Colon Cancer: The Exclusion of Native Americans and Hispanics from Clinical Trials in the United States
Yazzie GA1, Cayatineto HW1, Clyde CS1, Grunther B2 and de Soto JA1*
1Laboratory of Pharmacogenetics and Health Care Disparities, School of STEM, Dine College, USA
2Department of Information Technology, Dine College, USA
*Corresponding Author: de Soto JA, Laboratory of Pharmacogenetics and Health Care Disparities, School of STEM, Dine College, USA.
August 08, 2021; Published: August 19, 2021
Introduction: Each year there are 150,000 new cases of colon cancer in the United States. The chance of death for Hispanics and Native Americans who get colon cancer is much higher than whites even though both groups are much less likely to get colon cancer than whites. In this study, we look at the inclusion or exclusion of Hispanics and Native Americans from colon cancer clinical trials.
Methods: In this retrospective study, 48 colon cancer clinical trials in the United States with an aggregate of 421,530 participants performed within the last ten years were selected at random. These clinical trials were evaluated for the inclusion and exclusion of minorities.
Results: Though whites make up only 60.1% of the population they make up 89% of the colon cancer clinical trial participants. African Americans, and Hispanics who make up 13.4% and 18.5% of the population only made up 5.6% and 0.6% of the colon cancer clinical trial participants. Only two native Americans out of 421,530 colon cancer clinical trial participants could be identified.
Conclusion: Colon Cancer Clinical trials have systematically excluded Hispanics and Native Americans while minimizing the participation of African Americans. This may be directly related to the increased death rates seen in these groups and provides evidence for the non-generalizability of colon cancer clinical trials.
Keywords: Colon Cancer; Clinical Trials; Native Americans; Hispanics; African Americans; Health Care Disparities; Racism; Pharmacogenetics
- “Cancer Stat Facts: Colorectal Cancer”. National Cancer Institute (2021).
- Mariotto AB., et al. “Projections of the cost of cancer care in the United States: 2010-2020”. Journal of the National Cancer Institute2 (2011): 117-128.
- Thompson D. “Cancer Research: Where the Funding Goes”. Everyday Health. July (2021).
- Gollust SE., et al. “What Causes Racial Health Care Disparities? A Mixed-Methods Study Reveals Variability in How Health Care Providers Perceive Causal Attributions”. Inquiry 55 (2018): 0046958018762840.
- Shepherd SM., et al. “Racial and cultural minority experiences and perceptions of health care provision in a mid-western region”. International Journal of Equity Health 17 (2018): 33.
- Sohn H. “Racial and Ethnic Disparities in Health Insurance Coverage: Dynamics of Gaining and Losing Coverage over the Life-Course”. Population Research and Policy Review 2 (2018).
- Purnell TS., et al. “Achieving Health Equity: Closing The Gaps In Health Care Disparities, Interventions, And Research”. Health Affair (Millwood)8 (2016): 1410-1415.
- Alberts SR., et al. “Effect of Oxaliplatin, Fluorouracil, and Leucovorin with or without Cetuximab on Survival Among Patients With Resected Stage III Colon Cancer”. JAMA 13 (2012): 1383-1393.
- Allegra CJ., et al. “Bevacizumab in stage II-III colon cancer: 5-year update of the National Surgical Adjuvant Breast and Bowel Project C-08 trial”. Journal of Clinical Oncology3 (2013): 359-364.
- André T., et al. “Microsatellite-Instability-High Advanced Colorectal Cancer”. The New England Journal of Medicine 383 (2020): 2207-2218.
- Baron JA., et al. “A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas”. The New England Journal of Medicine 373 (2015): 1519-1530.
- Bertagnolli MM., et al. “Microsatellite instability and loss of heterozygosity at chromosomal location 18q: prospective evaluation of biomarkers for stages II and III colon cancer--a study of CALGB 9581 and 89803”. Journal of Clinical Oncology23 (2011): 3153-3162.
