AVAHO

Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.

The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.

Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.

“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.

Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.

The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.

Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:

• Include childhood cancer in universal health coverage.
• Develop national cancer control plans for low-income and middle-income countries.
• End out-of-pocket costs for childhood cancer.
• Establish national and regional cancer networks to increase access to care.
• Expand population-based cancer registries to include children.
• Invest in research and innovations in low-income and middle-income countries.

“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.

No funding sources were reported. The authors didn’t have any disclosures.

[email protected]

SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.

Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.

The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.

Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.

“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.

Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.

The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.

Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:

• Include childhood cancer in universal health coverage.
• Develop national cancer control plans for low-income and middle-income countries.
• End out-of-pocket costs for childhood cancer.
• Establish national and regional cancer networks to increase access to care.
• Expand population-based cancer registries to include children.
• Invest in research and innovations in low-income and middle-income countries.

“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.

No funding sources were reported. The authors didn’t have any disclosures.

[email protected]

SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.

Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.

The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.

Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.

“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.

Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.

The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.

Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:

• Include childhood cancer in universal health coverage.
• Develop national cancer control plans for low-income and middle-income countries.
• End out-of-pocket costs for childhood cancer.
• Establish national and regional cancer networks to increase access to care.
• Expand population-based cancer registries to include children.
• Invest in research and innovations in low-income and middle-income countries.

“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.

No funding sources were reported. The authors didn’t have any disclosures.

[email protected]

SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.

Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”

But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.

But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
 

COVID-19: A natural experiment

For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.

Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.

Until now.

The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.

The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
 

The pressure to ‘fight’

The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.

The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.

Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.

This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.

The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
 

Metaphors of war

These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.

Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.

When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.

After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.

Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

ORLANDO – Combination pepinemab and avelumab is well tolerated and shows antitumor activity in patients with advanced non–small cell lung cancer (NSCLC) who progressed on prior treatment, according to interim results from a phase 1b/2 trial.

Sharon Worcester/MDedge News

Treatment with pepinemab, an anti–semaphorin 4D antibody, and avelumab, a programmed death-ligand 1 (PD-L1) inhibitor, produced disease control rates of 59% in immunotherapy-resistant patients and 81% in immunotherapy-naive patients.

Michael Rahman Shafique, MD, of Moffitt Cancer Center in Tampa, Fla., reported these results at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The CLASSICAL-Lung trial initially enrolled 12 immunotherapy-naive patients with stage IIIb/IV NSCLC into a dose-escalation phase that examined pepinemab at doses of 5, 10, and 20 mg/kg along with 10 mg/kg of avelumab every 2 weeks.

Then, the trial enrolled 50 stage IIIb/IV patients – including 18 immunotherapy-naive patients and 32 who failed prior immunotherapy – into a phase 2 dose-expansion phase.

The 10 mg/kg pepinemab dose and 10 mg/kg avelumab dose were selected for the expansion phase based on the dose-escalation results, Dr. Shafique said. He explained that all three doses were safe, but “we were saturating the target at the 10-mg dose.”
 

Efficacy and safety

“In general, the safety data were encouraging,” Dr. Shafique said. “This was a very well-tolerated combination with no concerning safety signals. The most common adverse events were grade 1 and grade 2 fatigue, chills, pyrexia, and no grade 5 events attributable to the combination were reported.”

In the efficacy analysis, there were 29 evaluable patients who received pepinemab and avelumab after progressing on prior immunotherapy and were followed for at least 6 months. Two of these patients experienced a confirmed partial response (PR), and 15 had stable disease, for a disease control rate of 59%. Five patients had durable clinical benefit lasting at least 23 weeks, and three remained on active treatment at last follow-up, including one who had been on treatment for more than a year.

Of 21 evaluable immunotherapy-naive patients followed for at least 6 months, 5 experienced a confirmed PR, and 12 had stable disease, for a disease control rate of 81%. Three patients had clinical benefit lasting at least a year, and two remained on study and continued to receive treatment at last follow-up.

