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Guidelines: Convalescent plasma not recommended for most hospitalized with COVID
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”
The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:
- Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
- CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
- CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
- Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
- The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)
Multiple guidelines for use of CCP are similar
In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.
They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.
The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.
The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.
“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.
“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.
Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”
One strong recommendation
Dr. Barrett pointed out that four of the five recommendations are rated “weak.”
“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”
She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.
“That clinical bottom line is what most clinicians will look for,” she said.
“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”
The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Poor sleep raises risk for fatty liver disease
Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.
Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.
, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.
In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.
The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.
Rise in unhealthy lifestyles leads to increase in MALFD
The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”
Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.
Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.
However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.
To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.
Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.
MAFLD was diagnosed in those with hepatic steatosis and one of the following:
- Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
- Presence of diabetes.
- Evidence of metabolic dysregulation.
After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.
Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.
MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.
Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”
However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).
MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).
When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).
Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).
In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).
Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.
“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.
“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.
The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.
Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.
, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.
In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.
The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.
Rise in unhealthy lifestyles leads to increase in MALFD
The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”
Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.
Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.
However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.
To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.
Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.
MAFLD was diagnosed in those with hepatic steatosis and one of the following:
- Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
- Presence of diabetes.
- Evidence of metabolic dysregulation.
After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.
Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.
MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.
Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”
However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).
MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).
When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).
Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).
In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).
Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.
“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.
“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.
The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.
Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.
, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.
In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.
The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.
Rise in unhealthy lifestyles leads to increase in MALFD
The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”
Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.
Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.
However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.
To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.
Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.
MAFLD was diagnosed in those with hepatic steatosis and one of the following:
- Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
- Presence of diabetes.
- Evidence of metabolic dysregulation.
After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.
Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.
MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.
Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”
However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).
MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).
When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).
Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).
In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).
Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.
“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.
“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.
The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.
The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Trials data on COPD leave primary care docs in the dark
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
NYC switching children’s COVID vaccine sites to monkeypox
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
Seniors intend to receive variant-specific COVID booster in coming months
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
Sexual dysfunction, hair loss linked with long COVID
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE
A look at lung cancer screening in resource-limited countries
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
FROM WCLC 2022
How common are second primary lung cancers?
diagnosis, with about half occurring within 6 months of the first diagnosis. More than 80% of second primary cancers diagnosed within 2 years were stage 1, compared with about 25% when diagnosed more than 5 years later.
“With the growing adoption of lung cancer screening, more patients are being diagnosed with early-stage lung cancers and are able to achieve excellent long-term survival. After lung cancer diagnosis, these patients remain at high risk of developing a second primary lung cancer. The incidence, timing, and survival of second primary lung cancers is not well understood, particularly in a patient population with initial primary lung cancers detected via lung cancer screening,” said Alexandra Potter, who is a study coauthor.
The results were presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer sponsored by the International Association for the Study of Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
A 2012 study analyzed data from the SEER database and found that lung cancer survivors had a four- to sixfold increase in the risk of developing a second primary lung cancer, compared with the risk of lung cancer in the general population after adjusting for sex, age, race, and calendar year. “That study demonstrated that second primary lung cancers are an important risk among lung cancer survivors. However, it did not evaluate patients diagnosed with initial lung cancers detected via lung cancer screening. Thus, the incidence, timing, characteristics, and survival of lung cancers diagnosed among patients diagnosed with initial lung cancers detected via lung cancer screening remain unknown,” said Ms. Potter, who is a research assistant at Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
To address that question, the researchers used data from the National Lung Screening Trial, which compared low-dose computed tomography to chest x-ray and found that the former led to a 15%-20% lower risk of death. The new analysis included 1,405 patients who were diagnosed with stage I-III lung cancer and treated between 2002 and 2009. Of these patients, 5.8% went on to be diagnosed with a second primary lung cancer, at a rate of 1%-2% per year. Of the second lung cancers, 54.9% were synchronous, occurring within 6 months of the diagnosis, and 45.1% were metachronous, occurring later than 6 months; 65% of synchronous secondary cancers and 81% of metachronous cancers were diagnosed at stage I; 24% of synchronous and 14% of metachronous were stage III (P = .25). The median time to diagnosis of metachronous lung cancers was 2.7 years, and 27% of the second primary tumors were diagnosed 4 or more years after the first diagnosis.
