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As the number of confirmed cases of COVID-19 continues to grow, oncologists from all over the world are working together to stay informed on the latest developments, participate in pivotal research efforts, develop potentially life-saving medications, and share personal experiences faced in practice to ultimately improve patient care.
Ruben Mesa, MD
As the number of confirmed cases of COVID-19 continues to grow, oncologists from all over the world are working together to stay informed on the latest developments, participate in pivotal research efforts, develop potentially life-saving medications, and share personal experiences faced in practice to ultimately improve patient care.
On March 12, 2020, the World Health Organization (WHO) reported more than 20,000 confirmed COVID-19 cases and almost 1000 deaths in the European Region. Because of the rapid increase in the number of cases reported outside of China over the course of just 2 weeks, the organization deemed the outbreak to be a pandemic.1 As of March 26, 2020, the Centers for Disease Control and Prevention (CDC) has reported a total of 68,440 total confirmed and presumptive cases in the United States alone, with 994 deaths.2 In fact, according to data collected by the New York Times, the United States now leads the world in confirmed cases.3
“We realize that this is an unprecedented time; it’s a rapidly evolving situation that challenges us as cancer care physicians, but also as individuals,” said Ruben Mesa, MD, director of the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, moderator of a recent webinar on the virus hosted by Physicians’ Education Resource.®
Mesa was joined by a panel of experts including Amelia A. Langston, MD, director of the Bone Marrow Stem Cell Transplant Program at Emory University; Hope S. Rugo, MD, FASCO, a breast medical oncologist, professor of medicine, and director of Breast Oncology and Clinical Trials and Education at the University of California San Francisco (UCSF)’s Comprehensive Cancer Center; and Cardinale B. Smith, MD, PhD, a chief quality officer for cancer, a thoracic oncologist, and a palliative medicine physician at the Mount Sinai Health System.
“None of us on the panel are experts in COVID-19 with regard to cancer, I don’t believe such a thing exists yet, but we’re all cancer care—focused investigators who are dealing with this [pandemic] on a daily basis and we hope to share some of the challenges that we’re facing in practice, said Mesa.
Cancer Centers Implement Screening Strategies Upon Entry
To ensure the safety of providers and patients alike, academic institutions, care centers, and clinics have put several precautionary measures in place, including the implementation of preliminary screening practices at building entry points.
For example, UT Health San Antonio MD Anderson Cancer Center has instituted active temperature and symptom screening in a single doorway entry staffed by security personnel, according to Mesa. “We’ve had the other entrances closed for limited access, and that is just part of the measures that have been put into place at our center,” he said.
At UCSF, visitors are also screened upon entering, according to Rugo. In addition to showing their ID, visitors are asked a few questions related to symptoms, contact with someone who has had a suspected or confirmed case of COVID-19, or recent travel to a high-risk area, among others. If cleared, visitors will receive a sticker for the day that goes on their nametag. Those accompanying patients are also screened, and once cleared, they are led to a waiting room which allows them to remain 6 feet apart.
Patients will go up to their appointment alone, unless they require someone to accompany them. For example, someone who recently experienced a stroke may need their wife to help them along and a very young patient should have their parent with them, said Rugo. To reduce waiting time, visitors have recently been afforded the opportunity to complete part of the screening process via text.
“Additionally, we have set up respiratory screening clinics where people who are not well can go,” said Rugo. “Healthcare providers, [donned in personal protective equipment (PPE) can screen [patients] for COVID-19 there.”
Respiratory screening clinics have been set up at 3 sites on UCSF campuses. One of the sites opened on March 10, 2020, at Parnassus Heights, and the other 2 will open at the Mount Zion and Mission Bay sites.4 The clinics will offer screening capabilities for patients with respiratory illnesses who visit the campuses to ensure they receive the appropriate care.
Smith admitted that Mount Sinai has similar visitor management policies in place, but notably, staff have also started to take temperatures as part of their screening process. “We quickly realized that patients are very concerned that we won’t let them receive their treatment if they answer ‘Yes’ to a fever or ‘Yes’ to symptoms,” said Smith. “Patients were coming upstairs who actually had fevers…because they answered ‘No’ [on the questionnaire]. That meant extra exposure to our patients and our staff; as such, we’ve added temperature screening as well.”
Addressing Severe PPE Shortages
Cancer centers across the United States and around the world are facing shortages of PPE, which is impacting the care of patients and the safety of healthcare workers. In recognition of this growing issue, the CDC recently released strategies for optimizing the supply of facemasks.5 For example, some of the contingency capacity strategies include the removal of facemasks for visitors in public areas, the implementation of extended use of facemasks, and the restriction of facemasks to use by healthcare practitioners rather than patients for source control.
“Like many other centers around the country, we have a severe shortage of PPE, both in the hospital and in our outpatient clinics,” said Langston. “As such, we have been implementing conservation strategies to try to minimize the use of PPE, such as cleaning face shields and re-wearing gowns in cohorted units where only patients who are COVID-19 positive are staying.”
Although at the moment, Mount Sinai facilities have PPE, the institution has mandated that all healthcare workers in patient care areas, both inpatient and outpatient, wear a surgical mask, according to Smith. “Currently, we’re only using N95s for procedures deemed to be high aerosolizing, such as bronchoscopies, intubations, etc,” said Smith. “However, if we’re swabbing someone for COVID-19, that is not considered a high-aerosolizing procedure and we’re told to wear surgical makes along with the face shield for those procedures.”
