This has been a year of firsts and seconds for Monica M. Bertagnolli, MD, FACS, FASCO. This past October, Dr. Bertagnolli became the 16th Director of the National Cancer Institute (NCI), the first woman and the first clinical trials cooperative group chair to hold that position. Then, 2 months later, on December 14, 2002, Dr. Bertgnolli became the first publicly known Director of the NCI to be diagnosed with cancer and to undergo treatment while heading the agency.
On May 15, 2023, President Joseph Biden nominated Dr. Bertagnolli to be the next Director of the National Institutes of Health (NIH). If confirmed by the Senate, she would be only the second woman to hold that position on a permanent basis.
“We must expand the clinical trials enterprise to make sure that participation is much more widespread and to execute research that addresses the needs of everyone.”— Monica M. Bertagnolli, MD, FACS, FASCO
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Prior to becoming Director of the NCI, Dr. Bertagnolli was Chief of the Division of Surgical Oncology at Dana-Farber/Brigham and Women’s Cancer Center and Professor of Surgery at Harvard Medical School in Boston. A clinician and researcher specializing in the treatment of gastrointestinal malignancies that have genetic links to colon cancer for more than 25 years, Dr. Bertagnolli has led gastrointestinal correlative science initiatives within the NCI-funded Cancer Cooperative groups, where she helped integrate tumor-specific molecular markers of treatment outcomes into nationwide clinical cancer treatment protocols. An active ASCO member since 1995, Dr. Bertagnolli became the 55th President of ASCO in 2018.
This spring, the U.S. Department of Health and Human Services released a National Cancer Plan (https://nationalcancerplan.cancer.gov/national-cancer-plan.pdf) developed by the NCI and the NIH. It is intended to provide a framework to reach President Biden’s Cancer Moonshot initiative’s goal of “ending cancer as we know it,” by reducing cancer mortality by 50% within the next 25 years. The plan includes the following eight goals:
1) Prevent cancer
2) Detect cancers early
3) Develop effective treatments
4) Eliminate inequities
5) Deliver optimal care
6) Engage every person
7) Maximize data utility
8) Optimize the workforce.
Just before the official announcement of her nomination to lead the NIH, The ASCO Post talked with Dr. Bertagnolli about the status of her breast cancer diagnosis, how the increase in the fiscal year 2023 budget will impact NCI research grants, and how the implementation of the National Cancer Plan will involve all members of society to advance progress against cancer.
Getting Through Cancer Treatment
This past December, you announced that you had been diagnosed with early-stage, hormone receptor–positive, HER2-negative breast cancer. First, how are you feeling?
I am feeling great. My treatment has gone very well. I won’t say it has been fun; it is cancer treatment, and it is not easy, but I have a fantastic team taking care of me and have received wonderful support from the oncology community. It really does help you get through tough times when you have so many people sending you good wishes.
Understanding the Cancer Experience
I have talked with many oncologists who have been diagnosed with cancer, and many say that having cancer has given them greater empathy and understanding about how cancer affects their patients. Has having cancer changed your perspective of what it means to be a patient with cancer? How might your diagnosis impact your goals at the NCI?
The diagnosis is still pretty new to me. I am still receiving treatment, so I am in the early part of my journey. Of course, when you experience a health challenge, it gives you greater appreciation for what others are going through. My diagnosis has brought into sharper focus all the things good oncologists think about—including what data do we have to decide on the best treatment, what is most effective, how difficult will the treatment be, and what are the long-term consequences and side effects—because we are all hoping that people live long and healthy lives after they have a cancer diagnosis. It certainly brings what a patient experiences, both in the short and long term, into much sharper focus when you have cancer yourself.
Increasing NCI Research Grants
The NCI has received a $386 million increase in its FY2023 budget, plus an additional $22 million for the Cancer Moonshot initiative. How will the nearly 6% increase in funding impact NCI research and paylines for R01 grants, including early-stage investigator R01 grants.
First, early-stage investigators are very much our priority; with the additional funding, we were able to increase the payline for early-stage investigators from 16% to 17%. We also have a new program as part of the Cancer Moonshot initiative called the Moonshot Scholars Program, which is supported by Cancer Moonshot funding. It provides new funding for early-stage investigators with diverse perspectives and backgrounds.
The NCI’s research project grant (RPG) recipients encompass the creativity, innovation, and inspiration of our extramural research community. The funding applications that come to the NCI represent the best ideas in cancer research, so this funding mechanism is a very high priority for the NCI. With this budget increase, we were able to raise the research project grant payline from 11% to 12%.
We still have some challenges, even with the generous budget we got from Congress this year. Raising the RPG payline did not leave a lot left over to increase funding for some key programs that NCI investigators also count on. Thus, we were glad to see additional Moonshot funding, which helped us maintain momentum for important projects.
Supporting Every Patient With Cancer
Cancer research is at a critical juncture, especially in the investigation of advanced-stage disease and for such difficult-to-treat cancers as pancreatic cancer and glioblastoma. What are some of the greatest challenges facing the NCI, and what are your priorities?
The focus is clear. Too many people are dying of cancer, and too many people experience trauma and suffering from this disease, so that is our overarching priority. There are some diseases where we have made progress, and we can be heartened by that. This progress confirms that success is possible, and it leads us to push even harder in areas where we still don’t have the answers people need.
