Precision oncology must evolve to address health disparities

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Every person facing a cancer diagnosis deserves access to the best possible tests and treatments for their disease. It’s really that simple. Even better—it’s entirely feasible. 

Biomarker-based cancer therapies are the cornerstone of precision oncology and hold promise for expanding access to the most effective treatment options for every patient. With genomic profiling, we can find these biomarkers, and identify novel treatment and clinical trial options tied to these biomarkers. 

Yet for the field of precision oncology, as is the case across healthcare and society at large, that promise will not reach its fullest potential as long as racial disparities persist. 

Too many patients are left behind as precision oncology continues to propel us into a transformative era of personalized cancer care. In fact, approximately two out of three people with advanced cancer are not getting the broad genomic information about their cancer that could inform cancer care.1 

Entrenched barriers are holding us back, including difficulties accessing genomic testing, lack of ubiquitous expertise, and limited resources in diverse communities impeding clinical trial participation. The result is that people who receive biomarker testing or enroll in clinical trials often do so because of external factors rather than health need or equitable opportunity. 

Inequalities in care are especially glaring in cancer subtypes that show high incidence among minority patients. African Americans, for example, have a higher incidence of prostate cancer and poorer survival compared to other ethnic groups, and research is needed to define the factors that may drive these differences. 2-3

Clinical research and real-world data from this year’s ASCO conference provide further insights to help inform a path toward breaking down barriers to high-quality cancer care for all patients—a goal which will require collaboration and commitment across industry and academic groups.    

Precision medicine access challenges

Barriers to cancer care include high costs of treatment, transportation and language difficulties, lack of sick leave and non-existent or limited insurance, among others. Long-standing challenges such as medical provider bias and distrust of the medical establishment also remain major barriers, and we recognize that patients may face barriers to access at every step of their journey. This includes biomarker testing early in a patient journey, and early discussions about clinical trial options. 

Currently fewer than 10% of U.S. patients participate in clinical trials, with only 5 to 15% of those patients being non-Caucasian, and the access gap is actually widening in cancer trials.4-5 Non-Hispanic white patients are nearly twice as likely as African American patients and three times as likely as Hispanic patients to enroll in a cancer clinical trial.

This lack of diversity in enrollment can ultimately harm communities of color and lower-income areas by limiting access to investigational therapies that could be beneficial for their specific cancer. We have to do better.

Through research into testing, treatment and clinical trial disparities, the oncology community is working to identify and address inequalities in precision oncology and hopes to create a ripple effect across the entire healthcare system. That’s not an easy task, of course, and it will take all of us to enact change at an organizational and structural level to make a difference for patients. 

ASCO21: A spotlight on health disparities

The focus on health equity at this year’s ASCO meeting is yet another platform to have these important discussions around access to precision medicine and genomic testing, further highlighting the need for industry and academic groups alike to take action. 

As stated, persistent inequities in cancer care are driven by many factors. Our study, for example, found that access to comprehensive genomic profiling (CGP) early in the treatment course and clinical trial enrollment differ by ancestry, which may help explain disparities in prostate cancer care. 

Men of African and European ancestry had largely similar rates of actionable gene alterations, but men of African descent were less likely to receive CGP earlier in their treatment course and less likely to be treated on clinical trials—underscoring the extended time from diagnosis to implementation of precision medicine and lack of access to investigational therapies. These findings call for additional research into the complex barriers that may be causing ancestry-based gaps in care. 

Low rates of clinical trial participation among non-white patients are attributed, in part, to barriers driven by limited resources and the high financial burden of increased doctor visits, time away from work and travel-related expenses incurred with trial participation.6 

Two studies are currently underway focusing on the potential of decentralized clinical trials to address these challenges with the goal of increasing diversity in enrollment and access to investigational therapies: 

  • In the Alpha-T study, led by Roche using Foundation Medicine’s precision enrollment services, researchers at multiple institutions are enrolling patients with ALK-positive solid tumors, and treating them with alectinib. 
  • The TRACK study, led by the TargetCancer Foundation, also uses a similar trial design to enroll patients with rare cancers in a study analyzing benefits of molecular therapy. 

Through remote support, patients are participating in these trials from their local care setting, showing the massive opportunity we have to implement these types of clinical trials to expand access across patient populations. 

A commitment to every patient

Addressing disparities in oncology care requires multi-stakeholder collaboration. Together, we must remove barriers in cancer care and have these important conversations about health equity, as access to this high-quality care can significantly improve outcomes.

Both of us are working to expand equitable access to genomic testing and increase representation in real-world data. To achieve this, we collaborate with nonprofits, patient advocacy organizations and biopharma to better understand access barriers, to help with education, and to co-develop solutions to address barriers to clinical trials among underrepresented patient populations. 

And we are always looking for more partners with whom to make important progress for patients. For example, Foundation Medicine is a proud member of Genentech’s External Council for Inclusive Research, a purpose-driven partnership to establish new standards and principles for inclusive research.

Each new advance in precision medicine can inadvertently create additional education, awareness and access gaps. We must commit to ensuring all patients have access to advanced, high-quality cancer care and the information they need to make informed health decisions. 

And we recognize that racial and social inequalities in healthcare span more than just the oncology field—by working to ratify disparities in oncology, our hope is that the healthcare industry at large follows suit. 

Knowledge is power. Every person facing a cancer diagnosis deserves the opportunity to feel empowered, equipped with the best insights to have critical conversations about personalized treatment options, including if genomic testing or clinical trial enrollment is right for them and their specific cancer.


References

  1. L.E.K. interviews and analysis FMI-purchased Kantar data, SEER, MedPanel ‘Assessment of Market for Pan-Cancer Testing Wave 2’, IMS Health Medical Claims Data (DX) dataset (April 2015 to Dec 2016).
  2. Mahal BA, Alshalalfa M, Kensler KH, et al. Racial Differences in Genomic Profiling of Prostate Cancer. N Engl J Med. 2020 Sep 10;383(11):1083-1085. doi: 10.1056/NEJMc2000069. PMID: 32905685.
  3. Dess RT, Hartman HE, Mahal BA, et al. Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality. JAMA Oncol. 2019 Jul 1;5(7):975-983. doi: 10.1001/jamaoncol.2019.0826. PMID: 31120534; PMCID: PMC6547116.
  4. Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). Jul 2012;21(7):713-6. doi:10.1089/jwh.2012.3733.
  5. Duma N, Vera Aguilera J, Paludo J, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract 2018; 14(1): e1-e10.
  6. Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health 2006; 27: 1-28.
Brandon Mahal, MD
Assistant professor, radiation oncology; Assistant director, Community Outreach & Engagement, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Jeffrey Venstrom, MD
Senior vice president; Head, clinical development & medical affairs, Foundation Medicine
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