risk of distant recurrence for early-stage breast cancer, as well as whether a person will benefit from chemotherapy.

Still, the researchers pointed out that the information used to develop the Onctoype DX Breast Recurrence Score test came from studies where only about 5% to 6% of the women participating were Black.

“Underrepresentation of women from racial/ethnic minority groups in the development and validation of the [Recurrence Score] raises questions about the prognostic accuracy of the Oncotype DX Breast Recurrence Score test in populations other than non-Hispanic white people,” they wrote.

So the researchers did this study to see how accurate the Recurrence Scores were for women of different racial/ethnic groups.

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About the study

To do the study, the researchers analyzed the Recurrence Scores and diagnosis information from 86,033 women diagnosed with early-stage, estrogen-receptor-positive, HER2-negative breast cancer between 2004 and 2015.

The information came from the SEER Oncotype DX Database, a database containing variables related to Onctoype DX Breast Recurrence Score testing. The SEER databases are large registries of cancer cases from throughout the United States maintained by the National Institutes of Health.

Of the 86,033 women whose information was analyzed:

  • 74.4% were non-Hispanic white (64,069 women)
  • 7.8% were Black (6,719 women)
  • 9.2% were Hispanic (7,944 women)
  • 8.0% were Asian/Pacific Islander (6,950 women)
  • 0.4% were American Indian/Alaska Native (351 women)

Overall:

  • 98.7% of the women were diagnosed with stage I or stage II breast cancer
  • 85.6% had axillary node-negative breast cancer
  • 4.8% of the women with a low-risk Recurrence Score were treated with chemotherapy after surgery
  • 18% of the women with a medium-risk Recurrence Score were treated with chemotherapy after surgery
  • 65.8% of the women with a high-risk Recurrence Score were treated with chemotherapy after surgery
  • half of the women were followed for longer than 54 months and half were followed for shorter periods of time

The researchers analyzed the women’s demographic information and the characteristics of the breast cancers for each of the Recurrence Score categories.

The results showed that Black women were more likely than non-Hispanic white women to have a Recurrence Score greater than 25; a Recurrence Score greater than 25 means the cancer has a high risk of distant recurrence. This difference was statistically significant, which means that it was likely due to the difference in the women’s ethnicities and not just because of chance.

Other factors linked to a high-risk Recurrence Score included:

  • age younger than 40
  • larger tumor size
  • higher cancer stage and tumor grade
  • progesterone-receptor-negative cancer

The researchers then looked specifically at women with node-negative disease — meaning no breast cancer was found in the lymph nodes. Overall, the analysis found that Black women were more likely to die from breast cancer than non-Hispanic white women.

This higher risk of death from breast cancer for Black women was found in three Recurrence Score risk levels:

  • For Recurrence Scores 0 to 10, Black women were more than twice as likely to die.
  • For Recurrence Scores 11 to 25, Black women were 1.64 times more likely to die.
  • For Recurrence Scores greater than 25, Black women were 1.48 times more likely to die.

“This study suggests that Black women in the U.S. with [estrogen-receptor]-positive, [HER2]-negative, axillary lymph node-negative breast cancer are more likely to have a high-risk [Recurrence Score] and to experience breast cancer-specific mortality compared with non-Hispanic White women within the same risk group,” the researchers wrote in the conclusion. “In addition, the [Recurrence Score] provides less prognostic information for Black women. The findings suggest that Black women disproportionately develop aggressive [estrogen-receptor]-positive tumors and that the Oncotype DX Breast Recurrence Score test incompletely defines prognosis in these women.”

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What this means for you

The results of this study are concerning, especially for Black women who may be using Oncotype DX Breast Recurrence Score test results to help make decisions about chemotherapy.

Still, the study does have some limitations that may have affected the results:

  • The follow-up time was less than 5 years for more than half the women, which is relatively short. Research shows that about 50% of recurrences of early-stage, estrogen-receptor-positive breast cancer happen 5 years after diagnosis.
  • There is no information on whether the women stuck to their hormonal therapy treatment plans. If a woman didn’t complete the full course of treatment, she would be more likely to have a recurrence.
  • There was no information on what’s called “social determinants of health.” These are conditions in a person’s environment that affect health, including access to healthcare services, having enough food to eat, having a safe place to live, exposure to crime and violence, access to technology, and access to education.

Joseph Sparano, M.D., of the Albert Einstein College of Medicine, who conducted the TAILORx trial on the Oncotype DX Breast Recurrence Score Test, and Otis Brawley, M.D., of the John Hopkins School of Medicine, who is former chief medical and scientific officer of the American Cancer Society, offered reassurance in an editorial published with the study.

“… to our knowledge there is no evidence from any study that the principal conclusions derived from TAILORx regarding use of the 21-gene [Recurrence Score] to guide chemotherapy [do] not also hold true for racial and ethnic minorities,” they wrote.

“In addition, although the findings have substantial importance at the population level, the effect for individual patients for whom the [Recurrence Score] is being used to provide prognostic information is limited,” they continued. “For example, the crude breast cancer mortality rate for non-Hispanic Black women was only about 1% for those with node-negative disease and a [Recurrence Score] of 0 to 25 treated mainly with endocrine therapy alone ... although this likely underestimates the ultimate cancer mortality burden due to the limited follow-up.

“There is no doubt that achieving equal care is necessary for achieving health equity for racial and ethnic minorities with breast cancer and other cancer types, but it may not be sufficient for some cancer types, including [estrogen-receptor]-positive breast cancer,” they concluded. “Designing biologically driven, evidence-based clinical trials focused on racial disparities represents one such strategy. Greater representation of racial and ethnic minorities in prospective clinical trials, and population-based cohorts, linked to robust socioeconomic data and biospecimens, represents another approach that will provide the tools necessary to deconstruct racial and ethnic disparities in breast cancer and other cancers where disparities exist.”

So if you’re a Black woman who has been diagnosed with early-stage, estrogen-receptor-positive, HER2-negative breast cancer, it’s important to remember that you and your doctor will look at a number of factors when making decisions about chemotherapy, including:

  • your age
  • the size of the cancer
  • hormone receptor protein levels
  • the grade of the cancer
  • any other health conditions you have
  • your family history of cancer
  • any genomic test results
  • your personal preferences

The Oncotype DX Breast Recurrence Score is only one of those factors.

Together, you can make the best decisions for your unique situation.

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Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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