1. Eastman, Peggy

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The National Cancer Institute (NCI) has released its annual plan and budget proposal for fiscal year (FY) 2021, which will mark the landmark 50th anniversary of the National Cancer Act of 1971. The U.S. investment in cancer research sparked by that act has paid off in extraordinary progress, according to NCI Acting Director Douglas R. Lowy, MD.

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The NCI was established by the National Cancer Act of 1937, signed into law by President Franklin D. Roosevelt. The National Cancer Act of 1971, signed into law by President Richard M. Nixon, broadened NCI's scope and responsibilities and created the National Cancer Program, which is coordinated by NCI. NCI receives its budget from the U.S. Congress through appropriations to the U.S. Department of Health and Human Services and the National Institutes of Health (NIH).


Fifty years on, Lowy stressed that the nation must sustain its strong commitment to cancer research, because despite remarkable progress "cancer remains a formidable problem, and too many patients with cancer still face a grim prognosis." And the new NCI plan for 2021 decries the fact that "all people do not benefit equally from research advances." These disparities include certain racial and ethnic groups and rural populations. As an example, the age-adjusted death rate from all cancers has been falling, and in 2017 (the most recent year of available statistics) the age-adjusted rate of death from cancer was 2.1 percent lower than it was in 2016. But the mortality rate among blacks was 15 percent higher than among whites from 2012 through 2016.

Douglas R. Lowy, MD.... - Click to enlarge in new windowDouglas R. Lowy, MD. Douglas R. Lowy, MD

NCI is requesting $6.928 billion from Congress for FY 2021, an increase of $989 million. This requested allocation includes $195 million for Cancer Moonshot funding, which was authorized in the 21st Century Cures Act (Cancer Moonshot funding ends in FY 2023), and $50 million for the Childhood Cancer Data Initiative.


Upsurge in Research Needs

In recent years, "an unprecedented enthusiasm has permeated the research community," said Lowy in his introduction to the new NCI plan and budget proposal. "We are buoyed by the explosion of new research ideas, as evidenced by a 50 percent increase in grant applications to NCI over the past 5 years and the extraordinary number of new cancer drug approvals, which offer more options and hope to patients."


However, he issued a strong word of warning: "...if our budgets are unable to meet the pace of this growing interest and enthusiasm, we will be confronted with a serious challenge. If discouraged researchers leave the field, we will squander the tremendous momentum and innovation alive in the research community today. There can be no pause button for cancer research." As evidence of the enthusiasm cited by Lowy, while RO1 grant applications in cancer research grew by 50 percent from FY 2013 to FY 2018, applications to the rest of the NIH grew by less than 5 percent over the same time period.


Included in the "NCI Annual Plan & Budget Proposal for Fiscal Year 2021" is a substantial increase for RO1 research project grants, a key mechanism by which NCI supports investigator-initiated research. The new budget plan notes that "the increase in high-quality research applications has far outpaced the NCI budget and our ability to fund them at an acceptable success rate." In fact, the FY 2018 NCI success rate was 12 percent, as compared to 22 percent for the rest of the NIH. NCI maintains that the budget proposal for FY 2021 would give the institute "the flexibility to begin improving the payline for RO1 grants from the current 8th percentile to the 15th."


Even though strong Congressional support led to a nearly 20 percent increase in NCI's budget (in current dollars) from FY 2013 to FY 2018, the new NCI plan notes that even this increase was not enough to keep pace with the rise in scientific progress, and research projects deemed "highly meritorious" went unfunded. Its new plan and budget proposal states that "early-stage investigators will continue to be a high priority." In that regard, Lowy said, "Our investments must not only support cutting-edge research, but also strengthen the infrastructure that enables innovation and trains a diverse and talented workforce for the important work ahead."


He noted cancer researchers of today must address a number of unanswered questions, including: Why do many cancers initially respond to treatment and later become resistant? How can serious long-term side effects be reduced for survivors of childhood and adult cancers? How can high-quality cancer care be made available to all who need it?


Areas of Research Focus

NCI's Annual Plan & Budget Proposal for Fiscal Year 2021, which presents case histories of real cancer patients, focuses on three emerging areas of science:


1. the immune system and microbiome, tapping the potential of the innate immune system, and investigating how microbiomes shape the immune system and cancer development, progression and response to treatment;


2. artificial intelligence (AI), accelerating cancer research, and improving cancer care by leveraging the power of big data and advancements in computing technologies; and


3. implementation science-finding the best ways to integrate proven, effective cancer interventions into routine health settings so that all patients receive high-quality care.



