Blood test outreach, navigation could close colorectal cancer screening gap

Screening outreach works. Now what?
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Fecal blood test outreach and patient navigation have robust evidence to show they improve colorectal cancer screening rates, results of a meta-analysis show.

Both strategies increased screening rates by about 20 percentage points, according to results of the systematic review and meta-analysis reported in JAMA Internal Medicine.

“This finding suggests that broad implementation of either of these interventions could bring the current national screening rate of 63% close to the national goal of 80%,” wrote Michael K. Dougherty, MD, of the University of North Carolina at Chapel Hill, and his coauthors in the report.

Active distribution of fecal blood tests (FBTs) was tested in 17 of the studies in the main meta-analysis, which was limited to 73 trials that the researchers said were at low to medium risk of bias.

Most of those studies looked at mailing FBTs, though a few studies tied distribution to a patient encounter. Compared with usual care, FBT outreach was associated with increased screening, with a risk ratio of 2.26, Dr. Dougherty and his coauthors reported.

Patient navigation interventions, tested in 16 studies of low to medium bias risk, were usually done by health care professionals, though in a few cases, they involved lay or peer navigators.

Navigation was also associated with increased screening when compared with usual care, the investigators found. The risk ratio was 2.01, which increased to 2.33 for interventions that included some additional component more than a standardized reminder or mailing, such as a video decision aid or intensive automated reminders.

Patient reminders and patient education strategies were also associated with increased screening in the meta-analysis, both with risk ratios of 1.20.

Incorporating clinician reminders or academic detailing appeared to improve the net benefit of interventions, according to the investigators.

“Clinicians, health administrators, and policy makers should consider how to incorporate patient navigation, FBT outreach, and/or clinician prompts into their health care settings and sociocultural contexts,” Dr. Dougherty and his colleagues wrote in their report.

Multicomponent interventions appeared to have an edge over single-component interventions, they added.

In general, the aim of FBT outreach is to improve test distribution and thus overcome structural barriers to screening, the study authors wrote. Similarly, patient navigation is designed to help guide patients through the complex health care system and avoid barriers to care, which may be sociocultural, logistical, or educational.

Major funding for the study came from the University Cancer Research Fund of the University of North Carolina Lineberger Comprehensive Cancer Center. One coinvestigator reported institutional grant funding from Pfizer unrelated to the current study.

SOURCE: Dougherty MK et al. JAMA Intern Med. 2018 Oct 15. doi: 10.1001/jamainternmed.2018.4637.

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This systematic review and meta-analysis is an “ambitious project” that should inform decision makers, according to Beverly B. Green, MD, MPH.

“We can now safely say that, in general, no more studies are needed to demonstrate that outreach with fecal blood tests and patient navigation increase colorectal cancer screening,” Dr. Green wrote in an associated commentary.

Now, research should turn to other areas of colorectal cancer control, such as how to actually implement screening strategies and potentially adapt them for specific populations, she added. The effects of these interventions may be different in disadvantaged populations that have low screening rates and worse outcomes of colorectal cancer.

“Knowing that an intervention is effective in a highly controlled research setting does not guarantee local or widespread adoption,” she wrote. The interventions need to be “feasible, acceptable, and compatible” with existing fast-paced and complicated processes that provide day-to-day health care, and with the resources available to clinicians and organizations.

Dr. Green is with Kaiser Permanente Washington Health Research Institute in Seattle. Her comments appeared in an editorial in JAMA Internal Medicine (doi:10.1001/jamainternmed.2018.4627) . She reported no conflicts of interest.

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This systematic review and meta-analysis is an “ambitious project” that should inform decision makers, according to Beverly B. Green, MD, MPH.

“We can now safely say that, in general, no more studies are needed to demonstrate that outreach with fecal blood tests and patient navigation increase colorectal cancer screening,” Dr. Green wrote in an associated commentary.

Now, research should turn to other areas of colorectal cancer control, such as how to actually implement screening strategies and potentially adapt them for specific populations, she added. The effects of these interventions may be different in disadvantaged populations that have low screening rates and worse outcomes of colorectal cancer.

“Knowing that an intervention is effective in a highly controlled research setting does not guarantee local or widespread adoption,” she wrote. The interventions need to be “feasible, acceptable, and compatible” with existing fast-paced and complicated processes that provide day-to-day health care, and with the resources available to clinicians and organizations.

Dr. Green is with Kaiser Permanente Washington Health Research Institute in Seattle. Her comments appeared in an editorial in JAMA Internal Medicine (doi:10.1001/jamainternmed.2018.4627) . She reported no conflicts of interest.

Body

This systematic review and meta-analysis is an “ambitious project” that should inform decision makers, according to Beverly B. Green, MD, MPH.

“We can now safely say that, in general, no more studies are needed to demonstrate that outreach with fecal blood tests and patient navigation increase colorectal cancer screening,” Dr. Green wrote in an associated commentary.

Now, research should turn to other areas of colorectal cancer control, such as how to actually implement screening strategies and potentially adapt them for specific populations, she added. The effects of these interventions may be different in disadvantaged populations that have low screening rates and worse outcomes of colorectal cancer.

“Knowing that an intervention is effective in a highly controlled research setting does not guarantee local or widespread adoption,” she wrote. The interventions need to be “feasible, acceptable, and compatible” with existing fast-paced and complicated processes that provide day-to-day health care, and with the resources available to clinicians and organizations.

Dr. Green is with Kaiser Permanente Washington Health Research Institute in Seattle. Her comments appeared in an editorial in JAMA Internal Medicine (doi:10.1001/jamainternmed.2018.4627) . She reported no conflicts of interest.

Title
Screening outreach works. Now what?
Screening outreach works. Now what?

Fecal blood test outreach and patient navigation have robust evidence to show they improve colorectal cancer screening rates, results of a meta-analysis show.

Both strategies increased screening rates by about 20 percentage points, according to results of the systematic review and meta-analysis reported in JAMA Internal Medicine.

“This finding suggests that broad implementation of either of these interventions could bring the current national screening rate of 63% close to the national goal of 80%,” wrote Michael K. Dougherty, MD, of the University of North Carolina at Chapel Hill, and his coauthors in the report.

Active distribution of fecal blood tests (FBTs) was tested in 17 of the studies in the main meta-analysis, which was limited to 73 trials that the researchers said were at low to medium risk of bias.

Most of those studies looked at mailing FBTs, though a few studies tied distribution to a patient encounter. Compared with usual care, FBT outreach was associated with increased screening, with a risk ratio of 2.26, Dr. Dougherty and his coauthors reported.

Patient navigation interventions, tested in 16 studies of low to medium bias risk, were usually done by health care professionals, though in a few cases, they involved lay or peer navigators.

Navigation was also associated with increased screening when compared with usual care, the investigators found. The risk ratio was 2.01, which increased to 2.33 for interventions that included some additional component more than a standardized reminder or mailing, such as a video decision aid or intensive automated reminders.

Patient reminders and patient education strategies were also associated with increased screening in the meta-analysis, both with risk ratios of 1.20.

Incorporating clinician reminders or academic detailing appeared to improve the net benefit of interventions, according to the investigators.

“Clinicians, health administrators, and policy makers should consider how to incorporate patient navigation, FBT outreach, and/or clinician prompts into their health care settings and sociocultural contexts,” Dr. Dougherty and his colleagues wrote in their report.

Multicomponent interventions appeared to have an edge over single-component interventions, they added.

In general, the aim of FBT outreach is to improve test distribution and thus overcome structural barriers to screening, the study authors wrote. Similarly, patient navigation is designed to help guide patients through the complex health care system and avoid barriers to care, which may be sociocultural, logistical, or educational.

Major funding for the study came from the University Cancer Research Fund of the University of North Carolina Lineberger Comprehensive Cancer Center. One coinvestigator reported institutional grant funding from Pfizer unrelated to the current study.

SOURCE: Dougherty MK et al. JAMA Intern Med. 2018 Oct 15. doi: 10.1001/jamainternmed.2018.4637.

Fecal blood test outreach and patient navigation have robust evidence to show they improve colorectal cancer screening rates, results of a meta-analysis show.

Both strategies increased screening rates by about 20 percentage points, according to results of the systematic review and meta-analysis reported in JAMA Internal Medicine.

“This finding suggests that broad implementation of either of these interventions could bring the current national screening rate of 63% close to the national goal of 80%,” wrote Michael K. Dougherty, MD, of the University of North Carolina at Chapel Hill, and his coauthors in the report.

Active distribution of fecal blood tests (FBTs) was tested in 17 of the studies in the main meta-analysis, which was limited to 73 trials that the researchers said were at low to medium risk of bias.

Most of those studies looked at mailing FBTs, though a few studies tied distribution to a patient encounter. Compared with usual care, FBT outreach was associated with increased screening, with a risk ratio of 2.26, Dr. Dougherty and his coauthors reported.

Patient navigation interventions, tested in 16 studies of low to medium bias risk, were usually done by health care professionals, though in a few cases, they involved lay or peer navigators.

Navigation was also associated with increased screening when compared with usual care, the investigators found. The risk ratio was 2.01, which increased to 2.33 for interventions that included some additional component more than a standardized reminder or mailing, such as a video decision aid or intensive automated reminders.

