What’s New in Oncology Disparities
Biweekly Review

Irby Hunter, Jr., MD Medical Director Oncology Independent Medical Education Inc & Executive Publisher Oncology Disparities Peer Reviewed Scientific Journal

January 13^th, 2023

Christiane Truelove published an influential article shedding light on many key factors relating to the disturbing lack of DEI in clinical trials. The article cited the words of FDA Commissioner Robert M. Califf, M.D., “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health. Dr. Califf also stated, “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. ¹

Truelove’s article documented federal support for DEI in clinical trials by restating the goal of the Cancer Moonshoot initiative, which is to address inequities in cancer care, thereby helping to ensure that every community in America has access to cutting-edge cancer diagnostics therapeutic care and clinical trials. Several verified barriers to minority participation in clinical trials were discussed, including mistrust of the clinical research system, inadequate recruitment within the trial design, frequency of clinical trial-associated clinical visits, transportation hardships, and conflicting caregiver responsibilities.¹

As previously lauded on our website, the article identified FDA draft guidance titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials as a driving instrument to be used in the quest to enroll more participants from underrepresented racial and ethnic populations into clinical trials. Additional solutions, such as the Diversity of Participants in Clinical Trials Initiative sponsored by TransCelerate BioPharma Inc, a coalition of pharmaceutical companies, were reported upon in the article. The initiative includes several resources geared toward accelerating diversity in clinical trials, such as “Diversity Community-Based Site Engagement and Capacity Building” and “Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT).¹

ancer cells disseminate from primary to distant sites through the Tumor microenvironment of metastasis (TNEM) doorway density. TNEM is a biomarker of distant metastatic recurrence. TNEM has been shown to be higher in Black women vs White women with estrogen receptor (ER) positive/HER2-negative breast cancer who have residual disease after neoadjuvant chemotherapy, according to data from a retrospective study presented at the 2022 San Antonio Breast Cancer Symposium.² This disparity may explain poorer outcomes experienced by Black women.² The study cohort consisted of 96 patients who self-identified as Black and 87 patients who identified as White; the study analyzed the relationship between TMEM score, defined as the time from surgery to first distant recurrence.² Almost half (49%) of Black patients experienced distant recurrence compared with 34.5% of White patients.² Finally, Black women were found to be more likely to be diagnosed with higher-grade tumors.²

Immunohistochemistry was used to validate the primary findings coming from an independent cohort of head and neck cancer tumor specimens. The study was conducted to better understand the molecular biomarkers identified among Black patients diagnosed with head and neck cancer. Molecular features associated with race and clinical outcomes were determined. Black patients were found to be of a younger age at the time of diagnosis, present with more aggressive tumor grades, higher rates of metastasis, and worse survival rates when comparted to White patients diagnosed with head and neck cancers. Investigators concluded that molecular biomarkers might be related to environmental, social, and behavioral factors associated with racial disparities in head and neck cancers. Additionally, the researchers informed that unique tumor mutations and biological pathways have potential clinical utility in providing more targeted and individualized screening, diagnostic, and treatment modalities to improve health outcomes.³

The incidence of surgery refusal has increased by nearly 50% among Black and Hispanic women with potentially curable breast cancer diagnosis over the past decade. These findings were derived from an analysis of Surveillance, Epidemiology, and End Results (SEER) Program data. The study population included $56,450 Hispanic women and 57,537 non-Hispanic Black women who were offered surgery for breast cancer from 2005 to 2015. Among those who refused surgery, 29.7% were identified as Hispanic, and 70.3% were identified as Black. Refusal of surgery was significantly associated with an increased risk of death in both Black and Hispanic women. The lead investigator for the study Bridget Oppong MD, an associate professor in the Division of Surgical Oncology at the Ohio State University Medical School, cited the costs of surgery, advanced age, fear of surgical outcomes, and medical mistrust as common reasons to refuse surgery. Dr. Oppong reports building a direct relationship with surgeons as well as obtaining support from other breast cancer patients representing the ethnicity of the patient are important steps to take to overcome medical mistrust.

References:

1. Truelove, Christiane. 2022. Getting the balance right. January 2, 2023. PharmaLive.com. Getting the balance right – PharmaLive
2. Kuznar, Wayne. 2022. Racial Disparities Revealed in Prometastatic TME in Woman with Residual Breast Cancer Neoadjuvant Chemo. December 6, 2022. Onclive.com. Racial Disparity Revealed in Prometastatic TME in Women With Residual Breast Cancer After Neoadjuvant Chemo (onclive.com)
3. Mezghani, Nadaia et all. 2022. Molecular Subtypes of Head and Neck Cancer in Patients of African Ancestry. December 12, 2022. Clinical Cancer Research. Molecular Subtypes of Head and Neck Cancer in Patients of African Ancestry | Clinical Cancer Research | American Association for Cancer Research (aacrjournals.org). https://doi.org/10.1158/1078-0432.CCR-22-2258
4. Harris, Jason. 2023. Black, Hispanic Women Increasingly Likely to Refuse Surgery for Early Breast Cancer. January 1, 2023. OncoLive.com. Black, Hispanic Women Increasingly Likely to Refuse Surgery for Early Breast Cancer (onclive.com)