Leukemia, Myelodysplasia, Transplantation

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.

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.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

In the fall of 2019, the University of Pennsylvania in Philadelphia started a pilot program of home-based chemotherapy for two treatment regimens (one via infusion and one via injection). Six months later, the Cancer Care at Home program had treated 40 patients.

The uptake within the university’s large regional health system was acceptable but not rapid, admitted Amy Laughlin, MD, a hematology-oncology fellow involved with the program.

Then COVID-19 arrived, along with related travel restrictions.

Suddenly, in a 5-week period (March to April 7), 175 patients had been treated – a 300% increase from the first half year. Program staff jumped from 12 to 80 employees. The list of chemotherapies delivered went from two to seven, with more coming.

“We’re not the pilot anymore – we’re the standard of care,” Laughlin told Medscape Medical News.

“The impact [on patients] is amazing,” she said. “As long as you are selecting the right patients and right therapy, it is feasible and even preferable for a lot of patients.”

For example, patients with hormone-positive breast cancer who receive leuprolide (to shut down the ovaries and suppress estrogen production) ordinarily would have to visit a Penn facility for an injection every month, potentially for years. Now, a nurse can meet patients at home (or before the COVID-19 pandemic, even at their place of work) and administer the injection, saving the patient travel time and associated costs.

This home-based chemotherapy service does not appear to be offered elsewhere in the United States, and a major oncology organization – the Community Oncology Alliance – is opposed to the practice because of patient safety concerns.

The service is not offered at a sample of cancer centers queried by Medscape Medical News, including the Dana-Farber Cancer Institute in Boston, the Moffitt Cancer Center in Tampa, the Huntsman Cancer Institute in Salt Lake City, Utah, and Moores Cancer Center, the University of California, San Diego.

Opposition because of safety concerns

On April 9, the Community Oncology Alliance (COA) issued a statement saying it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”

The COA warned that “many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening.”

In contrast, in a recent communication related to COVID-19, the National Comprehensive Cancer Network tacitly endorsed the concept, stating that a number of chemotherapies may potentially be administered at home, but it did not include guidelines for doing so.

The American Society of Clinical Oncology said that chemotherapy at home is “an issue [we] are monitoring closely,” according to a spokesperson.

What’s involved

Criteria for home-based chemotherapy at Penn include use of anticancer therapies that a patient has previously tolerated and low toxicity (that can be readily managed in the home setting). In addition, patients must be capable of following a med chart.

The chemotherapy is reconstituted at a Penn facility in a Philadelphia suburb. A courier then delivers the drug to the patient’s home, where it is administered by an oncology-trained nurse. Drugs must be stable for at least a few hours to qualify for the program.

The Penn program started with two regimens: EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone) for lymphoma, and leuprolide acetate injections for either breast or prostate cancer.

The two treatments are polar opposites in terms of complexity, common usage, and time required, which was intended, said Laughlin.

Time to deliver the chemo varies from a matter of minutes with leuprolide to more than 2 hours for rituximab, a lymphoma drug that may be added to EPOCH.

The current list of at-home chemo agents in the Penn program also includes bortezomib, lanreotide, zoledronic acid, and denosumab. Soon to come are rituximab and pembrolizumab for lung cancer and head and neck cancer.

Already practiced in some European countries

Home-based chemotherapy dates from at least the 1980s in the medical literature and is practiced in some European countries.

A 2018 randomized study of adjuvant treatment with capecitabine and oxaliplatin for stage II/III colon cancer in Denmark, where home-based care has been practiced for the past 2 years and is growing in use, concluded that “it might be a valuable alternative to treatment at an outpatient clinic.”

However, in the study, there was no difference in quality of life between the home and outpatient settings, which is somewhat surprising, inasmuch as a major appeal to receiving chemotherapy at home is that it is less disruptive compared to receiving it in a hospital or clinic, which requires travel.

Also, chemo at home “may be resource intensive” and have a “lower throughput of patients due to transportation time,” cautioned the Danish investigators, who were from Herlev and Gentofte Hospital.

A 2015 review called home chemo “a safe and patient‐centered alternative to hospital‐ and outpatient‐based service.” Jenna Evans, PhD, McMaster University, Toronto, Canada, and lead author of that review, says there are two major barriers to infusion chemotherapy in homes.

One is inadequate resources in the community, such as oncology-trained nurses to deliver treatment, and the other is perceptions of safety and quality, including among healthcare providers.

COVID-19 might prompt more chemo at home, said Evans, a health policy expert, in an email to Medscape Medical News. “It is not unusual for change of this type and scale to require a seismic event to become more mainstream,” she argued.

Reimbursement for home-based chemo is usually the same as for chemo in a free-standing infusion suite, says Cassandra Redmond, PharmD, MBA, director of pharmacy, Penn Home Infusion Therapy.

Private insurers and Medicare cover a subset of infused medications at home, but coverage is limited. “The opportunity now is to expand these initiatives ... to include other cancer therapies,” she said about coverage.
 

This article first appeared on Medscape.com.

In the fall of 2019, the University of Pennsylvania in Philadelphia started a pilot program of home-based chemotherapy for two treatment regimens (one via infusion and one via injection). Six months later, the Cancer Care at Home program had treated 40 patients.

The uptake within the university’s large regional health system was acceptable but not rapid, admitted Amy Laughlin, MD, a hematology-oncology fellow involved with the program.

Then COVID-19 arrived, along with related travel restrictions.

Suddenly, in a 5-week period (March to April 7), 175 patients had been treated – a 300% increase from the first half year. Program staff jumped from 12 to 80 employees. The list of chemotherapies delivered went from two to seven, with more coming.

