Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.

Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.

Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.

As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.

A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.

Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.

In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”

Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”

Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.

A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.

Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:

1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.

2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.

3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO₂ monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.

There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.

In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.

Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.

Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.

Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.

Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.

Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.

As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.

A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.

Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.

In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”

Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”

Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.

A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.

Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:

1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.

2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.

3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO₂ monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.

There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.

In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.

Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.

Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.

Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.

Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.

Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.

As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.

A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.

Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.

In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”

Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”

Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.

A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.

Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:

1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.

2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.

3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO₂ monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.

There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.

In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.

Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.

Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.

Thursday was a big day in my ongoing quest to ask the question, “Why do people act that way?”

Paul Bradbury/Getty Images

You notice I said, “Ask the question.” I can always ask. I just can’t always answer.

Harriet listed her Chief Complaint as “psoriasis on the scalp.”

“My hairdresser says I have psoriasis,” she said.

I took a look. “You do,” I said. “Just one spot, though. Should be easy to control.”

I then ran through the list of what generally bothers people about scalp psoriasis. “It may come back now and then,” I said, “but you don’t have much of it and you haven’t had it long, so it shouldn’t take much effort to keep it under control. Psoriasis doesn’t cause permanent hair loss,” I added. “And you can color and condition your hair any way you want.”

Harriet smiled. That was what she wanted to hear. But it wasn’t all she wanted to hear.

“Why don’t I look you over completely?” I suggested. Harriet agreed. I found only lentigines and seborrheic keratoses all over, and I told her so.

“That’s wonderful,” said Harriet. “Just one more thing.”

“Sure.”

“That psoriasis on my head. It wouldn’t be cancer, would it?”

I opened my mouth to respond, but nothing came out. Sure, patients worry that anything they don’t understand might be cancer. But that’s to start with, not after a whole conversation about psoriasis. Right?

Maybe not.

“Not cancer,” I said. “Just some local inflammation.” Harriet was happy. I was perplexed. There’s always something new about patients to puzzle over.

Which I did for about 2 hours, until that puzzle was muscled out by another. I walked in to meet a very cheery Rory, who was punching his smartphone screen. “Wouldn’t you know it?” he said with a smile. “The same thing happened last time I came here. You walked in just as I was about to start a conference call.”

I thought of several responses, none of them appropriate.

“Last time you cauterized some of these milia thingies on my face,” said Rory. “I was hoping you could do that again.”

I peered at his face. “Sure,” I said, “if you want me to.”

“Just a sec,” said Rory, peering down at his phone. I assumed he was logging off the conference call.

“OK,” he said. “Go ahead.”

I revved up my Hyfrecator, which started to buzz.

“Wait, can they hear that?” Rory asked.

“Can who hear ... ?”

“This is Rory Stiefel,” he spoke into his phone. “Glad we could meet today. I wanted to talk to all of you about our plans to expand our network services into your Upper Midwestern territory.”

“Hold on,” I said (to myself), “You want me to desiccate your face while you’re expanding your network into the Upper Midwest??!!”

Rory motioned for me to continue. “Sure,” he said to his phone, “We can be up and running by the first of next month, no problem.” Apparently, the hum of the Hyfrecator wasn’t interrupting negotiations.

So I buzzed away, while Rory’s interlocutors responded with apparent enthusiasm. By the time he turned his other cheek, I figured he had occupied Minnesota.

“Did you get all the thingies?” Rory stage-whispered.

I nodded.

“Great!” he said, then turned back to his phone. “Well, this was a great meeting,” he said. “I’m glad we’re ready to go live. Talk to you guys next week to firm up logistics.” He punched the screen to sever the connection.

“Thanks for being so efficient,” he said, this time to me.

“No problem,” I said, now-silent Hyfrecator in hand.

“You’re sure you got them all?”
 

“I handed him a mirror. “Yes,” I said. “I got them all.”

“Well that’s terrific,” he said, jumping off the exam table and heading for the door. “Always a pleasure. See you next time!”

I don’t know exactly what he does, but Rory is one awesome multitasker.

As for me, I just have to consult the CPT code book to find the right designation for “Cautery of benign lesions during a corporate conference call, second episode.”

