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Chicago Multidisciplinary Symposium in Thoracic Oncology
Nivolumab monotherapy reaches advanced squamous NSCLC
CHICAGO – Nivolumab monotherapy resulted in a median overall survival of 8.2 months and a 1-year survival rate of 41% in advanced, heavily pretreated squamous cell non–small cell lung cancer in a phase II study.
Advanced, treatment-refractory squamous cell non–small cell lung cancer (NSCLC) is an area of high unmet need with no effective therapeutic options and this cohort was “truly” treatment refractory, study author Dr. Suresh Ramalingam said at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
Of the 117 patients, 65% had received at least three prior systemic regimens, 61% had progressive disease as their best response to the most recent therapy, and 76% came into the study within 3 months of completing their most recent therapy.
The patients had stage IIIB/IV disease and were given nivolumab 3 mg/kg IV every 2 weeks until progressive disease or unacceptable toxicity. Their median age was 65 years (range 37-87 years).
The study’s primary end point of objective response rate by independent radiology review was 15% (17/117 patients), including eight confirmed partial responses in patients with rapid progression on prior therapy, Dr. Ramalingam, director of medical oncology and the lung cancer program, Winship Cancer Institute of Emory University, Atlanta, said.
The median duration of response has not been reached and 76% of responses are ongoing. In all, 24% of patients received subsequent therapy, excluding subsequent immunotherapy.
Median progression-free survival (PFS) was 2 months and the 1-year PFS rate was 20%, he said.
An exploratory biomarker analysis of 76 evaluable samples showed nivolumab was clinically active in patients whose tumors were positive as well as negative for programmed death-ligand 1 expression.
Dr. Ramalingam highlighted a 73-year-old former smoker with stage IIIB disease and active brain metastasis at study entry who had stable disease after treatment with nivolumab that was ongoing at 68 weeks including a response in his brain lesions, despite having no prior central nervous system-directed therapy, and failing prior radiotherapy and three prior systemic regimens (cisplatin[Platinol]/gemcitabine [Gemzar], docetaxel [Taxotere], and vinorelbine [Navelbine]).
Overall, nivolumab was well tolerated, as shown by the fact that 85% of patients received at least 90% of their planned dose intensity, he said.
The safety profile was consistent with prior nivolumab studies, with 12% of patients discontinuing treatment because of toxicity. Two treatment-related deaths (one hypoxic pneumonia and one ischemic stroke) occurred in patients with multiple comorbidities and concurrent progressive disease.
A poster also presented at the meeting (Ab. 170, Gettinger, S.N., et al.) showed an objective response rate of 17% among 54 treatment-refractory patients given second-line or later nivolumab 1 mg/kg, 3 mg/kg, or 10 mg/kg every 2 weeks for squamous cell NSCLC, among other solid tumors. The median PFS was 3.8 months, 1-year PFS 27%, median overall survival 9.2 months, and 1-year overall survival 41%.
A phase III trial is also ongoing comparing overall survival of nivolumab vs. docetaxel in advanced squamous cell NSCLC after failure of prior platinum-based chemotherapy, Dr. Ramalingam said.
CHICAGO – Nivolumab monotherapy resulted in a median overall survival of 8.2 months and a 1-year survival rate of 41% in advanced, heavily pretreated squamous cell non–small cell lung cancer in a phase II study.
Advanced, treatment-refractory squamous cell non–small cell lung cancer (NSCLC) is an area of high unmet need with no effective therapeutic options and this cohort was “truly” treatment refractory, study author Dr. Suresh Ramalingam said at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
Of the 117 patients, 65% had received at least three prior systemic regimens, 61% had progressive disease as their best response to the most recent therapy, and 76% came into the study within 3 months of completing their most recent therapy.
The patients had stage IIIB/IV disease and were given nivolumab 3 mg/kg IV every 2 weeks until progressive disease or unacceptable toxicity. Their median age was 65 years (range 37-87 years).
The study’s primary end point of objective response rate by independent radiology review was 15% (17/117 patients), including eight confirmed partial responses in patients with rapid progression on prior therapy, Dr. Ramalingam, director of medical oncology and the lung cancer program, Winship Cancer Institute of Emory University, Atlanta, said.
The median duration of response has not been reached and 76% of responses are ongoing. In all, 24% of patients received subsequent therapy, excluding subsequent immunotherapy.
Median progression-free survival (PFS) was 2 months and the 1-year PFS rate was 20%, he said.
An exploratory biomarker analysis of 76 evaluable samples showed nivolumab was clinically active in patients whose tumors were positive as well as negative for programmed death-ligand 1 expression.
Dr. Ramalingam highlighted a 73-year-old former smoker with stage IIIB disease and active brain metastasis at study entry who had stable disease after treatment with nivolumab that was ongoing at 68 weeks including a response in his brain lesions, despite having no prior central nervous system-directed therapy, and failing prior radiotherapy and three prior systemic regimens (cisplatin[Platinol]/gemcitabine [Gemzar], docetaxel [Taxotere], and vinorelbine [Navelbine]).
Overall, nivolumab was well tolerated, as shown by the fact that 85% of patients received at least 90% of their planned dose intensity, he said.
The safety profile was consistent with prior nivolumab studies, with 12% of patients discontinuing treatment because of toxicity. Two treatment-related deaths (one hypoxic pneumonia and one ischemic stroke) occurred in patients with multiple comorbidities and concurrent progressive disease.
A poster also presented at the meeting (Ab. 170, Gettinger, S.N., et al.) showed an objective response rate of 17% among 54 treatment-refractory patients given second-line or later nivolumab 1 mg/kg, 3 mg/kg, or 10 mg/kg every 2 weeks for squamous cell NSCLC, among other solid tumors. The median PFS was 3.8 months, 1-year PFS 27%, median overall survival 9.2 months, and 1-year overall survival 41%.
