A Perfect Storm
The clinical trial regulations also expressly require plans to show that administrative burdens are not used to create barriers to cancer care for anyone who might benefit from participation in a clinical trial.9 The overarching goal of this push to eliminate financial and administrative barriers is to increase the enrollment of minority patients, especially those who do not live close to academic medical centers. In his April 2016 address at the annual meeting of the American Association for Cancer Research, Vice President Joseph Biden identified increased clinical trial participation as a key component of the administration’s cancer “moonshot” as well. Community medical oncologists will be called upon to facilitate and encourage clinical trial participation by their minority patients and should be supported in this endeavor by academic medical centers. With greater minority patient involvement, however, there also should be further research on how trial designs can better lead to clinically significant findings for minority patients. As Polite et al13 argue, at a bare minimum, basic sociodemographic and detailed comorbidity information should be prospectively collected and integrated with tumor and host biology data to better examine racial differences in cancer outcomes.
Initiatives also are needed to address the gap in referrals to cancer risk clinics so that more data are available on African American genetic variants, allowing the creation of more robust risk assessment models. Risk assessment relies on predictive statistical models to estimate an individual’s risk of developing cancer, and without accurate estimates of mutation prevalence in minority subgroups, these models’ reliability is compromised.14 As shown in a recent study at the University of Chicago’s Comprehensive Cancer Risk and Prevention Clinic using targeted genomic capture and next-generation sequencing, nearly one in four African American breast cancer patients referred to the clinic had inherited at least one damaging mutation that increased their risk for the most aggressive type of breast cancer.15
Adapted with permission from the American Cancer Society.
To identify damaging mutations only after a diagnosis of incurable breast cancer is a failure of prevention. As has been documented in Ashkenazi Jewish populations, there is evidence of high rates of inherited mutations in genes that increase the risk for aggressive breast cancers in populations of African ancestry. This is a fertile area for further research to better understand how these mutations affect the clinical course of breast cancer, what targeted interventions will increase the proportion of breast cancer diagnosed at stage 1, and what molecularly targeted treatments will produce a response in these tumors. Churpek et al15 also demonstrated the need for continued technological innovation to reduce the disparity gap, because next-generation sequencing is a faster and more cost-efficient way to evaluate multiple variants in many genes. This approach is particularly valuable for African Americans, who tend to have greater genetic diversity.16 The current administration is also heralding this approach to cancer care. In his 2015 State of the Union address, President Obama announced a precision medicine initiative, including a request for $70 million for the National Cancer Institute to investigate genes that may contribute to the risk of developing cancer.17 African American women should no longer be left behind in the push for personalized medicine that caters to a patient’s tumor biology and genetic profile. As Subbiah and Kurzrock state, universal genomic testing is not necessarily cost prohibitive, as the cost to obtain a “complete diagnosis and to select appropriate therapy may be miniscule compared with the money wasted on ill-chosen therapies.”18
In conclusion, there is an opportunity in the current climate of health care reform ushered in by the Affordable Care Act to address many of the discussed elements leading to the persistent racial mortality gap in breast cancer. We have argued that two substantial factors lead to this eroding gap. One is differences in tumor biology and genomics, and the second is a quality difference in patterns of care. In describing the perfect storm, Sebastian Junger19 wrote of the collision of two forces – a hurricane’s warm-air, low-pressure system and an anticyclone’s cool-air, high-pressure system – that combined to create a more powerful and devastating meteorological force. Similarly, we argue that it is the collision of these two factors – tumor biology and genomics with patterns of care – that leads to the breast cancer mortality gap. The delays, misuse, and underuse of treatment that we have underscored are of increased significance when patients present with more aggressive forms of breast cancer. Interventions to close this gap will take leaders at the patient, provider, payer, and community levels to drive system change.
