User login
Asthma step-up therapy in children improves outcomes
SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.
Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.
Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.
Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.
Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).
After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.
The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.
ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.
Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.
Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.
“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.
The research did not use external funding, and Dr. Snyder had no disclosures.
SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.
Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.
Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.
Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.
Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).
After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.
The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.
ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.
Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.
Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.
“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.
The research did not use external funding, and Dr. Snyder had no disclosures.
SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.
Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.
Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.
Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.
Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).
After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.
The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.
ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.
Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.
Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.
“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.
The research did not use external funding, and Dr. Snyder had no disclosures.
AT PAS 2017
Key clinical point:
Major finding: Children with poorly controlled asthma receiving step-up pharmacotherapy had a 68% lower risk of inpatient admission and 37% lower risk of emergency department visits for asthma (P less than .05).
Data source: The findings are based on a nonrandomized trial of 903 children, aged 2-18 years, tracked for 12 months in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio.
Disclosures: The research did not use external funding, and Dr. Snyder had no disclosures.
Tools measuring oxygen desaturation produced disparate data
WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.
The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.
AL showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).
This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.
“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”
The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.
ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).
When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.
Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.
“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.
When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.
Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.
Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.
Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.
Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.
The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.
AL showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).
This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.
“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”
The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.
ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).
When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.
Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.
“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.
When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.
Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.
Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.
Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.
Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.
The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.
AL showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).
This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.
“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”
The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.
ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).
When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.
Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.
“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.
When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.
Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.
Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.
Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.
Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Key clinical point:
Major finding: ODI tests analyzed using the ResMed APneaLink Plus system vs. Compumedics Grael Profusion PSG3 system reported ODI4% bias = 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) and ODI3% bias = 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour).
Data source: ODI test results for 106 participants in a sleep study at Monash Medical Centre.
Disclosures: Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.
Oral iron of no benefit in heart failure with iron deficiency
High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.
Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.
The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.
These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.
The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).
In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.
In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.
This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.
High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.
Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.
The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.
These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.
The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).
In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.
In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.
This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.
High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.
Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.
The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.
These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.
The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).
In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.
In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.
This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.
Key clinical point: High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure and iron deficiency.
Major finding: Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min).
Data source: A multicenter, randomized, double-blind, placebo-controlled phase II trial involving 225 patients treated for 16 weeks.
Disclosures: This study was funded by the National Heart, Lung, and Blood Institute (NCT02188784), which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.
SMILE, Your Myopia Has Just Been Treated Faster!
Fort Belvoir Community Hospital surgeons have performed the first small-incision lenticule extraction (SMILE) in the DoD, according to Health.mil News. The procedure to reduce or eliminate nearsightedness has been performed since 2011; the FDA recently approved it for the U.S.
The very fast and short-pulsed (femtosecond) laser creates a thin disc within the cornea, which is removed through a cut on the corneal surface. Removing the tissue changes the shape of the cornea.
The procedure takes 15 to 20 minutes with the laser activated for about 90 seconds per eye. Both eyes can be treated in the same session. With SMILE, unlike LASIK, no tissue is vaporized, meaning wound recovery time is faster, and with no corneal flap created, there is no risk of flap dislocation.
A clinical study found complications were rare, and by month 12 postsurgery there were only 4 reports of moderate or severe glare and 1 of moderate or severe halos. The most commonly reported effects were starbursts, blurred vision, and difficulty judging distance or depth perception, but at 12 months, more patients reported improvement than worsening. At the 6-month follow-up, 287 of 328 patients were seeing 20/20 or better without glasses.
“We are thrilled to extend this treatment option to active duty service members under the Warfighter Refractive Eye Surgery Program,” said U.S. Army Lt. Col. Bruce Rivers, director of the program at Belvoir Hospital.
The surgery will make a difference for patients. One of the first to have it done, Navy Petty Officer 1st Class Christopher Mahmood, a submarine mechanic, said, “On a submarine we have to be able to put our breathing equipment on in approximately 30 seconds, in case of emergency. Glasses make this difficult. Getting this surgery means I have one less thing to worry about while deployed and can focus 100 percent on the mission.”
The SMILE procedure will be available at Belvoir Hospital, San Diego Naval Medical Center, and Wilford Hall in San Antonio.
Fort Belvoir Community Hospital surgeons have performed the first small-incision lenticule extraction (SMILE) in the DoD, according to Health.mil News. The procedure to reduce or eliminate nearsightedness has been performed since 2011; the FDA recently approved it for the U.S.
The very fast and short-pulsed (femtosecond) laser creates a thin disc within the cornea, which is removed through a cut on the corneal surface. Removing the tissue changes the shape of the cornea.
The procedure takes 15 to 20 minutes with the laser activated for about 90 seconds per eye. Both eyes can be treated in the same session. With SMILE, unlike LASIK, no tissue is vaporized, meaning wound recovery time is faster, and with no corneal flap created, there is no risk of flap dislocation.