A phase III trial is also ongoing comparing overall survival of nivolumab vs. docetaxel in advanced squamous cell NSCLC after failure of prior platinum-based chemotherapy, Dr. Ramalingam said.
CHICAGO – Nivolumab monotherapy resulted in a median overall survival of 8.2 months and a 1-year survival rate of 41% in advanced, heavily pretreated squamous cell non–small cell lung cancer in a phase II study.
Advanced, treatment-refractory squamous cell non–small cell lung cancer (NSCLC) is an area of high unmet need with no effective therapeutic options and this cohort was “truly” treatment refractory, study author Dr. Suresh Ramalingam said at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
Of the 117 patients, 65% had received at least three prior systemic regimens, 61% had progressive disease as their best response to the most recent therapy, and 76% came into the study within 3 months of completing their most recent therapy.
The patients had stage IIIB/IV disease and were given nivolumab 3 mg/kg IV every 2 weeks until progressive disease or unacceptable toxicity. Their median age was 65 years (range 37-87 years).
The study’s primary end point of objective response rate by independent radiology review was 15% (17/117 patients), including eight confirmed partial responses in patients with rapid progression on prior therapy, Dr. Ramalingam, director of medical oncology and the lung cancer program, Winship Cancer Institute of Emory University, Atlanta, said.
The median duration of response has not been reached and 76% of responses are ongoing. In all, 24% of patients received subsequent therapy, excluding subsequent immunotherapy.
Median progression-free survival (PFS) was 2 months and the 1-year PFS rate was 20%, he said.
An exploratory biomarker analysis of 76 evaluable samples showed nivolumab was clinically active in patients whose tumors were positive as well as negative for programmed death-ligand 1 expression.
Dr. Ramalingam highlighted a 73-year-old former smoker with stage IIIB disease and active brain metastasis at study entry who had stable disease after treatment with nivolumab that was ongoing at 68 weeks including a response in his brain lesions, despite having no prior central nervous system-directed therapy, and failing prior radiotherapy and three prior systemic regimens (cisplatin[Platinol]/gemcitabine [Gemzar], docetaxel [Taxotere], and vinorelbine [Navelbine]).
Overall, nivolumab was well tolerated, as shown by the fact that 85% of patients received at least 90% of their planned dose intensity, he said.
The safety profile was consistent with prior nivolumab studies, with 12% of patients discontinuing treatment because of toxicity. Two treatment-related deaths (one hypoxic pneumonia and one ischemic stroke) occurred in patients with multiple comorbidities and concurrent progressive disease.
A poster also presented at the meeting (Ab. 170, Gettinger, S.N., et al.) showed an objective response rate of 17% among 54 treatment-refractory patients given second-line or later nivolumab 1 mg/kg, 3 mg/kg, or 10 mg/kg every 2 weeks for squamous cell NSCLC, among other solid tumors. The median PFS was 3.8 months, 1-year PFS 27%, median overall survival 9.2 months, and 1-year overall survival 41%.
A phase III trial is also ongoing comparing overall survival of nivolumab vs. docetaxel in advanced squamous cell NSCLC after failure of prior platinum-based chemotherapy, Dr. Ramalingam said.
FROM A THORACIC ONCOLOGY SYMPOSIUM
Key clinical point: Nivolumab monotherapy shows clinically meaningful efficacy in patients with advanced, heavily pretreated squamous cell NSCLC, an area of high unmet need.
Major finding: Median overall survival was 8.2 months and 1-year survival was 41%.
Data source: Phase II study in 117 patients with advanced, treatment-refractory squamous cell NSCLC.
Disclosures: The study was sponsored by Bristol-Myers Squibb and Ono Pharmaceuticals, developers of nivolumab. Dr. Ramalingam reported research funding from Bristol-Myers Squibb and a consultant/advisory relationship with Amgen, AstraZeneca, Aveo, Boehringer Ingelheim, Celgene, Genentech, Lilly, and Novartis.
Biopsy remains most costly lung cancer diagnosis tool
CHICAGO – Biopsies performed in patients ultimately not diagnosed with lung cancer accounted for 43% of the $38.3 million spent in lung cancer diagnostic costs in a Medicare analysis.
“We need to develop more precise risk stratification tools to better identify patients who require referrals for lung biopsy. This has the potential to reduce costs and improve patient outcomes,” study author Tasneem Lokhandwala, Ph.D., said during a press briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. To estimate the use of diagnostic tests in lung cancer diagnosis and detection as well as the costs incurred by Medicare patients, Dr. Lokhandwala and her associates used a random 5% sample of Medicare patients from Jan. 1, 2009 through Dec. 31, 2011.
In all, 8,979 patients, aged 65-74 years, were identified with an abnormal computed tomography scan from July 1, 2009 through Dec. 31, 2010. Their mean age was 69.3 years, 43.6% were male, and 86.5% white.
The date of the patient’s abnormal CT scan was defined as the index date. Patients diagnosed with any cancer, pneumonia, atelectasis, or tuberculosis in the 6-month preindex period were excluded.
During the 12-month follow-up period, 14% of patients were diagnosed with lung cancer, with a median time to diagnosis from the abnormal chest CT of 11 days.
Diagnostic tests used were chest x-rays for 54.4%, chest CT scans for 33%, chest positron emission tomography scans for 0.5%, and lung biopsy for 19.4%, Dr. Lokhandwala, a data analyst at Xcenda, Palm Harbor, Fla., reported.
Importantly, the National Comprehensive Cancer Network guidelines call for low-dose chest CT followed by a PET scan to identify patients for biopsy.
In terms of financial costs, the average total cost of the diagnostic work-up was $7,567 for patients diagnosed with lung cancer and $3,558 for those without a lung cancer diagnosis.
For both groups, these costs rose dramatically with the use of biopsy to $8,341 and $22,127, respectively, Dr. Lokhandwala said.
Of the 1,744 patients who underwent a biopsy, 19.3% experienced a biopsy-related adverse event. An adverse event increased the average cost of a biopsy fourfold from $8,869 to $37,745, she said.
