TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.

This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).

“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.

Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). The panel raised the upper age limit to 77 years of age to coincide with what Medicare covers, Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.

The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.

The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.

The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCO_M2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).

“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.

The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.

People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.

In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.

The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”

[email protected]

On Twitter @mitchelzoler

TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.

This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).

“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.

Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). The panel raised the upper age limit to 77 years of age to coincide with what Medicare covers, Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.

The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.

The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.

The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCO_M2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).

“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.

The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.

People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.

In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.

The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”

[email protected]

On Twitter @mitchelzoler

TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.

This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).

“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.

Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). The panel raised the upper age limit to 77 years of age to coincide with what Medicare covers, Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.

The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.

The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.

The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCO_M2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).

“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.

The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.

People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.

In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.

The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”

[email protected]

On Twitter @mitchelzoler

Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

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The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

[email protected]

The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets