Addressing Challenges in Precision Medicine and Genetic Testing in the Community

Jonathan Trent, MD, PhD

As technology advances to improve the quality of diagnosis, treatment, and care, real-world application remains of the upmost importance to community oncologists who must integrate these protocols into their day-to-day routines.

Perspectives from the community, academic, and scientific settings came together during a panel discussion on precision medicine and genetic testing in the community setting at the Association of Community Cancer Centers’ (ACCC) 44th Annual Meeting and Cancer Center Business Summit.

Lawrence D. Wagman, MD, executive medical director of St. Joseph’s Hospital, recapped the classic, modern, and future goals of precision medicine, as well as the challenges with genetic testing in the community setting.

“In precision medicine, the biggest challenge now is differentiating what is important and what is just interesting. Getting the cancers tested, getting enough tissue to send for testing, interpreting 20 to 40 pages of information, and then deciding what in that big packet of information is going to make a difference when we sit down with our patients is challenging,” said Wagman.

In the future, Wagman said that focus must be placed on evidence-based testing. In a nonscientific and nonexperimental setting like a community practice, evidence needs to be based on results that can be used in risk assessment, he explained.

Addressing some of the concerns expressed by Wagman, Catherine Fine, MS, CGC, lent her knowledge as a genetic counselor to the discussion on genetics and genomics in the community setting. As the leader of Clinical Cancer Services at Genome Medical, Fine said that the fear of losing patients to major academic centers is understandable, and telehealth companies like Genome Medical can assist community oncologists in retaining their patients.

"There is a lot of potential for genetics and genomics in the community, from accelerating diagnosis, to treatment of cancer, approving patient outcomes, reducing cost of care, and identifying at-risk relatives to help prevent cancer,” said Fine. “But, there are also so many barriers.”

One of the biggest barriers is a lack of access—either to resources, such as genetic counselors, geneticists, and certified genetic nurses, or provider education and experience. Additionally, there is a lack of alternative delivery models, Fine said, which may be solved by using an outside genetic counselor provided by a telehealth company.

Although there is good awareness of the value of genetics and genetic testing in the community, utilization of genetic services and testing appears to be lacking. For example, less than 20% of patients with breast and/or ovarian cancer who are eligible for genetic testing by NCCN criteria are actually offered testing, said Fine. This is a compounding problem, according to Fine, as the size of the genetic workforce remains relatively small at about 2500 geneticists and 4000 genetic counselors in the United States.

Fine and her team at Genome Medical propose an alternative delivery model for oncology teams that integrate a nationwide genomic medical practice to solve key patient and organizational concerns, such as missed or misinformed patients, the rapid evolution of somatic and germline therapeutics, and maintenance of accreditation and association standards. The third panelist, Jonathan Trent, MD, PhD, professor of medicine, Sylvester Comprehensive Cancer Center, University of Miami Health System, emphasized that precision medicine and genetic testing are not, and should not, be about the community setting versus the academic setting. He also focused on the future directions for precision medicine, both broadly and specifically, at Sylvester Comprehensive Cancer Center. This includes expanding accessibility to their molecular tumor board with Syapse to enhance operations.

“Precision oncology at our institution is to stay on top of this on a day-to-day basis and do what we can to optimize patient care,” said Trent.

In contribution to the concerns raised about accessibility in the community, Trent said that Sylvester plans to improve educational outreach about next-generation sequencing and making more informed clinical trial decisions. This means using molecular data to drive a selection of new clinical trials that have opened at Sylvester, with a focus on “molecular-driven, histology-agnostic therapies,” he noted.

For example, the DePICT study from Sylvester subsidizes NGS testing to ensure access to patients whose insurance does not cover tumor profiling. Trent says that increasing availability to next-generation sequencing testing may reduce disparities in clinical trial enrollment, specifically for women and minorities. This would, in turn, increase overall access to targeted therapy. The goal of studies like this is to reduce disparities in personalized oncology care.

Additionally, the TAPUR study (NCT02693535), which opened in January 2018 at Sylvester, will review every patient by precision medicine. Presently, 19 patients have consented to enroll in TAPUR and 8 patients are on treatment.

In conclusion, Wagman, who moderated the panel, said that the scientific data that is in development represents a bright future.

“It is important for caregivers to see what it takes to transition that information into reality. It is important for the people generating the data to be cognizant of what we need locally, and maybe come together to provide us with something consistent. Take out the competitive nature of the business world and put it into the collaborative nature of the healthcare world,” said Wagman.