A clinical study found complications were rare, and by month 12 postsurgery there were only 4 reports of moderate or severe glare and 1 of moderate or severe halos. The most commonly reported effects were starbursts, blurred vision, and difficulty judging distance or depth perception, but at 12 months, more patients reported improvement than worsening. At the 6-month follow-up, 287 of 328 patients were seeing 20/20 or better without glasses.
“We are thrilled to extend this treatment option to active duty service members under the Warfighter Refractive Eye Surgery Program,” said U.S. Army Lt. Col. Bruce Rivers, director of the program at Belvoir Hospital.
The surgery will make a difference for patients. One of the first to have it done, Navy Petty Officer 1st Class Christopher Mahmood, a submarine mechanic, said, “On a submarine we have to be able to put our breathing equipment on in approximately 30 seconds, in case of emergency. Glasses make this difficult. Getting this surgery means I have one less thing to worry about while deployed and can focus 100 percent on the mission.”
The SMILE procedure will be available at Belvoir Hospital, San Diego Naval Medical Center, and Wilford Hall in San Antonio.
Fort Belvoir Community Hospital surgeons have performed the first small-incision lenticule extraction (SMILE) in the DoD, according to Health.mil News. The procedure to reduce or eliminate nearsightedness has been performed since 2011; the FDA recently approved it for the U.S.
The very fast and short-pulsed (femtosecond) laser creates a thin disc within the cornea, which is removed through a cut on the corneal surface. Removing the tissue changes the shape of the cornea.
The procedure takes 15 to 20 minutes with the laser activated for about 90 seconds per eye. Both eyes can be treated in the same session. With SMILE, unlike LASIK, no tissue is vaporized, meaning wound recovery time is faster, and with no corneal flap created, there is no risk of flap dislocation.
A clinical study found complications were rare, and by month 12 postsurgery there were only 4 reports of moderate or severe glare and 1 of moderate or severe halos. The most commonly reported effects were starbursts, blurred vision, and difficulty judging distance or depth perception, but at 12 months, more patients reported improvement than worsening. At the 6-month follow-up, 287 of 328 patients were seeing 20/20 or better without glasses.
“We are thrilled to extend this treatment option to active duty service members under the Warfighter Refractive Eye Surgery Program,” said U.S. Army Lt. Col. Bruce Rivers, director of the program at Belvoir Hospital.
The surgery will make a difference for patients. One of the first to have it done, Navy Petty Officer 1st Class Christopher Mahmood, a submarine mechanic, said, “On a submarine we have to be able to put our breathing equipment on in approximately 30 seconds, in case of emergency. Glasses make this difficult. Getting this surgery means I have one less thing to worry about while deployed and can focus 100 percent on the mission.”
The SMILE procedure will be available at Belvoir Hospital, San Diego Naval Medical Center, and Wilford Hall in San Antonio.
Mycobacteria subset plagues pulmonary patients
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
FROM CHEST
Key clinical point: An optimal multidrug treatment has not yet been found for patients with nontuberculosis mycobacteria (NTM)–related pulmonary disease.
Major finding: The average proportion of sputum culture conversion (SCC) for patients with M. abscessus was 42% after subtraction for posttreatment relapses, but reached 79% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with M. xenopi, and 54% for those with M. malmoense.
Data source: A meta-analysis of 24 studies and 1,224 patients.
Disclosures: Dr. Roland Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Children’s asthma risk reduced with prenatal vitamin D supplementation
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
AT PAS 2017
Key clinical point: Higher levels of vitamin D3 in pregnancy led to a reduced risk of asthma or allergies in subsequent children at high risk for the condition.
Major finding: (P = .051).
Data source: A randomized controlled trial at three clinical centers from October 2009 through January 2015, involving 881 pregnant women whose children had a high risk of asthma or allergies and 806 subsequent children.
Disclosures: The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press, and consultation fees from AstraZeneca.
FDA: Fluoroquinolone use not linked to retina detachment, aortic problems
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
The Food and Drug Administration has found no evidence of a link between fluoroquinolone usage and retinal detachment or aortic aneurysm and dissection, according to a new Drug Safety Communication update on potential serious, disabling side effects of oral and injectable fluoroquinolone antibiotics.
Fluoroquinolones are used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
However, after reviewing patient cases and study findings, the FDA said the evidence didn’t support an association between fluoroquinolone usage and potential retinal or aortic dangers, according to its May 10, 2017, Drug Safety Communication update.
Serious side effects associated with fluoroquinolone use include hallucination, depression, suicidal thoughts, tendinitis and tendon rupture, a “pins and needles” feeling in the arms and legs, joint pain and swelling, skin rash, and severe diarrhea.