“Apart from the financial costs and the adverse events associated with tests and biopsies, there was also likely tremendous stress for those patients who ultimately were not found to have lung cancer,” press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
Dr. Gaspar agreed that the data highlight the need to better identify patients with lung cancer through the use of better imaging tests, follow-up CT or PET scans, or liquid biopsies.
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| Dr. Jennifer D. Cox |
Dr. Jennifer D. Cox, FCCP, comments: 43% of spending on lung cancer diagnosis is ultimately spent on those without lung cancer. Nearly 9000 patients were included in this study and ultimately 14 % of patients were diagnosed with lung cancer. The high rate of biopsy related complications, which occurred in nearly 20% of those patients biopsied, and the severe financial costs associated with the complications, emphasize the need for better screening practices and testing before sending patients to biopsy. As the current guidelines for screening that include low dose CT scan followed by PET CT before biopsy become more mainstream, hopefully these rates of complications and cost will go down.
Dr. Cox is a specialist in Critical Care, Lung Cancer at the Moffitt Cancer Center in Tampa, FL.
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| Dr. Jennifer D. Cox |
Dr. Jennifer D. Cox, FCCP, comments: 43% of spending on lung cancer diagnosis is ultimately spent on those without lung cancer. Nearly 9000 patients were included in this study and ultimately 14 % of patients were diagnosed with lung cancer. The high rate of biopsy related complications, which occurred in nearly 20% of those patients biopsied, and the severe financial costs associated with the complications, emphasize the need for better screening practices and testing before sending patients to biopsy. As the current guidelines for screening that include low dose CT scan followed by PET CT before biopsy become more mainstream, hopefully these rates of complications and cost will go down.
Dr. Cox is a specialist in Critical Care, Lung Cancer at the Moffitt Cancer Center in Tampa, FL.
|
| Dr. Jennifer D. Cox |
Dr. Jennifer D. Cox, FCCP, comments: 43% of spending on lung cancer diagnosis is ultimately spent on those without lung cancer. Nearly 9000 patients were included in this study and ultimately 14 % of patients were diagnosed with lung cancer. The high rate of biopsy related complications, which occurred in nearly 20% of those patients biopsied, and the severe financial costs associated with the complications, emphasize the need for better screening practices and testing before sending patients to biopsy. As the current guidelines for screening that include low dose CT scan followed by PET CT before biopsy become more mainstream, hopefully these rates of complications and cost will go down.
Dr. Cox is a specialist in Critical Care, Lung Cancer at the Moffitt Cancer Center in Tampa, FL.
CHICAGO – Biopsies performed in patients ultimately not diagnosed with lung cancer accounted for 43% of the $38.3 million spent in lung cancer diagnostic costs in a Medicare analysis.
“We need to develop more precise risk stratification tools to better identify patients who require referrals for lung biopsy. This has the potential to reduce costs and improve patient outcomes,” study author Tasneem Lokhandwala, Ph.D., said during a press briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. To estimate the use of diagnostic tests in lung cancer diagnosis and detection as well as the costs incurred by Medicare patients, Dr. Lokhandwala and her associates used a random 5% sample of Medicare patients from Jan. 1, 2009 through Dec. 31, 2011.
In all, 8,979 patients, aged 65-74 years, were identified with an abnormal computed tomography scan from July 1, 2009 through Dec. 31, 2010. Their mean age was 69.3 years, 43.6% were male, and 86.5% white.
The date of the patient’s abnormal CT scan was defined as the index date. Patients diagnosed with any cancer, pneumonia, atelectasis, or tuberculosis in the 6-month preindex period were excluded.
During the 12-month follow-up period, 14% of patients were diagnosed with lung cancer, with a median time to diagnosis from the abnormal chest CT of 11 days.
Diagnostic tests used were chest x-rays for 54.4%, chest CT scans for 33%, chest positron emission tomography scans for 0.5%, and lung biopsy for 19.4%, Dr. Lokhandwala, a data analyst at Xcenda, Palm Harbor, Fla., reported.
Importantly, the National Comprehensive Cancer Network guidelines call for low-dose chest CT followed by a PET scan to identify patients for biopsy.
In terms of financial costs, the average total cost of the diagnostic work-up was $7,567 for patients diagnosed with lung cancer and $3,558 for those without a lung cancer diagnosis.
For both groups, these costs rose dramatically with the use of biopsy to $8,341 and $22,127, respectively, Dr. Lokhandwala said.
Of the 1,744 patients who underwent a biopsy, 19.3% experienced a biopsy-related adverse event. An adverse event increased the average cost of a biopsy fourfold from $8,869 to $37,745, she said.
“Apart from the financial costs and the adverse events associated with tests and biopsies, there was also likely tremendous stress for those patients who ultimately were not found to have lung cancer,” press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
Dr. Gaspar agreed that the data highlight the need to better identify patients with lung cancer through the use of better imaging tests, follow-up CT or PET scans, or liquid biopsies.
CHICAGO – Biopsies performed in patients ultimately not diagnosed with lung cancer accounted for 43% of the $38.3 million spent in lung cancer diagnostic costs in a Medicare analysis.
“We need to develop more precise risk stratification tools to better identify patients who require referrals for lung biopsy. This has the potential to reduce costs and improve patient outcomes,” study author Tasneem Lokhandwala, Ph.D., said during a press briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. To estimate the use of diagnostic tests in lung cancer diagnosis and detection as well as the costs incurred by Medicare patients, Dr. Lokhandwala and her associates used a random 5% sample of Medicare patients from Jan. 1, 2009 through Dec. 31, 2011.
In all, 8,979 patients, aged 65-74 years, were identified with an abnormal computed tomography scan from July 1, 2009 through Dec. 31, 2010. Their mean age was 69.3 years, 43.6% were male, and 86.5% white.
