Mixed Topics

From colonoscopies to endoscopic ultrasound, gastroenterology is fundamentally a procedure-based specialty. Given that reality, making a decision to have as much control as possible over the entire process just makes sense for many GI practices.

Back in 2008, I was in charge of the process to develop a pathology lab at Arizona Digestive Health, a physician group with 26 locations throughout the state, as part of our decision to form a supergroup with eight ambulatory surgery centers. For us, having ambulatory surgery centers had been a game changer. We learned we could double our efficiency with procedures when we controlled the process from start to finish. We began to consider other processes – in this case pathology – that we could improve.

Prior to running our own pathology lab, doctors who read our slides were general pathologists who did not always understand the language of gastroenterology. We had results that came back by fax that were often cumbersome to read and did not always give us the information we needed in the way we needed it. Consistency was a problem. We knew we needed a change.

I cannot lie – setting up and running your own pathology lab is not always easy. But with the right factors in place, here are some benefits to consider when you are making a decision about joining a practice.
 

Quality, efficiency can lead to opportunity

Our lab has three GI fellowship–trained pathologists reading our slides. That means they are highly specialized and know exactly what we are looking for in a pathology report. We have a 24-hour turnaround for results. A courier service delivers biopsy specimens from our endoscopy centers to our path lab every day, and each morning our gastropathologists have a stack of pathology slides waiting for them. It’s added predictability and stability to the process, and we get the level of quality, specificity, and uniformity we need in a report.

The efficiencies are beneficial and it has given us more leverage in our negotiations with payers. We know what our costs are and have great quality metrics as well as read rates that we can provide. This signals to health plans that quality is a top priority for us.

We have also gained a reputational benefit with patients. Although much of the work is happening behind the scenes for our patients, they get results faster and a consistency with costs. It also allows us to easily access the slides of patients we have been seeing for years, giving us a richer data set and more confidence in our diagnosis.

Now that we have our own lab, we can look at our pathology data and conduct studies that will benefit all patients. For example, a few of our GI fellows were able to work with our pathologists to conduct a study on adenoma detection rates, exhausting a tissue block when no adenoma was found on initial review. We found a significant increase in adenoma detection using this method; we plan to publish results soon. The ability to conduct this kind of research is worth considering when early career gastroenterologists are selecting a practice to join.

And last but not least, having our own pathology lab acts as a unifying force for our group, which is spread out across 26 offices. When diagnoses are available and we get a call from our pathologist, we know to pick up the phone immediately.
 

What to consider before jumping in

Setting up our own pathology lab from the ground up was a learning process. We had enough patient volume for the move to make sense, so it is possible that smaller practices might not be able to make the investment if they have lower patient volume or cannot control their specimen flow. One option is to set up a technical lab and contract out for the slide reading. We felt it was important for our pathologists to also be our practice partners, and time has proven this to be a good decision for us.

We designed a lab with our work flow in mind, and it helped to have a pathologist on board from the beginning who knows gastroenterology. We even created our own lab information system with the help of a software engineer. It took a little bit over a year from conception to a functioning comprehensive lab.

Of course, there are regulatory factors to consider – the federal physician self-referral (Stark) law and the federal Anti-Markup Rule – come to mind. But we made sure to get a legal opinion that allows us to comply with the law. That’s something anyone who wants to make a move in this direction should do.

Looking back over the experience, I would not do anything differently. Yes, there are startup costs and a learning curve. But the quality we get from having our own pathology lab dedicated to GI and the efficiencies we have gained are well worth it.

Dr. Berggreen is the president of Arizona Digestive Health and chief strategy officer of the GI Alliance. He is also a board member of the Digestive Health Physicians Association. He received his doctorate at Louisiana State University, New Orleans. He is the former site director of the Good Samaritan GI Fellowship Program and named one of Phoenix Magazine’s “Top Docs.”

From colonoscopies to endoscopic ultrasound, gastroenterology is fundamentally a procedure-based specialty. Given that reality, making a decision to have as much control as possible over the entire process just makes sense for many GI practices.

Back in 2008, I was in charge of the process to develop a pathology lab at Arizona Digestive Health, a physician group with 26 locations throughout the state, as part of our decision to form a supergroup with eight ambulatory surgery centers. For us, having ambulatory surgery centers had been a game changer. We learned we could double our efficiency with procedures when we controlled the process from start to finish. We began to consider other processes – in this case pathology – that we could improve.

Prior to running our own pathology lab, doctors who read our slides were general pathologists who did not always understand the language of gastroenterology. We had results that came back by fax that were often cumbersome to read and did not always give us the information we needed in the way we needed it. Consistency was a problem. We knew we needed a change.

I cannot lie – setting up and running your own pathology lab is not always easy. But with the right factors in place, here are some benefits to consider when you are making a decision about joining a practice.
 

Quality, efficiency can lead to opportunity

Our lab has three GI fellowship–trained pathologists reading our slides. That means they are highly specialized and know exactly what we are looking for in a pathology report. We have a 24-hour turnaround for results. A courier service delivers biopsy specimens from our endoscopy centers to our path lab every day, and each morning our gastropathologists have a stack of pathology slides waiting for them. It’s added predictability and stability to the process, and we get the level of quality, specificity, and uniformity we need in a report.

The efficiencies are beneficial and it has given us more leverage in our negotiations with payers. We know what our costs are and have great quality metrics as well as read rates that we can provide. This signals to health plans that quality is a top priority for us.

We have also gained a reputational benefit with patients. Although much of the work is happening behind the scenes for our patients, they get results faster and a consistency with costs. It also allows us to easily access the slides of patients we have been seeing for years, giving us a richer data set and more confidence in our diagnosis.

Now that we have our own lab, we can look at our pathology data and conduct studies that will benefit all patients. For example, a few of our GI fellows were able to work with our pathologists to conduct a study on adenoma detection rates, exhausting a tissue block when no adenoma was found on initial review. We found a significant increase in adenoma detection using this method; we plan to publish results soon. The ability to conduct this kind of research is worth considering when early career gastroenterologists are selecting a practice to join.

And last but not least, having our own pathology lab acts as a unifying force for our group, which is spread out across 26 offices. When diagnoses are available and we get a call from our pathologist, we know to pick up the phone immediately.
 

What to consider before jumping in

Setting up our own pathology lab from the ground up was a learning process. We had enough patient volume for the move to make sense, so it is possible that smaller practices might not be able to make the investment if they have lower patient volume or cannot control their specimen flow. One option is to set up a technical lab and contract out for the slide reading. We felt it was important for our pathologists to also be our practice partners, and time has proven this to be a good decision for us.

We designed a lab with our work flow in mind, and it helped to have a pathologist on board from the beginning who knows gastroenterology. We even created our own lab information system with the help of a software engineer. It took a little bit over a year from conception to a functioning comprehensive lab.

Of course, there are regulatory factors to consider – the federal physician self-referral (Stark) law and the federal Anti-Markup Rule – come to mind. But we made sure to get a legal opinion that allows us to comply with the law. That’s something anyone who wants to make a move in this direction should do.

Looking back over the experience, I would not do anything differently. Yes, there are startup costs and a learning curve. But the quality we get from having our own pathology lab dedicated to GI and the efficiencies we have gained are well worth it.

Dr. Berggreen is the president of Arizona Digestive Health and chief strategy officer of the GI Alliance. He is also a board member of the Digestive Health Physicians Association. He received his doctorate at Louisiana State University, New Orleans. He is the former site director of the Good Samaritan GI Fellowship Program and named one of Phoenix Magazine’s “Top Docs.”

From colonoscopies to endoscopic ultrasound, gastroenterology is fundamentally a procedure-based specialty. Given that reality, making a decision to have as much control as possible over the entire process just makes sense for many GI practices.

Back in 2008, I was in charge of the process to develop a pathology lab at Arizona Digestive Health, a physician group with 26 locations throughout the state, as part of our decision to form a supergroup with eight ambulatory surgery centers. For us, having ambulatory surgery centers had been a game changer. We learned we could double our efficiency with procedures when we controlled the process from start to finish. We began to consider other processes – in this case pathology – that we could improve.

Prior to running our own pathology lab, doctors who read our slides were general pathologists who did not always understand the language of gastroenterology. We had results that came back by fax that were often cumbersome to read and did not always give us the information we needed in the way we needed it. Consistency was a problem. We knew we needed a change.

I cannot lie – setting up and running your own pathology lab is not always easy. But with the right factors in place, here are some benefits to consider when you are making a decision about joining a practice.
 

Quality, efficiency can lead to opportunity

Our lab has three GI fellowship–trained pathologists reading our slides. That means they are highly specialized and know exactly what we are looking for in a pathology report. We have a 24-hour turnaround for results. A courier service delivers biopsy specimens from our endoscopy centers to our path lab every day, and each morning our gastropathologists have a stack of pathology slides waiting for them. It’s added predictability and stability to the process, and we get the level of quality, specificity, and uniformity we need in a report.

The efficiencies are beneficial and it has given us more leverage in our negotiations with payers. We know what our costs are and have great quality metrics as well as read rates that we can provide. This signals to health plans that quality is a top priority for us.

We have also gained a reputational benefit with patients. Although much of the work is happening behind the scenes for our patients, they get results faster and a consistency with costs. It also allows us to easily access the slides of patients we have been seeing for years, giving us a richer data set and more confidence in our diagnosis.

Now that we have our own lab, we can look at our pathology data and conduct studies that will benefit all patients. For example, a few of our GI fellows were able to work with our pathologists to conduct a study on adenoma detection rates, exhausting a tissue block when no adenoma was found on initial review. We found a significant increase in adenoma detection using this method; we plan to publish results soon. The ability to conduct this kind of research is worth considering when early career gastroenterologists are selecting a practice to join.

And last but not least, having our own pathology lab acts as a unifying force for our group, which is spread out across 26 offices. When diagnoses are available and we get a call from our pathologist, we know to pick up the phone immediately.
 

What to consider before jumping in

Setting up our own pathology lab from the ground up was a learning process. We had enough patient volume for the move to make sense, so it is possible that smaller practices might not be able to make the investment if they have lower patient volume or cannot control their specimen flow. One option is to set up a technical lab and contract out for the slide reading. We felt it was important for our pathologists to also be our practice partners, and time has proven this to be a good decision for us.

We designed a lab with our work flow in mind, and it helped to have a pathologist on board from the beginning who knows gastroenterology. We even created our own lab information system with the help of a software engineer. It took a little bit over a year from conception to a functioning comprehensive lab.

Of course, there are regulatory factors to consider – the federal physician self-referral (Stark) law and the federal Anti-Markup Rule – come to mind. But we made sure to get a legal opinion that allows us to comply with the law. That’s something anyone who wants to make a move in this direction should do.

Looking back over the experience, I would not do anything differently. Yes, there are startup costs and a learning curve. But the quality we get from having our own pathology lab dedicated to GI and the efficiencies we have gained are well worth it.

Dr. Berggreen is the president of Arizona Digestive Health and chief strategy officer of the GI Alliance. He is also a board member of the Digestive Health Physicians Association. He received his doctorate at Louisiana State University, New Orleans. He is the former site director of the Good Samaritan GI Fellowship Program and named one of Phoenix Magazine’s “Top Docs.”

For oncologists and other clinicians caring for patients with cancer, the COVID-19 pandemic represents a dynamic clinical challenge that is changing daily and that can feel overwhelming at times, say experts.

“Oncology clinicians are well versed in caring for immunosuppressed patients with cancer, of all ages,” Merry-Jennifer Markham, MD, interim chief of the Division of Hematology and Oncology at the University of Florida Health, Gainesville, told Medscape Medical News.

However, she emphasized that, during this COVID-19 outbreak, “we must be especially diligent about screening for symptoms and exposure, and we must recognize that our older patients with cancer may be especially vulnerable.”

Patients with cancer who are in active treatment are immunosuppressed and are more susceptible to infection and to complications from infection, Markham pointed out. “While we don’t yet have much data on how COVID-19 impacts patients with cancer, I have to suspect that patients undergoing active cancer treatment may be especially vulnerable to the more severe illness associated with COVID-19,” she said.

Indeed, a recent report from China that was published in the Lancet Oncology supports this. The authors suggest that patients with cancer are at higher risk for COVID-19 and have a worse prognosis if they become infected than do those without cancer.
 

Commonsense rules

Commonsense rules apply for all patients with cancer, regardless of age, said Markham. Measures include thorough handwashing, staying home when sick, and avoiding sick contacts.

Markham, who acts as an expert spokesperson for the American Society of Clinical Oncology, provides information on what patients with cancer need to know about COVID-19 at Cancer.net, the society’s website for patients with cancer.

“Unfortunately, this outbreak of COVID-19 is happening rapidly and in real time,” Markham noted. “The entire medical community is learning as we go, rather than having the luxury of years of evidence-based literature to guide us.”

Another expert agrees. “Unfortunately, there are not a lot of data on how COVID-19 affects cancer patients,” Cardinale Smith, MD, PhD, director of Quality for Cancer Services in the Mount Sinai Health System, New York City, said in an interview.

“We need to minimize the risk for patients and minimize our own exposure by treating this situation like we would a really bad flu season,” Smith told Medscape Medical News. “Some patients have had a bad outcome, but the vast majority do not. The best we can do is stay calm and focused.”

At Mount Sinai, for patients with cancer, routine, nonurgent appointments are being rescheduled for May, Smith said. Those in active treatment are screened by telephone 24 to 48 hours before arrival, after which they undergo a full risk assessment in an isolation room. Those with a respiratory infection are given a mask.

“Patients are very anxious and worried about COVID-19,” said Smith, who has young children and an elderly parent at home. “We don’t have all the answers, and this can heighten anxiety.”

To help allay fears, social workers are asking patients with cancer who express anxiety to discuss their concerns and provide information. A one-page handout on both flu and COVID-10 is available in the waiting room.

The Web portal MyChart gives patients access to updated information on COVID-19 precautions and provides links to the hospital website and to the US Centers for Disease Control and Prevention. Patients who are not feeling well can speak to someone or get answers if they have additional questions.

When counseling patients, Smith advises them to use “an abundance of caution” and to be creative in efforts to minimize risk. “My suggestion is to use FaceTime and Skype to connect and communicate with your community,” she said.

Some churches are conducting services via teleconferencing to minimize risk, and seniors’ centers that offer yoga and other classes are also beginning to provide services virtually, she pointed out.
 

Data from China

A report published February 14 in the Lancet Oncology appears to be the first analysis in the literature to focus on COVID-19 in patients with cancer.

“Patients with cancer are more susceptible to infection than individuals without cancer because of their systemic immunosuppressive state caused by the malignancy and anticancer treatments, such as chemotherapy or surgery,” write the authors, led by Wenhua Liang, MD, of Guangzhou Medical University. However, in correspondence published in the Lancet Oncology, other experts in China question some of Liang’s and colleagues’ findings.

