by Norman E. Sharpless, MD, Director of the National Cancer Institute
At NCI, a Robust and Rapid Response to the COVID-19 Pandemic was originally published by the National Cancer Institute.
Late last week, I convened an emergency meeting of two key NCI advisory boards, the Board of Scientific Advisors and the National Cancer Advisory Board. This meeting was the first entirely virtual joint gathering of these two boards. It was held so that NCI leadership could bring board members up to date on the institute’s response to the COVID-19 pandemic, and also so that NCI could receive advice from the boards on our pandemic response plans. Watch a recording of the full meeting.
So much about this meeting was extraordinary, not the least of which are the circumstances that required it. Needless to say, we are in the midst of an extremely challenging time, one marked by significant loss of life, an unprecedented economic downturn and an unimaginable upheaval in daily life.
At NCI, we know that these problems are particularly acute for people with cancer and their families. Some patients are at higher risk of severe illness from COVID-19 because their cancer, or the treatment of that cancer, has left them weakened and more vulnerable to complications. In addition, many types of effective cancer treatments like palliative chemotherapy, surgery and radiation have been postponed or cancelled to minimize the risk of exposure to the virus, but leaving these patients at higher risk of suffering from their cancer.
I’ve talked with many of my colleagues in cancer centers across the country, and they are deeply concerned. They and their institutions are also taking whatever steps possible to adapt to the situation as best they can, knowing it won’t always be enough to meet their patients’ needs.
At NCI we’re also adapting to the situation, taking measures to help keep the nation’s cancer research enterprise operating to the fullest extent possible. During last week’s meeting, I stressed to the board members that NCI’s number one priority is, and always will be, advancing cancer research and doing what we can to reduce the burden of cancer.
But I also reminded them that NCI, as the world’s largest cancer research organization, has tremendous expertise and unique research capabilities that make our participation in the response to this pandemic a moral obligation.
Indeed, as an organization, NCI has much to offer, including:
- a long history of virology research, including work that helped lead to the discovery of HIV and the first AIDS treatments, and the development and broad-scale testing of the HPV vaccine
- a nationwide research infrastructure that includes large academic institutions with top experts, experienced clinicians and a proven track record of conducting complex clinical studies
- a huge portfolio of partnerships and collaborative relationships with government and public health institutions and private-sector companies
- the Frederick National Laboratory for Cancer Research (FNLCR), which houses advanced technologies and research resources that are of direct and immediate relevance to a viral pandemic
The board meeting largely focused on providing an overview of some of the activities specific to the pandemic NCI has embarked upon in the last four to six weeks. The sheer amount of work that’s been done, and the speed with which it’s been done, is nothing short of amazing.
Redirecting Resources and Expertise at Frederick National Lab
The FNLCR is the only Federally Funded Research and Development Center (FFRDC) dedicated to biomedical research. Located in Frederick, Maryland, FNLCR is a research powerhouse with top-notch scientists and cutting-edge technologies. As NCI Deputy Director Doug Lowy, MD, explained during last week’s board meeting, FNLCR is perfectly suited to respond to a crisis like the coronavirus pandemic. And NCI is bringing those resources to bear in response to COVID-19.
Serology Testing: Assessing the Immune Response
Researchers at FNLCR have launched an initiative focused on serology, a word that, unexpectedly, has now entered the popular lexicon. Serology is the process of measuring a person’s immune response to an infection in the form of antibodies in the blood.
The HPV Serology Laboratory at FNLCR has long played a central role in helping to develop and standardize serology tests for antibodies to cancer-causing HPV types. The lab has been temporarily repurposed to work on serology testing for the novel coronavirus, including working with the Food and Drug Administration (FDA) to validate serology tests submitted to the agency by outside scientists and companies.
Staff in the HPV Serology Laboratory also are collaborating closely with colleagues at the National Institutes of Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), and several academic medical centers, including several in regions of the country hard-hit by the virus, like New York.
Serology testing will be necessary for the country to return to some semblance of normalcy by, among other things, identifying those who have had an infection and have evidence of immunity from COVID-19. Serology testing is also being used to screen blood from those who have had and recovered from COVID-19 for the production of convalescent plasma, a potential treatment for others with serious disease.