Patient reminders and patient education strategies were also associated with increased screening in the meta-analysis, both with risk ratios of 1.20.

Incorporating clinician reminders or academic detailing appeared to improve the net benefit of interventions, according to the investigators.

“Clinicians, health administrators, and policy makers should consider how to incorporate patient navigation, FBT outreach, and/or clinician prompts into their health care settings and sociocultural contexts,” Dr. Dougherty and his colleagues wrote in their report.

Multicomponent interventions appeared to have an edge over single-component interventions, they added.

In general, the aim of FBT outreach is to improve test distribution and thus overcome structural barriers to screening, the study authors wrote. Similarly, patient navigation is designed to help guide patients through the complex health care system and avoid barriers to care, which may be sociocultural, logistical, or educational.

Major funding for the study came from the University Cancer Research Fund of the University of North Carolina Lineberger Comprehensive Cancer Center. One coinvestigator reported institutional grant funding from Pfizer unrelated to the current study.

SOURCE: Dougherty MK et al. JAMA Intern Med. 2018 Oct 15. doi: 10.1001/jamainternmed.2018.4637.

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Key clinical point: Fecal blood test outreach and patient navigation improved colorectal cancer screening rates.

Major finding: Compared with usual care, fecal blood test outreach and navigation were associated with increased screening, with risk ratios of 2.26 and 2.01, respectively.

Study details: A systematic review and meta-analysis including 73 randomized trials at low to medium risk of bias.

Disclosures: Major funding was provided by the University of North Carolina Lineberger Comprehensive Cancer Center. One study author reported institutional grant funding unrelated to the study.

Source: Dougherty MK et al. JAMA Intern Med. 2018 Oct 15. doi: 10.1001/jamainternmed.2018.4637.

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Obese PE patients have lower risk of death

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SAN ANTONIO—Patients with pulmonary embolism (PE) have a lower mortality risk if they are obese, according to a retrospective analysis of nearly 2 million PE discharges.

The obese patients had a lower mortality risk despite receiving more thrombolytics and mechanical intubation, said study investigator Zubair Khan, MD, of the University of Toledo Medical Center in Ohio.

“Surprisingly, the mortality of PE was significantly less in obese patients,” Dr. Khan said. “When we initiated the study, we did not expect this result.”

Dr. Khan discussed this result in a presentation at CHEST 2018.

Dr. Khan noted that the association between obesity and lower mortality, sometimes called the “obesity paradox,” has been observed in studies of other chronic health conditions, including stable heart failure, coronary artery disease, unstable angina, myocardial infarction, and also in some PE studies.

His team’s study, conducted using the National Inpatient Sample database, included adults with a primary discharge diagnosis of PE between 2002 and 2014. The researchers included 1,959,018 PE discharges, of which 312,770 (16%) had an underlying obesity diagnosis.

Obese PE patients had more risk factors and more severe disease but an overall mortality of 2.2%, compared with 3.7% in PE patients without obesity (P<0.001), Dr. Khan reported.

Hypertension was significantly more prevalent in the obese PE patients (65% vs. 50.5%; P<0.001), as was chronic lung disease and chronic liver disease.

Obese patients more often received thrombolytics (3.6% vs. 1.9%; P<0.001) and mechanical ventilation (5.8% vs. 4%; P<0.001), and they more frequently had cardiogenic shock (0.65% vs. 0.45%; P<0.001).

The obese PE patients were more often female, black, and younger than 65 years of age.

Notably, the prevalence of obesity in PE patients more than doubled over the course of the study period, from 10.2% in 2002 to 22.6% in 2014.

The lower mortality in obese patients might be explained by increased levels of endocannabinoids, which have shown protective effects in rat and mouse studies, Dr. Khan said.

“I think it’s a rich area for more and further research, especially in basic science,” he added.

Dr. Khan and his coauthors said they had no relationships relevant to the study.

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Woman on a scale

SAN ANTONIO—Patients with pulmonary embolism (PE) have a lower mortality risk if they are obese, according to a retrospective analysis of nearly 2 million PE discharges.

The obese patients had a lower mortality risk despite receiving more thrombolytics and mechanical intubation, said study investigator Zubair Khan, MD, of the University of Toledo Medical Center in Ohio.

“Surprisingly, the mortality of PE was significantly less in obese patients,” Dr. Khan said. “When we initiated the study, we did not expect this result.”

Dr. Khan discussed this result in a presentation at CHEST 2018.

Dr. Khan noted that the association between obesity and lower mortality, sometimes called the “obesity paradox,” has been observed in studies of other chronic health conditions, including stable heart failure, coronary artery disease, unstable angina, myocardial infarction, and also in some PE studies.

His team’s study, conducted using the National Inpatient Sample database, included adults with a primary discharge diagnosis of PE between 2002 and 2014. The researchers included 1,959,018 PE discharges, of which 312,770 (16%) had an underlying obesity diagnosis.

Obese PE patients had more risk factors and more severe disease but an overall mortality of 2.2%, compared with 3.7% in PE patients without obesity (P<0.001), Dr. Khan reported.

Hypertension was significantly more prevalent in the obese PE patients (65% vs. 50.5%; P<0.001), as was chronic lung disease and chronic liver disease.

Obese patients more often received thrombolytics (3.6% vs. 1.9%; P<0.001) and mechanical ventilation (5.8% vs. 4%; P<0.001), and they more frequently had cardiogenic shock (0.65% vs. 0.45%; P<0.001).

The obese PE patients were more often female, black, and younger than 65 years of age.

Notably, the prevalence of obesity in PE patients more than doubled over the course of the study period, from 10.2% in 2002 to 22.6% in 2014.

The lower mortality in obese patients might be explained by increased levels of endocannabinoids, which have shown protective effects in rat and mouse studies, Dr. Khan said.

“I think it’s a rich area for more and further research, especially in basic science,” he added.

Dr. Khan and his coauthors said they had no relationships relevant to the study.

Woman on a scale

SAN ANTONIO—Patients with pulmonary embolism (PE) have a lower mortality risk if they are obese, according to a retrospective analysis of nearly 2 million PE discharges.

The obese patients had a lower mortality risk despite receiving more thrombolytics and mechanical intubation, said study investigator Zubair Khan, MD, of the University of Toledo Medical Center in Ohio.

“Surprisingly, the mortality of PE was significantly less in obese patients,” Dr. Khan said. “When we initiated the study, we did not expect this result.”

Dr. Khan discussed this result in a presentation at CHEST 2018.

Dr. Khan noted that the association between obesity and lower mortality, sometimes called the “obesity paradox,” has been observed in studies of other chronic health conditions, including stable heart failure, coronary artery disease, unstable angina, myocardial infarction, and also in some PE studies.

His team’s study, conducted using the National Inpatient Sample database, included adults with a primary discharge diagnosis of PE between 2002 and 2014. The researchers included 1,959,018 PE discharges, of which 312,770 (16%) had an underlying obesity diagnosis.

Obese PE patients had more risk factors and more severe disease but an overall mortality of 2.2%, compared with 3.7% in PE patients without obesity (P<0.001), Dr. Khan reported.

Hypertension was significantly more prevalent in the obese PE patients (65% vs. 50.5%; P<0.001), as was chronic lung disease and chronic liver disease.

Obese patients more often received thrombolytics (3.6% vs. 1.9%; P<0.001) and mechanical ventilation (5.8% vs. 4%; P<0.001), and they more frequently had cardiogenic shock (0.65% vs. 0.45%; P<0.001).

The obese PE patients were more often female, black, and younger than 65 years of age.

Notably, the prevalence of obesity in PE patients more than doubled over the course of the study period, from 10.2% in 2002 to 22.6% in 2014.

The lower mortality in obese patients might be explained by increased levels of endocannabinoids, which have shown protective effects in rat and mouse studies, Dr. Khan said.

“I think it’s a rich area for more and further research, especially in basic science,” he added.

Dr. Khan and his coauthors said they had no relationships relevant to the study.

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RCC incidence held steady through 2015 while mortality rates plummeted

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Renal cell carcinoma (RCC) incidence rates increased in recent years, but have stabilized, while mortality rates have dropped precipitously, according to an analysis of more than 20 years of U.S. cancer registry data.

The introduction of antiangiogenic agents is likely one key factor that led to the mortality decrease, said authors of the analysis of Surveillance, Epidemiology, and End Results data from 1992 to 2015.

Incidence trends are likely more complex and may reflect the interplay between increased detection, on one hand, and decreases in modifiable risk factors such as smoking on the other, the authors reported in Clinical Genitourinary Cancer.

The analysis, conducted by Anas M. Saad, a final-year medical student at Ain Shams University, Cairo; Thai H. Ho, MD, PhD, of Mayo Clinic Cancer Center, Phoenix; and coinvestigators, included a total of 104,584 patients with an RCC diagnosis, of whom nearly 64% were male and 80% were white. The majority of tumors were small and localized at diagnosis, and clear cell was the histologic subtype in 44%, according to the report.

Overall incidence of RCC was 11.3 per 100,000 person-years over the 1992-2015 study period, Dr. Saad and coauthors said in their report.

The incidence rate increased by about 2.4% per year, averaged over the course of the entire study period, though the plateau in rates began around 2008, according to the investigators. A figure in their report shows that the age-adjusted rate was just over 8 per 100,000 person-years in 1992; it climbed steadily until 2008, at which point it remained in the range of about 12-14 per 100,000 person-years for the next 7 years.