“We will continue to assess safety issues with fluoroquinolones, and will update the public if additional actions are needed,” the FDA said in a statement.
Lung cancer metastatic sites differ by histology, tumor factors
GENEVA – A review of data on more than 75,000 patients with lung cancer has revealed distinct patterns of metastasis according to subtype, a finding that could help in surveillance, treatment planning, and prophylaxis, an investigator contends.
Patients with small cell lung cancer (SCLC) had significantly higher rates of liver metastases than patients with non–small cell lung cancer (NSCLC), while patients with NSCLC had significantly higher rates of metastases to bone, reported Mohamed Hendawi, MD, a visiting scholar at the Ohio State University Medical Center in Columbus.
“Predictors for liver metastasis were small cell and adenocarcinoma histology, lower and upper lobe locations, and high grade tumors. Predictors for metastasis to brain were advanced age at diagnosis, adenocarcinoma and small-cell histology, lower lobe [and] main bronchus locations, and high grade tumors,” he wrote in a scientific poster presented at the European Lung Cancer Conference.
Dr. Hendawi drew records on all patients with metastatic lung cancer included in the 2010-2013 Surveillance, Epidemiology, and End Results database. He used univariate and multivariate logistic regression models to evaluate predictors of metastasis.
The data set included a total of 76,254 patients with metastatic lung cancer, of which 17% were SCLC and 83% were NSCLC tumors. In 54% of patients, the primary tumor was in the right lung; in 38%, it was in the left lung; and, in 8% of patients, the primary tumor was bilateral.
The rates of metastases to bone were high in both major lung cancer types but, as noted before, were significantly higher in patients with NSCLC: 37% compared with 34% for patients with SCLC (P less than .001).
In contrast, the incidence of liver metastases in SCLC was more than double that of NSCLC: 46% vs. 20%, respectively (P less than .001). There were slightly, but significantly, fewer cases of brain metastases at the time of diagnosis among patients with SCLC: 25% vs. 26% (P = .003).
Histologic subtypes significantly associated with both brain and liver metastases were, in descending order, adenocarcinomas, small cell, and squamous cell cancers.
Although carcinoid lung cancers accounted for only 2.1% of all tumors, they were associated with a high rate of metastasis to brain at diagnosis (44.8%).
As noted, independent risk factors for liver metastasis were small cell and adenocarcinoma histologies (P less than .001), tumors in the upper lobe (P = .028), and high-grade tumor (P less than .001).
Independent predictors for brain metastases were advanced age at diagnosis (P less than .001), adenocarcinoma and small-cell histologies (P less than .001), lower lobe or main bronchus locations (P = .004), and higher-grade tumors (P less than .001).
In a poster discussion session, Paolo Boffetta, MD, MPH, from the Icahn School of Medicine at Mount Sinai in New York City, the invited discussant, commented that, while he thought that the data were interesting, “the main issue I had with this poster is that it’s limited to patients with metastasis, so we cannot really evaluate the risk of metastasis according to the different histological types and the absolute risk of developing metastases in one or the other organ but only the relative risk of developing metastasis in one organ versus the other having one or the other histology.”
“So, we really don’t know whether the risk is increased in one group or decreased in the other one that generates these differences,” he said.
The study did not receive outside support. Dr. Hendawi declared no conflicts of interest.
GENEVA – A review of data on more than 75,000 patients with lung cancer has revealed distinct patterns of metastasis according to subtype, a finding that could help in surveillance, treatment planning, and prophylaxis, an investigator contends.
Patients with small cell lung cancer (SCLC) had significantly higher rates of liver metastases than patients with non–small cell lung cancer (NSCLC), while patients with NSCLC had significantly higher rates of metastases to bone, reported Mohamed Hendawi, MD, a visiting scholar at the Ohio State University Medical Center in Columbus.
“Predictors for liver metastasis were small cell and adenocarcinoma histology, lower and upper lobe locations, and high grade tumors. Predictors for metastasis to brain were advanced age at diagnosis, adenocarcinoma and small-cell histology, lower lobe [and] main bronchus locations, and high grade tumors,” he wrote in a scientific poster presented at the European Lung Cancer Conference.
Dr. Hendawi drew records on all patients with metastatic lung cancer included in the 2010-2013 Surveillance, Epidemiology, and End Results database. He used univariate and multivariate logistic regression models to evaluate predictors of metastasis.
The data set included a total of 76,254 patients with metastatic lung cancer, of which 17% were SCLC and 83% were NSCLC tumors. In 54% of patients, the primary tumor was in the right lung; in 38%, it was in the left lung; and, in 8% of patients, the primary tumor was bilateral.
The rates of metastases to bone were high in both major lung cancer types but, as noted before, were significantly higher in patients with NSCLC: 37% compared with 34% for patients with SCLC (P less than .001).