Any help, dear colleagues, with people or coding, will be appreciated.

I can always ask ...
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Thursday was a big day in my ongoing quest to ask the question, “Why do people act that way?”

Paul Bradbury/Getty Images

You notice I said, “Ask the question.” I can always ask. I just can’t always answer.

Harriet listed her Chief Complaint as “psoriasis on the scalp.”

“My hairdresser says I have psoriasis,” she said.

I took a look. “You do,” I said. “Just one spot, though. Should be easy to control.”

I then ran through the list of what generally bothers people about scalp psoriasis. “It may come back now and then,” I said, “but you don’t have much of it and you haven’t had it long, so it shouldn’t take much effort to keep it under control. Psoriasis doesn’t cause permanent hair loss,” I added. “And you can color and condition your hair any way you want.”

Harriet smiled. That was what she wanted to hear. But it wasn’t all she wanted to hear.

“Why don’t I look you over completely?” I suggested. Harriet agreed. I found only lentigines and seborrheic keratoses all over, and I told her so.

“That’s wonderful,” said Harriet. “Just one more thing.”

“Sure.”

“That psoriasis on my head. It wouldn’t be cancer, would it?”

I opened my mouth to respond, but nothing came out. Sure, patients worry that anything they don’t understand might be cancer. But that’s to start with, not after a whole conversation about psoriasis. Right?

Maybe not.

“Not cancer,” I said. “Just some local inflammation.” Harriet was happy. I was perplexed. There’s always something new about patients to puzzle over.

Which I did for about 2 hours, until that puzzle was muscled out by another. I walked in to meet a very cheery Rory, who was punching his smartphone screen. “Wouldn’t you know it?” he said with a smile. “The same thing happened last time I came here. You walked in just as I was about to start a conference call.”

I thought of several responses, none of them appropriate.

“Last time you cauterized some of these milia thingies on my face,” said Rory. “I was hoping you could do that again.”

I peered at his face. “Sure,” I said, “if you want me to.”

“Just a sec,” said Rory, peering down at his phone. I assumed he was logging off the conference call.

“OK,” he said. “Go ahead.”

I revved up my Hyfrecator, which started to buzz.

“Wait, can they hear that?” Rory asked.

“Can who hear ... ?”

“This is Rory Stiefel,” he spoke into his phone. “Glad we could meet today. I wanted to talk to all of you about our plans to expand our network services into your Upper Midwestern territory.”

“Hold on,” I said (to myself), “You want me to desiccate your face while you’re expanding your network into the Upper Midwest??!!”

Rory motioned for me to continue. “Sure,” he said to his phone, “We can be up and running by the first of next month, no problem.” Apparently, the hum of the Hyfrecator wasn’t interrupting negotiations.

So I buzzed away, while Rory’s interlocutors responded with apparent enthusiasm. By the time he turned his other cheek, I figured he had occupied Minnesota.

“Did you get all the thingies?” Rory stage-whispered.

I nodded.

“Great!” he said, then turned back to his phone. “Well, this was a great meeting,” he said. “I’m glad we’re ready to go live. Talk to you guys next week to firm up logistics.” He punched the screen to sever the connection.

“Thanks for being so efficient,” he said, this time to me.

“No problem,” I said, now-silent Hyfrecator in hand.

“You’re sure you got them all?”
 

“I handed him a mirror. “Yes,” I said. “I got them all.”

“Well that’s terrific,” he said, jumping off the exam table and heading for the door. “Always a pleasure. See you next time!”

I don’t know exactly what he does, but Rory is one awesome multitasker.

As for me, I just have to consult the CPT code book to find the right designation for “Cautery of benign lesions during a corporate conference call, second episode.”

Any help, dear colleagues, with people or coding, will be appreciated.

I can always ask ...
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Thursday was a big day in my ongoing quest to ask the question, “Why do people act that way?”

Paul Bradbury/Getty Images

You notice I said, “Ask the question.” I can always ask. I just can’t always answer.

Harriet listed her Chief Complaint as “psoriasis on the scalp.”

“My hairdresser says I have psoriasis,” she said.

I took a look. “You do,” I said. “Just one spot, though. Should be easy to control.”

I then ran through the list of what generally bothers people about scalp psoriasis. “It may come back now and then,” I said, “but you don’t have much of it and you haven’t had it long, so it shouldn’t take much effort to keep it under control. Psoriasis doesn’t cause permanent hair loss,” I added. “And you can color and condition your hair any way you want.”

Harriet smiled. That was what she wanted to hear. But it wasn’t all she wanted to hear.

“Why don’t I look you over completely?” I suggested. Harriet agreed. I found only lentigines and seborrheic keratoses all over, and I told her so.

“That’s wonderful,” said Harriet. “Just one more thing.”

“Sure.”

“That psoriasis on my head. It wouldn’t be cancer, would it?”

I opened my mouth to respond, but nothing came out. Sure, patients worry that anything they don’t understand might be cancer. But that’s to start with, not after a whole conversation about psoriasis. Right?

Maybe not.

“Not cancer,” I said. “Just some local inflammation.” Harriet was happy. I was perplexed. There’s always something new about patients to puzzle over.

Which I did for about 2 hours, until that puzzle was muscled out by another. I walked in to meet a very cheery Rory, who was punching his smartphone screen. “Wouldn’t you know it?” he said with a smile. “The same thing happened last time I came here. You walked in just as I was about to start a conference call.”

I thought of several responses, none of them appropriate.

“Last time you cauterized some of these milia thingies on my face,” said Rory. “I was hoping you could do that again.”

I peered at his face. “Sure,” I said, “if you want me to.”

“Just a sec,” said Rory, peering down at his phone. I assumed he was logging off the conference call.

“OK,” he said. “Go ahead.”

I revved up my Hyfrecator, which started to buzz.

“Wait, can they hear that?” Rory asked.

“Can who hear ... ?”

“This is Rory Stiefel,” he spoke into his phone. “Glad we could meet today. I wanted to talk to all of you about our plans to expand our network services into your Upper Midwestern territory.”

“Hold on,” I said (to myself), “You want me to desiccate your face while you’re expanding your network into the Upper Midwest??!!”

Rory motioned for me to continue. “Sure,” he said to his phone, “We can be up and running by the first of next month, no problem.” Apparently, the hum of the Hyfrecator wasn’t interrupting negotiations.

So I buzzed away, while Rory’s interlocutors responded with apparent enthusiasm. By the time he turned his other cheek, I figured he had occupied Minnesota.

“Did you get all the thingies?” Rory stage-whispered.

I nodded.

“Great!” he said, then turned back to his phone. “Well, this was a great meeting,” he said. “I’m glad we’re ready to go live. Talk to you guys next week to firm up logistics.” He punched the screen to sever the connection.

“Thanks for being so efficient,” he said, this time to me.

“No problem,” I said, now-silent Hyfrecator in hand.

“You’re sure you got them all?”
 

“I handed him a mirror. “Yes,” I said. “I got them all.”

“Well that’s terrific,” he said, jumping off the exam table and heading for the door. “Always a pleasure. See you next time!”

I don’t know exactly what he does, but Rory is one awesome multitasker.

As for me, I just have to consult the CPT code book to find the right designation for “Cautery of benign lesions during a corporate conference call, second episode.”

Any help, dear colleagues, with people or coding, will be appreciated.

I can always ask ...
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Successive screenings to detect congenital hypothyroidism in preterm infants is key to identifying cases that would otherwise lead to permanent and decompensated hypothyroidism, reported Niamh McGrath, MD, of the department of pediatric endocrinology at Children’s University Hospital, Dublin, and her associates in the Journal of Pediatrics.

In a population-based prospective review of 898,424 records between 2004 and 2016, Dr. McGrath and her associates identified all preterm infants less than 33 weeks diagnosed with congenital hypothyroidism and receiving treatment with levothyroxine. Of the infants screened, just 53 were selected to participate in the study, including 26 who were diagnosed at the first thyroid-stimulating hormone (TSH) screening and 27 who had delayed TSH elevation.

Gestational age ranged from 23 to 33 weeks, median birth weight measured 1.2 kg, median serum TSH concentration at the time of diagnosis was 78.3 mU/L, and median free thyroxine concentration was 8.9 pmol/L.

For half of the infants ultimately diagnosed, congenital hypothyroidism was not detected during the initial newborn screening. The authors also noted that 25% of patients with delayed TSH elevation had been exposed to iodine while undergoing surgery for necrotizing enterocolitis; after age 28 days, four of these infants were found to have elevated TSH. They cautioned that while this finding emphasizes the need for close monitoring and repeat screening of infants who have been exposed to iodine for up to 1 month following exposure, they could not be certain that the iodine exposure was responsible for the transient hypothyroidism in these patients.


Dr. McGrath and her associates emphasized the importance of repeat TSH screening for all preterm infants, noting that standard protocol screenings conducted just once at age 2 weeks or 4 weeks are not sufficient to effectively identify all cases of congenital hypothyroidism in which TSH elevation is delayed. Instead, they recommended measuring TSH on days 3-5 and at 1 week, 2 weeks, 4 weeks, and term-corrected gestational age.

“Our data are consistent with studies showing a high incidence of delayed TSH rise, particularly in very-low-birth-weight infants,” the authors wrote. They speculated that delays in detecting primary congenital hypothyroidism could be caused by the suppression of TSH secretion as a result of “hypothalamic-pituitary immaturity, medication administration, and effects of serious neonatal illness.” In fact, had standard, recommended 2-week-only screening protocols been followed with their patient population, fully 48% of infants with delayed TSH elevation would have been overlooked; half of these patients were later found to have decompensated hypothyroidism.

Neurodevelopmental disability caused by congenital hypothyroidism, which affects roughly 1 in every 2,000-4,000 births, is increasingly being prevented with newborn screenings that identify the condition early, but the incidence of congenital hypothyroidism has increased considerably in the past 20 years. The authors attribute this increase to the gradual change in screening cutoff levels and the rise in number of preterm infants who are surviving.

The need for a second screening, as well as appropriate timing and optimal TSH cutoff, are “subjects of active debate,” the authors wrote. The latest European screening guidelines recommend second screenings for preterm and low-birth-weight infants at either 2 weeks of age or 2 weeks following preliminary screening. Although they make no recommendations regarding additional screenings, American Academy of Pediatrics guidelines, published in 2006, cite a “disproportionate incidence” of delayed increase in TSH and congenital hypothyroidism in infants with very low birth weight. Dr. McGrath and her associates speculated that not all screening programs have adopted repeat screening of preterm infants, perhaps because of the low yield results, “the transient nature of most cases” detected, as well as conflicting long-term data on neurodevelopmental outcomes.

Dr. McGrath receives funding from the Children’s Fund for Health. The authors declared no conflicts of interest.

SOURCE: McGrath N et al. J Pediatr. 2018 Oct 24. doi: 10.1016/j.jpeds.2018.09.044.

Successive screenings to detect congenital hypothyroidism in preterm infants is key to identifying cases that would otherwise lead to permanent and decompensated hypothyroidism, reported Niamh McGrath, MD, of the department of pediatric endocrinology at Children’s University Hospital, Dublin, and her associates in the Journal of Pediatrics.

In a population-based prospective review of 898,424 records between 2004 and 2016, Dr. McGrath and her associates identified all preterm infants less than 33 weeks diagnosed with congenital hypothyroidism and receiving treatment with levothyroxine. Of the infants screened, just 53 were selected to participate in the study, including 26 who were diagnosed at the first thyroid-stimulating hormone (TSH) screening and 27 who had delayed TSH elevation.

Gestational age ranged from 23 to 33 weeks, median birth weight measured 1.2 kg, median serum TSH concentration at the time of diagnosis was 78.3 mU/L, and median free thyroxine concentration was 8.9 pmol/L.