The report by Liang and colleagues concerns a prospective cohort of 1590 patients with COVID-19.

There were 2007 laboratory-confirmed cases of COVID-19 among patients admitted to 575 hospitals throughout China as of January 31. Of those cases, 417 were excluded from the analysis because of insufficient information regarding disease history.

The team reports that of 18 patients with cancer and COVID-19, 39% were at significantly higher risk for “severe events.” By comparison, of 1572 patients with COVID-19 who did not have cancer, 8% were at significantly higher risk (P = .0003). These events included rapid clinical deterioration that required admission to intensive care; invasive ventilation; or death.

Patients with cancer experienced a much more rapid deterioration in clinical status than did those without cancer. The median time to severe events was 13 days, vs 43 days (hazard ratio [HR] adjusted for age, 3.56; P < .0001).

The analysis also shows that patients who underwent chemotherapy or surgery in the past month had a 75% risk of experiencing clinically severe events, compared with a 43% risk for those who had not received recent treatment.

After adjusting for other risk factors, including age and smoking history, older age was the only risk factor for severe events (odds ratio [OR], 1.43; 95% confidence interval [CI], 0.97 – 2.12; P = .072), the study authors say.

Patients with lung cancer did not have a higher probability of severe events compared with patients with other cancer types (20% vs 62%, respectively; P = .294).

Liang and colleagues conclude that these findings provide “a timely reminder to physicians that more intensive attention should be paid to patients with cancer, in case of rapid deterioration.”

The team also proposes three strategies for managing patients with cancer who are at risk for COVID-19 or any other severe infectious disease. They recommend that intentional postponement of adjuvant chemotherapy or elective surgery be considered for patients with stable cancer who live in areas where disease is endemic. Stronger “personal protection provisions” could also be made for patients with cancer or for cancer survivors. Lastly, for patients with cancer who have COVID-19, especially those who are older or who have comorbidities, more intensive surveillance or treatment should be considered.

However, in comments in the Lancet Oncology, other authors in China say these findings should be interpreted with caution.

One group suggests that the increased susceptibility to COVID-19 in patients with cancer could be the result of higher rates of smoking compared with patients who did not have cancer. “Overall, current evidence remains insufficient to explain a conclusive association between cancer and COVID-19,” say Huahao Shen, PhD, of Zhejiang University School of Medicine, Hangzhou, Zhejiang, and colleagues.

Another group suggests that the significantly higher median age of patients with cancer compared with noncancer patients (63 years vs 49 years) may have contributed to poor prognosis.

These authors, led by Li Zhang, MD, PhD, and Hanping Wang, MD, of Peking Union Medical College and the Chinese Academy of Medical Sciences, Beijing, emphasize that patients with cancer need online medical counseling and that critical cases need to be identified and treated.

“In endemic areas outside Wuhan, decisions on whether or not to postpone cancer treatment need to made on a patient-by-patient basis and according to the risk to the patient and the prevailing situation because delays could lead to tumor progression and ultimately poorer outcomes,” they write.

The study was funded by the China National Science Foundation and the Key Project of Guangzhou Scientific Research Project. Liang and coauthors, Shen and coauthors, Zhang, Wang, and Smith have disclosed no relevant financial relationships. Markham has relationships with Aduro Biotech, Lilly, Tesaro, Novartis, and VBL Therapeutics.

This article first appeared on Medscape.com.

For oncologists and other clinicians caring for patients with cancer, the COVID-19 pandemic represents a dynamic clinical challenge that is changing daily and that can feel overwhelming at times, say experts.

“Oncology clinicians are well versed in caring for immunosuppressed patients with cancer, of all ages,” Merry-Jennifer Markham, MD, interim chief of the Division of Hematology and Oncology at the University of Florida Health, Gainesville, told Medscape Medical News.

However, she emphasized that, during this COVID-19 outbreak, “we must be especially diligent about screening for symptoms and exposure, and we must recognize that our older patients with cancer may be especially vulnerable.”

Patients with cancer who are in active treatment are immunosuppressed and are more susceptible to infection and to complications from infection, Markham pointed out. “While we don’t yet have much data on how COVID-19 impacts patients with cancer, I have to suspect that patients undergoing active cancer treatment may be especially vulnerable to the more severe illness associated with COVID-19,” she said.

Indeed, a recent report from China that was published in the Lancet Oncology supports this. The authors suggest that patients with cancer are at higher risk for COVID-19 and have a worse prognosis if they become infected than do those without cancer.
 

Commonsense rules

Commonsense rules apply for all patients with cancer, regardless of age, said Markham. Measures include thorough handwashing, staying home when sick, and avoiding sick contacts.

Markham, who acts as an expert spokesperson for the American Society of Clinical Oncology, provides information on what patients with cancer need to know about COVID-19 at Cancer.net, the society’s website for patients with cancer.

“Unfortunately, this outbreak of COVID-19 is happening rapidly and in real time,” Markham noted. “The entire medical community is learning as we go, rather than having the luxury of years of evidence-based literature to guide us.”

Another expert agrees. “Unfortunately, there are not a lot of data on how COVID-19 affects cancer patients,” Cardinale Smith, MD, PhD, director of Quality for Cancer Services in the Mount Sinai Health System, New York City, said in an interview.

“We need to minimize the risk for patients and minimize our own exposure by treating this situation like we would a really bad flu season,” Smith told Medscape Medical News. “Some patients have had a bad outcome, but the vast majority do not. The best we can do is stay calm and focused.”

At Mount Sinai, for patients with cancer, routine, nonurgent appointments are being rescheduled for May, Smith said. Those in active treatment are screened by telephone 24 to 48 hours before arrival, after which they undergo a full risk assessment in an isolation room. Those with a respiratory infection are given a mask.

“Patients are very anxious and worried about COVID-19,” said Smith, who has young children and an elderly parent at home. “We don’t have all the answers, and this can heighten anxiety.”

To help allay fears, social workers are asking patients with cancer who express anxiety to discuss their concerns and provide information. A one-page handout on both flu and COVID-10 is available in the waiting room.

The Web portal MyChart gives patients access to updated information on COVID-19 precautions and provides links to the hospital website and to the US Centers for Disease Control and Prevention. Patients who are not feeling well can speak to someone or get answers if they have additional questions.

When counseling patients, Smith advises them to use “an abundance of caution” and to be creative in efforts to minimize risk. “My suggestion is to use FaceTime and Skype to connect and communicate with your community,” she said.

Some churches are conducting services via teleconferencing to minimize risk, and seniors’ centers that offer yoga and other classes are also beginning to provide services virtually, she pointed out.
 

Data from China

A report published February 14 in the Lancet Oncology appears to be the first analysis in the literature to focus on COVID-19 in patients with cancer.

“Patients with cancer are more susceptible to infection than individuals without cancer because of their systemic immunosuppressive state caused by the malignancy and anticancer treatments, such as chemotherapy or surgery,” write the authors, led by Wenhua Liang, MD, of Guangzhou Medical University. However, in correspondence published in the Lancet Oncology, other experts in China question some of Liang’s and colleagues’ findings.

The report by Liang and colleagues concerns a prospective cohort of 1590 patients with COVID-19.

There were 2007 laboratory-confirmed cases of COVID-19 among patients admitted to 575 hospitals throughout China as of January 31. Of those cases, 417 were excluded from the analysis because of insufficient information regarding disease history.

The team reports that of 18 patients with cancer and COVID-19, 39% were at significantly higher risk for “severe events.” By comparison, of 1572 patients with COVID-19 who did not have cancer, 8% were at significantly higher risk (P = .0003). These events included rapid clinical deterioration that required admission to intensive care; invasive ventilation; or death.

Patients with cancer experienced a much more rapid deterioration in clinical status than did those without cancer. The median time to severe events was 13 days, vs 43 days (hazard ratio [HR] adjusted for age, 3.56; P < .0001).

The analysis also shows that patients who underwent chemotherapy or surgery in the past month had a 75% risk of experiencing clinically severe events, compared with a 43% risk for those who had not received recent treatment.

After adjusting for other risk factors, including age and smoking history, older age was the only risk factor for severe events (odds ratio [OR], 1.43; 95% confidence interval [CI], 0.97 – 2.12; P = .072), the study authors say.

Patients with lung cancer did not have a higher probability of severe events compared with patients with other cancer types (20% vs 62%, respectively; P = .294).

Liang and colleagues conclude that these findings provide “a timely reminder to physicians that more intensive attention should be paid to patients with cancer, in case of rapid deterioration.”

The team also proposes three strategies for managing patients with cancer who are at risk for COVID-19 or any other severe infectious disease. They recommend that intentional postponement of adjuvant chemotherapy or elective surgery be considered for patients with stable cancer who live in areas where disease is endemic. Stronger “personal protection provisions” could also be made for patients with cancer or for cancer survivors. Lastly, for patients with cancer who have COVID-19, especially those who are older or who have comorbidities, more intensive surveillance or treatment should be considered.

However, in comments in the Lancet Oncology, other authors in China say these findings should be interpreted with caution.

One group suggests that the increased susceptibility to COVID-19 in patients with cancer could be the result of higher rates of smoking compared with patients who did not have cancer. “Overall, current evidence remains insufficient to explain a conclusive association between cancer and COVID-19,” say Huahao Shen, PhD, of Zhejiang University School of Medicine, Hangzhou, Zhejiang, and colleagues.

Another group suggests that the significantly higher median age of patients with cancer compared with noncancer patients (63 years vs 49 years) may have contributed to poor prognosis.

These authors, led by Li Zhang, MD, PhD, and Hanping Wang, MD, of Peking Union Medical College and the Chinese Academy of Medical Sciences, Beijing, emphasize that patients with cancer need online medical counseling and that critical cases need to be identified and treated.

“In endemic areas outside Wuhan, decisions on whether or not to postpone cancer treatment need to made on a patient-by-patient basis and according to the risk to the patient and the prevailing situation because delays could lead to tumor progression and ultimately poorer outcomes,” they write.

The study was funded by the China National Science Foundation and the Key Project of Guangzhou Scientific Research Project. Liang and coauthors, Shen and coauthors, Zhang, Wang, and Smith have disclosed no relevant financial relationships. Markham has relationships with Aduro Biotech, Lilly, Tesaro, Novartis, and VBL Therapeutics.

This article first appeared on Medscape.com.

For oncologists and other clinicians caring for patients with cancer, the COVID-19 pandemic represents a dynamic clinical challenge that is changing daily and that can feel overwhelming at times, say experts.

“Oncology clinicians are well versed in caring for immunosuppressed patients with cancer, of all ages,” Merry-Jennifer Markham, MD, interim chief of the Division of Hematology and Oncology at the University of Florida Health, Gainesville, told Medscape Medical News.

However, she emphasized that, during this COVID-19 outbreak, “we must be especially diligent about screening for symptoms and exposure, and we must recognize that our older patients with cancer may be especially vulnerable.”

Patients with cancer who are in active treatment are immunosuppressed and are more susceptible to infection and to complications from infection, Markham pointed out. “While we don’t yet have much data on how COVID-19 impacts patients with cancer, I have to suspect that patients undergoing active cancer treatment may be especially vulnerable to the more severe illness associated with COVID-19,” she said.

Indeed, a recent report from China that was published in the Lancet Oncology supports this. The authors suggest that patients with cancer are at higher risk for COVID-19 and have a worse prognosis if they become infected than do those without cancer.
 

Commonsense rules

Commonsense rules apply for all patients with cancer, regardless of age, said Markham. Measures include thorough handwashing, staying home when sick, and avoiding sick contacts.

Markham, who acts as an expert spokesperson for the American Society of Clinical Oncology, provides information on what patients with cancer need to know about COVID-19 at Cancer.net, the society’s website for patients with cancer.

“Unfortunately, this outbreak of COVID-19 is happening rapidly and in real time,” Markham noted. “The entire medical community is learning as we go, rather than having the luxury of years of evidence-based literature to guide us.”

Another expert agrees. “Unfortunately, there are not a lot of data on how COVID-19 affects cancer patients,” Cardinale Smith, MD, PhD, director of Quality for Cancer Services in the Mount Sinai Health System, New York City, said in an interview.

“We need to minimize the risk for patients and minimize our own exposure by treating this situation like we would a really bad flu season,” Smith told Medscape Medical News. “Some patients have had a bad outcome, but the vast majority do not. The best we can do is stay calm and focused.”

At Mount Sinai, for patients with cancer, routine, nonurgent appointments are being rescheduled for May, Smith said. Those in active treatment are screened by telephone 24 to 48 hours before arrival, after which they undergo a full risk assessment in an isolation room. Those with a respiratory infection are given a mask.

“Patients are very anxious and worried about COVID-19,” said Smith, who has young children and an elderly parent at home. “We don’t have all the answers, and this can heighten anxiety.”

To help allay fears, social workers are asking patients with cancer who express anxiety to discuss their concerns and provide information. A one-page handout on both flu and COVID-10 is available in the waiting room.

The Web portal MyChart gives patients access to updated information on COVID-19 precautions and provides links to the hospital website and to the US Centers for Disease Control and Prevention. Patients who are not feeling well can speak to someone or get answers if they have additional questions.

When counseling patients, Smith advises them to use “an abundance of caution” and to be creative in efforts to minimize risk. “My suggestion is to use FaceTime and Skype to connect and communicate with your community,” she said.

Some churches are conducting services via teleconferencing to minimize risk, and seniors’ centers that offer yoga and other classes are also beginning to provide services virtually, she pointed out.
 

Data from China

A report published February 14 in the Lancet Oncology appears to be the first analysis in the literature to focus on COVID-19 in patients with cancer.

“Patients with cancer are more susceptible to infection than individuals without cancer because of their systemic immunosuppressive state caused by the malignancy and anticancer treatments, such as chemotherapy or surgery,” write the authors, led by Wenhua Liang, MD, of Guangzhou Medical University. However, in correspondence published in the Lancet Oncology, other experts in China question some of Liang’s and colleagues’ findings.

The report by Liang and colleagues concerns a prospective cohort of 1590 patients with COVID-19.

There were 2007 laboratory-confirmed cases of COVID-19 among patients admitted to 575 hospitals throughout China as of January 31. Of those cases, 417 were excluded from the analysis because of insufficient information regarding disease history.

The team reports that of 18 patients with cancer and COVID-19, 39% were at significantly higher risk for “severe events.” By comparison, of 1572 patients with COVID-19 who did not have cancer, 8% were at significantly higher risk (P = .0003). These events included rapid clinical deterioration that required admission to intensive care; invasive ventilation; or death.

Patients with cancer experienced a much more rapid deterioration in clinical status than did those without cancer. The median time to severe events was 13 days, vs 43 days (hazard ratio [HR] adjusted for age, 3.56; P < .0001).

The analysis also shows that patients who underwent chemotherapy or surgery in the past month had a 75% risk of experiencing clinically severe events, compared with a 43% risk for those who had not received recent treatment.