In contrast, the incidence of liver metastases in SCLC was more than double that of NSCLC: 46% vs. 20%, respectively (P less than .001). There were slightly, but significantly, fewer cases of brain metastases at the time of diagnosis among patients with SCLC: 25% vs. 26% (P = .003).
Histologic subtypes significantly associated with both brain and liver metastases were, in descending order, adenocarcinomas, small cell, and squamous cell cancers.
Although carcinoid lung cancers accounted for only 2.1% of all tumors, they were associated with a high rate of metastasis to brain at diagnosis (44.8%).
As noted, independent risk factors for liver metastasis were small cell and adenocarcinoma histologies (P less than .001), tumors in the upper lobe (P = .028), and high-grade tumor (P less than .001).
Independent predictors for brain metastases were advanced age at diagnosis (P less than .001), adenocarcinoma and small-cell histologies (P less than .001), lower lobe or main bronchus locations (P = .004), and higher-grade tumors (P less than .001).
In a poster discussion session, Paolo Boffetta, MD, MPH, from the Icahn School of Medicine at Mount Sinai in New York City, the invited discussant, commented that, while he thought that the data were interesting, “the main issue I had with this poster is that it’s limited to patients with metastasis, so we cannot really evaluate the risk of metastasis according to the different histological types and the absolute risk of developing metastases in one or the other organ but only the relative risk of developing metastasis in one organ versus the other having one or the other histology.”
“So, we really don’t know whether the risk is increased in one group or decreased in the other one that generates these differences,” he said.
The study did not receive outside support. Dr. Hendawi declared no conflicts of interest.
GENEVA – A review of data on more than 75,000 patients with lung cancer has revealed distinct patterns of metastasis according to subtype, a finding that could help in surveillance, treatment planning, and prophylaxis, an investigator contends.
Patients with small cell lung cancer (SCLC) had significantly higher rates of liver metastases than patients with non–small cell lung cancer (NSCLC), while patients with NSCLC had significantly higher rates of metastases to bone, reported Mohamed Hendawi, MD, a visiting scholar at the Ohio State University Medical Center in Columbus.
“Predictors for liver metastasis were small cell and adenocarcinoma histology, lower and upper lobe locations, and high grade tumors. Predictors for metastasis to brain were advanced age at diagnosis, adenocarcinoma and small-cell histology, lower lobe [and] main bronchus locations, and high grade tumors,” he wrote in a scientific poster presented at the European Lung Cancer Conference.
Dr. Hendawi drew records on all patients with metastatic lung cancer included in the 2010-2013 Surveillance, Epidemiology, and End Results database. He used univariate and multivariate logistic regression models to evaluate predictors of metastasis.
The data set included a total of 76,254 patients with metastatic lung cancer, of which 17% were SCLC and 83% were NSCLC tumors. In 54% of patients, the primary tumor was in the right lung; in 38%, it was in the left lung; and, in 8% of patients, the primary tumor was bilateral.
The rates of metastases to bone were high in both major lung cancer types but, as noted before, were significantly higher in patients with NSCLC: 37% compared with 34% for patients with SCLC (P less than .001).
In contrast, the incidence of liver metastases in SCLC was more than double that of NSCLC: 46% vs. 20%, respectively (P less than .001). There were slightly, but significantly, fewer cases of brain metastases at the time of diagnosis among patients with SCLC: 25% vs. 26% (P = .003).
Histologic subtypes significantly associated with both brain and liver metastases were, in descending order, adenocarcinomas, small cell, and squamous cell cancers.
Although carcinoid lung cancers accounted for only 2.1% of all tumors, they were associated with a high rate of metastasis to brain at diagnosis (44.8%).
As noted, independent risk factors for liver metastasis were small cell and adenocarcinoma histologies (P less than .001), tumors in the upper lobe (P = .028), and high-grade tumor (P less than .001).
Independent predictors for brain metastases were advanced age at diagnosis (P less than .001), adenocarcinoma and small-cell histologies (P less than .001), lower lobe or main bronchus locations (P = .004), and higher-grade tumors (P less than .001).
In a poster discussion session, Paolo Boffetta, MD, MPH, from the Icahn School of Medicine at Mount Sinai in New York City, the invited discussant, commented that, while he thought that the data were interesting, “the main issue I had with this poster is that it’s limited to patients with metastasis, so we cannot really evaluate the risk of metastasis according to the different histological types and the absolute risk of developing metastases in one or the other organ but only the relative risk of developing metastasis in one organ versus the other having one or the other histology.”
“So, we really don’t know whether the risk is increased in one group or decreased in the other one that generates these differences,” he said.
The study did not receive outside support. Dr. Hendawi declared no conflicts of interest.