For half of the infants ultimately diagnosed, congenital hypothyroidism was not detected during the initial newborn screening. The authors also noted that 25% of patients with delayed TSH elevation had been exposed to iodine while undergoing surgery for necrotizing enterocolitis; after age 28 days, four of these infants were found to have elevated TSH. They cautioned that while this finding emphasizes the need for close monitoring and repeat screening of infants who have been exposed to iodine for up to 1 month following exposure, they could not be certain that the iodine exposure was responsible for the transient hypothyroidism in these patients.


Dr. McGrath and her associates emphasized the importance of repeat TSH screening for all preterm infants, noting that standard protocol screenings conducted just once at age 2 weeks or 4 weeks are not sufficient to effectively identify all cases of congenital hypothyroidism in which TSH elevation is delayed. Instead, they recommended measuring TSH on days 3-5 and at 1 week, 2 weeks, 4 weeks, and term-corrected gestational age.

“Our data are consistent with studies showing a high incidence of delayed TSH rise, particularly in very-low-birth-weight infants,” the authors wrote. They speculated that delays in detecting primary congenital hypothyroidism could be caused by the suppression of TSH secretion as a result of “hypothalamic-pituitary immaturity, medication administration, and effects of serious neonatal illness.” In fact, had standard, recommended 2-week-only screening protocols been followed with their patient population, fully 48% of infants with delayed TSH elevation would have been overlooked; half of these patients were later found to have decompensated hypothyroidism.

Neurodevelopmental disability caused by congenital hypothyroidism, which affects roughly 1 in every 2,000-4,000 births, is increasingly being prevented with newborn screenings that identify the condition early, but the incidence of congenital hypothyroidism has increased considerably in the past 20 years. The authors attribute this increase to the gradual change in screening cutoff levels and the rise in number of preterm infants who are surviving.

The need for a second screening, as well as appropriate timing and optimal TSH cutoff, are “subjects of active debate,” the authors wrote. The latest European screening guidelines recommend second screenings for preterm and low-birth-weight infants at either 2 weeks of age or 2 weeks following preliminary screening. Although they make no recommendations regarding additional screenings, American Academy of Pediatrics guidelines, published in 2006, cite a “disproportionate incidence” of delayed increase in TSH and congenital hypothyroidism in infants with very low birth weight. Dr. McGrath and her associates speculated that not all screening programs have adopted repeat screening of preterm infants, perhaps because of the low yield results, “the transient nature of most cases” detected, as well as conflicting long-term data on neurodevelopmental outcomes.

Dr. McGrath receives funding from the Children’s Fund for Health. The authors declared no conflicts of interest.

SOURCE: McGrath N et al. J Pediatr. 2018 Oct 24. doi: 10.1016/j.jpeds.2018.09.044.

Successive screenings to detect congenital hypothyroidism in preterm infants is key to identifying cases that would otherwise lead to permanent and decompensated hypothyroidism, reported Niamh McGrath, MD, of the department of pediatric endocrinology at Children’s University Hospital, Dublin, and her associates in the Journal of Pediatrics.

In a population-based prospective review of 898,424 records between 2004 and 2016, Dr. McGrath and her associates identified all preterm infants less than 33 weeks diagnosed with congenital hypothyroidism and receiving treatment with levothyroxine. Of the infants screened, just 53 were selected to participate in the study, including 26 who were diagnosed at the first thyroid-stimulating hormone (TSH) screening and 27 who had delayed TSH elevation.

Gestational age ranged from 23 to 33 weeks, median birth weight measured 1.2 kg, median serum TSH concentration at the time of diagnosis was 78.3 mU/L, and median free thyroxine concentration was 8.9 pmol/L.

For half of the infants ultimately diagnosed, congenital hypothyroidism was not detected during the initial newborn screening. The authors also noted that 25% of patients with delayed TSH elevation had been exposed to iodine while undergoing surgery for necrotizing enterocolitis; after age 28 days, four of these infants were found to have elevated TSH. They cautioned that while this finding emphasizes the need for close monitoring and repeat screening of infants who have been exposed to iodine for up to 1 month following exposure, they could not be certain that the iodine exposure was responsible for the transient hypothyroidism in these patients.


