Veterans Affairs' National Precision Oncology Program Continues Expansion

By Gail Gourley

In 2016, President Barack Obama announced launch of the National Cancer Moonshot initiative, aimed at accelerating a decade’s worth of advances in cancer research, treatment, and prevention into five years, essentially doubling the rate of progress against cancer. The Department of Defense and the Department of Veterans Affairs (VA) were, from the beginning of the initiative, elements of the envisioned whole-of-government approach devoting resources to this effort.

The National Precision Oncology Program (NPOP) is part of the VA’s dynamic effort to support the Moonshot initiative. Led by the VA National Oncology Program, NPOP provides genetic testing and reporting of tumor samples, expertise to interpret testing results for the best treatment of veterans’ cancer, and information sharing for clinical and research purposes.

Michael Kelley, MD, is the VA National Oncology Program director, chief of hematology–oncology at Durham VA Medical Center, and professor of medicine at Duke University in North Carolina.

As the country’s largest integrated health care network, the VA sees about 50,000 new cancer diagnoses per year among enrolled veterans. For male veterans, prostate and lung cancer are the most common, and breast and lung cancer are the most prevalent in women veterans. Compared to the non-veteran U.S. population, veterans have slightly higher overall cancer rates.

Historically, medical treatment for cancer has been non-precise, where patients with the same cancer diagnosis and stage receive the same treatment. In contrast, Michael Kelley, MD, VA National Oncology Program director; professor of medicine, Duke University; and chief, hematology-oncology, Durham VA Medical Center, described precision oncology as “understanding the molecular basis of [an individual’s] cancer – not cancer in general, but an individual’s cancer – and using that to guide care and, in particular, treatment decisions.”

As described in an August 2020 abstract authored by Kelley and published in the Federal Practitioner, one of the earliest examples of precision oncology was tumor testing for the estrogen receptor in breast cancer, distinguishing those breast tumors sensitive to hormonal treatments from those that are not. Another early example, in 2004, linked mutation of the EGFR gene with response to medications like gefitinib and erlotinib, and it was subsequently shown that patients without the EGFR mutation derived no benefit from those drugs. Thus, Kelley wrote, “the precision oncology paradigm is using a molecular diagnostic as part of the indication for an antineoplastic agent, resulting in improved therapeutic efficacy and often reduced toxicity. By 2015, multiple examples of DNA-based gene alterations that predict drug response were known, including at least five in non-small cell lung cancer.”

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The VA demonstrated its commitment in 2015 to implementing precision oncology, launching a regional program for DNA sequencing of solid tumors. That program transformed into NPOP in 2016 with the Moonshot initiative and has continued to develop and expand.

In 2016, prostate cancer was the first included in the program, and lung cancer was formally added last year, Kelley said. Breast cancer’s inclusion in NPOP was announced last year and is being implemented starting this fiscal year. Experts already in the system are working on future inclusion of melanoma, brain cancers, and gynecologic malignancies.

One of the earliest examples of precision oncology was tumor testing for the estrogen receptor in breast cancer, which distinguishes breast tumors sensitive to hormonal treatments from those that are not. Breast cancer is the most common cancer in women veterans.

In precision oncology, tumor testing is necessary to understand an individual’s cancer. “We’re systematically going through lung and prostate cancer [patients] to make sure that they have the appropriate testing,” Kelley said. “But there are other tumor types that we think also should have systematic testing. Breast is one of those and we’ll be [developing] that,” he said, adding that they’re working to identify recommended testing for bladder cancer, esophageal cancer, kidney cancer, and head and neck cancer. “There is a whole list that we’ve made for many tumor types, not every tumor type because there are about 700 of them, but for many tumor types in terms of identifying what type of testing we recommend.”

PAST YEAR’S PROGRAM GROWTH – ACCESS, CLINICAL PATHWAYS, TELEONCOLOGY

Kelley identified some of the most significant developments as expansion. “Access to precision oncology has continued to expand over the last year. The use of the testing that’s necessary to do precision oncology has increased over 100%, so that’s been a very significant uptick. And the number of sites where it’s done routinely is also going up, and now I think has been used in the last year pretty much at every oncology practice in VA,” he said. As of 2021, more than 14,000 veterans have been tested through NPOP.