Understanding the Genetics of COVID-19 Outcomes
NCI has also launched a series of genomics studies to try to identify genetic alterations that are associated with good and poor outcomes from COVID-19. One study will specifically focus on people with cancer.
That effort is being led by Stephen J. Chanock, MD, director of NCI’s Division of Cancer Epidemiology and Genetics — in partnership with investigators from NIAID and the National Human Genome Research Institute — and conducted largely through FNLCR. Using samples collected from people infected with the novel coronavirus, their goal is to rapidly identify genetic variants associated with an individual’s outcome to infection.
The hope is to not only better understand the biology of infection with this particular coronavirus, but also to identify potential targets for new treatments and provide insights that can possibly be used for screening purposes.
An important aspect of this effort will be to rapidly and broadly share the data from these studies with the research community.
Identifying Potential New Therapies for COVID-19
FNLCR is also home to NCI’s RAS Initiative, an effort to develop new therapies for cancers driven by mutated forms of RAS genes, particularly KRAS. Such cancers include highly deadly types like pancreatic and lung cancer, and thus efforts to create RAS-targeted therapies have been a high priority for the cancer research community.
FNLCR is now using some of the advances made via the RAS Initiative to try to identify new therapies for COVID-19. Part of that effort includes a resource, known as a screening library, that has been used successfully to identify chemical compounds that can block the activity of the mutated KRAS proteins that drive tumor growth.
That screening library is now being used to identify potential chemical compounds that can block the activity of a key enzyme, known as a protease, that the novel coronavirus relies on to make more copies of itself in infected cells.
In collaboration with the Argonne National Laboratory at the University of Chicago (another FFRDC), compounds identified in these screens that block the activity of this protease will undergo additional testing and refinement to develop them into potential therapies for COVID-19.
Adapting Cancer Clinical Trials, Launching New Trials
Not surprisingly, the COVID-19 pandemic has had a substantial impact on cancer clinical trials. I have spoken with directors and other staff from NCI-designated cancer centers and this is a serious concern.
As NCI Deputy Director Jim Doroshow, MD, reported at the board meeting, accrual to NCI-funded treatment clinical trials has dropped by half, a trend that is expected to persist. Accrual to certain trials has continued — for example, those offering life-saving therapies or those for patients who have no other options for therapy — but accrual to most other types of trials has sharply declined.
In response, NCI has worked with FDA and NCI’s clinical trials programs to implement numerous measures to limit disruptions to trials. These steps entail allowing much more flexibility in trial operations, including:
- directly shipping orally administered drugs being tested in a trial to patients or their local physicians
- allowing standard testing and assessments that would usually require in-person visits by patients to the trial site to be conducted by a patient’s local physician, who can then send the results to the trial investigators
- much greater flexibility in complying with requirements written into clinical trials for conducting follow-up tests and reporting data
These are just some of the many changes that have been made to ensure that trials can proceed and produce meaningful data.
In addition to changes to ongoing cancer trials, NCI is working with collaborators to launch clinical studies specific to patients affected by cancer and COVID-19. That includes a “compassionate use” protocol for the drug tocilizumab (Actimra) in cancer patients with COVID-19 who have severe respiratory complications thought to be caused by a hyperactive immune response known as cytokine release syndrome.
The protocol — which will make the drug available to up to 200 patients who are not able to enroll in an ongoing phase III clinical trial of the drug being run by the drug’s manufacturer, Genentech — was written in four days by NCI investigators. The eligibility criteria for the study are planned to be adjusted so that both adult and pediatric patients undergoing treatment (including stem cell transplants and immunotherapy) are included. NCI is working with Genentech to get the protocol launched as quickly as possible.
In addition, plans are being finalized for a large clinical cohort study of people with cancer who have COVID-19, involving all of NCI’s clinical trials programs (e.g., NCTN, NCORP).
