Precision medicine – tailoring treatments to individual patients – represents a key element of modern-day cancer care. So the question is, how does one bring precision medicine clinical trials from academic cancer centers to the community setting, especially in rural parts of the country?
That was the topic of a session Sunday morning at the American Society of Clinical Oncology’s 2018 annual meeting, currently underway at Chicago’s McCormick Place convention center, titled “Overcoming Unique Obstacles to Implementing Precision Medicine Trials in the Community Setting.”
The session featured Edward Kim, an oncologist who heads the Levine Cancer Institute’s solid tumor oncology program in Charlotte, North Carolina; Mike Thompson, an oncologist and director of the early phase cancer research program at Milwaukee-based Aurora Advanced Healthcare; and Lora Black, a nurse and senior director of clinical research at Sioux Falls, South Dakota-based Sanford Health’s division.
To a large extent, progress is already being made. In her presentation, Black showed a chart comparing Sanford’s success implementing precision medicine with that of the Cleveland Clinic and The University of Texas MD Anderson Cancer Center in Houston, since Sanford implemented its program in 2013. Among 109 patients, Sanford was able to find genomically matched treatments for 39.4 percent, compare with 10 percent of 250 patients at the Cleveland Clinic and 41 percent of 2,000 at MD Anderson. Meanwhile, it found genomically matched clinical trials for 16.2 percent of patients, compared with 3 percent at the Cleveland Clinic and 11 percent at MD Anderson. Sanford includes 45 hospitals, 289 clinics and more than 1,300 physicians across the upper Midwest, according to its website.
“This is flyover country, and we’re getting it done,” Thompson said.
Aurora includes 15 hospitals, more than 150 clinics and 70 pharmacies in eastern Wisconsin.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Implementing precision medicine across such a widely dispersed healthcare network comes with its own challenges, especially considering the importance of pathology, genetic counseling and the like. With that in mind, telemedicine plays an important role. Thompson said Aurora has implemented video conferencing throughout the system, for example.
Telehealth has become a hot topic in healthcare in recent years. Danville, Pennsylvania-based Geisinger has implemented telehealth across its system, including for use in precision medicine, combining pop health genomics with patients electronic health records. Through that, it can alert patients to potential cancer risks based on their genome. Indeed, an important component of genome sequencing is that patients have an altruistic interest in helping science and helping fellow patients, Kim said in his talk.
For pathology, coordination between clinics and labs is also crucial, lest a tissue sample be deemed insufficient in quality for next-generation sequencing and other tests, Black and Kim said.
A related consideration is staffing. When implementing a precision medicine research program, a key need is a program director who can act as a central point person, Black said. That person oversees the enormous team effort that a precision medicine program entails, including the physicians, information technology, genetic counseling, research coordinators and others.
One person can also handle tasks for multiple sites within a network. For example, Kim said that Levine and Sanford both have regional clinical research coordinators, with Levine’s coordinators each handling two to three sites. With such a tightly integrated network, Kim said, Levine was able to enroll two patients from Lincolnton, North Carolina – a town in the Charlotte metropolitan area with a population around 10,000 – into ASCO’s TAPUR study. TAPUR – which stands for Targeted Agent Profiling Utilization Registry – aims to describe the safety and efficacy of Food and Drug Administration-approved targeted drugs for patients with advanced cancer with potentially actionable genomic alterations. The study is set to enroll 1,440 patients, according to ClinicalTrials.gov.
Photo: iLexx, Getty Images