After adjusting for other risk factors, including age and smoking history, older age was the only risk factor for severe events (odds ratio [OR], 1.43; 95% confidence interval [CI], 0.97 – 2.12; P = .072), the study authors say.

Patients with lung cancer did not have a higher probability of severe events compared with patients with other cancer types (20% vs 62%, respectively; P = .294).

Liang and colleagues conclude that these findings provide “a timely reminder to physicians that more intensive attention should be paid to patients with cancer, in case of rapid deterioration.”

The team also proposes three strategies for managing patients with cancer who are at risk for COVID-19 or any other severe infectious disease. They recommend that intentional postponement of adjuvant chemotherapy or elective surgery be considered for patients with stable cancer who live in areas where disease is endemic. Stronger “personal protection provisions” could also be made for patients with cancer or for cancer survivors. Lastly, for patients with cancer who have COVID-19, especially those who are older or who have comorbidities, more intensive surveillance or treatment should be considered.

However, in comments in the Lancet Oncology, other authors in China say these findings should be interpreted with caution.

One group suggests that the increased susceptibility to COVID-19 in patients with cancer could be the result of higher rates of smoking compared with patients who did not have cancer. “Overall, current evidence remains insufficient to explain a conclusive association between cancer and COVID-19,” say Huahao Shen, PhD, of Zhejiang University School of Medicine, Hangzhou, Zhejiang, and colleagues.

Another group suggests that the significantly higher median age of patients with cancer compared with noncancer patients (63 years vs 49 years) may have contributed to poor prognosis.

These authors, led by Li Zhang, MD, PhD, and Hanping Wang, MD, of Peking Union Medical College and the Chinese Academy of Medical Sciences, Beijing, emphasize that patients with cancer need online medical counseling and that critical cases need to be identified and treated.

“In endemic areas outside Wuhan, decisions on whether or not to postpone cancer treatment need to made on a patient-by-patient basis and according to the risk to the patient and the prevailing situation because delays could lead to tumor progression and ultimately poorer outcomes,” they write.

The study was funded by the China National Science Foundation and the Key Project of Guangzhou Scientific Research Project. Liang and coauthors, Shen and coauthors, Zhang, Wang, and Smith have disclosed no relevant financial relationships. Markham has relationships with Aduro Biotech, Lilly, Tesaro, Novartis, and VBL Therapeutics.

This article first appeared on Medscape.com.

The biggest cancer research meeting of the year has been canceled as a reaction to the novel coronavirus (COVID-19) outbreak, which has also led to many other medical conferences being canceled or postponed.

The annual meeting of the American Association for Cancer Research (AACR) was due to take place April 24-29 in San Diego, California. More than 24,000 delegates from 80 countries and more than 500 exhibitors were expected to attend.

There are plans to reschedule it for later this year.

This has been a “difficult decision,” said the AACR board of directors, but “we believe that the decision to postpone the meeting is absolutely the correct one to safeguard our meeting participants from further potential exposure to the coronavirus.”

The board goes on to explain that “this evidence-based decision was made after a thorough review and discussion of all factors impacting the annual meeting, including the US government’s enforcement of restrictions on international travelers to enter the US; the imposition of travel restrictions issued by US government agencies, cancer centers, academic institutions, and pharmaceutical and biotech companies; and the counsel of infectious disease experts. It is clear that all of these elements significantly affect the ability of delegates, speakers, presenters of proffered papers, and exhibitors to participate fully in the annual meeting.”

Other cancer conferences that were planned for March and that have been canceled include the following:

• European Breast Cancer Conference (EBCC), Barcelona, Spain, which was to have taken place March 18-20. This conference has been postponed and will now take place September 30 to October 2 at the same venue. Abstracts that have been accepted for the initial conference will remain in the program, and organizers will reopen abstract submissions in May.
• National Comprehensive Cancer Network (NCCN), Orlando, Florida, was scheduled for March 19-22. This conference has been postponed. No new dates have been provided, but the society notes that “NCCN staff is working as quickly as possible to notify all conference registrants about the postponement and further information regarding the refund process.”
• European Association of Urology (EAU), Amsterdam, the Netherlands, at which there is always new research presented on prostate, kidney, and bladder cancer, was due to take place March 20-24. This conference has been postponed to July 2020.
• Society of Gynecologic Oncology (SGO), in Toronto, Canada, which was scheduled for March 28-31. SGO is “exploring alternatives for delivering the science and education.”

Overall, the move to cancel medical conferences over the next few months is a good idea, commented F. Perry Wilson, MD, MSCE, associate professor of medicine and director of Yale’s Program of Applied Translational Research, in a Medscape Medical News commentary.

“There’s a pretty straightforward case here,” he argued. “Medical professionals are at higher risk for exposure to coronavirus because we come into contact with lots and lots of patients. Gathering a large group of medical professionals in a single place increases the risk for exposure further. Factor in airplane flights to and from the conferences, and the chance that infection is spread is significant.”

This article first appeared on Medscape.com.

The biggest cancer research meeting of the year has been canceled as a reaction to the novel coronavirus (COVID-19) outbreak, which has also led to many other medical conferences being canceled or postponed.

The annual meeting of the American Association for Cancer Research (AACR) was due to take place April 24-29 in San Diego, California. More than 24,000 delegates from 80 countries and more than 500 exhibitors were expected to attend.

There are plans to reschedule it for later this year.

This has been a “difficult decision,” said the AACR board of directors, but “we believe that the decision to postpone the meeting is absolutely the correct one to safeguard our meeting participants from further potential exposure to the coronavirus.”

The board goes on to explain that “this evidence-based decision was made after a thorough review and discussion of all factors impacting the annual meeting, including the US government’s enforcement of restrictions on international travelers to enter the US; the imposition of travel restrictions issued by US government agencies, cancer centers, academic institutions, and pharmaceutical and biotech companies; and the counsel of infectious disease experts. It is clear that all of these elements significantly affect the ability of delegates, speakers, presenters of proffered papers, and exhibitors to participate fully in the annual meeting.”

Other cancer conferences that were planned for March and that have been canceled include the following:

• European Breast Cancer Conference (EBCC), Barcelona, Spain, which was to have taken place March 18-20. This conference has been postponed and will now take place September 30 to October 2 at the same venue. Abstracts that have been accepted for the initial conference will remain in the program, and organizers will reopen abstract submissions in May.
• National Comprehensive Cancer Network (NCCN), Orlando, Florida, was scheduled for March 19-22. This conference has been postponed. No new dates have been provided, but the society notes that “NCCN staff is working as quickly as possible to notify all conference registrants about the postponement and further information regarding the refund process.”
• European Association of Urology (EAU), Amsterdam, the Netherlands, at which there is always new research presented on prostate, kidney, and bladder cancer, was due to take place March 20-24. This conference has been postponed to July 2020.
• Society of Gynecologic Oncology (SGO), in Toronto, Canada, which was scheduled for March 28-31. SGO is “exploring alternatives for delivering the science and education.”

Overall, the move to cancel medical conferences over the next few months is a good idea, commented F. Perry Wilson, MD, MSCE, associate professor of medicine and director of Yale’s Program of Applied Translational Research, in a Medscape Medical News commentary.

“There’s a pretty straightforward case here,” he argued. “Medical professionals are at higher risk for exposure to coronavirus because we come into contact with lots and lots of patients. Gathering a large group of medical professionals in a single place increases the risk for exposure further. Factor in airplane flights to and from the conferences, and the chance that infection is spread is significant.”

This article first appeared on Medscape.com.

The biggest cancer research meeting of the year has been canceled as a reaction to the novel coronavirus (COVID-19) outbreak, which has also led to many other medical conferences being canceled or postponed.