This study will collect comprehensive documentation from more than 2,000 patients of all ages — such as their cancer type, the treatments they receive, and their symptoms — and follow them for an extended period to better understand the virus’s effect on people with cancer. This effort will contribute to the serology and genomics studies being conducted at FNLCR as well.
Silver Linings and Next Steps
One thing that stands out to me is that some positive developments have emerged from this otherwise terrible situation.
Among them, we have seen that telehealth is having its moment. As I said at the meeting, researchers involved in implementation science will have a unique opportunity to analyze the impact that telehealth has had on our ability to manage patient care during this pandemic and how telehealth can be most effectively used, and expanded, going forward.
I predict that those being treated for cancer are going to like having some of their care delivered by telehealth, and that many will want to continue using telehealth for some aspects of their care long after the pandemic has ended.
It’s also been inspiring to witness how quickly government health agencies can move when we really need to. New research efforts have been developed and launched with remarkable speed. Processes that can take months or longer have happened sometimes in a matter of days.
As we heard during the board meeting, NCI-designated cancer centers have also taken bold and fast action. Many have already launched clinical trials involving cancer patients with COVID-19, on their own or in collaboration with other cancer centers.
In my opinion, we have learned some important lessons that will change, for the better, how we plan and conduct research and how we care for patients.
As NCI continues our work to make progress in cancer research while also contributing to the global effort to address COVID-19, we will continue to use many communication channels to keep the community informed of our activities. That includes more information on the initiatives described here and others, and the evolving impact of this pandemic on the research community, including a high-priority group for NCI: investigators who are early in their careers.
In the meantime, please stay safe. And please continue to follow directives from public health officials on physical distancing and other measures that will help us to flatten the curve of this pandemic —and, hopefully soon, allow us to begin to emerge from it.
By Jonathan A. Haas, MD, Chairman, Department of Radiation Oncology, Perlmutter Cancer Center at NYU Winthrop Hospital
I've only been nervous only a few times as a radiation oncologist: My first day of residency at PENN, my first solo tandem and ovoids as an attending, and very few others during my 27 years in New York. I worked the day of 9/11. I managed to get back to New York with all transit shut down to open up my department after being stuck in Boston the day after Hurricane Sandy, and I’ve dealt with numerous black swan events that had the potential to destroy our department. None of those scared me like walking into NYU Winthrop this past Saturday morning, through the same entrance I had walked in through since I was an intern in 1993.
Our hospital is in the epicenter of the current COVID-19 pandemic, and our administration sent an email last week asking all physicians, including the specialists, to consider volunteering to help the intensivists, internists, surgeons, PAs, respiratory therapists and many others who had been working tirelessly for the past month. When a radiation oncologist is on the list, you know things are really bad.
I thought about not volunteering, as it had been decades since I did anything remotely resembling internal medicine, but we go into this field to help people when they need us most. It is easy to be a firefighter when there is no fire and similarly easy to be a physician when people aren't sick. The hospital knew our skillset wasn't in this field, and they told us there would be ample support, that we would never be alone. I said yes, got temporary COVID disaster privileges through the Department of Medicine, and, embarrassingly afraid, showed up at 6:45 a.m. on Saturday for my 12-hour shift. We were well prepared on PPE donning and doffing and had prep videos and handouts on O2 delivery systems and other basics of COVID 101 management. My team had a fantastic internist and a wound care PA who answered every question I had. After an hour, the long forgotten skills I thought of as lost forever were coming back.
On a nuts and bolts level, it seemed that most of the patients had the same issues, and the majority of care (at least on my non-ICU floor) was mostly algorithmic: Checking O2 sats and reacting accordingly, checking the COVID panel with inflammatory markers and D-dimers and reacting accordingly. One area in which we as rad oncs do have as a unique skill set is speaking to scared patients given a new, potentially fatal diagnosis ― in this case, COVID-19. We do that every single day in our clinic with the myriad cancers we treat, explaining in lay terms what is going on to try to calm scared patients. We rounded on the patients, but with only one person going into the room with proper PPE ― for obvious reasons. I waited for morning labs to come back exactly as I had done as an intern in 1993, wrote my note in EPIC, called family members (this is super important because, unlike during normal times, the family is not allowed in the hospital to see their loved one) and checked O2 sats several times per day, as this is where patients seem to run into most trouble.