Among those with synchronous tumors, 5- and 10-year survival rates were 55.2% and 39.5%. The rates were 90.0% and 30.8% among metachronous tumors, respectively. Ms. Potter emphasized that most patients with second primary cancer were diagnosed at stage I, suggesting that it is very possible to catch these cancers early. But patients who were diagnosed with a second primary tumor 4 or more years after their first diagnosis had a greater likelihood of later-stage second cancer. Medical societies generally recommend CT screening surveillance every 6 months for 2 years following a lung cancer diagnosis, then annually thereafter. The greater frequency of later-stage cancer detected after 4 years suggests that surveillance may be flagging as time goes on. “These data highlight the importance of lifelong follow up after initial lung cancer diagnosis,” said Ms. Potter.
She also emphasized the importance of smoking cessation and ongoing abstinence following a diagnosis of lung cancer. “About 70% of patients in the NLST who developed second primary lung cancer currently smoked at the time of entry into the trial. Smoking cessation can help reduce patients’ risk of developing second primary lung cancers,” she said. Ms. Potter has no relevant financial disclosures.
diagnosis, with about half occurring within 6 months of the first diagnosis. More than 80% of second primary cancers diagnosed within 2 years were stage 1, compared with about 25% when diagnosed more than 5 years later.
“With the growing adoption of lung cancer screening, more patients are being diagnosed with early-stage lung cancers and are able to achieve excellent long-term survival. After lung cancer diagnosis, these patients remain at high risk of developing a second primary lung cancer. The incidence, timing, and survival of second primary lung cancers is not well understood, particularly in a patient population with initial primary lung cancers detected via lung cancer screening,” said Alexandra Potter, who is a study coauthor.
The results were presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer sponsored by the International Association for the Study of Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
A 2012 study analyzed data from the SEER database and found that lung cancer survivors had a four- to sixfold increase in the risk of developing a second primary lung cancer, compared with the risk of lung cancer in the general population after adjusting for sex, age, race, and calendar year. “That study demonstrated that second primary lung cancers are an important risk among lung cancer survivors. However, it did not evaluate patients diagnosed with initial lung cancers detected via lung cancer screening. Thus, the incidence, timing, characteristics, and survival of lung cancers diagnosed among patients diagnosed with initial lung cancers detected via lung cancer screening remain unknown,” said Ms. Potter, who is a research assistant at Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
To address that question, the researchers used data from the National Lung Screening Trial, which compared low-dose computed tomography to chest x-ray and found that the former led to a 15%-20% lower risk of death. The new analysis included 1,405 patients who were diagnosed with stage I-III lung cancer and treated between 2002 and 2009. Of these patients, 5.8% went on to be diagnosed with a second primary lung cancer, at a rate of 1%-2% per year. Of the second lung cancers, 54.9% were synchronous, occurring within 6 months of the diagnosis, and 45.1% were metachronous, occurring later than 6 months; 65% of synchronous secondary cancers and 81% of metachronous cancers were diagnosed at stage I; 24% of synchronous and 14% of metachronous were stage III (P = .25). The median time to diagnosis of metachronous lung cancers was 2.7 years, and 27% of the second primary tumors were diagnosed 4 or more years after the first diagnosis.
Among those with synchronous tumors, 5- and 10-year survival rates were 55.2% and 39.5%. The rates were 90.0% and 30.8% among metachronous tumors, respectively. Ms. Potter emphasized that most patients with second primary cancer were diagnosed at stage I, suggesting that it is very possible to catch these cancers early. But patients who were diagnosed with a second primary tumor 4 or more years after their first diagnosis had a greater likelihood of later-stage second cancer. Medical societies generally recommend CT screening surveillance every 6 months for 2 years following a lung cancer diagnosis, then annually thereafter. The greater frequency of later-stage cancer detected after 4 years suggests that surveillance may be flagging as time goes on. “These data highlight the importance of lifelong follow up after initial lung cancer diagnosis,” said Ms. Potter.