Dr. McGrath and her associates emphasized the importance of repeat TSH screening for all preterm infants, noting that standard protocol screenings conducted just once at age 2 weeks or 4 weeks are not sufficient to effectively identify all cases of congenital hypothyroidism in which TSH elevation is delayed. Instead, they recommended measuring TSH on days 3-5 and at 1 week, 2 weeks, 4 weeks, and term-corrected gestational age.

“Our data are consistent with studies showing a high incidence of delayed TSH rise, particularly in very-low-birth-weight infants,” the authors wrote. They speculated that delays in detecting primary congenital hypothyroidism could be caused by the suppression of TSH secretion as a result of “hypothalamic-pituitary immaturity, medication administration, and effects of serious neonatal illness.” In fact, had standard, recommended 2-week-only screening protocols been followed with their patient population, fully 48% of infants with delayed TSH elevation would have been overlooked; half of these patients were later found to have decompensated hypothyroidism.

Neurodevelopmental disability caused by congenital hypothyroidism, which affects roughly 1 in every 2,000-4,000 births, is increasingly being prevented with newborn screenings that identify the condition early, but the incidence of congenital hypothyroidism has increased considerably in the past 20 years. The authors attribute this increase to the gradual change in screening cutoff levels and the rise in number of preterm infants who are surviving.

The need for a second screening, as well as appropriate timing and optimal TSH cutoff, are “subjects of active debate,” the authors wrote. The latest European screening guidelines recommend second screenings for preterm and low-birth-weight infants at either 2 weeks of age or 2 weeks following preliminary screening. Although they make no recommendations regarding additional screenings, American Academy of Pediatrics guidelines, published in 2006, cite a “disproportionate incidence” of delayed increase in TSH and congenital hypothyroidism in infants with very low birth weight. Dr. McGrath and her associates speculated that not all screening programs have adopted repeat screening of preterm infants, perhaps because of the low yield results, “the transient nature of most cases” detected, as well as conflicting long-term data on neurodevelopmental outcomes.

Dr. McGrath receives funding from the Children’s Fund for Health. The authors declared no conflicts of interest.

SOURCE: McGrath N et al. J Pediatr. 2018 Oct 24. doi: 10.1016/j.jpeds.2018.09.044.

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”

The American College of Obstetricians and Gynecologists (ACOG) recommends that girls receive their first reproductive health visit between the ages of 13 and 15 years to discuss healthy relationships in addition to general reproductive health, according to a new committee opinion.

The recommendation, published online Oct. 24, emphasizes that such early visits provide opportunities for ob.gyns. to educate teenage girls and their guardians about age-appropriate health issues, such as sexual relationships, dating violence, and sexual coercion. Between the ages of 13 years and 15 years is an ideal window because middle school is a time that some adolescents develop their first romantic and sexual relationships (Obstet Gynecol. 2018; 132[5]:1317-18 doi: 10.1097/AOG.0000000000002946).

“Creating a nonjudgmental environment and educating staff on the unique concerns of adolescents are helpful ways to provide effective and appropriate care to this group of patients,” the authors wrote.

Ob.gyns. can use the early meeting to discuss key aspects of a healthy relationship with patients, including communication, self-respect, and mutual respect, while helping adolescents identify the characteristics of an unhealthy relationships such as dishonesty, intimidation, disrespect, and abuse, according to the opinion. As part of the discussion, ob.gyns. also may counsel patients to define their current relationship and their expectations for future relationships. Both relationships with and without sexual intimacy should be discussed, the opinion advises.

The recommendation reminds health care professionals to be mindful of federal and state confidentiality laws and that they be aware of mandatory reporting laws when intimate partner violence, teen dating violence, or statutory rape is suspected. In addition, the opinion notes that pregnant and parenting adolescents; lesbian, gay, bisexual, transgender, queer, or questioning (LGBTQ) individuals; and adolescents with physical and mental disabilities are at particular risk of disparities in the health care system.

“The promotion of healthy relationships in these groups requires the obstetrician-gynecologist to be aware of the unique barriers and hurdles to sexual and nonsexual expression, as well as to health care,” the opinion states. “Interventions to promote healthy relationships and a strong sexual health framework are more effective when started early and can affect indicators of long-term individual health and public health.”

