Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Higher cardiovascular risk burden, as measured by the Framingham General Cardiovascular Risk Score (FGCRS), is associated with neurodegenerative signs in the brain and may predict cognitive decline over time.

“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.

“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”

Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.

The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
 

Assessing cardiovascular risk and cognition

The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).

Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.

A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.

Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.

At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.

Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.

The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.

Bringing dementia prevention into the exam room early

Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.

“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.

“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”

Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.

Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.

Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.

Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.

The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.

Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.

Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.

This article appeared on Medscape.com.

Higher cardiovascular risk burden, as measured by the Framingham General Cardiovascular Risk Score (FGCRS), is associated with neurodegenerative signs in the brain and may predict cognitive decline over time.

“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.

“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”

Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.

The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
 

Assessing cardiovascular risk and cognition

The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).

Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.

A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.

Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.

At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.

Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.

The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.

Bringing dementia prevention into the exam room early

Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.

“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.

“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”

Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.

Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.

Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.

Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.

The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.

Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.

Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.

This article appeared on Medscape.com.

Higher cardiovascular risk burden, as measured by the Framingham General Cardiovascular Risk Score (FGCRS), is associated with neurodegenerative signs in the brain and may predict cognitive decline over time.

“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patient’s cognitive health as they age,” said Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, in a press release.

“Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”

Dr. Xu and first author Ruixue Song, MSc, also from Tianjin Medical University, published their findings online ahead of print May 18 in the Journal of the American College of Cardiology.

The World Health Organization projects that up to 82 million people will have dementia by 2050. Given the lack of effective treatments for dementia, identifying modifiable risk factors for cognitive decline and aggressively managing them is an increasingly appealing strategy.
 

Assessing cardiovascular risk and cognition

The researchers followed 1,588 dementia-free participants from the Rush Memory and Aging Project for 21 years (median, 5.8 years). FGCRS was assessed at baseline and categorized into tertiles (lowest, middle, and highest). Mean age of the studied population was 79.5 years, 75.8% of participants were female, and mean Framingham score was 15.6 (range, 4 to 28).

Annual evaluations included assessment of episodic memory (memory of everyday events), semantic memory (long-term memory), working memory (short-term memory), visuospatial ability (capacity to identify visual and spatial relationships among objects), and perceptual speed (ability to accurately and completely compare letters, numbers, objects, pictures, or patterns) using 19 tests to derive a composite score.

A subsample (n = 378) of participants underwent MRI, and structural total and regional brain volumes were estimated.

Linear regression was used to estimate beta-coefficients for the relationship between cardiovascular risk burden at baseline and longitudinally. If the beta-coefficient is negative, the interpretation is that for every 1-unit increase in the predictor variable (FGCRS), the outcome variable (cognitive function) will decrease by the beta-coefficient value.

At baseline, higher FGCRS was related to small but consistent (although not usually statistically significant) decreases in hippocampal volume, gray matter, and total brain volume.

Considered longitudinally, participants in the highest-risk tertile of FGCRS experienced faster decline in global cognition (beta = −0.019), episodic memory (beta = −0.023), working memory (beta = −0.021), and perceptual speed (beta = −0.027) during follow-up (P < .05 for all) than those in the lowest-risk tertile.

The declines in semantic memory (beta = –0.012) and visuospatial ability (beta = –0.010) did not reach statistical significance.

Bringing dementia prevention into the exam room early

Commenting on the research, Costantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York City, said the study has immediate clinical usefulness.

“The link between the cardiovascular risk factors and dementia is well known, but in your doctor’s office, that link is not seen. If your GP or cardiologist sees you with high blood pressure, he’s not immediately going to think about the risk of dementia 20 years later,” said Dr. Iadecola.

“What this study does is it directly links a simple score that’s commonly used to assess cardiovascular risk to dementia risk, which can be used to counsel patients and, hopefully, reduce the risk of both cardiovascular disease and cognitive disorders.”

Dr. Iadecola wrote an editorial together with Neal S. Parikh, MD, MS, also from Weill Cornell Medicine, that accompanied the findings of the trial.

Even neurologists sometimes fail to make the connection between vascular risk and dementia, he said. “They think that by making a stroke patient move their hand better, they’re treating them, but 30% of stroke patients get dementia 6 or 8 months later and they’re missing this link between cerebrovascular pathology and dementia.

Dr. Iadecola is one of 26 experts who authored the recent Berlin Manifesto, an effort led by Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in Ontario, Canada, to raise awareness of the link between cardiovascular and brain health.

Dr. Hachinski coined the term “brain attack” and devised the Hachinski Ischemic Score that remains the standard for identifying a vascular component of cognitive impairment.

