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A blood test to detect lung cancer inches toward the clinic
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO - Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.
In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO - Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.
In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO - Uptake of recommended low-dose CT for lung cancer screening has been dismal. Blood-based assays are an attractive alternative being explored by the Circulating Cell–Free Genome Atlas (CCGA) project. Interim results of a CCGA study of 561 individuals without cancer and 118 patients with lung cancers of all stages have found that a trio of assays searching for molecular signatures in plasma cell-free DNA achieved roughly 50% sensitivity for detection of early-stage (stage I-IIIA) lung cancers and 91% sensitivity for detection of late-stage (stage IIIB-IV) lung cancers.
In this video interview from the annual meeting of the American Society of Clinical Oncology, lead study author Geoffrey R. Oxnard, MD, of the Dana-Farber Cancer Institute, Boston, discusses the science behind these assays, how they may fill an unmet medical need, and ongoing work to bring them into the clinic.
REPORTING FROM ASCO 2018
Screening for brain mets could improve quality of life for some with breast cancer
Despite having more extensive metastases at presentation, breast cancer patients had outcomes after brain-directed therapy similar to those of lung cancer patients, results of a retrospective, single-center study show.
The breast cancer patients had larger and more numerous brain metastases compared with the non-small-cell lung cancer (NSCLC) patients, according to study results published in JAMA Oncology.
However, median survival was not statistically different between groups, at 1.45 years for the breast cancer patients and 1.09 years for NSCLC patients (P = .06), wrote Daniel N. Cagney, MD, of Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, and his coauthors.
“This finding suggests that intracranial disease in patients with breast cancer was not more aggressive or resistant to treatment, but rather was diagnosed at a later stage,” noted Dr. Cagney and his colleagues.
They described a retrospective analysis of 349 patients with breast cancer and 659 patients with NSCLC, all treated between 2000 and 2015 at Dana-Farber/Brigham and Women’s Cancer Center.
Median metastasis diameter at presentation was 17 mm for the breast cancer patients, compared with 14 mm for the lung cancer patients (P less than .001). Breast cancer patients were significantly more likely to be symptomatic, have seizures, harbor brainstem involvement, and have leptomeningeal disease at the time of diagnosis, the researchers wrote.
“After initial brain-directed therapy, no significant differences in recurrence or treatment-based intracranial outcomes were found between the two groups,” they noted. However, neurological death was seen in 37.3% of the breast cancer group versus 19.9% of the lung cancer group (P less than .001).
Dr. Cagney and his coauthors said they conducted the study to identify the potential value of brain-directed MRI screening in breast cancer, which they said is “important given the impact of neurological compromise on quality of life.”
Brain metastases are common in some subsets of breast cancer patients, yet National Comprehensive Cancer Network guidelines do not recommend brain-directed screening in breast cancer, “a recommendation that is based only on expert consensus given the lack of definitive or prospective studies on this issue,” they wrote.
In light of their findings, the investigators suggest that brain-directed MRI screening is important for breast cancer patients who present with potential for intracranial involvement.
“Early identification of intracranial disease facilitates less invasive or less toxic approaches, such as stereotactic radiosurgery or careful use of promising systemic agents, rather than [whole brain radiation therapy] or neurosurgical resection.” they wrote.
In this study, whole brain radiation therapy was more common in the breast cancer group (59.9% versus 42.9% for the lung cancer group; P less than .001), the investigators noted.
Dr. Cagney and colleagues had no conflicts of interest to report.
SOURCE: Cagney DN et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0813.
Despite having more extensive metastases at presentation, breast cancer patients had outcomes after brain-directed therapy similar to those of lung cancer patients, results of a retrospective, single-center study show.
The breast cancer patients had larger and more numerous brain metastases compared with the non-small-cell lung cancer (NSCLC) patients, according to study results published in JAMA Oncology.
However, median survival was not statistically different between groups, at 1.45 years for the breast cancer patients and 1.09 years for NSCLC patients (P = .06), wrote Daniel N. Cagney, MD, of Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, and his coauthors.
“This finding suggests that intracranial disease in patients with breast cancer was not more aggressive or resistant to treatment, but rather was diagnosed at a later stage,” noted Dr. Cagney and his colleagues.
