General Thoracic

Less than one-third of smokers hospitalized for myocardial infarction receive any kind of smoking cessation therapy during their stay in hospital, according to a poster presented at the annual meeting of the American College of Cardiology.

“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.

Brett Mulcahy/ThinkStock

Less than one-third of smokers hospitalized for myocardial infarction receive any kind of smoking cessation therapy during their stay in hospital, according to a poster presented at the annual meeting of the American College of Cardiology.

“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.

Brett Mulcahy/ThinkStock

Less than one-third of smokers hospitalized for myocardial infarction receive any kind of smoking cessation therapy during their stay in hospital, according to a poster presented at the annual meeting of the American College of Cardiology.

“Inpatient smoking cessation therapy coupled with outpatient follow-up can significantly improve long-term smoking cessation rates, but little is known about how often smoking cessation therapies are used among hospitalized patients,” wrote Dr Quinn R. Pack and coauthors from the Baystate Medical Center in Springfield, and Massachusetts General Hospital.

Brett Mulcahy/ThinkStock

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.

Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.

The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.

Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.

The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   

Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.

After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.

A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.

There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.

Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.

Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”

By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.

Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”

Neither the investigators nor the editorial writer had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.

The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.

Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.

The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   

Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.

After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.

A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.

There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.

Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.

Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”

By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.

Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”

Neither the investigators nor the editorial writer had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.

The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.

Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.

The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   

Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.

After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.

A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.

There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.

Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.

Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”

By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.

Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”

Neither the investigators nor the editorial writer had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

Osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor selective for both EGFR and T790M mutations that render cancers resistant to EGFR-TKIs, yielded a high overall response rate, “encouraging” progression-free survival, and a durable treatment response in advanced non–small cell lung cancer (NSCLC) that had progressed despite EGFR-TKI therapy, according to a report published online Feb. 21 in the Journal of Clinical Oncology.

In a manufacturer-sponsored, open-label phase II trial, 198 patients in 10 countries took 80 mg of oral osimertinib once daily for a median duration of 13.2 months (range, 1-18 months). The overall response rate was 62%, and the median duration of response was 15.2 months. The disease control rate was 90%, said James Chih-Hsin Yang, MD, PhD, of National Taiwan Hospital, Taipei, and his associates.

The median progression-free survival was 12.3 months, and the treatment benefit was generally consistent across all subgroups of patients regardless of age, smoking status, previous therapies, and duration of treatment. Questionnaire responses showed that patients “had consistent and sustained improvements in key lung cancer symptoms including dyspnea, cough, chest pain, and pain in the arm or shoulder,” as well as in global health status and physical functioning. This is particularly noteworthy because some patients had received “many (up to 11) lines of cancer therapy before osimertinib,” the investigators reported (J Clin Oncol. 2017 Feb 21. doi: 10.1200/jco.2016.70.3223).

“We also report encouraging systemic progression-free survival with osimertinib in patients with CNS metastases, and a high CNS response rate (64%) in those with measurable CNS lesions,” they wrote. This finding is particularly important “because new pharmacologic strategies are needed to treat brain metastases, given the long-term complications of brain radiation,” they added.

Osimertinib was generally well tolerated, with 21% of patients having adverse effects leading to dose interruptions and 5% to dose reductions. Nine patients (3%) discontinued the agent because of adverse effects, which included interstitial lung disease (3 fatal cases), QT prolongation, a reduced neutrophil count, and severe vomiting and diarrhea.

This trial was sponsored by AstraZeneca. Dr. Yang and his associates reported ties to numerous industry sources.

Osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor selective for both EGFR and T790M mutations that render cancers resistant to EGFR-TKIs, yielded a high overall response rate, “encouraging” progression-free survival, and a durable treatment response in advanced non–small cell lung cancer (NSCLC) that had progressed despite EGFR-TKI therapy, according to a report published online Feb. 21 in the Journal of Clinical Oncology.