Halfway through the day, at least 50 cars drove through the circular front entrance of the hospital, many with balloons on the car, loudly honking their horns and thanking everyone on the frontlines working that day. What struck me most, though, was the camaraderie everyone had in the hospital. There were no "specialists," just a group of dedicated health professionals working in a dangerous place to help the people in our community. Everyone answered every question I had, and never once did I feel out of place taking care of these sick patients.
When the shift was over, I carefully changed out of my scrubs in the hospital, placed them and the sneakers I wore in a plastic bag, drove home and immediately showered. This also was information that I had been well prepped on.
While this has been a devastating experience for both our patient community in New York and our health care system, I have never been more proud to be a medical doctor (note that I didn't say radiation oncologist) and will be forever changed in the most positive way going forward. If you have the opportunity to help your colleagues on the floor and go back to your roots as if you just finished medical school, please take it. You are helping your community, you are helping your colleagues, and you will be helping yourself. For those who take this on, I am happy to speak to you about what was given to me to prepare by our surgical and medical services.
By ASTRO Journals Team
This month celebrates Deaf History Month, a commemorative time to celebrate deaf history as well as contributions made by the deaf community to American culture and society. We recently sat down with Colin Hill, MD, to discuss his recent publication, “Assessing and providing culturally competent care in radiation oncology for deaf cancer patients,” in the ASTRO Journal Advances in Radiation Oncology. Dr. Hill is one of a few deaf physicians in the United States and is currently completing his residency in radiation oncology at Johns Hopkins. He is a third-generation deaf member of his family and identifies as culturally Deaf, capitalized to reflect that he identifies with the culture and that deafness is not merely a disability.
As Dr. Hill explains in his paper, among people with hearing loss in the United States, there is a distinct linguistic and cultural minority of patients who identify as culturally Deaf and use American Sign Language (ASL), but these patients have not been well studied. Dr. Hill and the research team set out to better understand the needs and challenges deaf patients experience when receiving oncological treatment and performed a review of the literature using the PubMed database to descriptively characterize any existing treatment disparities in this population. Dr. Hill and his team used systematic analysis to identify three universal barriers to care:
- Poor health literacy among deaf adults.
- Accessibility to tailored health care resources for cancer-specific information.
- Poor linguistic and cultural competency among physicians, as physicians and other providers are limited by the lack of educational opportunities or practice guidelines that address how to provide culturally and linguistic sensitive oncological care.
To learn more, we reached out to Dr. Hill to answer a few questions.
Looking at the bigger picture, how could your findings impact patient care? What do you see as the key practice-changing implications of the research?
Colin Hill, MD (CH): We hope this is practice changing by, first, promoting awareness among medical providers about this patient population, emphasizing that they have unique linguistic and cultural needs that have been poorly addressed to date. Second, we hope to eventually promote change on a specialty and national level by developing a standardized care model to guide radiation oncologists and other providers in how to create total communication accessibility within a culturally sensitive framework when treating deaf patients.
Did anything about your findings surprise you?
CH: Shockingly, in a focus group interview, a deaf woman with breast cancer admitted, when asked, she still did not know what cancer was despite being a survivor! It is tragic that such reports of communication failures still exist. Even if a patient is limited by poor health literacy, we need to make every effort to ensure that we create the kind of communication accessibly to prevent such things from happening with our own patients.
How can organizations such as the NAD improve access for deaf patients?
CH: The National Association of the Deaf (NAD) has worked to improve care for deaf patients by improving accessibility for interpreting services, mental health, and creating legal precedents to set standards of care. However, their voice remains small and has not been heard by many in the medical community. The question, in my mind, should rather be what can we do to help organizations like the NAD continue to advance health care for deaf patients and magnify their voice to even further corners of the medical community. Specialty societies should be at the forefront of this conversation. For example, my co-authors, Drs. Curtiland Deville and Brandi Page, are members of ASTRO’s Committee on Health Equity, Diversity and Inclusion (CHEDI), which is poised to lead and collaborate on such initiatives given their mission to advance the status of minorities and the underserved in oncology through educational and professional opportunities, advocacy and awareness.
