Weekly Updates on Coronavirus (COVID-19) from Lung Cancer Groups

We are at a critical moment in the ongoing COVID-19 pandemic. New cases are rapidly escalating throughout the country, and we are positioned to see explosive growth as people travel and gather to celebrate the Thanksgiving holiday with loved ones. While our understanding of how to treat COVID-19 has grown significantly since the disease first burst onto the scene, deaths continue to mount, with the US now seeing the most daily deaths since May.

The realities of the current situation are compounded by our collective national fatigue and desire to return to some sense of normalcy. When we look at website hits for these joint statements over time, we see a lot of activity in the spring when COVID-19 was “new,” but those numbers have dropped off substantially through the summer and fall. This stands in stark contrast to the growth of cases through subsequent waves of infection.

The take-home message is that we must not let our guard down! Please continue to wear a mask, watch your distance and wash your hands. Our collective actions over the next few weeks CAN make a difference in helping curb the recent surge. We also recognize the importance of balance, particularly for patients with cancer who fear they may not have another Thanksgiving or Christmas. For practical guidance on how to navigate your holidays safely, please refer to this helpful discussion.

Despite the current situation, there is reason for hope. We can now see the light at the end of the tunnel with the recent announcements that both Moderna and Pfizer/BioNTech have developed highly effective COVID-19 vaccines, with others in the pipeline. You can find a comprehensive overview of how vaccine trials work and current vaccine efforts underway here.

Additionally, monoclonal antibody therapies continue to make progress. Eli Lilly recently received Emergency Use Authorization from the FDA for its antibody therapy in recently diagnosed, high-risk patients. Regeneron also received a lot of press when its antibody therapy was used to treat President Trump.

VACCINE FAQS

The development of a new class of mRNA-based vaccines has raised many questions, particularly among the lung cancer community. We have been collecting these questions and will do our best to address them here.

1. How do mRNA vaccines work?

Messenger RNA (mRNA) is the recipe for making a protein. The mRNA gets injected into the body and is taken up by cells that “read the recipe” for making the SARS-CoV-2 spike protein. This is the protein normally expressed as a “crown” on the virus particle and is the part of the virus that binds to the receptor found on cells in the lungs and in other tissues throughout the body. Once these cells take up the mRNA and make the spike protein, they can display pieces of spike on their cell surface to signal the immune cells to become activated. B cells are a type of immune cells that make antibodies that can block virus binding. CD4 T cells support B cells to make antibodies while CD8 T cells can kill virus-infected cells. This is illustrated in the figure below for Moderna’s vaccine (though Pfizer/BioNTech’s vaccine works in the same manner).

2. How do we know these vaccines are safe?

All new drugs and vaccines go through extensive testing as part of the clinical trials process (summarized in the NYTimes link above). Both the Moderna and Pfizer/BioNTech vaccines are currently in Phase 3 clinical trials, reporting nearly 95% efficacy and no significant safety issues. It is important to note that these trials have been conducted in thousands of patients. However, "no significant safety issues" does not mean the vaccines don’t come with some unpleasant side effects, which are short-lived. Those effects should not be a reason to avoid the vaccine. Educating healthcare providers on the mRNA technology and ensuring them that the vaccines are safe will be key to a successful rollout.

3. When will the vaccines be available? Will patients with lung cancer be prioritized?

Based on the safety and efficacy profiles of both vaccines, it is expected that people will start receiving them before the end of the year, perhaps as soon as December 12 in the US. Many national experts are developing guidance for vaccine distribution, with the National Academies issuing a framework that would see healthcare workers, frontline workers, and those in high-risk categories being eligible to be vaccinated first. Given that several studies have now reported high mortality rates in patients with lung cancer who contract COVID-19, it is widely expected that lung cancer patients would be among those first eligible to receive the vaccine in the early stages of rollout.

4. Should I take the first vaccine available or wait for a later-generation one?

As stated earlier, both the Moderna and Pfizer/BioNTech vaccines are highly effective with a strong safety profile. There have been fears among many that the rush to produce a vaccine would result in compromised safety or efficacy, but adherence to standards established by the FDA and other agencies assures us that these vaccines are safe.

It is important to note that before mRNA vaccines were developed in the fight against COVID-19, they were being developed to help combat cancer. Both Moderna and BioNTech (the company that partnered with Pfizer on its COVID-19 vaccine) have been developing mRNA vaccine technology for some time in the hopes of using this approach to treat various forms of cancer as well as other infectious diseases.

Given the unique threat that COVID-19 presents to the lung cancer community, we strongly encourage you to have a discussion with your doctor about getting the vaccine as soon as it is available to you. As for choosing between these two specific vaccines, the technology is essentially identical. Both require two shots over the course of a few weeks. The differences come down to logistical challenges of ensuring facilities have proper freezers for maintaining the vaccines at the appropriate subzero temperatures.

Other vaccine candidates are in development that use different technology platforms. It remains possible that some future vaccines may require only a single dose (such as Janssen’s vaccine) or be administered differently (intranasal vs injection).

Until those vaccines gain approval, the current decision will be based on availability of the two mRNA-based vaccines.

It is worth noting that a multi-institutional, NCI-funded grant has been awarded to study antibody responses to SARS-CoV-2 infection in lung cancer patients as compared to healthy people. This effort will try to answer why lung cancer patients seem to have worse outcomes from COVID-19 and will study responses in patients receiving a vaccine compared to those who do not.

UNANSWERED QUESTIONS

Several questions remain about the new mRNA vaccines:

• Can these vaccines completely prevent infection, or will they just prevent symptoms from developing?
• Can people who receive the vaccine still transmit the virus to others?
• How long will any resulting immunity last? Previous results from these types of vaccines in other settings suggest that protection may wane after a year.

More data is needed before we can answer these questions.

FINAL TAKEAWAY

There is no escaping the seriousness of our current national crisis – COVID-19 cases are increasing everywhere and so we must do what we can to protect ourselves and our loved ones a little while longer.

However, hope is on the horizon. We can face 2021 knowing that, through the power of science, this pandemic will eventually come to an end.

HAPPY HOLIDAYS AND PLEASE STAY SAFE!

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers

The daily news reports are a stark reminder that the COVID-19 pandemic is far from over. Consistent with experts’ fears for the fall, new cases are on the rise across the US and in Europe.

Caught in the grips of this unprecedented public health crisis for almost all of 2020, Americans are growing fatigued and restless. The lockdowns in the spring and the extended period of social distancing needed to keep the virus at bay are negatively impacting people’s mental health. For many, it is the lack of touch, a simple hug, that we miss the most.

And this is the time of year when we start looking to Thanksgiving to reunite with family and loved ones, a time often celebrated with large gatherings, extended celebrations and warm embraces. But, at a time when cases are once again surging across the country, each of these activities presents a serious risk for virus transmission. This risk comes at even greater cost for the lung cancer community given the increased likelihood of severe disease and heightened mortality for lung cancer patients who contract COVID-19.

Recently, several health experts have weighed in on how best to approach the holiday to ensure maximal safety. Dr. Anthony Fauci, the nation’s leading infectious disease expert, has suggested Americans need to strongly weigh the risk-benefit of having Thanksgiving gatherings. In places or states with a high number of new cases, some experts even advise canceling (or at least postponing) this year’s celebration. You can check each state’s COVID-19 new case activity here.

While we all feel the need to be close to our loved ones at this time of year especially, we want to urge all of you to do your homework and take appropriate precautions to protect yourselves and those around you. You can use a risk calculator to decide the level of risk. To assist with your planning, the CDC also provides a list of Thanksgiving activities at different risk levels. The table below offers example activities at different risk levels for virus spread.

We realize that celebrating the holidays is an important part of our tradition. We, therefore, suggest that you identify an inner circle of family and friends (your social distancing crew) who will be taking precautions with you during the holidays so you can celebrate safely! The holidays can be stressful, and with the pandemic adding a new layer of stress, do not forget to take care of your mental health.

How can you vote safely during the pandemic?

Election day is coming, and it’s important to make your voice heard. If you’re concerned about how to vote safely during a pandemic, Consumer Reports offers a Guide to Voting During a Pandemic that covers several different approaches to voting. The CDC has also issued special COVID-19 safety recommendations for voters. Many of their suggestions are familiar by now; however, the CDC also discusses additional precautions specifically for in-person voting. Some examples:

• Avoid delays by verifying your voter info and having any necessary registration forms ready.
• Bring your own black pen (or stylus, if used in your precinct).
• Review a sample ballot in advance so you can vote and depart quickly.
• Use early voting, if available in your jurisdiction.
• Vote at off-peak times, such as mid-morning.
• If driving to the polls and your schedule allows, monitor the voter line from your car and join it when it’s shorter.