The uptick in incidence from 1992 to 2008 was concentrated mostly in localized and regional RCC, rather than distant disease, according to Dr. Saad and colleagues.

The overall incidence-based mortality rate for RCC was 5.3 per 100,000 person-years from 1992 to 2015, Dr. Saad and coauthors said.

Mortality rates increased from 1992 and peaked in 2001, at which point they started to drop at an ever accelerating pace. The annual percent decrease in that mortality rate was 1.5% between 2001 and 2008, 9.3% between 2008 and 2013, and 32.2% from 2013 to 2015, according to the report.

Incidence rate trends are probably affected by increases in incidental diagnoses and changes in RCC risk factor prevalence, investigators noted. For example, there has been a significant increase in use of advanced abdominal imaging, which has improved sensitivity in picking up renal masses, but cannot reliably distinguish between benign and malignant features, they said. On the other hand, smoking, which increases risk of RCC, has been trending downward for decades, which they said correlated with RCC trends.

Authors said RCC survival has been improved by antiangiogenic agents known as vascular endothelial growth factor inhibitors, and more recently immune checkpoint therapies, as clinical trials have shown.

“The decreasing mortality trend starting in 2007 and continuing until 2015 is associated with the introduction of such therapies for RCC treatment,” Dr. Saad and coauthors said in their report.

Support for the study came from the National Cancer Institute and the Department of Defense. Dr. Saad and coauthors declared that they had no conflicts of interest.

SOURCE: Saad AM et al. Clin Genitourin Cancer. 2018. doi: 10.1016/j.clgc.2018.10.002.

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Renal cell carcinoma (RCC) incidence rates increased in recent years, but have stabilized, while mortality rates have dropped precipitously, according to an analysis of more than 20 years of U.S. cancer registry data.

The introduction of antiangiogenic agents is likely one key factor that led to the mortality decrease, said authors of the analysis of Surveillance, Epidemiology, and End Results data from 1992 to 2015.

Incidence trends are likely more complex and may reflect the interplay between increased detection, on one hand, and decreases in modifiable risk factors such as smoking on the other, the authors reported in Clinical Genitourinary Cancer.

The analysis, conducted by Anas M. Saad, a final-year medical student at Ain Shams University, Cairo; Thai H. Ho, MD, PhD, of Mayo Clinic Cancer Center, Phoenix; and coinvestigators, included a total of 104,584 patients with an RCC diagnosis, of whom nearly 64% were male and 80% were white. The majority of tumors were small and localized at diagnosis, and clear cell was the histologic subtype in 44%, according to the report.

Overall incidence of RCC was 11.3 per 100,000 person-years over the 1992-2015 study period, Dr. Saad and coauthors said in their report.

The incidence rate increased by about 2.4% per year, averaged over the course of the entire study period, though the plateau in rates began around 2008, according to the investigators. A figure in their report shows that the age-adjusted rate was just over 8 per 100,000 person-years in 1992; it climbed steadily until 2008, at which point it remained in the range of about 12-14 per 100,000 person-years for the next 7 years.

The uptick in incidence from 1992 to 2008 was concentrated mostly in localized and regional RCC, rather than distant disease, according to Dr. Saad and colleagues.

The overall incidence-based mortality rate for RCC was 5.3 per 100,000 person-years from 1992 to 2015, Dr. Saad and coauthors said.

Mortality rates increased from 1992 and peaked in 2001, at which point they started to drop at an ever accelerating pace. The annual percent decrease in that mortality rate was 1.5% between 2001 and 2008, 9.3% between 2008 and 2013, and 32.2% from 2013 to 2015, according to the report.

Incidence rate trends are probably affected by increases in incidental diagnoses and changes in RCC risk factor prevalence, investigators noted. For example, there has been a significant increase in use of advanced abdominal imaging, which has improved sensitivity in picking up renal masses, but cannot reliably distinguish between benign and malignant features, they said. On the other hand, smoking, which increases risk of RCC, has been trending downward for decades, which they said correlated with RCC trends.

Authors said RCC survival has been improved by antiangiogenic agents known as vascular endothelial growth factor inhibitors, and more recently immune checkpoint therapies, as clinical trials have shown.

“The decreasing mortality trend starting in 2007 and continuing until 2015 is associated with the introduction of such therapies for RCC treatment,” Dr. Saad and coauthors said in their report.

Support for the study came from the National Cancer Institute and the Department of Defense. Dr. Saad and coauthors declared that they had no conflicts of interest.

SOURCE: Saad AM et al. Clin Genitourin Cancer. 2018. doi: 10.1016/j.clgc.2018.10.002.

 

Renal cell carcinoma (RCC) incidence rates increased in recent years, but have stabilized, while mortality rates have dropped precipitously, according to an analysis of more than 20 years of U.S. cancer registry data.

The introduction of antiangiogenic agents is likely one key factor that led to the mortality decrease, said authors of the analysis of Surveillance, Epidemiology, and End Results data from 1992 to 2015.

Incidence trends are likely more complex and may reflect the interplay between increased detection, on one hand, and decreases in modifiable risk factors such as smoking on the other, the authors reported in Clinical Genitourinary Cancer.

The analysis, conducted by Anas M. Saad, a final-year medical student at Ain Shams University, Cairo; Thai H. Ho, MD, PhD, of Mayo Clinic Cancer Center, Phoenix; and coinvestigators, included a total of 104,584 patients with an RCC diagnosis, of whom nearly 64% were male and 80% were white. The majority of tumors were small and localized at diagnosis, and clear cell was the histologic subtype in 44%, according to the report.

Overall incidence of RCC was 11.3 per 100,000 person-years over the 1992-2015 study period, Dr. Saad and coauthors said in their report.

The incidence rate increased by about 2.4% per year, averaged over the course of the entire study period, though the plateau in rates began around 2008, according to the investigators. A figure in their report shows that the age-adjusted rate was just over 8 per 100,000 person-years in 1992; it climbed steadily until 2008, at which point it remained in the range of about 12-14 per 100,000 person-years for the next 7 years.

The uptick in incidence from 1992 to 2008 was concentrated mostly in localized and regional RCC, rather than distant disease, according to Dr. Saad and colleagues.

The overall incidence-based mortality rate for RCC was 5.3 per 100,000 person-years from 1992 to 2015, Dr. Saad and coauthors said.

Mortality rates increased from 1992 and peaked in 2001, at which point they started to drop at an ever accelerating pace. The annual percent decrease in that mortality rate was 1.5% between 2001 and 2008, 9.3% between 2008 and 2013, and 32.2% from 2013 to 2015, according to the report.

Incidence rate trends are probably affected by increases in incidental diagnoses and changes in RCC risk factor prevalence, investigators noted. For example, there has been a significant increase in use of advanced abdominal imaging, which has improved sensitivity in picking up renal masses, but cannot reliably distinguish between benign and malignant features, they said. On the other hand, smoking, which increases risk of RCC, has been trending downward for decades, which they said correlated with RCC trends.

Authors said RCC survival has been improved by antiangiogenic agents known as vascular endothelial growth factor inhibitors, and more recently immune checkpoint therapies, as clinical trials have shown.

“The decreasing mortality trend starting in 2007 and continuing until 2015 is associated with the introduction of such therapies for RCC treatment,” Dr. Saad and coauthors said in their report.

Support for the study came from the National Cancer Institute and the Department of Defense. Dr. Saad and coauthors declared that they had no conflicts of interest.

SOURCE: Saad AM et al. Clin Genitourin Cancer. 2018. doi: 10.1016/j.clgc.2018.10.002.

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Key clinical point: In recent years, renal cell carcinoma incidence rates have stabilized, while mortality due to the disease has dropped sharply.

Major finding: Mortality rates increased from 1992 and peaked in 2001, at which point they started to drop at an ever accelerating pace, culminating in an annual percent decrease of 32.2% in the 2013-2015 time period.

Study details: Analysis including more than 104,000 patients with an RCC diagnosis in the Surveillance, Epidemiology and End Results (SEER) database from 1992 to 2015.

Disclosures: Support for the study came from the National Cancer Institute and the Department of Defense. Study authors declared that they had no conflicts of interest.

Source: Saad AM et al. Clin Genitourin Cancer. 2018. doi: 10.1016/j.clgc.2018.10.002.

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Obesity, weight gain linked to colorectal cancer risk in younger women

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Obesity and weight gain are linked to increased risk of colorectal cancer in younger women, according to an analysis of a large, prospective U.S. cohort study.

Young women who were obese had a nearly twofold increase in risk of early-onset colorectal cancer, compared with women of normal weight, authors of the study reported in JAMA Oncology.

The findings suggest body weight could be used to “personalize and complement” early cancer screening strategies among adults younger than 50 years, said investigator Po-Hong Liu, MD, of Washington University, St. Louis, and coauthors.

“Given that most of these younger cases are diagnosed symptomatically with more advanced tumors and with a significant influence on years of life lost, our findings reinforce the benefits of maintaining a healthy weight throughout life,” Dr. Liu and coinvestigators said in their report.

