Roxanne Nelson

CHICAGO –Only 4% of patients with liver cancer who are awaiting transplant undergo external-beam radiotherapy (EBRT), even though this is a safe and effective bridging therapy. It is greatly underutilized compared to other liver-directed therapies, according to new findings.

“This highlights a real-world gap in the treatment armamentarium for hepatocellular carcinoma [HCC],” said Nima Nabavizadeh, MD, associate professor of radiation oncology and residency program director at the Oregon Health and Science University, Portland.

He was speaking at the annual meeting of the American Society for Radiation Oncology.

These new data suggest there is reluctance within transplant programs to utilize radiotherapy as a bridging therapy prior to liver transplant, said Hyun Kim, MD, chief, GI service, department of radiation oncology, Washington University and the Alvin J. Siteman Cancer Center, St. Louis.

“This is despite 10-year-old data from Princess Margaret and Toronto General Hospital showing that external-beam radiation is a safe and feasible bridging therapy,” he said. “More modern data from the same institutions indicate that patients bridged with stereotactic body radiotherapy ablative radiation doses delivered with high conformality have similar survival as patients bridged with radiofrequency ablation.”

Dr. Kim also noted that even after transplant, rates of intrahepatic recurrence can be as high as 10%. Approximately 60% of patients experience recurrence of any type within 3 years.

“Nonablative local therapies leave viable disease, which may permit metastatic progression while the patient awaits transplant,” he said in an interview. This new analysis highlights the need for well-designed clinical trials with modern endpoints to evaluate which bridging therapy is most beneficial for the patient, he added.

In this current “era of radiomics, deep learning, and liquid biopsies, we have unprecedented tools and responsibility to ensure that our practice continues to improve in a data-centric fashion and not remain paused in the paradigm of a previous era,” Dr. Kim said.
 

A leading cause of death worldwide

HCC is a leading cause of cancer death worldwide, and the incidence is rising within the United States. Transplant is often the best option for long-term survival for patients with localized HCC and advanced cirrhosis, Dr. Nabavizadeh told the meeting.

Because patients often have to wait months to over a year for a transplant, many patients receive liver-directed bridging therapy to prevent tumor growth or spread and to maintain their eligibility for transplant, he explained.

These bridging therapies include thermal ablation procedures, transarterial chemoembolization (TACE), and Y-90 radioembolization, as well as EBRT.

To investigate how these therapies were being used, Dr. Nabavizadeh and colleagues conducted a retrospective study in which they analyzed data from the United Network for Organ Sharing, a nonprofit organization that manages the only national liver transplant waiting list in the United States.

They identified patients on the transplant list who had applied for Model of End-Stage Liver Disease (MELD) exceptions so as to be prioritized on the waiting list.

A total of 18,447 HCC patients submitted MELD exception applications during the study period (October 2013 to June 2020). More than half of these patients (n = 11,171; 60.6%) received a transplant. After submitting the exception application, the median time for receiving a transplant was 7 months.

Of the total group, 15,759 patients (85.4%) received liver-directed therapy while waiting for the transplant, but only 658 patients (3.6% of the overall cohort) received EBRT, either alone or in combination with another therapy.

“The majority of patients received chemoembolization, and ERBT represents a very small percentage,” Dr. Nabavizadeh said.

During the study period, the use of transarterial chemoembolization decreased. It has largely been replaced by thermal ablation and Y-90 radioembolization. The analysis also showed that the use of EBRT had increased over the past several years, but its utilization still remained well below that of the other therapies.

TACE was the most utilized therapy. It was used for 39.6% of patients, followed by thermal ablation (12.8%) and radioembolization (8.7%). Almost a quarter of patients (22.2%) received a combination of non-EBRT therapies.

“We found that EBRT use significantly differed by region,” Dr. Nabavizadeh said. The highest usage (8.7%) was in Great Lakes states. In the Southeast, it was used for 1.7% patients.

No statistical differences were observed in clinicopathologic factors between the patients who received EBRT and those who did not.
 

Transplant is curative

Transplant is curative both for cancer and underlying cirrhosis, but patients may experience disease progression while waiting for transplant, noted Jessica Karen Wong, MD, assistant professor, department of radiation oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

“Radiation, specifically, stereotactic body radiation therapy, is a safe and effective bridging therapy but was only used in a small minority of eligible patients in this national database,” she said. “Although the use of radiation as bridging therapy is increasing over time, it continues to be underutilized. Increasing the use of radiation provides an opportunity to improve patient care for hepatocellular carcinoma patients awaiting a liver transplant.”

Dr. Nabavizadeh and Dr. Wong have disclosed no relevant financial relationships. Dr. Kim has received research funding and speaker honorarium from Varian and ViewRay.

A version of this article first appeared on Medscape.com.

CHICAGO –Only 4% of patients with liver cancer who are awaiting transplant undergo external-beam radiotherapy (EBRT), even though this is a safe and effective bridging therapy. It is greatly underutilized compared to other liver-directed therapies, according to new findings.

“This highlights a real-world gap in the treatment armamentarium for hepatocellular carcinoma [HCC],” said Nima Nabavizadeh, MD, associate professor of radiation oncology and residency program director at the Oregon Health and Science University, Portland.

He was speaking at the annual meeting of the American Society for Radiation Oncology.

These new data suggest there is reluctance within transplant programs to utilize radiotherapy as a bridging therapy prior to liver transplant, said Hyun Kim, MD, chief, GI service, department of radiation oncology, Washington University and the Alvin J. Siteman Cancer Center, St. Louis.

“This is despite 10-year-old data from Princess Margaret and Toronto General Hospital showing that external-beam radiation is a safe and feasible bridging therapy,” he said. “More modern data from the same institutions indicate that patients bridged with stereotactic body radiotherapy ablative radiation doses delivered with high conformality have similar survival as patients bridged with radiofrequency ablation.”

Dr. Kim also noted that even after transplant, rates of intrahepatic recurrence can be as high as 10%. Approximately 60% of patients experience recurrence of any type within 3 years.

“Nonablative local therapies leave viable disease, which may permit metastatic progression while the patient awaits transplant,” he said in an interview. This new analysis highlights the need for well-designed clinical trials with modern endpoints to evaluate which bridging therapy is most beneficial for the patient, he added.

In this current “era of radiomics, deep learning, and liquid biopsies, we have unprecedented tools and responsibility to ensure that our practice continues to improve in a data-centric fashion and not remain paused in the paradigm of a previous era,” Dr. Kim said.
 

A leading cause of death worldwide

HCC is a leading cause of cancer death worldwide, and the incidence is rising within the United States. Transplant is often the best option for long-term survival for patients with localized HCC and advanced cirrhosis, Dr. Nabavizadeh told the meeting.

Because patients often have to wait months to over a year for a transplant, many patients receive liver-directed bridging therapy to prevent tumor growth or spread and to maintain their eligibility for transplant, he explained.

These bridging therapies include thermal ablation procedures, transarterial chemoembolization (TACE), and Y-90 radioembolization, as well as EBRT.

To investigate how these therapies were being used, Dr. Nabavizadeh and colleagues conducted a retrospective study in which they analyzed data from the United Network for Organ Sharing, a nonprofit organization that manages the only national liver transplant waiting list in the United States.

They identified patients on the transplant list who had applied for Model of End-Stage Liver Disease (MELD) exceptions so as to be prioritized on the waiting list.

A total of 18,447 HCC patients submitted MELD exception applications during the study period (October 2013 to June 2020). More than half of these patients (n = 11,171; 60.6%) received a transplant. After submitting the exception application, the median time for receiving a transplant was 7 months.

Of the total group, 15,759 patients (85.4%) received liver-directed therapy while waiting for the transplant, but only 658 patients (3.6% of the overall cohort) received EBRT, either alone or in combination with another therapy.

“The majority of patients received chemoembolization, and ERBT represents a very small percentage,” Dr. Nabavizadeh said.

During the study period, the use of transarterial chemoembolization decreased. It has largely been replaced by thermal ablation and Y-90 radioembolization. The analysis also showed that the use of EBRT had increased over the past several years, but its utilization still remained well below that of the other therapies.

TACE was the most utilized therapy. It was used for 39.6% of patients, followed by thermal ablation (12.8%) and radioembolization (8.7%). Almost a quarter of patients (22.2%) received a combination of non-EBRT therapies.

“We found that EBRT use significantly differed by region,” Dr. Nabavizadeh said. The highest usage (8.7%) was in Great Lakes states. In the Southeast, it was used for 1.7% patients.

No statistical differences were observed in clinicopathologic factors between the patients who received EBRT and those who did not.
 

Transplant is curative

Transplant is curative both for cancer and underlying cirrhosis, but patients may experience disease progression while waiting for transplant, noted Jessica Karen Wong, MD, assistant professor, department of radiation oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

“Radiation, specifically, stereotactic body radiation therapy, is a safe and effective bridging therapy but was only used in a small minority of eligible patients in this national database,” she said. “Although the use of radiation as bridging therapy is increasing over time, it continues to be underutilized. Increasing the use of radiation provides an opportunity to improve patient care for hepatocellular carcinoma patients awaiting a liver transplant.”

Dr. Nabavizadeh and Dr. Wong have disclosed no relevant financial relationships. Dr. Kim has received research funding and speaker honorarium from Varian and ViewRay.

A version of this article first appeared on Medscape.com.

CHICAGO –Only 4% of patients with liver cancer who are awaiting transplant undergo external-beam radiotherapy (EBRT), even though this is a safe and effective bridging therapy. It is greatly underutilized compared to other liver-directed therapies, according to new findings.

“This highlights a real-world gap in the treatment armamentarium for hepatocellular carcinoma [HCC],” said Nima Nabavizadeh, MD, associate professor of radiation oncology and residency program director at the Oregon Health and Science University, Portland.

He was speaking at the annual meeting of the American Society for Radiation Oncology.

These new data suggest there is reluctance within transplant programs to utilize radiotherapy as a bridging therapy prior to liver transplant, said Hyun Kim, MD, chief, GI service, department of radiation oncology, Washington University and the Alvin J. Siteman Cancer Center, St. Louis.

“This is despite 10-year-old data from Princess Margaret and Toronto General Hospital showing that external-beam radiation is a safe and feasible bridging therapy,” he said. “More modern data from the same institutions indicate that patients bridged with stereotactic body radiotherapy ablative radiation doses delivered with high conformality have similar survival as patients bridged with radiofrequency ablation.”

Dr. Kim also noted that even after transplant, rates of intrahepatic recurrence can be as high as 10%. Approximately 60% of patients experience recurrence of any type within 3 years.

“Nonablative local therapies leave viable disease, which may permit metastatic progression while the patient awaits transplant,” he said in an interview. This new analysis highlights the need for well-designed clinical trials with modern endpoints to evaluate which bridging therapy is most beneficial for the patient, he added.

In this current “era of radiomics, deep learning, and liquid biopsies, we have unprecedented tools and responsibility to ensure that our practice continues to improve in a data-centric fashion and not remain paused in the paradigm of a previous era,” Dr. Kim said.
 

A leading cause of death worldwide

HCC is a leading cause of cancer death worldwide, and the incidence is rising within the United States. Transplant is often the best option for long-term survival for patients with localized HCC and advanced cirrhosis, Dr. Nabavizadeh told the meeting.

Because patients often have to wait months to over a year for a transplant, many patients receive liver-directed bridging therapy to prevent tumor growth or spread and to maintain their eligibility for transplant, he explained.

These bridging therapies include thermal ablation procedures, transarterial chemoembolization (TACE), and Y-90 radioembolization, as well as EBRT.

To investigate how these therapies were being used, Dr. Nabavizadeh and colleagues conducted a retrospective study in which they analyzed data from the United Network for Organ Sharing, a nonprofit organization that manages the only national liver transplant waiting list in the United States.

They identified patients on the transplant list who had applied for Model of End-Stage Liver Disease (MELD) exceptions so as to be prioritized on the waiting list.

A total of 18,447 HCC patients submitted MELD exception applications during the study period (October 2013 to June 2020). More than half of these patients (n = 11,171; 60.6%) received a transplant. After submitting the exception application, the median time for receiving a transplant was 7 months.

Of the total group, 15,759 patients (85.4%) received liver-directed therapy while waiting for the transplant, but only 658 patients (3.6% of the overall cohort) received EBRT, either alone or in combination with another therapy.

“The majority of patients received chemoembolization, and ERBT represents a very small percentage,” Dr. Nabavizadeh said.

During the study period, the use of transarterial chemoembolization decreased. It has largely been replaced by thermal ablation and Y-90 radioembolization. The analysis also showed that the use of EBRT had increased over the past several years, but its utilization still remained well below that of the other therapies.

TACE was the most utilized therapy. It was used for 39.6% of patients, followed by thermal ablation (12.8%) and radioembolization (8.7%). Almost a quarter of patients (22.2%) received a combination of non-EBRT therapies.

“We found that EBRT use significantly differed by region,” Dr. Nabavizadeh said. The highest usage (8.7%) was in Great Lakes states. In the Southeast, it was used for 1.7% patients.

No statistical differences were observed in clinicopathologic factors between the patients who received EBRT and those who did not.
 

Transplant is curative

Transplant is curative both for cancer and underlying cirrhosis, but patients may experience disease progression while waiting for transplant, noted Jessica Karen Wong, MD, assistant professor, department of radiation oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

“Radiation, specifically, stereotactic body radiation therapy, is a safe and effective bridging therapy but was only used in a small minority of eligible patients in this national database,” she said. “Although the use of radiation as bridging therapy is increasing over time, it continues to be underutilized. Increasing the use of radiation provides an opportunity to improve patient care for hepatocellular carcinoma patients awaiting a liver transplant.”

Dr. Nabavizadeh and Dr. Wong have disclosed no relevant financial relationships. Dr. Kim has received research funding and speaker honorarium from Varian and ViewRay.

A version of this article first appeared on Medscape.com.

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

Immigration and Customs Enforcement will no longer detain most migrant women who are pregnant, postpartum, or nursing for deportation. This reverses the policy previously put in place by the Trump administration.

Under the new directive, ICE officials generally will not detain or arrest women who are pregnant or nursing, or who have given birth within the previous year. In a July 1 memo signed by ICE Acting Director Tae Johnson, ICE officers are directed to house women in “an appropriate facility to manage their care.”

The memo goes on to state that “generally ICE should not detain, arrest, or take into custody for an administrative violation of the immigration laws individuals known to be pregnant, post partum, or nursing unless release is prohibited by law or exceptional circumstances exist.”

In addition, ICE is also required to evaluate those individuals who are already in custody “to determine if continued detention is appropriate.”

During the Obama administration, pregnant women were generally not detained except under extraordinary circumstances. However, these policies were reversed after Donald Trump took office, and there was an 80% increase in the number of times ICE detained pregnant women in the year that followed implementation of the new directive – from 1,160 in 2017 to 2,097 in 2018.

The new guidance now goes even further than the directive issued under President Obama as it also includes women who are nursing and the 1-year postpartum period.

This policy stems from the Biden-Harris administration’s plan to reform the immigration system, part of which was to create a more humane asylum system. In a statement released early in February 2021, the White House stated that the “Trump administration’s policies at the border have caused chaos, cruelty, and confusion,” and that they will now “begin to roll back the most damaging policies adopted by the prior administration, while taking effective action to manage migration across the region.” After migrant women are taken into custody, pregnancy tests are administered as part of regular health screenings. If women are found to be pregnant, the new ICE policy states that they “generally” should be released from detention.

However, there will still be circumstances when pregnant and postpartum women may be detained, such as when there is a high risk that the individual is violent or a national security concern. In these cases, a field office director must approve the arrest and detention as well as making sure that the women receive appropriate medical care.

“The harmful consequences of immigration detention have been documented for years,” said Rebekah Wolf, JD, staff attorney with the American Immigration Council. “Our 2017 joint complaint urging a thorough investigation into the increasing numbers of pregnant women facing harm in detention, illustrated the disturbing practice of detaining pregnant women and the lack of quality medical care provided to these women.”

She added that the “federal government should not be in the business of detaining pregnant or nursing individuals, and it’s good to see the Biden administration directing ICE to finally take meaningful steps to limit enforcement activities in this manner. We are hopeful that this announcement is an indication of a broader shift on detention policy.”

There are currently 13 pregnant women in ICE custody, and they are being considered for release under the new policy.

Immigration and Customs Enforcement will no longer detain most migrant women who are pregnant, postpartum, or nursing for deportation. This reverses the policy previously put in place by the Trump administration.

Under the new directive, ICE officials generally will not detain or arrest women who are pregnant or nursing, or who have given birth within the previous year. In a July 1 memo signed by ICE Acting Director Tae Johnson, ICE officers are directed to house women in “an appropriate facility to manage their care.”

The memo goes on to state that “generally ICE should not detain, arrest, or take into custody for an administrative violation of the immigration laws individuals known to be pregnant, post partum, or nursing unless release is prohibited by law or exceptional circumstances exist.”

In addition, ICE is also required to evaluate those individuals who are already in custody “to determine if continued detention is appropriate.”

During the Obama administration, pregnant women were generally not detained except under extraordinary circumstances. However, these policies were reversed after Donald Trump took office, and there was an 80% increase in the number of times ICE detained pregnant women in the year that followed implementation of the new directive – from 1,160 in 2017 to 2,097 in 2018.

The new guidance now goes even further than the directive issued under President Obama as it also includes women who are nursing and the 1-year postpartum period.

This policy stems from the Biden-Harris administration’s plan to reform the immigration system, part of which was to create a more humane asylum system. In a statement released early in February 2021, the White House stated that the “Trump administration’s policies at the border have caused chaos, cruelty, and confusion,” and that they will now “begin to roll back the most damaging policies adopted by the prior administration, while taking effective action to manage migration across the region.” After migrant women are taken into custody, pregnancy tests are administered as part of regular health screenings. If women are found to be pregnant, the new ICE policy states that they “generally” should be released from detention.

However, there will still be circumstances when pregnant and postpartum women may be detained, such as when there is a high risk that the individual is violent or a national security concern. In these cases, a field office director must approve the arrest and detention as well as making sure that the women receive appropriate medical care.

“The harmful consequences of immigration detention have been documented for years,” said Rebekah Wolf, JD, staff attorney with the American Immigration Council. “Our 2017 joint complaint urging a thorough investigation into the increasing numbers of pregnant women facing harm in detention, illustrated the disturbing practice of detaining pregnant women and the lack of quality medical care provided to these women.”

She added that the “federal government should not be in the business of detaining pregnant or nursing individuals, and it’s good to see the Biden administration directing ICE to finally take meaningful steps to limit enforcement activities in this manner. We are hopeful that this announcement is an indication of a broader shift on detention policy.”