She also emphasized the importance of smoking cessation and ongoing abstinence following a diagnosis of lung cancer. “About 70% of patients in the NLST who developed second primary lung cancer currently smoked at the time of entry into the trial. Smoking cessation can help reduce patients’ risk of developing second primary lung cancers,” she said. Ms. Potter has no relevant financial disclosures.
diagnosis, with about half occurring within 6 months of the first diagnosis. More than 80% of second primary cancers diagnosed within 2 years were stage 1, compared with about 25% when diagnosed more than 5 years later.
“With the growing adoption of lung cancer screening, more patients are being diagnosed with early-stage lung cancers and are able to achieve excellent long-term survival. After lung cancer diagnosis, these patients remain at high risk of developing a second primary lung cancer. The incidence, timing, and survival of second primary lung cancers is not well understood, particularly in a patient population with initial primary lung cancers detected via lung cancer screening,” said Alexandra Potter, who is a study coauthor.
The results were presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer sponsored by the International Association for the Study of Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
A 2012 study analyzed data from the SEER database and found that lung cancer survivors had a four- to sixfold increase in the risk of developing a second primary lung cancer, compared with the risk of lung cancer in the general population after adjusting for sex, age, race, and calendar year. “That study demonstrated that second primary lung cancers are an important risk among lung cancer survivors. However, it did not evaluate patients diagnosed with initial lung cancers detected via lung cancer screening. Thus, the incidence, timing, characteristics, and survival of lung cancers diagnosed among patients diagnosed with initial lung cancers detected via lung cancer screening remain unknown,” said Ms. Potter, who is a research assistant at Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
To address that question, the researchers used data from the National Lung Screening Trial, which compared low-dose computed tomography to chest x-ray and found that the former led to a 15%-20% lower risk of death. The new analysis included 1,405 patients who were diagnosed with stage I-III lung cancer and treated between 2002 and 2009. Of these patients, 5.8% went on to be diagnosed with a second primary lung cancer, at a rate of 1%-2% per year. Of the second lung cancers, 54.9% were synchronous, occurring within 6 months of the diagnosis, and 45.1% were metachronous, occurring later than 6 months; 65% of synchronous secondary cancers and 81% of metachronous cancers were diagnosed at stage I; 24% of synchronous and 14% of metachronous were stage III (P = .25). The median time to diagnosis of metachronous lung cancers was 2.7 years, and 27% of the second primary tumors were diagnosed 4 or more years after the first diagnosis.
Among those with synchronous tumors, 5- and 10-year survival rates were 55.2% and 39.5%. The rates were 90.0% and 30.8% among metachronous tumors, respectively. Ms. Potter emphasized that most patients with second primary cancer were diagnosed at stage I, suggesting that it is very possible to catch these cancers early. But patients who were diagnosed with a second primary tumor 4 or more years after their first diagnosis had a greater likelihood of later-stage second cancer. Medical societies generally recommend CT screening surveillance every 6 months for 2 years following a lung cancer diagnosis, then annually thereafter. The greater frequency of later-stage cancer detected after 4 years suggests that surveillance may be flagging as time goes on. “These data highlight the importance of lifelong follow up after initial lung cancer diagnosis,” said Ms. Potter.
She also emphasized the importance of smoking cessation and ongoing abstinence following a diagnosis of lung cancer. “About 70% of patients in the NLST who developed second primary lung cancer currently smoked at the time of entry into the trial. Smoking cessation can help reduce patients’ risk of developing second primary lung cancers,” she said. Ms. Potter has no relevant financial disclosures.
FROM WCLC 2022
FDA approves Enhertu (trastuzumab deruxtecan) for HER2 lung cancer
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer.
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer.
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer.
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
More than 64% of younger adults with lung cancer diagnosed at later stages
Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.
The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.
“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.
The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.
And : Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.
There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
Study methodology
The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.
Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.
Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).
The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.
Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.
The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.
“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.
The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.
And : Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.
There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
Study methodology
The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.
Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.
Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).
The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.
Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.
The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.
“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.
The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.
The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.
Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.
And : Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.
There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
Study methodology
The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.
Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.
Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).
The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.
FROM WCLC 2022