The current study has some strengths and limitations, noted Dr. Iadecola. The average age of participants was 80 years, which is appropriate given the high risk for cognitive decline at this age, but the generalizability of the study may be limited given that most participants were white women.

Going forward, he said, rigorous studies are needed to confirm these findings and to determine how to best prevent dementia through treatment of individual cardiovascular risk factors.

Dr. Xu has received grants from nonindustry entities, including the Swedish Research Council and the National Natural Science Foundation of China. The study was funded by the European Union’s Horizon 320230 research and innovation program. Dr. Iadecola is a member of the scientific advisory board for Broadview Ventures.

This article appeared on Medscape.com.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

COVID-19 has changed many things in the medical landscape as practices have closed, many physicians are transitioning to telemedicine, and emergency departments struggle to provide safe environments for their employees.

Medscape’s latest physician survey, conducted from Oct. 4, 2019, to Feb. 10, 2020, illustrates what gastroenterology looked like just before the coronavirus arrived.

While the average gastroenterologist salary did rise from 2019, the increase was minimal, going from $417,000 in 2019 to $419,000 in 2020, a 0.48% increase. In comparison, average income for all specialists was $346,000 in this year’s survey, up by 1.5% from the $341,000 earned in 2019, Medscape reported.

Prospects for next year, however, are grim. “We found out that we have a 10% salary decrease effective May 2 to Dec. 25. Our bonus will be based on clinical productivity, and since our numbers are down, that is likely to go away,” a pediatric emergency physician told Medscape.

Many gastroenterologists felt unfairly compensated in 2020, with only 52% reporting that they were satisfied with their salary. This was on the lower end of the 29 specialties included in the survey, which ranged from nephrology at 44% to oncology, emergency medicine, and radiology at 67%.

There was a notable disparity in the number of hours men spent seeing patients in comparison with women – while female GIs worked 38.3 hours a week, male GIs worked 42.5 hours. The average specialist saw patients 38 hours a week. This disparity in hours also translated into a notably higher salary for men: $430,000 versus $375,000. The number of hours gastroenterologists spent on paperwork and administration was roughly middle of the pack at 14.3 hours a week.

In the end, 80% of gastroenterologists said that they would choose to practice medicine again, compared with 77% for all physicians, and 91% said that they would choose gastroenterology again.

The respondents were Medscape members who had been invited to participate. The sample size was 17,461 physicians, and compensation was modeled and estimated based on a range of variables across 6 years of survey data. The sampling error was ±0.74%.

lfranki@mdedge.com

COVID-19 has changed many things in the medical landscape as practices have closed, many physicians are transitioning to telemedicine, and emergency departments struggle to provide safe environments for their employees.

Medscape’s latest physician survey, conducted from Oct. 4, 2019, to Feb. 10, 2020, illustrates what gastroenterology looked like just before the coronavirus arrived.

While the average gastroenterologist salary did rise from 2019, the increase was minimal, going from $417,000 in 2019 to $419,000 in 2020, a 0.48% increase. In comparison, average income for all specialists was $346,000 in this year’s survey, up by 1.5% from the $341,000 earned in 2019, Medscape reported.

Prospects for next year, however, are grim. “We found out that we have a 10% salary decrease effective May 2 to Dec. 25. Our bonus will be based on clinical productivity, and since our numbers are down, that is likely to go away,” a pediatric emergency physician told Medscape.

Many gastroenterologists felt unfairly compensated in 2020, with only 52% reporting that they were satisfied with their salary. This was on the lower end of the 29 specialties included in the survey, which ranged from nephrology at 44% to oncology, emergency medicine, and radiology at 67%.

There was a notable disparity in the number of hours men spent seeing patients in comparison with women – while female GIs worked 38.3 hours a week, male GIs worked 42.5 hours. The average specialist saw patients 38 hours a week. This disparity in hours also translated into a notably higher salary for men: $430,000 versus $375,000. The number of hours gastroenterologists spent on paperwork and administration was roughly middle of the pack at 14.3 hours a week.

In the end, 80% of gastroenterologists said that they would choose to practice medicine again, compared with 77% for all physicians, and 91% said that they would choose gastroenterology again.

The respondents were Medscape members who had been invited to participate. The sample size was 17,461 physicians, and compensation was modeled and estimated based on a range of variables across 6 years of survey data. The sampling error was ±0.74%.

lfranki@mdedge.com

COVID-19 has changed many things in the medical landscape as practices have closed, many physicians are transitioning to telemedicine, and emergency departments struggle to provide safe environments for their employees.

Medscape’s latest physician survey, conducted from Oct. 4, 2019, to Feb. 10, 2020, illustrates what gastroenterology looked like just before the coronavirus arrived.