They described a retrospective analysis of 349 patients with breast cancer and 659 patients with NSCLC, all treated between 2000 and 2015 at Dana-Farber/Brigham and Women’s Cancer Center.
Median metastasis diameter at presentation was 17 mm for the breast cancer patients, compared with 14 mm for the lung cancer patients (P less than .001). Breast cancer patients were significantly more likely to be symptomatic, have seizures, harbor brainstem involvement, and have leptomeningeal disease at the time of diagnosis, the researchers wrote.
“After initial brain-directed therapy, no significant differences in recurrence or treatment-based intracranial outcomes were found between the two groups,” they noted. However, neurological death was seen in 37.3% of the breast cancer group versus 19.9% of the lung cancer group (P less than .001).
Dr. Cagney and his coauthors said they conducted the study to identify the potential value of brain-directed MRI screening in breast cancer, which they said is “important given the impact of neurological compromise on quality of life.”
Brain metastases are common in some subsets of breast cancer patients, yet National Comprehensive Cancer Network guidelines do not recommend brain-directed screening in breast cancer, “a recommendation that is based only on expert consensus given the lack of definitive or prospective studies on this issue,” they wrote.
In light of their findings, the investigators suggest that brain-directed MRI screening is important for breast cancer patients who present with potential for intracranial involvement.
“Early identification of intracranial disease facilitates less invasive or less toxic approaches, such as stereotactic radiosurgery or careful use of promising systemic agents, rather than [whole brain radiation therapy] or neurosurgical resection.” they wrote.
In this study, whole brain radiation therapy was more common in the breast cancer group (59.9% versus 42.9% for the lung cancer group; P less than .001), the investigators noted.
Dr. Cagney and colleagues had no conflicts of interest to report.
SOURCE: Cagney DN et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0813.
Despite having more extensive metastases at presentation, breast cancer patients had outcomes after brain-directed therapy similar to those of lung cancer patients, results of a retrospective, single-center study show.
The breast cancer patients had larger and more numerous brain metastases compared with the non-small-cell lung cancer (NSCLC) patients, according to study results published in JAMA Oncology.
However, median survival was not statistically different between groups, at 1.45 years for the breast cancer patients and 1.09 years for NSCLC patients (P = .06), wrote Daniel N. Cagney, MD, of Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, and his coauthors.
“This finding suggests that intracranial disease in patients with breast cancer was not more aggressive or resistant to treatment, but rather was diagnosed at a later stage,” noted Dr. Cagney and his colleagues.
They described a retrospective analysis of 349 patients with breast cancer and 659 patients with NSCLC, all treated between 2000 and 2015 at Dana-Farber/Brigham and Women’s Cancer Center.
Median metastasis diameter at presentation was 17 mm for the breast cancer patients, compared with 14 mm for the lung cancer patients (P less than .001). Breast cancer patients were significantly more likely to be symptomatic, have seizures, harbor brainstem involvement, and have leptomeningeal disease at the time of diagnosis, the researchers wrote.
“After initial brain-directed therapy, no significant differences in recurrence or treatment-based intracranial outcomes were found between the two groups,” they noted. However, neurological death was seen in 37.3% of the breast cancer group versus 19.9% of the lung cancer group (P less than .001).
Dr. Cagney and his coauthors said they conducted the study to identify the potential value of brain-directed MRI screening in breast cancer, which they said is “important given the impact of neurological compromise on quality of life.”
Brain metastases are common in some subsets of breast cancer patients, yet National Comprehensive Cancer Network guidelines do not recommend brain-directed screening in breast cancer, “a recommendation that is based only on expert consensus given the lack of definitive or prospective studies on this issue,” they wrote.
In light of their findings, the investigators suggest that brain-directed MRI screening is important for breast cancer patients who present with potential for intracranial involvement.
“Early identification of intracranial disease facilitates less invasive or less toxic approaches, such as stereotactic radiosurgery or careful use of promising systemic agents, rather than [whole brain radiation therapy] or neurosurgical resection.” they wrote.
In this study, whole brain radiation therapy was more common in the breast cancer group (59.9% versus 42.9% for the lung cancer group; P less than .001), the investigators noted.
Dr. Cagney and colleagues had no conflicts of interest to report.
SOURCE: Cagney DN et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0813.