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers

As of September 18, 2020, the US has had 6.7 million cases of COVID-19, with just over 198,000 deaths. The Midwest is leading new cases, with 8 cities in Wisconsin appearing on The New York Times list of the 20 metro areas with fastest-growing cases.

With the run-up to the US Presidential election now less than two months away, recent weeks have seen a growing national dialog on the potential availability of a SARS-CoV-2 vaccine. In this week’s update, we want to review some basic concepts on vaccines, the clinical trials process for ensuring vaccine safety and provide an update on the current status of the various vaccine candidates currently under development.

What is a vaccine? How long do vaccines last?

In the most basic terms, a vaccine is a substance that can stimulate the body’s immune response to provide protection against diseases caused by different viruses and bacteria. Some vaccines provide potentially life-long protection (measles) while others provide long-term protection but still require periodic “booster” shots (tetanus being a classic example). Still others require annual vaccination because of the nature of the virus – influenza virus (that causes “flu”) undergoes changes from year to year and so the formulation for the vaccine changes each year to accommodate these changes and offer the best protection possible.
(PSA: don’t forget to get your flu shot this year!)

How are vaccines tested?

Everyone feels a great sense of urgency to develop a vaccine for SARS-CoV-2 so we can think about returning to some degree of “normalcy” in our daily lives. A concerted global effort is currently underway not only to develop a safe and effective vaccine but to develop other treatments as well (including so called monoclonal antibodies as well as novel antiviral treatments). In the US, the administration has developed what it refers to as “Operation Warp Speed” to try to accelerate vaccine development.

Without getting into a political debate, we want to offer a brief overview of what goes into getting a vaccine approved. Specifically, once a candidate vaccine is identified, its safety and efficacy (how well it works) must be validated through a rigorous clinical trials process as shown in the schematic below:

For a great overview of how vaccines are developed, the different types of vaccines, how they are tested and the status of current efforts to develop a SARS-CoV-2 vaccine, we refer you to an excellent resource put together by The New York Times. 

Vaccine Safety

Historically, the United States Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has been responsible for regulating vaccines in the US.  Recently, the scientific integrity of both the FDA and the Centers for Disease Control and Prevention (CDC) have come into question over fears that they may be rushing vaccine development in the interest of political expediency. Because of this concern, many of the pharmaceutical companies at the forefront of the effort to develop a SARS-CoV-2 vaccine signed an unprecedented pledge affirming their commitment to vaccine safety.

Politics aside, the scientific community must ensure any potential vaccine is both safe AND effective before it is approved and administered to the public. Past experience with the development of SARS and MERS (Middle-Eastern Respiratory Syndrome) vaccines has taught us that coronavirus vaccines need thorough testing. A recent incident that occurred during the Phase 3 clinical trial of AstraZeneca’s vaccine candidate highlights why vaccine safety is paramount. The initial lack of details about the nature of the incident raised concerns about lack of transparency by the drug companies developing these vaccines. In response to mounting pressure, several of the leading contenders have made their protocols public.

Hope on the Horizon

Despite the challenges associated with developing an effective vaccine against SARS-CoV-2, there are several reasons to be hopeful:

1. The science is advancing at a historic and unprecedented pace. Previously, the fastest vaccine ever made (against mumps) took four years to develop.
2. We have access to novel vaccine development platforms and also experience with coronavirus vaccine development[A2]  with SARS and MERS. Scientists are building on this pool of available knowledge to develop a vaccine against SARS-CoV-2.
3. We have gone from first identifying a novel virus (SARS-CoV-2) as the cause of COVID-19 (Dec 2019) to having the sequence of the viral genome (Jan 2020) and the pursuit of multiple, compelling vaccine efforts within the span of only six months.

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers

It has been more than 6 months since the first cases of COVID-19 hit the United States. We issued our first update on March 3, a week before the World Health Organization declared a global pandemic on March 11. As of August 24, 2020, cases in the United States continue to rise unabated, with over 5.6 million total cases and 175,000 deaths. Countries in Western Europe that had seen a decrease in case load have recently seen small outbreaks, indicating that community spread continues to be a high possibility.  

So we are left to wonder: when can we resume normal activities in our lives?

The straightforward answer to that question is when we have achieved a reasonable level of herd (or community) immunity, which occurs when a high percentage of the community is immune to a disease through vaccination and/or prior illness (natural infection). Herd immunity is critical because it not only prevents the spread of infection but also protects people who may not be able to receive a vaccine (for example, the elderly or the severely immunocompromised in whom the immune system is unable to mount a protective response against the virus).

Epidemiologists are hard at work figuring out what levels of herd immunity will protect us from SARS-CoV-2. Initial models suggested that the percentage of people who need to be immune to the virus to achieve herd immunity was around 70%. However, recent research suggests a lower threshold, on the order of only 40%. It is extremely important to keep in mind that no matter the threshold of immunity required, these estimates are based on mathematical models and not true population-based studies.

Our current level of potential immunity to SARS-CoV-2 (the virus that causes COVID-19) is measured using an antibody assay that detects past exposure to the virus whether or not a person had symptoms of COVID-19. Herd immunity through natural infection may depend on location. For example, levels of herd immunity may be lower in rural areas where people are more spread out than in cities, which are more crowded. Also, older people may be more susceptible to the virus and succumb to the disease, whereas younger people may recover from infections and add to the “pool” of herd immunity. Recent research from a COVID-19 hotspot, New York City, looking at the percentage of people who are “antibody-positive” shows a huge variation within the five boroughs of the city. It is therefore possible that the harder hit areas, such as parts of Brooklyn and Queens, may be close to achieving a herd immunity threshold whereas other parts of the city may not (assuming that the antibody tests are accurate and antibodies are long-lasting). This is especially important to keep in mind because it clearly demonstrates that achieving a high percentage of immune individuals through natural infection is not an easy task and comes with a price (please refer to our past update on seropositivity from July 13, 2020).

We are interested in knowing what topics we should cover in future updates. Please share your thoughts with us by taking this short (1-2 minute) anonymous survey.

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers

These updates began on March 3, 2020—a week before the World Health Organization declared COVID-19 a pandemic—when concerns arose in the lung cancer community regarding news out of China about a novel respiratory virus especially deadly to patients with lung cancer. Dr. Upal Basu Roy (who holds a Masters in Public Health), Dr. Amy Moore (whose PhD research was in virology), and Janet Freeman-Daily (a lung cancer research advocate) led lung cancer patient advocacy groups’ efforts to provide vetted, scientific information with a unified voice. Our goal is to provide a trusted source of information that each member of the community can use to assess their risk and make healthy choices for themselves and their families.

As of July 26, 2020, there have been over 16 million cases of COVID-19 worldwide. This week, the US surpassed 4 million cases—while our nation accounts for just over 4% of the world’s population, we make up 25% of virus cases. Another alarming statistic is the rapid pace with which we keep hitting stark new milestones—it took a mere 15 days for our cases to jump from 3 million to 4 million. These numbers reflect the exponential growth of viruses when appropriate public health measures are not heeded by enough members of the population.

SUMMARY OF AACR COVID-19 AND CANCER CONFERENCE

The American Association of Cancer Research held a special virtual conference titled “COVID-19 and Cancer” on July 20-22, 2020. It is increasingly apparent that cancer and COVID-19 present a unique and unfortunate convergence, with lung cancer patients being among the most at risk for severe symptoms from the disease. This conference grew out of the research community’s need to understand the intersection of these two diseases and reflects the rapid mobilization of cancer scientists to apply their talents to finding solutions to this unprecedented global crisis. As one scientist stated, it is our “moral obligation” to help.

The lung cancer advocacy groups had two “poster” presentations at this conference. The first one summarized the origins of our joint COVID-19 statements and their impact on the lung cancer community. The second one discussed patient concerns that have emerged through these updates and how the advocacy groups can develop programs to address them.

1. What is the latest data on risk of COVID-19 for lung cancer patients?

Several real-world studies were presented at the conference that addressed overall risk for cancer patients as well as lung cancer in particular. Real-world studies rely on data collected from patients receiving treatment at their regular cancer centers or hospitals (ie, patients not receiving treatment through a clinical trial). Currently, real-world data seems to be the richest source of data for learning about how SARS-CoV-2 (as a virus) and COVID-19 (as a disease) impact cancer patients.