“We’re not the pilot anymore – we’re the standard of care,” Laughlin told Medscape Medical News.

“The impact [on patients] is amazing,” she said. “As long as you are selecting the right patients and right therapy, it is feasible and even preferable for a lot of patients.”

For example, patients with hormone-positive breast cancer who receive leuprolide (to shut down the ovaries and suppress estrogen production) ordinarily would have to visit a Penn facility for an injection every month, potentially for years. Now, a nurse can meet patients at home (or before the COVID-19 pandemic, even at their place of work) and administer the injection, saving the patient travel time and associated costs.

This home-based chemotherapy service does not appear to be offered elsewhere in the United States, and a major oncology organization – the Community Oncology Alliance – is opposed to the practice because of patient safety concerns.

The service is not offered at a sample of cancer centers queried by Medscape Medical News, including the Dana-Farber Cancer Institute in Boston, the Moffitt Cancer Center in Tampa, the Huntsman Cancer Institute in Salt Lake City, Utah, and Moores Cancer Center, the University of California, San Diego.

Opposition because of safety concerns

On April 9, the Community Oncology Alliance (COA) issued a statement saying it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”

The COA warned that “many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening.”

In contrast, in a recent communication related to COVID-19, the National Comprehensive Cancer Network tacitly endorsed the concept, stating that a number of chemotherapies may potentially be administered at home, but it did not include guidelines for doing so.

The American Society of Clinical Oncology said that chemotherapy at home is “an issue [we] are monitoring closely,” according to a spokesperson.

What’s involved

Criteria for home-based chemotherapy at Penn include use of anticancer therapies that a patient has previously tolerated and low toxicity (that can be readily managed in the home setting). In addition, patients must be capable of following a med chart.

The chemotherapy is reconstituted at a Penn facility in a Philadelphia suburb. A courier then delivers the drug to the patient’s home, where it is administered by an oncology-trained nurse. Drugs must be stable for at least a few hours to qualify for the program.

The Penn program started with two regimens: EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone) for lymphoma, and leuprolide acetate injections for either breast or prostate cancer.

The two treatments are polar opposites in terms of complexity, common usage, and time required, which was intended, said Laughlin.

Time to deliver the chemo varies from a matter of minutes with leuprolide to more than 2 hours for rituximab, a lymphoma drug that may be added to EPOCH.

The current list of at-home chemo agents in the Penn program also includes bortezomib, lanreotide, zoledronic acid, and denosumab. Soon to come are rituximab and pembrolizumab for lung cancer and head and neck cancer.

Already practiced in some European countries

Home-based chemotherapy dates from at least the 1980s in the medical literature and is practiced in some European countries.

A 2018 randomized study of adjuvant treatment with capecitabine and oxaliplatin for stage II/III colon cancer in Denmark, where home-based care has been practiced for the past 2 years and is growing in use, concluded that “it might be a valuable alternative to treatment at an outpatient clinic.”

However, in the study, there was no difference in quality of life between the home and outpatient settings, which is somewhat surprising, inasmuch as a major appeal to receiving chemotherapy at home is that it is less disruptive compared to receiving it in a hospital or clinic, which requires travel.

Also, chemo at home “may be resource intensive” and have a “lower throughput of patients due to transportation time,” cautioned the Danish investigators, who were from Herlev and Gentofte Hospital.

A 2015 review called home chemo “a safe and patient‐centered alternative to hospital‐ and outpatient‐based service.” Jenna Evans, PhD, McMaster University, Toronto, Canada, and lead author of that review, says there are two major barriers to infusion chemotherapy in homes.

One is inadequate resources in the community, such as oncology-trained nurses to deliver treatment, and the other is perceptions of safety and quality, including among healthcare providers.

COVID-19 might prompt more chemo at home, said Evans, a health policy expert, in an email to Medscape Medical News. “It is not unusual for change of this type and scale to require a seismic event to become more mainstream,” she argued.

Reimbursement for home-based chemo is usually the same as for chemo in a free-standing infusion suite, says Cassandra Redmond, PharmD, MBA, director of pharmacy, Penn Home Infusion Therapy.

Private insurers and Medicare cover a subset of infused medications at home, but coverage is limited. “The opportunity now is to expand these initiatives ... to include other cancer therapies,” she said about coverage.
 

This article first appeared on Medscape.com.

In the fall of 2019, the University of Pennsylvania in Philadelphia started a pilot program of home-based chemotherapy for two treatment regimens (one via infusion and one via injection). Six months later, the Cancer Care at Home program had treated 40 patients.

The uptake within the university’s large regional health system was acceptable but not rapid, admitted Amy Laughlin, MD, a hematology-oncology fellow involved with the program.

Then COVID-19 arrived, along with related travel restrictions.

Suddenly, in a 5-week period (March to April 7), 175 patients had been treated – a 300% increase from the first half year. Program staff jumped from 12 to 80 employees. The list of chemotherapies delivered went from two to seven, with more coming.

“We’re not the pilot anymore – we’re the standard of care,” Laughlin told Medscape Medical News.

“The impact [on patients] is amazing,” she said. “As long as you are selecting the right patients and right therapy, it is feasible and even preferable for a lot of patients.”

For example, patients with hormone-positive breast cancer who receive leuprolide (to shut down the ovaries and suppress estrogen production) ordinarily would have to visit a Penn facility for an injection every month, potentially for years. Now, a nurse can meet patients at home (or before the COVID-19 pandemic, even at their place of work) and administer the injection, saving the patient travel time and associated costs.

