Precision medicine is changing cancer care in profound ways. It is expected that the number of patients who benefit from precision medicine will continue to increase in the coming years, as treatments become more effective and research yields more insights on patient populations who are most likely to respond to therapies.
However, that promise is only as good as our ability to make precision medicine approaches available to all patients who may benefit. Recognizing the need to confront barriers and identify solutions to expand precision medicine approaches across the country, in January, ASCO convened a panel discussion, Precision Medicine: Expanding Opportunities. The discussion, aimed at examining the issues in deploying precision medicine in oncology practice, was the first in ASCO’s new State of Cancer Care in America™ event series.
“Precision medicine is allowing us to deliver better care, faster than previously possible, and with greater accuracy in well-defined subsets of our patients,” said 2017–2018 ASCO President Bruce E. Johnson, MD, FASCO, in his opening remarks. “It’s transforming cancer care for our patients who are not only living longer, but living better. The outcomes we’re seeing in patients underscore the importance of making precision medicine accessible to every patient with cancer.”
Since 2014, ASCO has published a series of annual State of Cancer Care in America reports to examine important trends in the cancer care delivery system. Now, ASCO is broadening its State of Cancer Care in America initiative to include national events on pressing cancer care topics, timely in-depth articles that explore certain facets of care delivery, and additional materials that detail the current state of cancer care.
Many Definitions, One Goal
THE CANCER COMMUNITY uses the term “precision medicine” to refer to different approaches to cancer care: personalized medicine, targeted therapy, immunotherapy, genomics. In the event’s opening remarks, ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, emphasized the importance of agreeing on a definition for precision medicine to help break down the barriers that exist in operationalizing it across the cancer care infrastructure.
'A Second Chance at Life'
Illustrating the value precision medicine brings to patients was cancer survivor Judy Wilkins. After a diagnosis of non-Hodgkin follicular lymphoma, Ms. Wilkins tried four different chemotherapy regimens over the course of a year and a half. None of them worked. Cautiously, and with trepidation, Ms. Wilkins entered a clinical trial in which she was one of the first people in the nation to be successfully treated with chimeric antigen receptor (CAR) T-cell therapy. Just 6 weeks after her T-cell transplant, her scans showed no signs of cancer. Ms. Wilkins is healthy and feeling great. “If you’re in a position to go into a clinical trial, do it. It gave me a second chance at life,” she said.“ASCO believes precision medicine shouldn’t just be about cutting-edge cancer treatments for a select few,” Dr. Hudis said. “It should also be about providing the highest quality care to all of society, and this should be done in a personal way that reflects individual patients’ goals and aims. We believe this is one of several next steps for precision medicine.”
Dr. Johnson—whose presidential theme focuses on expanding access to precision medicine—agreed. “Precision medicine is defined as an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person,” he said. “We drive progress by delivering care that is truly personalized—by considering each person’s unique genetics, environment, and lifestyle to prevent cancer in patients at high risk, and when not possible, to diagnose cancer early and treat it effectively.”
Confronting Complex Challenges
INCREASING PATIENT access to precision medicine comes with multifaceted, complex challenges that must be addressed so that the maximum number of patients benefit from new treatments and technologies.
ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FSCT, FASCO, who served as the moderator for the event, led the discussion in which panelists identified several barriers that hinder the expansion of precision medicine, particularly at the community level.
Panelists discussed topics ranging from the biology of tumors, to genomic test interpretation and regulation, to the type of education needed for clinicians to use precision medicine in their practices.
Dr. Schilsky and speakers during Panel One. Photo by Stephen Barrett.
One of the challenges facing all oncologists in this relatively new field of precision medicine is the combination of biomarker testing with immunotherapies. Panelist Suzanne Topalian, MD, said that while there has been huge progress in the field, some of these treatments are relatively new to the community, and there are many unanswered questions about who is most likely to benefit. The dual approach of more research along with an increase in physician education was discussed as one solution.
Panelists agreed that one of the major challenges in the field is genomic testing: how it is conducted, the interpretation of results, and the sharing of genomic data. There was also unanimous recognition that genomic testing—and subsequently, newer treatments such as immunotherapy—places a cost burden on both patients and the health-care system.
“The goal is to keep up with [precision medicine] enough so you continue to make progress and we move toward a more rational, evidence-based system,” said panelist Robert Califf, MD. “We need a community where everyone works together, and it needs to be very transparent, because the cost of doing the wrong test and getting the wrong test answer will be more catastrophic than not giving the right drug.”
Panelist Robert Dubois, MD, PhD, echoed similar views and emphasized the disconnect between the personalization of medicine and the impersonalized system of paying for medicine. Panelists pointed to a new payment model for chimeric antigen receptor (CAR) T-cell therapy: only pay for the therapy if it works. While Dr. Dubois did not say this concept was the right or only solution, he stressed the importance of decreasing cost barriers for patients.
Precision Medicine in Practice: Efforts to Accelerate Learning
THE ONCOLOGY COMMUNITY is testing and adopting innovative strategies to address the barriers to expanding access to precision medicine. A second panel of leading voices in oncology described programs and approaches to spur the uptick of precision medicine in a community setting. The focus on community practice remains an integral part in advancing precision medicine nationwide, as nearly 85% of people with cancer receive care in community settings.1
Panelist Lincoln D. Nadauld, MD, PhD, of Intermountain Healthcare, a state-wide health system with cancer practices across Utah, built a fully operational genomics and precision medicine service that is embedded throughout the health system. The program brings cutting-edge care to patients that was once considered available only through major academic cancer centers.