Registry data is entered by the patient’s treating physician after the patient has a confirmed diagnosis of COVID-19. Data from two big registries were presented at this conference.

• The CCC19 registry is a multi-institutional, North American effort for all types of cancer. It reported that lung cancer patients were at higher risk of developing a more severe form of COVID-19. Other factors that predicted worse outcomes included older age, poor performance status, presence of co-morbidities, prior or current history of smoking, and a cancer that was progressing. The CCC-19 study showed an overall mortality of 26% for lung cancer patients with COVID-19, the highest of all the cancer types analyzed.
• The TERAVOLT registry is a multi-institutional, international effort dedicated to thoracic (lung-related) cancers.  TERAVOLT data on 400 COVID-19 patients showed overall mortality of 35.5% for patients who had lung cancer and a higher mortality of 41% for patients who have small cell lung cancer (SCLC). This increases the challenges presented by the pandemic to rural communities in the Southeast, where SCLC burden is high. Poor performance status was associated with more severe COVID-19 symptoms for SCLC patients.  The patients in this study are primarily European, where the standard of cancer care may be different than in the US. It is important to keep in mind that SCLC is highly aggressive and has a higher symptom burden than non-small cell lung cancer.

Single-institution data provide convenient samples to understand the natural history of a specific disease. At the conference, data from Memorial Sloan Kettering Cancer Center in New York City showed that prior immunotherapy for lung cancer did not impact outcomes of SARS-CoV-2–positive lung cancer patients. This data seems to contradict other registry-based efforts which have suggested that immunotherapy may predict worse outcomes. At the height of the pandemic in NYC, 20% of MSKCC’s lung cancer patients with COVID-19 died but many, including those with late-stage cancer, recovered. This study suggests patient-specific factors (such as type of treatment and patient characteristics) may determine overall risk and susceptibility to worse outcomes. It is important to keep in mind that standard of care and patient characteristics may be unique in a specific institution and therefore the results may not be generalizable.

One study presented at the conference that looked at electronic health records of patients in the US showed that an active cancer diagnosis coupled with co-morbidities such as diabetes and hypertension predicted worse outcomes for COVID-19.

Some common themes emerged for lung cancer patients:

• Patient-specific factors such as older age, presence of lung comorbidities such as chronic obstructive pulmonary disease, and a poor performance status (higher than 1) are associated with a risk of developing a more severe form of COVID-19.
• Certain treatments such as chemotherapy (either alone or in combination) may increase the risk of developing a severe form of COVID-19 due to the immunosuppressive effects of chemotherapy.

We are still learning about how patient-specific factors and treatment-specific factors related to lung cancer can influence the severity of COVID-19. It is best to discuss how an individual patient’s situation will be impacted with the treating physician.

What is abundantly clear at this point is that multiple studies point to increased risk and worse outcomes in lung cancer patients with COVID-19. As the pandemic continues to spread throughout the US, it is imperative that lung cancer patients continue to take the threat seriously and take appropriate steps to protect themselves and those around them:

• Limit unnecessary travel (particularly to areas where COVID-19 is prevalent)
• Practice social distancing,
• Wash hands frequently (or use hand sanitizers when handwashing is unavailable), and
• WEAR A MASK when out in public.

2. How has the COVID-19 pandemic impacted oncologists and the cancer healthcare community?

The impact of the COVID-19 pandemic on the mental health of oncologists cannot be underestimated. Several studies suggest that oncologists will likely suffer from “burn-out ” syndrome and post-traumatic stress disorder (PTSD). Two studies documenting the effect of the pandemic on mental health of oncology professionals were presented at the conference.

• One study looked at 300 oncologists in Western Europe and the United States during the first phase of the pandemic. Two biggest fears reported by the oncologists (almost 75% of participants) were “fear that their patients would get sick” and “fear that their family members would get sick.” Several oncologists opted to live away from their families during their oncology service to protect their families (Symposium 7, Dr. Gabriella Pravettoni).
• In the second study reported at the Keynote Symposium, which included 1570 oncologists from 102 countries, more than 75% of the oncologists reported that they feared contracting COVID-19 (July 21 Keynote, Dr. Solange Peters).

Both these studies highlight the importance of developing adequate mental health support services for healthcare professionals as the effects of the pandemic emerge.  

As patients and advocates who work regularly and intimately with oncology healthcare professionals, we must not forget to express our gratitude to all members of the patient care team.

RESOURCES AND WEBSITES

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites 
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers.

As of June 28, 2020, the United States has reported more than 2.5 million cases of COVID-19 and 125,484 deaths. We are now seeing a rapid escalation in cases in states across the US. Some would argue that these increases simply reflect more testing, but that only tells part of the story. Perhaps a more meaningful metric is the rate of new hospitalizations and ICU bed capacity. Seven states (AZ, AR, CA, NC, SC, TN, TX) are now reporting their highest hospitalization rates since the pandemic started. In hard-hit Houston, TX, ICU bed occupancy stands at 97% at Texas Medical Center. Though only a quarter of that number is currently due to COVID-19 cases, there is once again growing concern about the ability of our hospitals to handle the rapidly increasing number of patients, especially once a second wave of infections strikes.

There are also some changing demographics with this most recent uptick in cases, including growing numbers among young adults ages 20-30. While that may seem to be good news at first, since younger people for the most part have a less severe form of the disease than the elderly or those with underlying comorbidities, this also creates a potential reservoir of the virus that could rapidly extend to more vulnerable populations in the surrounding community.

In the absence of a vaccine or an effective treatment, our best modes of protection remain continued social distancing, frequent handwashing, and wearing masks or facial coverings. A paper from The Lancet supports the use of face masks in reducing transmission in both the healthcare and community setting. The lack of a spike in cases related to recent national protests also suggests that masks played a large role in preventing transmission of the virus. As cases continue to rise across the country, more and more states  are beginning to mandate the use of masks or facial coverings, as shown below:

Additional Recent Studies

Outcomes

In our June 15, 2020 update, we presented findings from the TERAVOLT study, which has reported an increased mortality rate (33%) in lung cancer patients with COVID-19. Some have questioned this study’s findings and how translatable they are to the situation here in the US. New data from Memorial Sloan Kettering Cancer Center (MSKCC) in NYC were reported for a cohort of 102 patients with both lung cancer and COVID-19. Of these patients, 62% were hospitalized and 25% died. Of the patients who required ICU-level care (21%), 72% died. However, COVID-19 severity appeared to correlate more with patient-specific factors than with tumor-specific characteristics or treatments. Thus, while this is a small study, it does reinforce the vulnerability of lung cancer patients to COVID-19. Another study from Memorial Sloan Kettering Cancer Center looked at a cohort of 423 cancer patients with COVID-19 (8% of whom were lung cancer patients) and found that 20% developed severe respiratory illness (including 9% who required mechanical ventilation) and 12% died within 30 days. In addition, the authors found that administration of immunotherapy was associated with a higher risk of complications. Despite small sample size of patients from single institutions and from different countries, all these studies reinforce two points: cancer patients may be at a higher risk of developing complications from COVID-19 and various patient-specific (such as lung damage from radiation therapy) and treatment-specific (immunosuppressive treatments such as chemotherapy) factors determine the extent of severity.

Antibody Response

New research  out of China suggests that the antibody response (a measure of immunity) to SARS-CoV-2 infection may not last as long as for other respiratory viruses, particularly among asymptomatic patients. The study, published in Nature Medicine, suggests that antibody levels fall off by more than 70% in both asymptomatic and symptomatic patients by 8 weeks following infection. Though the sample size is small, if true, these results have important implications for establishing “herd immunity” (also sometimes referred to as community immunity) through natural infection as well as vaccination efforts.

Radiological Findings

Additionally, the paper above described radiological imaging findings in the lungs of asymptomatic patients, including ground-glass opacities as shown below. Coupled with prior reports of extreme lung damage in some patients (including a healthy 20-year-old woman who required a double-lung transplant), these data, though from a small cohort of patients, affirm that there is still much we do not know yet about COVID-19’s impacts and whether infection has a lasting impact on lung function in patients who recover. In the case of lung cancer, the overlap between radiological findings in COVID-19 and lung cancer complicates diagnosis, treatment, and management of patients.

In light of these studies and others that suggest an increased risk for patients with lung cancer, researchers from the fields of lung cancer, virology, immunology, and epidemiology are rapidly mobilizing to create large-scale programs to address questions such as:

1. What is the relative risk of COVID-19 for lung cancer patients?
2. How many lung cancer patients have been infected with SARS-CoV-2 and have antibodies against the virus?
3. What are the features of the immune response to SARS-CoV-2?
4. What are the long-term implications for lung cancer patients who recover from COVID-19?

