FDA Grants Pembrolizumab Priority Review for TMB-High Tumors
April 07, 2020 04:24pm
By Lisa Astor
In an interview with Targeted Oncology, Kashyap Patel, MD, discussed the COVID-19 pandemic and the implementation of new precautions in his practice as the number of COVID-19 infected persons rises in the state.
Kashyap Patel, MD
In South Carolina (SC), the coronavirus disease 2019 (COVID-19) has thus far infected 195 people1and has led to 3 deaths.2The spread of the virus has impacted practices across the country, and Carolina Blood and Cancer Care Associates located in Rock Hill and Lancaster, has made adjustments to ensure the safety of their patients and staff while COVID-19 remains an issue.
“Right now, we are taking it day by day. Our top priority is to take care of patients with established nodes,” said Kashyap Patel, MD.
On March 13, Governor Henry McMaster declared a State of Emergency which impacted business and governmental operations in all 46 counties.2The county of Lancaster was of top concern in the governor’s public address.3On March 22, another 2 Lancaster County cases were reported4by the SC Department of Health and Environmental Control, bringing the total number to 5.5In preparation of further action in Lancaster County, Carolina Blood and Cancer Care Associates closed the Lancaster office for all but one day each week.
In Rock Hill, SC, Carolina Blood and Cancer Care Associates continues operations with significant changes including the implementation of telehealth, postponing treatment for patients with less aggressive cases, and applying a new triage system as another safety measure.
In an interview withTargeted Oncology, Patel, CEO and leading oncologist of Carolina Blood and Cancer Care Associates, and vice president of the Community Oncology Alliance, discussed the COVID-19 pandemic and the implementation of new precautions in his practice as the number of COVID-19 infected persons rises in the state.
TARGETED ONCOLOGY: What has been the overall impact of COVID-19 on the oncology community?
Patel: The impact has been quite variable depending on the location that you are in. Colleagues who are located in Seattle are actually experiencing a serious staff shortage. Many other practices are experiencing stock shortages, patients are afraid to come to the clinic, and the amount of stress put on the practices [is concerning].
TARGETED ONCOLOGY: What changes have been implemented at you center?
Patel: First of all, we're having staff meetings about twice per week during which we go over Center for Disease Control and Prevention guidelines and educating our employees. We've started triaging patients for their temperature as soon as they come in the office. If their temperature is more than 100.4, we usually ask them to either go to the hospital. But for stable patients, we see them for their appointment.
The second thing we've done is for the patients who come for routine follow-up, for example, [for patients receiving] anastrozole (Arimidex) or letrozole (Femara) who are not at high risk of any complications, we've started using telehealth. For each patient on the schedule, the front office triages them and then the physician talks to each patient about what schedule they take. We ask them how they are doing and depending on the necessity of them coming in the clinic for intervention, we may ask them to come in. If not, we continue to do telehealth, which includes making necessary recommendations, calling in prescriptions, or coercing them to go to the hospital if need be. So, for about two-thirds of our patients, we're doing telehealth, and for about one-third, we are seeing them in person.
We also starting screening patients' need for treatment. For some patients who need treatment right away, we don't wait, but for those patients whose treatment can wait for a month or 2, we are trying to hold off because we do not want to expose them to the possibility of getting infected. We are taking every precaution.
We have implemented staff security as well. As you know, masks are in short supply. We've acquired some masks from the conception companies that can be put on the nose. Employees are instructed to take their temperature at home before coming into the clinic. If they have any COVID-19 symptoms, we request that they quarantine themselves for 2 weeks.
Our operations have been limited to 1 office, and our hours have also been limited. At the same time, we are continuing to provide full salary to our employees. As of today, we are continuing full force in our support of our patients and employees.
TARGETED ONCOLOGY: Governor McMaster declared a state of emergency in SC and shut down some operations in Lancaster County where 1 of your offices is. How has this impacted your ability to treat patients and how are you handling the issue?
Patel: We knew that this was coming, and we prepared. We asked all the patients in our Lancaster office to come to the Rock Hill office, if necessary. The Lancaster office will be kept open 1 day a week, and because we are a medical facility, I'm sure the government will allow us to keep operating. Otherwise, patients are instructed to come to Rock Hill on all other days or use our telehealth service.
TARGETED ONCOLOGY: For patients that have been referred by your practice to larger research centers, how is their treatment changing as the pandemic evolves?
Patel:Clinical trials will be off the table right now because patients cannot travel into the state, and if they are exposed to coronavirus, their treatment could be impacted. It is also difficult to continue clinical trials if patients are traveling more than 40 minutes away from home. They may not be able to make it back for follow-up care, considering travel restrictions and curfew. Those larger institutions are facing staff shortages as well. Right now, we are taking it day by day. Our top priority is to take care of patients with established nodes.
TARGETED ONCOLOGY: How are you promoting disease prevention to patients and staff during this time?
Patel: A lot of display boards have been placed in the waiting area of the clinic and exam rooms. Another thing is, when I come in contact with patients, I tell them to practice social distancing and frequently wash their hands. If you look at the way the coronavirus family of disease spread, it is the fomites and droplets from infected people. When our bodies touch the hands of those people or a surface, and we touch our face, from there we can contract the disease. Our nostrils are the most susceptible site. Although there is not much research around this, exposure to the sun may help because the virus cannot survive in 32 degrees Celsius or higher.
TARGETED ONCOLOGY: What advice can you give to other community practice at this time?
Patel: The practices should concentrate their resources instead of operating in multiple locations; they should bring all the patients to 1 location, if possible.
TARGETED ONCOLOGY: What advice do you have for regulatory and governmental bodies as they continue to manage this crisis?
Patel: This is 1 time where I think that the FDA should look into prior data because they traditionally go for phase II and III trials, but that takes a long time. In situations like this, other countries have certain drugs to try and treat the disease. Try to compile those data.
Also, in the 21st Century Cures Act there is a provision about using the disease registry, whether it is retrospective or prospective. That would help the FDA make a concurrent decision instead of waiting for a long trial to complete. This is a recommendation I have for society as a whole, it is time to take a different approach to evaluate drugs and getting them on the market. For coronavirus, drugs like hydroxychloroquine (Plaquenil) is already approved for the use in Malaria and if FDA can establish and/or examine the disease/drug registry for COVID-19 patients treated overseas with hydroxychlorouin, a decision can be made quickly for it's application in the COVID-19 treatment in the United States.