ASCO President Dr Daniel F. Hayes Applauds Recommendations for Cancer Moonshot

Last week, the Blue Ribbon Panel (BRP)—a committee of scientific experts, patient advocates, and representatives from the pharmaceutical industry, appointed to lead the White House’s Cancer Moonshot initiative—released a preliminary report that included important recommendations that can support faster, more precise treatments for patients diagnosed with cancer, with potential for much improved outcomes.

The American Journal of Managed Care reached out to Daniel F. Hayes, MD, FASCO, 2016-2017 president of the American Society of Clinical Oncology (ASCO), to understand his perception of how these recommendations would impact cancer care in the United States. Following is an excerpt from the interview, which can be accessed in the upcoming (October) issue of Evidence-Based Oncology.

AJMC: One of the suggestions of the BRP is to better link databases to assimilate patient information across systems, with the potential for patients being recruited to participate on trials. Since interoperability remains a significant challenge for our healthcare system, do you foresee this as a more long-term recommendation?

Hayes: Widespread interoperability for sharing electronic health information is critical for optimal cancer care. It’s incredible that we have a standardized method for streaming TV shows but not for taking care of sick patients. I’m pleased that the panel included this recommendation in the report. Frankly, this is the kind of innovation that we cannot put on the “long-term” track.

The cancer community—the entire medical community, actually—needs to put our full support behind interoperability so that it is achieved more quickly. The American public does not suffer lack of access and interoperability when it comes to other potentially sensitive information (for example, financial information). We should expect no less when it comes to the medical information needed to stay healthy and treat illness, especially a serious diagnosis like cancer. This is the kind of innovation that the Moonshot requires. ASCO is fully supportive of this transformative idea.

AJMC: How are individual clinics and smaller practices adopting interoperability?

Hayes: There are 2 issues embedded in this question: 1) the adoption of electronic health records (EHRs) and 2) interoperability among them. Individual clinics and smaller practices are having a very difficult time, especially with the first. The problem isn’t isolated to just small practices, however. Even large, internationally recognized cancer institutions may be in a situation where they’re using multiple electronic records systems that do not talk across clinics and departments—whether they are across town, in different states, or right next door to one another. This is a major concern in oncology, where we routinely work with patients going to multiple medical providers across the continuum of care, eg, radiation therapy, surgery, chemotherapy, imaging, pathology, etc. Gaining access to medical information and seamlessly integrating and analyzing it for patients across multiple providers takes more effort than it should.

Because of this, ASCO has called on Congress to address this issue directly. ASCO issued the following 4 recommendations, which should be part of the Moonshot initiative:

• Congress should enact legislation as quickly as possible to ensure widespread interoperability is achieved.
• Congress should pass legislation to remove barriers to interoperability, especially information blocking.
• Policymakers should ensure that cancer patients, oncologists, and other oncology providers do not bear the costs of achieving interoperable EHRs and of companies refraining from information blocking.
• Federal officials should work with ASCO and other stakeholders to ensure that healthcare providers have the information necessary to be prudent purchasers and users of health information technology systems.

We are pleased that the BRP included the idea of a National Cancer Data Ecosystem. ASCO is building this with CancerLinQ and working with patient organizations and our colleagues across the medical professions to integrate data.

AJMC: While pediatric cancers have received specific recommendations from the panel to improve clinical outcomes, geriatric cancers have not. Your thoughts on that?

Hayes: You raise a very important point. It is admirable that the BRP recognized unique issues facing children with cancer, which ASCO supports. We also need to put focus on older adults with cancer because oncology clinicians face tremendous challenges in meeting their cancer care needs.

Patients over 65 make up 60% of those diagnosed with cancer and 70% of cancer deaths. ASCO issued a statement in October 2015 that includes recommendations on improving the evidence base for treating older adults with cancer (Improving the Evidence Base for Treating Older Adults With Cancer, J Oncol Pract). ASCO’s Moonshot recommendations to the National Cancer Institute (NCI)'s BRP included many items from the statement, including broadening eligibility criteria to facilitate greater participation of older adults in research, conducting pragmatic trials that focus on broader patient populations, and conducting research with real-world data.

Many of the Moonshot initiative’s recommendations are likely to improve care for older patients, even if the specific recommendations are much broader. As efforts are made to implement these recommendations, however, it will be important to ensure that they consider the needs of geriatric patients.