While the average gastroenterologist salary did rise from 2019, the increase was minimal, going from $417,000 in 2019 to $419,000 in 2020, a 0.48% increase. In comparison, average income for all specialists was $346,000 in this year’s survey, up by 1.5% from the $341,000 earned in 2019, Medscape reported.

Prospects for next year, however, are grim. “We found out that we have a 10% salary decrease effective May 2 to Dec. 25. Our bonus will be based on clinical productivity, and since our numbers are down, that is likely to go away,” a pediatric emergency physician told Medscape.

Many gastroenterologists felt unfairly compensated in 2020, with only 52% reporting that they were satisfied with their salary. This was on the lower end of the 29 specialties included in the survey, which ranged from nephrology at 44% to oncology, emergency medicine, and radiology at 67%.

There was a notable disparity in the number of hours men spent seeing patients in comparison with women – while female GIs worked 38.3 hours a week, male GIs worked 42.5 hours. The average specialist saw patients 38 hours a week. This disparity in hours also translated into a notably higher salary for men: $430,000 versus $375,000. The number of hours gastroenterologists spent on paperwork and administration was roughly middle of the pack at 14.3 hours a week.

In the end, 80% of gastroenterologists said that they would choose to practice medicine again, compared with 77% for all physicians, and 91% said that they would choose gastroenterology again.

The respondents were Medscape members who had been invited to participate. The sample size was 17,461 physicians, and compensation was modeled and estimated based on a range of variables across 6 years of survey data. The sampling error was ±0.74%.

lfranki@mdedge.com

Despite decreases in overall opioid overdose deaths in 2018, deaths involving synthetic opioids, cocaine, and other psychostimulants increased sharply in the United States, and alcohol and suicide deaths also rose, new data show.

A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died from alcohol, drugs, and suicide. Experts warn that these “deaths of despair” may well increase in the wake of COVID-19.

A study released earlier in May estimated that an additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the pandemic (Petterson S et al. “Projected Deaths of Despair From COVID-19,” Well Being Trust. May 8, 2020. WellBeingTrust.org).

“These data are a clarion call to action,” TFAH President and CEO John Auerbach said in a news release.

“We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” he said.

“And there’s another immediate concern: The COVID-19 crisis has increased the health burdens and economic pressures on many communities of color,” said Mr. Auerbach.

According to the report, the 2018 national rate for alcohol, drug, and suicide deaths combined was only slightly lower than that reported in 2017 (46.4 vs 46.6 per 100,000).

Among the key findings in the report:

• 37,329 Americans died from alcohol-induced causes in 2018; the rate was up 4% over 2017.
• Alcohol-induced deaths were highest among American Indians (30.0 per 100,000) and adults aged 55 to 74 (27.6 per 100,000). For all population groups, rates of alcohol-related deaths were higher in 2018 than in 2017 except for people aged 17 years and younger, for whom the rate held steady.
• Despite a 4% decline in all drug-induced deaths and a 2% drop in all opioid-related deaths, 2018 saw sharp increases in deaths involving synthetic opioids (up 10%), cocaine (up 5%), and other psychostimulants, such as methamphetamine, ecstasy, amphetamine, and prescription stimulants (up 22%).
• Suicide claimed the lives of 48,344 Americans in 2018. The suicide rate in 2018 was 2% higher than in 2017 and 25% higher than in 2008.
• Suicide rates increased across all demographics except for adults aged 18-54 years, among whom the rate remained stable. Suicide death rates were highest in males (23.4 per 100,000), rural residents (19.7 per 100,000), whites (16.8 per 100,000), and American Indian/Alaska Natives (14.1 per 100,000).
• Between 2017 and 2018, 27 states had higher rates (above 0.04%) of alcohol, drug, and suicide deaths; 23 states and the District of Columbia had lower rates of deaths from those causes.
• States with the highest alcohol, drug, and suicide death rates in 2018 were West Virginia (84.9 per 100,000), New Mexico (82.8 per 100,000), New Hampshire (68.2 per 100,000), and Alaska (67.8 per 100,000).
• States with the lowest rates in 2018 were Texas (31.7 per 100,000), Mississippi (31.7 per 100,000), and Hawaii (34.6 per 100,000).

“Quite simply, too many Americans are dying from preventable causes. The profound racial health disparities seen in these data show that many ethnic minority groups are being left behind in our response efforts,” Benjamin F. Miller, PsyD, Well Being Trust chief strategy officer, said in the release.

“The nation needs a comprehensive framework for excellence in mental health and well-being, one that intentionally provides solutions for American Indians, blacks, Asians and Latinos. With all the other COVID-19 related investments, it’s time for the federal government to fully invest in mental health now and for all states to take action,” said Dr. Miller.