Their analysis was based on the ongoing Nurses Health Study II, which began in 1989 and enrolled a total of 116,430 women between the ages of 25 and 42 years in 14 U.S. states. Women completed questionnaires on demographics, medical and health information, and lifestyle factors every 2 years after enrollment.

Dr. Liu and colleagues were able to document 114 cases of colorectal cancer over a median of 13.9 years of follow-up in 85,256 women who had no cancer or inflammatory bowel disease when they were enrolled in the study. The median age at diagnosis for these cancers was 45 years.

Obesity was independently associated with increased risk of these early-onset colorectal cancers, the investigators found in multivariable analysis.

Women with a body mass index of 30 kg/m2 or higher had a relative risk of 1.93 (95% confidence interval, 1.15-3.25) versus women with normal BMIs in the 18.5-22.9 kg/m2 range, according to results of the analysis, they reported.

There was an apparent linear trend between increasing weight and increasing colorectal cancer risk, they added in their report.

They also found links between BMI in early adulthood and risk of early-onset colorectal cancer, including a relative risk of 1.63 for women who reported a BMI of 23 kg/m2 or higher at 18 years of age, versus women with a BMI of 18.5-20.9 kg/m2 at that age.

Similarly, increase in weight since early adulthood was associated with increased cancer risk, they reported.

While the link between excess weight and colorectal cancer incidence and mortality is well established in previous studies, this study is one of few reports looking at the association in younger individuals, according to Dr. Liu and colleagues.

This is thought to be the first prospective study looking at the link between obesity and risk of colorectal cancer diagnosed before the age of 50, they added.

The study was funded by grants from the National Institutes of Health. Dr. Liu had no conflict of interest disclosures related to the study. One coauthor reported consulting fees from Bayer Pharma AG, Janssen, and Pfizer.

SOURCE: Liu P-H et al. JAMA Oncol. 2018 Oct 11. doi: 10.1001/jamaoncol.2018.4280.

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Obesity and weight gain are linked to increased risk of colorectal cancer in younger women, according to an analysis of a large, prospective U.S. cohort study.

Young women who were obese had a nearly twofold increase in risk of early-onset colorectal cancer, compared with women of normal weight, authors of the study reported in JAMA Oncology.

The findings suggest body weight could be used to “personalize and complement” early cancer screening strategies among adults younger than 50 years, said investigator Po-Hong Liu, MD, of Washington University, St. Louis, and coauthors.

“Given that most of these younger cases are diagnosed symptomatically with more advanced tumors and with a significant influence on years of life lost, our findings reinforce the benefits of maintaining a healthy weight throughout life,” Dr. Liu and coinvestigators said in their report.

Their analysis was based on the ongoing Nurses Health Study II, which began in 1989 and enrolled a total of 116,430 women between the ages of 25 and 42 years in 14 U.S. states. Women completed questionnaires on demographics, medical and health information, and lifestyle factors every 2 years after enrollment.

Dr. Liu and colleagues were able to document 114 cases of colorectal cancer over a median of 13.9 years of follow-up in 85,256 women who had no cancer or inflammatory bowel disease when they were enrolled in the study. The median age at diagnosis for these cancers was 45 years.

Obesity was independently associated with increased risk of these early-onset colorectal cancers, the investigators found in multivariable analysis.

Women with a body mass index of 30 kg/m2 or higher had a relative risk of 1.93 (95% confidence interval, 1.15-3.25) versus women with normal BMIs in the 18.5-22.9 kg/m2 range, according to results of the analysis, they reported.

There was an apparent linear trend between increasing weight and increasing colorectal cancer risk, they added in their report.

They also found links between BMI in early adulthood and risk of early-onset colorectal cancer, including a relative risk of 1.63 for women who reported a BMI of 23 kg/m2 or higher at 18 years of age, versus women with a BMI of 18.5-20.9 kg/m2 at that age.

Similarly, increase in weight since early adulthood was associated with increased cancer risk, they reported.

While the link between excess weight and colorectal cancer incidence and mortality is well established in previous studies, this study is one of few reports looking at the association in younger individuals, according to Dr. Liu and colleagues.

This is thought to be the first prospective study looking at the link between obesity and risk of colorectal cancer diagnosed before the age of 50, they added.

The study was funded by grants from the National Institutes of Health. Dr. Liu had no conflict of interest disclosures related to the study. One coauthor reported consulting fees from Bayer Pharma AG, Janssen, and Pfizer.

SOURCE: Liu P-H et al. JAMA Oncol. 2018 Oct 11. doi: 10.1001/jamaoncol.2018.4280.

 

Obesity and weight gain are linked to increased risk of colorectal cancer in younger women, according to an analysis of a large, prospective U.S. cohort study.

Young women who were obese had a nearly twofold increase in risk of early-onset colorectal cancer, compared with women of normal weight, authors of the study reported in JAMA Oncology.

The findings suggest body weight could be used to “personalize and complement” early cancer screening strategies among adults younger than 50 years, said investigator Po-Hong Liu, MD, of Washington University, St. Louis, and coauthors.

“Given that most of these younger cases are diagnosed symptomatically with more advanced tumors and with a significant influence on years of life lost, our findings reinforce the benefits of maintaining a healthy weight throughout life,” Dr. Liu and coinvestigators said in their report.

Their analysis was based on the ongoing Nurses Health Study II, which began in 1989 and enrolled a total of 116,430 women between the ages of 25 and 42 years in 14 U.S. states. Women completed questionnaires on demographics, medical and health information, and lifestyle factors every 2 years after enrollment.

Dr. Liu and colleagues were able to document 114 cases of colorectal cancer over a median of 13.9 years of follow-up in 85,256 women who had no cancer or inflammatory bowel disease when they were enrolled in the study. The median age at diagnosis for these cancers was 45 years.

Obesity was independently associated with increased risk of these early-onset colorectal cancers, the investigators found in multivariable analysis.

Women with a body mass index of 30 kg/m2 or higher had a relative risk of 1.93 (95% confidence interval, 1.15-3.25) versus women with normal BMIs in the 18.5-22.9 kg/m2 range, according to results of the analysis, they reported.

There was an apparent linear trend between increasing weight and increasing colorectal cancer risk, they added in their report.

They also found links between BMI in early adulthood and risk of early-onset colorectal cancer, including a relative risk of 1.63 for women who reported a BMI of 23 kg/m2 or higher at 18 years of age, versus women with a BMI of 18.5-20.9 kg/m2 at that age.

Similarly, increase in weight since early adulthood was associated with increased cancer risk, they reported.

While the link between excess weight and colorectal cancer incidence and mortality is well established in previous studies, this study is one of few reports looking at the association in younger individuals, according to Dr. Liu and colleagues.

This is thought to be the first prospective study looking at the link between obesity and risk of colorectal cancer diagnosed before the age of 50, they added.

The study was funded by grants from the National Institutes of Health. Dr. Liu had no conflict of interest disclosures related to the study. One coauthor reported consulting fees from Bayer Pharma AG, Janssen, and Pfizer.

SOURCE: Liu P-H et al. JAMA Oncol. 2018 Oct 11. doi: 10.1001/jamaoncol.2018.4280.

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Key clinical point: Obesity, weight gain, and high BMI at a young age in women were linked to increased risk of early-onset colorectal cancer.

Major finding: Women with a BMI of 30 or higher had a relative risk of 1.93 (95% CI, 1.15-3.25) versus women with BMIs in the 18.5-22.9 range.

Study details: Analysis of 114 documented colorectal cancer cases in 85,256 women in the Nurses Health Study II who had no cancer or inflammatory bowel disease at enrollment.

Disclosures: The study was funded by grants from the National Institutes of Health. Dr. Liu had no conflict of interest disclosures related to the study. One coauthor reported consulting fees from Bayer Pharma A.G., Janssen, and Pfizer.

Source: Liu P-H et al. JAMA Oncol. 2018 Oct 11. doi: 10.1001/jamaoncol.2018.4280.

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Poor outcomes for RCC with nodal involvement: Time to reconsider staging criteria?

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Among patients with stage III renal cell carcinoma (RCC) by current staging criteria, survival outcomes are worse for those who have pathological nodal involvement, results of a retrospective study suggest.

Survival was significantly shorter for stage III patients with nodal involvement versus those with no involvement, and was “equivalent” to survival in stage IV RCC patients, according to study author Jose A. Karam, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his coauthors.

“If these findings are validated in other studies, consideration should be given to reclassifying patients with stage III, pN1 disease as having stage IV disease,” Dr. Karam and his coauthors wrote in Cancer.

Dr. Karam and his colleagues looked at records for patients with RCC of any histologic subtype who had undergone radical or partial nephrectomy between 1993 and 2012. Their analysis included a total of 389 patients with stage III disease, including 274 with node-positive disease (pT3N0M0) and 115 with node-negative disease (pT123N1M0), along with 523 patients who had stage IV disease.

They found that median overall survival was just 2.4 years (95% confidence interval, 1.7-4.1) for stage III, node-positive disease patients, compared with 10.2 years (95% CI, 8.7-not estimable [NE]) for stage III, node-negative disease and 2.4 years (95% CI, 2.1-3.0) for stage IV disease.

There was a significant difference in overall survival between the three groups, but no significant difference between patients with stage III node-positive disease and stage IV disease, the investigators wrote.

