Investigators Evaluate MBC Survival in Studies Addressing Race, Ethnicity, Socioeconomic Disparities

Data on disparities in outcomes by race, ethnicity, and socioeconomic status (SES) in patients with metastatic breast cancer (MBC) were presented on June 6 during a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The session addressed such subjects as patient quality of life following treatment with ribociclib, overall survival (OS) and progression-free survival following treatment for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease and triple-negative disease.

Rachel A. Freedman, MD, MPH, led the first discussion, which was on disparities in MBC and focused on promoting equity to improve outcomes in the disease. Freedman is medical director of the Dana-Farber Cancer Institute (DFCI) Collaborative and Strategic Alliances program, a senior physician in medical oncology at DFCI, and an associate professor of medicine at Harvard Medical School. She highlighted the interrelationship between SES and survival in MBC and increasing participation among Black patients in MBC clinical trials.

MBC Survival Disparities by SES/Neighborhood Deprivation Index¹
Patients living in neighborhoods or areas classified as having a lower SES, especially Black patients, are more likely to have worse survival outcomes following a diagnosis of MBC. Lower SES was shown to be an independent predictor of OS in MBC and was associated with a 19% greater risk of poor survival (HR, 1.19; 95% CI, 1.04-1.37; P = .01).

“Poorer outcomes in African American patients are likely due to the association between lower SES and African American race,” the authors wrote.

A team of investigators from the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center and the Women’s Cancer Research Center used comprehensive data from their Metastatic Breast Cancer Database for 1246 patients who received an MBC diagnosis and were treated for it between 2000 and 2017. They used Neighborhood Deprivation Index (NDI), also known as the Area Deprivation Index, scores to evaluate MBC survival as influenced by SES and race. These scores were derived from the Neighborhood Atlas via zip code.²

“The NDI is a novel approach to looking at area level SES. It really is a measurement for neighborhood disadvantage,” Freedman stated. “There are multiple factors that are pulled into this index that measure education, income, and household composition.”

Patients were divided into 2 groups. Those in the low-deprivation/upper SES group (n = 414) had NDI scores in the bottom tertile, and those in the high-deprivation/lower SES group (n = 832) had NDI scores in the middle or top tertile. The median study follow-up was 2.27 years; mean ages were similar at 56.1 (12.8) and 57.6 (13.0) years in the low- and high-SES groups, respectively; mean tumor sizes were identical, at 3.5 cm each; and most patients in each group (55.2% and 52.6%) had estrogen receptor (ER)-positive/HER2-negative disease. More patients in the high-deprivation/lower SES group were African American than those in the low-deprivation/higher SES cohort, at 10.5% vs 3.7%.

“Race was the only baseline characteristic that was significantly different between the SES groups,” the study authors wrote.

For the primary OS outcome, the Kaplan-Meier survival analysis shows consistent higher and longer survival rates among patients with MBC living in an upper-SES area and who are Caucasian vs those who live in a lower-SES area and are African American. Over the 16 years in this analysis, more than twice as many patients living in a lower-SES area died (756 vs 373 in a higher-SES area), with corresponding median survivals of 2.3 vs 2.7 years. In addition, African American patients survived at a lower rate than Caucasian patients: 93% died following a median survival of 1.8 years compared with 91% following a median survival of 2.5 years.

However, using a Cox proportional hazard model, race was shown to factor less in MBC OS when SES was accounted for.

Freedman concluded that although these findings add more evidence that SES mediates much of what we see when it comes to racial disparities, “we don’t really understand how NDI specifically impacts outcomes.”

Overall, the authors posited that future research needs to investigate health care investments in low-SES neighborhoods, assess MBC treatment disparities, and attempt to understand how the stress and inflammatory pathways that adversely influence poor health outcomes are themselves influenced by neighborhood. And Freedman reiterated that investigators and clinicians need to have a standardized method of collecting information on social determinants of health.

MBC Clinical Trial Participation Disparities³
Having lived with de novo MBC since July of 2015, Stephanie Walker, BSN, first navigated her advanced diagnosis as part of Athenex Oncology’s Facing MBC Together campaign.⁴ Now she is a member of the Metastatic Breast Cancer Alliance and lead author on an abstract that discusses findings from the patient-led initiative, The BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) Research Project. The authors noted goal of BECOME is “to better represent Black people in cancer research by increasing access to clinical trials for MBC.”⁵

“It is vital to have diverse patient enrollment in research. Research informs everything we do in clinic,” Freedman emphasized. “It’s how we understand short-term, long-term, and late effects; efficacy; toxicity; quality of life; the patient experience; genomic and biomarker profiles; and cancer prevention and risk assessment.” She added that if clinical trials fail to represent the population affected by a disease, clinicians are unable to sufficiently inform their patients.