The annual meeting of the American Association for Cancer Research (AACR) was due to take place April 24-29 in San Diego, California. More than 24,000 delegates from 80 countries and more than 500 exhibitors were expected to attend.

There are plans to reschedule it for later this year.

This has been a “difficult decision,” said the AACR board of directors, but “we believe that the decision to postpone the meeting is absolutely the correct one to safeguard our meeting participants from further potential exposure to the coronavirus.”

The board goes on to explain that “this evidence-based decision was made after a thorough review and discussion of all factors impacting the annual meeting, including the US government’s enforcement of restrictions on international travelers to enter the US; the imposition of travel restrictions issued by US government agencies, cancer centers, academic institutions, and pharmaceutical and biotech companies; and the counsel of infectious disease experts. It is clear that all of these elements significantly affect the ability of delegates, speakers, presenters of proffered papers, and exhibitors to participate fully in the annual meeting.”

Other cancer conferences that were planned for March and that have been canceled include the following:

• European Breast Cancer Conference (EBCC), Barcelona, Spain, which was to have taken place March 18-20. This conference has been postponed and will now take place September 30 to October 2 at the same venue. Abstracts that have been accepted for the initial conference will remain in the program, and organizers will reopen abstract submissions in May.
• National Comprehensive Cancer Network (NCCN), Orlando, Florida, was scheduled for March 19-22. This conference has been postponed. No new dates have been provided, but the society notes that “NCCN staff is working as quickly as possible to notify all conference registrants about the postponement and further information regarding the refund process.”
• European Association of Urology (EAU), Amsterdam, the Netherlands, at which there is always new research presented on prostate, kidney, and bladder cancer, was due to take place March 20-24. This conference has been postponed to July 2020.
• Society of Gynecologic Oncology (SGO), in Toronto, Canada, which was scheduled for March 28-31. SGO is “exploring alternatives for delivering the science and education.”

Overall, the move to cancel medical conferences over the next few months is a good idea, commented F. Perry Wilson, MD, MSCE, associate professor of medicine and director of Yale’s Program of Applied Translational Research, in a Medscape Medical News commentary.

“There’s a pretty straightforward case here,” he argued. “Medical professionals are at higher risk for exposure to coronavirus because we come into contact with lots and lots of patients. Gathering a large group of medical professionals in a single place increases the risk for exposure further. Factor in airplane flights to and from the conferences, and the chance that infection is spread is significant.”

This article first appeared on Medscape.com.

Disease progression is associated with worsening health-related quality of life (HRQOL) among patients with metastatic cancers, results of an observational study suggest.

The findings highlight the importance of patient-relevant outcomes when evaluating novel therapies for patients with metastatic cancers, according to Norbert Marschner, MD, of Praxis für interdisziplinäre onkologie und hämatologie in Freiburg, Germany, and colleagues. The researchers reported the findings in JAMA Network Open.

They used four nationwide German registries to evaluate the association of disease progression with HRQOL in patients receiving systemic therapy for metastatic colorectal, lung, pancreatic, or breast cancer.

The analysis included 2,314 adults with documented disease progression across 203 institutions in Germany. Data collection occurred during routine follow-up visits at participating centers during 2011-2018.

Various patient-reported outcome questionnaires were used to measure HRQOL and symptom severity among participants. For the present study, the team enrolled patients at the start of any systemic palliative treatment, defined as targeted therapy, chemotherapy, or endocrine therapy.

Mixed-model analyses of more than 8,000 questionnaires showed that the first disease progression was associated with significant deterioration in 37 of 45 HRQOL scales overall, 17 of which were considered clinically meaningful.

With respect to cancer type, significant worsening after the first progression occurred in 12 of 14 colorectal cancer HRQOL scales, 11 of 14 lung cancer scales, 10 of 10 pancreatic cancer scales, and 4 of 7 breast cancer scales.

The deterioration in global HRQOL associated with the first progression was of greatest magnitude in lung cancer (6.7 points; P < .001), followed by pancreatic cancer (5.4 points; P < .001), colorectal cancer (3.5 points; P = .002), and breast cancer (2.4 points; P = .001).

The researchers also found that 38 of 45 HRQOL scales showed a greater degree of worsening after the second disease progression than after the first. They observed significant worsening after the second disease progression in 32 of 45 HRQOL scales, and all 32 were considered clinically meaningful.

The researchers acknowledged that a key limitation of this study was the observational design. As a result, the study did not include specifications related to tumor assessment, such as frequency, timing, or criteria.

“We suggest that progression-related endpoints in metastatic breast, colorectal, lung, or pancreatic cancer should be considered when evaluating the benefit of novel treatments, in addition to survival, morbidity, and HRQOL outcomes,” the researchers concluded.

The registries used in this study are funded by iOMEDICO and industry sponsors. The authors disclosed relationships with iOMEDICO and several pharmaceutical companies.

SOURCE: Marschner N et al. JAMA Netw Open. 2020 Mar 10. doi: 10.1001/jamanetworkopen.2020.0643.

Disease progression is associated with worsening health-related quality of life (HRQOL) among patients with metastatic cancers, results of an observational study suggest.

The findings highlight the importance of patient-relevant outcomes when evaluating novel therapies for patients with metastatic cancers, according to Norbert Marschner, MD, of Praxis für interdisziplinäre onkologie und hämatologie in Freiburg, Germany, and colleagues. The researchers reported the findings in JAMA Network Open.

They used four nationwide German registries to evaluate the association of disease progression with HRQOL in patients receiving systemic therapy for metastatic colorectal, lung, pancreatic, or breast cancer.

The analysis included 2,314 adults with documented disease progression across 203 institutions in Germany. Data collection occurred during routine follow-up visits at participating centers during 2011-2018.

Various patient-reported outcome questionnaires were used to measure HRQOL and symptom severity among participants. For the present study, the team enrolled patients at the start of any systemic palliative treatment, defined as targeted therapy, chemotherapy, or endocrine therapy.

Mixed-model analyses of more than 8,000 questionnaires showed that the first disease progression was associated with significant deterioration in 37 of 45 HRQOL scales overall, 17 of which were considered clinically meaningful.

With respect to cancer type, significant worsening after the first progression occurred in 12 of 14 colorectal cancer HRQOL scales, 11 of 14 lung cancer scales, 10 of 10 pancreatic cancer scales, and 4 of 7 breast cancer scales.

The deterioration in global HRQOL associated with the first progression was of greatest magnitude in lung cancer (6.7 points; P < .001), followed by pancreatic cancer (5.4 points; P < .001), colorectal cancer (3.5 points; P = .002), and breast cancer (2.4 points; P = .001).

The researchers also found that 38 of 45 HRQOL scales showed a greater degree of worsening after the second disease progression than after the first. They observed significant worsening after the second disease progression in 32 of 45 HRQOL scales, and all 32 were considered clinically meaningful.

The researchers acknowledged that a key limitation of this study was the observational design. As a result, the study did not include specifications related to tumor assessment, such as frequency, timing, or criteria.

“We suggest that progression-related endpoints in metastatic breast, colorectal, lung, or pancreatic cancer should be considered when evaluating the benefit of novel treatments, in addition to survival, morbidity, and HRQOL outcomes,” the researchers concluded.

The registries used in this study are funded by iOMEDICO and industry sponsors. The authors disclosed relationships with iOMEDICO and several pharmaceutical companies.

SOURCE: Marschner N et al. JAMA Netw Open. 2020 Mar 10. doi: 10.1001/jamanetworkopen.2020.0643.