This home-based chemotherapy service does not appear to be offered elsewhere in the United States, and a major oncology organization – the Community Oncology Alliance – is opposed to the practice because of patient safety concerns.

The service is not offered at a sample of cancer centers queried by Medscape Medical News, including the Dana-Farber Cancer Institute in Boston, the Moffitt Cancer Center in Tampa, the Huntsman Cancer Institute in Salt Lake City, Utah, and Moores Cancer Center, the University of California, San Diego.

Opposition because of safety concerns

On April 9, the Community Oncology Alliance (COA) issued a statement saying it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”

The COA warned that “many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening.”

In contrast, in a recent communication related to COVID-19, the National Comprehensive Cancer Network tacitly endorsed the concept, stating that a number of chemotherapies may potentially be administered at home, but it did not include guidelines for doing so.

The American Society of Clinical Oncology said that chemotherapy at home is “an issue [we] are monitoring closely,” according to a spokesperson.

What’s involved

Criteria for home-based chemotherapy at Penn include use of anticancer therapies that a patient has previously tolerated and low toxicity (that can be readily managed in the home setting). In addition, patients must be capable of following a med chart.

The chemotherapy is reconstituted at a Penn facility in a Philadelphia suburb. A courier then delivers the drug to the patient’s home, where it is administered by an oncology-trained nurse. Drugs must be stable for at least a few hours to qualify for the program.

The Penn program started with two regimens: EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone) for lymphoma, and leuprolide acetate injections for either breast or prostate cancer.

The two treatments are polar opposites in terms of complexity, common usage, and time required, which was intended, said Laughlin.

Time to deliver the chemo varies from a matter of minutes with leuprolide to more than 2 hours for rituximab, a lymphoma drug that may be added to EPOCH.

The current list of at-home chemo agents in the Penn program also includes bortezomib, lanreotide, zoledronic acid, and denosumab. Soon to come are rituximab and pembrolizumab for lung cancer and head and neck cancer.

Already practiced in some European countries

Home-based chemotherapy dates from at least the 1980s in the medical literature and is practiced in some European countries.

A 2018 randomized study of adjuvant treatment with capecitabine and oxaliplatin for stage II/III colon cancer in Denmark, where home-based care has been practiced for the past 2 years and is growing in use, concluded that “it might be a valuable alternative to treatment at an outpatient clinic.”

However, in the study, there was no difference in quality of life between the home and outpatient settings, which is somewhat surprising, inasmuch as a major appeal to receiving chemotherapy at home is that it is less disruptive compared to receiving it in a hospital or clinic, which requires travel.

Also, chemo at home “may be resource intensive” and have a “lower throughput of patients due to transportation time,” cautioned the Danish investigators, who were from Herlev and Gentofte Hospital.

A 2015 review called home chemo “a safe and patient‐centered alternative to hospital‐ and outpatient‐based service.” Jenna Evans, PhD, McMaster University, Toronto, Canada, and lead author of that review, says there are two major barriers to infusion chemotherapy in homes.

One is inadequate resources in the community, such as oncology-trained nurses to deliver treatment, and the other is perceptions of safety and quality, including among healthcare providers.

COVID-19 might prompt more chemo at home, said Evans, a health policy expert, in an email to Medscape Medical News. “It is not unusual for change of this type and scale to require a seismic event to become more mainstream,” she argued.

Reimbursement for home-based chemo is usually the same as for chemo in a free-standing infusion suite, says Cassandra Redmond, PharmD, MBA, director of pharmacy, Penn Home Infusion Therapy.

Private insurers and Medicare cover a subset of infused medications at home, but coverage is limited. “The opportunity now is to expand these initiatives ... to include other cancer therapies,” she said about coverage.
 

This article first appeared on Medscape.com.

Given the possibility that children with hematologic malignancies may have increased susceptibility to coronavirus disease 2019 (COVID-19), clinicians from China and the United States have proposed a plan for preventing and managing outbreaks in hospitals’ pediatric hematology and oncology departments.

The plan is focused primarily on infection prevention and control strategies, Yulei He, MD, of Chengdu (China) Women’s and Children’s Central Hospital and colleagues explained in an article published in The Lancet Haematology.

The authors noted that close contact with COVID-19 patients is thought to be the main route of transmission, and a retrospective study indicated that 41.3% of initial COVID-19 cases were caused by hospital-related transmission.

“Children with hematological malignancies might have increased susceptibility to infection with SARS-CoV-2 because of immunodeficiency; therefore, procedures are needed to avoid hospital-related transmission and infection for these patients,” the authors wrote.
 

Preventing the spread of infection

Dr. He and colleagues advised that medical staff be kept up-to-date with the latest information about COVID-19 and perform assessments regularly to identify cases in their departments.

The authors also recommended establishing a COVID-19 expert committee – consisting of infectious disease physicians, hematologists, oncologists, radiologists, pharmacists, and hospital infection control staff – to make medical decisions in multidisciplinary consultation meetings. In addition, the authors recommended regional management strategies be adopted to minimize cross infection within the hospital. Specifically, the authors proposed creating the following four zones:

1. A surveillance and screening zone for patients potentially infected with SARS-CoV-2

2. A suspected-case quarantine zone where patients thought to have COVID-19 are isolated in single rooms

3. A confirmed-case quarantine zone where patients are treated for COVID-19

4. A hematology/oncology ward for treating non–COVID-19 patients with malignancies.

Dr. He and colleagues also stressed the importance of providing personal protective equipment for all zones, along with instructions for proper use and disposal. The authors recommended developing and following specific protocols for outpatient visits in the hematology/oncology ward, and providing COVID-19 prevention and control information to families and health care workers.
 