There are currently 13 pregnant women in ICE custody, and they are being considered for release under the new policy.

Immigration and Customs Enforcement will no longer detain most migrant women who are pregnant, postpartum, or nursing for deportation. This reverses the policy previously put in place by the Trump administration.

Under the new directive, ICE officials generally will not detain or arrest women who are pregnant or nursing, or who have given birth within the previous year. In a July 1 memo signed by ICE Acting Director Tae Johnson, ICE officers are directed to house women in “an appropriate facility to manage their care.”

The memo goes on to state that “generally ICE should not detain, arrest, or take into custody for an administrative violation of the immigration laws individuals known to be pregnant, post partum, or nursing unless release is prohibited by law or exceptional circumstances exist.”

In addition, ICE is also required to evaluate those individuals who are already in custody “to determine if continued detention is appropriate.”

During the Obama administration, pregnant women were generally not detained except under extraordinary circumstances. However, these policies were reversed after Donald Trump took office, and there was an 80% increase in the number of times ICE detained pregnant women in the year that followed implementation of the new directive – from 1,160 in 2017 to 2,097 in 2018.

The new guidance now goes even further than the directive issued under President Obama as it also includes women who are nursing and the 1-year postpartum period.

This policy stems from the Biden-Harris administration’s plan to reform the immigration system, part of which was to create a more humane asylum system. In a statement released early in February 2021, the White House stated that the “Trump administration’s policies at the border have caused chaos, cruelty, and confusion,” and that they will now “begin to roll back the most damaging policies adopted by the prior administration, while taking effective action to manage migration across the region.” After migrant women are taken into custody, pregnancy tests are administered as part of regular health screenings. If women are found to be pregnant, the new ICE policy states that they “generally” should be released from detention.

However, there will still be circumstances when pregnant and postpartum women may be detained, such as when there is a high risk that the individual is violent or a national security concern. In these cases, a field office director must approve the arrest and detention as well as making sure that the women receive appropriate medical care.

“The harmful consequences of immigration detention have been documented for years,” said Rebekah Wolf, JD, staff attorney with the American Immigration Council. “Our 2017 joint complaint urging a thorough investigation into the increasing numbers of pregnant women facing harm in detention, illustrated the disturbing practice of detaining pregnant women and the lack of quality medical care provided to these women.”

She added that the “federal government should not be in the business of detaining pregnant or nursing individuals, and it’s good to see the Biden administration directing ICE to finally take meaningful steps to limit enforcement activities in this manner. We are hopeful that this announcement is an indication of a broader shift on detention policy.”

There are currently 13 pregnant women in ICE custody, and they are being considered for release under the new policy.

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

Hematology-oncology patients who receive treatment in the intensive care unit often develop delirium, and according to new findings, mechanical ventilation, high-dose corticosteroid use, and brain metastases were identified as independent risk factors.

Roughly half of all hematology-oncology patients who were admitted to the ICU experienced delirium, explained lead author Rachel Klosko, PharmD, PGY-2 cardiology pharmacy resident at the Ohio State University, Columbus.

“Delirium was associated with increased mortality, an increase in hospital length of stay, and increased length of stay in the ICU,” she said.

Dr. Klosko presented the study results at the at the Critical Care Congress sponsored by the Society of Critical Care Medicine (SCCM), which was held virtually this year.

Delirium is an acute and fluctuating disturbance of consciousness and cognition and fluctuates in severity. Critically ill patients are subject to numerous risk factors for delirium. “It can occur in independently of any known neurological disorder,” said Dr. Klosko, adding that its occurrence has been associated with poorer outcomes in ICU patients.

In this study, Dr. Klosko and colleagues sought to determine the incidence of delirium in cancer patients who were admitted to the ICU, as well as identify the associated risk factors and recognize potential consequences of the development of delirium in this patient population.

They conducted a single center, retrospective, cohort study that evaluated patients between the ages of 18 and 89 years who were admitted to the hematology-oncology medical or surgical ICU between July 1, 2018, and June 30, 2019.

The study’s primary endpoint was the incidence of delirium within 7 days of ICU admission, defined as two positive Confusion Assessment Method for the ICU (CAM-ICU) assessments within 24 hours. Patients identified with delirium were compared to those without it, for the evaluation of secondary endpoints that included hospital mortality and ICU and hospital length of stay. The researchers also sought to identify independent risk factors for delirium in this population.

A total of 244 patients were included in the final analysis. Of this group, 125 (51.2%) experienced delirium during their stay in the ICU, and 119 (48.8%) did not.

Mortality in the delirium group was significantly higher at 32.8% vs. 15.1% (P = .001). In addition, the delirium group was associated with significantly higher ICU length of stay (6 days vs. 3 days, P < .001) and hospital length of stay (21 days vs. 12 days, P < .001).

“When comparing the baseline characteristics between the two groups, the delirium group had a longer hospital length prior to ICU admission, a higher SOFA score, a higher rate of brain metastases, a higher rate of shock, and higher receipt of high-dose steroids, benzodiazepines, and immunotherapy,” said Dr. Klosko.

After multivariable regression, four variables were included in the final model. Among patients with delirium, the SOFA score increased by 25% (odds ratio[OR] 1.25, P < .001), while the odds of delirium were almost four times higher among those treated with high-dose corticosteroids (OR 3.79, P = .004). Delirium was also eight times higher (OR 8.48, P < .001) among those who received mechanical ventilation and five times higher in (OR 5.38, P = .015) in patients with brain metastases.

Dr. Klosko noted that the main limitations for this study were that it was a single center retrospective analysis, and that patients were reviewed within the first 7 days of ICU admission. “This potentially missed patients who developed delirium outside of this time frame,” she said. In addition, “too few patients received high-dose benzodiazepines,” and “none of the patients received continuous neuromuscular blockade.”

However, in “contrast to these limitations, this is the largest study to date that has analyzed delirium in this population,” Dr. Klosko said.

Commenting on the study, Brenda Pun, DNP, RN, director of data quality at the Vanderbilt Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tenn., pointed out that the goal of this study was to describe delirium in this specific population. “But I will take a step backward and say that they are just confirming that these patients look like other ICU patients in many regards,” she said.

She explained that the sicker patients are, the higher the rates of delirium. “We have implemented strategies to lower these rates, and they have improved,” Dr. Pun said. “Ten years ago, I would say that 80% of patients who were on a ventilator would have delirium but now the rates are around 50% and that’s what we are typically seeing now.”