Similarly, median cancer-specific survival was 2.8 years (95% CI, 1.8-4.8) for stage III node-positive disease, not reached (95% CI, 10.2-NE) for stage III node-negative disease, and 2.4 years (95% CI, 2.1-3.0) for stage IV disease, the investigators wrote.

In multivariate analysis, pathological lymph node involvement in the stage III patients was independently associated with worse overall and cancer-specific survival.

Dr. Karam and his coauthors wrote that it may be prudent to revise the current staging system to reclassify node-positive patients if further research confirms their findings. By the current American Joint Committee on Cancer tumor, nodes, and metastases staging manual, patients can be classified as stage III on the basis of either primary tumor status (pT3) or pathological lymph node involvement, they said.

The incidence of pathological, node-positive disease in RCC ranges from 2%-10% in studies, with 5-year survival rates that are “poor” at 5%-30%, the authors noted in their report.

“Even in the targeted therapy era, adjuvant therapy with tyrosine kinase inhibitors does not appear to improve on these outcomes in patients with pN-positive disease,” they wrote.

Funding support for the research came from the National Institutes of Health/National Cancer Institute. Dr. Karam reported serving as a consultant/advisory board member for Pfizer, EMD Serono, Novartis, and Roche/Genentech, and that the MD Anderson Cancer Center has received clinical trial research funding from Roche/Genentech, though none of these disclosures were related to the current report.

SOURCE: Karam JA et al. Cancer. 2018 Oct 1. doi: 10.1002/cncr.31661.

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Among patients with stage III renal cell carcinoma (RCC) by current staging criteria, survival outcomes are worse for those who have pathological nodal involvement, results of a retrospective study suggest.

Survival was significantly shorter for stage III patients with nodal involvement versus those with no involvement, and was “equivalent” to survival in stage IV RCC patients, according to study author Jose A. Karam, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his coauthors.

“If these findings are validated in other studies, consideration should be given to reclassifying patients with stage III, pN1 disease as having stage IV disease,” Dr. Karam and his coauthors wrote in Cancer.

Dr. Karam and his colleagues looked at records for patients with RCC of any histologic subtype who had undergone radical or partial nephrectomy between 1993 and 2012. Their analysis included a total of 389 patients with stage III disease, including 274 with node-positive disease (pT3N0M0) and 115 with node-negative disease (pT123N1M0), along with 523 patients who had stage IV disease.

They found that median overall survival was just 2.4 years (95% confidence interval, 1.7-4.1) for stage III, node-positive disease patients, compared with 10.2 years (95% CI, 8.7-not estimable [NE]) for stage III, node-negative disease and 2.4 years (95% CI, 2.1-3.0) for stage IV disease.

There was a significant difference in overall survival between the three groups, but no significant difference between patients with stage III node-positive disease and stage IV disease, the investigators wrote.

Similarly, median cancer-specific survival was 2.8 years (95% CI, 1.8-4.8) for stage III node-positive disease, not reached (95% CI, 10.2-NE) for stage III node-negative disease, and 2.4 years (95% CI, 2.1-3.0) for stage IV disease, the investigators wrote.

In multivariate analysis, pathological lymph node involvement in the stage III patients was independently associated with worse overall and cancer-specific survival.

Dr. Karam and his coauthors wrote that it may be prudent to revise the current staging system to reclassify node-positive patients if further research confirms their findings. By the current American Joint Committee on Cancer tumor, nodes, and metastases staging manual, patients can be classified as stage III on the basis of either primary tumor status (pT3) or pathological lymph node involvement, they said.

The incidence of pathological, node-positive disease in RCC ranges from 2%-10% in studies, with 5-year survival rates that are “poor” at 5%-30%, the authors noted in their report.

“Even in the targeted therapy era, adjuvant therapy with tyrosine kinase inhibitors does not appear to improve on these outcomes in patients with pN-positive disease,” they wrote.

Funding support for the research came from the National Institutes of Health/National Cancer Institute. Dr. Karam reported serving as a consultant/advisory board member for Pfizer, EMD Serono, Novartis, and Roche/Genentech, and that the MD Anderson Cancer Center has received clinical trial research funding from Roche/Genentech, though none of these disclosures were related to the current report.

SOURCE: Karam JA et al. Cancer. 2018 Oct 1. doi: 10.1002/cncr.31661.

 

Among patients with stage III renal cell carcinoma (RCC) by current staging criteria, survival outcomes are worse for those who have pathological nodal involvement, results of a retrospective study suggest.

Survival was significantly shorter for stage III patients with nodal involvement versus those with no involvement, and was “equivalent” to survival in stage IV RCC patients, according to study author Jose A. Karam, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his coauthors.

“If these findings are validated in other studies, consideration should be given to reclassifying patients with stage III, pN1 disease as having stage IV disease,” Dr. Karam and his coauthors wrote in Cancer.

Dr. Karam and his colleagues looked at records for patients with RCC of any histologic subtype who had undergone radical or partial nephrectomy between 1993 and 2012. Their analysis included a total of 389 patients with stage III disease, including 274 with node-positive disease (pT3N0M0) and 115 with node-negative disease (pT123N1M0), along with 523 patients who had stage IV disease.

They found that median overall survival was just 2.4 years (95% confidence interval, 1.7-4.1) for stage III, node-positive disease patients, compared with 10.2 years (95% CI, 8.7-not estimable [NE]) for stage III, node-negative disease and 2.4 years (95% CI, 2.1-3.0) for stage IV disease.

There was a significant difference in overall survival between the three groups, but no significant difference between patients with stage III node-positive disease and stage IV disease, the investigators wrote.

Similarly, median cancer-specific survival was 2.8 years (95% CI, 1.8-4.8) for stage III node-positive disease, not reached (95% CI, 10.2-NE) for stage III node-negative disease, and 2.4 years (95% CI, 2.1-3.0) for stage IV disease, the investigators wrote.

In multivariate analysis, pathological lymph node involvement in the stage III patients was independently associated with worse overall and cancer-specific survival.

Dr. Karam and his coauthors wrote that it may be prudent to revise the current staging system to reclassify node-positive patients if further research confirms their findings. By the current American Joint Committee on Cancer tumor, nodes, and metastases staging manual, patients can be classified as stage III on the basis of either primary tumor status (pT3) or pathological lymph node involvement, they said.

The incidence of pathological, node-positive disease in RCC ranges from 2%-10% in studies, with 5-year survival rates that are “poor” at 5%-30%, the authors noted in their report.

“Even in the targeted therapy era, adjuvant therapy with tyrosine kinase inhibitors does not appear to improve on these outcomes in patients with pN-positive disease,” they wrote.

Funding support for the research came from the National Institutes of Health/National Cancer Institute. Dr. Karam reported serving as a consultant/advisory board member for Pfizer, EMD Serono, Novartis, and Roche/Genentech, and that the MD Anderson Cancer Center has received clinical trial research funding from Roche/Genentech, though none of these disclosures were related to the current report.

SOURCE: Karam JA et al. Cancer. 2018 Oct 1. doi: 10.1002/cncr.31661.

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Key clinical point: Among patients with stage III renal cell carcinoma, survival outcomes for those with nodal involvement are worse than for those with no nodal involvement and comparable with patients with stage IV disease, suggesting a potential need to revisit current staging criteria.

Major finding: Overall survival was 2.4 years for stage III node-positive disease, 10.2 years for stage III, node-negative disease, and 2.4 years for stage IV disease.

Study details: A retrospective study including 912 patients with renal cell carcinoma who underwent radical or partial nephrectomy between 1993 and 2012.

Disclosures: Funding was reported from the National Institutes of Health/National Cancer Institute. One study author provided disclosures with Pfizer, EMD Serono, Novartis, and Roche/Genentech.

Source: Karam JA et al. Cancer. 2018 Oct 1. doi: 10.1002/cncr.31661.

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Bias in the clinical setting can impact patient care

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Mon, 06/17/2019 - 07:29

– Physicians and other health care providers may harbor implicit, or unconscious, biases that contribute to health care disparities, patient communication researcher Stacey Passalacqua, PhD, said here at the annual meeting of the American College of Chest Physicians.

Implicit biases are beliefs or attitudes, for example, about certain social groups, that exist outside of a health care provider’s conscious awareness, said Dr. Passalacqua of the department of communication at the University of Texas, San Antonio. If bias is implicit, it can be difficult self-assess.

Patients at risk for biased treatment include African Americans, women, Native Americans, LGBT patients, disabled patients, and patients with substance abuse disorders, among other social, ethnic, and racial groups, Dr. Passalacqua told attendees in workshops at the meeting.

“If a health care provider has negative biases toward a particular patient – maybe they think that these patients doesn’t care that much about their health or that they really have no interest in participating – then obviously that health care provider is far less likely to engage that patient in shared decision making,” she said in a video interview.

Diagnosis and treatment are subject to influence by the bias that physicians have toward certain patient groups, according to Dr. Passalacqua. For example, she said women with heart disease are less likely to be accurately diagnosed.

The bias in the medical setting might be mitigated by the presence of more individuals from the at-risk groups in the health care workforce, she added. In one recent retrospective study, investigators found that after an MI, a woman treated by a male physician was associated with higher mortality, while women and men had similar outcomes when treated by female physicians.

“That is one of the reasons why it is so important to have a diverse workforce, to have health care providers of different ethnicities, of different genders, or different backgrounds, because they are less subject to some of these implicit biases that we know are highly problematic in health care,” she said in the interview.