Managing cancer treatment

For patients with acute leukemias who have induction chemotherapy planned, Dr. He and colleagues argued that scheduled chemotherapy should not be interrupted unless COVID-19 is suspected or diagnosed. The authors said treatment should not be delayed more than 7 days during induction, consolidation, or the intermediate phase of chemotherapy because the virus has an incubation period of 2-7 days. This will allow a short period of observation to screen for potential infection.

The authors recommended that patients with lymphoma and solid tumors first undergo COVID-19 screening and then receive treatment in hematology/oncology wards “according to their chemotherapy schedule, and without delay, until they are in complete remission.”

“If the patient is in complete remission, we recommend a treatment delay of no more than 7 days to allow a short period of observation to screen for COVID-19,” the authors added.

Maintenance chemotherapy should not be delayed for more than 14 days, Dr. He and colleagues wrote. “This increase in the maximum delay before chemotherapy strikes a balance between the potential risk of SARS-CoV-2 infection and tumor recurrence, since pediatric patients in this phase of treatment have a reduced risk of tumor recurrence,” the authors added.
 

Caring for patients with COVID-19

For inpatients diagnosed with COVID-19, Dr. He and colleagues recommended the following:

• Prioritize COVID-19 treatment for children with primary disease remission.
• For children not in remission, prioritize treatment for critical patients.
• Isolated patients should be treated for COVID-19, and their chemotherapy should be temporarily suspended or reduced in intensity..

Dr. He and colleagues noted that, by following these recommendations for infection prevention, they had no cases of COVID-19 among children in their hematology/oncology departments. However, the authors said the recommendations “could fail to some extent” based on “differences in medical resources, health care settings, and the policy of the specific government.”

The authors said their recommendations should be updated continuously as new information and clinical evidence emerges.

Dr. He and colleagues reported having no conflicts of interest.

[email protected]

SOURCE: He Y et al. Lancet Haematol. doi: 10/1016/s2352-3026(20)30104-6.

Given the possibility that children with hematologic malignancies may have increased susceptibility to coronavirus disease 2019 (COVID-19), clinicians from China and the United States have proposed a plan for preventing and managing outbreaks in hospitals’ pediatric hematology and oncology departments.

The plan is focused primarily on infection prevention and control strategies, Yulei He, MD, of Chengdu (China) Women’s and Children’s Central Hospital and colleagues explained in an article published in The Lancet Haematology.

The authors noted that close contact with COVID-19 patients is thought to be the main route of transmission, and a retrospective study indicated that 41.3% of initial COVID-19 cases were caused by hospital-related transmission.

“Children with hematological malignancies might have increased susceptibility to infection with SARS-CoV-2 because of immunodeficiency; therefore, procedures are needed to avoid hospital-related transmission and infection for these patients,” the authors wrote.
 

Preventing the spread of infection

Dr. He and colleagues advised that medical staff be kept up-to-date with the latest information about COVID-19 and perform assessments regularly to identify cases in their departments.

The authors also recommended establishing a COVID-19 expert committee – consisting of infectious disease physicians, hematologists, oncologists, radiologists, pharmacists, and hospital infection control staff – to make medical decisions in multidisciplinary consultation meetings. In addition, the authors recommended regional management strategies be adopted to minimize cross infection within the hospital. Specifically, the authors proposed creating the following four zones:

1. A surveillance and screening zone for patients potentially infected with SARS-CoV-2

2. A suspected-case quarantine zone where patients thought to have COVID-19 are isolated in single rooms

3. A confirmed-case quarantine zone where patients are treated for COVID-19

4. A hematology/oncology ward for treating non–COVID-19 patients with malignancies.

Dr. He and colleagues also stressed the importance of providing personal protective equipment for all zones, along with instructions for proper use and disposal. The authors recommended developing and following specific protocols for outpatient visits in the hematology/oncology ward, and providing COVID-19 prevention and control information to families and health care workers.
 

Managing cancer treatment

For patients with acute leukemias who have induction chemotherapy planned, Dr. He and colleagues argued that scheduled chemotherapy should not be interrupted unless COVID-19 is suspected or diagnosed. The authors said treatment should not be delayed more than 7 days during induction, consolidation, or the intermediate phase of chemotherapy because the virus has an incubation period of 2-7 days. This will allow a short period of observation to screen for potential infection.

The authors recommended that patients with lymphoma and solid tumors first undergo COVID-19 screening and then receive treatment in hematology/oncology wards “according to their chemotherapy schedule, and without delay, until they are in complete remission.”

“If the patient is in complete remission, we recommend a treatment delay of no more than 7 days to allow a short period of observation to screen for COVID-19,” the authors added.

Maintenance chemotherapy should not be delayed for more than 14 days, Dr. He and colleagues wrote. “This increase in the maximum delay before chemotherapy strikes a balance between the potential risk of SARS-CoV-2 infection and tumor recurrence, since pediatric patients in this phase of treatment have a reduced risk of tumor recurrence,” the authors added.
 

Caring for patients with COVID-19

For inpatients diagnosed with COVID-19, Dr. He and colleagues recommended the following:

• Prioritize COVID-19 treatment for children with primary disease remission.
• For children not in remission, prioritize treatment for critical patients.
• Isolated patients should be treated for COVID-19, and their chemotherapy should be temporarily suspended or reduced in intensity..

Dr. He and colleagues noted that, by following these recommendations for infection prevention, they had no cases of COVID-19 among children in their hematology/oncology departments. However, the authors said the recommendations “could fail to some extent” based on “differences in medical resources, health care settings, and the policy of the specific government.”