Another ongoing endeavor within NPOP is development of clinical pathways, or standardized, evidence-based disease management and treatment protocols. “The very beginning is to formally define what it is we want to happen for patients most of the time, and this is called a clinical pathway,” Kelley explained. “We’ve gotten together groups of experts to talk about what the pathway should look like and written that down now for four cancer types and starting on three more. That defines what we want to have happen, and then start to measure that [so] we make sure that we don’t miss anybody, essentially; so, systematically provide that advice to clinicians.”

Precision oncology utilizes the molecular basis of an individual’s cancer to guide treatment decisions.

A third area of robust effort has been teleOncology, seeking to realign the urban supply and the rural demand for oncologists. About one-third of enrolled veterans live in rural areas, where telehealth can provide important health care services to veterans in locations where that care might be otherwise inaccessible. That is true for precision oncology, which has worked over the past year to expand its use and applications.

“Our teleOncology service is expanding access to expert oncologists in areas where they don’t have those oncologists, such as in many rural areas,” Kelley said. “That has been a big area that we’ve been working on this past year.”

He explained, “If you have a problem and you go to the person who is an expert in your problem, you’re probably going to get it fixed. You’re going to get it fixed the first time, you’re not going to get things that you don’t need, and it’s going to be better.”

The VA’s first teleOncology session was conducted on June 25, 2018 by Dr. Michael Kelley with a veteran from the Veterans Health Care System of the Ozarks in Fayetteville, Arkansas, which had lost its on-staff oncologist and reached out for assistance and expertise. Expansion of teleOncology services, especially to veterans in rural areas, has remained a strong priority.

For example, Kelley said, “I’m a thoracic oncologist, so I specialize in patients with lung cancer. I have seen lung cancer patients basically every day of my professional career, 35 years, so when I see another patient with lung cancer, I probably have seen something similar. And if I haven’t, I’ve probably read about it. Whatever it is, I’m going to probably be able to deal with it and deal with it on the spot, and do so in a way which is consistent with the very best practice. It’s the same thing for my colleagues who see patients with colon cancer or kidney cancer or bladder cancer or brain cancers. So, if you’re in central South Dakota, and you have a melanoma, a type of skin cancer, and have the need for an expert opinion, that expert opinion could come to you, or it could be your doctor. That person who’s at a major cancer center can come to you and take care of you where you are. You don’t have to go to Minneapolis or San Diego or anyplace else in the country. This is what telehealth is doing for precision oncology. You can see this in action, and it’s tremendous.”

Kelley said the use of telehealth for oncology care has increased during the COVID-19 pandemic, specifically between one hospital and another, but mostly because teleOncology was expanding even before the pandemic. “We were already building plans in 2019 to expand the service,” he said, and also acknowledged the pandemic’s effect reduced early skepticism in some, “including patients and providers. I think the COVID pandemic has helped expand this type of care at a very rapid pace.”

PRECISION ONCOLOGY SYSTEM OF EXCELLENCE

These highlighted areas of the program’s progress over the last year – access expansion, establishment of clinical pathways, and utilization of telehealth to provide oncology care to veterans – is all within the context of a “system of excellence.”

“That’s the big vision,” Kelley said. “In the past, we talked about centers of excellence, a physical location where we have experts.” Some patients would have access to those centers, but others might need to travel there.

Expansion of types of precision oncology testing and their applications could help determine which individuals are at higher risk of getting cancer and result in earlier screening imaging, such as CT scans.

“But we’ve envisioned something different than having centers of excellence. We want a system of excellence where the veterans don’t have to go anywhere [for cancer care]. The system comes to them,” Kelley continued. For example, some of the 130 sites of clinical care would have cancer experts, “but if you’re at a site that doesn’t have an expert in your tumor type, you could still access an expert either because your oncologist communicates with that person, and the oncologist is using a clinical pathway which is already designed by the experts, or the expert oncologist could actually come to you by telehealth.”

Additionally, Kelley pointed to the complexity of precision oncology testing and interpretation, and that another benefit of a system of excellence is providing education to physicians on “what this testing can do, what it can’t do, when to use it, when not to use it, how to interpret it when you do the testing, and how to apply that for different types of patients,” he said, adding that through electronic consults, “any physician or any provider, anywhere in the system, can ask for help with this type of testing.”