FROM JAMA ONCOLOGY
Key clinical point: Breast cancer patients presented with larger and more numerous brain metastases compared with non–small-cell lung cancer patients, but after brain-directed therapy, there were no differences in outcomes between groups.
Major finding: Median survival was 1.45 years for breast cancer patients and 1.09 for NSCLC patients.
Study details: A retrospective analysis of 349 patients with breast cancer and 659 patients with NSCLC treated between 2000 and 2015 at Dana-Farber/Brigham and Women’s Cancer Center.
Disclosures: The authors reported no conflicts of interest.
Source: Cagney DN et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0813.
Uptake of lung cancer screening is exceedingly low
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
REPORTING FROM ASCO 2018
Key clinical point: The rate of lung cancer screening among eligible patients is overall very low.
Major finding: Just 1.9% of estimated, eligible current and former heavy smokers in the United States underwent low-dose CT screening for lung cancer in 2016.
Study details: Nationwide, cross-sectional cohort study of screening among an estimated 7,612,975 eligible smokers.
Disclosures: Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
Source: Pham DC et al. ASCO 2018. Abstract 6504.
Checkpoint inhibitors well tolerated by NSCLC patients with preexisting autoimmune disease
For patients with non–small-cell lung cancer (NSCLC), preexisting autoimmune disease (AID) does not increase the risk of immune-related adverse events (irAEs) with checkpoint inhibitor therapy, according to investigators.
Flares of AID during therapy were generally mild, and toxicity rates were only slightly increased in patients with AID, they wrote in Journal of Clinical Oncology.
Approximately 14%-25% of patients with lung cancer also have AID, but patients with AID are typically excluded from clinical trials. “This presents a tremendous knowledge gap,” wrote lead author Giulia C. Leonardi, MD, of the Dana-Farber Cancer Institute in Boston, and coauthors.
The retrospective study comprised 56 patients with NSCLC and preexisting autoimmune disease from five academic cancer centers. Almost half of the patients had a rheumatologic disorder, 29% had a dermatologic disorder, 16% had an endocrine disorder, 11% had inflammatory bowel disease, 5% had a neurologic condition, 3% had rheumatic fever, and one patient (2%) had autoimmune hemolytic anemia.
Patients received either a programmed death-1 or programmed death-ligand 1 inhibitor as monotherapy. Median treatment time was 3.1 months, and median follow-up time after starting therapy was 17.5 months.
Eleven percent of patients with preexisting AID developed grade 3 or 4 irAEs, which is similar to 7%-15% of patients in clinical trials. Although 23% of patients experienced a flare of their preexisting AID, these flares were generally mild – no patients discontinued immunotherapy because of a flare. In contrast, 14% of patients halted therapy because of toxicity, a marginally higher number than 3%-8% of patients in trials.
Checkpoint inhibitors are now a mainstay treatment for a lung cancer, including three approved drugs: nivolumab, pembrolizumab, and atezolizumab. “Almost every patient with advanced NSCLC will likely receive a [checkpoint] inhibitor at some point over the course of their disease,” the authors noted. As checkpoint inhibitors may lead to fatal irAEs, the possible interplay between these immunotherapies and AID requires investigation.
“Our study adds to the growing body of evidence supporting the use of immunotherapy in patients with cancer with preexisting AID, albeit with close monitoring for adverse events,” the researchers concluded.
SOURCE: Leonardi GC et al. J Clin Oncol. 2018* May 20. doi: 10.1200/JCO.2017.77.0305.
*Correction, 5/22/18: An earlier version of this article misstated the year in this citation.
For patients with non–small-cell lung cancer (NSCLC), preexisting autoimmune disease (AID) does not increase the risk of immune-related adverse events (irAEs) with checkpoint inhibitor therapy, according to investigators.
Flares of AID during therapy were generally mild, and toxicity rates were only slightly increased in patients with AID, they wrote in Journal of Clinical Oncology.
Approximately 14%-25% of patients with lung cancer also have AID, but patients with AID are typically excluded from clinical trials. “This presents a tremendous knowledge gap,” wrote lead author Giulia C. Leonardi, MD, of the Dana-Farber Cancer Institute in Boston, and coauthors.
