May 4, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

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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) reports 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:

  • What are the implications of COVID-19 for my personal cancer treatment?
  • How do I make sense of contradictory COVID-19 information?
  • 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 for 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 here.

 

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 are 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 anti-malarial 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.

EBM Pyramid and EBM Page Generator, copyright 2006 Trustees of Dartmouth College and Yale University. All Rights Reserved. Produced by Jan Glover, David Izzo, Karen Odato and Lei Wang.

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 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
  1. American Medical Association resources for healthcare providers.

March 30, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.

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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 life-saving 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 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:
  1. 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
  1. If you cannot avoid air travel, check out this handy article on “Dirtiest Places on Airplanes: How to Avoid Germshttps://time.com/4877041/dirtiest-places-on-airplanes/


GO2 Foundation for Lung Cancer
(Amy Moore, PhD amoore@go2foundation.org )
LUNGevity Foundation (Upal Basu Roy, PhD, MPH ubasuroy@lungevity.org )
Lung Cancer Foundation of America (Kim Norris KNorris@lcfamerica.org )
Lung Cancer Research Foundation (Jan Baranski, PhD jbaranski@lcrf.org)
LungCAN (Kimberly Lester kimberly@lungcan.org)

@IASLC STARS program statement about #coronavirus and #COVID19

The IASLC STARS program develops new patient research advocates (PRAs) to help accelerate lung cancer research. You’ll find program info and PRA and Mentor applications at https://www.iaslc.org/Research-Education/Supportive-Training-for-Advocates-in-Research-and-Science-STARS>https://www.iaslc.org/Research-Education/Supportive-Training-for-Advocates-in-Research-and-Science-STARS.

We encourage you to apply by March 16!

Be sure to read the Guidelines and FAQs before applying. They contain useful information you’ll need to make a strong application.

The program is making contingency plans to ensure STARS will happen in some form despite concerns about the novel coronavirus and COVID-19. Here’s the official IASLC statement:

 

PLEASE NOTE A CHANGE IN PROGRAM REQUIREMENTS, AS OF 9-MARCH-2020:
Yes, you CAN still apply if you or your loved one has experienced cancer progression recently. The health and safety of the lung cancer community is our top priority. PRAs and Mentors who have or had lung cancer and who are selected for the program will need to provide a letter from their primary lung cancer physician stating that the applicant is in adequate health to travel to Singapore in August 2020 and fully participate in all required STARS activities.

Lung cancer patient and 2019 STARS Mentor Jill Feldman blogged her experience with the program here: https://lungcancer.net/living/stars-program/

Hear more about the IASLC STARS program in this video:

Targeted Therapies in Lung Cancer (#TTLC20) 20th Anniversary Meeting — IASLC Podcast

Ever wonder what happens at the annual IASLC Targeted Therapies in Lung Cancer (#TTLC20) meeting in Santa Monica, California? To mark the meeting’s 20th Anniversay this week, I chatted with two of the co-chairs, Drs. Paul Bunn and Suresh Ramalingam, on the IASLC “Lung Cancer Considered” podcast. Listen or download here:

Help guide efforts to modernize ClinicalTrials.gov — submit comments by 14-March-2020

ALL HANDS ON DECK! Engaged patients, patient advocates, research advocates:  this means YOU.

Clinicaltrials.gov (the federal website that lists all available clinical trials) is being modernized, and they want to hear from YOU. Please submit your comments and suggestions about the clinical trials submission process, site functionality, data standards, ease of searching, etc by 14-Mar-2020 at https://nlmenterprise.co1.qualtrics.com/jfe/form/SV_e2rLEUAx99myump

A public meeting will be held April 30 to discuss the submissions.

What is an IRB and why should patients care?