Policy recommendations outlined in the report include investing in prevention; reducing risk factors and promoting resilience in children, families, and communities; engaging all sectors of society to address mental health and substance use disorders; limiting access to lethal means of suicide; and promoting safe storage of medications and firearms.
 

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

Despite decreases in overall opioid overdose deaths in 2018, deaths involving synthetic opioids, cocaine, and other psychostimulants increased sharply in the United States, and alcohol and suicide deaths also rose, new data show.

A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died from alcohol, drugs, and suicide. Experts warn that these “deaths of despair” may well increase in the wake of COVID-19.

A study released earlier in May estimated that an additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the pandemic (Petterson S et al. “Projected Deaths of Despair From COVID-19,” Well Being Trust. May 8, 2020. WellBeingTrust.org).

“These data are a clarion call to action,” TFAH President and CEO John Auerbach said in a news release.

“We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” he said.

“And there’s another immediate concern: The COVID-19 crisis has increased the health burdens and economic pressures on many communities of color,” said Mr. Auerbach.

According to the report, the 2018 national rate for alcohol, drug, and suicide deaths combined was only slightly lower than that reported in 2017 (46.4 vs 46.6 per 100,000).

Among the key findings in the report:

• 37,329 Americans died from alcohol-induced causes in 2018; the rate was up 4% over 2017.
• Alcohol-induced deaths were highest among American Indians (30.0 per 100,000) and adults aged 55 to 74 (27.6 per 100,000). For all population groups, rates of alcohol-related deaths were higher in 2018 than in 2017 except for people aged 17 years and younger, for whom the rate held steady.
• Despite a 4% decline in all drug-induced deaths and a 2% drop in all opioid-related deaths, 2018 saw sharp increases in deaths involving synthetic opioids (up 10%), cocaine (up 5%), and other psychostimulants, such as methamphetamine, ecstasy, amphetamine, and prescription stimulants (up 22%).
• Suicide claimed the lives of 48,344 Americans in 2018. The suicide rate in 2018 was 2% higher than in 2017 and 25% higher than in 2008.
• Suicide rates increased across all demographics except for adults aged 18-54 years, among whom the rate remained stable. Suicide death rates were highest in males (23.4 per 100,000), rural residents (19.7 per 100,000), whites (16.8 per 100,000), and American Indian/Alaska Natives (14.1 per 100,000).
• Between 2017 and 2018, 27 states had higher rates (above 0.04%) of alcohol, drug, and suicide deaths; 23 states and the District of Columbia had lower rates of deaths from those causes.
• States with the highest alcohol, drug, and suicide death rates in 2018 were West Virginia (84.9 per 100,000), New Mexico (82.8 per 100,000), New Hampshire (68.2 per 100,000), and Alaska (67.8 per 100,000).
• States with the lowest rates in 2018 were Texas (31.7 per 100,000), Mississippi (31.7 per 100,000), and Hawaii (34.6 per 100,000).

“Quite simply, too many Americans are dying from preventable causes. The profound racial health disparities seen in these data show that many ethnic minority groups are being left behind in our response efforts,” Benjamin F. Miller, PsyD, Well Being Trust chief strategy officer, said in the release.

“The nation needs a comprehensive framework for excellence in mental health and well-being, one that intentionally provides solutions for American Indians, blacks, Asians and Latinos. With all the other COVID-19 related investments, it’s time for the federal government to fully invest in mental health now and for all states to take action,” said Dr. Miller.

Policy recommendations outlined in the report include investing in prevention; reducing risk factors and promoting resilience in children, families, and communities; engaging all sectors of society to address mental health and substance use disorders; limiting access to lethal means of suicide; and promoting safe storage of medications and firearms.
 

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

Despite decreases in overall opioid overdose deaths in 2018, deaths involving synthetic opioids, cocaine, and other psychostimulants increased sharply in the United States, and alcohol and suicide deaths also rose, new data show.

A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died from alcohol, drugs, and suicide. Experts warn that these “deaths of despair” may well increase in the wake of COVID-19.

A study released earlier in May estimated that an additional 75,000 Americans could die by suicide, drugs, or alcohol abuse because of the pandemic (Petterson S et al. “Projected Deaths of Despair From COVID-19,” Well Being Trust. May 8, 2020. WellBeingTrust.org).

“These data are a clarion call to action,” TFAH President and CEO John Auerbach said in a news release.

“We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” he said.

“And there’s another immediate concern: The COVID-19 crisis has increased the health burdens and economic pressures on many communities of color,” said Mr. Auerbach.