The date of the patient’s abnormal CT scan was defined as the index date. Patients diagnosed with any cancer, pneumonia, atelectasis, or tuberculosis in the 6-month preindex period were excluded.
During the 12-month follow-up period, 14% of patients were diagnosed with lung cancer, with a median time to diagnosis from the abnormal chest CT of 11 days.
Diagnostic tests used were chest x-rays for 54.4%, chest CT scans for 33%, chest positron emission tomography scans for 0.5%, and lung biopsy for 19.4%, Dr. Lokhandwala, a data analyst at Xcenda, Palm Harbor, Fla., reported.
Importantly, the National Comprehensive Cancer Network guidelines call for low-dose chest CT followed by a PET scan to identify patients for biopsy.
In terms of financial costs, the average total cost of the diagnostic work-up was $7,567 for patients diagnosed with lung cancer and $3,558 for those without a lung cancer diagnosis.
For both groups, these costs rose dramatically with the use of biopsy to $8,341 and $22,127, respectively, Dr. Lokhandwala said.
Of the 1,744 patients who underwent a biopsy, 19.3% experienced a biopsy-related adverse event. An adverse event increased the average cost of a biopsy fourfold from $8,869 to $37,745, she said.
“Apart from the financial costs and the adverse events associated with tests and biopsies, there was also likely tremendous stress for those patients who ultimately were not found to have lung cancer,” press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
Dr. Gaspar agreed that the data highlight the need to better identify patients with lung cancer through the use of better imaging tests, follow-up CT or PET scans, or liquid biopsies.
FROM A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point: Biopsy costs remain a significant proportion of the overall cost of diagnosing lung cancer.
Major finding: 43% of the $38.3 million spent in lung cancer diagnostic costs were due to biopsies for patients ultimately not diagnosed with lung cancer.
Data source: Retrospective study using a random 5% sample of 8,979 Medicare patients.
Disclosures: Dr. Lokhandwala reported employment with Xcenda. Her coauthors disclosed employment with Xcenda or GE Healthcare.
PC providers have knowledge gaps in lung cancer screening
CHICAGO – Nearly one-fourth of primary care providers were unaware of current lung cancer screening guidelines in a survey of 212 PC providers in North Carolina, a state with one of the nation’s highest lung cancer death rates.
Only 12% of respondents ordered low-dose computed tomography (LDCT) in the past year to screen their patients at high risk for lung cancer, while 21% ordered a chest x-ray, a nonrecommended screening test, said Dr. Jennifer Lewis of Wake Forest University, Winston-Salem, N.C.
The use of LDCT screening for high-risk patients has been recommended by multiple health care organizations including the American College of Chest Physicians, American Lung Association, and U.S. Preventative Services Task Force. The 2013 USPSTF recommendations call for annual LDCT screening for adults aged 55-80 years who have a 30–pack-year smoking history and currently smoke or have quit within the past 15 years.
The survey found that 67% of providers knew screening was recommended for current and former smokers, but less than half knew the eligible age to initiate screening in any guideline is 50-55 years (35%), the eligible age to stop screening is 75-80 years (29%), and that a 1-year screening interval is recommended (25%).
Only 47% of respondents knew three or more of the guideline components and 24% knew no components.
Providers who knew three or more guideline components, however, were significantly more likely to use LDCT screening (P = .0002), Dr. Lewis said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The online survey was sent to 488 primary care providers, including physicians, physician assistants, and nurse practitioners, affiliated with Wake Forest Baptist Health. Of the 293 respondents (60%), 212 providers cared for patients older than age 40 years in the past year and were eligible for the study.
Less than half of respondents (42%) perceived of LDCT as “very” or even moderately effective in reducing cancer-specific mortality.
“In actuality, if you look at the number needed to screen to prevent one lung cancer death, low-dose CT is more effective than mammography or even flexible sigmoidoscopy,” she observed.
The major perceived barrier to LDCT screening was financial cost to patients. Other barriers were false positives, patient awareness of screening, incidental finding, and insurance coverage.
To put the study in perspective, 12,000 lives could be saved each year if low-dose CT screening were fully implemented, Dr. Lewis said. Before this can happen, providers need education. The good news is that 80% of respondents said they want more education.
“This education should focus on the effectiveness of low-dose CT screening in saving lives from cancer, the guideline recommendations (meaning who to screen, when to screen, and how often), as well as the correct lung cancer screening test,” she said. “This is all needed before providers can have those shared decision-making conversations with their patients.”
Although the survey was conducted at Wake Forest, the “results and conclusions can likely be extrapolated to much of the primary care population in the United States,” session moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
CHICAGO – Nearly one-fourth of primary care providers were unaware of current lung cancer screening guidelines in a survey of 212 PC providers in North Carolina, a state with one of the nation’s highest lung cancer death rates.
Only 12% of respondents ordered low-dose computed tomography (LDCT) in the past year to screen their patients at high risk for lung cancer, while 21% ordered a chest x-ray, a nonrecommended screening test, said Dr. Jennifer Lewis of Wake Forest University, Winston-Salem, N.C.
The use of LDCT screening for high-risk patients has been recommended by multiple health care organizations including the American College of Chest Physicians, American Lung Association, and U.S. Preventative Services Task Force. The 2013 USPSTF recommendations call for annual LDCT screening for adults aged 55-80 years who have a 30–pack-year smoking history and currently smoke or have quit within the past 15 years.
The survey found that 67% of providers knew screening was recommended for current and former smokers, but less than half knew the eligible age to initiate screening in any guideline is 50-55 years (35%), the eligible age to stop screening is 75-80 years (29%), and that a 1-year screening interval is recommended (25%).
Only 47% of respondents knew three or more of the guideline components and 24% knew no components.
Providers who knew three or more guideline components, however, were significantly more likely to use LDCT screening (P = .0002), Dr. Lewis said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The online survey was sent to 488 primary care providers, including physicians, physician assistants, and nurse practitioners, affiliated with Wake Forest Baptist Health. Of the 293 respondents (60%), 212 providers cared for patients older than age 40 years in the past year and were eligible for the study.