As an example of a potential AI application for widespread use, the new NCI plan cites the detection and prevention of cervical cancer. Led by Mark Schiffman, MD, MPH, NCI's intramural program, collaborators developed a computer algorithm that analyzes images of a woman's cervix and accurately identifies precancerous changes and cancers. Schiffman, a senior investigator in NCI's Division of Cancer Epidemiology and Genetics, noted that cervical cancer has a uniform etiology and pathogenesis worldwide; HPV is the cause. Looking to the future, the new NCI plan notes that with this AI algorithm, "Effective point-of-care cervical cancer screening might become achievable worldwide using contemporary digital cameras."


The new NCI plan states that overall, "integration of AI technology in cancer care could improve the accuracy and speed of diagnosis, aid clinical decision-making, and lead to better health outcomes." For these reasons, AI has a chance to "play an important role in reducing health disparities, particularly in low-resource settings."

Mark Schiffman, MD, ... - Click to enlarge in new windowMark Schiffman, MD, MPH. Mark Schiffman, MD, MPH

NCI plans to invest in AI as well as in research on the immune system and integrating effective cancer interventions into routine health settings. The institute's vision, as stated in this new plan, is that "more cancers will be prevented because a person's cancer risk will be known and reduced effectively."


NCI's new plan and budget proposal states that the strong U.S. investment in cancer research since 1971 has led to new paradigms "that were once unimaginable." These include the following:


* therapies that unleash the power of a person's immune system to attack his or her cancer;


* agents that target previously "undruggable" proteins driving cancer development and growth;


* noninvasive molecular tests to detect precancers and early cancers; and


* vaccines to prevent cancers not associated with infection.



The American Association for Cancer Research (AACR) has continually stressed the importance of robust, sustained, and predictable annual funding increases for the NCI and the NIH, along with the FDA and the CDC.


ASCO has also long advocated for strong, sustained federal funding for cancer research. As previously reported in Oncology Times, ASCO's publication "Clinical Cancer Advances 2018" named adoptive cell immunotherapy the ASCO 2018 advance of the year. Then-ASCO President Bruce E. Johnson, MD, FASCO, noted that the first clinical trial of CAR T-cell therapy in children with acute lymphoblastic leukemia was funded in part by grants from NCI. In addition, researchers at NCI's Center for Cancer Research were the first to report on possible CAR T-cell therapy for multiple myeloma.


"These discoveries follow decades of prior research on immunology and cancer biology, much of which was supported by federal dollars," wrote Johnson, Chief Clinical Research Officer and Institute Physician at the Dana-Farber Cancer Institute and Brigham and Women's Hospital, in his introduction to "Clinical Cancer Advances 2018." In fact, Johnson noted that many of the top advances included in that publication were made possible by funding from NCI and NIH.

Bruce E. Johnson, MD... - Click to enlarge in new windowBruce E. Johnson, MD, FASCO. Bruce E. Johnson, MD, FASCO

CAR T-cell therapy is an example of a bench-to-bedside success story. Current ASCO President Howard A. "Skip" Burris III, MD, FACP, recently issued a statement applauding the Centers for Medicare and Medicaid Services for releasing a national coverage determination on CAR T-cell therapy that provides increased access to this cutting-edge therapy nationwide for Medicare beneficiaries. The coverage decision is largely consistent with ASCO's principles for CAR T-cell therapy coverage, which support coverage for all FDA-approved indications of this treatment, said Burris, President of Clinical Operations and Chief Medical Officer for Sarah Cannon, the Cancer Institute of HCA Healthcare, and an Associate of Tennessee Oncology PLLC.


In releasing NCI's new plan and budget proposal, Lowy emphasized the evolving nature of cancer research. "Today's investments lay the foundation for tomorrow's breakthroughs, just as today's advances were built on earlier discoveries made since the National Cancer Act was signed into law. We must intensify our pursuit of better outcomes for patients and their loved ones. We owe them nothing less."

Howard A. Burris III... - Click to enlarge in new windowHoward A. Burris III, MD, FACP. Howard A. Burris III, MD, FACP

Peggy Eastman is a contributing writer.