According to the report, the 2018 national rate for alcohol, drug, and suicide deaths combined was only slightly lower than that reported in 2017 (46.4 vs 46.6 per 100,000).

Among the key findings in the report:

• 37,329 Americans died from alcohol-induced causes in 2018; the rate was up 4% over 2017.
• Alcohol-induced deaths were highest among American Indians (30.0 per 100,000) and adults aged 55 to 74 (27.6 per 100,000). For all population groups, rates of alcohol-related deaths were higher in 2018 than in 2017 except for people aged 17 years and younger, for whom the rate held steady.
• Despite a 4% decline in all drug-induced deaths and a 2% drop in all opioid-related deaths, 2018 saw sharp increases in deaths involving synthetic opioids (up 10%), cocaine (up 5%), and other psychostimulants, such as methamphetamine, ecstasy, amphetamine, and prescription stimulants (up 22%).
• Suicide claimed the lives of 48,344 Americans in 2018. The suicide rate in 2018 was 2% higher than in 2017 and 25% higher than in 2008.
• Suicide rates increased across all demographics except for adults aged 18-54 years, among whom the rate remained stable. Suicide death rates were highest in males (23.4 per 100,000), rural residents (19.7 per 100,000), whites (16.8 per 100,000), and American Indian/Alaska Natives (14.1 per 100,000).
• Between 2017 and 2018, 27 states had higher rates (above 0.04%) of alcohol, drug, and suicide deaths; 23 states and the District of Columbia had lower rates of deaths from those causes.
• States with the highest alcohol, drug, and suicide death rates in 2018 were West Virginia (84.9 per 100,000), New Mexico (82.8 per 100,000), New Hampshire (68.2 per 100,000), and Alaska (67.8 per 100,000).
• States with the lowest rates in 2018 were Texas (31.7 per 100,000), Mississippi (31.7 per 100,000), and Hawaii (34.6 per 100,000).

“Quite simply, too many Americans are dying from preventable causes. The profound racial health disparities seen in these data show that many ethnic minority groups are being left behind in our response efforts,” Benjamin F. Miller, PsyD, Well Being Trust chief strategy officer, said in the release.

“The nation needs a comprehensive framework for excellence in mental health and well-being, one that intentionally provides solutions for American Indians, blacks, Asians and Latinos. With all the other COVID-19 related investments, it’s time for the federal government to fully invest in mental health now and for all states to take action,” said Dr. Miller.

Policy recommendations outlined in the report include investing in prevention; reducing risk factors and promoting resilience in children, families, and communities; engaging all sectors of society to address mental health and substance use disorders; limiting access to lethal means of suicide; and promoting safe storage of medications and firearms.
 

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

A novel penclomedine shows promising safety and efficacy in some adolescent and young adult patients with cancers involving the central nervous system, according to phase 1/2 clinical trial findings.

The trial included 15 patients, aged 15-39 years, with measurable cancer involving the CNS who were treated with the agent 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN).

Two of these patients were “in their 59th month of survival and doing well” as of April, when the data were presented at the AACR virtual meeting I.

One of the patients with long-term survival benefit had non–small cell lung cancer, and one had astrocytoma, Lee Roy Morgan, MD, PhD, chief executive officer of Dekk-Tec Inc., New Orleans, reported during a poster presentation.

Patients with glioblastoma, however, “did not do well,” said Dr. Morgan, an adjunct professor at Tulane University in New Orleans. He noted that none of the five glioblastoma patients experienced a long-term response.
 

Safety

Study subjects were treated with the maximum tolerated dose (MTD) of DM-CHOC-PEN as identified in an earlier study. Patients with liver involvement received 75 mg/m², and those without liver involvement received up to 98.7 mg/m². Dosing was by 3-hour intravenous administration once every 21 days as lab tests and subject status allowed.

DM-CHOC-PEN was generally well tolerated. One patient experienced grade 2 vasogenic edema, and another experienced seizures. Both were secondary to tumor swelling, and both resolved with tumor regression.

No grade 3 toxicities occurred at the MTD, and “no renal, hematological, hepatic, or pulmonary toxicities were noted using the MTD in this trial,” Dr. Morgan said.
 

Mechanism

DM-CHOC-PEN is a polychlorinated pyridine with a cholesteryl carbonate attachment that induces lipophilicity, which potentiates the drug’s penetration of the blood-brain barrier and its entry into the brain and brain cancers, Dr. Morgan explained.

He added that DM-CHOC-PEN is a bis-alkylator that binds to DNA’s cytosine/guanine nucleotides. The agent does not require hepatic activation, it crosses the blood-brain barrier intact, and accumulates in CNS tumors but not normal CNS tissue, he said.

