Abstract
Health disparities in breast cancer outcomes according to race/ethnicity are well documented. Randomized clinical trials (RCT) offer an opportunity to evaluate differences in disease biology and response to therapy that may contribute to disparities. We conducted a PubMed search to identify all English language original reports of breast cancer RCT from October 2001 to October 2006. The primary outcomes of interest were reporting of accrual and results by race or ethnicity of trial subjects. We evaluated the correlation between study characteristics and reporting of race/ethnicity. A total of 197 eligible trials were identified among 29 journals. Accrual was reported by race in 17% of studies and results analyzed by race in only 2%. Reporting of race was associated with National Cancer Institute funding (38 vs. 13%, P = 0.001), US cooperative group trials (52 vs. 13%, P < 0.0001), trials with US sites (43 vs. 5%, P < 0.0001), and trials enrolling > 500 subjects (24 vs. 12%, P = 0.055). Pharmaceutical industry funding, # of centers, stage of disease, nature of experimental intervention and study outcomes were not associated with reporting of race. Among US studies reporting trial accrual by race/ethnicity, the mean accrual distribution was 81% white, 7.6% black, 9.6% Asian, and 7.2% Hispanic subjects. The majority of breast cancer RCT fail to report the race/ethnicity of participants. Low accrual of black subjects and failure to report accrual and outcomes by race in RCT may contribute to difficulty in understanding and overcoming health disparities in breast cancer.
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Ries LAG, Harkins D, Krapcho M, et al. (eds) SEER Cancer Statistics Review, 1975–2003. http://seer.cancer.gov/csr/1975_2003
Curtis E, Quale C, Haggstrom D, Smith-Bindman R (2008) Racial and ethnic differences in breast cancer survival: how much is explained by screening, tumor severity, biology, treatment, comorbidities, and demographics? Cancer 112(1):171–180. doi:10.1002/cncr.23131
Eley JW, Hill HA, Chen VW, Austin DF, Wesley MN, Muss HB, Greenberg RS, Coates RJ, Correa P, Redmond CK et al (1994) Racial differences in survival from breast cancer. Results of the National Cancer Institute Black/White cancer survival study. JAMA 272(12):947–954. doi:10.1001/jama.272.12.947
Newman LA, Griffith KA, Jatoi I, Simon MS, Crowe JP, Colditz GA (2006) Meta-analysis of survival in African American and white American patients with breast cancer: ethnicity compared with socioeconomic status. J Clin Oncol 24(9):1342–1349. doi:10.1200/JCO.2005.03.3472
Bach PB, Schrag D, Brawley OW, Galaznik A, Yakren S, Begg CB (2002) Survival of blacks and whites after a cancer diagnosis. JAMA 287(16):2106–2113. doi:10.1001/jama.287.16.2106
Ghafoor A, Jemal A, Ward E, Cokkinides V, Smith R, Thun M (2003) Trends in breast cancer by race and ethnicity. CA Cancer J Clin 53(6):342–355. doi:10.3322/canjclin.53.6.342
Li CI, Malone KE, Daling JR (2003) Differences in breast cancer stage, treatment, and survival by race and ethnicity. Arch Intern Med 163(1):49–56. doi:10.1001/archinte.163.1.49
Bickell NA, Wang JJ, Oluwole S, Schrag D, Godfrey H, Hiotis K, Mendez J, Guth AA (2006) Missed opportunities: racial disparities in adjuvant breast cancer treatment. J Clin Oncol 24(9):1357–1362. doi:10.1200/JCO.2005.04.5799
Tammemagi CM, Nerenz D, Neslund-Dudas C, Feldkamp C, Nathanson D (2005) Comorbidity and survival disparities among black and white patients with breast cancer. JAMA 294(14):1765–1772. doi:10.1001/jama.294.14.1765
Carey LA, Perou CM, Livasy CA, Dressler LG, Cowan D, Conway K, Karaca G, Troester MA, Tse CK, Edmiston S et al (2006) Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA 295(21):2492–2502. doi:10.1001/jama.295.21.2492
Hahn KM, Bondy ML, Selvan M, Lund MJ, Liff JM, Flagg EW, Brinton LA, Porter P, Eley JW, Coates RJ (2007) Factors associated with advanced disease stage at diagnosis in a population-based study of patients with newly diagnosed breast cancer. Am J Epidemiol 166(9):1035–1044. doi:10.1093/aje/kwm177