The retrospective study comprised 56 patients with NSCLC and preexisting autoimmune disease from five academic cancer centers. Almost half of the patients had a rheumatologic disorder, 29% had a dermatologic disorder, 16% had an endocrine disorder, 11% had inflammatory bowel disease, 5% had a neurologic condition, 3% had rheumatic fever, and one patient (2%) had autoimmune hemolytic anemia.
Patients received either a programmed death-1 or programmed death-ligand 1 inhibitor as monotherapy. Median treatment time was 3.1 months, and median follow-up time after starting therapy was 17.5 months.
Eleven percent of patients with preexisting AID developed grade 3 or 4 irAEs, which is similar to 7%-15% of patients in clinical trials. Although 23% of patients experienced a flare of their preexisting AID, these flares were generally mild – no patients discontinued immunotherapy because of a flare. In contrast, 14% of patients halted therapy because of toxicity, a marginally higher number than 3%-8% of patients in trials.
Checkpoint inhibitors are now a mainstay treatment for a lung cancer, including three approved drugs: nivolumab, pembrolizumab, and atezolizumab. “Almost every patient with advanced NSCLC will likely receive a [checkpoint] inhibitor at some point over the course of their disease,” the authors noted. As checkpoint inhibitors may lead to fatal irAEs, the possible interplay between these immunotherapies and AID requires investigation.
“Our study adds to the growing body of evidence supporting the use of immunotherapy in patients with cancer with preexisting AID, albeit with close monitoring for adverse events,” the researchers concluded.
SOURCE: Leonardi GC et al. J Clin Oncol. 2018* May 20. doi: 10.1200/JCO.2017.77.0305.
*Correction, 5/22/18: An earlier version of this article misstated the year in this citation.
For patients with non–small-cell lung cancer (NSCLC), preexisting autoimmune disease (AID) does not increase the risk of immune-related adverse events (irAEs) with checkpoint inhibitor therapy, according to investigators.
Flares of AID during therapy were generally mild, and toxicity rates were only slightly increased in patients with AID, they wrote in Journal of Clinical Oncology.
Approximately 14%-25% of patients with lung cancer also have AID, but patients with AID are typically excluded from clinical trials. “This presents a tremendous knowledge gap,” wrote lead author Giulia C. Leonardi, MD, of the Dana-Farber Cancer Institute in Boston, and coauthors.
The retrospective study comprised 56 patients with NSCLC and preexisting autoimmune disease from five academic cancer centers. Almost half of the patients had a rheumatologic disorder, 29% had a dermatologic disorder, 16% had an endocrine disorder, 11% had inflammatory bowel disease, 5% had a neurologic condition, 3% had rheumatic fever, and one patient (2%) had autoimmune hemolytic anemia.
Patients received either a programmed death-1 or programmed death-ligand 1 inhibitor as monotherapy. Median treatment time was 3.1 months, and median follow-up time after starting therapy was 17.5 months.
Eleven percent of patients with preexisting AID developed grade 3 or 4 irAEs, which is similar to 7%-15% of patients in clinical trials. Although 23% of patients experienced a flare of their preexisting AID, these flares were generally mild – no patients discontinued immunotherapy because of a flare. In contrast, 14% of patients halted therapy because of toxicity, a marginally higher number than 3%-8% of patients in trials.
Checkpoint inhibitors are now a mainstay treatment for a lung cancer, including three approved drugs: nivolumab, pembrolizumab, and atezolizumab. “Almost every patient with advanced NSCLC will likely receive a [checkpoint] inhibitor at some point over the course of their disease,” the authors noted. As checkpoint inhibitors may lead to fatal irAEs, the possible interplay between these immunotherapies and AID requires investigation.
“Our study adds to the growing body of evidence supporting the use of immunotherapy in patients with cancer with preexisting AID, albeit with close monitoring for adverse events,” the researchers concluded.
SOURCE: Leonardi GC et al. J Clin Oncol. 2018* May 20. doi: 10.1200/JCO.2017.77.0305.
*Correction, 5/22/18: An earlier version of this article misstated the year in this citation.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: Eleven percent of patients with autoimmune disease experienced grade 3 or 4 immune-related adverse events, compared with 7%-15% of patients without autoimmune disease.
Study details: A retrospective study of 56 patients with NSCLC and preexisting autoimmune disease from five academic cancer centers.