Pre- and on-treatment biopsies performed on the same lesion about 5 weeks apart demonstrated “a pretty drastic reduction in viable tumor,” Dr. Shafique noted.

“Even in patients with stable disease, many of them had absent tumor on these repeat, on-treatment biopsies,” he said, also noting that CD8-positive T-cell density increased in most tumors following treatment in patients who had a PR or stable disease, and the levels appeared to correspond with response.
 

Mechanism of action

Despite advances in immunotherapy, NSCLC patients often are refractory or acquire resistance to currently available agents, but semaphorin 4D “seems to shift the balance in the microenvironment to one of myeloid-induced immune suppression and generally a protumor, if you will, microenvironment,” Dr. Shafique said.

“Blockade of semaphorin 4D with pepinemab, we think, helps relieve this suppressive environment and actually seems to stimulate infiltration of T cells and improve T-cell activity in these tumors,” he added. He went on to explain that the mechanism of action is believed to generally be through suppression of myeloid cell trafficking to the tumor and myeloid cell cytokine secretion.

Further, and more importantly for cancer immunotherapy, preclinical models suggest that anti–semaphorin 4D antibodies are synergistic with various checkpoint inhibitors, including the PD-L1 inhibitor avelumab and others, Dr. Shafique said.

Indeed, these early CLASSICAL-Lung trial findings “do support the mechanism of action being reversing this myeloid-induced suppression in the microenvironment and improving T-cell infiltration and activity,” and they support a potential benefit of combining anti–semaphorin 4D antibodies and checkpoint inhibition in advanced NSCLC after progression on prior therapy, Dr. Shafique added.

Sharon Worcester/MDedge News

Invited discussant Timothy A. Yap, MBBS, of the University of Texas MD Anderson Cancer Center in Houston, said that “inhibition of [semaphorin 4D] promotes functional immune infiltration into the [tumor microenvironment] and, therefore, is a rational way of inhibiting tumor progression” in NSCLC and other cancers.

The CLASSICAL-Lung trial “didn’t escalate all the way to the [maximum tolerated dose] but did demonstrate durable on-treatment increases in CD8-positive T-cell infiltration, including in 79% of patients with low or null PD-L1 expression, as proof of mechanism,” Dr. Yap said, noting the responses in both immunotherapy-naive and immunotherapy-resistant patients.

“So I guess the key question will be, ‘Is this an active combination in NSCLC?’ ” Dr. Yap said. “In my opinion, yes it is, but is it going to be enough to take it past registration?”
 

Next steps

As next steps for the investigators, Dr. Yap suggested looking at a more specific population of PD-L1–low or –null immunotherapy-resistant NSCLC patients, considering adding a chemotherapy agent to the pepinemab/avelumab combination, or perhaps going “straight to a randomized phase 2/3 trial [comparing the combination with] pembrolizumab.”

“The investigators should also consider other tumor types beyond non–small cell lung cancer with this particular combination,” he said.

The preclinical data with respect to the anti–semaphorin 4D antibody suggest that study in combination with other agents, such as anti–CTLA-4 agents or anti-LAG3 agents, is also warranted, Dr. Yap added, noting that triplet combinations might also be worth investigating.

The CLASSICAL-Lung trial is funded by Vaccinex and Merck. Dr. Shafique reported a consulting or advisory role with GlaxoSmithKline. Dr. Yap reported relationships with numerous pharmaceutical companies, including Merck. MD Anderson’s Institute of Applied Cancer Science, where Dr. Yap serves as medical director, has a commercial interest in DNA damage response inhibitors and other inhibitors.

[email protected]

SOURCE: Shafique MR et al. ASCO-SITC 2020, Abstract 75.

ORLANDO – Combination pepinemab and avelumab is well tolerated and shows antitumor activity in patients with advanced non–small cell lung cancer (NSCLC) who progressed on prior treatment, according to interim results from a phase 1b/2 trial.