Further, it “is not a substrate for [p-glycoprotein] transport; thus, it doesn’t easily get out of the brain,” Dr. Morgan said. He noted that DM-CHOC-PEN can be used with other agents, such as temozolomide and bis-chloroethylnitrosourea, because of the difference in mechanisms of action.

This study was supported by Louisiana state grants, the National Cancer Institute, the National Institute of General Medical Sciences, and the Small Business Innovation Research program. Dr. Morgan reported having no disclosures, but he is chief executive officer of Dekk-Tec Inc., which is developing DM-CHOC-PEN.

sworcester@mdedge.com

SOURCE: Morgan L et al. AACR 2020, Abstract CT181.

A novel penclomedine shows promising safety and efficacy in some adolescent and young adult patients with cancers involving the central nervous system, according to phase 1/2 clinical trial findings.

The trial included 15 patients, aged 15-39 years, with measurable cancer involving the CNS who were treated with the agent 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN).

Two of these patients were “in their 59th month of survival and doing well” as of April, when the data were presented at the AACR virtual meeting I.

One of the patients with long-term survival benefit had non–small cell lung cancer, and one had astrocytoma, Lee Roy Morgan, MD, PhD, chief executive officer of Dekk-Tec Inc., New Orleans, reported during a poster presentation.

Patients with glioblastoma, however, “did not do well,” said Dr. Morgan, an adjunct professor at Tulane University in New Orleans. He noted that none of the five glioblastoma patients experienced a long-term response.
 

Safety

Study subjects were treated with the maximum tolerated dose (MTD) of DM-CHOC-PEN as identified in an earlier study. Patients with liver involvement received 75 mg/m², and those without liver involvement received up to 98.7 mg/m². Dosing was by 3-hour intravenous administration once every 21 days as lab tests and subject status allowed.

DM-CHOC-PEN was generally well tolerated. One patient experienced grade 2 vasogenic edema, and another experienced seizures. Both were secondary to tumor swelling, and both resolved with tumor regression.

No grade 3 toxicities occurred at the MTD, and “no renal, hematological, hepatic, or pulmonary toxicities were noted using the MTD in this trial,” Dr. Morgan said.
 

Mechanism

DM-CHOC-PEN is a polychlorinated pyridine with a cholesteryl carbonate attachment that induces lipophilicity, which potentiates the drug’s penetration of the blood-brain barrier and its entry into the brain and brain cancers, Dr. Morgan explained.

He added that DM-CHOC-PEN is a bis-alkylator that binds to DNA’s cytosine/guanine nucleotides. The agent does not require hepatic activation, it crosses the blood-brain barrier intact, and accumulates in CNS tumors but not normal CNS tissue, he said.

Further, it “is not a substrate for [p-glycoprotein] transport; thus, it doesn’t easily get out of the brain,” Dr. Morgan said. He noted that DM-CHOC-PEN can be used with other agents, such as temozolomide and bis-chloroethylnitrosourea, because of the difference in mechanisms of action.

This study was supported by Louisiana state grants, the National Cancer Institute, the National Institute of General Medical Sciences, and the Small Business Innovation Research program. Dr. Morgan reported having no disclosures, but he is chief executive officer of Dekk-Tec Inc., which is developing DM-CHOC-PEN.

sworcester@mdedge.com

SOURCE: Morgan L et al. AACR 2020, Abstract CT181.

A novel penclomedine shows promising safety and efficacy in some adolescent and young adult patients with cancers involving the central nervous system, according to phase 1/2 clinical trial findings.

The trial included 15 patients, aged 15-39 years, with measurable cancer involving the CNS who were treated with the agent 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN).

Two of these patients were “in their 59th month of survival and doing well” as of April, when the data were presented at the AACR virtual meeting I.

One of the patients with long-term survival benefit had non–small cell lung cancer, and one had astrocytoma, Lee Roy Morgan, MD, PhD, chief executive officer of Dekk-Tec Inc., New Orleans, reported during a poster presentation.

Patients with glioblastoma, however, “did not do well,” said Dr. Morgan, an adjunct professor at Tulane University in New Orleans. He noted that none of the five glioblastoma patients experienced a long-term response.
 

Safety

Study subjects were treated with the maximum tolerated dose (MTD) of DM-CHOC-PEN as identified in an earlier study. Patients with liver involvement received 75 mg/m², and those without liver involvement received up to 98.7 mg/m². Dosing was by 3-hour intravenous administration once every 21 days as lab tests and subject status allowed.

DM-CHOC-PEN was generally well tolerated. One patient experienced grade 2 vasogenic edema, and another experienced seizures. Both were secondary to tumor swelling, and both resolved with tumor regression.