The American College of Obstetricians and Gynecologists (ACOG) recommends that girls receive their first reproductive health visit between the ages of 13 and 15 years to discuss healthy relationships in addition to general reproductive health, according to a new committee opinion.

The recommendation, published online Oct. 24, emphasizes that such early visits provide opportunities for ob.gyns. to educate teenage girls and their guardians about age-appropriate health issues, such as sexual relationships, dating violence, and sexual coercion. Between the ages of 13 years and 15 years is an ideal window because middle school is a time that some adolescents develop their first romantic and sexual relationships (Obstet Gynecol. 2018; 132[5]:1317-18 doi: 10.1097/AOG.0000000000002946).

“Creating a nonjudgmental environment and educating staff on the unique concerns of adolescents are helpful ways to provide effective and appropriate care to this group of patients,” the authors wrote.

Ob.gyns. can use the early meeting to discuss key aspects of a healthy relationship with patients, including communication, self-respect, and mutual respect, while helping adolescents identify the characteristics of an unhealthy relationships such as dishonesty, intimidation, disrespect, and abuse, according to the opinion. As part of the discussion, ob.gyns. also may counsel patients to define their current relationship and their expectations for future relationships. Both relationships with and without sexual intimacy should be discussed, the opinion advises.

The recommendation reminds health care professionals to be mindful of federal and state confidentiality laws and that they be aware of mandatory reporting laws when intimate partner violence, teen dating violence, or statutory rape is suspected. In addition, the opinion notes that pregnant and parenting adolescents; lesbian, gay, bisexual, transgender, queer, or questioning (LGBTQ) individuals; and adolescents with physical and mental disabilities are at particular risk of disparities in the health care system.

“The promotion of healthy relationships in these groups requires the obstetrician-gynecologist to be aware of the unique barriers and hurdles to sexual and nonsexual expression, as well as to health care,” the opinion states. “Interventions to promote healthy relationships and a strong sexual health framework are more effective when started early and can affect indicators of long-term individual health and public health.”

The American College of Obstetricians and Gynecologists (ACOG) recommends that girls receive their first reproductive health visit between the ages of 13 and 15 years to discuss healthy relationships in addition to general reproductive health, according to a new committee opinion.

The recommendation, published online Oct. 24, emphasizes that such early visits provide opportunities for ob.gyns. to educate teenage girls and their guardians about age-appropriate health issues, such as sexual relationships, dating violence, and sexual coercion. Between the ages of 13 years and 15 years is an ideal window because middle school is a time that some adolescents develop their first romantic and sexual relationships (Obstet Gynecol. 2018; 132[5]:1317-18 doi: 10.1097/AOG.0000000000002946).

“Creating a nonjudgmental environment and educating staff on the unique concerns of adolescents are helpful ways to provide effective and appropriate care to this group of patients,” the authors wrote.

Ob.gyns. can use the early meeting to discuss key aspects of a healthy relationship with patients, including communication, self-respect, and mutual respect, while helping adolescents identify the characteristics of an unhealthy relationships such as dishonesty, intimidation, disrespect, and abuse, according to the opinion. As part of the discussion, ob.gyns. also may counsel patients to define their current relationship and their expectations for future relationships. Both relationships with and without sexual intimacy should be discussed, the opinion advises.

The recommendation reminds health care professionals to be mindful of federal and state confidentiality laws and that they be aware of mandatory reporting laws when intimate partner violence, teen dating violence, or statutory rape is suspected. In addition, the opinion notes that pregnant and parenting adolescents; lesbian, gay, bisexual, transgender, queer, or questioning (LGBTQ) individuals; and adolescents with physical and mental disabilities are at particular risk of disparities in the health care system.

“The promotion of healthy relationships in these groups requires the obstetrician-gynecologist to be aware of the unique barriers and hurdles to sexual and nonsexual expression, as well as to health care,” the opinion states. “Interventions to promote healthy relationships and a strong sexual health framework are more effective when started early and can affect indicators of long-term individual health and public health.”

A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

mzoler@mdedge.com

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

mzoler@mdedge.com

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

mzoler@mdedge.com

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.