FROM ELCC
Key clinical point: Lung cancers tend to metastasize to different organs based on histology and other clinical factors.
Major finding: The incidence of metastasis to bone was higher in patients with NSCLC than SCLC, while liver metastases were more than twice as high among patients with SCLC.
Data source: Review of Surveillance, Epidemiology, and End Results data on 76,254 patients with metastatic lung cancer.
Disclosures: The study did not receive outside support. Dr. Hendawi declared no conflicts of interest.
It Pays to Get Screened for Colon Cancer
Although cancer death rates have been decreasing for the general population, they’ve been increasing for American Indians, according to the American Indian Cancer Foundation (AICAF). The AICAF cites a number of barriers to prevention and care, such as low awareness of risks, distrust of medical systems and research, health beliefs that may conflict with prevention practices, and low awareness of screening options.
The Northern Plains region has some of the highest rates of cancer diagnoses and death in the U.S. Colon cancer, for example, is 53% higher in Northern Plains American Indians, AICAF says. Although screening rates are improving, fewer than half of Northern Plains American Indians aged ≥ 50 years have had a colorectal cancer screening, according to the Association of American Indian Physicians.
The cancer mortality rates are the result of a “complex set of factors” that the AICAF is beginning to address with a comprehensive set of approaches. For instance, in addition to educating the public, AICAF, in partnership with the Minnesota Department of Health and Get Your Rear in Gear Colon Cancer Coalition is putting money where its mouth is, with the “Refer-a-Relative” program.
“We are all related,” the campaign says: “Help your community and end colon cancer!” Refer-a-Relative encourages Native Americans in the Minneapolis-St. Paul metropolitan area to get screened, and then to refer up to 5 relatives aged ≥ 50 years for screening. Patients receive a $20 gift card for completing screening, and $10 for each relative who completes screening. The relatives receive a $20 gift card and can refer more people.
The screening project is 1 branch of the AICAF’s interest in innovating clinical systems at IHS, Tribal, and Urban (ITU) clinics. Much of the work is based on the Improving Northern Plains American Indian Colorectal Cancer Screening (INPACS) project with ITU clinics. The AICAF invites interested ITU clinics to join the Clinical Cancer Screening Network. For more information, infographics, and other patient education materials, visit www.americanindiancancer.org.
Although cancer death rates have been decreasing for the general population, they’ve been increasing for American Indians, according to the American Indian Cancer Foundation (AICAF). The AICAF cites a number of barriers to prevention and care, such as low awareness of risks, distrust of medical systems and research, health beliefs that may conflict with prevention practices, and low awareness of screening options.
The Northern Plains region has some of the highest rates of cancer diagnoses and death in the U.S. Colon cancer, for example, is 53% higher in Northern Plains American Indians, AICAF says. Although screening rates are improving, fewer than half of Northern Plains American Indians aged ≥ 50 years have had a colorectal cancer screening, according to the Association of American Indian Physicians.
The cancer mortality rates are the result of a “complex set of factors” that the AICAF is beginning to address with a comprehensive set of approaches. For instance, in addition to educating the public, AICAF, in partnership with the Minnesota Department of Health and Get Your Rear in Gear Colon Cancer Coalition is putting money where its mouth is, with the “Refer-a-Relative” program.
“We are all related,” the campaign says: “Help your community and end colon cancer!” Refer-a-Relative encourages Native Americans in the Minneapolis-St. Paul metropolitan area to get screened, and then to refer up to 5 relatives aged ≥ 50 years for screening. Patients receive a $20 gift card for completing screening, and $10 for each relative who completes screening. The relatives receive a $20 gift card and can refer more people.
The screening project is 1 branch of the AICAF’s interest in innovating clinical systems at IHS, Tribal, and Urban (ITU) clinics. Much of the work is based on the Improving Northern Plains American Indian Colorectal Cancer Screening (INPACS) project with ITU clinics. The AICAF invites interested ITU clinics to join the Clinical Cancer Screening Network. For more information, infographics, and other patient education materials, visit www.americanindiancancer.org.
Although cancer death rates have been decreasing for the general population, they’ve been increasing for American Indians, according to the American Indian Cancer Foundation (AICAF). The AICAF cites a number of barriers to prevention and care, such as low awareness of risks, distrust of medical systems and research, health beliefs that may conflict with prevention practices, and low awareness of screening options.
The Northern Plains region has some of the highest rates of cancer diagnoses and death in the U.S. Colon cancer, for example, is 53% higher in Northern Plains American Indians, AICAF says. Although screening rates are improving, fewer than half of Northern Plains American Indians aged ≥ 50 years have had a colorectal cancer screening, according to the Association of American Indian Physicians.