The authors said their recommendations should be updated continuously as new information and clinical evidence emerges.

Dr. He and colleagues reported having no conflicts of interest.

[email protected]

SOURCE: He Y et al. Lancet Haematol. doi: 10/1016/s2352-3026(20)30104-6.

Given the possibility that children with hematologic malignancies may have increased susceptibility to coronavirus disease 2019 (COVID-19), clinicians from China and the United States have proposed a plan for preventing and managing outbreaks in hospitals’ pediatric hematology and oncology departments.

The plan is focused primarily on infection prevention and control strategies, Yulei He, MD, of Chengdu (China) Women’s and Children’s Central Hospital and colleagues explained in an article published in The Lancet Haematology.

The authors noted that close contact with COVID-19 patients is thought to be the main route of transmission, and a retrospective study indicated that 41.3% of initial COVID-19 cases were caused by hospital-related transmission.

“Children with hematological malignancies might have increased susceptibility to infection with SARS-CoV-2 because of immunodeficiency; therefore, procedures are needed to avoid hospital-related transmission and infection for these patients,” the authors wrote.
 

Preventing the spread of infection

Dr. He and colleagues advised that medical staff be kept up-to-date with the latest information about COVID-19 and perform assessments regularly to identify cases in their departments.

The authors also recommended establishing a COVID-19 expert committee – consisting of infectious disease physicians, hematologists, oncologists, radiologists, pharmacists, and hospital infection control staff – to make medical decisions in multidisciplinary consultation meetings. In addition, the authors recommended regional management strategies be adopted to minimize cross infection within the hospital. Specifically, the authors proposed creating the following four zones:

1. A surveillance and screening zone for patients potentially infected with SARS-CoV-2

2. A suspected-case quarantine zone where patients thought to have COVID-19 are isolated in single rooms

3. A confirmed-case quarantine zone where patients are treated for COVID-19

4. A hematology/oncology ward for treating non–COVID-19 patients with malignancies.

Dr. He and colleagues also stressed the importance of providing personal protective equipment for all zones, along with instructions for proper use and disposal. The authors recommended developing and following specific protocols for outpatient visits in the hematology/oncology ward, and providing COVID-19 prevention and control information to families and health care workers.
 

Managing cancer treatment

For patients with acute leukemias who have induction chemotherapy planned, Dr. He and colleagues argued that scheduled chemotherapy should not be interrupted unless COVID-19 is suspected or diagnosed. The authors said treatment should not be delayed more than 7 days during induction, consolidation, or the intermediate phase of chemotherapy because the virus has an incubation period of 2-7 days. This will allow a short period of observation to screen for potential infection.

The authors recommended that patients with lymphoma and solid tumors first undergo COVID-19 screening and then receive treatment in hematology/oncology wards “according to their chemotherapy schedule, and without delay, until they are in complete remission.”

“If the patient is in complete remission, we recommend a treatment delay of no more than 7 days to allow a short period of observation to screen for COVID-19,” the authors added.

Maintenance chemotherapy should not be delayed for more than 14 days, Dr. He and colleagues wrote. “This increase in the maximum delay before chemotherapy strikes a balance between the potential risk of SARS-CoV-2 infection and tumor recurrence, since pediatric patients in this phase of treatment have a reduced risk of tumor recurrence,” the authors added.
 

Caring for patients with COVID-19

For inpatients diagnosed with COVID-19, Dr. He and colleagues recommended the following:

• Prioritize COVID-19 treatment for children with primary disease remission.
• For children not in remission, prioritize treatment for critical patients.
• Isolated patients should be treated for COVID-19, and their chemotherapy should be temporarily suspended or reduced in intensity..

Dr. He and colleagues noted that, by following these recommendations for infection prevention, they had no cases of COVID-19 among children in their hematology/oncology departments. However, the authors said the recommendations “could fail to some extent” based on “differences in medical resources, health care settings, and the policy of the specific government.”

The authors said their recommendations should be updated continuously as new information and clinical evidence emerges.

Dr. He and colleagues reported having no conflicts of interest.

[email protected]

SOURCE: He Y et al. Lancet Haematol. doi: 10/1016/s2352-3026(20)30104-6.

Approximately one-third of high-risk chronic lymphocytic leukemia (CLL) patients received chemoimmunotherapy that was not aligned with current CLL treatment recommendations, according to a study based upon data from the informCLL registry. In addition, low levels of prognostic marker testing in these patients was a concern.

Researchers assessed data from 840 enrolled CLL patients, of whom 459 (55%) were previously untreated, and 381 (45%) had relapsed/refractory disease. In terms of therapy, chemoimmunotherapy was more common in previously untreated patients, compared with relapsed/refractory patients (42% vs. 23%), whereas ibrutinib was more frequently used in relapsed/refractory vs. previously untreated patients (51% vs. 39%), according to the researchers.

Fluorescent in situ hybridization (FISH) testing, TP53 mutation, and immunoglobulin heavy chain somatic hypermutation biomarker testing were performed infrequently across all patients at registry enrollment, according to the authors.

Among patients who were tested, the rate of mutated TP53 was the same for previously untreated (14/54; 26%) and relapsed/refractory patients (9/35; 26%). In those patients who were tested, 34% with del(17p), a chromosomal deletion, and 26% of mutated TP53 patients received chemoimmunotherapy combinations. The authors stated that this was concerning in that it contradicts consensus guidelines based on data from several clinical studies. Chemoimmunotherapy is not recommended for these high-risk patients because of poor disease and survival outcomes with this treatment strategy, according to the authors.