Less than half of respondents (42%) perceived of LDCT as “very” or even moderately effective in reducing cancer-specific mortality.
“In actuality, if you look at the number needed to screen to prevent one lung cancer death, low-dose CT is more effective than mammography or even flexible sigmoidoscopy,” she observed.
The major perceived barrier to LDCT screening was financial cost to patients. Other barriers were false positives, patient awareness of screening, incidental finding, and insurance coverage.
To put the study in perspective, 12,000 lives could be saved each year if low-dose CT screening were fully implemented, Dr. Lewis said. Before this can happen, providers need education. The good news is that 80% of respondents said they want more education.
“This education should focus on the effectiveness of low-dose CT screening in saving lives from cancer, the guideline recommendations (meaning who to screen, when to screen, and how often), as well as the correct lung cancer screening test,” she said. “This is all needed before providers can have those shared decision-making conversations with their patients.”
Although the survey was conducted at Wake Forest, the “results and conclusions can likely be extrapolated to much of the primary care population in the United States,” session moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
CHICAGO – Nearly one-fourth of primary care providers were unaware of current lung cancer screening guidelines in a survey of 212 PC providers in North Carolina, a state with one of the nation’s highest lung cancer death rates.
Only 12% of respondents ordered low-dose computed tomography (LDCT) in the past year to screen their patients at high risk for lung cancer, while 21% ordered a chest x-ray, a nonrecommended screening test, said Dr. Jennifer Lewis of Wake Forest University, Winston-Salem, N.C.
The use of LDCT screening for high-risk patients has been recommended by multiple health care organizations including the American College of Chest Physicians, American Lung Association, and U.S. Preventative Services Task Force. The 2013 USPSTF recommendations call for annual LDCT screening for adults aged 55-80 years who have a 30–pack-year smoking history and currently smoke or have quit within the past 15 years.
The survey found that 67% of providers knew screening was recommended for current and former smokers, but less than half knew the eligible age to initiate screening in any guideline is 50-55 years (35%), the eligible age to stop screening is 75-80 years (29%), and that a 1-year screening interval is recommended (25%).
Only 47% of respondents knew three or more of the guideline components and 24% knew no components.
Providers who knew three or more guideline components, however, were significantly more likely to use LDCT screening (P = .0002), Dr. Lewis said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The online survey was sent to 488 primary care providers, including physicians, physician assistants, and nurse practitioners, affiliated with Wake Forest Baptist Health. Of the 293 respondents (60%), 212 providers cared for patients older than age 40 years in the past year and were eligible for the study.
Less than half of respondents (42%) perceived of LDCT as “very” or even moderately effective in reducing cancer-specific mortality.
“In actuality, if you look at the number needed to screen to prevent one lung cancer death, low-dose CT is more effective than mammography or even flexible sigmoidoscopy,” she observed.
The major perceived barrier to LDCT screening was financial cost to patients. Other barriers were false positives, patient awareness of screening, incidental finding, and insurance coverage.
To put the study in perspective, 12,000 lives could be saved each year if low-dose CT screening were fully implemented, Dr. Lewis said. Before this can happen, providers need education. The good news is that 80% of respondents said they want more education.
“This education should focus on the effectiveness of low-dose CT screening in saving lives from cancer, the guideline recommendations (meaning who to screen, when to screen, and how often), as well as the correct lung cancer screening test,” she said. “This is all needed before providers can have those shared decision-making conversations with their patients.”
Although the survey was conducted at Wake Forest, the “results and conclusions can likely be extrapolated to much of the primary care population in the United States,” session moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado at Denver, Aurora, said.
FROM A THORACIC ONCOLOGY SYMPOSIUM
Key clinical point: Patients at high risk for lung cancer are more likely to receive screening when their primary care provider is familiar with lung cancer screening guidelines.
Major finding: 47% of respondents knew three or more guideline components and 24% knew none.
Data source: Online survey of 212 primary care providers.
Disclosures: Dr. Lewis and her coauthors reported having no financial disclosures.
CheckMate 012: Nivolumab plus chemo less than stellar
CHICAGO– Combining the PD-1 checkpoint inhibitor nivolumab with first-line chemotherapy for advanced non–small cell lung cancer produced responses no better than those previously reported for chemotherapy alone, according to results of CheckMate 012.
There was a “hint” of benefit with one of the regimens, however, prompting study author Dr. Scott J. Antonia to argue that the combination treatment strategy should not be abandoned.
Nivolumab 5 mg plus paclitaxel/carboplatin resulted in an “encouraging” 18-month overall survival rate of 86%, a lack of progressors at first evaluation, and a median overall survival that had yet to be reached at 2 years.
Overall, responses were independent of programmed death-1 (PD-1) status and toxicity was manageable.
“It is my opinion that these data support further development of concurrent bimodality therapies,” Dr. Antonia from the Moffitt Cancer Center, Tampa, said at the Chicago Multidisciplinary Symposium in Thoracic Oncology, where the data were presented.
Session comoderator Dr. Karen Kelly from University of California–Davis Comprehensive Cancer Center, Sacramento, said in an interview, “At best, there was a hint” of benefit with the combination. The results also have to be put into perspective of the “very, very small” sample size and weighed against the increase in side effects.
In all, 23 of the 56 patients had a grade 3 adverse event and 2 had a grade 4 event. There were no treatment-related deaths, but 12 patients discontinued therapy because of treatment-related adverse events.
Still, Dr. Kelly agreed that combination PD-1 inhibition and chemotherapy should continue to be explored.
“Absolutely,” she said, but added, “I suspect we’ll see the exact same finding with all of the other trials. It’s been very consistent across the refractory stage diseases, every drug has been the same.”
Nivolumab is under review for non–small cell lung cancer (NSCLC) in Europe, and drug developer Bristol-Myers Squibb is expected to complete submission for third-line, pretreated squamous cell NSCLC in the United States by year’s end.