In summary, we continue to advise our community to maintain public health precautions as they go about their daily activities such as household chores and groceries. In a recent New York Times article, former director of the CDC (under the Obama administration) Dr. Tom Frieden says, “Start with the three Ws: wear a mask, wash your hands, and watch your distance.” Now more than three months into the pandemic, hospitals and clinics have excellent procedures in place to ensure that patients are kept safe during clinic appointments. We strongly advise lung cancer patients to check with their doctors on what these precautions are, in case they are concerned about getting exposed to SARS-CoV-2 while seeking healthcare. It is not advisable to miss clinic appointments without consulting your healthcare team.

AACR Virtual Conferences

Lung cancer patient advocates attended AACR’s Virtual Annual Meeting II on June 22-24. As expected, many presentations focused on the intersection of COVID-19 and cancer as well as our current national dialog on racial issues. Dr. Lisa Newman presented work on the double hit minority cancer patients are facing as a result of the ongoing pandemic. Dr. Ned Sharpless, Director of the National Cancer Institute (NCI), reported data predicting an additional 10K cancer deaths over the next decade as a result of missed screenings, delays in diagnosis, and reductions in cancer care. Though these models were for breast and colorectal cancer, there is equal concern about the potential impacts on lung cancer. The lung cancer advocacy groups must continue to push forward policies that protect minority communities and ensure access to continued screening and care during the current crisis.

Thank you to everyone who participated in our recent survey to collect data on the value of these updates and patient concerns that have emerged as a result. We are pleased to report that we have had two abstracts accepted for presentation at the upcoming AACR Virtual Meeting: COVID-19 and Cancer being held July 22-24. Our community will be well represented as we learn even more about the intersection of these two diseases and the implications for lung cancer in particular.

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers.

This past week marked a grim milestone in the United States, as we officially surpassed 100,000 deaths from COVID-19. Our groups continue to recommend that the lung cancer community adhere to best practices to limit exposure, including wearing masks/face coverings when out in public, frequent handwashing, ongoing social distancing, and limiting nonessential travel.

Normally at this time, representatives from our respective organizations would be in Chicago for the annual American Society of Clinical Oncology (ASCO) meeting, for which over 40,000 oncology professionals gather to share best practices in clinical oncology research and academic and community practice. In light of the ongoing pandemic, ASCO 2020 was held as a virtual conference.

Note: There are many exciting updates and recent FDA drug approvals in the lung cancer space. These are being shared via other channels through our respective organizations and will not be covered here since our goal is to focus exclusively on relevant COVID-19 updates for the lung cancer community.

In this week’s update, we will cover three topics:

1. COVID-19 presentations from ASCO 2020
2. Advocacy groups participating in IASLC “Lung Cancer Considered” podcast
3. Advocacy groups collecting data for AACR COVID-19 and Cancer conference

COVID-19 presentations from ASCO 2020

Previous reports have suggested that lung cancer patients infected with COVID-19 have worse outcomes. During ASCO 2020, we heard updates from two different registry efforts focused on tracking cancer patient outcomes:

1. The COVID-19 and Cancer Consortium (CCC19) registry is tracking outcomes across all cancer types. The major finding from this study is that patients with actively progressing cancer were five times more likely to die within 30 days of diagnosis with COVID-19 compared to patients who were in remission or had no evidence of disease. As ASCO President Dr. Howard A. Burris III states, "For people with cancer, the impact of COVID-19 is especially severe, whether they have been exposed to the virus or not. Patients with cancer are typically older adults, often with other underlying conditions, and their immune systems may be suppressed by the cancer, or due to chemotherapy, radiation, or other treatment.” These data are consistent with previous early reports and suggest that patients with active cancer are uniquely vulnerable and face worse outcomes upon infection with the virus that causes COVID-19.
2. A second registry effort, called TERAVOLT (for Thoracic cancERs international coVid 19 cOLlaboraTion), is specifically tracking outcomes for lung cancer patients infected with COVID-19. For this study, 400 patients were included in the analysis, the majority of whom had stage IV cancer. Among this cohort, 141 patients died of COVID-19, with 334 of the patients requiring hospitalization. Those patients receiving chemotherapy, either alone or in combination, within three months of a diagnosis of COVID-19 fared the worst, with a significantly increased risk of dying (64%) compared to those who did not receive chemotherapy.

Take-home message from these studies: COVID-19 presents a unique threat to all cancer patients, especially those with lung cancer. Various international efforts are underway to understand these risks and what it means for patients and their cancer care. As states continue to reopen, it is important not to let your guard down and to maintain all the precautions you have been taking over the past few months. This virus has not gone away and it is important that you and your loved ones take appropriate steps to minimize exposure.

Advocacy groups participate in IASLC “Lung Cancer Considered” podcast

Authors of these weekly updates, including Dr. Jan Baranski, Janet Freeman-Daily, Dr. Amy Moore, and Dr. Upal Basu Roy, recently participated in the International Association for the Study of Lung Cancer (IASLC) “Lung Cancer Considered” podcast. They were joined by Jill Feldman, Dr. Alice Berger, Dr. Christine Lovly, and Dr. Brendon Stiles to discuss impacts of COVID-19 on lung cancer research. Despite the obstacles created by the pandemic, lung cancer research marches on and we think you will be encouraged and inspired by the discussion. Listen to the podcast here.

Advocacy groups collecting data for AACR "COVID-19 and Cancer" conference

In light of the COVID-19 pandemic and its impact on cancer care, AACR is convening a special conference focused on the presentation of emerging data in basic, clinical, and epidemiologic research related to COVID-19 and cancer. Lung cancer patients are especially vulnerable to developing a serious case of COVID-19. In order to provide the community accurate, up-to-date, and curated scientific information on COVID-19 and cancer, lung cancer patient advocacy groups have come together to support our community through joint advocacy updates.

We need your help and your perspective! We are inviting you to participate in this 10-minute survey to capture your concerns about COVID-19, and whether you found this collaboration and the updates useful. The survey will close at midnight Pacific Daylight Time, Friday, June 5, 2020, to allow us to prepare abstracts for submission to the AACR "COVID-19 and Cancer" virtual meeting.

If you prefer, you can copy and paste this link in your web browser to take the survey: https://www.surveymonkey.com/r/LC_JT_Updates

The data we collect from the survey will also be shared openly across all advocacy groups once the conference is completed. Thank you for your help and for providing us your perspective.

Resources and websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know-
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins COVID-19 Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer And COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites  
   • Directory of local health department websites  
8. American Medical Association resources for healthcare providers.

Download this statement

The authors of this weekly advocacy update are all scientists (nerds) and so before we get to this week’s update, indulge a little humor: “May the Fourth be with you!” Now back to our regularly scheduled programming:

As of May 2, 2020, the Centers for Disease Control and Prevention (CDC) reported 1,062,446 cases of COVID-19 and 62,406 COVID-19-associated deaths. Many states are beginning to loosen restrictions and reopen certain businesses.  It is worth noting that in Georgia, the first state to reopen, the shelter-in-place policy has been extended through June 12, 2020, for the most at-risk populations, including those over age 65; those in nursing homes or long-term care facilities; those with chronic lung disease, moderate to severe asthma, severe heart disease, class III/severe obesity, diabetes, liver disease, chronic kidney disease and undergoing dialysis; as well as those who are immunocompromised.

On Friday, May 1, 2020, the Food and Drug Administration (FDA) granted emergency use authorization for the antiviral drug remdesivir for the most severely ill COVID-19 patients. While this is an encouraging development, we must provide a word of caution in that we still do not have effective treatments for broad use by the general public or a vaccine.

In light of the ongoing COVID-19 pandemic, the American Association of Cancer Research (AACR) shifted its annual meeting to a virtual format and broke it into two separate events. The first was held on April 27 -28, 2020. In this week’s update, we will discuss some of the information presented during this meeting and what it means for the cancer community. In particular, we will focus on answering three questions:

1. What are the implications of COVID-19 for my personal cancer treatment?
2. How do I make sense of contradictory COVID-19 information?
3. What are the impacts of COVID-19 on cancer research?

What are the implications of COVID-19 for my personal cancer treatment?