Dr. Pun emphasized that this study shows that delirium is like the “canary in the coal mine” or a red flag. “It’s a sign that something is wrong and that we need to pay attention, because the patient’s outcome may be worse,” she said. “So this is saying that we need to see if there is something that can be changed or modified to decrease the incidence of delirium—these are important questions.”

There was no outside sponsor. The authors had no disclosures. Dr. Pun has no disclosures.

There has been a marked increase in the time to antibiotic administration for ICU patients with sepsis across Veterans Affairs (VA) hospitals, but there is no evidence that they are being given inappropriately, according to new findings.

Accelerating time-to-antibiotics in sepsis means that patients will be treated earlier, but it could also result in more patients receiving antibiotics, including those without infection. This in turn may contribute to antimicrobial resistance.

“The time to antibiotics for sepsis accelerated across VA hospitals, and declined from 5.8 to 4.8 hours between 2013 and 2018,” said lead study author Sarah Seelye, PhD, data scientist at the U.S. Department of Veterans Affairs, Ann Arbor, Mich. “Despite this, there was no evidence between hospital level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis.”

The results were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, which was held virtually this year.

“Many hospitals have initiated programs like this to accelerate the use of antibiotics in patients with severe sepsis, but at the same time, there is growing concern that earlier antibiotic initiation may result in increased antibiotic treatment overall, including those without infection,” said Dr. Seelye. “However, to date, there is little evidence to support this claim.”

The goal of their study was to investigate whether hospital-level acceleration in antibiotic timing for sepsis was associated with increasing antibiotic use among patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential infection in 132 VA hospitals during the period from 2013 to 2018. Of these patients, 608,128 (55.2%) received antibiotics within 48 hours of presentation to the emergency department. A total of 117,435 (10.7%) met the criteria for sepsis.

Hospitals were classified into tertiles of antibiotic acceleration for sepsis: rapid, slow, and flat.

In the VA system, patients with severe sepsis began receiving faster antibiotic treatment in 2017, compared with earlier years. In 2017-2018 more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

In 2017-2018, more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

Hospitals categorized as rapid accelerators decreased their time to antibiotic initiation from 6.4 hours to 4.5 hours, while slow accelerators went from 5.6 to 4.6 hours from 2013 to 2018, and flat accelerators remained stable during the time period (5.3 hours down to 5.2 hours).

However, statistical analysis showed no real difference between the three groups in antibiotic prescribing.

“Despite this, there was no evidence between hospital-level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis,” said Dr. Seelye.

Weighing in on the study results, Craig M. Coopersmith, MD, professor of surgery at Emory University, Atlanta, noted that these results are very convincing, considering the size of the study and that it encompassed 132 different facilities.

“It’s difficult to say how generalizable these results are but they are definitely generalizable to all hospitals in the VA system,” he said. “In general, there are similarities between large health care systems, and it would be surprising if we found the opposite to be true in non-VA health systems.”

However, he emphasized that there is some possibility that the results would not be identical because different health care systems have different methods of providing care.

“This paper does show that you can get antibiotics into patients faster, which can be life saving, without inappropriately using them on everybody,” Dr. Coopersmith said.

He explained that there is more attention being paid now to antibiotic stewardship, compared with 10 or 15 years ago. “Given the choice of giving someone a single dose of antibiotics who may not need it, as opposed to withholding them from someone who is septic which is life threatening, the risk benefit ratio weighs heavily towards starting them early,” he said. “And then escalate rapidly.”

There has been a marked increase in the time to antibiotic administration for ICU patients with sepsis across Veterans Affairs (VA) hospitals, but there is no evidence that they are being given inappropriately, according to new findings.

Accelerating time-to-antibiotics in sepsis means that patients will be treated earlier, but it could also result in more patients receiving antibiotics, including those without infection. This in turn may contribute to antimicrobial resistance.

“The time to antibiotics for sepsis accelerated across VA hospitals, and declined from 5.8 to 4.8 hours between 2013 and 2018,” said lead study author Sarah Seelye, PhD, data scientist at the U.S. Department of Veterans Affairs, Ann Arbor, Mich. “Despite this, there was no evidence between hospital level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis.”

The results were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, which was held virtually this year.

“Many hospitals have initiated programs like this to accelerate the use of antibiotics in patients with severe sepsis, but at the same time, there is growing concern that earlier antibiotic initiation may result in increased antibiotic treatment overall, including those without infection,” said Dr. Seelye. “However, to date, there is little evidence to support this claim.”

The goal of their study was to investigate whether hospital-level acceleration in antibiotic timing for sepsis was associated with increasing antibiotic use among patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential infection in 132 VA hospitals during the period from 2013 to 2018. Of these patients, 608,128 (55.2%) received antibiotics within 48 hours of presentation to the emergency department. A total of 117,435 (10.7%) met the criteria for sepsis.

Hospitals were classified into tertiles of antibiotic acceleration for sepsis: rapid, slow, and flat.

In the VA system, patients with severe sepsis began receiving faster antibiotic treatment in 2017, compared with earlier years. In 2017-2018 more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

In 2017-2018, more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

Hospitals categorized as rapid accelerators decreased their time to antibiotic initiation from 6.4 hours to 4.5 hours, while slow accelerators went from 5.6 to 4.6 hours from 2013 to 2018, and flat accelerators remained stable during the time period (5.3 hours down to 5.2 hours).

However, statistical analysis showed no real difference between the three groups in antibiotic prescribing.

“Despite this, there was no evidence between hospital-level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis,” said Dr. Seelye.

Weighing in on the study results, Craig M. Coopersmith, MD, professor of surgery at Emory University, Atlanta, noted that these results are very convincing, considering the size of the study and that it encompassed 132 different facilities.

“It’s difficult to say how generalizable these results are but they are definitely generalizable to all hospitals in the VA system,” he said. “In general, there are similarities between large health care systems, and it would be surprising if we found the opposite to be true in non-VA health systems.”

However, he emphasized that there is some possibility that the results would not be identical because different health care systems have different methods of providing care.

“This paper does show that you can get antibiotics into patients faster, which can be life saving, without inappropriately using them on everybody,” Dr. Coopersmith said.