Nivolumab is already under priority review in the United States for pretreated advanced melanoma, and it became the world’s first approved PD-1 inhibitor with the July 2014 approval for unresectable melanoma in Japan, where it is sold under the trade name Opdivo.
PD-1 inhibitors have proven to be very active drugs in NSCLC, raising the inevitable question of whether they would be even more effective when combined with chemotherapy.
CheckMate 012 assigned 56 patients with chemotherapy-naive stage IIIb or IV NSCLC to platinum-based doublet chemotherapy given in four 21-day cycles plus nivolumab 10 mg/kg or 5 mg/kg intravenous every 3 weeks until disease progression or unacceptable toxicity.
Patients with squamous histology got nivolumab 10 mg plus gemcitabine (Gemzar) 1,250 mg/m2 and cisplatin (Platinol) 75 mg/m2; nonsquamous patients got nivolumab 10 mg plus pemetrexed (Alimta) 500 mg/m2 and cisplatin 75 mg/m2; and patients with any histology got either nivolumab 10 mg or 5 mg plus paclitaxel (Taxol) 200 mg/m2 and carboplatin AUC 6.
The patients’ median age was 64 years, 96% had stage IV disease, and 66% had adenocarcinoma. Five percent of patients had prior erlotinib (Tarceva), but none were in the nivolumab 5-mg group.
The objective response rate for nivolumab 10 mg/kg was 33% with gemcitabine/cisplatin, 47% with pemetrexed/cisplatin, and 47% with paclitaxel/carboplatin, Dr. Antonia said. Stable disease was reported in 58%, 47%, and 27%.
The objective response rate for the 14 patients in the nivolumab 5 mg/kg arm fell in the same range at 43%. Stable disease was also 43%.
Despite being given the higher 10-mg dose of nivolumab, overall survival at 18 months was only 33% for those also on gemcitabine/cisplatin, 60% for pemetrexed/cisplatin, and 40% for paclitaxel/carboplatin. Median overall survival was 51 weeks, 83 weeks, and 65 weeks, he said.
CHICAGO– Combining the PD-1 checkpoint inhibitor nivolumab with first-line chemotherapy for advanced non–small cell lung cancer produced responses no better than those previously reported for chemotherapy alone, according to results of CheckMate 012.
There was a “hint” of benefit with one of the regimens, however, prompting study author Dr. Scott J. Antonia to argue that the combination treatment strategy should not be abandoned.
Nivolumab 5 mg plus paclitaxel/carboplatin resulted in an “encouraging” 18-month overall survival rate of 86%, a lack of progressors at first evaluation, and a median overall survival that had yet to be reached at 2 years.
Overall, responses were independent of programmed death-1 (PD-1) status and toxicity was manageable.
“It is my opinion that these data support further development of concurrent bimodality therapies,” Dr. Antonia from the Moffitt Cancer Center, Tampa, said at the Chicago Multidisciplinary Symposium in Thoracic Oncology, where the data were presented.
Session comoderator Dr. Karen Kelly from University of California–Davis Comprehensive Cancer Center, Sacramento, said in an interview, “At best, there was a hint” of benefit with the combination. The results also have to be put into perspective of the “very, very small” sample size and weighed against the increase in side effects.
In all, 23 of the 56 patients had a grade 3 adverse event and 2 had a grade 4 event. There were no treatment-related deaths, but 12 patients discontinued therapy because of treatment-related adverse events.
Still, Dr. Kelly agreed that combination PD-1 inhibition and chemotherapy should continue to be explored.
“Absolutely,” she said, but added, “I suspect we’ll see the exact same finding with all of the other trials. It’s been very consistent across the refractory stage diseases, every drug has been the same.”
Nivolumab is under review for non–small cell lung cancer (NSCLC) in Europe, and drug developer Bristol-Myers Squibb is expected to complete submission for third-line, pretreated squamous cell NSCLC in the United States by year’s end.
Nivolumab is already under priority review in the United States for pretreated advanced melanoma, and it became the world’s first approved PD-1 inhibitor with the July 2014 approval for unresectable melanoma in Japan, where it is sold under the trade name Opdivo.
PD-1 inhibitors have proven to be very active drugs in NSCLC, raising the inevitable question of whether they would be even more effective when combined with chemotherapy.
CheckMate 012 assigned 56 patients with chemotherapy-naive stage IIIb or IV NSCLC to platinum-based doublet chemotherapy given in four 21-day cycles plus nivolumab 10 mg/kg or 5 mg/kg intravenous every 3 weeks until disease progression or unacceptable toxicity.
Patients with squamous histology got nivolumab 10 mg plus gemcitabine (Gemzar) 1,250 mg/m2 and cisplatin (Platinol) 75 mg/m2; nonsquamous patients got nivolumab 10 mg plus pemetrexed (Alimta) 500 mg/m2 and cisplatin 75 mg/m2; and patients with any histology got either nivolumab 10 mg or 5 mg plus paclitaxel (Taxol) 200 mg/m2 and carboplatin AUC 6.
The patients’ median age was 64 years, 96% had stage IV disease, and 66% had adenocarcinoma. Five percent of patients had prior erlotinib (Tarceva), but none were in the nivolumab 5-mg group.
The objective response rate for nivolumab 10 mg/kg was 33% with gemcitabine/cisplatin, 47% with pemetrexed/cisplatin, and 47% with paclitaxel/carboplatin, Dr. Antonia said. Stable disease was reported in 58%, 47%, and 27%.
The objective response rate for the 14 patients in the nivolumab 5 mg/kg arm fell in the same range at 43%. Stable disease was also 43%.
Despite being given the higher 10-mg dose of nivolumab, overall survival at 18 months was only 33% for those also on gemcitabine/cisplatin, 60% for pemetrexed/cisplatin, and 40% for paclitaxel/carboplatin. Median overall survival was 51 weeks, 83 weeks, and 65 weeks, he said.