Disease progression is associated with worsening health-related quality of life (HRQOL) among patients with metastatic cancers, results of an observational study suggest.

The findings highlight the importance of patient-relevant outcomes when evaluating novel therapies for patients with metastatic cancers, according to Norbert Marschner, MD, of Praxis für interdisziplinäre onkologie und hämatologie in Freiburg, Germany, and colleagues. The researchers reported the findings in JAMA Network Open.

They used four nationwide German registries to evaluate the association of disease progression with HRQOL in patients receiving systemic therapy for metastatic colorectal, lung, pancreatic, or breast cancer.

The analysis included 2,314 adults with documented disease progression across 203 institutions in Germany. Data collection occurred during routine follow-up visits at participating centers during 2011-2018.

Various patient-reported outcome questionnaires were used to measure HRQOL and symptom severity among participants. For the present study, the team enrolled patients at the start of any systemic palliative treatment, defined as targeted therapy, chemotherapy, or endocrine therapy.

Mixed-model analyses of more than 8,000 questionnaires showed that the first disease progression was associated with significant deterioration in 37 of 45 HRQOL scales overall, 17 of which were considered clinically meaningful.

With respect to cancer type, significant worsening after the first progression occurred in 12 of 14 colorectal cancer HRQOL scales, 11 of 14 lung cancer scales, 10 of 10 pancreatic cancer scales, and 4 of 7 breast cancer scales.

The deterioration in global HRQOL associated with the first progression was of greatest magnitude in lung cancer (6.7 points; P < .001), followed by pancreatic cancer (5.4 points; P < .001), colorectal cancer (3.5 points; P = .002), and breast cancer (2.4 points; P = .001).

The researchers also found that 38 of 45 HRQOL scales showed a greater degree of worsening after the second disease progression than after the first. They observed significant worsening after the second disease progression in 32 of 45 HRQOL scales, and all 32 were considered clinically meaningful.

The researchers acknowledged that a key limitation of this study was the observational design. As a result, the study did not include specifications related to tumor assessment, such as frequency, timing, or criteria.

“We suggest that progression-related endpoints in metastatic breast, colorectal, lung, or pancreatic cancer should be considered when evaluating the benefit of novel treatments, in addition to survival, morbidity, and HRQOL outcomes,” the researchers concluded.

The registries used in this study are funded by iOMEDICO and industry sponsors. The authors disclosed relationships with iOMEDICO and several pharmaceutical companies.

SOURCE: Marschner N et al. JAMA Netw Open. 2020 Mar 10. doi: 10.1001/jamanetworkopen.2020.0643.

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center.

The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.

The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.

“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.

The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.

As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.

The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.

Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”

The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.

“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.

Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”

The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center.

The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.

The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.

“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.

The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.

As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.

The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.

Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”

The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.

“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.

Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”

The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center.

The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.

The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.

“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.

The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.

As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.

The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.

Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”

The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.

“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.

Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”

The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”

This article first appeared on Medscape.com.

The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.

“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.

Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.

In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.

Updates on those plans will be posted on the AAD’s website at www.aad.org.

The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.

“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.

Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.

In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.

Updates on those plans will be posted on the AAD’s website at www.aad.org.

The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.

“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.

Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.

In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.

Updates on those plans will be posted on the AAD’s website at www.aad.org.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Stress-related disorders may put individuals at increased risk of neurodegenerative conditions such as Alzheimer’s disease later in life, conceivably through a cerebrovascular pathway, according to authors of a large population- and sibling-matched cohort study. Individuals with posttraumatic stress disorder (PTSD), acute stress reaction, adjustment disorder, or other stress reactions had an 80% increased risk of vascular neurodegenerative diseases, according to results of the study, which was based on Swedish population registry data.

Risk of primary neurodegenerative diseases was increased as well in people with those conditions, but only by 31%, according to lead author Huan Song, MD, PhD, of Sichuan University in Chengdu, China.

“The stronger association observed for neurodegenerative diseases with a vascular component, compared with primary neurodegenerative diseases, suggested a considerable role of a possible cerebrovascular pathway,” Dr. Song and coauthors said in a report on the study appearing in JAMA Neurology.

While some previous studies have linked stress-related disorders to neurodegenerative diseases – particularly PTSD and dementia – this is believed to be the first, according to the investigators, to comprehensively evaluate all stress-related disorders in relation to the most common neurodegenerative conditions.

When considering neurodegenerative conditions separately, they found a statistically significant association between stress-related disorders and Alzheimer’s disease, while linkages with Parkinson’s disease and amyotrophic lateral sclerosis (ALS) were “comparable” but associations did not reach statistical significance, according to investigators.

Based on these findings, stress reduction should be recommended in addition to daily physical activity, mental activity, and a heart-healthy diet to potentially reduce risk of onset or worsening of cognitive decline, according to Chun Lim, MD, PhD, medical director of the cognitive neurology unit at Beth Israel Deaconess Medical Center in Boston.

“We don’t really have great evidence that anything slows down the progression of Alzheimer’s disease, but there are some suggestions that for people who lead heart-healthy lifestyles or adhere to a Mediterranean diet, fewer develop cognitive issues over 5-10 years,” Dr. Lim said in an interview. “Because of this paper, stress reduction may be one additional way to hopefully help these patients these patients that have or are concerned about cognitive issues.”

The population-matched cohort of the study included 61,748 individuals with stress-related disorders and 595,335 matched individuals without those disorders, while the sibling-matched cohort included 44,839 individuals with those disorders and 78,482 without. The median age at the start of follow-up was 47 years and 39.4% of those with stress-related disorders were male.

During follow-up, the incidence of neurodegenerative diseases per 1,000 person-years was 1.50 for individuals with stress-related disorders, versus 0.82 for those without stress-related disorders, according to the report. Risk of primary neurodegenerative diseases was increased among those with stress-related disorders, compared with those without, with a hazard ratio of 1.31 (95% confidence interval, 1.15-1.48). However, the risk of vascular neurodegenerative diseases was significantly higher, with an HR of 1.80 (95% CI, 1.40-2.31; P = .03 for the difference between hazard ratios).

Results of the matched sibling cohort supported results of the population-matched cohort, though the elevated risk of vascular neurodegenerative diseases among those with stress-related disorders was “slightly lower” than in the population-based cohort, Dr. Song and coauthors wrote in their report.

Beyond causing a host of hormonal and medical issues, stress can lead to sleep issues that may have long-term consequences, Dr. Lim noted in the interview.

“There’s some thought that quality sleep is important for memory formation, and if people are under a fair amount of stress and they have really poor sleep, that can also lead to cognitive issues including memory impairment,” he said.

“There are these multiple avenues that may be contributing to the accelerated development of these kinds of issues,” he added, “so I think this paper suggests more ways to counsel the patients about using lifestyle modifications to slow down the development of these cognitive impairments.”

Funding for the study came from the Swedish Research Council, Icelandic Research Fund; ,European Research Council the Karolinska Institutet, Swedish Research Council, and West China Hospital. Authors of the study provided disclosures related to those organizations as well as Shire/Takeda and Evolan.

SOURCE: Song H et al. JAMA Neurol. 2020 Mar 9. doi: 10.1001/jamaneurol.2020.0117.

Stress-related disorders may put individuals at increased risk of neurodegenerative conditions such as Alzheimer’s disease later in life, conceivably through a cerebrovascular pathway, according to authors of a large population- and sibling-matched cohort study. Individuals with posttraumatic stress disorder (PTSD), acute stress reaction, adjustment disorder, or other stress reactions had an 80% increased risk of vascular neurodegenerative diseases, according to results of the study, which was based on Swedish population registry data.