Image credit:  This Photo by Unknown Author is licensed under CC BY-ND

Better lung cancer treatment lowers overall cancer death rate–yet stigma persists

STAT News published an article today titled “U.S. cancer death rate drops by largest annual margin ever, report says.” An excerpt says:

The overall cancer death rate has been falling about 1.5% a year since 1991. It fell 2.2% from 2016 to 2017, according to the new American Cancer Society report. That’s the largest drop ever seen in national cancer statistics going back to 1930, said Rebecca Siegel, the lead author.  ‘It’s absolutely driven by lung cancer,’ which accounts for about a quarter of all cancer deaths, she said. Take lung cancer out of the mix, and the 2017 rate drop is 1.4%, she added.

Experts mainly credit advances in treatment. Topping the list are refinements in surgery, better diagnostic scanning, and more precise use of radiation.

They also celebrate the impact of newer drugs. Genetic testing can now identify specific cancer cell mutations, which allow more targeted therapy using newer pharmaceuticals that are a step beyond traditional chemotherapy.

This news reinforces National Cancer Institute (NCI) data published in 2019 that the lung cancer 5-year survival rate rose to 19.4% for all types of lung cancer.  When I was diagnosed with lung cancer in 2011, the 5-year survival rate for lung cancer was only 16%, and the majority of lung cancer patients survived less than one year. As the STAT article says, it has a LOT do with newer lung cancer diagnosis and treatment options. A major contributor is genomic testing of tumors, and the targeted therapies that can inhibit cancer cells driven by altered genes.  Patients on some targeted therapies have a median survival of over five years! About 30% of non-small cell lung cancer patients are currently eligible to take some form of targeted therapy, and that number may soon rise to 50%.

The benefits of targeted therapies have just begun to affect the NCI’s five-year survival stats. The first successful lung cancer targeted therapy clinical trial (crizotinib for ALK-positive non-small cell lung cancer) began in 2007, and the drug was approved in 2011. The NCI’s 2019 stats are based on data collected between 2009 and 2015. The survival rate will continue to go up due to approval of more targeted therapies, as well as the advent of immunotherapy (first approved in 2014), more precise radiation treatments, better surgical techniques, and early detection with lung cancer screening. When lung cancer is caught in early stages, 80% of patients are CURABLE.

However, despite obtaining their information from same source (the Associated Press), some media outlets have emphasized different angles of this story. An National Public Radio (NPR) article states, “What’s behind the decline [in cancer deaths]? In part, smoking rates have fallen steadily, which means the biggest risk factor for lung cancer has fallen appreciably. New cancer treatments are also playing a role, Siegel says.” (That’s ALL NPR’s article says about the contribution of better lung cancer treatment to the reduction of cancer deaths).

I wish the media would stop emphasizing smoking cessation as the cure for lung cancer death, instead of the significant advancements lung cancer treatment. Anyone with lungs can get lung cancer. An increasing number of lung cancer cases (currently around 20%) occur in never smokers. While overall lung cancer deaths have been dropping slightly, the death rate in young women who have never smoked is actually RISING. The World Health Organization has acknolwedged that air pollution is a risk factor for lung cancer, as is exposure to radon gas and other environmental exposures.

Crediting smoking cessation as the primary reason for reduction in lung cancer deaths perpetuates stigma, which contributes to worse lung cancer outcomes through physician nihilism, patient anxiety depression, and reduced funding for lung cancer research. Once a person has been diagnosed with a serious disease, they should receive the same compassion and treatment regardless of their personal characteristics. Blaming the patient and telling them to stop smoking never cured anyone.  But it may prevent the patient from experiencing the best possible outcome for their disease. Why won’t the media emphasize very real contribution–and the hope–offered by better lung cancer treatments ?

So, when you see news about the reduction in cancer deaths (and lung cancer in particular), please look past the errant “due primarily to smoking reduction” emphasis.  Focus instead on the hope offered by cancer research and the increasing number of new lung cancer therapies.  We don’t have a lung cancer cure for everyone, but researchers are working on it. Those touched by lung cancer need that hope.

We’re getting better at killing lung cancer.  Stigma is SO much harder to kill.