The cancer mortality rates are the result of a “complex set of factors” that the AICAF is beginning to address with a comprehensive set of approaches. For instance, in addition to educating the public, AICAF, in partnership with the Minnesota Department of Health and Get Your Rear in Gear Colon Cancer Coalition is putting money where its mouth is, with the “Refer-a-Relative” program.
“We are all related,” the campaign says: “Help your community and end colon cancer!” Refer-a-Relative encourages Native Americans in the Minneapolis-St. Paul metropolitan area to get screened, and then to refer up to 5 relatives aged ≥ 50 years for screening. Patients receive a $20 gift card for completing screening, and $10 for each relative who completes screening. The relatives receive a $20 gift card and can refer more people.
The screening project is 1 branch of the AICAF’s interest in innovating clinical systems at IHS, Tribal, and Urban (ITU) clinics. Much of the work is based on the Improving Northern Plains American Indian Colorectal Cancer Screening (INPACS) project with ITU clinics. The AICAF invites interested ITU clinics to join the Clinical Cancer Screening Network. For more information, infographics, and other patient education materials, visit www.americanindiancancer.org.
G-CSF safe, but antibiotics are more concerning in SCLC
GENEVA – In patients with limited stage–small cell lung cancer (LS-SCLC) treated with concurrent chemotherapy and radiation, the use of antibiotics to prevent febrile neutropenia was associated with worse outcomes, but granulocyte-colony stimulating factor (G-CSF) prescribed for the same purposes appeared to be safe, reported investigators.
In a subanalysis of data on patients with early SCLC enrolled in the phase III CONVERT trial comparing chemotherapy with concurrent once-daily vs. twice-daily radiation, the use of antibiotic prophylaxis of neutropenia was associated with worse overall survival (OS) and progression-free survival, (PFS) compared with no antibiotics, reported Fabio Gomes, MD, from the Christie NHS Foundation Trust Hospital in Manchester, England.
The use of G-CSF was, however, associated with higher rates of grade 3 or 4 thrombocytopenia and anemia, requiring supportive measures, he acknowledged.
The role of G-CSF with concurrent thoracic radiotherapy is controversial because of safety concerns, but data are scarce, Dr. Gomes said. He noted that the American Society of Clinical Oncology guidelines on the use of white blood cell growth factors recommend against their routine use.
However, some of those concerns arose in the mid-1990s when granulocyt macrophage–stimulating colony factor (GM-CSF) was used, rather than G-CSF, which acts on only a single blood lineage, namely neutrophils. Additionally, modern radiology techniques are more precise than they were 20 years ago, reducing the risk of toxicity, he noted.
In the CONVERT trial, 547 patients with LS-SCLC were randomly assigned to receive four to six cycles of cisplatin and etoposide chemotherapy concurrently with either once daily thoracic radiation for a total dose of 66 Gy divided into 33 fractions delivered over 45 days or to twice-daily radiation at a total dose of 45 Gy divided into 30 fractions delivered over 19 days.
There was no difference between the groups in the primary endpoint of overall survival.
In the subanalysis reported here, Gomes et al. looked at the use of G-CSF, delivered at the investigator’s discretion, in 487 patients. Approximately 40% of patients in the subanalysis received G-CSF during at least one treatment cycle.
Prophylactic antibiotics were recommended by the investigators for use in association with at least one chemotherapy cycle, and 49% of patients in the subanalysis received them during at least one cycle.
Hematological toxicities included grade 3 or 4 thrombocytopenia occurring in 29.9% of patients who received G-CSF, vs. 13.3% of those who did not (P less than .001). The rates were similar between the once-daily and twice-daily radiation groups.
Grade 3 or 4 anemia occurred in 16.9% of patients who received G-CSF, vs. 10.7% of those who didn’t (P = .027). The difference was significant only among patients in the twice-daily radiation arm (20.9% vs. 8.3%, respectively; P = .004).
Patients in the twice-daily radiation arms who received G-CSF also required more platelet transfusion, compared with the once-daily arm (P less than .001), and, in both arms, G-CSF was associated with more red-cell transfusions (P = .007 for once-daily and .001 for twice daily).
G-CSF was not associated with either pneumonitis or esophagitis, and there were no differences in treatment-related deaths with either G-CSF or antibiotics.
Median OS by G-CSF use was 29 months with and 27 months without, a difference that was not significant (P = .08). Median PFS also did not differ by G-CSF use or nonuse.
When it came to antibiotic prophylaxis, however, both median OS and PFS were significant worse with antibiotic use (OS, 24 months with vs. 33 months without; P = .016; PFS, P = .03).
“We are very reassured that there are no significant additional toxicities [with G-CSF] from radiation in the acute setting,” commented Sanjay Popat, FRCP, PhD, from the Royal Marsden Hospital in London, the invited discussant.