Since we first started providing these updates in early March 2020, there has been growing evidence that lung cancer patients infected with COVID-19 have worse outcomes. During the AACR plenary session on “COVID-19 and Cancer,” an international team led by Dr. Marina Garassino presented early data for TERAVOLT, a global registry collecting characteristics and outcomes of patients with thoracic cancers affected by COVID-19. They reported a disturbingly high mortality rate of 34.6% (66/191) among patients with thoracic cancers.

As research advocates serving the lung cancer community, we recognize that these data are alarming. The immediate implications of these results fall in line with what we have been advising those who fall in high-risk groups, including lung cancer patients: continue to practice social distancing when possible, wear protective face coverings when out in public, wash hands often, and minimize travel to essential needs only (medical appointments, procuring groceries or prescriptions).

Our April 20, 2020, update discussed the increasing role of telehealth in management of patient care, and our April 27, 2020, update focused on the guidelines issued by leading medical organizations and societies. Our March 30, 2020, update included impacts on clinical trials—as states begin to reopen, some trial sites are resuming enrollment. Thus, it remains imperative that you talk with your treatment team about your individual treatment plan.

Indeed, as a result of the COVID-19 pandemic, doctors and scientists are reevaluating treatment schedules and the “usual way of doing business.” One example is the recent April 28, 2020, FDA approval for a new dosing regimen for the immunotherapy drug pembrolizumab. This approval is based on data presented at the 2020 AACR Virtual Meeting.

Dr. Jacob Sands, a leading lung cancer medical oncologist at Dana-Farber Cancer Institute, provides a nice discussion on the importance of individualized lung cancer management in the COVID-19 era.

How do I make sense of contradictory COVID-19 information?

We recommend that you follow information from trusted and medically vetted websites such as the CDC, the WHO, and the IASLC. Information on how to access these websites is included in the Resources and websites section below.

Our understanding of COVID-19 is evolving rapidly. This means that what was true a month ago may not be true under current circumstances, as doctors and scientists generate more evidence. You might hear contradictory information from different sources or at different times. As an example, the antimalarial and autoimmune disease drug hydroxychloroquine was shown to have positive effect in COVID-19 patients in early studies. However, further study with more patients showed hydroxychloroquine was not as effective as it was initially thought to be, and highlighted the fact that hydroxychloroquine comes with a range of side effects that make it unsuitable for use in patients with heart issues. This is a great example of the scientific method whereby a finding or a hypothesis changes as new information is gathered.

We also caution on how one should interpret information shared across media and press during these times. COVID-19 is a global pandemic and is affecting the oncology community everywhere in the world. Given the urgent global need for information on effective COVID-19 management, healthcare providers are sharing preliminary information as quickly as possible with the goal of learning from each other’s experiences. This means that not all information shared publicly will have the same level of evidence as formal clinical trials. The information is important and valuable, but it is not yet validated in large groups of patients.

When judging what you read from publicly available sources, we suggest you use the Evidence-Based Medicine (EBM) Pyramid as a guiding framework

Higher quality of evidence takes longer to get published to allow for collecting larger amounts of data, statistical analysis, and scientific peer review. Most of the literature currently available on COVID-19 and lung cancer are case reports and studies of a small number of patients in a few institutions.  COVID-19 has not been around long enough to enable large, formal clinical trials about its impact on lung cancer treatment. If you have questions about whether published COVID-19 findings might affect your lung cancer treatment, please discuss your individual situation with your treating physician.

What are the impacts of COVID-19 on the state of academic cancer research?

Most academic research institutions, including universities and hospitals, have shut down most research labs and closed enrollment in some clinical trials to accommodate government-imposed shelter in place mandates and protect researchers’ lives. Only critical research, such as maintaining cell lines or animal models for preclinical research and some clinical trials with strong evidence of effectiveness, is being allowed to continue. These are institutionally mandated restrictions that have been put into place to protect university staff. Some researchers who are also clinicians have been deployed to assist with COVID-19-related clinical duties. Bench scientists who are not involved with clinical duties have been advised to work from home in activities such as grant and manuscript writing, and data analysis.

Funders of academic lung cancer research in the US such as the National Cancer Institute, the Department of Defense, and private non-profits (e.g.,  LUNGevity Foundation, GO2 Foundation, Lung Cancer Research Foundation, Lung Cancer Foundation of America) have all made concessions to accommodate the needs of the scientific community and best support investigators during this critical time, while trying to minimize any delays in lung cancer research. Concessions include:

• Extended deadlines for grant applications
• Allowing the use of grant funds for salaries and stipends even when researchers are not working in the laboratory
• Flexibility regarding project extensions and accommodating unanticipated costs such as loss of animals and chemicals bought for experiments
• Allowing grantees more time to report on awards after an award is completed
• Numerous flexibilities regarding expenditures of funds, such as money already spent in conferences and travels

Resources and Websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. COVID-19: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins Coronavirus Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer and COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites
   • Directory of local health department websites
8. American Medical Association resources for healthcare providers

Download this statement

As of April 18, 2020, the Centers for Disease Control and Prevention (CDC) reports 661,712 cases of COVID-19 and 33,049 COVID-19-associated deaths. A recent study conducted by researchers at Stanford University suggests that this number is an underrepresentation of the total number of infected individuals. We must urge caution with interpretation of this study, which is still undergoing peer review. Some are interpreting the findings to mean we should accelerate loosening of social distancing policies across the country. However, researchers still do not know if the presence of antibodies confers protection or how long such immunity might last. Further, in the absence of any effective therapeutics or a vaccine, local flareups are still a risk, as has been witnessed in other countries. Social distancing is working and should be maintained for now.

In this week’s update, we address the following important topics:

Role of telehealth in the era of COVID-19

1. What is telehealth?
2. How is the use of telehealth changing during the COVID-19 pandemic?
3. What are some of the barriers to broad uptake of telehealth during the current crisis?
4. How do I know if I am eligible to obtain telehealth services?

Impact of COVID-19 on lung cancer clinical trials

1. How is the FDA allowing the use of telehealth for lung cancer clinical trials?
2. If a patient is receiving their drug through a pharmacy at the clinical trial site, can they now receive the drug through home delivery without having to change the protocol?
3. If a patient is receiving a drug given through infusion, can they now receive the clinical trial treatment through home infusion?

Role of telehealth in the era of COVID-19

1. What is telehealth?

The terms “telehealth” and “telemedicine” are used interchangeably to describe using telecommunications technologies to deliver health care. It includes a variety of services that deliver health care, public health, and health education, and ranges from methods as simple as telephone calls and email to live video, mobile apps, remote patient monitoring and uploading scan images. The Center for Connected Health Policy (CCHP) provides an excellent overview of telehealth here.

2. How is the use of telehealth changing during the COVID-19 pandemic?

In light of the COVID-19 pandemic, federal and state policies are rapidly adapting to allow for greater utilization of telehealth services. The Centers for Medicare and Medicaid Services (CMS) have created some useful fact sheets highlighting various policy changes, including this one summarizing Medicare telemedicine services and this one addressing sweeping regulatory changes to meet patients’ needs during this time. Private health insurance companies are also modifying their policies to enable greater use of telehealth. CCHP is maintaining an updated list of COVID-19 telehealth coverage policies.

3. What are some of the barriers to broad uptake of telehealth during the current crisis?

The challenge with adapting telehealth policies in real-time to address an unfolding and unprecedented public health crisis is that, in a pre-COVID-19 world, federal and state policies varied widely in how telehealth services were provided and covered. Most of the current challenges relate to regulatory and reimbursement issues, including licensure requirements. Even as the popularity of telehealth among patients grows, private healthcare payers have been slow to embrace the technology. The Federation of State Medical Boards is maintaining an updated list of states currently waiving telehealth licensure requirements.

The “digital divide” is also a barrier to accessing telehealth. Patients who are elderly, in areas with poor Internet or cellular coverage, or economically disadvantaged may not be able to access the technology necessary to telehealth.

4. How do I know if I am eligible to obtain telehealth services? What can I do to ensure broader access?

Again, laws vary by state regarding how telehealth is being implemented and what health insurance companies and providers can do. Review your health insurance plan benefits and policies frequently to learn how they may be changing. This CCHP list of COVID-19 state actions may also be helpful.

CCHP also monitors state and federal telehealth legislation to provide a clear overview of policy across the nation. As a citizen, you can monitor legislation that has been introduced in your state and testify to show your support or opposition. You can call your legislators to ensure your needs are being heard.

For a great overview and more in-depth discussion on all of these points on telehealth, please check out GO₂ Foundation for Lung Cancer’s Rapid Response Living Room from April 14, 2020, featuring Dr. Joelle Fathi.

