Journal Article
. 2015 Nov;34(2).
doi: 10.1200/JCO.2015.63.2489.

Racial Variation in the Uptake of Oncotype DX Testing for Early-Stage Breast Cancer

Megan C Roberts 1 Morris Weinberger 2 Stacie B Dusetzina 2 Michaela A Dinan 2 Katherine E Reeder-Hayes 2 Lisa A Carey 2 Melissa A Troester 2 Stephanie B Wheeler 2 
  • PMID: 26598755
  •     34 References
  •     15 citations


Purpose: Oncotype DX (ODX) is a tumor gene-profiling test that aids in adjuvant chemotherapy decision-making. ODX has the potential to improve quality of care; however, if not equally accessible across racial groups, disparities in cancer care quality may persist or worsen. We examined racial disparities in ODX testing uptake.

Methods: We used data from the Carolina Breast Cancer Study, phase III, a longitudinal, population-based study of 2,998 North Carolina women who received a diagnosis of breast cancer between 2008 and 2014. Our primary analysis used modified Poisson regression to determine the association between race and whether ODX testing was ordered among two strata: node-negative and node-positive breast cancer.

Results: A total of 1,468 women with estrogen receptor-positive, human epidermal growth factor receptor-2-negative, stage I or II breast cancer met inclusion criteria. Black patients had higher-grade and larger tumors, more comorbidities, younger age at diagnosis, and lower socioeconomic status than non-black women. Overall, 42% of women had ODX test results in their pathology reports. Compared with those who did not receive ODX testing, women who received ODX testing tended to be younger and have medium tumor size and grade. Our regression analyses indicated no racial disparities in ODX uptake among node-negative patients. However, racial differences were detected among node-positive patients, with black patients being 46% less likely to receive ODX testing than non-black women (adjusted relative risk, 0.54; 95% CI, 0.35 to 0.84; P = .006).

Conclusion: We did not find racial disparities in ODX testing for node-negative patients for whom ODX testing is guideline recommended and widely covered by insurers. However, our findings suggest that a newer, non-guideline-concordant application of ODX testing for node-positive breast cancer was accessed less by black women than by non-black women, reflecting more guideline concordant care among black women.

Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes.
Scott D Ramsey, William E Barlow, +6 authors, Gabriel N Hortobagyi.
Contemp Clin Trials, 2012 Sep 25; 34(1). PMID: 23000081    Free PMC article.
Utilization of Oncotype DX in an Inner City Population: Race or Place?
Amber A Guth, Susan Fineberg, +2 authors, Nina A Bickell.
Int J Breast Cancer, 2014 Jan 24; 2013. PMID: 24455283    Free PMC article.
Racial variation in adjuvant chemotherapy initiation among breast cancer patients receiving oncotype DX testing.
Megan C Roberts, Morris Weinberger, +5 authors, Stephanie B Wheeler.
Breast Cancer Res Treat, 2015 Jul 29; 153(1). PMID: 26216535    Free PMC article.
Participation in cancer clinical trials: race-, sex-, and age-based disparities.
Vivek H Murthy, Harlan M Krumholz, Cary P Gross.
JAMA, 2004 Jun 10; 291(22). PMID: 15187053
Highly Cited.
Adoption of gene expression profile testing and association with use of chemotherapy among women with breast cancer.
Michael J Hassett, Samuel M Silver, +12 authors, Jane C Weeks.
J Clin Oncol, 2012 May 16; 30(18). PMID: 22585699    Free PMC article.
Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009.
Michaela A Dinan, Xiaojuan Mi, +3 authors, Lesley H Curtis.
JAMA Oncol, 2015 Jul 17; 1(2). PMID: 26181015
Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer.
John Hornberger, Leon E Cosler, Gary H Lyman.
Am J Manag Care, 2005 May 19; 11(5). PMID: 15898220
Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer?
Juhi Asad, Allyson F Jacobson, +7 authors, Paul I Tartter.
Am J Surg, 2008 Sep 24; 196(4). PMID: 18809056
Oncotype dx results in multiple primary breast cancers.
Michael J Toole, Kelley M Kidwell, Catherine Van Poznak.
Breast Cancer (Auckl), 2014 Jan 24; 8. PMID: 24453493    Free PMC article.
Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Mitch Dowsett, Jack Cuzick, +11 authors, Steven Shak.
J Clin Oncol, 2010 Mar 10; 28(11). PMID: 20212256
Highly Cited.
A modified poisson regression approach to prospective studies with binary data.
Guangyong Zou.
Am J Epidemiol, 2004 Mar 23; 159(7). PMID: 15033648
Highly Cited.
When does a difference become a disparity? Conceptualizing racial and ethnic disparities in health.
Paul L Hebert, Jane E Sisk, Elizabeth A Howell.
Health Aff (Millwood), 2008 Mar 12; 27(2). PMID: 18332492
The influence of a gene expression profile on breast cancer decisions.
Leonard R Henry, Alexander Stojadinovic, +3 authors, Peter W Soballe.
J Surg Oncol, 2009 Feb 11; 99(6). PMID: 19204954
The impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancer.
Richard H de Boer, Caroline Baker, +3 authors, G Bruce Mann.
Med J Aust, 2013 Aug 06; 199(3). PMID: 23909545
Impact of Oncotype DX on treatment decisions in ER-positive, node-negative breast cancer with histologic correlation.
Julianne R Biroschak, Gordon F Schwartz, +4 authors, Sun Yong Lee.
Breast J, 2013 Apr 26; 19(3). PMID: 23614365
Who gets genomic testing for breast cancer recurrence risk?
J T DeFrank, T Salz, K Reeder-Hayes, N T Brewer.
Public Health Genomics, 2013 Aug 01; 16(5). PMID: 23899493    Free PMC article.
21-Gene recurrence scores: racial differences in testing, scores, treatment, and outcome.
Mary Jo Lund, Marina Mosunjac, +7 authors, Ruth M O'Regan.
Cancer, 2011 Jul 02; 118(3). PMID: 21720988
Factors influencing treatment recommendations in node-negative breast cancer.
Elisabeth Edstrom Elder, Sally Baron Hay, Katrina Moore.
J Oncol Pract, 2011 May 03; 7(1). PMID: 21532807    Free PMC article.
Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer.
J Albanell, A González, +17 authors, A Lluch.
Ann Oncol, 2011 Jun 10; 23(3). PMID: 21652577
TAILORx: trial assigning individualized options for treatment (Rx).
Joseph A Sparano.
Clin Breast Cancer, 2006 Nov 10; 7(4). PMID: 17092406
Cancer statistics, 2013.
Rebecca Siegel, Deepa Naishadham, Ahmedin Jemal.
CA Cancer J Clin, 2013 Jan 22; 63(1). PMID: 23335087
Highly Cited.
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies.
Gary H Lyman, Leon E Cosler, Nicole M Kuderer, John Hornberger.
Cancer, 2007 Feb 22; 109(6). PMID: 17311307
Cancer patients, doctors and nurses vary in their willingness to undertake cancer chemotherapy.
R M Bremnes, K Andersen, E A Wist.
Eur J Cancer, 1995 Nov 01; 31A(12). PMID: 8562147
Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer.
Shelby D Reed, Michaela A Dinan, Kevin A Schulman, Gary H Lyman.
Genet Med, 2012 Sep 15; 15(3). PMID: 22975761    Free PMC article.
Patient preferences concerning the trade-off between the risks and benefits of routine radiation therapy after conservative surgery for early-stage breast cancer.
J A Hayman, D L Fairclough, J R Harris, J C Weeks.
J Clin Oncol, 1997 Mar 01; 15(3). PMID: 9060570
Extension of the modified Poisson regression model to prospective studies with correlated binary data.
G Y Zou, Allan Donner.
Stat Methods Med Res, 2011 Nov 11; 22(6). PMID: 22072596
Highly Cited.
Racial disparities in cancer survival among randomized clinical trials patients of the Southwest Oncology Group.
Kathy S Albain, Joseph M Unger, +2 authors, Dawn L Hershman.