Risk of primary neurodegenerative diseases was increased as well in people with those conditions, but only by 31%, according to lead author Huan Song, MD, PhD, of Sichuan University in Chengdu, China.

“The stronger association observed for neurodegenerative diseases with a vascular component, compared with primary neurodegenerative diseases, suggested a considerable role of a possible cerebrovascular pathway,” Dr. Song and coauthors said in a report on the study appearing in JAMA Neurology.

While some previous studies have linked stress-related disorders to neurodegenerative diseases – particularly PTSD and dementia – this is believed to be the first, according to the investigators, to comprehensively evaluate all stress-related disorders in relation to the most common neurodegenerative conditions.

When considering neurodegenerative conditions separately, they found a statistically significant association between stress-related disorders and Alzheimer’s disease, while linkages with Parkinson’s disease and amyotrophic lateral sclerosis (ALS) were “comparable” but associations did not reach statistical significance, according to investigators.

Based on these findings, stress reduction should be recommended in addition to daily physical activity, mental activity, and a heart-healthy diet to potentially reduce risk of onset or worsening of cognitive decline, according to Chun Lim, MD, PhD, medical director of the cognitive neurology unit at Beth Israel Deaconess Medical Center in Boston.

“We don’t really have great evidence that anything slows down the progression of Alzheimer’s disease, but there are some suggestions that for people who lead heart-healthy lifestyles or adhere to a Mediterranean diet, fewer develop cognitive issues over 5-10 years,” Dr. Lim said in an interview. “Because of this paper, stress reduction may be one additional way to hopefully help these patients these patients that have or are concerned about cognitive issues.”

The population-matched cohort of the study included 61,748 individuals with stress-related disorders and 595,335 matched individuals without those disorders, while the sibling-matched cohort included 44,839 individuals with those disorders and 78,482 without. The median age at the start of follow-up was 47 years and 39.4% of those with stress-related disorders were male.

During follow-up, the incidence of neurodegenerative diseases per 1,000 person-years was 1.50 for individuals with stress-related disorders, versus 0.82 for those without stress-related disorders, according to the report. Risk of primary neurodegenerative diseases was increased among those with stress-related disorders, compared with those without, with a hazard ratio of 1.31 (95% confidence interval, 1.15-1.48). However, the risk of vascular neurodegenerative diseases was significantly higher, with an HR of 1.80 (95% CI, 1.40-2.31; P = .03 for the difference between hazard ratios).

Results of the matched sibling cohort supported results of the population-matched cohort, though the elevated risk of vascular neurodegenerative diseases among those with stress-related disorders was “slightly lower” than in the population-based cohort, Dr. Song and coauthors wrote in their report.

Beyond causing a host of hormonal and medical issues, stress can lead to sleep issues that may have long-term consequences, Dr. Lim noted in the interview.

“There’s some thought that quality sleep is important for memory formation, and if people are under a fair amount of stress and they have really poor sleep, that can also lead to cognitive issues including memory impairment,” he said.

“There are these multiple avenues that may be contributing to the accelerated development of these kinds of issues,” he added, “so I think this paper suggests more ways to counsel the patients about using lifestyle modifications to slow down the development of these cognitive impairments.”

Funding for the study came from the Swedish Research Council, Icelandic Research Fund; ,European Research Council the Karolinska Institutet, Swedish Research Council, and West China Hospital. Authors of the study provided disclosures related to those organizations as well as Shire/Takeda and Evolan.

SOURCE: Song H et al. JAMA Neurol. 2020 Mar 9. doi: 10.1001/jamaneurol.2020.0117.

Stress-related disorders may put individuals at increased risk of neurodegenerative conditions such as Alzheimer’s disease later in life, conceivably through a cerebrovascular pathway, according to authors of a large population- and sibling-matched cohort study. Individuals with posttraumatic stress disorder (PTSD), acute stress reaction, adjustment disorder, or other stress reactions had an 80% increased risk of vascular neurodegenerative diseases, according to results of the study, which was based on Swedish population registry data.

Risk of primary neurodegenerative diseases was increased as well in people with those conditions, but only by 31%, according to lead author Huan Song, MD, PhD, of Sichuan University in Chengdu, China.

“The stronger association observed for neurodegenerative diseases with a vascular component, compared with primary neurodegenerative diseases, suggested a considerable role of a possible cerebrovascular pathway,” Dr. Song and coauthors said in a report on the study appearing in JAMA Neurology.

While some previous studies have linked stress-related disorders to neurodegenerative diseases – particularly PTSD and dementia – this is believed to be the first, according to the investigators, to comprehensively evaluate all stress-related disorders in relation to the most common neurodegenerative conditions.

When considering neurodegenerative conditions separately, they found a statistically significant association between stress-related disorders and Alzheimer’s disease, while linkages with Parkinson’s disease and amyotrophic lateral sclerosis (ALS) were “comparable” but associations did not reach statistical significance, according to investigators.

Based on these findings, stress reduction should be recommended in addition to daily physical activity, mental activity, and a heart-healthy diet to potentially reduce risk of onset or worsening of cognitive decline, according to Chun Lim, MD, PhD, medical director of the cognitive neurology unit at Beth Israel Deaconess Medical Center in Boston.

“We don’t really have great evidence that anything slows down the progression of Alzheimer’s disease, but there are some suggestions that for people who lead heart-healthy lifestyles or adhere to a Mediterranean diet, fewer develop cognitive issues over 5-10 years,” Dr. Lim said in an interview. “Because of this paper, stress reduction may be one additional way to hopefully help these patients these patients that have or are concerned about cognitive issues.”

The population-matched cohort of the study included 61,748 individuals with stress-related disorders and 595,335 matched individuals without those disorders, while the sibling-matched cohort included 44,839 individuals with those disorders and 78,482 without. The median age at the start of follow-up was 47 years and 39.4% of those with stress-related disorders were male.

During follow-up, the incidence of neurodegenerative diseases per 1,000 person-years was 1.50 for individuals with stress-related disorders, versus 0.82 for those without stress-related disorders, according to the report. Risk of primary neurodegenerative diseases was increased among those with stress-related disorders, compared with those without, with a hazard ratio of 1.31 (95% confidence interval, 1.15-1.48). However, the risk of vascular neurodegenerative diseases was significantly higher, with an HR of 1.80 (95% CI, 1.40-2.31; P = .03 for the difference between hazard ratios).

Results of the matched sibling cohort supported results of the population-matched cohort, though the elevated risk of vascular neurodegenerative diseases among those with stress-related disorders was “slightly lower” than in the population-based cohort, Dr. Song and coauthors wrote in their report.

Beyond causing a host of hormonal and medical issues, stress can lead to sleep issues that may have long-term consequences, Dr. Lim noted in the interview.

“There’s some thought that quality sleep is important for memory formation, and if people are under a fair amount of stress and they have really poor sleep, that can also lead to cognitive issues including memory impairment,” he said.

“There are these multiple avenues that may be contributing to the accelerated development of these kinds of issues,” he added, “so I think this paper suggests more ways to counsel the patients about using lifestyle modifications to slow down the development of these cognitive impairments.”

Funding for the study came from the Swedish Research Council, Icelandic Research Fund; ,European Research Council the Karolinska Institutet, Swedish Research Council, and West China Hospital. Authors of the study provided disclosures related to those organizations as well as Shire/Takeda and Evolan.

SOURCE: Song H et al. JAMA Neurol. 2020 Mar 9. doi: 10.1001/jamaneurol.2020.0117.