Sharon Worcester/MDedge News

Treatment with pepinemab, an anti–semaphorin 4D antibody, and avelumab, a programmed death-ligand 1 (PD-L1) inhibitor, produced disease control rates of 59% in immunotherapy-resistant patients and 81% in immunotherapy-naive patients.

Michael Rahman Shafique, MD, of Moffitt Cancer Center in Tampa, Fla., reported these results at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The CLASSICAL-Lung trial initially enrolled 12 immunotherapy-naive patients with stage IIIb/IV NSCLC into a dose-escalation phase that examined pepinemab at doses of 5, 10, and 20 mg/kg along with 10 mg/kg of avelumab every 2 weeks.

Then, the trial enrolled 50 stage IIIb/IV patients – including 18 immunotherapy-naive patients and 32 who failed prior immunotherapy – into a phase 2 dose-expansion phase.

The 10 mg/kg pepinemab dose and 10 mg/kg avelumab dose were selected for the expansion phase based on the dose-escalation results, Dr. Shafique said. He explained that all three doses were safe, but “we were saturating the target at the 10-mg dose.”
 

Efficacy and safety

“In general, the safety data were encouraging,” Dr. Shafique said. “This was a very well-tolerated combination with no concerning safety signals. The most common adverse events were grade 1 and grade 2 fatigue, chills, pyrexia, and no grade 5 events attributable to the combination were reported.”

In the efficacy analysis, there were 29 evaluable patients who received pepinemab and avelumab after progressing on prior immunotherapy and were followed for at least 6 months. Two of these patients experienced a confirmed partial response (PR), and 15 had stable disease, for a disease control rate of 59%. Five patients had durable clinical benefit lasting at least 23 weeks, and three remained on active treatment at last follow-up, including one who had been on treatment for more than a year.

Of 21 evaluable immunotherapy-naive patients followed for at least 6 months, 5 experienced a confirmed PR, and 12 had stable disease, for a disease control rate of 81%. Three patients had clinical benefit lasting at least a year, and two remained on study and continued to receive treatment at last follow-up.

Pre- and on-treatment biopsies performed on the same lesion about 5 weeks apart demonstrated “a pretty drastic reduction in viable tumor,” Dr. Shafique noted.

“Even in patients with stable disease, many of them had absent tumor on these repeat, on-treatment biopsies,” he said, also noting that CD8-positive T-cell density increased in most tumors following treatment in patients who had a PR or stable disease, and the levels appeared to correspond with response.
 

Mechanism of action

Despite advances in immunotherapy, NSCLC patients often are refractory or acquire resistance to currently available agents, but semaphorin 4D “seems to shift the balance in the microenvironment to one of myeloid-induced immune suppression and generally a protumor, if you will, microenvironment,” Dr. Shafique said.

“Blockade of semaphorin 4D with pepinemab, we think, helps relieve this suppressive environment and actually seems to stimulate infiltration of T cells and improve T-cell activity in these tumors,” he added. He went on to explain that the mechanism of action is believed to generally be through suppression of myeloid cell trafficking to the tumor and myeloid cell cytokine secretion.

Further, and more importantly for cancer immunotherapy, preclinical models suggest that anti–semaphorin 4D antibodies are synergistic with various checkpoint inhibitors, including the PD-L1 inhibitor avelumab and others, Dr. Shafique said.

Indeed, these early CLASSICAL-Lung trial findings “do support the mechanism of action being reversing this myeloid-induced suppression in the microenvironment and improving T-cell infiltration and activity,” and they support a potential benefit of combining anti–semaphorin 4D antibodies and checkpoint inhibition in advanced NSCLC after progression on prior therapy, Dr. Shafique added.

Sharon Worcester/MDedge News

Invited discussant Timothy A. Yap, MBBS, of the University of Texas MD Anderson Cancer Center in Houston, said that “inhibition of [semaphorin 4D] promotes functional immune infiltration into the [tumor microenvironment] and, therefore, is a rational way of inhibiting tumor progression” in NSCLC and other cancers.