“Current clinical practice is not keeping pace with recommendations and guidelines for prognostic

marker testing and subsequent selection of appropriate therapy,” the authors stated.

“Even with the approval of novel agents and updated guidelines, low rates of prognostic biomarker testing may lead to suboptimal therapy choices for patients with unknown risk status. In addition, we note that the presence of high-risk features (del(17p) and TP53) is unfortunately not translating to choosing the optimal therapy for these patients,” the researchers concluded.

The study was sponsored by an AbbVie Company and Janssen. The authors reported consulting and grants from these and other pharmaceutical companies.

[email protected]

SOURCE: Mato AR et al. Clin Lymphoma Myeloma Leuk. 2020;20(3):174-83.

Approximately one-third of high-risk chronic lymphocytic leukemia (CLL) patients received chemoimmunotherapy that was not aligned with current CLL treatment recommendations, according to a study based upon data from the informCLL registry. In addition, low levels of prognostic marker testing in these patients was a concern.

Researchers assessed data from 840 enrolled CLL patients, of whom 459 (55%) were previously untreated, and 381 (45%) had relapsed/refractory disease. In terms of therapy, chemoimmunotherapy was more common in previously untreated patients, compared with relapsed/refractory patients (42% vs. 23%), whereas ibrutinib was more frequently used in relapsed/refractory vs. previously untreated patients (51% vs. 39%), according to the researchers.

Fluorescent in situ hybridization (FISH) testing, TP53 mutation, and immunoglobulin heavy chain somatic hypermutation biomarker testing were performed infrequently across all patients at registry enrollment, according to the authors.

Among patients who were tested, the rate of mutated TP53 was the same for previously untreated (14/54; 26%) and relapsed/refractory patients (9/35; 26%). In those patients who were tested, 34% with del(17p), a chromosomal deletion, and 26% of mutated TP53 patients received chemoimmunotherapy combinations. The authors stated that this was concerning in that it contradicts consensus guidelines based on data from several clinical studies. Chemoimmunotherapy is not recommended for these high-risk patients because of poor disease and survival outcomes with this treatment strategy, according to the authors.

“Current clinical practice is not keeping pace with recommendations and guidelines for prognostic

marker testing and subsequent selection of appropriate therapy,” the authors stated.

“Even with the approval of novel agents and updated guidelines, low rates of prognostic biomarker testing may lead to suboptimal therapy choices for patients with unknown risk status. In addition, we note that the presence of high-risk features (del(17p) and TP53) is unfortunately not translating to choosing the optimal therapy for these patients,” the researchers concluded.

The study was sponsored by an AbbVie Company and Janssen. The authors reported consulting and grants from these and other pharmaceutical companies.

[email protected]

SOURCE: Mato AR et al. Clin Lymphoma Myeloma Leuk. 2020;20(3):174-83.

Approximately one-third of high-risk chronic lymphocytic leukemia (CLL) patients received chemoimmunotherapy that was not aligned with current CLL treatment recommendations, according to a study based upon data from the informCLL registry. In addition, low levels of prognostic marker testing in these patients was a concern.

Researchers assessed data from 840 enrolled CLL patients, of whom 459 (55%) were previously untreated, and 381 (45%) had relapsed/refractory disease. In terms of therapy, chemoimmunotherapy was more common in previously untreated patients, compared with relapsed/refractory patients (42% vs. 23%), whereas ibrutinib was more frequently used in relapsed/refractory vs. previously untreated patients (51% vs. 39%), according to the researchers.

Fluorescent in situ hybridization (FISH) testing, TP53 mutation, and immunoglobulin heavy chain somatic hypermutation biomarker testing were performed infrequently across all patients at registry enrollment, according to the authors.

Among patients who were tested, the rate of mutated TP53 was the same for previously untreated (14/54; 26%) and relapsed/refractory patients (9/35; 26%). In those patients who were tested, 34% with del(17p), a chromosomal deletion, and 26% of mutated TP53 patients received chemoimmunotherapy combinations. The authors stated that this was concerning in that it contradicts consensus guidelines based on data from several clinical studies. Chemoimmunotherapy is not recommended for these high-risk patients because of poor disease and survival outcomes with this treatment strategy, according to the authors.

“Current clinical practice is not keeping pace with recommendations and guidelines for prognostic

marker testing and subsequent selection of appropriate therapy,” the authors stated.

“Even with the approval of novel agents and updated guidelines, low rates of prognostic biomarker testing may lead to suboptimal therapy choices for patients with unknown risk status. In addition, we note that the presence of high-risk features (del(17p) and TP53) is unfortunately not translating to choosing the optimal therapy for these patients,” the researchers concluded.

The study was sponsored by an AbbVie Company and Janssen. The authors reported consulting and grants from these and other pharmaceutical companies.

[email protected]

SOURCE: Mato AR et al. Clin Lymphoma Myeloma Leuk. 2020;20(3):174-83.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

The US Food and Drug Administration has approved luspatercept (Reblozyl, Bristol-Myers Squibb/Acceleron) for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The green light represents the first treatment advancement in MDS in more than a decade, says an expert in the field.

Luspatercept is the first and so far only erythroid maturation agent (EMA), and was launched last year when it was approved for the treatment of anemia in adults with beta thalassemia, who require regular red blood cell transfusions.

The new approval is for the treatment of anemia in adult patients with very low- to intermediate-risk MDS with ring sideroblasts and patients with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, after they have progressed on treatment with an erythropoiesis-stimulating agent and who require two or more red blood cell (RBC) units over 8 weeks.

Luspatercept is not a substitute for RBC transfusions in patients who require immediate correction of anemia.