CHICAGO– Combining the PD-1 checkpoint inhibitor nivolumab with first-line chemotherapy for advanced non–small cell lung cancer produced responses no better than those previously reported for chemotherapy alone, according to results of CheckMate 012.
There was a “hint” of benefit with one of the regimens, however, prompting study author Dr. Scott J. Antonia to argue that the combination treatment strategy should not be abandoned.
Nivolumab 5 mg plus paclitaxel/carboplatin resulted in an “encouraging” 18-month overall survival rate of 86%, a lack of progressors at first evaluation, and a median overall survival that had yet to be reached at 2 years.
Overall, responses were independent of programmed death-1 (PD-1) status and toxicity was manageable.
“It is my opinion that these data support further development of concurrent bimodality therapies,” Dr. Antonia from the Moffitt Cancer Center, Tampa, said at the Chicago Multidisciplinary Symposium in Thoracic Oncology, where the data were presented.
Session comoderator Dr. Karen Kelly from University of California–Davis Comprehensive Cancer Center, Sacramento, said in an interview, “At best, there was a hint” of benefit with the combination. The results also have to be put into perspective of the “very, very small” sample size and weighed against the increase in side effects.
In all, 23 of the 56 patients had a grade 3 adverse event and 2 had a grade 4 event. There were no treatment-related deaths, but 12 patients discontinued therapy because of treatment-related adverse events.
Still, Dr. Kelly agreed that combination PD-1 inhibition and chemotherapy should continue to be explored.
“Absolutely,” she said, but added, “I suspect we’ll see the exact same finding with all of the other trials. It’s been very consistent across the refractory stage diseases, every drug has been the same.”
Nivolumab is under review for non–small cell lung cancer (NSCLC) in Europe, and drug developer Bristol-Myers Squibb is expected to complete submission for third-line, pretreated squamous cell NSCLC in the United States by year’s end.
Nivolumab is already under priority review in the United States for pretreated advanced melanoma, and it became the world’s first approved PD-1 inhibitor with the July 2014 approval for unresectable melanoma in Japan, where it is sold under the trade name Opdivo.
PD-1 inhibitors have proven to be very active drugs in NSCLC, raising the inevitable question of whether they would be even more effective when combined with chemotherapy.
CheckMate 012 assigned 56 patients with chemotherapy-naive stage IIIb or IV NSCLC to platinum-based doublet chemotherapy given in four 21-day cycles plus nivolumab 10 mg/kg or 5 mg/kg intravenous every 3 weeks until disease progression or unacceptable toxicity.
Patients with squamous histology got nivolumab 10 mg plus gemcitabine (Gemzar) 1,250 mg/m2 and cisplatin (Platinol) 75 mg/m2; nonsquamous patients got nivolumab 10 mg plus pemetrexed (Alimta) 500 mg/m2 and cisplatin 75 mg/m2; and patients with any histology got either nivolumab 10 mg or 5 mg plus paclitaxel (Taxol) 200 mg/m2 and carboplatin AUC 6.
The patients’ median age was 64 years, 96% had stage IV disease, and 66% had adenocarcinoma. Five percent of patients had prior erlotinib (Tarceva), but none were in the nivolumab 5-mg group.
The objective response rate for nivolumab 10 mg/kg was 33% with gemcitabine/cisplatin, 47% with pemetrexed/cisplatin, and 47% with paclitaxel/carboplatin, Dr. Antonia said. Stable disease was reported in 58%, 47%, and 27%.
The objective response rate for the 14 patients in the nivolumab 5 mg/kg arm fell in the same range at 43%. Stable disease was also 43%.
Despite being given the higher 10-mg dose of nivolumab, overall survival at 18 months was only 33% for those also on gemcitabine/cisplatin, 60% for pemetrexed/cisplatin, and 40% for paclitaxel/carboplatin. Median overall survival was 51 weeks, 83 weeks, and 65 weeks, he said.
FROM A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point: Adding nivolumab to chemotherapy did not enhance overall responses in advanced NSCLC, although there was a suggestion of benefit with paclitaxel/carboplatin.
Major finding: Overall survival at 18 months was 86% with nivolumab 5 mg plus paclitaxel/carboplatin.
Data source: Phase I safety study in 56 patients with stage IIIB or IV NSCLC.
Disclosures: Bristol-Myers Squibb sponsored the study. Dr. Antonia reported serving as a consultant for and honoraria from Bristol-Myers Squibb and a research grant from MedImmune. Dr. Kelly reported no conflicting interests.
Do small lung adenocarcinomas need subclassifying?
CHICAGO– Five-year survival rates are nearly identical for small lung carcinomas classified as adenocarcinoma in situ or minimally invasive adenocarcinoma, a systematic review shows.
At 5 years, disease-free survival was 97% for patients with lung adenocarcinoma in situ (AIS) and 96.7% in those with minimally invasive adenocarcinoma (MIA) (P = .34).
Overall survival rates were 97.5% and 96% (P = .58).
“Our findings raise questions regarding the necessity of classifying these types of tumors into two separate categories when it may not provide any additional prognostic information,” lead author Madhusmita Behera, Ph.D., said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The review included 18 clinical studies involving 863 patients with tumors 3 cm or less in size that were classified as AIS (no tumor invasion) or MIA (≤ 0.5 cm foci of invasion), according to the 2011 International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) international lung adenocarcinoma classification (J. Thor. Oncol. 2011;6:244-85).
Part of the rationale for separating AIS and MIS was that it was believed patients with minimal invasion would have worse prognosis, Dr. Behera, a researcher at the Winship Cancer Institute of Emory University, Atlanta, explained.
Instead, “Patients who have minimal invasion have equally great survival outcomes as those with adenocarcinoma in situ,” she said. “That’s the message we wanted to give out, that patients have excellent outcomes regardless of what category they belong to.”