According to Rugo, the best way to combat the issue of limited resources is to reduce testing. “You don’t have to use PPE if you reduce testing.” Decreasing the number of patients undergoing elective surgeries could also be beneficial, she added. Another approach that is under discussion for reducing PPE as well as exposure is to treat patients with small, hormone receptor—positive breast cancers with endocrine therapy, according to Rugo. “By doing that, you can delay their surgery for 3 or 4 months, thus saving PPE.”
New testing mechanisms that do not require a separate person to perform the swab could help the situation. “If people can test themselves, that would also save a tremendous amount of PPE because that’s a big area in which it’s being used right now.” Swab-less tests as well as at-home tests are also actively being researched.
On March 21, 2020, the FDA issued the first emergency use authorization for a point-of-care diagnostic for COVID-19 to the Cepheid Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified labs and select patient care settings.6 With this test, results can be received within hours rather than days. The company plans to rapidly roll out the test on March 30, 2020. “This kind of testing uses a machine, it doesn’t require a lot of training, it has a very quick 45-minute turnaround time for results, and you don’t use a nasal swab,” said Rugo. “That’s the goal: to go past nasal swabs, which are a big issue as [they are also in very short supply.”
Embracing the Shift to Telemedicine
To quell the spread of COVID-19, and to protect healthcare practitioners and patients from infection, many hospitals and cancer centers are employing the use of telemedicine. The strategy has been recommended by the CDC and oncologists are working hard to embrace the benefits of and overcome the challenges faced with the approach.
“The use of telemedicine has vastly increased, and most of our visits have been converted to video visits, unless someone needs to come in for an intravenous infusion or examination,” said Rugo. “You can do an 8-point physical exam by telemedicine; I think this whole system is great. You can really communicate with the patient, [maintain] a really nice relationship with them, and you can document everything very nicely.”
Mesa added that his day mostly consisted of e-visits, and he found the platform to be very robust. However, patients who are not accustomed to utilizing such technology may need some extra assistance in preparing for the virtual appointment.
“It could work really well for patients with solid tumors and those who aren’t receiving active treatment,” added Langston. “However, it’s much harder [to do these virtual visits with my] patients who have active blood cancers who are receiving chemotherapy and will need blood counts and transfusions. In a sense, by doing telemedicine on those other patients, you’re protecting my patients [from exposure].”
What Does COVID-19 Mean for Clinical Trials?
Challenges associated with the COVID-19 pandemic, such as quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations for site personnel of trial subjects, have all significantly impacted clinical trials of medical products, including drugs, devices, and biological products.
In recognition of the issue, the FDA issued guidance for industry, investigators, and institutional review boards conducting clinical trials at this time.7 Bearing this information in mind, investigators have taken proactive measures to appropriately manage their trials.
“My university has been very proactive both in trying to help us navigate how to manage our trails and also to provide us with as much support and encouragement as possible,” said Rugo. “We’re committed to taking care of patients who are on clinical trials; that’s really important.”
At UCSF, clinical research coordinators have been told to work from home. Without them, the questions of what should be done with regard to updated consents, obtaining toxicity information, and getting orders signed, remained open. Now, updated consents are being done via DocuSign. Investigators are also working to ensure that patients weren’t coming in to the clinic unnecessarily; as such, they have been checking labs prior to scheduled visits to determine the best course of action, said Rugo. For patients who do not need to come in, investigators are shipping the medication to them and holding video visits instead.
“The part of new accruals is just very painful for all of us,” said Rugo. “If a trial doesn’t require tissue biopsies, mailing tissues, or special labs, blood samples that are processed in special ways and sent off, we can continue to accrue in a limited way. However, for those trials that require any of those factors, we can’t accrue right now, and I believe that’s true across the board, across different centers in the United States.”
Mesa’s research team is approaching the issue on a trial by trial basis. Based on the uniqueness of the option under investigation, the feasibility of conducting the trial, and how crucial the research is, investigators will decide whether to continue accrual or not, according to Mesa. “Without question, it certainly has been limited us to a significant degree,” he said.
Looking Ahead
Despite the challenges faced with COVID-19, the panelists were in agreement about one thing: when faced with adversity, the oncology community has really come together to learn as much as they can about the virus and put themselves on the front lines of the battle in a valiant attempt to protect their patients from infection and continue to provide them with the best care possible.
“I’m really inspired by the people I work with and how willing most of them are to get in there, pitch in, and do whatever needs to be done to solve problems that we never even dreamed we would be confronting,” said Johnson. “Not only is this situation frightening for us with respect to the care of our patients, but it’s also frightening on a personal level because we’re placing ourselves in harm’s way.”
Smith likened oncologists within the community to first responders and added that the community is really gathering around healthcare workers, lifting them up, and showing increased gratitude for all of the ongoing efforts being made. “It’s just really lovely to know that in a time of crisis, we can all come together,” she said.
Mesa echoed such sentiments, especially with regard to how those within the medical community are working together to disseminate information pertaining to the virus and advances that are being made seemingly on a daily basis in the battle against COVID-19. “By spreading our knowledge and ideas, our patients will be better served,” concluded Mesa.