He explained that there is more attention being paid now to antibiotic stewardship, compared with 10 or 15 years ago. “Given the choice of giving someone a single dose of antibiotics who may not need it, as opposed to withholding them from someone who is septic which is life threatening, the risk benefit ratio weighs heavily towards starting them early,” he said. “And then escalate rapidly.”

There has been a marked increase in the time to antibiotic administration for ICU patients with sepsis across Veterans Affairs (VA) hospitals, but there is no evidence that they are being given inappropriately, according to new findings.

Accelerating time-to-antibiotics in sepsis means that patients will be treated earlier, but it could also result in more patients receiving antibiotics, including those without infection. This in turn may contribute to antimicrobial resistance.

“The time to antibiotics for sepsis accelerated across VA hospitals, and declined from 5.8 to 4.8 hours between 2013 and 2018,” said lead study author Sarah Seelye, PhD, data scientist at the U.S. Department of Veterans Affairs, Ann Arbor, Mich. “Despite this, there was no evidence between hospital level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis.”

The results were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, which was held virtually this year.

“Many hospitals have initiated programs like this to accelerate the use of antibiotics in patients with severe sepsis, but at the same time, there is growing concern that earlier antibiotic initiation may result in increased antibiotic treatment overall, including those without infection,” said Dr. Seelye. “However, to date, there is little evidence to support this claim.”

The goal of their study was to investigate whether hospital-level acceleration in antibiotic timing for sepsis was associated with increasing antibiotic use among patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential infection in 132 VA hospitals during the period from 2013 to 2018. Of these patients, 608,128 (55.2%) received antibiotics within 48 hours of presentation to the emergency department. A total of 117,435 (10.7%) met the criteria for sepsis.

Hospitals were classified into tertiles of antibiotic acceleration for sepsis: rapid, slow, and flat.

In the VA system, patients with severe sepsis began receiving faster antibiotic treatment in 2017, compared with earlier years. In 2017-2018 more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

In 2017-2018, more than 20% of sepsis patients had received their first treatment within 2 hours, compared with 14% in 2013-1014.

Hospitals categorized as rapid accelerators decreased their time to antibiotic initiation from 6.4 hours to 4.5 hours, while slow accelerators went from 5.6 to 4.6 hours from 2013 to 2018, and flat accelerators remained stable during the time period (5.3 hours down to 5.2 hours).

However, statistical analysis showed no real difference between the three groups in antibiotic prescribing.

“Despite this, there was no evidence between hospital-level antibiotic acceleration in sepsis and antibiotic use among all patients with potential sepsis,” said Dr. Seelye.

Weighing in on the study results, Craig M. Coopersmith, MD, professor of surgery at Emory University, Atlanta, noted that these results are very convincing, considering the size of the study and that it encompassed 132 different facilities.

“It’s difficult to say how generalizable these results are but they are definitely generalizable to all hospitals in the VA system,” he said. “In general, there are similarities between large health care systems, and it would be surprising if we found the opposite to be true in non-VA health systems.”

However, he emphasized that there is some possibility that the results would not be identical because different health care systems have different methods of providing care.

“This paper does show that you can get antibiotics into patients faster, which can be life saving, without inappropriately using them on everybody,” Dr. Coopersmith said.

He explained that there is more attention being paid now to antibiotic stewardship, compared with 10 or 15 years ago. “Given the choice of giving someone a single dose of antibiotics who may not need it, as opposed to withholding them from someone who is septic which is life threatening, the risk benefit ratio weighs heavily towards starting them early,” he said. “And then escalate rapidly.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

The first targeted therapy for patients with advanced non–small cell lung cancer (NSCLC) harboring MET mutations, capmatinib (Tabrecta), has shown deep and durable responses, conclude investigators of the pivotal trial that led to the drug’s approval.

Responses were seen in all patients regardless of how many previous drugs they had been treated with, although responses were particularly pronounced among patients who were treatment naive.

Capmatinib and a companion assay received FDA approval in May 2020 for the treatment of adults with metastatic NSCLC harboring MET exon 14–skipping mutations.

These MET mutations occur in 3%-4% of NSCLC patients. MET amplifications occur in 1%-6% of NSCLC patients. They have been associated with poor response to chemotherapy and immunotherapy.

“Prior to this approval, there weren’t any approved therapies for this group of patients,” noted Edward Garon, MD, associate professor of hematology and oncology at the University of California, Los Angeles, who led the pivotal trial.

“There are several drugs that have been used off label for MET exon 14 skipping mutations, but none with an indication for it,” he said in an interview.

Garon emphasized that capmatinib was particularly robust for patients who had not received prior therapy, although he added that it was also very effective for those who had been previously treated.

“The drug has been approved and it is available, and we have already written prescriptions for it at our clinic,” said Dr. Garon, “although, at our clinic, the majority of patients using it were part of the [pivotal] clinical trial.”

That trial is the phase 2 GEOMETRY mono-1 study. Results from the study were presented at a meeting earlier this year and have now been published in the New England Journal of Medicine.

It was conducted in a cohort of 364 patients with advanced NSCLC. Patients were stratified into five cohorts and two expansion cohorts, which were assigned according to MET status and previous lines of therapy. Across cohorts 1 through 5, a total of 97 patients had a MET exon 14–skipping mutation, and 210 had MET amplification. All patients were treated with capmatinib 400 mg twice daily.

Among patients with a MET exon 14 skipping mutation, an overall response was observed in 41% of previously treated patients and in 68% of those who had not previously been treated.

“That is a very high response rate, and clearly this drug is targeting this mutation,” said Fred Hirsch, MD, PhD, executive director, Center for Thoracic Oncology, Mount Sinai Health System, New York, who was approached for comment. “It’s very active, and you don’t get those responses with chemotherapy.”

The median duration of response was 9.7 months among previously treated patients and 12.6 months among those who were treatment naive. Median progression-free survival (PFS) was 5.4 months and 12.4 months, respectively.

In the cohort of patients with MET amplification, the overall response was 12% among those whose tumor tissue had a gene copy number of 6-9. The overall response rate was 9% among those with a gene copy number of 4 or 5, and it was 7% among those with a gene copy number of less than 4.

Median PFS was 2.7 months for patients whose tumor tissue had a gene copy number of 6-9 and in those with a gene copy number of 4 or 5. PFS rose to 3.6 months for patients with a gene copy number of less than 4.