Rich information is needed to understand what is going on, due to the limited depth of current data available, she continued, data that are often not self-reported. This includes not combining race and ethnicity categories, which studies often do, despite “dramatically different” genetics, cultures, and geographies, for example.

To overcome these barriers, BECOME conducted both a literature review (34 articles) and a patient-led web-based survey, with sponsorship from the MBCA. Recruitment took place through social media posts and MBCA emails. Of the 424 survey respondents (from 31 virtual interviews), 24% self-identified as Black. Among this Black patient population, 37% had a postgraduate degree or had taken postgraduate courses, most were aged 25 to 44 years (29%) or 45 to 54 years (33%), private insurance was the most common coverage (42%), and 59% of their oncologists were affiliated with an academic or university medical system.

Although approximately 15% of patients with cancer in the United States are Black, only 4% to 6% of clinical trial participants are Black, the study authors pointed out. Led by Walker, their primary study objectives were to understand trial participation barriers among Black patients with MBC and identify actions to increase that participation. “Only when trial participants reflect the diversity of the general population can oncologists understand how a drug works across subpopulations,” Walker and her coauthors wrote.
Data show that 80% of Black patients with MBC would consider participating in clinical trials, 83% are somewhat likely to consider participating, and 92% have an interest in learning about clinical trials. But only 36% have received as much information as they wanted from their oncologist and care team, and just over half, 54%, are aware there are MBC trials. The top barriers these patients identified as preventing their clinical trial participation were total necessary appointments and tests (40%), travel time (47%), potential extra medical costs (51%), overall financial burden (56%), difficulty finding trials (64%), and insurance not taken at centers running trials (73%). Forty percent also reported that no one on their team had told them about trials.
Black patients wanting to learn more about MBC clinical trials, compared with non-Black patients, felt that the most effective ways to inspire their trust were to learn about the trials from someone of their race/ethnicity (67% vs 10%), from someone who has had breast cancer (73% vs 44%), from someone who has had MBC (73% vs 51%), and from a fellow trial participant (72% vs 48%). In fact, the BECOME study authors noted, “Black patients were more likely than non-Black patients to want to learn about clinical trials from someone with shared experience.”

Addressing patient concerns was another top issue identified in the BECOME study. Compared with non-Black patients, Black patients were more worried about potential adverse effects (73% vs 66%) and drug effectiveness (63% vs 62%), were more likely to believe unstudied treatments were harmful (57% vs 31%), were less likely to believe all patients would be treated fairly and equally during a trial (32% vs 56%), and were principally motivated to participate “to ensure people with my racial or ethnic identity will benefit” (83% vs 51%). In addition, 73% of Black respondents to the BECOME survey vs 91% of non-Black respondents indicated they trust trials overall.

“These findings are consistent with past cited barriers,” Freedman noted, “and highlight the importance of trust, education, logistics, and expense—all of which are actionable.”

For dynamic and positive change to take place, efforts must be improved at every step in the clinical trial process—planning, enrollment, and post trial, she emphasized. Freedman echoed the study authors, who highlighted the need to share results and develop diversity strategies, expand the survey respondent base, step up patient education efforts, expand patient assistance efforts in finding trials, and even train health care providers to communicate with patients more effectively.More specifically, the BECOME study authors came up with these 4 overarching action steps:

• Enhance awareness about trials
• Build trust through clear communication
• Address concerns
• Help patients find and access trials

All stakeholders have a role to play in increasing Black patient participation, the BECOME authors concluded.

References
1. Narayanan SP, Rosenzweig MQ, Ren D, Oesterreich S, Lee AV, Brufsky A. Effect of socioeconomic status as measured by Neighborhood Deprivation Index on survival in metastatic breast cancer. Abstract presented at: 2022 ASCO Annual Meeting; June 3-7, 2022; Chicago, IL. Abstract 1013. Accessed June 6, 2022. https://meetings.asco.org/abstracts-presentations/208057
2. Neighborhood Atlas. Center for Health Disparities Research/University of Wisconsin School of Medicine and Public Health. Accessed June 6, 2022. https://bit.ly/3HQTR3K
3. Walker S, Carlson M, White CB, Howell J, Felder TM. Increasing Black patient participation in metastatic breast cancer clinical trials: the BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project. Abstract presented at: 2022 ASCO Annual Meeting; June 3-7, 2022; Chicago, IL Abstract 1014. Accessed June 6, 2022. https://meetings.asco.org/abstracts-presentations/208058
4. Shaw M. Being each other’s hero: facing MBC together. The American Journal of Managed Care®. August 25, 2020. Accessed June 6, 2022. https://www.ajmc.com/view/being-each-others-hero-facing-mbc-together
5. BECOME: Black Experience of Clinical Trials and Opportunities for Meaningful Engagement. Metastatic Breast Cancer Alliance. Accessed June 6, 2022. https://www.mbcalliance.org/projects/become/