“However, we have no data as yet on the impact of G-CSF usage on febrile neutropenia, which is of course the fundamental that we’re aiming to improve in the hope that this will contribute to [lowering] costs,” he added.
The study was sponsored by the Christie Hospital National Health Service Foundation Trust, Cancer Research UK, EORTC, GECP, GFPC, and IFCT. Dr. Gomes reported no relevant disclosures. Dr. Popat reported consultation, honoraria, travel expenses, and institutional research from multiple entities.
GENEVA – In patients with limited stage–small cell lung cancer (LS-SCLC) treated with concurrent chemotherapy and radiation, the use of antibiotics to prevent febrile neutropenia was associated with worse outcomes, but granulocyte-colony stimulating factor (G-CSF) prescribed for the same purposes appeared to be safe, reported investigators.
In a subanalysis of data on patients with early SCLC enrolled in the phase III CONVERT trial comparing chemotherapy with concurrent once-daily vs. twice-daily radiation, the use of antibiotic prophylaxis of neutropenia was associated with worse overall survival (OS) and progression-free survival, (PFS) compared with no antibiotics, reported Fabio Gomes, MD, from the Christie NHS Foundation Trust Hospital in Manchester, England.
The use of G-CSF was, however, associated with higher rates of grade 3 or 4 thrombocytopenia and anemia, requiring supportive measures, he acknowledged.
The role of G-CSF with concurrent thoracic radiotherapy is controversial because of safety concerns, but data are scarce, Dr. Gomes said. He noted that the American Society of Clinical Oncology guidelines on the use of white blood cell growth factors recommend against their routine use.
However, some of those concerns arose in the mid-1990s when granulocyt macrophage–stimulating colony factor (GM-CSF) was used, rather than G-CSF, which acts on only a single blood lineage, namely neutrophils. Additionally, modern radiology techniques are more precise than they were 20 years ago, reducing the risk of toxicity, he noted.
In the CONVERT trial, 547 patients with LS-SCLC were randomly assigned to receive four to six cycles of cisplatin and etoposide chemotherapy concurrently with either once daily thoracic radiation for a total dose of 66 Gy divided into 33 fractions delivered over 45 days or to twice-daily radiation at a total dose of 45 Gy divided into 30 fractions delivered over 19 days.
There was no difference between the groups in the primary endpoint of overall survival.
In the subanalysis reported here, Gomes et al. looked at the use of G-CSF, delivered at the investigator’s discretion, in 487 patients. Approximately 40% of patients in the subanalysis received G-CSF during at least one treatment cycle.
Prophylactic antibiotics were recommended by the investigators for use in association with at least one chemotherapy cycle, and 49% of patients in the subanalysis received them during at least one cycle.
Hematological toxicities included grade 3 or 4 thrombocytopenia occurring in 29.9% of patients who received G-CSF, vs. 13.3% of those who did not (P less than .001). The rates were similar between the once-daily and twice-daily radiation groups.
Grade 3 or 4 anemia occurred in 16.9% of patients who received G-CSF, vs. 10.7% of those who didn’t (P = .027). The difference was significant only among patients in the twice-daily radiation arm (20.9% vs. 8.3%, respectively; P = .004).
Patients in the twice-daily radiation arms who received G-CSF also required more platelet transfusion, compared with the once-daily arm (P less than .001), and, in both arms, G-CSF was associated with more red-cell transfusions (P = .007 for once-daily and .001 for twice daily).
G-CSF was not associated with either pneumonitis or esophagitis, and there were no differences in treatment-related deaths with either G-CSF or antibiotics.
Median OS by G-CSF use was 29 months with and 27 months without, a difference that was not significant (P = .08). Median PFS also did not differ by G-CSF use or nonuse.
When it came to antibiotic prophylaxis, however, both median OS and PFS were significant worse with antibiotic use (OS, 24 months with vs. 33 months without; P = .016; PFS, P = .03).
“We are very reassured that there are no significant additional toxicities [with G-CSF] from radiation in the acute setting,” commented Sanjay Popat, FRCP, PhD, from the Royal Marsden Hospital in London, the invited discussant.
“However, we have no data as yet on the impact of G-CSF usage on febrile neutropenia, which is of course the fundamental that we’re aiming to improve in the hope that this will contribute to [lowering] costs,” he added.
The study was sponsored by the Christie Hospital National Health Service Foundation Trust, Cancer Research UK, EORTC, GECP, GFPC, and IFCT. Dr. Gomes reported no relevant disclosures. Dr. Popat reported consultation, honoraria, travel expenses, and institutional research from multiple entities.