The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%). These events were mostly of grade 1 or 2. Treatment-related serious adverse events occurred in 13% of patients. The incidence was lower in the groups with shorter duration of exposure. Treatment was discontinued in 11% of patients (consistent across cohorts) because of adverse events.

Dr. Hirsch commented that the results for patients with NSCLC and brain metastases were particularly noteworthy. “Brain metastases are, unfortunately, a common problem in patients with lung cancer,” he said. “Now, we have a drug that is effective for MET mutation and CNS involvement and can penetrate the blood-brain barrier, and this is a very encouraging situation.”

He pointed out that 7 of 13 patients with brain metastases responded to treatment with capmatinib. “Four patients have a complete response, and that is very encouraging,” said Dr. Hirsch. “This is clearly a deal-breaker in my opinion.”
 

The future is bright

Dr. Hirsch noted that the evidence supporting capmatinib is strong, even though a larger prospective study with a control group is lacking. “If we have a patient with this mutation, and knowing that there is a drug with a response rate of 68%, that is a good reason to try the drug up front. The data are sufficient that it should be offered to the patient, even without a control group.”

Capmatinib is the latest of many targeted drugs that have been launched in recent years, and several immunotherapies are also now available for treatment of this disease. These new therapies are making this a “very encouraging time in lung cancer,” Dr. Hirsch commented.

“We are seeing long-term survival, and, eventually, we may start seeing potential cures for some patients,” he said. “But at the very least, we are seeing very good long-term results with many of these targeted therapies, and we are continuing to learn more about resistant mechanisms. I can’t wait to see future in the field.”

The study was funded by Novartis Pharmaceuticals. Dr. Garon reports consulting or advisory roles with Dracen and research funding (institutional) from Merck, Genentech, AstraZeneca, Novartis, Lilly, Bristol-Myers Squibb, Mirati Therapeutics, Dynavax, Iovance Biotherapeutics, and Neon Therapeutics. His coauthors have disclosed numerous relationships with industry, as listed in the original article. Dr. Hirsch has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The first targeted therapy for patients with advanced non–small cell lung cancer (NSCLC) harboring MET mutations, capmatinib (Tabrecta), has shown deep and durable responses, conclude investigators of the pivotal trial that led to the drug’s approval.

Responses were seen in all patients regardless of how many previous drugs they had been treated with, although responses were particularly pronounced among patients who were treatment naive.

Capmatinib and a companion assay received FDA approval in May 2020 for the treatment of adults with metastatic NSCLC harboring MET exon 14–skipping mutations.

These MET mutations occur in 3%-4% of NSCLC patients. MET amplifications occur in 1%-6% of NSCLC patients. They have been associated with poor response to chemotherapy and immunotherapy.

“Prior to this approval, there weren’t any approved therapies for this group of patients,” noted Edward Garon, MD, associate professor of hematology and oncology at the University of California, Los Angeles, who led the pivotal trial.

“There are several drugs that have been used off label for MET exon 14 skipping mutations, but none with an indication for it,” he said in an interview.

Garon emphasized that capmatinib was particularly robust for patients who had not received prior therapy, although he added that it was also very effective for those who had been previously treated.

“The drug has been approved and it is available, and we have already written prescriptions for it at our clinic,” said Dr. Garon, “although, at our clinic, the majority of patients using it were part of the [pivotal] clinical trial.”

That trial is the phase 2 GEOMETRY mono-1 study. Results from the study were presented at a meeting earlier this year and have now been published in the New England Journal of Medicine.

It was conducted in a cohort of 364 patients with advanced NSCLC. Patients were stratified into five cohorts and two expansion cohorts, which were assigned according to MET status and previous lines of therapy. Across cohorts 1 through 5, a total of 97 patients had a MET exon 14–skipping mutation, and 210 had MET amplification. All patients were treated with capmatinib 400 mg twice daily.

Among patients with a MET exon 14 skipping mutation, an overall response was observed in 41% of previously treated patients and in 68% of those who had not previously been treated.

“That is a very high response rate, and clearly this drug is targeting this mutation,” said Fred Hirsch, MD, PhD, executive director, Center for Thoracic Oncology, Mount Sinai Health System, New York, who was approached for comment. “It’s very active, and you don’t get those responses with chemotherapy.”

The median duration of response was 9.7 months among previously treated patients and 12.6 months among those who were treatment naive. Median progression-free survival (PFS) was 5.4 months and 12.4 months, respectively.

In the cohort of patients with MET amplification, the overall response was 12% among those whose tumor tissue had a gene copy number of 6-9. The overall response rate was 9% among those with a gene copy number of 4 or 5, and it was 7% among those with a gene copy number of less than 4.

Median PFS was 2.7 months for patients whose tumor tissue had a gene copy number of 6-9 and in those with a gene copy number of 4 or 5. PFS rose to 3.6 months for patients with a gene copy number of less than 4.

The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%). These events were mostly of grade 1 or 2. Treatment-related serious adverse events occurred in 13% of patients. The incidence was lower in the groups with shorter duration of exposure. Treatment was discontinued in 11% of patients (consistent across cohorts) because of adverse events.

Dr. Hirsch commented that the results for patients with NSCLC and brain metastases were particularly noteworthy. “Brain metastases are, unfortunately, a common problem in patients with lung cancer,” he said. “Now, we have a drug that is effective for MET mutation and CNS involvement and can penetrate the blood-brain barrier, and this is a very encouraging situation.”

He pointed out that 7 of 13 patients with brain metastases responded to treatment with capmatinib. “Four patients have a complete response, and that is very encouraging,” said Dr. Hirsch. “This is clearly a deal-breaker in my opinion.”
 

The future is bright

Dr. Hirsch noted that the evidence supporting capmatinib is strong, even though a larger prospective study with a control group is lacking. “If we have a patient with this mutation, and knowing that there is a drug with a response rate of 68%, that is a good reason to try the drug up front. The data are sufficient that it should be offered to the patient, even without a control group.”

Capmatinib is the latest of many targeted drugs that have been launched in recent years, and several immunotherapies are also now available for treatment of this disease. These new therapies are making this a “very encouraging time in lung cancer,” Dr. Hirsch commented.

“We are seeing long-term survival, and, eventually, we may start seeing potential cures for some patients,” he said. “But at the very least, we are seeing very good long-term results with many of these targeted therapies, and we are continuing to learn more about resistant mechanisms. I can’t wait to see future in the field.”