Moy B, Tu D, Pater JL, Ingle JN, Shepherd LE, Whelan TJ, Goss PE (2006) Clinical outcomes of ethnic minority women in MA.17: a trial of letrozole after 5 years of tamoxifen in postmenopausal women with early stage breast cancer. Ann Oncol 17(11):1637–1643. doi:10.1093/annonc/mdl177
Polite BN, Cirrincione C, Fleming GF, Berry DA, Seidman A, Muss H, Norton L, Shapiro C, Bakri K, Marcom K et al (2008) Racial differences in clinical outcomes from metastatic breast cancer: a pooled analysis of CALGB 9342 and 9840–Cancer and Leukemia Group B. J Clin Oncol 26(16):2659–2665. doi:10.1200/JCO.2007.13.9782
Revitalization Act NIH In: PL 103-43. 1993
Peppercorn J, Blood E, Winer E, Partridge A (2007) Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer 109(7):1239–1246. doi:10.1002/cncr.22528
Arpino G, Nair Krishnan M, Doval Dinesh C, Bardou VJ, Clark GM, Elledge RM (2003) Idoxifene versus tamoxifen: a randomized comparison in postmenopausal patients with metastatic breast cancer. Ann Oncol 14(2):233–241. doi:10.1093/annonc/mdg097
Williams DR, Lavizzo-Mourey R, Warren RC (1994) The concept of race and health status in America. Public Health Rep 109(1):26–41
Goetz MP, Knox SK, Suman VJ, Rae JM, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL et al (2007) The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat 101(1):113–121. doi:10.1007/s10549-006-9428-0
Lea RA, Roberts RL, Green MR, Kennedy MA, Chambers GK (2008) Allele frequency differences of cytochrome P450 polymorphisms in a sample of New Zealand Maori. N Z Med J 121(1272):33–37
Ma CX, Adjei AA, Salavaggione OE, Coronel J, Pelleymounter L, Wang L, Eckloff BW, Schaid D, Wieben ED, Weinshilboum RM (2005) Human aromatase: gene resequencing and functional genomics. Cancer Res 65(23):11071–11082. doi:10.1158/0008-5472.CAN-05-1218
Swanson GM, Bailar JC 3rd (2002) Selection and description of cancer clinical trials participants–science or happenstance? Cancer 95(5):950–959. doi:10.1002/cncr.10785
Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW (1996) Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 88(12):812–816. doi:10.1093/jnci/88.12.812
Murthy VH, Krumholz HM, Gross CP (2004) Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA 291(22):2720–2726. doi:10.1001/jama.291.22.2720
US Cancer Statistics Working Group United States Cancer Statistics: 1999–2005 Incidence and Mortality Web-based Report. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2009. Available at: www.cdc.gov/uscs
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research – Amended, October, 2001. Available via the internet: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm; Accessed 7 May 2008
Albain K, Unger J, Hutchins L et al. Outcome of African Amercans on Southwest Oncology Group (SWOG) breast cancer adjuvant therapy trials. In: San Antonio Breast Cancer Symposium San Antonio, TX 2003
Woodward WA, Huang EH, McNeese MD, Perkins GH, Tucker SL, Strom EA, Middleton L, Hahn K, Hortobagyi GN, Buchholz TA (2006) African–American race is associated with a poorer overall survival rate for breast cancer patients treated with mastectomy and doxorubicin-based chemotherapy. Cancer 107(11):2662–2668. doi:10.1002/cncr.22281
Markman M, Petersen J, Montgomery R (2008) An examination of the influence of patient race and ethnicity on expressed interest in learning about cancer clinical trials. J Cancer Res Clin Oncol 134(1):115–118. doi:10.1007/s00432-007-0263-4
McCaskill-Stevens W, McKinney MM, Whitman CG, Minasian LM (2005) Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience. J Clin Oncol 23(22):5247–5254. doi:10.1200/JCO.2005.22.236
Acknowledgments
JP is supported by a grant from the American Society of Clinical Oncology and the Breast Cancer Research Foundation in conjunction with the David and Barbara B. Hirschhorn Foundation. We wish to acknowledge the thoughtful review of this manuscript by Bercedis Peterson.
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Mitchell, K.W., Carey, L.A. & Peppercorn, J. Reporting of race and ethnicity in breast cancer research: room for improvement. Breast Cancer Res Treat 118, 511–517 (2009). https://doi.org/10.1007/s10549-009-0411-4
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DOI: https://doi.org/10.1007/s10549-009-0411-4