The studies were published between 2011 and 2014 and included 451 AIS patients and 344 MIA patients. One study reported survival data on 68 patients with AIS and MIA grouped together.
All patients underwent surgical resection. There was no evidence that patients with MIA tumors received more treatment, Dr. Behera said.
Press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado, Denver, said oncologists usually think of invasive cancers as being more serious than adenocarcinoma in situ and possibly needing more intensive treatment. The outcomes in both groups, however, were excellent and treatment, usually surgical resection, should be the same in both groups.
Dr. Gaspar went on to say that too often the public and physicians think of lung cancer as a male gender cancer occurring in current or former smokers, but that Dr. Behera’s study reminds us that lung cancer is increasingly common in nonsmokers and women.
Of the 863 patients, 61% were female and 43% were smokers. The median age was 67.5 years and median tumor size 1.3 cm.
For the whole population, the 5-year disease-free survival rate was 97.7% and overall survival rate 97.3%.
CHICAGO– Five-year survival rates are nearly identical for small lung carcinomas classified as adenocarcinoma in situ or minimally invasive adenocarcinoma, a systematic review shows.
At 5 years, disease-free survival was 97% for patients with lung adenocarcinoma in situ (AIS) and 96.7% in those with minimally invasive adenocarcinoma (MIA) (P = .34).
Overall survival rates were 97.5% and 96% (P = .58).
“Our findings raise questions regarding the necessity of classifying these types of tumors into two separate categories when it may not provide any additional prognostic information,” lead author Madhusmita Behera, Ph.D., said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The review included 18 clinical studies involving 863 patients with tumors 3 cm or less in size that were classified as AIS (no tumor invasion) or MIA (≤ 0.5 cm foci of invasion), according to the 2011 International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) international lung adenocarcinoma classification (J. Thor. Oncol. 2011;6:244-85).
Part of the rationale for separating AIS and MIS was that it was believed patients with minimal invasion would have worse prognosis, Dr. Behera, a researcher at the Winship Cancer Institute of Emory University, Atlanta, explained.
Instead, “Patients who have minimal invasion have equally great survival outcomes as those with adenocarcinoma in situ,” she said. “That’s the message we wanted to give out, that patients have excellent outcomes regardless of what category they belong to.”
The studies were published between 2011 and 2014 and included 451 AIS patients and 344 MIA patients. One study reported survival data on 68 patients with AIS and MIA grouped together.
All patients underwent surgical resection. There was no evidence that patients with MIA tumors received more treatment, Dr. Behera said.
Press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado, Denver, said oncologists usually think of invasive cancers as being more serious than adenocarcinoma in situ and possibly needing more intensive treatment. The outcomes in both groups, however, were excellent and treatment, usually surgical resection, should be the same in both groups.
Dr. Gaspar went on to say that too often the public and physicians think of lung cancer as a male gender cancer occurring in current or former smokers, but that Dr. Behera’s study reminds us that lung cancer is increasingly common in nonsmokers and women.
Of the 863 patients, 61% were female and 43% were smokers. The median age was 67.5 years and median tumor size 1.3 cm.
For the whole population, the 5-year disease-free survival rate was 97.7% and overall survival rate 97.3%.
CHICAGO– Five-year survival rates are nearly identical for small lung carcinomas classified as adenocarcinoma in situ or minimally invasive adenocarcinoma, a systematic review shows.
At 5 years, disease-free survival was 97% for patients with lung adenocarcinoma in situ (AIS) and 96.7% in those with minimally invasive adenocarcinoma (MIA) (P = .34).
Overall survival rates were 97.5% and 96% (P = .58).
“Our findings raise questions regarding the necessity of classifying these types of tumors into two separate categories when it may not provide any additional prognostic information,” lead author Madhusmita Behera, Ph.D., said during a briefing at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.
The review included 18 clinical studies involving 863 patients with tumors 3 cm or less in size that were classified as AIS (no tumor invasion) or MIA (≤ 0.5 cm foci of invasion), according to the 2011 International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) international lung adenocarcinoma classification (J. Thor. Oncol. 2011;6:244-85).
Part of the rationale for separating AIS and MIS was that it was believed patients with minimal invasion would have worse prognosis, Dr. Behera, a researcher at the Winship Cancer Institute of Emory University, Atlanta, explained.
Instead, “Patients who have minimal invasion have equally great survival outcomes as those with adenocarcinoma in situ,” she said. “That’s the message we wanted to give out, that patients have excellent outcomes regardless of what category they belong to.”
The studies were published between 2011 and 2014 and included 451 AIS patients and 344 MIA patients. One study reported survival data on 68 patients with AIS and MIA grouped together.
All patients underwent surgical resection. There was no evidence that patients with MIA tumors received more treatment, Dr. Behera said.
Press briefing moderator Dr. Laurie E. Gaspar, professor and chair of radiation oncology at the University of Colorado, Denver, said oncologists usually think of invasive cancers as being more serious than adenocarcinoma in situ and possibly needing more intensive treatment. The outcomes in both groups, however, were excellent and treatment, usually surgical resection, should be the same in both groups.
Dr. Gaspar went on to say that too often the public and physicians think of lung cancer as a male gender cancer occurring in current or former smokers, but that Dr. Behera’s study reminds us that lung cancer is increasingly common in nonsmokers and women.
Of the 863 patients, 61% were female and 43% were smokers. The median age was 67.5 years and median tumor size 1.3 cm.
For the whole population, the 5-year disease-free survival rate was 97.7% and overall survival rate 97.3%.
FROM A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point: Comparable 5-year survival rates call into question the need to classify small lung carcinomas as adenocarcinoma in situ vs. minimally invasive adenocarcinoma.
Major finding: 5-year overall survival was 97.5% for lung adenocarcinoma in situ and 96% for minimally invasive adenocarcinoma (P = .58).
Data source: Pooled analysis of 18 lung cancer studies from 2011 to 2014.
Disclosures: Dr. Behera and her coauthors reported no financial disclosures.