Should language services for deaf patients be a standard of care for deaf patients?
CH: The Americans with Disabilities Act (ADA) states health care systems and providers are required to ensure effective communication with patients through reasonable accommodations, but this wording is very ambiguous since it remains unclear what that actually means. Several articles highlighted the fact that many physicians often resort to inadequate modes of communication with their patients, such as lip-reading to communicate. Moreover, if interpreting services are provided, the quality of interpretation can be very variable, and it is difficult for providers without any ASL fluency to assess the quality of interpretation. In our opinion, communication accessibility should be viewed as a right. As providers, we need to ensure we understand what communication accessibility actually means for a deaf patient, and how we can create that.
How do you propose we reach patients that have low health literacy?
CH: This is a challenging question, and the reason for the literacy level of a patient is often complex and multifactorial. However, a study showed that even in deaf patients with post-secondary education the literacy levels were lower than expected. This raises the question on how much of this is due to the lack of accessible health care resources for information. For example, many informational videos online often lack captions and would not be accessible to the deaf patient [RTanswers.org proudly provides closed captions for all patient videos]. Creating resources that are inclusive of deaf patients may be one solution.
In your study, you mention that a couple medical schools have implemented programs. What is the role of the residency programs, medical schools and the ACGME? What would be your recommendations for short term actions that could be implemented quickly to help bridge the gap?
CH: Recognizing that culturally Deaf patients are also an underrepresented minority, rather than just a group of patients with a disability, may help spearhead efforts to recruit and train practitioners dedicated to serving this population. The creation of specialized training tracks in areas with a large deaf population could provide opportunities for further training. Promoting the development of educational initiatives that foster linguistic and cultural competency for deaf patients or similar groups could become a goal for the ACGME. Fortunately, our residency program recently presented a related topic at ASTRO, entitled “Establishing an American Sign Language (ASL) Inclusive Residency Training Program” as a starting guide for other residency programs that may be interested in creating inclusive programs.
What would you recommend for a health care practitioner reading this study as the next steps they can personally take to provide care for their deaf patients?
CH: We encourage practitioners to work on creating the ability to provide for ASL interpretation for all clinical encounters. When possible, in-person interpreting encounters should be favored over video remote interpretation. For those located in an area with close proximity to a large deaf community, directly engaging the community for advice on how to improve the quality of interpretation and general guidelines about accessibility may be very beneficial. Furthermore, hospitals often have a Patient and Family Advisory Council (PFAC) that can help provide such community advice for a hospital.
What are your next steps? Will you be pursuing further study?
CH: We are currently working on performing retrospective analysis to characterize the treatment outcomes for deaf patients with cancer compared to the general population. We also hope to eventually develop guidelines that help providers provide linguistic and culturally sensitive care to deaf patients.
More on commemorating Deaf History Month: March 13- April 15
Deaf History Month celebrates deaf history and, in particular, contributions made by the deaf community to American culture and society. Deaf History Month recognizes three major events for the deaf community:
- April 15, 1817, on which established the American School for the Deaf in Hartford, Connecticut, the first permanent school for persons who are deaf in the United States.
- April 8, 1864, when President Abraham Lincoln signed the charter for Gallaudet University in Washington, DC, the only university in the world designed to accommodate students who are deaf and hard of hearing.
- March 13, 1988, the date of the Deaf President Now (DPN) protest at Gallaudet University, which led to the appointment of the first ever deaf president of the university.
By Matt Spraker, MD, PhD, @SprakerMDPhD
Patient Safety Awareness Week, an annual celebration of patient safety and quality improvement initiatives, took place this year on March 8-14. Even in the midst of the COVID-19 global outbreak, radiation oncology professionals took to social media (#PSAW20) to highlight their dedication to delivering safe and high-quality radiation therapy to their patients. Some took a more traditional approach and highlighted their important contributions to patient safety. Dr. Tom Boike (@TomBoike) shared that he was out on an APEx accreditation survey, and Dr. Louis Potters (@DrPotters) showed a new chapter of Dr. Leonard Gunderson’s textbook focused on patient safety and quality improvement. Others decided to push the envelope with the latest trends. Quality and safety expert radiation oncologist Dr. Sue Evans (@SueEvansMDMPH) shared our field’s first TikTok video that showcases Yale’s patient safety efforts while rocking out to the internet’s most famous safety song “I Wanna be Safe” by Derek Wilson.