Kelley continued, “You need a team to be able to do this really well, and you have to have access to that expertise. Our precision oncology system of excellence delivers that expertise to the place where it’s needed, when it’s needed.”

LINKING RESEARCH AND CLINICAL PRACTICE

The integration of research and clinical practice is another important aspect of cancer care that works to improve results for patients. “Research has been involved from the very beginning,” Kelley said. As part of standard clinical practice for many patients with cancer, it involves not only research, but also access to clinical trials or enrollment in clinical studies.

Research also contributes to the success of programs that are being implemented, such as the teleOncology service, for example. “We want [the programs] to be successful, and our research colleagues can be very helpful in designing implementation strategies, measuring the success of those strategies, and then providing feedback to us on what the effectiveness of that is,” Kelley said. “There is good alignment in terms of the big picture, what the goals are.”

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Kelley said that with the core of precision oncology consisting of doing molecular testing and then treating patients, much can be learned from the large number of patients who are being treated in the VA and their outcomes of care. In this link between research and clinical, “information from one is fed into the other, and that drives this engine of immediate application of new discoveries. You have discoveries and then you immediately are able to apply them,” he said.

FUTURE OUTLOOK

Kelley highlighted three future developments in precision oncology looking ahead five to 10 years that he believes improve patient outcomes.

First, he said, “I think this has probably been true for some time already, but what is needed to drive the learning health care system to be more efficient is better information systems. What I see is that those information systems will continue to improve, so that it allows us to be able to gather the information needed for any individual patient more quickly and accurately, and it will also allow us to learn from that data more quickly.

The VA is participating in a study doing germline genetic testing for possible inherited genetic variants on women who would be screened for breast cancer. Using risk results from that genetic testing could, within the clinical study context, impact recommended frequency or starting age of mammograms.

“Another thing I see is that the types of testing that will be available and their applications will become larger,” he continued. “For example, right now [as] we’re talking about the precision oncology program, the way it’s practiced is mostly for patients who have metastatic or advanced stage disease, but that testing is going to be applied more and more for patients with earlier stage disease. And it’s already being applied in some limited ways, but it will probably be applied more frequently, in patients who don’t have cancer at all, but who are at risk for getting cancer, which is everybody.”

For example, he explained, “For lung cancer screening, right now, we ask patients, ‘How much did you smoke, how long ago did you quit?’ and then we decide, ‘Okay, you get a CT scan, and you don’t.’ But it may be that we do a test, and say, ‘[although] you smoked a lot, this test shows that you’re not at high risk for getting cancer,’ whereas this other person is at high risk, and maybe doesn’t even have a smoking history, and so that person might get a CT scan.

“This is being applied in breast cancer,” he continued. Currently, there are recommendations that are tailored based on family history or risk, “but there’s a study that VA is participating in that is doing germline genetic testing [testing healthy cells for genetic variants that may have been inherited] on women who would be screened for breast cancer and using the result of that testing to make recommendations, within the context of a clinical study, as to how soon and how frequently they would get the testing. If you’re low risk, you might not need a mammogram every year; every other year may be more than enough. And you may start [mammograms] younger if you have a high risk for getting breast cancer, for example.”

Kelley added, “We’re talking a lot about genes and DNA sequencing, but there are other types of molecular testing, and many of those will become more prominent,” including that “the ability to measure a lot of proteins all at once is becoming easier… These types of molecular tests, I think, will start to have more and more applications in oncology.”

A third area Kelley identified “is the treatment options that we’ll be able to reach for will continue to expand. They’ve been expanding at a vicious rate the last five years. It’s amazing how many drugs have been approved, and new indications for old drugs. That is going to continue to accelerate. New types of drugs, new categories of drugs that we don’t have right now will start to become more prevalent.”

With the continued expansion of access and expertise of NPOP in mind, Kelley concluded with a message to veterans: “For cancer treatment, if you’re a veteran, I think we have the very best cancer care in the world, and it can come to you,” he said. “If you have cancer, please consider using the VA and we will extend our expertise to you wherever you are.”

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