Disclosures: The Kaplan Research Fund and Jeni Fund, Memorial Sloan Kettering Cancer Center, the American Cancer Society, and the University of Texas MD Anderson Cancer Center sponsored the study. The researchers reported receiving financial support from Merck, Novartis, Genentech, and other companies.
Source: Leonardi GC et al. J Clin Oncol. 2018 May 20. doi: 10.1200/JCO.2017.77.0305.
Palliative care may reduce suicide among lung cancer patients
according to new research that will be presented at an international conference of the American Thoracic Society.
“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.
The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.
The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.
Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.
While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.
Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.
More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.
according to new research that will be presented at an international conference of the American Thoracic Society.
“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.
The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.
The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.
Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.
While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.
Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.
More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.
according to new research that will be presented at an international conference of the American Thoracic Society.
“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.
The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.
The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.
Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.
While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.
Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.
More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.
FROM ATS 2018
Upfront NGS testing of metastatic NSCLC saves money, time
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
REPORTING FROM THE ASCO ANNUAL MEETING
Key clinical point:
Major finding: Relative to exclusionary, sequential, or panel testing, NGS testing could save up to $2.1 million among CMS beneficiaries and up to $250,842 among patients covered by commercial insurance.
Study details: A decision analytic modeling study in hypothetical cohorts of 1 million insurance plan enrollees.
Disclosures: Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
Source: Pennell et al. ASCO Annual Meeting, Abstract 9031.
Is cancer immunotherapy more effective in men than women?
Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.
In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.
They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).
Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.
“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.
This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.
However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.
The authors also looked at whether the studies that compared immunotherapies with nonimmunological therapies might show a different effect, but they still found a significantly higher benefit in men, compared with women.
The overall study population was two-thirds male and one-third female. The checkpoint inhibitors used were ipilimumab, tremelimumab, nivolumab, and pembrolizumab, and the trials were conducted in patients with melanoma, non–small cell lung cancer, head and neck cancer, renal cell carcinoma, urothelial tumors, gastric tumors, and mesothelioma.
Men have almost double the risk of mortality from cancer than do women, the authors said, with the greatest differences seen in melanoma, lung cancer, larynx cancer, esophagus cancer, and bladder cancer.
“This male-biased mortality is hypothesized to reflect differences not only in behavioral and biological factors, including causes of cancer and hormonal regulation, but also in the immune system.”
Despite this, sex is rarely taken into account when new therapeutic approaches are tested, the authors said.
They also commented on the fact that there was a relatively low number of women included in each trial, an issue that was recognized as far back as the 1990s as a major problem in medical trials.
“Our results further highlight this problem, showing clinically relevant differences in the efficacy of two important classes of immunological drugs, namely anti–CTLA-4 and anti–PD-1 antibodies, when compared with controls in male and female patients with advanced solid tumors,” they wrote.
They noted that they couldn’t exclude the possibility that the effect may be the result of other variables that were distributed differently between the sexes. However, they also qualified this by saying that variables known to affect the efficacy of immune checkpoint inhibitors, such as PD-L1 expression and mutation status, were not likely to explain the results.
Given their findings, the authors said a patient’s sex should be taken into account when weighing the risks and benefits of checkpoint inhibitors given the magnitude of benefit was sex-dependent. They also called for future immunotherapy studies to include more women.
No funding or conflicts of interest were declared.
SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.
While cancer immunotherapy represents one of the most significant clinical advances in cancer treatment in the past decade, the basic but important clinical question about different effects between men and woman has not been addressed until now. The authors of this study are to be congratulated on such a comprehensive and well-conducted analysis, but the data does not completely support their final conclusion that checkpoint inhibitors benefit men more than women.
There are a large number of baseline characteristics of solid tumors that might differ between men and women and that have also been reported to impact the outcomes of patients treated with checkpoint inhibitors. Some of these may be lifestyle or behavioral characteristics – such as different smoking habits between men and women with non–small cell lung cancer – or differences in the distribution of oncogenic driver mutations between men and women.
We should therefore be cautious in jumping to conclusions and changing the current standard of care with respect to checkpoint inhibitors. In particular, we should not be denying treatment to women who are otherwise indicated for checkpoint inhibitors, based on these findings.