The CLASSICAL-Lung trial “didn’t escalate all the way to the [maximum tolerated dose] but did demonstrate durable on-treatment increases in CD8-positive T-cell infiltration, including in 79% of patients with low or null PD-L1 expression, as proof of mechanism,” Dr. Yap said, noting the responses in both immunotherapy-naive and immunotherapy-resistant patients.

“So I guess the key question will be, ‘Is this an active combination in NSCLC?’ ” Dr. Yap said. “In my opinion, yes it is, but is it going to be enough to take it past registration?”
 

Next steps

As next steps for the investigators, Dr. Yap suggested looking at a more specific population of PD-L1–low or –null immunotherapy-resistant NSCLC patients, considering adding a chemotherapy agent to the pepinemab/avelumab combination, or perhaps going “straight to a randomized phase 2/3 trial [comparing the combination with] pembrolizumab.”

“The investigators should also consider other tumor types beyond non–small cell lung cancer with this particular combination,” he said.

The preclinical data with respect to the anti–semaphorin 4D antibody suggest that study in combination with other agents, such as anti–CTLA-4 agents or anti-LAG3 agents, is also warranted, Dr. Yap added, noting that triplet combinations might also be worth investigating.

The CLASSICAL-Lung trial is funded by Vaccinex and Merck. Dr. Shafique reported a consulting or advisory role with GlaxoSmithKline. Dr. Yap reported relationships with numerous pharmaceutical companies, including Merck. MD Anderson’s Institute of Applied Cancer Science, where Dr. Yap serves as medical director, has a commercial interest in DNA damage response inhibitors and other inhibitors.

[email protected]

SOURCE: Shafique MR et al. ASCO-SITC 2020, Abstract 75.

ORLANDO – Combination pepinemab and avelumab is well tolerated and shows antitumor activity in patients with advanced non–small cell lung cancer (NSCLC) who progressed on prior treatment, according to interim results from a phase 1b/2 trial.

Sharon Worcester/MDedge News

Treatment with pepinemab, an anti–semaphorin 4D antibody, and avelumab, a programmed death-ligand 1 (PD-L1) inhibitor, produced disease control rates of 59% in immunotherapy-resistant patients and 81% in immunotherapy-naive patients.

Michael Rahman Shafique, MD, of Moffitt Cancer Center in Tampa, Fla., reported these results at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The CLASSICAL-Lung trial initially enrolled 12 immunotherapy-naive patients with stage IIIb/IV NSCLC into a dose-escalation phase that examined pepinemab at doses of 5, 10, and 20 mg/kg along with 10 mg/kg of avelumab every 2 weeks.

Then, the trial enrolled 50 stage IIIb/IV patients – including 18 immunotherapy-naive patients and 32 who failed prior immunotherapy – into a phase 2 dose-expansion phase.

The 10 mg/kg pepinemab dose and 10 mg/kg avelumab dose were selected for the expansion phase based on the dose-escalation results, Dr. Shafique said. He explained that all three doses were safe, but “we were saturating the target at the 10-mg dose.”
 

Efficacy and safety

“In general, the safety data were encouraging,” Dr. Shafique said. “This was a very well-tolerated combination with no concerning safety signals. The most common adverse events were grade 1 and grade 2 fatigue, chills, pyrexia, and no grade 5 events attributable to the combination were reported.”

In the efficacy analysis, there were 29 evaluable patients who received pepinemab and avelumab after progressing on prior immunotherapy and were followed for at least 6 months. Two of these patients experienced a confirmed partial response (PR), and 15 had stable disease, for a disease control rate of 59%. Five patients had durable clinical benefit lasting at least 23 weeks, and three remained on active treatment at last follow-up, including one who had been on treatment for more than a year.

