Breast cancer is the most common cancer among women in the United States and worldwide. In addition, hormone receptor-positive axillary lymph node-negative disease accounts for about half of all breast cancer cases in the United States. 
Undated research results from the TAILORx show that even with equivalent treatments in women with hormone receptor-positive, HER2-negative breast cancer, black women had a significantly higher recurrence of breast cancer and increased overall mortality compared with white women in a large phase III clinical trial. .
Findings released from the federally funded TAILORx study, presented in June 2018, showed that most women with hormone receptor-positive, HER2-negative, axillary-gland negative breast cancer did not benefit from chemotherapy at an early stage.
On average, half of all breast cancers are hormone receptor positive, HER2 negative and axillary node negative. The TAILORx study shows that chemotherapy in about 70% of these women can be avoided when their use is guided by the test, which will reduce the chemotherapy limit to 30% that we can predict.
"[The TAILORx study, would never have happened without federal funding for cancer research [and I expect that the results] the care will immediately transform and benefit. This data provides physicians and patients with critical reassurance that they can use genomic information to make better treatment decisions in women with breast cancer at an early stage. Practically speaking, this means that thousands of women will be able to avoid chemotherapy, with all its side effects, while still achieving excellent long-term results, "says Harold Burstein, MD, PhD, FASCO, at the time of the release of the study data during the annual meeting as the American Society of Clinical Oncology (ASCO) in June 2018.
The updated data from the study, which included a statistical analysis of the impact of ethnicity, were presented at the San Antonio Breast Cancer Symposium (SABCS), held on 4-8 December 2018.
TAILORx was sponsored by the National Cancer Institute, part of the National Institutes of Health. It was designed and guided by the ECOG-ACRIN Cancer Research Group. The study was partially supported by the Breast Cancer Research Foundation, Susan G. Komen, and the Postal service of the United States (USPS) Breast Cancer Research Stamp.
"Our findings are consistent with previous studies indicating that black women with hormone receptor-positive, HER2-negative breast cancer have worse prognoses than women with a different racial and ethnic background, even if they have access to the same cancer care today," said Kathy S. Albain, MD, FACP, FASCO, Huizenga Family Endowed Chair in Oncology Research and professor of medicine at Loyola University's Chicago Stritch School of Medicine and director of the breast and thoracic oncology programs at the Cardinal Bernardin Cardinal Center of Loyola Medicine in Maywood, Illinois.
"This suggests that additional research is needed to determine the basis for these racial inequalities and also emphasizes the need to promote the build-up of minority group building in clinical trials with cancer."
Albain and his colleagues analyzed the association between clinical outcomes and race among participants in the TAILORx study, in which more than 10,000 women with the most common type of early breast cancer (hormone receptor positive, HER2 negative, axillary lymph node negative) were evaluated .
After enrollment in the TAILORx study, the tumors of the patients were analyzed using the Gencic Health 21-gene Oncotype DX recurrence score test (RS, on a scale of 0-100), which predicts that cancer reappears. Oncotype DX is one of the many commercially available gene expression tests that provide prognostic information in hormone receptor-positive breast cancer.
Patients with low risk (RS score of 0-10) was only treated with hormone therapy, while patients at high risk (RS score 26 and higher) were treated with hormone therapy and chemotherapy.
Patients with a average risk of recurrence (RS score of 11-25) – the primary research group – were randomized to receive hormone therapy and chemotherapy or hormone therapy alone.
Of the 9,719 breast cancer patients that can be evaluated, 8,189 (84%) were white, 693 (7%) were black, 405 (4%) were Asian and 432 (4%) were of a different or unknown breed. In terms of ethnicity, 7,635 (79%) were non-Hispanic, 889 (9%) were Hispanic, and 1,195 (12%) were of unknown ethnicity. The test showed no significant difference in RS distribution or mean RS between white and black participants.
Use and type of chemotherapy after surgery were comparable between black and white participants and between the Spanish and non-Spanish population. Moreover, the use, type and duration of hormone therapy were similar between black and white participants and between Spanish and non-Spanish populations.
In an analysis of the entire experimental population, black women had an absolute risk of 4% of recurrence or death. When the authors compared the results between black and white women, they discovered that black women had a 39% higher relative risk of returning breast cancer and a 52% higher relative risk of death.
Sixty-eight percent of the black women in the trial had an RS score of 11-25. In this intermediate group, there was an 80% higher relative risk of recurrence in black women compared with white women. There was a 67% higher relative risk of death in black women compared with white women.
When ethnicity was studied, women with a Spanish ethnicity generally had better results than non-Hispanic women, noted Albain.
"The racial differences observed in this study were not explained by differences in recurrence score, duration or reported adherence, nor were they explained by the use of chemotherapy, or characteristics such as age, tumor size or tumor grade," Albain said.
"Our results suggest that biological differences may contribute to the significantly different outcomes of black women compared to others with breast cancer."
Limitations of the study include the retrospective nature of the analysis, the lack of sufficient ability to address specific questions in the breed / ethnicity subsets and a dependence on self-reported adherence to hormone therapy.
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Latest editorial review: December 13, 2018
Featured image: General session during the annual San Antonio Breast Cancer Symposium in San Antonio, TX. Courtesy: 2018 © MedMeetingImages / Todd Buchanan. Used with permission
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