GENEVA – In patients with limited stage–small cell lung cancer (LS-SCLC) treated with concurrent chemotherapy and radiation, the use of antibiotics to prevent febrile neutropenia was associated with worse outcomes, but granulocyte-colony stimulating factor (G-CSF) prescribed for the same purposes appeared to be safe, reported investigators.
In a subanalysis of data on patients with early SCLC enrolled in the phase III CONVERT trial comparing chemotherapy with concurrent once-daily vs. twice-daily radiation, the use of antibiotic prophylaxis of neutropenia was associated with worse overall survival (OS) and progression-free survival, (PFS) compared with no antibiotics, reported Fabio Gomes, MD, from the Christie NHS Foundation Trust Hospital in Manchester, England.
The use of G-CSF was, however, associated with higher rates of grade 3 or 4 thrombocytopenia and anemia, requiring supportive measures, he acknowledged.
The role of G-CSF with concurrent thoracic radiotherapy is controversial because of safety concerns, but data are scarce, Dr. Gomes said. He noted that the American Society of Clinical Oncology guidelines on the use of white blood cell growth factors recommend against their routine use.
However, some of those concerns arose in the mid-1990s when granulocyt macrophage–stimulating colony factor (GM-CSF) was used, rather than G-CSF, which acts on only a single blood lineage, namely neutrophils. Additionally, modern radiology techniques are more precise than they were 20 years ago, reducing the risk of toxicity, he noted.
In the CONVERT trial, 547 patients with LS-SCLC were randomly assigned to receive four to six cycles of cisplatin and etoposide chemotherapy concurrently with either once daily thoracic radiation for a total dose of 66 Gy divided into 33 fractions delivered over 45 days or to twice-daily radiation at a total dose of 45 Gy divided into 30 fractions delivered over 19 days.
There was no difference between the groups in the primary endpoint of overall survival.
In the subanalysis reported here, Gomes et al. looked at the use of G-CSF, delivered at the investigator’s discretion, in 487 patients. Approximately 40% of patients in the subanalysis received G-CSF during at least one treatment cycle.
Prophylactic antibiotics were recommended by the investigators for use in association with at least one chemotherapy cycle, and 49% of patients in the subanalysis received them during at least one cycle.
Hematological toxicities included grade 3 or 4 thrombocytopenia occurring in 29.9% of patients who received G-CSF, vs. 13.3% of those who did not (P less than .001). The rates were similar between the once-daily and twice-daily radiation groups.
Grade 3 or 4 anemia occurred in 16.9% of patients who received G-CSF, vs. 10.7% of those who didn’t (P = .027). The difference was significant only among patients in the twice-daily radiation arm (20.9% vs. 8.3%, respectively; P = .004).
Patients in the twice-daily radiation arms who received G-CSF also required more platelet transfusion, compared with the once-daily arm (P less than .001), and, in both arms, G-CSF was associated with more red-cell transfusions (P = .007 for once-daily and .001 for twice daily).
G-CSF was not associated with either pneumonitis or esophagitis, and there were no differences in treatment-related deaths with either G-CSF or antibiotics.
Median OS by G-CSF use was 29 months with and 27 months without, a difference that was not significant (P = .08). Median PFS also did not differ by G-CSF use or nonuse.
When it came to antibiotic prophylaxis, however, both median OS and PFS were significant worse with antibiotic use (OS, 24 months with vs. 33 months without; P = .016; PFS, P = .03).
“We are very reassured that there are no significant additional toxicities [with G-CSF] from radiation in the acute setting,” commented Sanjay Popat, FRCP, PhD, from the Royal Marsden Hospital in London, the invited discussant.
“However, we have no data as yet on the impact of G-CSF usage on febrile neutropenia, which is of course the fundamental that we’re aiming to improve in the hope that this will contribute to [lowering] costs,” he added.
The study was sponsored by the Christie Hospital National Health Service Foundation Trust, Cancer Research UK, EORTC, GECP, GFPC, and IFCT. Dr. Gomes reported no relevant disclosures. Dr. Popat reported consultation, honoraria, travel expenses, and institutional research from multiple entities.
FROM ELCC
Key clinical point: Febrile neutropenia prophylaxis with G-CSF was safe, but prophylactic antibiotics were associated with worse overall survival in patients with limited stage–small cell lung cancer.
Major finding: Both median overall and progression-free survival were lower among patients who received prophylactic antibiotics. There were no differences in survival by G-CSF use.
Data source: Subanalysis of data on 487 patients in the phase III CONVERT trial comparing once-daily and twice daily radiation concurrent with chemotherapy in LS-SCLC.
Disclosures: The study was sponsored by the Christie Hospital National Health Service Foundation Trust, Cancer Research UK, EORTC, GECP, GFPC, and IFCT. Dr. Gomes reported no relevant disclosures. Dr. Popat reported consultation, honoraria, travel expenses, and institutional research from multiple entities.