Of 21 evaluable immunotherapy-naive patients followed for at least 6 months, 5 experienced a confirmed PR, and 12 had stable disease, for a disease control rate of 81%. Three patients had clinical benefit lasting at least a year, and two remained on study and continued to receive treatment at last follow-up.

Pre- and on-treatment biopsies performed on the same lesion about 5 weeks apart demonstrated “a pretty drastic reduction in viable tumor,” Dr. Shafique noted.

“Even in patients with stable disease, many of them had absent tumor on these repeat, on-treatment biopsies,” he said, also noting that CD8-positive T-cell density increased in most tumors following treatment in patients who had a PR or stable disease, and the levels appeared to correspond with response.
 

Mechanism of action

Despite advances in immunotherapy, NSCLC patients often are refractory or acquire resistance to currently available agents, but semaphorin 4D “seems to shift the balance in the microenvironment to one of myeloid-induced immune suppression and generally a protumor, if you will, microenvironment,” Dr. Shafique said.

“Blockade of semaphorin 4D with pepinemab, we think, helps relieve this suppressive environment and actually seems to stimulate infiltration of T cells and improve T-cell activity in these tumors,” he added. He went on to explain that the mechanism of action is believed to generally be through suppression of myeloid cell trafficking to the tumor and myeloid cell cytokine secretion.

Further, and more importantly for cancer immunotherapy, preclinical models suggest that anti–semaphorin 4D antibodies are synergistic with various checkpoint inhibitors, including the PD-L1 inhibitor avelumab and others, Dr. Shafique said.

Indeed, these early CLASSICAL-Lung trial findings “do support the mechanism of action being reversing this myeloid-induced suppression in the microenvironment and improving T-cell infiltration and activity,” and they support a potential benefit of combining anti–semaphorin 4D antibodies and checkpoint inhibition in advanced NSCLC after progression on prior therapy, Dr. Shafique added.

Sharon Worcester/MDedge News

Invited discussant Timothy A. Yap, MBBS, of the University of Texas MD Anderson Cancer Center in Houston, said that “inhibition of [semaphorin 4D] promotes functional immune infiltration into the [tumor microenvironment] and, therefore, is a rational way of inhibiting tumor progression” in NSCLC and other cancers.

The CLASSICAL-Lung trial “didn’t escalate all the way to the [maximum tolerated dose] but did demonstrate durable on-treatment increases in CD8-positive T-cell infiltration, including in 79% of patients with low or null PD-L1 expression, as proof of mechanism,” Dr. Yap said, noting the responses in both immunotherapy-naive and immunotherapy-resistant patients.

“So I guess the key question will be, ‘Is this an active combination in NSCLC?’ ” Dr. Yap said. “In my opinion, yes it is, but is it going to be enough to take it past registration?”
 

Next steps

As next steps for the investigators, Dr. Yap suggested looking at a more specific population of PD-L1–low or –null immunotherapy-resistant NSCLC patients, considering adding a chemotherapy agent to the pepinemab/avelumab combination, or perhaps going “straight to a randomized phase 2/3 trial [comparing the combination with] pembrolizumab.”

“The investigators should also consider other tumor types beyond non–small cell lung cancer with this particular combination,” he said.

The preclinical data with respect to the anti–semaphorin 4D antibody suggest that study in combination with other agents, such as anti–CTLA-4 agents or anti-LAG3 agents, is also warranted, Dr. Yap added, noting that triplet combinations might also be worth investigating.

The CLASSICAL-Lung trial is funded by Vaccinex and Merck. Dr. Shafique reported a consulting or advisory role with GlaxoSmithKline. Dr. Yap reported relationships with numerous pharmaceutical companies, including Merck. MD Anderson’s Institute of Applied Cancer Science, where Dr. Yap serves as medical director, has a commercial interest in DNA damage response inhibitors and other inhibitors.

[email protected]

SOURCE: Shafique MR et al. ASCO-SITC 2020, Abstract 75.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.