No grade 3 toxicities occurred at the MTD, and “no renal, hematological, hepatic, or pulmonary toxicities were noted using the MTD in this trial,” Dr. Morgan said.
 

Mechanism

DM-CHOC-PEN is a polychlorinated pyridine with a cholesteryl carbonate attachment that induces lipophilicity, which potentiates the drug’s penetration of the blood-brain barrier and its entry into the brain and brain cancers, Dr. Morgan explained.

He added that DM-CHOC-PEN is a bis-alkylator that binds to DNA’s cytosine/guanine nucleotides. The agent does not require hepatic activation, it crosses the blood-brain barrier intact, and accumulates in CNS tumors but not normal CNS tissue, he said.

Further, it “is not a substrate for [p-glycoprotein] transport; thus, it doesn’t easily get out of the brain,” Dr. Morgan said. He noted that DM-CHOC-PEN can be used with other agents, such as temozolomide and bis-chloroethylnitrosourea, because of the difference in mechanisms of action.

This study was supported by Louisiana state grants, the National Cancer Institute, the National Institute of General Medical Sciences, and the Small Business Innovation Research program. Dr. Morgan reported having no disclosures, but he is chief executive officer of Dekk-Tec Inc., which is developing DM-CHOC-PEN.

sworcester@mdedge.com

SOURCE: Morgan L et al. AACR 2020, Abstract CT181.

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

Patients with hematological malignancies are at high risk of invasive Staphylococcus pneumoniae. Multiple myeloma (MM) patients, in particular, have been found to have one of the highest incidences of invasive pneumococcal disease. However, researchers found that a full three-dose vaccination regimen by 13-valent pneumococcal conjugate (PCV13) vaccine was protective in MM patients when provided between treatment courses, according to a study reported in Vaccine.

The researchers performed a prospective study of 18 adult patients who were vaccinated with PCV13, compared with 18 control-matched patients from 2017 to 2020. The three-dose vaccination regimen was provided between treatment courses with novel target agents (bortezomib, lenalidomide, ixazomib) with a minimum of a 1-month interval. They used the incidence of pneumonias during the one-year observation period as the primary outcome.

Totally there were 12 cases (33.3%) of clinically and radiologically confirmed pneumonias in the entire study group (n = 36), with a distribution between the vaccinated and nonvaccinated groups of 3 (16.7%) and 9 (50%). respectively (P = .037).

The absolute risk reduction seen with vaccination was 33.3%, and the number needed to treat with PCV13 vaccination in MM patients receiving novel agents was 3.0; (95% confidence interval 1.61-22.1). In addition, there were no adverse effects seen from vaccination, according to the authors.

“Despite the expected decrease in immunological response to vaccination during the chemotherapy, we have shown the clinical effectiveness of a PCV13 vaccination schedule based on 3 doses given with a minimum 1 month interval between the courses of novel agents,” the investigators concluded.

The authors reported that they had no relevant disclosures.
 

mlesney@mdedge.com

SOURCE: Stoma I et al. Vaccine. 2020 May 14; doi.org/10.1016/j.vaccine.2020.05.024.

Patients with hematological malignancies are at high risk of invasive Staphylococcus pneumoniae. Multiple myeloma (MM) patients, in particular, have been found to have one of the highest incidences of invasive pneumococcal disease. However, researchers found that a full three-dose vaccination regimen by 13-valent pneumococcal conjugate (PCV13) vaccine was protective in MM patients when provided between treatment courses, according to a study reported in Vaccine.

The researchers performed a prospective study of 18 adult patients who were vaccinated with PCV13, compared with 18 control-matched patients from 2017 to 2020. The three-dose vaccination regimen was provided between treatment courses with novel target agents (bortezomib, lenalidomide, ixazomib) with a minimum of a 1-month interval. They used the incidence of pneumonias during the one-year observation period as the primary outcome.

Totally there were 12 cases (33.3%) of clinically and radiologically confirmed pneumonias in the entire study group (n = 36), with a distribution between the vaccinated and nonvaccinated groups of 3 (16.7%) and 9 (50%). respectively (P = .037).

The absolute risk reduction seen with vaccination was 33.3%, and the number needed to treat with PCV13 vaccination in MM patients receiving novel agents was 3.0; (95% confidence interval 1.61-22.1). In addition, there were no adverse effects seen from vaccination, according to the authors.

“Despite the expected decrease in immunological response to vaccination during the chemotherapy, we have shown the clinical effectiveness of a PCV13 vaccination schedule based on 3 doses given with a minimum 1 month interval between the courses of novel agents,” the investigators concluded.