- Brown JC., et al. “A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results. A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results”. Contemporary Clinical Trials 47 (2016): 366-375.
- Burke CA., et al. “Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis”. The New England Journal of Medicine 383 (2020): 1028-1039.
- Chakravarthy AP., et al. “Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204)”. Oncologist5 (2020): e798-e807.
- Chibaudel B., et al. “Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer- A Secondary Analysis of the AVANT Trial”. JAMA Network Open 10 (2020): e2020425.
- Coronado GD., et al. “Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes”. BMC Cancer 14 (2014): 55.
- Dalerba P., et al. “CDX2 as a Prognostic Biomarker in Stage II and Stage III Colon Cancer”. The New England Journal of Medicine 374 (2016): 211-222.
- Green BB., et al. “Impact of continued mailed fecal tests in the patient-centered medical home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up randomized trial”. Cancer2 (2016): 312-321.
- Guercio BJ., et al. “Coffee Intake, Recurrence, and Mortality in Stage III Colon Cancer: Results From CALGB 89803”. Journal of Clinical Oncology 33 (2015): 3598-3607.
- Haller DJ., et al. “Impact of age and medical comorbidity on adjuvant treatment outcomes for stage III colon cancer: a pooled analysis of individual patient data from four randomized, controlled trials”. Annals of Oncology4 (2015): 715-724.
- Henning SM., et al. “Phenolic acid concentrations in plasma and urine from men consuming green or black tea and potential chemopreventive properties for colon cancer”. Molecular Nutrition and Food Research 3 (2013): 483-493.
- Huang J., et al. “Comparison of FOLFIRI with or without cetuximab in patients with resected stage III colon cancer; NCCTG (Alliance) intergroup trial N0147”. Clinical Colorectal Cancer 2 (2014): 100-109.
- Jafari MD., et al. “Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study”. Journal of the American College of Surgeons1 (2015): 82-92.e1.
- Kim SR., et al. “Tumour sidedness and intrinsic subtypes in patients with stage II/III colon cancer: analysis of NSABP C-07 (NRG Oncology)”. British Journal of Cancer5 (2018): 629-633.
- Kopetz S., et al. “Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer”. The New England Journal of Medicine 381 (2019): 1632-1643.
- Landry JC., et al. “Phase II Trial of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: 5-Year Clinical Outcomes ECOG-ACRIN Cancer Research Group E3204”. Oncologist 6 (2015): 615-616.
- Leichman L., et al. “Phase II Study of Olaparib (AZD-2281) After Standard Systemic Therapies for Disseminated Colorectal Cancer”. Oncologist 2 (2015): 172-177.
- Levine EA., et al. “Gene Expression Profiling of Peritoneal Metastases from Appendiceal and Colon Cancer Demonstrates Unique Biologic Signatures and Predicts Patient Outcomes”. Journal of the American College of Surgeons4 (2012): 599-607.
- Li Y., et al. “Effects of vitamin E from supplements and diet on colonic α- and γ-tocopherol concentrations in persons at increased colon cancer risk”. Nutrition Cancer1 (2015): 73-81.
- Liao X., et al. “Aspirin Use, Tumor PIK3CA Mutation, and Colorectal-Cancer Survival”. The New England Journal of Medicine 367 (2012): 1596-1606.
- McCahill LE., et al. “Primary mFOLFOX6 plus bevacizumab without resection of the primary tumor for patients presenting with surgically unresectable metastatic colon cancer and an intact asymptomatic colon cancer: definitive analysis of NSABP trial C-10”. Journal of Clinical Oncology26 (2012): 3223-3228.
- Morales-Oyarvide V., et al. “Dietary Insulin Load and Cancer Recurrence and Survival in Patients with Stage III Colon Cancer: Findings From CALGB”. JNCI Journal of the National Cancer Institute2 (2019): djy098.
- Ogino S., et al. “Predictive and prognostic roles of BRAF mutation in stage III colon cancer: results from intergroup trial CALGB 89803”. Clinical Cancer Research3 (2012): 890-900.