Precision Medicine: Expanding Opportunities Panelists
PANEL ONE- Suzanne Topalian, MD, Associate Director, Johns Hopkins Bloomberg- Kimmel Institute for Cancer Immunotherapy
- Robert Califf, MD, Vice Chancellor for Health Data Science, Duke Health; former U.S. Food and Drug Administration (FDA) Commissioner
- Anna B. Berry, MD, Scientific Director, Personalized Medicine Program, Swedish Cancer Institute
- Robert Dubois, MD, PhD, Chief Science Officer and Executive Vice President, National Pharmaceutical Council
- Otis Brawley, MD, MACP, FASCO, FACE, Chief Medical Officer, American Cancer Society
- Barbara McAneny, MD, FASCO, President-Elect, American Medical Association; Chief Executive Officer, New Mexico Oncology Hematology Consultants
- Edward Kim, MD, Chair, Solid Tumor Oncology and Investigational Therapeutics, Levine Cancer Institute; Chair, Targeted Agent and Profiling Utilization Registry (TAPUR) Steering Group
- Meg Gaines, JD, Attorney, cancer survivor, and Founder of the Center for Patient Partnerships at the University of Wisconsin
- Lincoln D. Nadauld, MD, PhD, Medical Director of Cancer Genomics, Intermountain Healthcare
“Precision medicine became the way to democratize that kind of high-level specialty cancer care,” Dr. Nadauld said. The program includes full-time staff to get treatments approved on behalf of patients, a clinical protocol for monitoring patient outcomes, as well as access to precision medicine–based clinical trials. After the program’s implementation, Dr. Nadauld and his colleagues analyzed data gathered from the program and found that patients who received precision medicine services had a prolonged progression-free survival compared with those who did not.
“Making patients live longer: Isn’t that the point of medicine?” Dr. Nadauld said.
Panelist Edward Kim, MD, echoed the need to conduct more clinical trials at the community level. Dr. Kim is the Chair of ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study steering group and oversees the trial throughout Carolinas Healthcare System. The TAPUR Study is ASCO’s first clinical trial and is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the U.S. Food and Drug Administration. Small, rural practices are empowered to provide precision medicine to their patients because of the health system backing of trials like TAPUR. He noted that it’s not enough for a practice to simply offer precision medicine services without measuring outcomes.
“A la carte, or maverick medicine, is not doing anything to help the ecosystem of precision medicine,” Dr. Kim said. “Community clinical trials advance cancer care by allowing physicians to measure and report data.”
In addition to community-based clinical trials, panelist Barbara McAneny, MD, FASCO, described her own practice’s use of pathways to help support busy community oncologists who often treat several different tumor types. Dr. McAneny’s practice partnered with 16 other oncology practices from around the country to create pathways, supported in part by the ASCO COME HOME program.
“By creating pathways, we’re ensuring high-value care is being delivered to patients. It gives us a decision support tool to make sure we’re providing the right genomic test, at the right time during treatment, for the right patient,” Dr. McAneny said.
Beyond pathways, payer involvement, data sharing, and patient engagement were identified as important success factors to implementing precision medicine across communities in the United States.
Panelist Meg Gaines, JD, a metastatic ovarian cancer survivor whose work focuses on engaging patients in shared decision-making, emphasized the need to ensure that patients treated with precision medicine approaches are fully involved and understand their care and course of treatment from the time of diagnosis.
“Precision medicine excites me. It was not available to me during the course of my cancer treatment, and I’m living with long-term side effects from traditional cancer treatment,” Ms. Gaines said. “But most patients do not know about this brave new world in cancer care. [Oncologists] have these great new tools in [their] toolkit but are still trying to figure out these tools [themselves]. However, if we don’t engage patients from the very beginning, we’re going to say ‘no thanks.’”
Another challenge facing both patients and providers is balancing hope and hype. While critics say precision medicine provides a false sense of hope to patients because just a small percentage of those with advanced cancer benefit from it, oncologists and patients are optimistic and cautious.
“It is the art of medicine to create enough hope to get people going without creating unfair, and sometimes cruel, expectations,” said Dr. McAneny. “You have to learn this part of being a physician: how to take the information that you have and translate it into something that resonates with a culture that the patient brings to it.”
What Comes Next
ASCO CONTINUES to engage with stakeholders from across the cancer care delivery system to improve access to precision medicine. Dr. Johnson has devoted his presidential term and theme to increasing access to precision medicine for patients, while working to address the challenges echoed by both panels at the event.
ASCO embraces precision medicine with optimism, even with the significant tasks that lie ahead for oncology clinicians. “I’ve been in oncology since 1977, and when you have a long perspective like that, the progress we’ve made is nothing short of breathtaking,” Dr. Schilsky said. “There’s a huge sense of optimism right now, and almost all of us can now foresee a time in the next 10 or 15 years when immunotherapy will be the therapy of choice for all patients with cancer.”
Watch the recording of ASCO’s inaugural State of Cancer Care in America event: Precision Medicine: Expanding Opportunities at facebook.com/ASCOcancer/videos. ■
REFERENCE
1. Copur MS, Ramaekers R, Gönen M, et al: J Oncol Pract 12:67- 68, 2016.
Originally published in ASCO Connection. © American Society of Clinical Oncology. “ASCO Hosts Inaugural State of Cancer Care in America Event to Examine Issues in Precision Medicine.” ASCO Connection, April 2018. All rights reserved.