Dr. Passalacqua had no disclosures related to her presentation.

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– Physicians and other health care providers may harbor implicit, or unconscious, biases that contribute to health care disparities, patient communication researcher Stacey Passalacqua, PhD, said here at the annual meeting of the American College of Chest Physicians.

Implicit biases are beliefs or attitudes, for example, about certain social groups, that exist outside of a health care provider’s conscious awareness, said Dr. Passalacqua of the department of communication at the University of Texas, San Antonio. If bias is implicit, it can be difficult self-assess.

Patients at risk for biased treatment include African Americans, women, Native Americans, LGBT patients, disabled patients, and patients with substance abuse disorders, among other social, ethnic, and racial groups, Dr. Passalacqua told attendees in workshops at the meeting.

“If a health care provider has negative biases toward a particular patient – maybe they think that these patients doesn’t care that much about their health or that they really have no interest in participating – then obviously that health care provider is far less likely to engage that patient in shared decision making,” she said in a video interview.

Diagnosis and treatment are subject to influence by the bias that physicians have toward certain patient groups, according to Dr. Passalacqua. For example, she said women with heart disease are less likely to be accurately diagnosed.

The bias in the medical setting might be mitigated by the presence of more individuals from the at-risk groups in the health care workforce, she added. In one recent retrospective study, investigators found that after an MI, a woman treated by a male physician was associated with higher mortality, while women and men had similar outcomes when treated by female physicians.

“That is one of the reasons why it is so important to have a diverse workforce, to have health care providers of different ethnicities, of different genders, or different backgrounds, because they are less subject to some of these implicit biases that we know are highly problematic in health care,” she said in the interview.

Dr. Passalacqua had no disclosures related to her presentation.

– Physicians and other health care providers may harbor implicit, or unconscious, biases that contribute to health care disparities, patient communication researcher Stacey Passalacqua, PhD, said here at the annual meeting of the American College of Chest Physicians.

Implicit biases are beliefs or attitudes, for example, about certain social groups, that exist outside of a health care provider’s conscious awareness, said Dr. Passalacqua of the department of communication at the University of Texas, San Antonio. If bias is implicit, it can be difficult self-assess.

Patients at risk for biased treatment include African Americans, women, Native Americans, LGBT patients, disabled patients, and patients with substance abuse disorders, among other social, ethnic, and racial groups, Dr. Passalacqua told attendees in workshops at the meeting.

“If a health care provider has negative biases toward a particular patient – maybe they think that these patients doesn’t care that much about their health or that they really have no interest in participating – then obviously that health care provider is far less likely to engage that patient in shared decision making,” she said in a video interview.

Diagnosis and treatment are subject to influence by the bias that physicians have toward certain patient groups, according to Dr. Passalacqua. For example, she said women with heart disease are less likely to be accurately diagnosed.

The bias in the medical setting might be mitigated by the presence of more individuals from the at-risk groups in the health care workforce, she added. In one recent retrospective study, investigators found that after an MI, a woman treated by a male physician was associated with higher mortality, while women and men had similar outcomes when treated by female physicians.

“That is one of the reasons why it is so important to have a diverse workforce, to have health care providers of different ethnicities, of different genders, or different backgrounds, because they are less subject to some of these implicit biases that we know are highly problematic in health care,” she said in the interview.

Dr. Passalacqua had no disclosures related to her presentation.

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Dupilumab offers extra benefits to asthmatic teens

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– For adolescents with asthma, treatment with the biologic agent dupilumab provided benefits that were at least comparable with what was seen in adults, results from a retrospective analysis of a randomized, phase 3 study suggest.

Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, NY
Andrew Bowser/MDedge News
Dr. Neil M.H. Graham

Adolescents had reduced asthma exacerbations in line with what was seen in adults and had improvements in lung function that were at a greater magnitude than adults, according to study coauthor Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, N.Y.

“We think, overall, it’s a very good treatment response from this drug in this high-risk population, and it is generally well tolerated, as we’ve seen in other studies,” Dr. Graham said in a podium presentation at the annual meeting of the American College of Chest Physicians.

Dr. Graham presented results of an analysis of the 1,902-patient, phase 3 Liberty Asthma QUEST trial, published in May 2018 in the New England Journal of Medicine.

Top-line results of QUEST showed that treatment with dupilumab, a fully human anti–IL-4Ra monoclonal antibody, resulted in significantly lower rates of severe asthma exacerbation, along with improved lung function, in patients aged 12 years and older with moderate to severe asthma.

Now, this retrospective analysis shows that, in adolescents, improvements from baseline to week 12 in forced expiratory volume in 1 second (FEV1) were significant and at a greater magnitude than in adults, according to Dr. Graham and his coinvestigators.

The improvement over 12 weeks in FEV1 for adolescents was 0.36 L and 0.27 L, respectively, for the 200- and 300-mg doses of dupilumab (P less than .05 vs. placebo for both), Dr. Graham and his coinvestigators reported. In adults, the improvement was 0.12 L.

The annualized exacerbation rate dropped by 46.4% for those adolescents who received 200 mg dupilumab, though there was no treatment effect versus placebo for dupilumab 300 mg; the investigators said the lack of effect in this retrospective analysis could have been caused by imbalances in prior event rates or the small sample size.

A total of 107 out of 1,902 patients in QUEST were adolescents, and of those, 68 were randomly assigned to dupilumab, according to the report. Injection site reaction was the most common adverse event in adolescents in both dosing groups.

Dr. Graham reported disclosures related to his employment with Regeneron. Study coauthors reported disclosures related to Regeneron, AstraZeneca, Sanofi, Teva Pharmaceutical, GlaxoSmithKline, Boehringer Ingelheim, Merck, Genentech, and others.

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– For adolescents with asthma, treatment with the biologic agent dupilumab provided benefits that were at least comparable with what was seen in adults, results from a retrospective analysis of a randomized, phase 3 study suggest.

Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, NY
Andrew Bowser/MDedge News
Dr. Neil M.H. Graham

Adolescents had reduced asthma exacerbations in line with what was seen in adults and had improvements in lung function that were at a greater magnitude than adults, according to study coauthor Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, N.Y.

“We think, overall, it’s a very good treatment response from this drug in this high-risk population, and it is generally well tolerated, as we’ve seen in other studies,” Dr. Graham said in a podium presentation at the annual meeting of the American College of Chest Physicians.

Dr. Graham presented results of an analysis of the 1,902-patient, phase 3 Liberty Asthma QUEST trial, published in May 2018 in the New England Journal of Medicine.

Top-line results of QUEST showed that treatment with dupilumab, a fully human anti–IL-4Ra monoclonal antibody, resulted in significantly lower rates of severe asthma exacerbation, along with improved lung function, in patients aged 12 years and older with moderate to severe asthma.

Now, this retrospective analysis shows that, in adolescents, improvements from baseline to week 12 in forced expiratory volume in 1 second (FEV1) were significant and at a greater magnitude than in adults, according to Dr. Graham and his coinvestigators.

The improvement over 12 weeks in FEV1 for adolescents was 0.36 L and 0.27 L, respectively, for the 200- and 300-mg doses of dupilumab (P less than .05 vs. placebo for both), Dr. Graham and his coinvestigators reported. In adults, the improvement was 0.12 L.

The annualized exacerbation rate dropped by 46.4% for those adolescents who received 200 mg dupilumab, though there was no treatment effect versus placebo for dupilumab 300 mg; the investigators said the lack of effect in this retrospective analysis could have been caused by imbalances in prior event rates or the small sample size.

A total of 107 out of 1,902 patients in QUEST were adolescents, and of those, 68 were randomly assigned to dupilumab, according to the report. Injection site reaction was the most common adverse event in adolescents in both dosing groups.

Dr. Graham reported disclosures related to his employment with Regeneron. Study coauthors reported disclosures related to Regeneron, AstraZeneca, Sanofi, Teva Pharmaceutical, GlaxoSmithKline, Boehringer Ingelheim, Merck, Genentech, and others.

– For adolescents with asthma, treatment with the biologic agent dupilumab provided benefits that were at least comparable with what was seen in adults, results from a retrospective analysis of a randomized, phase 3 study suggest.

Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, NY
Andrew Bowser/MDedge News
Dr. Neil M.H. Graham

Adolescents had reduced asthma exacerbations in line with what was seen in adults and had improvements in lung function that were at a greater magnitude than adults, according to study coauthor Neil M.H. Graham, MD, of Regeneron Pharmaceuticals, Tarrytown, N.Y.

“We think, overall, it’s a very good treatment response from this drug in this high-risk population, and it is generally well tolerated, as we’ve seen in other studies,” Dr. Graham said in a podium presentation at the annual meeting of the American College of Chest Physicians.

Dr. Graham presented results of an analysis of the 1,902-patient, phase 3 Liberty Asthma QUEST trial, published in May 2018 in the New England Journal of Medicine.

Top-line results of QUEST showed that treatment with dupilumab, a fully human anti–IL-4Ra monoclonal antibody, resulted in significantly lower rates of severe asthma exacerbation, along with improved lung function, in patients aged 12 years and older with moderate to severe asthma.