One of the most discussed topics was RO-ILS: Radiation Oncology Incident Learning System®. This multi-center database stores data about unsafe conditions and patient safety incidents in radiation oncology with a patient safety organization to facilitate shared learning and quality improvement in a secure, non-punitive environment. The program has been sponsored by ASTRO and the AAPM as well as supported by numerous industry partners and sister societies. During #PSAW20, ASTRO (@ASTRO_org) shared RO-ILS in Review, which documents the first five years of experience of the program. RO-ILS has over 500 enrolled facilities from almost every state and has collected reports on over 12,000 safety events and the program continues to grow. Oregon Health & Science University (@OHSURadMed) shared that they were implementing RO-ILS just in time for the #PSAW20 celebration! ASTRO also released an APEx in Review report, highlighting the reduction made to the accreditation timeline as a result of programmatic improvements and evidence indicators with low compliance — areas for improvement by our community!
Many #PSAW20 posts highlighted specific strategies that departments have used to improve patient safety. Dr. Evans highlighted a RO-ILS program document on implementing a “Great Catch Program,” which can be used to improve departmental safety culture and support incident reporting. Dr. Eric Ford (@EricFor85220573) shared the “Great Catch” pin, which is awarded to professionals in the Great Catch Program at the University of Washington. Dr. Ann Raldow (@AnnRaldow_MD) shared a video about a collaboration between UCLA, UCSF (@UCSFCancer), and the Richmond VA that uses computer automation to reduce the risk of therapeutic radiation incidents. She also shared another #UCLARadOnc video that discusses 100% prospective peer review for SRS and SBRT treatments. Dr. Elizabeth Covington (@elizapowerpuff) shared two videos on her work with colleagues at University of Alabama regarding a script to reduce shift errors and an open source solution for complying with TG-263 structured naming.
Toward the end of the week, the #PSAW20 discussions urgently shifted focus toward keeping patients and radiation oncology professionals safe during the COVID19 pandemic. On March 14-15, Radiation Nation (@Rad_Nation), led by Drs. Matthew Katz (@subatomicdoc) and Richard Simcock (@BreastDocUK), hosted an urgent radiation oncology journal club on Twitter which drew 121 contributors from around the globe. The discussion focused on four key domains (listed below) and was summarized in a blog post by Dr. Simcock and led to rapid publication of a paper.
Four key domains of the journal club discussion:
- How do we deliver treatments with reduced workforce?
- Are there ways of working remotely that can still utilize an isolated workforce?
- Do we move to more simple plans and/or hypofractionate?
- What barriers exist to making these changes urgently?
- What risks to our patients can we mitigate?
- Should we change/stop/delay certain treatments?
- How do we treat a confirmed #COVID case with #radonc?
The international community of radiation oncologists have demonstrated their exceptional commitment to patient safety with their response to the COVID-19 pandemic. Drs. Ramesh Rengan and Ford and their team published a webinar and an editorial with recommendations for clinical management based on early experiences in Seattle. Authors from Italy, Switzerland and China (Wuhan), among others, have shared their lessons learned on how best to keep our patients and ourselves safe in these unprecedented times. Links to these articles and more have been cataloged and shared by ASTRO. ASTRO also released FAQs, clinical and coding guidance and is actively advocating on behalf of the community. As new information emerges, ASTRO continues to collate and develop resources to support our field.
While #PSAW20 occurred in the midst of significant challenges facing our field, radiation oncologists have delivered an inspiring response to help each other keep everybody safe. When clinical operations return to normal, I hope that we can apply all we have learned to continue to optimize patient safety and quality improvement for all of our patients across the world.