The FDA approval in MDS is based on results from the pivotal, placebo-controlled, phase 3 MEDALIST trial, conducted in 229 patients with very-low–, low- and intermediate-risk non-del(5q) MDS with ring sideroblasts. All patients were RBC transfusion-dependent and had disease that was refractory to, or unlikely to respond to, erythropoiesis-stimulating agents. Results were published in January in the New England Journal of Medicine. The study was funded by Acceleron Pharma and Celgene, which was later acquired by Bristol-Myers Squibb.

These results were first presented at the 2018 annual meeting of the American Society of Hematology (ASH), as reported by Medscape Medical News. At the time, ASH President Alexis Thompson, MD, said it appears that luspatercept can improve the production of endogenous RBCs by enhancing the maturation of these cells in the bone marrow. The drug significantly reduced the need for RBC transfusions, and “this is a very exciting advance for patients who would have few other treatment options,” she said.

“Anemia and the chronic need for transfusions is a very big issue for these patients,” commented lead study author Pierre Fenaux, MD, PhD, from Hôpital Saint-Louis in Paris, France. “With low hemoglobin levels, patients are tired all the time and have an increased risk of falls and cardiovascular events. When you can improve hemoglobin levels, you really see a difference in quality of life.”

The MEDALIST trial is an important milestone for patients with lower-risk, transfusion-dependent MDS, commented Elizabeth Griffiths, MD, associate professor of oncology and director of MDS, Roswell Park Comprehensive Cancer Center, Buffalo, New York.

“No new agents have been approved for MDS in the last 10 years, highlighting this development as a substantial step forward for the MDS community,” she told Medscape Medical News. “Current therapies are time-intensive and only modestly beneficial.”

“The availability of a new, effective drug — particularly relevant to those harboring SF3B1 mutations — is an exciting development and is likely to offer meaningful improvements in quality of life,” Griffiths said. “Since these patients tend to live longer than others with MDS, there are many patients in my clinical practice who would have fit the enrollment criteria for this study. Such patients are eagerly awaiting the opportunity for a decrease in transfusion burden.”
 

Study Details

In the trial, luspatercept reduced the severity of anemia — 38% of the 153 patients who received luspatercept achieved transfusion independence for 8 weeks or longer compared with 13% of the 76 patients receiving placebo (P < .001).

In the study, patients received luspatercept at a starting dose of 1.0 mg/kg with titration up to 1.75 mg/kg, if needed, or placebo, subcutaneously every 3 weeks for at least 24 weeks.

During the 16 weeks before the initiation of treatment, study patients had received a median of 5 RBC units transfusions during an 8-week period (43.2% of patients had ≥ 6 RBC units, 27.9% had ≥ 4 to < 6 RBC units, and 28.8% had < 4 RBC units). At baseline, 138 (60.3%), 58 (25.3%), and 32 (14%) patients had serum erythropoietin levels less than 200 IU/L, 200-500 IU/L, and greater than 500 IU/L, respectively.

The most common luspatercept-associated adverse events (any grade) in the trial were fatigue, diarrhea, asthenia, nausea, and dizziness. Grade 3 or 4 treatment-emergent adverse events were reported in 42.5% of patients who received luspatercept and 44.7% of patients who received placebo. The incidence of adverse events decreased over time, according to the study authors.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved luspatercept (Reblozyl, Bristol-Myers Squibb/Acceleron) for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The green light represents the first treatment advancement in MDS in more than a decade, says an expert in the field.

Luspatercept is the first and so far only erythroid maturation agent (EMA), and was launched last year when it was approved for the treatment of anemia in adults with beta thalassemia, who require regular red blood cell transfusions.

The new approval is for the treatment of anemia in adult patients with very low- to intermediate-risk MDS with ring sideroblasts and patients with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, after they have progressed on treatment with an erythropoiesis-stimulating agent and who require two or more red blood cell (RBC) units over 8 weeks.

Luspatercept is not a substitute for RBC transfusions in patients who require immediate correction of anemia.

The FDA approval in MDS is based on results from the pivotal, placebo-controlled, phase 3 MEDALIST trial, conducted in 229 patients with very-low–, low- and intermediate-risk non-del(5q) MDS with ring sideroblasts. All patients were RBC transfusion-dependent and had disease that was refractory to, or unlikely to respond to, erythropoiesis-stimulating agents. Results were published in January in the New England Journal of Medicine. The study was funded by Acceleron Pharma and Celgene, which was later acquired by Bristol-Myers Squibb.

These results were first presented at the 2018 annual meeting of the American Society of Hematology (ASH), as reported by Medscape Medical News. At the time, ASH President Alexis Thompson, MD, said it appears that luspatercept can improve the production of endogenous RBCs by enhancing the maturation of these cells in the bone marrow. The drug significantly reduced the need for RBC transfusions, and “this is a very exciting advance for patients who would have few other treatment options,” she said.

“Anemia and the chronic need for transfusions is a very big issue for these patients,” commented lead study author Pierre Fenaux, MD, PhD, from Hôpital Saint-Louis in Paris, France. “With low hemoglobin levels, patients are tired all the time and have an increased risk of falls and cardiovascular events. When you can improve hemoglobin levels, you really see a difference in quality of life.”

The MEDALIST trial is an important milestone for patients with lower-risk, transfusion-dependent MDS, commented Elizabeth Griffiths, MD, associate professor of oncology and director of MDS, Roswell Park Comprehensive Cancer Center, Buffalo, New York.

“No new agents have been approved for MDS in the last 10 years, highlighting this development as a substantial step forward for the MDS community,” she told Medscape Medical News. “Current therapies are time-intensive and only modestly beneficial.”