J Natl Cancer Inst, 2009 Jul 09; 101(14). PMID: 19584328    Free PMC article.
Highly Cited.
Unequal treatment: confronting racial and ethnic disparities in health care.
Alan Nelson.
J Natl Med Assoc, 2002 Aug 03; 94(8). PMID: 12152921    Free PMC article.
Highly Cited.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
Kathy S Albain, William E Barlow, +20 authors, Breast Cancer Intergroup of North America.
Lancet Oncol, 2009 Dec 17; 11(1). PMID: 20005174    Free PMC article.
Highly Cited.
Coverage policy development for personalized medicine: private payer perspectives on developing policy for the 21-gene assay.
Julia R Trosman, Stephanie L Van Bebber, Kathryn A Phillips.
J Oncol Pract, 2011 Jan 05; 6(5). PMID: 21197187    Free PMC article.
Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features.
Lori J Goldstein, Robert Gray, +12 authors, Joseph A Sparano.
J Clin Oncol, 2008 Aug 06; 26(25). PMID: 18678838    Free PMC article.
Highly Cited.
Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study.
Lisa A Carey, Charles M Perou, +14 authors, Robert C Millikan.
JAMA, 2006 Jun 08; 295(21). PMID: 16757721
Highly Cited.
Conveying genomic recurrence risk estimates to patients with early-stage breast cancer: oncologist perspectives.
Elizabeth Spellman, Nadiyah Sulayman, +4 authors, Suzanne C O'Neill.
Psychooncology, 2013 Mar 01; 22(9). PMID: 23447452    Free PMC article.
Underutilization of gene expression profiling for early-stage breast cancer in California.
Rosemary D Cress, Yingjia S Chen, +2 authors, Kenneth W Kizer.
Cancer Causes Control, 2016 Apr 22; 27(6). PMID: 27097910    Free PMC article.
Utilization and impact of 21-gene recurrence score assay for breast cancer in clinical practice across the United States: lessons learned from the 2010 to 2012 National Cancer Data Base analysis.
Amila Orucevic, Robert E Heidel, John L Bell.
Breast Cancer Res Treat, 2016 May 22; 157(3). PMID: 27206678    Free PMC article.
Chemotherapy decisions and patient experience with the recurrence score assay for early-stage breast cancer.
Christopher R Friese, Yun Li, +6 authors, Steven J Katz.
Cancer, 2016 Oct 25; 123(1). PMID: 27775837    Free PMC article.
The influence of 21-gene recurrence score assay on chemotherapy use in a population-based sample of breast cancer patients.
Yun Li, Allison W Kurian, +6 authors, Timothy P Hofer.
Breast Cancer Res Treat, 2016 Dec 25; 161(3). PMID: 28012085    Free PMC article.
Low utility of Oncotype DX® in the clinic.
Luisel J Ricks-Santi, John Tyson McDonald.
Cancer Med, 2017 Feb 02; 6(3). PMID: 28145091    Free PMC article.
Outcomes in patients with early-stage breast cancer who underwent a 21-gene expression assay.
Carlos H Barcenas, Akshara Raghavendra, +10 authors, Debu Tripathy.
Cancer, 2017 Feb 16; 123(13). PMID: 28199747    Free PMC article.
Oncotype DX breast cancer recurrence score can be predicted with a novel nomogram using clinicopathologic data.
Amila Orucevic, John L Bell, Alison P McNabb, Robert E Heidel.
Breast Cancer Res Treat, 2017 Mar 01; 163(1). PMID: 28243897    Free PMC article.
Racial Differences in PAM50 Subtypes in the Carolina Breast Cancer Study.
Melissa A Troester, Xuezheng Sun, +16 authors, Charles M Perou.
J Natl Cancer Inst, 2017 Sep 02; 110(2). PMID: 28859290    Free PMC article.
Use of 21-gene recurrence score assay to individualize adjuvant chemotherapy recommendations in ER+/HER2- node positive breast cancer-A National Cancer Database study.
Prema P Peethambaram, Tanya L Hoskin, +3 authors, Judy C Boughey.
NPJ Breast Cancer, 2017 Oct 27; 3. PMID: 29067357    Free PMC article.
The Era of Multigene Panels Comes? The Clinical Utility of Oncotype DX and MammaPrint.
Ling Xin, Yin-Hua Liu, Tracey A Martin, Wen G Jiang.
World J Oncol, 2017 Nov 18; 8(2). PMID: 29147432    Free PMC article.
Race and delays in breast cancer treatment across the care continuum in the Carolina Breast Cancer Study.
Katherine E Reeder-Hayes, Sophie E Mayer, +5 authors, Melissa A Troester.
Cancer, 2019 Aug 10; 125(22). PMID: 31398265    Free PMC article.
Racial Differences in 21-Gene Recurrence Scores Among Patients With Hormone Receptor-Positive, Node-Negative Breast Cancer.
Andreana N Holowatyj, Michele L Cote, +5 authors, Kristen S Purrington.
J Clin Oncol, 2018 Jan 18; 36(7). PMID: 29341832    Free PMC article.
Outcomes of Hormone-Receptor Positive, HER2-Negative Breast Cancers by Race and Tumor Biological Features.
Halei C Benefield, Katherine E Reeder-Hayes, +11 authors, Melissa A Troester.
JNCI Cancer Spectr, 2021 Jan 15; 5(1). PMID: 33442657    Free PMC article.
Differences in Breast Cancer Presentation at Time of Diagnosis for Black and White Women in High Resource Settings.
Jo-Ann Osei-Twum, Sahra Gedleh, Aisha Lofters, Onye Nnorom.
J Immigr Minor Health, 2021 Mar 16;. PMID: 33721146
Integrating biology and access to care in addressing breast cancer disparities: 25 years' research experience in the Carolina Breast Cancer Study.
Marc A Emerson, Katherine E Reeder-Hayes, +6 authors, Melissa A Troester.
Curr Breast Cancer Rep, 2021 Apr 06; 12(3). PMID: 33815665    Free PMC article.