The study was funded by Novartis Pharmaceuticals. Dr. Garon reports consulting or advisory roles with Dracen and research funding (institutional) from Merck, Genentech, AstraZeneca, Novartis, Lilly, Bristol-Myers Squibb, Mirati Therapeutics, Dynavax, Iovance Biotherapeutics, and Neon Therapeutics. His coauthors have disclosed numerous relationships with industry, as listed in the original article. Dr. Hirsch has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The first targeted therapy for patients with advanced non–small cell lung cancer (NSCLC) harboring MET mutations, capmatinib (Tabrecta), has shown deep and durable responses, conclude investigators of the pivotal trial that led to the drug’s approval.

Responses were seen in all patients regardless of how many previous drugs they had been treated with, although responses were particularly pronounced among patients who were treatment naive.

Capmatinib and a companion assay received FDA approval in May 2020 for the treatment of adults with metastatic NSCLC harboring MET exon 14–skipping mutations.

These MET mutations occur in 3%-4% of NSCLC patients. MET amplifications occur in 1%-6% of NSCLC patients. They have been associated with poor response to chemotherapy and immunotherapy.

“Prior to this approval, there weren’t any approved therapies for this group of patients,” noted Edward Garon, MD, associate professor of hematology and oncology at the University of California, Los Angeles, who led the pivotal trial.

“There are several drugs that have been used off label for MET exon 14 skipping mutations, but none with an indication for it,” he said in an interview.

Garon emphasized that capmatinib was particularly robust for patients who had not received prior therapy, although he added that it was also very effective for those who had been previously treated.

“The drug has been approved and it is available, and we have already written prescriptions for it at our clinic,” said Dr. Garon, “although, at our clinic, the majority of patients using it were part of the [pivotal] clinical trial.”

That trial is the phase 2 GEOMETRY mono-1 study. Results from the study were presented at a meeting earlier this year and have now been published in the New England Journal of Medicine.

It was conducted in a cohort of 364 patients with advanced NSCLC. Patients were stratified into five cohorts and two expansion cohorts, which were assigned according to MET status and previous lines of therapy. Across cohorts 1 through 5, a total of 97 patients had a MET exon 14–skipping mutation, and 210 had MET amplification. All patients were treated with capmatinib 400 mg twice daily.

Among patients with a MET exon 14 skipping mutation, an overall response was observed in 41% of previously treated patients and in 68% of those who had not previously been treated.

“That is a very high response rate, and clearly this drug is targeting this mutation,” said Fred Hirsch, MD, PhD, executive director, Center for Thoracic Oncology, Mount Sinai Health System, New York, who was approached for comment. “It’s very active, and you don’t get those responses with chemotherapy.”

The median duration of response was 9.7 months among previously treated patients and 12.6 months among those who were treatment naive. Median progression-free survival (PFS) was 5.4 months and 12.4 months, respectively.

In the cohort of patients with MET amplification, the overall response was 12% among those whose tumor tissue had a gene copy number of 6-9. The overall response rate was 9% among those with a gene copy number of 4 or 5, and it was 7% among those with a gene copy number of less than 4.

Median PFS was 2.7 months for patients whose tumor tissue had a gene copy number of 6-9 and in those with a gene copy number of 4 or 5. PFS rose to 3.6 months for patients with a gene copy number of less than 4.

The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%). These events were mostly of grade 1 or 2. Treatment-related serious adverse events occurred in 13% of patients. The incidence was lower in the groups with shorter duration of exposure. Treatment was discontinued in 11% of patients (consistent across cohorts) because of adverse events.

Dr. Hirsch commented that the results for patients with NSCLC and brain metastases were particularly noteworthy. “Brain metastases are, unfortunately, a common problem in patients with lung cancer,” he said. “Now, we have a drug that is effective for MET mutation and CNS involvement and can penetrate the blood-brain barrier, and this is a very encouraging situation.”

He pointed out that 7 of 13 patients with brain metastases responded to treatment with capmatinib. “Four patients have a complete response, and that is very encouraging,” said Dr. Hirsch. “This is clearly a deal-breaker in my opinion.”
 

The future is bright

Dr. Hirsch noted that the evidence supporting capmatinib is strong, even though a larger prospective study with a control group is lacking. “If we have a patient with this mutation, and knowing that there is a drug with a response rate of 68%, that is a good reason to try the drug up front. The data are sufficient that it should be offered to the patient, even without a control group.”

Capmatinib is the latest of many targeted drugs that have been launched in recent years, and several immunotherapies are also now available for treatment of this disease. These new therapies are making this a “very encouraging time in lung cancer,” Dr. Hirsch commented.

“We are seeing long-term survival, and, eventually, we may start seeing potential cures for some patients,” he said. “But at the very least, we are seeing very good long-term results with many of these targeted therapies, and we are continuing to learn more about resistant mechanisms. I can’t wait to see future in the field.”

The study was funded by Novartis Pharmaceuticals. Dr. Garon reports consulting or advisory roles with Dracen and research funding (institutional) from Merck, Genentech, AstraZeneca, Novartis, Lilly, Bristol-Myers Squibb, Mirati Therapeutics, Dynavax, Iovance Biotherapeutics, and Neon Therapeutics. His coauthors have disclosed numerous relationships with industry, as listed in the original article. Dr. Hirsch has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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

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

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

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

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

The article was published April 16 in Nature Medicine.

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

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

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

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

Restructuring care

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

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

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

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

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

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

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

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

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

Capacity of facilities

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

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

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

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

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

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

Future research

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

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

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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

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

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

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

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

The article was published April 16 in Nature Medicine.

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

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

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

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

Restructuring care

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

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

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

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

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

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

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

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

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

Capacity of facilities

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

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

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

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

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

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

Future research

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

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

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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

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

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

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

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

The article was published April 16 in Nature Medicine.

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

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

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

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

Restructuring care

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

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

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

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

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

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

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

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

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

Capacity of facilities

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

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

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

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

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

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

Future research

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

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

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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

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

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

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

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

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

Half of those in active treatment report disruptions

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

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

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

Financial concerns

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

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

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

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

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

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

Taking action

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

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

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

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

Half of those in active treatment report disruptions

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

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

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

Financial concerns

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

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

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

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

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

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

Taking action

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

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

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

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

Half of those in active treatment report disruptions

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

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

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

Financial concerns

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

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

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

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

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

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

Taking action

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

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

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

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

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.