The authors reported that they had no relevant disclosures.
 

mlesney@mdedge.com

SOURCE: Stoma I et al. Vaccine. 2020 May 14; doi.org/10.1016/j.vaccine.2020.05.024.

Patients with hematological malignancies are at high risk of invasive Staphylococcus pneumoniae. Multiple myeloma (MM) patients, in particular, have been found to have one of the highest incidences of invasive pneumococcal disease. However, researchers found that a full three-dose vaccination regimen by 13-valent pneumococcal conjugate (PCV13) vaccine was protective in MM patients when provided between treatment courses, according to a study reported in Vaccine.

The researchers performed a prospective study of 18 adult patients who were vaccinated with PCV13, compared with 18 control-matched patients from 2017 to 2020. The three-dose vaccination regimen was provided between treatment courses with novel target agents (bortezomib, lenalidomide, ixazomib) with a minimum of a 1-month interval. They used the incidence of pneumonias during the one-year observation period as the primary outcome.

Totally there were 12 cases (33.3%) of clinically and radiologically confirmed pneumonias in the entire study group (n = 36), with a distribution between the vaccinated and nonvaccinated groups of 3 (16.7%) and 9 (50%). respectively (P = .037).

The absolute risk reduction seen with vaccination was 33.3%, and the number needed to treat with PCV13 vaccination in MM patients receiving novel agents was 3.0; (95% confidence interval 1.61-22.1). In addition, there were no adverse effects seen from vaccination, according to the authors.

“Despite the expected decrease in immunological response to vaccination during the chemotherapy, we have shown the clinical effectiveness of a PCV13 vaccination schedule based on 3 doses given with a minimum 1 month interval between the courses of novel agents,” the investigators concluded.

The authors reported that they had no relevant disclosures.
 

mlesney@mdedge.com

SOURCE: Stoma I et al. Vaccine. 2020 May 14; doi.org/10.1016/j.vaccine.2020.05.024.

The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.

The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.

The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone.

Olaparib becomes the second PARP inhibitor approved by the FDA for use in prostate cancer this week. Earlier, rucaparib (Rubraca, Clovis Oncology) was approved for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic).

Olaparib is also indicated for use in ovarian, breast, and pancreatic cancers.

The FDA also approved two companion diagnostic devices for treatment with olaparib: the FoundationOne CDx test (Foundation Medicine) for the selection of patients carrying HRR gene alterations and the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the selection of patients carrying germline BRCA1/2 alterations.

The approval was based on results from the open-label, multicenter PROfound trial, which randomly assigned 387 patients to olaparib 300 mg twice daily and to investigator’s choice of enzalutamide or abiraterone acetate. All patients received a GnRH analogue or had prior bilateral orchiectomy.

The study involved two cohorts. Patients with mutations in either BRCA1, BRCA2, or ATM were randomly assigned in cohort A (n = 245); patients with mutations among 12 other genes involved in the HRR pathway were randomly assigned in cohort B (n = 142); those with co-mutations were assigned to cohort A.

The major efficacy outcome of the trial was radiological progression-free survival (rPFS) (cohort A).

In cohort A, patients receiving olaparib had a median rPFS of 7.4 months vs 3.6 months among patients receiving investigator’s choice (hazard ratio [HR], 0.34; P < .0001). Median overall survival was 19.1 months vs 14.7 months (HR, 0.69; P = .0175) and the overall response rate was 33% vs 2% (P < .0001).

In cohort A+B, patients receiving olaparib had a median rPFS of 5.8 months vs 3.5 months among patients receiving investigator’s choice (HR, 0.49; P < .0001).

The study results were first presented at the 2019 annual meeting of the European Society for Medical Oncology. At that time, study investigator Maha Hussain, MD, Northwestern University, Chicago, said the rPFS result and other outcomes were a “remarkable achievement” in such heavily pretreated patients with prostate cancer.

Patients with prostate cancer should now undergo genetic testing of tumor tissue to identify the roughly 30% of patients who can benefit – as is already routinely being done for breast, ovarian, and lung cancer, said experts at ESMO.

The most common adverse reactions with olaparib (≥10% of patients) were anemia, nausea, fatigue (including asthenia), decreased appetite, diarrhea, vomiting, thrombocytopenia, cough, and dyspnea. Venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients randomly assigned to olaparib, compared with 3.1% of those receiving investigator’s choice of enzalutamide or abiraterone.

Olaparib carries the warning that myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in <1.5% of patients exposed to it as a monotherapy, and that the majority of events had a fatal outcome.

The recommended olaparib dose is 300 mg taken orally twice daily, with or without food.

This article first appeared on Medscape.com.