- Pavelitz T., et al. “MRE11-Deficiency Associated with Improved Long-Term Disease Free Survival and Overall Survival in a Subset of Stage III Colon Cancer Patients in Randomized CALGB 89803 Trial”. Plos One10 (2014): e108483.
- Pernicka JSG., et al. “Radiomics-based prediction of microsatellite instability in colorectal cancer at initial computed tomography evaluation”. Abdom Radiology (NY) 11 (2019): 3755-3763.
- Phipps AI., et al. “Physical activity and outcomes in patients with stage III”. Cancer Epidemiology, Biomarkers and Prevention 6 (2018): 696-703.
- Phipps AI., et al. “Associations Between Cigarette Smoking Status and Colon Cancer Prognosis Among Participants in North Central Cancer Treatment Group Phase III Trial N0147”. Journal of Clinical Oncology16 (2013): 2016-2023.
- Pogue-Geile K., et al. “Defective mismatch repair and benefit from bevacizumab for colon cancer: findings from NSABP C-08”. Journal of the National Cancer Institute13 (2013): 989-992.
- Protic M., et al. “Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial”. Journal of the American College of Surgeons3 (2015): 643-651.
- Schmoll HJ., et al. “Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials”. Lancet Oncology13 (2014): 1481-1492.
- Sinicrope FA., et al. “Association of obesity with DNA mismatch repair status and clinical outcome in patients with stage II or III colon carcinoma participating in NCCTG and NSABP adjuvant chemotherapy trials”. Journal of Clinical Oncology4 (2012): 406-412.
- Sinicrope FA., et al. “Body mass index at diagnosis and survival among colon cancer patients enrolled in clinical trials of adjuvant chemotherapy”. Cancer 8 (2013): 1528-1536.
- Sinicrope FA., et al. “Prognostic impact of deficient DNA mismatch repair in patients with stage III colon cancer from a randomized trial of FOLFOX-based adjuvant chemotherapy”. Journal of Clinical Oncology29 (2013): 3664-3672.
- Smith JJ., et al. “Experimentally Derived Metastasis Gene Expression Profile Predicts Recurrence and Death in Patients with Colon Cancer”. Gastroenterology 3 (2010): 958-968.
- Song M., et al. “Marine omega-3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance)”. International Journal of Cancer2 (2019): 380-389.
- Song N., et al. “Clinical Outcome From Oxaliplatin Treatment in Stage II/III Colon Cancer According to Intrinsic Subtypes: Secondary Analysis of NSABP C-07/NRG Oncology Randomized Clinical Trial”. JAMA Oncology9 (2016): 1162-1169.
- Sticca RP., et al. “Current Use and Surgical Efficacy of Laparoscopic Colectomy in Colon Cancer”. Journal of the American College of Surgeons1 (2013).
- Thompson JH., et al. “Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial”. Contemporary Clinical Trials 67 (2018): 11-15.
- Tran E., et al. “T-Cell Transfer Therapy Targeting MutantKRAS in Cancer”. The New England Journal of Medicine 375 (2016): 2255-2262.
- Van Blarigan EL., et al. “Association of Survival With Adherence to the American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors After Colon Cancer Diagnosis: The CALGB 89803/Alliance Trial”. JAMA Oncology6 (2018): 783-790.
- Zaanan A., et al. “Prognostic Impact of Deficient DNA Mismatch Repair and Mutations in KRAS, and BRAF V600E in Patients with Lymph Node-Positive Colon Cancer”. Current Colorectal Cancer Reports 3 (2014): 346-353.
- Zauber AG., et al. “Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths”. The New England Journal of Medicine8 (2012): 687-696.
- Greg Yothers., et al. “Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses”. Journal of Clinical Oncology28 (2011): 3768-3774.
- Katzung B. Basic and Clinical Pharmacology. Lange (2020).
- Abraham J., et al. “The Bethesda Handbook of Clinical Oncology”. Walters Klewer (2014).