“The availability of a new, effective drug — particularly relevant to those harboring SF3B1 mutations — is an exciting development and is likely to offer meaningful improvements in quality of life,” Griffiths said. “Since these patients tend to live longer than others with MDS, there are many patients in my clinical practice who would have fit the enrollment criteria for this study. Such patients are eagerly awaiting the opportunity for a decrease in transfusion burden.”
 

Study Details

In the trial, luspatercept reduced the severity of anemia — 38% of the 153 patients who received luspatercept achieved transfusion independence for 8 weeks or longer compared with 13% of the 76 patients receiving placebo (P < .001).

In the study, patients received luspatercept at a starting dose of 1.0 mg/kg with titration up to 1.75 mg/kg, if needed, or placebo, subcutaneously every 3 weeks for at least 24 weeks.

During the 16 weeks before the initiation of treatment, study patients had received a median of 5 RBC units transfusions during an 8-week period (43.2% of patients had ≥ 6 RBC units, 27.9% had ≥ 4 to < 6 RBC units, and 28.8% had < 4 RBC units). At baseline, 138 (60.3%), 58 (25.3%), and 32 (14%) patients had serum erythropoietin levels less than 200 IU/L, 200-500 IU/L, and greater than 500 IU/L, respectively.

The most common luspatercept-associated adverse events (any grade) in the trial were fatigue, diarrhea, asthenia, nausea, and dizziness. Grade 3 or 4 treatment-emergent adverse events were reported in 42.5% of patients who received luspatercept and 44.7% of patients who received placebo. The incidence of adverse events decreased over time, according to the study authors.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved luspatercept (Reblozyl, Bristol-Myers Squibb/Acceleron) for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The green light represents the first treatment advancement in MDS in more than a decade, says an expert in the field.

Luspatercept is the first and so far only erythroid maturation agent (EMA), and was launched last year when it was approved for the treatment of anemia in adults with beta thalassemia, who require regular red blood cell transfusions.

The new approval is for the treatment of anemia in adult patients with very low- to intermediate-risk MDS with ring sideroblasts and patients with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, after they have progressed on treatment with an erythropoiesis-stimulating agent and who require two or more red blood cell (RBC) units over 8 weeks.

Luspatercept is not a substitute for RBC transfusions in patients who require immediate correction of anemia.

The FDA approval in MDS is based on results from the pivotal, placebo-controlled, phase 3 MEDALIST trial, conducted in 229 patients with very-low–, low- and intermediate-risk non-del(5q) MDS with ring sideroblasts. All patients were RBC transfusion-dependent and had disease that was refractory to, or unlikely to respond to, erythropoiesis-stimulating agents. Results were published in January in the New England Journal of Medicine. The study was funded by Acceleron Pharma and Celgene, which was later acquired by Bristol-Myers Squibb.

These results were first presented at the 2018 annual meeting of the American Society of Hematology (ASH), as reported by Medscape Medical News. At the time, ASH President Alexis Thompson, MD, said it appears that luspatercept can improve the production of endogenous RBCs by enhancing the maturation of these cells in the bone marrow. The drug significantly reduced the need for RBC transfusions, and “this is a very exciting advance for patients who would have few other treatment options,” she said.

“Anemia and the chronic need for transfusions is a very big issue for these patients,” commented lead study author Pierre Fenaux, MD, PhD, from Hôpital Saint-Louis in Paris, France. “With low hemoglobin levels, patients are tired all the time and have an increased risk of falls and cardiovascular events. When you can improve hemoglobin levels, you really see a difference in quality of life.”

The MEDALIST trial is an important milestone for patients with lower-risk, transfusion-dependent MDS, commented Elizabeth Griffiths, MD, associate professor of oncology and director of MDS, Roswell Park Comprehensive Cancer Center, Buffalo, New York.

“No new agents have been approved for MDS in the last 10 years, highlighting this development as a substantial step forward for the MDS community,” she told Medscape Medical News. “Current therapies are time-intensive and only modestly beneficial.”

“The availability of a new, effective drug — particularly relevant to those harboring SF3B1 mutations — is an exciting development and is likely to offer meaningful improvements in quality of life,” Griffiths said. “Since these patients tend to live longer than others with MDS, there are many patients in my clinical practice who would have fit the enrollment criteria for this study. Such patients are eagerly awaiting the opportunity for a decrease in transfusion burden.”
 

Study Details

In the trial, luspatercept reduced the severity of anemia — 38% of the 153 patients who received luspatercept achieved transfusion independence for 8 weeks or longer compared with 13% of the 76 patients receiving placebo (P < .001).

In the study, patients received luspatercept at a starting dose of 1.0 mg/kg with titration up to 1.75 mg/kg, if needed, or placebo, subcutaneously every 3 weeks for at least 24 weeks.

During the 16 weeks before the initiation of treatment, study patients had received a median of 5 RBC units transfusions during an 8-week period (43.2% of patients had ≥ 6 RBC units, 27.9% had ≥ 4 to < 6 RBC units, and 28.8% had < 4 RBC units). At baseline, 138 (60.3%), 58 (25.3%), and 32 (14%) patients had serum erythropoietin levels less than 200 IU/L, 200-500 IU/L, and greater than 500 IU/L, respectively.

The most common luspatercept-associated adverse events (any grade) in the trial were fatigue, diarrhea, asthenia, nausea, and dizziness. Grade 3 or 4 treatment-emergent adverse events were reported in 42.5% of patients who received luspatercept and 44.7% of patients who received placebo. The incidence of adverse events decreased over time, according to the study authors.

This article first appeared on Medscape.com.