Impact of COVID-19 on lung cancer clinical trials

The United States Food and Drug Administration (FDA) has issued guidance to clinical trial sponsors (pharmaceutical companies and government agencies), institutional review boards (IRBs), and researchers on how to adapt lung cancer clinical trials in the era of COVID-19. The FDA emphasizes that patients’ safety should be at the forefront of considerations at all times. Below, we answer three important questions for patients (and their caregivers).

1. How is the FDA allowing the use of telehealth for lung cancer clinical trials?

The FDA allows for changes to be made to the clinical trial protocol without prior FDA review or approval if the change is intended to protect the life and well-being of the patient. Therefore, changes in protocol conduct necessary to immediately assure patient safety, such as use of telehealth for safety monitoring instead of on-site visits, can be immediately implemented once the new protocol has been approved by an IRB. The FDA can then be subsequently notified. It is important to note that the consult is just one part of patient safety monitoring. The patient’s clinical trial team and the clinical trial sponsor will also need to have a clear plan in place to ensure that patient safety is prioritized in case routine monitoring such as blood tests and heart function exams are unable to be conducted.

2. If a patient is receiving their drug through a pharmacy at the clinical trial site, can they now receive the drug through home delivery?

The FDA understands that there may be a risk of exposure to SARS-CoV-2 when a patient visits a clinical trial site. In case a patient is receiving their drug (such as a targeted therapy pill) through their clinical trial site pharmacy, the clinical trial sponsor now has the option of directly mailing the drug to the patient’s home as long as the following conditions are met:

• The patient already takes the pill at home as part of the trial protocol
• The shipment of the drug to the patient’s home does not affect the chemical nature of the drug
• The sponsor keeps a clear track of number of pills shipped to the patient’s home and is able to share this information with the FDA when asked

3. If a patient is receiving a drug given through infusion, can they now receive the clinical trial treatment through home infusion?

This is an extremely important question for the lung cancer community—where clinical trials often require an infusion of a chemotherapy, an immunotherapy, an angiogenesis inhibitor, or a combination of the above.

The FDA understands and appreciates that a patient may be exposed to SARS-CoV-2 when they travel to their routine clinical trial infusion center. Therefore, the FDA is open to alternative sites for administration (eg, home nursing or alternative sites closer to a patient’s home where the infusion is given by trained medical personnel who are not part of the study team). The ultimate decision to allow this switch to home infusion or local infusion is based on the following criteria:

• The shipment of the drug to the local infusion center or to the patient’s home does not affect the chemical nature of the drug
• The sponsor keeps a clear track of the amount of shipped to the patient’s home and is able to share this information with the FDA when asked

Another option is delaying or discontinuing infusion for a period of time while the patient continues to be on the study. This decision needs to be made jointly by the clinical trial team and the patient.

Note: The ultimate decision on whether to allow a home infusion or local infusion is highly dependent on the drug being tested. Some infusions cannot be given at a local infusion center or through home infusion. Examples include drugs that require ability to manage potential infusion reactions with specific medication, or treatments such as gene therapy or cell therapy that require exacting handling procedures and patient monitoring.

LUNGevity Foundation recently conducted an Oncology Center of Excellence (OCE) listening session with FDA leadership and lung cancer patients. Stay tuned for the recorded webinar that can be accessed here.

Resources and Websites

1. IASLC’s Guide to COVID-19 and Lung Cancer
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. Coronavirus: What People with Cancer Should Know
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC)
4. Johns Hopkins Coronavirus Resource Center
5. Interactive map of US COVID-19 cases by state
6. The One-Two Punch: Cancer and COVID-19 (an important perspective for cancer patients)
7. You can find information specific to your state or city or town on your health department’s website.
   • Directory of state department of health websites
   • Directory of local health department websites
8. American Medical Association resources for healthcare providers
9. If you cannot avoid air travel, check out “Dirtiest Places on Airplanes: How to Avoid Germs”

Download this statement

The number of confirmed cases of COVID-19 continues to grow in the US. As of April 5, 2020, there are 312,089 confirmed cases of COVID-19 in the US. These numbers may be an underestimation of the true burden of the disease due to lack of testing and a high proportion of asymptomatic yet infectious individuals.

To get a real-time understanding of the cases in the US, you can access the map through The New York Times.

In this week’s update, we answer the following important questions:

1. Is social distancing working?
2. Do I continue to social distance?
3. Do I leave my city to go to someplace safe—such as a rural area?
4. Should I use homemade masks to protect myself?
5. Can I travel within the United States?

1. Is social distancing working?

YES, IT IS!  Washington and California quickly imposed statewide social distancing through stringent shelter-in-place or stay-at-home policies once deaths occurred within their borders.  The graph below shows that COVID-19 deaths are still increasing in these two states, but not as fast as in other states. Deaths in New York State are doubling every 2 days, but in Washington State deaths are doubling only every 7 days.

The most up-to-date version of the graph below can be accessed from the New York Times website here.

The CDC continues to recommend social distancing to help decrease transmission of COVID-19 within the community. Social distancing measures, such as cancelling public gatherings and avoiding crowds, can slow the spread of the virus and spread cases out over a longer period of time, which can help hospitals provide care while avoiding being overwhelmed by patients. Social distancing helps “flatten the curve” in the spread of an infectious disease.

This is especially critical because hospitals and health systems are working at full capacity. Flattening the curve ensures that systems are functional and people who require care the most can get the attention they need. The CDC recommends a distance of 6 feet or 2 meters as the minimum distance between individuals as part of COVID-19 mitigation strategy.

We encourage you to check out CDC’s COVID-19 community mitigation strategies here.

2. Do I continue to social distance?

YES, social distancing is currently the only known public health measure that can protect us from SARS-CoV-2. Social distancing minimizes risk of exposure to the virus. It is important to keep in mind that social distancing is NOT the same as social isolation. We encourage you to keep in touch with all your family, friends, and loved ones through phone and video conversations. Just because we are social distancing doesn’t mean we have to be socially isolated.

Social distancing is different from self-quarantine. Self-quarantine should be practiced by people who have been exposed to SARS-CoV-2 and who are at risk for coming down with COVID-19. It involves:

• Using standard hygiene such as frequently washing your hands and not touching your face
• Not sharing things like towels and utensils with other people who share the same household
• Staying at home and not having any visitors
• Staying at least 6 feet away from other people in your household

You do not need to have symptoms of COVID-19 to self-quarantine. Caregivers who have travelled or are leaving their homes frequently to run errands may choose to self-quarantine especially in COVID-19 hot zones.

3. Do I leave my city to go to someplace safe—such as a rural area?

NO! You should not be leaving your urban apartment or home and moving to a rural area for the following reasons:

• You do not know if you or a loved one has been infected with SARS-CoV-2. An infected individual might not have any symptoms but still can continue to infect others.
• You may not have access to your regular doctors and healthcare in a rural setting.
• Small rural areas are not equipped to handle an influx of people. They may not have an adequate number of grocery and produce stores. More importantly, they may not have adequate medical care facilities should there be an emergency.

Do not indulge in “disaster gentrification” for your own safety, the safety of your loved ones, and that of other community members. It is our duty to keep rural communities insulated from this disease as much as possible.

4. Should I use homemade masks to protect myself?

YES! The CDC reports that a significant portion of individuals with COVID-19 lack symptoms (“asymptomatic”) and that even those who will eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others before showing symptoms. This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms.  In light of this new evidence, CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain (eg, grocery stores and pharmacies) especially in areas of significant community-based transmission.

Masks should be worn in conjunction with maintaining adequate social distancing. It is also important to keep in mind that these face masks are not surgical masks or N95 masks (to be used primarily by healthcare workers as part of personal protective equipment).

Please watch this handy video to make your own homemade masks:

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover.html

4. Should I travel within the US?

Though the CDC does not typically make suggestions about domestic travel, they highly recommend avoiding all non-essential travel within the US. Several cities and states already have a shelter-in-place order. Points to keep in mind should you need to consider domestic travel (from the CDC):

• Is COVID-19 present in your home community? If so, avoid traveling to avoid spreading the virus. You might be required to enter quarantine at your destination.
• Is COVID-19 spreading in the area where you are travelling to?
• Will you or your travel companion(s) be in close contact with others during your trip?
• Are you or your travel companion(s) more likely to get severe illness if you get COVID-19?
• Do you have a plan for taking time off from work in case you are told to stay home for 14 days for self-monitoring or if you get sick with COVID-19?
• Do you live with someone who is older or has a serious, chronic medical condition (especially important for caregivers)?