As for the priorities, for me, they are the things that support every patient with cancer, literally every patient with cancer. Some of these overarching activities are, first, continued support for fundamental science, which brings us the new discoveries that lead to better care. Second, accelerated emphasis on collecting and sharing data, especially data from the clinical care environment, so we can deliver results that address questions about how cancer affects peoples’ lives.
“We are all working together across all levels of society to conquer this disease [cancer]. It is exhilarating and heartwarming to see us all in this fight together.”— Monica M. Bertagnolli, MD, FACS, FASCO
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And, finally, working to expand our clinical trials enterprise is a priority. We have a lot of very promising discoveries and approaches to treat cancer for which we do not have enough bandwidth to thoroughly test in clinical trials. We must expand the clinical trials enterprise to make sure that participation is much more widespread and to execute research that addresses the needs of everyone, including those communities of patients who have been traditionally left out of clinical research.
Engaging All Stakeholders to -Advance Progress in Treating Cancer
In April, the U.S. Department of Health and Human Services released the National Cancer Plan that was developed by the NIH and the NCI. The plan will require a collaborative effort among all stakeholders in the cancer community. How will the NCI coordinate these efforts? How will you implement the goals and strategies outlined in the National Cancer Plan?
The National Cancer Plan outlines eight goals describing “what success looks like.” If these goals are achieved, we will truly end cancer as we know it and dramatically reduce deaths from cancer.
The first stage of the plan was to get it out into the public domain, and it is now posted on our website (https://nationalcancerplan.cancer.gov). We are asking everyone who is interested in joining this effort to read the plan, because it is designed to be an instrument to help us engage every person and every organization needed to truly tackle this awful disease.
The NCI plays an important role as a funder, sponsor, and agency conducting research that is crucial to advancing progress in treating cancer. But others must assist if we are to accomplish all the goals in the National Cancer Plan. For example, any new discovery made in a basic science laboratory needs to be carried all the way through translational and clinical research to prove that it helps people. Once this is accomplished, we must make sure the treatment reaches the people who need it and is widely applied throughout our health system, including all segments of our society that have real challenges achieving access to the best in health care. The National Cancer Plan encompasses all of this and acknowledges that although research is interwoven through everything we do at the NCI, research alone cannot end cancer. We need the help of all sectors of society to work together to make faster progress, including other governmental agencies, the private sector, academia, health-care providers, industry, professional societies, and patient advocates.
Now, a plan is just a piece of paper unless it generates action. You asked how we are going to implement the plan. The NCI, in collaboration with the White House Office of Science and Technology Policy, will promote a wide range of events designed to engage all parties in National Cancer Plan activities. Leaders of our implementation team include members of the President’s Cancer Panel who serve as advisors to the President for the National Cancer Program. The current Chair of the President’s Cancer Panel is Elizabeth M. Jaffee, MD, Deputy Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; and she is joined by Mitchel S. Berger, MD, Director of the Brain Tumor Center and principal investigator for the SPORE Brain Tumor Program at the University of California San Francisco; and Carol L. Brown, MD, FACOG, FACS, a gynecologic cancer surgeon and Chief Health Equity Officer at Memorial Sloan Kettering Cancer Center, New York.
Together with the staff of the NCI, the members of the President’s Cancer Panel will track progress by performing annual assessments to identify both progress and areas that need more emphasis or that might need to be modified to achieve the goals outlined in the National Cancer Plan. These assessments will be published yearly, along with occasional in-depth reports for each of the eight goals. With these efforts, the National Cancer Plan can be a living document, and over time, we will use it to demonstrate progress and make required course corrections to achieve its goals.
Making Survivorship an Active Focus of Research
There are nearly 18 million cancer survivors in the United States, and that number is expected to increase to 26 million by 2040. However, many survivors face ongoing late effects and financial toxicity from cancer and its treatment, especially adult survivors of childhood cancer and adolescent and young adult survivors. How focused is the NCI on long-term survivorship, financial toxicity from the high cost of treatments, and eliminating health disparities in oncology to ensure that patients receive high-quality care?
Cancer survivors are critically important to NCI’s efforts. People surviving cancer experience a wide variety of conditions related to their cancer, each with unique needs. For example, survivors of childhood cancer may have lifelong side effects from their cancer treatment, as well as risk of recurrent cancer, including secondary malignancies.
There is a growing population of survivors who are living with metastatic disease or with primary disease that cannot be completely eliminated by treatment. Issues faced by survivors include not only physical challenges, but social, financial, and emotional challenges. Understanding these needs and developing approaches to address them are critical areas of cancer research.
To “end cancer as we know it,” means that anyone who faces a cancer diagnosis can go on to live a full and active life, free of cancer’s harmful effects. Even better would be for us to be able to prevent cancer, so people never have to experience the harm that cancer brings.
I’ll end by saying that one of the wonderful aspects of being the Director of the NCI is the community that rallies around this real challenge for our society, and being Director has been a great honor and a great pleasure. With the implementation of the Cancer Moonshot’s National Cancer Plan, we are all working together across all levels of society to conquer this disease. It is exhilarating and heartwarming to see us all in this fight together.
DISCLOSURE: Dr. Bertagnolli reported no conflicts of interest.