In a manufacturer-sponsored, open-label phase II trial, 198 patients in 10 countries took 80 mg of oral osimertinib once daily for a median duration of 13.2 months (range, 1-18 months). The overall response rate was 62%, and the median duration of response was 15.2 months. The disease control rate was 90%, said James Chih-Hsin Yang, MD, PhD, of National Taiwan Hospital, Taipei, and his associates.

The median progression-free survival was 12.3 months, and the treatment benefit was generally consistent across all subgroups of patients regardless of age, smoking status, previous therapies, and duration of treatment. Questionnaire responses showed that patients “had consistent and sustained improvements in key lung cancer symptoms including dyspnea, cough, chest pain, and pain in the arm or shoulder,” as well as in global health status and physical functioning. This is particularly noteworthy because some patients had received “many (up to 11) lines of cancer therapy before osimertinib,” the investigators reported (J Clin Oncol. 2017 Feb 21. doi: 10.1200/jco.2016.70.3223).

“We also report encouraging systemic progression-free survival with osimertinib in patients with CNS metastases, and a high CNS response rate (64%) in those with measurable CNS lesions,” they wrote. This finding is particularly important “because new pharmacologic strategies are needed to treat brain metastases, given the long-term complications of brain radiation,” they added.

Osimertinib was generally well tolerated, with 21% of patients having adverse effects leading to dose interruptions and 5% to dose reductions. Nine patients (3%) discontinued the agent because of adverse effects, which included interstitial lung disease (3 fatal cases), QT prolongation, a reduced neutrophil count, and severe vomiting and diarrhea.

This trial was sponsored by AstraZeneca. Dr. Yang and his associates reported ties to numerous industry sources.

Osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor selective for both EGFR and T790M mutations that render cancers resistant to EGFR-TKIs, yielded a high overall response rate, “encouraging” progression-free survival, and a durable treatment response in advanced non–small cell lung cancer (NSCLC) that had progressed despite EGFR-TKI therapy, according to a report published online Feb. 21 in the Journal of Clinical Oncology.

In a manufacturer-sponsored, open-label phase II trial, 198 patients in 10 countries took 80 mg of oral osimertinib once daily for a median duration of 13.2 months (range, 1-18 months). The overall response rate was 62%, and the median duration of response was 15.2 months. The disease control rate was 90%, said James Chih-Hsin Yang, MD, PhD, of National Taiwan Hospital, Taipei, and his associates.

The median progression-free survival was 12.3 months, and the treatment benefit was generally consistent across all subgroups of patients regardless of age, smoking status, previous therapies, and duration of treatment. Questionnaire responses showed that patients “had consistent and sustained improvements in key lung cancer symptoms including dyspnea, cough, chest pain, and pain in the arm or shoulder,” as well as in global health status and physical functioning. This is particularly noteworthy because some patients had received “many (up to 11) lines of cancer therapy before osimertinib,” the investigators reported (J Clin Oncol. 2017 Feb 21. doi: 10.1200/jco.2016.70.3223).

“We also report encouraging systemic progression-free survival with osimertinib in patients with CNS metastases, and a high CNS response rate (64%) in those with measurable CNS lesions,” they wrote. This finding is particularly important “because new pharmacologic strategies are needed to treat brain metastases, given the long-term complications of brain radiation,” they added.

Osimertinib was generally well tolerated, with 21% of patients having adverse effects leading to dose interruptions and 5% to dose reductions. Nine patients (3%) discontinued the agent because of adverse effects, which included interstitial lung disease (3 fatal cases), QT prolongation, a reduced neutrophil count, and severe vomiting and diarrhea.

This trial was sponsored by AstraZeneca. Dr. Yang and his associates reported ties to numerous industry sources.

The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.

“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).

The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.

The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.

Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).

Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.

For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).

While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.

One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.

Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.

The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.

“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).

The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.

The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.

Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).

Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.

For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).

While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.

One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.

Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.

The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.

“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).

The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.

The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.

Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).

Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.

For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).

While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.

One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.

Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]