Resources and Websites

1. IASLC’s Guide to COVID-19 and Lung Cancer – https://www.lungcancernews.org/iaslcs-guide-to-covid-19-and-lung-cancer/
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. Coronavirus: What People with Cancer Should Know - https://www.cancer.gov/contact/emergency-preparedness/coronavirus
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), which can be found here:
   • https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
   • https://www.cdc.gov/coronavirus/2019-ncov/index.html
4. Johns Hopkins Coronavirus Resource Center is one of the best places to get current updates. https://coronavirus.jhu.edu/
5. Interactive map of US COVID-19 cases by state - https://www.politico.com/interactives/2020/coronavirus-testing-by-state-chart-of-new-cases/
6. The One-Two Punch: Cancer and Coronavirus (an important perspective for cancer patients) - https://www.forbes.com/sites/miriamknoll/2020/03/20/the-one-two-punch-cancer-and-coronavirus/#73744a4358e6
7. You can find information specific to your state or city or town on your health department’s website.
   • A list of state department of health websites can be found here:https://www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html
   • A list of local health department websites can be found here: https://www.naccho.org/membership/lhd-directory
8. The American Medical Association is also maintaining a resource website for healthcare providers. You can find more information here: https://www.ama-assn.org/delivering-care/public-health/covid-19-2019-novel-coronavirus-resource-center-physicians
9. If you cannot avoid air travel, check out this handy article on “Dirtiest Places on Airplanes: How to Avoid Germs” https://time.com/4877041/dirtiest-places-on-airplanes/

Download this statement

As of March 30, 2020, cases of the virus surge in countries around the world. The United States now has the highest number of COVID-19 cases globally. The CDC has issued a travel advisory for the New York tri-state area, which has the highest number of cases in the country. 

In this week’s update, we discuss lung cancer treatment and clinical trials in the era of COVID-19. The information presented in this update, though current, is a work in progress built on very little data. Implementation across institutions and trial sites will vary based on availability of resources and healthcare workers.

Also, please don’t forget to check out the Resources list.

Lung cancer treatment and COVID-19

The oncology community is currently balancing treatment decisions for lung cancer patients, in light of the COVID-19 pandemic. Two factors are being used to decide what’s best for our patients:

• Whether a delay in cancer diagnostic tests or treatment presents more risk than potential COVID-19 exposure in the clinic
• Whether a difference in treatment approach can help reduce clinic visits and interactions with others

The CDC continues to recommend social distancing to help decrease transmission of COVID-19 within the community. Social distancing measures, such as cancelling public gatherings and avoiding crowds, can slow the spread of the virus and spread cases out over a longer period of time, which can help hospitals provide care while avoiding being overwhelmed by patients. Social distancing helps “flatten the curve” in the spread of an infectious disease. This is especially critical because hospitals and health systems are working at full capacity. Flattening the curve ensures that systems are functional and people who require care the most can get the attention they need. The CDC recommends a distance of 6 feet or 2 meters as the minimum distance between individuals as part of COVID-19 mitigation strategy.

Currently, lung cancer patients may need to engage with the oncology care system for the following reasons:

• clinic visits
• tissue and liquid biopsies
• surgical procedures 
• infusion sessions for chemotherapy or immunotherapy (or both)
• refill targeted therapy drugs
• radiation treatments
• hospital admissions
• blood draws for laboratory tests, and
• imaging tests to check if treatments are working

Also, family members may sometimes accompany patients when they are visiting their doctors.

Recent studies out of China suggest that hospital admissions and repeated clinic visits increase the risk of COVID-19 exposure for patients. Further, a JAMA Oncology study reported that the infection risk for cancer patients in a tertiary care institution was 2-fold higher than the cumulative incidence observed in the city of Wuhan over the same time period. In light of these data and the rapidly evolving COVID-19 pandemic, the oncology community has come up with the following suggestions for cancer treatment. Please be advised that these recommendations are subject to change.

Small Cell Lung Cancer (SCLC):

If you have a confirmed diagnosis, you may not wish to delay treatment (such as chemotherapy and radiation). You and your doctor should discuss what’s right for you.

Early stage non-small cell lung cancer (NSCLC) (Stage I to IIIB):

• If you have already had surgery, your doctor may decide to not start with adjuvant chemotherapy and/or radiation.
• If you have not yet had surgery, you and your doctor may decide to wait on the surgery or your doctor may suggest stereotactic body radiation therapy (SBRT).
• If you are currently having chemo-radiation, your doctor may decide to continue with your treatment or wait on additional treatment.

Advanced stage non-small cell lung cancer (NSCLC) (Stage IIIC-IV):

• If you are on a targeted therapy (pill), you may continue with your treatment as planned. Make sure to check with your doctor and pharmacist to ensure an adequate supply of your cancer medication.
• If you are already on immunotherapy or chemotherapy, your doctor may decide to continue with your treatment, space out infusions, or postpone treatment. They may decide to have you receive infusions at your local clinic or even home infusion, as needed.
• If you are already undergoing radiation therapy, your doctor may choose to hold off on additional treatment, reduce the number of treatments, or keep you on treatment as planned, based on your individual health situation.

Several recent forums have discussed the management of lung cancer during the COVID-19 pandemic. Topics that are currently being addressed by lung cancer providers/thought leaders include:

• How to determine whether pneumonitis is resulting from checkpoint inhibitor or COVID-19 infection
• Should immunotherapy be withheld from patients whose tumors do not have known driver mutations (as determined by molecular testing)?
• Spacing out or postponing infusions for patients on pemetrexed or immunotherapy maintenance
• Reducing the number of fractions used in radiation therapy
• Uncertainty regarding how COVID-19 treatments in clinical trials (such as remdesivir and hydroxychloroquine) may interact with immunotherapy drugs and tyrosine kinase inhibitors
• The growing role for liquid biopsies in places where surgical biopsies are not currently practical (use of mobile phlebotomy too)
• Challenges of spacing out chemotherapy schedules in light of current reimbursement
• Growing role for telemedicine (effective for managing patients but loss of doctor-patient bond)
• Educating others on their care teams to overcome lung cancer nihilism and stigma

All treatment decisions should be made jointly by you and your doctor. Do not change your treatment plan or doctor’s visit without consulting your doctor first.

Telehealth or remote consults may be an option for checking in with your doctor. Also, there may be the option to be referred to a “COVID-19-free” hospital or treatment center.

Clinical trials and COVID-19

Clinical trials continue to be a source of lifesaving therapies for lung cancer patients. The COVID-19 pandemic has affected the conduct of clinical trials due to the following reasons:

• Questions related to safety of patients traveling to trial sites and undergoing trial-related procedures
• Potential shortage of healthcare providers to conduct trial-related activities
• Interruptions to the supply chain of the drug(s) being tested

The US Food and Drug Administration (FDA) has recently issued guidance to help clinical trial sponsors figure out the best approaches to ensure that trials can proceed within resource-constrained settings. A clinical trial sponsor in this case is defined as any entity (for example, a pharmaceutical company) involved in the development and testing of drugs and other interventions in clinical trials. Below we have summarized key points from the FDA guidance that are important from the patient perspective.

For clinical trials that are already ongoing:

• Sponsors should consider each circumstance, assess the potential impact on the safety of trial, and modify study conduct accordingly. Decisions regarding this could include continuing trial recruitment, continuing use of the new drug(s) for patients already involved in the trial, and the need to change patient monitoring schedules throughout the trial. Clinical trial participants should be kept updated on any changes that a sponsor decides to implement.
• Sponsors, doctors involved in the trials, and Institutional Review Boards (IRBs) may decide that the protection of a patient’s safety, welfare, and rights would be best served by continuing or by discontinuing use of the investigational product or participation in the trial. However, such decisions will depend on the specific circumstances of the clinical trial and the patients enrolled.
• Given that trial participants may be unable to come to investigational sites due to protocol-specified visits, sponsors should assess whether alternative methods for safety evaluations could be implemented when necessary and feasible. Additionally, in deciding to continue or discontinue use or administration of the new drug(s), sponsors should consider whether the safety of participants can be ensured by implementing the alternative approach of monitoring such as local scans and blood tests. Sometimes, patients may require additional safety monitoring.

Several sponsors already have different measures in place to allow conduct of clinical trials and avoid as much disruption as possible, such as:

• Allowing patients to have blood draws and CT scans at local cancer centers and clinics
• Shipping drug supplies to patients, especially for targeted therapy (pills) trials
• Remote consent
• Mobile phlebotomy

If you are part of a clinical trial, we recommend you discuss your trial participation immediately with your research team.  If you were considering enrolling in a clinical trial, you may want to discuss with your treating physician what options are available for you. Any decision about trial participation should be made jointly by you and your healthcare team.

Resources and Websites

1. IASLC’s Guide to COVID-19 and Lung Cancer – https://www.lungcancernews.org/iaslcs-guide-to-covid-19-and-lung-cancer/
2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. Coronavirus: What People with Cancer Should Know - https://www.cancer.gov/contact/emergency-preparedness/coronavirus
3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), which can be found here:
   • https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
   • https://www.cdc.gov/coronavirus/2019-ncov/index.html
4. Johns Hopkins Coronavirus Resource Center is one of the best places to get current updates. https://coronavirus.jhu.edu/
5. Interactive map of US COVID-19 cases by state - https://www.politico.com/interactives/2020/coronavirus-testing-by-state-chart-of-new-cases/
6. The One-Two Punch: Cancer and Coronavirus (an important perspective for cancer patients) - https://www.forbes.com/sites/miriamknoll/2020/03/20/the-one-two-punch-cancer-and-coronavirus/#73744a4358e6
7. You can find information specific to your state or city or town on your health department’s website.
   • A list of state department of health websites can be found here:https://www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html
   • A list of local health department websites can be found here: https://www.naccho.org/membership/lhd-directory
8. The American Medical Association is also maintaining a resource website for healthcare providers. You can find more information here: https://www.ama-assn.org/delivering-care/public-health/covid-19-2019-novel-coronavirus-resource-center-physicians
9. If you cannot avoid air travel, check out this handy article on “Dirtiest Places on Airplanes: How to Avoid Germs” https://time.com/4877041/dirtiest-places-on-airplanes/

Download this statement

The World Health Organization officially declared the COVID-19 outbreak a pandemic on March 11, 2020. As cases of the virus surge in countries around the world, with Italy being particularly hard hit, many nations are taking extreme steps to mitigate the outbreak, including whole country lockdowns. Here in the United States, the President declared a national emergency on March 13, 2020.

In this week’s update, we discuss four important topics related to COVID-19.

1. Social distancing and why it matters for COVID-19

COVID-19 is caused by the virus SARS-CoV-2. Individuals infected with SARS-CoV-2 appear to shed the virus from their respiratory tract (e.g., when coughing) even when symptoms may be very minor. Individuals infected with SARS-CoV-2 appear to shed the virus from their respiratory tract during the prodromal period.¹ The prodromal period is part of an infectious disease cycle. It is defined as the period during which the symptoms felt by an infected individual may not be very specific or severe. The infected person can still perform usual functions and can therefore continue to be infectious. An infected individual can shed virus with very minor signs and symptoms.² This explains why we are seeing widespread transmission in the community (this didn’t happen with SARS).

The reproductive number (R₀)– the number of secondary infections generated from one infected individual – is estimated to be between 2 and 2.5 for COVID-19 virus.³ This means that a single infected person infects 2.5 people, which is higher than for the influenza virus. Approximately 3 to 5 days after infection, a person starts shedding virus and can infect others. Therefore, within a month, a single case can lead to 244 new cases.

The CDC now recommends social distancing to help decrease transmission of COVID-19 within the community.⁴ Social distancing measures, such as cancelling public gatherings and avoiding crowds, can slow the spread of the virus and spread cases out over a longer period of time, which can help hospitals provide care while avoiding being overwhelmed by patients. Social distancing helps “flatten the curve” in the spread of an infectious disease. This is especially critical because hospitals and health systems are working at full capacity. Flattening the curve ensures that systems are functional and people who require care the most can get the attention they need. The CDC recommends a distance of 6 feet or 2 meters as the minimum distance between individuals. ⁵

In case you are interested, we invite you to take a look at the CDC’s community transmission mitigation strategy document (cdc.gov/coronavirus/2019-ncov/downloads/community-mitigation-strategy.pdf).

2. Appointments with your oncologist: virtual or in-person?

It may be a good idea to consider rescheduling or switching to a virtual appointment if your treating physician or cancer center provides this option. Note that virtual appointments are not appropriate for infusions for chemotherapy or immunotherapy, or potentially critical scans. If you have an oncology visit due in the next couple of months, please contact your treating physician as soon as possible to discuss what’s the right approach for you and whether they anticipate any drug shortages due to supply chain disruption.

Several hospitals are now limiting the number of visitors and/or people accompanying patients to no more than one at a time.  In Seattle, the area hardest hit with cases, some hospitals are implementing the following measures to avoid being overwhelmed⁶:

• People with routine appointments are being screened for symptoms. Those who are sick are required to wear a mask or may not be allowed to enter the clinic. 
• Elective surgeries are being postponed.
• Patients who have flu-like symptoms or other concerns are asked to CALL their doctor rather than going directly to the Emergency Department or Urgent Care.
• If you are having difficulty breathing, please do go to the Emergency Department.

3. COVID-19 testing: where we are now

We are seeing transmission in the community, so it’s likely the virus is more widespread in the United States than we imagine. However, we don’t have hard data because testing was not implemented in the earlier days of the epidemic in the US.⁷ Right now, most people need to have symptoms before they can be tested.  As more test kits are distributed, testing will hopefully expand.  Drive-through testing has been made available in a few locations but is not yet widely available. As we have stated previously, the symptoms of COVID-19 infection include fever, dry cough and shortness of breath. If you suspect that you have been infected, you should call your doctor or local health department to determine next steps. The availability of tests varies on where you live.

The CDC is maintaining an updated list of where tests are currently being performed in the US.⁸

Additionally, state health departments are a valuable resource, providing hotlines and websites with information about what to do if you are concerned that you or a loved one might be infected (links in the references).

4. Voices from the community

Please check out Janet Freeman-Daily’s article where she describes her experience as a lung cancer survivor with a cough and the difficulties she faced to get tested for COVID-19. Janet lives in the Seattle, WA area, a COVID-19 hotspot.

Fred Hutchinson Cancer Research Center in Seattle published a helpful blog post, “Coronavirus: what cancer patients need to know.”

Resources and websites:

1. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. Coronavirus: What People with Cancer Should Know - https://www.cancer.gov/contact/emergency-preparedness/coronavirus
2. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), which can be found here:

• https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
• https://www.cdc.gov/coronavirus/2019-ncov/index.html

3. Johns Hopkins Coronavirus Resource Center is one of the best places to get current updates. https://coronavirus.jhu.edu/
4. You can find information specific to your state or city or town on your health department’s website.

• A list of state department of health websites can be found here: https://www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html
• A list of local health department websites can be found here: https://www.naccho.org/membership/lhd-directory

5. The American Medical Association is also maintaining a resource website for healthcare providers. You can find more information here: https://www.ama-assn.org/delivering-care/public-health/covid-19-2019-novel-coronavirus-resource-center-physicians
6. If you cannot avoid air travel, check out this handy article on “Dirtiest Places on Airplanes: How to Avoid Germs”: https://time.com/4877041/dirtiest-places-on-airplanes/

References

1. Chan JF, Yuan S, Kok KH, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020;395(10223):514-523.
2. Hoehl S, Berger A, Kortenbusch M, et al. Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China. N Engl J Med. 2020.
3. WHO. Coronavirus disease 2019 (COVID-19) Situation Report – 46. 2020.
4. CDC. Implementation of Mitigation Strategies for Communities with Local COVID-19 Transmission Coronavirus Disease 2019 (COVID-19) Web site. cdc.gov/coronavirus/2019-ncov/downloads/community-mitigation-strategy.pdf. Published 2020. Accessed March 15, 2020.
5. CDC. IInterim US Guidance for Risk Assessment and Public Health Management of Persons with Potential Coronavirus Disease 2019 (COVID-19) Exposures: Geographic Risk and Contacts of Laboratory-confirmed Cases. Coronavirus Disease 2019 (COVID-19) Web site. https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html. Published 2020. Accessed March 15, 2020.
6. UW. COVID-19 (formerly called Novel Coronavirus). https://www.uwmedicine.org/coronavirus. Published 2020. Accessed 2020, March 15.
7. Lambert J, Saey TH. Social distancing, not travel bans, is crucial to limiting coronavirus’ spread. Science News2020.
8. CDC. Testing in U.S. Coronavirus Disease 2019 (COVID-19) Web site. https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html. Published 2020. Accessed March 15, 2020.