December 27, 2022
Irby Hunter, Jr., MD Medical Director Oncology Independent Medical Education Inc & Executive Publisher Oncology Disparities Peer Reviewed Scientific Journal
A Look Back at 2022
The published studies posted on the oncodisparities.com website during the fourth quarter of 2022 were impactful in chronicling evidence to support the existence of health disparities experienced by underrepresented patients. The editorial staff uploaded published articles underlining the ongoing clinical disparities problem in oncology and hematology. Clinical trial enrollment, screening, and patient care represent a small sample of the many topics highlighted this quarter. Disparities in the gender of principal investigators and the allocation of research funding were pointed out to our readers. Differences in treatment outcomes in both GI and GU malignancies were shared. The work of multiple research teams identified disparities in overall survival rates as well as in patient care. Solutions to disparities spanning from targeted tumor therapy and social media influence were highlighted on the website.
Published Evidence of Disparities
The well-known disparities in breast cancer treatment outcomes were once shared on the website again. The Breast Cancer Research Foundation identified a stark mortality gap between Black and white women diagnosed with breast cancer. Black women suffer from slightly lower rates of breast cancer; however, they are more likely to die from the disease than white women.1 Additionally, The American Cancer Society reports that black women are disproportionately affected by aggressive subtypes of breast cancer and have the lowest survival rates for all subtypes of the disease.
Investigators identified alarming disparities in the incidence and mortality associated with certain solid tumors. Schafer et al. l revealed that the highest mortality rates for prostate cancer among White male patients were found in the Western region of the United States. Their study, which was published in the Journal of European Urology, indicated that when compared with White Male patients, Black patients had approximately 70% to 110% higher incidence and mortality rates for prostate cancer, respectfully. The researchers showed persistent sociodemographic disparities and unfavorable trends in incidence or mortality for all four major genitourinary cancers (bladder, kidney, prostate, and testicular) for male and female patients across the United States.
Researchers from the University of Minnesota Medical School have identified notable instances of disparities in surgical recommendations provided to ethnic minority patients. The investigating team examined more than 600,000 patients with intracranial tumors for the purpose of examining racial and socioeconomic disparities in the surgical management of primary brain tumors. The study clearly underscored an implicit bias in clinical decision-making. According to study findings, Black patients were more likely not to receive provider-driven recommendations for surgical removal of several brain tumors when compared to White patients, including meningioma, glioblastoma, pituitary adenoma, and vestibular schwannoma. Study results highlight a concern for unrecognized bias in treatment recommendation independent of clinical and demographic factors such as tumor characteristics, comorbidities, insurance status, and rural-urban continuum.
Studies associating disparities to the cellular characteristics of tumors were posted on the website, as well. In a study presented at the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved in Atlanta, Georgia, researchers identified that differences in tumor characteristics that may assist in explaining sex- and race-based disparities in patients with metastatic non-small cell lung cancer (NSCLC). The study focused on 4710 patients with metastatic NSCLC. Study results highlighted key disparities in overall survival based on gender and ethnic differences.
First, women were more likely than men to be diagnosed with metastatic NSCLC, regardless of race or ethnicity. The average overall survival was longer for women than for men –42 months and 26 months, respectively. Second, a higher tumor mutation burden was associated with inferior overall survival. Black patients were more likely to have a high tumor mutation burden than non-Black patients (9% and 5%, respectively, P=.019). Finally, an increased risk of death was seen in patients who were younger than 50 years of age at diagnosis when compared with patients diagnosed at 50-70 years of age. Compared with non-Hispanic patients, Hispanic patients were more likely to be diagnosed with metastatic NSCLC prior to the age of 50 (18% vs. 7%, P <.001).
Published Thought Leader Solutions
In 2022, more than 1.9 million Americans will face a new cancer diagnosis.5 A recent publication reported that while Blacks and Latinx citizens comprise 13% and 18% of the US population, respectively, in pivotal trials submitted to the FDA supporting new drug applications from 2007 to 2018, Blacks (5.4%) and Latinx (7.2%) were underrepresented.6 Black women are nearly twice as likely than white women to receive a breast cancer diagnosis in an advanced stage of the disease and are 40% more likely to die than white women.7 These statistics were shared on the website and confirm the need for potentiating measures that were shared on the website to diminish cancer disparities: DEI plans, diversity in clinical trial enrollment, molecular profiling, and funding.