Now, this retrospective analysis shows that, in adolescents, improvements from baseline to week 12 in forced expiratory volume in 1 second (FEV1) were significant and at a greater magnitude than in adults, according to Dr. Graham and his coinvestigators.

The improvement over 12 weeks in FEV1 for adolescents was 0.36 L and 0.27 L, respectively, for the 200- and 300-mg doses of dupilumab (P less than .05 vs. placebo for both), Dr. Graham and his coinvestigators reported. In adults, the improvement was 0.12 L.

The annualized exacerbation rate dropped by 46.4% for those adolescents who received 200 mg dupilumab, though there was no treatment effect versus placebo for dupilumab 300 mg; the investigators said the lack of effect in this retrospective analysis could have been caused by imbalances in prior event rates or the small sample size.

A total of 107 out of 1,902 patients in QUEST were adolescents, and of those, 68 were randomly assigned to dupilumab, according to the report. Injection site reaction was the most common adverse event in adolescents in both dosing groups.

Dr. Graham reported disclosures related to his employment with Regeneron. Study coauthors reported disclosures related to Regeneron, AstraZeneca, Sanofi, Teva Pharmaceutical, GlaxoSmithKline, Boehringer Ingelheim, Merck, Genentech, and others.

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Key clinical point: Dupilumab’s benefits in adolescents with moderate to severe asthma are at least comparable with what has been reported in adults.

Major finding: The improvement over 12 weeks in forced expiratory volume in 1 second for adolescents was 0.36 L and 0.27 L, respectively, for the 200- and 300-mg doses of dupilumab versus 0.12 L for adults.

Study details: A retrospective analysis of 1,902 patients (including 107 adolescents) in Liberty Asthma QUEST, a recently reported randomized, phase 3 trial.

Disclosures: Several study coauthors reported employment with Regeneron. Dr. Graham reported disclosures related to his employment with Regeneron. Other reported disclosures were related to AstraZeneca, Sanofi, Teva Pharmaceutical, GlaxoSmithKline, Boehringer Ingelheim, Merck, and Genentech, among other entities.

Source: Graham NMH et al. CHEST. 2018 Oct. doi: 10.1016/j/chest.2018.08.002.

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CT for evaluating pulmonary embolism overused

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Fri, 01/04/2019 - 10:36

– The recommended approach to evaluating suspected pulmonary embolism is “greatly underutilized” in the Veterans Health Administration system, Nancy Hsu, MD, said at the annual meeting of the American College of Chest Physicians.

Dr. Nancy Hsu of the VA Greater Los Angeles Healthcare System
Andrew Bowser/MDedge News
Dr. Nancy Hsu

Most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and highly sensitive D-dimer prior to ordering CT pulmonary angiography (CTPA) for suspected pulmonary embolism (PE), according to results of a survey by Dr. Hsu and her coinvestigator, Guy Soo Hoo, MD.

While CTPA has become the imaging modality of choice for evaluating suspected PE, it is overused and potentially avoidable in one-third of cases, said Dr. Hsu, who is with the VA Greater Los Angeles Healthcare System.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu said.

Dr. Hsu and Dr. Soo Hoo surveyed 606 individuals at 18 Veterans Integrated Service Networks (VISNs) and 143 medical centers. A total of 120 fully completed questionnaires were analyzed.

Most respondents (63%) were chiefs, and 80% had 11+ years of experience, Dr. Hsu reported.

Almost all respondents (85%) said CDR with or without D-dimer was not required before ordering a CTPA, survey results show, while only about 7% required both.

“A very small minority of [Veterans Integrated Service Networks], or geographic regions, contained even one hospital that adhered to the guidelines,” Dr. Hsu added.

Though further analysis was limited by sample size, the average CTPA yield for PE appeared to be higher when both components were used in the evaluation, according to Dr. Hsu, who noted an 11.9% yield for CDR plus D-dimer.

Use of CTPA appeared lower at sites with CDR and D-dimer testing, Dr. Hsu added.

These results suggest a need for further research to compare CTPA use and yield in sites that have the algorithm in place, Dr. Hsu told attendees at the meeting.

Adherence to the CDR plus D-dimer diagnostic strategy is “modest at best” despite being a Top 5 Choosing Wisely recommendation in pulmonary medicine, Dr. Hsu told attendees.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, Dr. Hsu said.

“It’s all about balancing risks and benefits,” she said from the podium in a discussion of the study results.

Dr. Hsu and Dr. Soo Hoo disclosed that they had no relationships relevant to their research.

SOURCE: Hsu N et al. CHEST. 2018 Oct. doi: 10.1016/j.chest.2018.08.937

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– The recommended approach to evaluating suspected pulmonary embolism is “greatly underutilized” in the Veterans Health Administration system, Nancy Hsu, MD, said at the annual meeting of the American College of Chest Physicians.

Dr. Nancy Hsu of the VA Greater Los Angeles Healthcare System
Andrew Bowser/MDedge News
Dr. Nancy Hsu

Most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and highly sensitive D-dimer prior to ordering CT pulmonary angiography (CTPA) for suspected pulmonary embolism (PE), according to results of a survey by Dr. Hsu and her coinvestigator, Guy Soo Hoo, MD.

While CTPA has become the imaging modality of choice for evaluating suspected PE, it is overused and potentially avoidable in one-third of cases, said Dr. Hsu, who is with the VA Greater Los Angeles Healthcare System.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu said.

Dr. Hsu and Dr. Soo Hoo surveyed 606 individuals at 18 Veterans Integrated Service Networks (VISNs) and 143 medical centers. A total of 120 fully completed questionnaires were analyzed.

Most respondents (63%) were chiefs, and 80% had 11+ years of experience, Dr. Hsu reported.

Almost all respondents (85%) said CDR with or without D-dimer was not required before ordering a CTPA, survey results show, while only about 7% required both.

“A very small minority of [Veterans Integrated Service Networks], or geographic regions, contained even one hospital that adhered to the guidelines,” Dr. Hsu added.

Though further analysis was limited by sample size, the average CTPA yield for PE appeared to be higher when both components were used in the evaluation, according to Dr. Hsu, who noted an 11.9% yield for CDR plus D-dimer.

Use of CTPA appeared lower at sites with CDR and D-dimer testing, Dr. Hsu added.

These results suggest a need for further research to compare CTPA use and yield in sites that have the algorithm in place, Dr. Hsu told attendees at the meeting.

Adherence to the CDR plus D-dimer diagnostic strategy is “modest at best” despite being a Top 5 Choosing Wisely recommendation in pulmonary medicine, Dr. Hsu told attendees.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, Dr. Hsu said.

“It’s all about balancing risks and benefits,” she said from the podium in a discussion of the study results.

Dr. Hsu and Dr. Soo Hoo disclosed that they had no relationships relevant to their research.

SOURCE: Hsu N et al. CHEST. 2018 Oct. doi: 10.1016/j.chest.2018.08.937

– The recommended approach to evaluating suspected pulmonary embolism is “greatly underutilized” in the Veterans Health Administration system, Nancy Hsu, MD, said at the annual meeting of the American College of Chest Physicians.

Dr. Nancy Hsu of the VA Greater Los Angeles Healthcare System
Andrew Bowser/MDedge News
Dr. Nancy Hsu

Most Veterans Affairs sites did not require incorporation of a clinical decision rule (CDR) and highly sensitive D-dimer prior to ordering CT pulmonary angiography (CTPA) for suspected pulmonary embolism (PE), according to results of a survey by Dr. Hsu and her coinvestigator, Guy Soo Hoo, MD.

While CTPA has become the imaging modality of choice for evaluating suspected PE, it is overused and potentially avoidable in one-third of cases, said Dr. Hsu, who is with the VA Greater Los Angeles Healthcare System.

“In the 10 years following the advent of CTPA use, there was a 14-fold increase in usage, but there was no change in mortality,” Dr. Hsu said. “This is consistent with overdiagnosis.”

Indiscriminate use of CTPA results in unnecessary and avoidable radiation exposure, contrast-related reactions, and treatment-related bleeding, Dr. Hsu said.

Dr. Hsu and Dr. Soo Hoo surveyed 606 individuals at 18 Veterans Integrated Service Networks (VISNs) and 143 medical centers. A total of 120 fully completed questionnaires were analyzed.

Most respondents (63%) were chiefs, and 80% had 11+ years of experience, Dr. Hsu reported.

Almost all respondents (85%) said CDR with or without D-dimer was not required before ordering a CTPA, survey results show, while only about 7% required both.

“A very small minority of [Veterans Integrated Service Networks], or geographic regions, contained even one hospital that adhered to the guidelines,” Dr. Hsu added.

Though further analysis was limited by sample size, the average CTPA yield for PE appeared to be higher when both components were used in the evaluation, according to Dr. Hsu, who noted an 11.9% yield for CDR plus D-dimer.

Use of CTPA appeared lower at sites with CDR and D-dimer testing, Dr. Hsu added.

These results suggest a need for further research to compare CTPA use and yield in sites that have the algorithm in place, Dr. Hsu told attendees at the meeting.

Adherence to the CDR plus D-dimer diagnostic strategy is “modest at best” despite being a Top 5 Choosing Wisely recommendation in pulmonary medicine, Dr. Hsu told attendees.

The biggest barrier to optimal practice may be the fear of having a patient who “falls through the cracks” based on false-negative CDR and D-dimer data, according to Dr. Hsu.