Examples of the Panel’s recommendations that have potential to improve care for older adults:

• The network for patient engagement has the potential to increase older adults’ participation in clinical trials by matching patients based on the tumor profile to appropriate trials.
• The National Cancer Data Ecosystem for Sharing and Analysis could provide data on older adults from real-world settings, which would complement research from randomized clinical trials that often exclude older adults.
• The focus on research into symptom management is particularly relevant to older adults because this population often places great value on endpoints other than overall survival (eg, functional independence).

AJMC: As we transition toward precision healthcare, there is no dearth of diagnostic tests or molecular data on tumors. However, data interpretation seems a significant challenge. Does the report address this issue?

Hayes: Several sections of the report include provisions that would help advance our understanding of diagnostic testing and molecular profiling data:

• Network for Direct Patient Engagement—making testing accessible and enabling data sharing and participation in molecularly-driven clinical trials
• Fusion Oncoproteins in Pediatric Cancer—improve understanding of the role of oncoproteins in pediatric cancers and identify therapeutic targets
• Retrospective analysis of biospecimens from patients treated with standard of care—we may discover molecular biomarkers for response or resistance
• Generation of human tumor atlases—documenting the genetic lesions and cellular interactions that guide the development of each tumor as it evolves from a precancerous lesion to advanced cancer

Many of these recommendations build on important work that the NCI is already engaged in, such as genomic testing and investigation of molecularly-driven therapies in the adult and pediatric MATCH trials and Lung-MAP trial, biospecimen banking and analysis through the National Clinical Trials Network and the Cooperative Groups before it, the Exceptional Responders Programs, and The Cancer Genome Atlas that advanced basic science understanding of common tumors.

ASCO has, over the last 3 decades, provided evidence-based guidelines for using tumor biomarker tests to direct patient care, and we have helped establish criteria for doing so. Because we believe that “a bad tumor biomarker test is as bad as a bad drug,” we have recently supported an analysis of increasing the value of tumor biomarker tests performed by the National Academy of Medicine (formerly the Institute of Medicine).

In our recommendations to the BRP, ASCO also discussed the need to better understand molecular testing through the Coverage with Data Development mechanism, as well as leveraging clinical trials like ASCO’s TAPUR study to test whether drugs used for a molecular target in 1 cancer are effective for the same target in other cancers, and using learning healthcare systems like CancerLinQ to accumulate and analyze data on testing and associated therapies.

The question you raise also points to the importance of a strong, definitive role for the FDA in pre-market regulation of testing that is used to indicate precision therapies. In an era where we are using targeted drugs (especially drugs that may work only if the target is present), it is vital that we understand the safety and efficacy of the test that indicates whether a tumor has the target.

AJMC: Do you think we need greater emphasis on cancer prevention research?

Hayes: Yes, absolutely. We were really pleased to see the BRP included a focus on improving prevention research within its report to the NCI. The panel specifically highlighted people at higher risk for cancer because of their family history and the need to implement screening. ASCO also believes it is important to advance research related to behavioral changes and socioeconomic factors that influence population health behaviors that prevent people from doing what we know works to prevent cancer, such as energy balance and obesity prevention and treatment.

AJMC: What is your realistic estimate on the impact of the panel’s recommendations on improving cancer outcomes? Which aspect of cancer care do you expect to see the biggest strides?

Hayes: The panel’s thoughtful work makes an important contribution to the Cancer Moonshot initiative. We will be eager to see how the Cancer Moonshot Task Force and Vice President [Joe Biden] move ahead with their reports. The recommendations could significantly expedite our nation’s progress against cancer, if Congress provides the crucial additional funding to support the Cancer Moonshot initiative. ASCO is heavily engaged in the discussion as the work proceeds.

We are pleased the panel also sent recommendations to the Task Force for policy changes related to cancer research and care delivery. ASCO is working closely with the vice president’s office to advance policy and regulatory changes that will help streamline research, standardize regulatory requirements, and enable public-private partnerships to extend the Moonshot initiative. Sometimes being innovative requires finding the straight line through a process than can get lost in the endless loops of bureaucracy. We are optimistic that the Moonshot initiative will provide a shot in the arm to move our already impressive anticancer efforts forward, and we advocate for a sustained program to support the research and care delivery that is needed to maintain them.