Diversity Equity and Inclusion Plans
A recent study conducted by Northwestern Medicine reports that non-white racial and ethnic groups are underrepresented in OB-GYN clinical trials. Published in JAMA Surgery in December of 2022, the study indicates that of the 1,300 US OB-GYN clinical trials with results on ClinicalTrials.gov and 1,147 clinical trial publications between 2007-2020, only 51% of trials and 75% of publications reported race and ethnicity data. This study found all OB-GYN subspecialties-not just areas pertaining to pregnancy- lack racial and ethnic representation in clinical trials and research publications. One culprit for the existence of these disparities is thought to be the fact that the majority of scientific journals do not require scientists to declare studies by race and ethnicity, despite clinicaltrials.gov highly recommending this policy. Also, many patients representing minority ethnic and racial populations lack access to clinical access to physician offices participating in clinical trials.
NIH’s National Institute on Minority Health and Health Disparities encourages principal investigators to include participants with a variety of lived experiences and living conditions, as well as characteristics like race and ethnicity, age, sex, and sexual orientation, thereby permitting all communities to benefit from scientific evidence. Likewise, FDA has issued a draft guidance for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials. FDA’s “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” strongly recommends that pharmaceutical companies submit Race and Ethnicity Diversity Plans to the FDA earlier on during the clinical trial research design phase.
Diversity in Clinical Trial Enrollment
In December of 2021, ASCO and ACCC published a transformative research statement in the Journal of Clinical Oncology titled “Increasing Racial and Ethnicity Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement. The joint declaration details specific actions to engage the entire cancer clinical trial ecosystem in expanding the participation of underrepresented individuals in research that advances focus on key areas that address barriers to cancer clinical trials, including access to clinical trials, equity-focused design, partnerships among stakeholder groups; continuous education and training; equity, diversity, and inclusion investment; and sharing data and strategies.
Molecular Profiling
Luiz Reaz, M.D. FACP, FCCP, immediate past president of the Florida Society of Clinical Oncology (FLASCO), is one of the many thought leaders evaluating precision medicine in the form of biomarker testing as a potential scientific solution to the oncologic disparities. Cancer precision medicine is a transition away from the less specific approach to the way cancer patients have been managed historically. Cancer precision medicine is the use of therapeutics, notably gene and protein expression patterns, that benefit a subset of patients whose tumors display specific molecular or cellular features. Precision medicine is transforming how both common and rare malignancies are being diagnosed and treated.
In November 2022, FLASCO brought together oncologists to address closing health equity gaps and to discuss new research and policy geared to diminishing cancer disparities. The thought leaders identified how disparities in molecular profiling are responsible for several of the inferior cancer treatment outcomes in minority patients. Biomarker testing was lauded as scientific instrument being used to fundamentally transform and enhance the way cancer is diagnosed and treated, thereby playing impactful role in diminishing cancer disparities. Biomarker testing looks for alterations in cancer’s genes and can help identify the underlying drivers of a tumor. Biomarker testing can determine the ideal therapy for patients allowing clinicians to prescribe targeted, precision therapies for cancer patients.
Research and Community Intervention Funding
Valley-Mount Sinai Comprehensive Cancer Care is the recipient of a $652,000 grant over three years from BD, a global medical technology company headquartered in Franklin Lakes, New Jersey. The grant will fund diversity, equity, and inclusion interventions that will increase access to clinical trials among underrepresented patient populations, including racial and ethnic minority groups.
In 2021, Novartis launched More Than Just Words, a comprehensive initiative created to provide resources, systems, and community for Black women to increase health equity in breast cancer. In response to an urgent need to correct health disparities, “The More Than Just Words” initiative encourages Black women to get screened appropriately; promotes equitable care among minority breast cancer patients; works to increase the number of Black patients participating in clinical research; and supports the research and development of innovative life-extending treatments.