On the other hand, judicious use of CTPA likely avoids negative sequelae related to radiation, contrast exposure, and treatment-related bleeding, Dr. Hsu said.

“It’s all about balancing risks and benefits,” she said from the podium in a discussion of the study results.

Dr. Hsu and Dr. Soo Hoo disclosed that they had no relationships relevant to their research.

SOURCE: Hsu N et al. CHEST. 2018 Oct. doi: 10.1016/j.chest.2018.08.937

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REPORTING FROM CHEST 2018

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Key clinical point: The recommended approach to evaluating suspected pulmonary embolism was underutilized in VA facilities.

Major finding: 85% of respondents said incorporation of a clinical decision rule plus highly sensitive D-dimer was not required prior to CTPA.

Study details: Analysis of 120 survey questionnaires completed by individuals working in Veterans Integrated Service Networks and medical centers.

Disclosures: Study authors reported no conflicts of interest.

Source: Hsu N et al. CHEST 2018 Oct. doi: 10/1016/j.chest.2018.08.937.

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Bacteremic sepsis in ALL tied to neurocognitive dysfunction

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Bacteremic sepsis in ALL tied to neurocognitive dysfunction

Child with cancer Photo by Bill Branson
Photo by Bill Branson
Child with leukemia

Bacteremic sepsis during acute lymphoblastic leukemia (ALL) treatment may contribute to neurocognitive dysfunction later in life, results of a cohort study suggest.

Pediatric ALL survivors who had sepsis while on treatment performed worse on measures of intelligence, attention, executive function, and processing speed than survivors with no sepsis history, according to study results.

Links between sepsis and impaired neurocognitive function found in this study have “practice-changing implications” for cancer survivors, investigators reported in JAMA Pediatrics.

“Prevention of infection, early recognition and appropriate management of sepsis, and preemptive neurocognitive interventions should be prioritized, because these might prevent or ameliorate neurologic damage,” said Joshua Wolf, MBBS, of St. Jude Children’s Research Hospital, Memphis, and the coauthors of the report.

The study included 212 children who, at a median age of 5 years, had received risk-adapted chemotherapy for ALL with no hematopoietic cell transplant or cranial irradiation.

Sixteen of the patients (7.5%) had a history of bacteremic sepsis during ALL therapy, according to retrospectively obtained data.

As a part of the study, all patients participated in neurocognitive testing, which was done at a median of 7.7 years after diagnosis.

Patients with a history of bacteremic sepsis performed poorly on multiple measures of neurocognitive function, as compared with all other patients, according to results of analyses that were adjusted for multiple potentially confounding factors, such as age, race, and leukemia risk category.

Although not all neurocognitive measures were significantly different between groups, survivors with a sepsis history performed worse on evaluations of spatial planning (difference, 0.78; 95% CI, 0.57-1.00), verbal fluency (0.38; 95% CI, 0.14-0.62), and attention (0.63; 95% CI, 0.30-0.95), among other measures.

This is believed to be the first published study looking at potential links between sepsis during ALL treatment and long-term neurocognitive dysfunction, investigators said. However, similar observations have been made in other patient populations, they added.

Exactly how sepsis might lead to neurocognitive deficits remains unclear.

“In the population of children with cancer, these mechanisms might be augmented by increased blood-brain barrier permeability to neurotoxic chemotherapy drugs,” the investigators said in their report.

Further study is needed to look at potential brain injury mechanisms and to validate the current findings in other ALL patient cohorts, they concluded.

The study was supported by the National Institute of Mental Health, the National Cancer Institute, and the American Lebanese Syrian Associated Charities. The researchers reported having no conflicts of interest.

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Child with cancer Photo by Bill Branson
Photo by Bill Branson
Child with leukemia

Bacteremic sepsis during acute lymphoblastic leukemia (ALL) treatment may contribute to neurocognitive dysfunction later in life, results of a cohort study suggest.

Pediatric ALL survivors who had sepsis while on treatment performed worse on measures of intelligence, attention, executive function, and processing speed than survivors with no sepsis history, according to study results.

Links between sepsis and impaired neurocognitive function found in this study have “practice-changing implications” for cancer survivors, investigators reported in JAMA Pediatrics.

“Prevention of infection, early recognition and appropriate management of sepsis, and preemptive neurocognitive interventions should be prioritized, because these might prevent or ameliorate neurologic damage,” said Joshua Wolf, MBBS, of St. Jude Children’s Research Hospital, Memphis, and the coauthors of the report.

The study included 212 children who, at a median age of 5 years, had received risk-adapted chemotherapy for ALL with no hematopoietic cell transplant or cranial irradiation.

Sixteen of the patients (7.5%) had a history of bacteremic sepsis during ALL therapy, according to retrospectively obtained data.

As a part of the study, all patients participated in neurocognitive testing, which was done at a median of 7.7 years after diagnosis.

Patients with a history of bacteremic sepsis performed poorly on multiple measures of neurocognitive function, as compared with all other patients, according to results of analyses that were adjusted for multiple potentially confounding factors, such as age, race, and leukemia risk category.

Although not all neurocognitive measures were significantly different between groups, survivors with a sepsis history performed worse on evaluations of spatial planning (difference, 0.78; 95% CI, 0.57-1.00), verbal fluency (0.38; 95% CI, 0.14-0.62), and attention (0.63; 95% CI, 0.30-0.95), among other measures.

This is believed to be the first published study looking at potential links between sepsis during ALL treatment and long-term neurocognitive dysfunction, investigators said. However, similar observations have been made in other patient populations, they added.

Exactly how sepsis might lead to neurocognitive deficits remains unclear.

“In the population of children with cancer, these mechanisms might be augmented by increased blood-brain barrier permeability to neurotoxic chemotherapy drugs,” the investigators said in their report.

Further study is needed to look at potential brain injury mechanisms and to validate the current findings in other ALL patient cohorts, they concluded.

The study was supported by the National Institute of Mental Health, the National Cancer Institute, and the American Lebanese Syrian Associated Charities. The researchers reported having no conflicts of interest.

Child with cancer Photo by Bill Branson
Photo by Bill Branson
Child with leukemia

Bacteremic sepsis during acute lymphoblastic leukemia (ALL) treatment may contribute to neurocognitive dysfunction later in life, results of a cohort study suggest.

Pediatric ALL survivors who had sepsis while on treatment performed worse on measures of intelligence, attention, executive function, and processing speed than survivors with no sepsis history, according to study results.

Links between sepsis and impaired neurocognitive function found in this study have “practice-changing implications” for cancer survivors, investigators reported in JAMA Pediatrics.

“Prevention of infection, early recognition and appropriate management of sepsis, and preemptive neurocognitive interventions should be prioritized, because these might prevent or ameliorate neurologic damage,” said Joshua Wolf, MBBS, of St. Jude Children’s Research Hospital, Memphis, and the coauthors of the report.

The study included 212 children who, at a median age of 5 years, had received risk-adapted chemotherapy for ALL with no hematopoietic cell transplant or cranial irradiation.

Sixteen of the patients (7.5%) had a history of bacteremic sepsis during ALL therapy, according to retrospectively obtained data.

As a part of the study, all patients participated in neurocognitive testing, which was done at a median of 7.7 years after diagnosis.

Patients with a history of bacteremic sepsis performed poorly on multiple measures of neurocognitive function, as compared with all other patients, according to results of analyses that were adjusted for multiple potentially confounding factors, such as age, race, and leukemia risk category.

Although not all neurocognitive measures were significantly different between groups, survivors with a sepsis history performed worse on evaluations of spatial planning (difference, 0.78; 95% CI, 0.57-1.00), verbal fluency (0.38; 95% CI, 0.14-0.62), and attention (0.63; 95% CI, 0.30-0.95), among other measures.

This is believed to be the first published study looking at potential links between sepsis during ALL treatment and long-term neurocognitive dysfunction, investigators said. However, similar observations have been made in other patient populations, they added.

Exactly how sepsis might lead to neurocognitive deficits remains unclear.

“In the population of children with cancer, these mechanisms might be augmented by increased blood-brain barrier permeability to neurotoxic chemotherapy drugs,” the investigators said in their report.

Further study is needed to look at potential brain injury mechanisms and to validate the current findings in other ALL patient cohorts, they concluded.

The study was supported by the National Institute of Mental Health, the National Cancer Institute, and the American Lebanese Syrian Associated Charities. The researchers reported having no conflicts of interest.

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COPD: Triple trumps dual therapy regardless of baseline reversibility

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– Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Dr. Robert Wise of Johns Hopkins University
Andrew D. Bowser/MDedge News
Dr. Robert Wise

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV1 of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

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– Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Dr. Robert Wise of Johns Hopkins University
Andrew D. Bowser/MDedge News
Dr. Robert Wise

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV1 of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

 

– Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Dr. Robert Wise of Johns Hopkins University
Andrew D. Bowser/MDedge News
Dr. Robert Wise

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV1 of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

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REPORTING FROM CHEST 2018

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Key clinical point: Triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) is superior to UMEC/VI in COPD patients regardless of baseline bronchodilator reversibility.

Major finding: Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction.

Study details: Retrospective analysis of IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

Disclosures: Study authors reported disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

Source: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j/chest.2018.08.662.

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