Omar Abdel-Rahman, MD, is from the clinical oncology department of the faculty of medicine at Ain Shams University in Cairo and from the Tom Baker Cancer Centre in Calgary. These comments are taken from an accompanying editorial (Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045[18]30270-5.) No conflicts of interest were declared.
While cancer immunotherapy represents one of the most significant clinical advances in cancer treatment in the past decade, the basic but important clinical question about different effects between men and woman has not been addressed until now. The authors of this study are to be congratulated on such a comprehensive and well-conducted analysis, but the data does not completely support their final conclusion that checkpoint inhibitors benefit men more than women.
There are a large number of baseline characteristics of solid tumors that might differ between men and women and that have also been reported to impact the outcomes of patients treated with checkpoint inhibitors. Some of these may be lifestyle or behavioral characteristics – such as different smoking habits between men and women with non–small cell lung cancer – or differences in the distribution of oncogenic driver mutations between men and women.
We should therefore be cautious in jumping to conclusions and changing the current standard of care with respect to checkpoint inhibitors. In particular, we should not be denying treatment to women who are otherwise indicated for checkpoint inhibitors, based on these findings.
Omar Abdel-Rahman, MD, is from the clinical oncology department of the faculty of medicine at Ain Shams University in Cairo and from the Tom Baker Cancer Centre in Calgary. These comments are taken from an accompanying editorial (Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045[18]30270-5.) No conflicts of interest were declared.
While cancer immunotherapy represents one of the most significant clinical advances in cancer treatment in the past decade, the basic but important clinical question about different effects between men and woman has not been addressed until now. The authors of this study are to be congratulated on such a comprehensive and well-conducted analysis, but the data does not completely support their final conclusion that checkpoint inhibitors benefit men more than women.
There are a large number of baseline characteristics of solid tumors that might differ between men and women and that have also been reported to impact the outcomes of patients treated with checkpoint inhibitors. Some of these may be lifestyle or behavioral characteristics – such as different smoking habits between men and women with non–small cell lung cancer – or differences in the distribution of oncogenic driver mutations between men and women.
We should therefore be cautious in jumping to conclusions and changing the current standard of care with respect to checkpoint inhibitors. In particular, we should not be denying treatment to women who are otherwise indicated for checkpoint inhibitors, based on these findings.
Omar Abdel-Rahman, MD, is from the clinical oncology department of the faculty of medicine at Ain Shams University in Cairo and from the Tom Baker Cancer Centre in Calgary. These comments are taken from an accompanying editorial (Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045[18]30270-5.) No conflicts of interest were declared.
Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.
In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.
They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).
Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.
“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.
This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.
However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.
The authors also looked at whether the studies that compared immunotherapies with nonimmunological therapies might show a different effect, but they still found a significantly higher benefit in men, compared with women.
The overall study population was two-thirds male and one-third female. The checkpoint inhibitors used were ipilimumab, tremelimumab, nivolumab, and pembrolizumab, and the trials were conducted in patients with melanoma, non–small cell lung cancer, head and neck cancer, renal cell carcinoma, urothelial tumors, gastric tumors, and mesothelioma.
Men have almost double the risk of mortality from cancer than do women, the authors said, with the greatest differences seen in melanoma, lung cancer, larynx cancer, esophagus cancer, and bladder cancer.
“This male-biased mortality is hypothesized to reflect differences not only in behavioral and biological factors, including causes of cancer and hormonal regulation, but also in the immune system.”
Despite this, sex is rarely taken into account when new therapeutic approaches are tested, the authors said.
They also commented on the fact that there was a relatively low number of women included in each trial, an issue that was recognized as far back as the 1990s as a major problem in medical trials.
“Our results further highlight this problem, showing clinically relevant differences in the efficacy of two important classes of immunological drugs, namely anti–CTLA-4 and anti–PD-1 antibodies, when compared with controls in male and female patients with advanced solid tumors,” they wrote.
They noted that they couldn’t exclude the possibility that the effect may be the result of other variables that were distributed differently between the sexes. However, they also qualified this by saying that variables known to affect the efficacy of immune checkpoint inhibitors, such as PD-L1 expression and mutation status, were not likely to explain the results.
Given their findings, the authors said a patient’s sex should be taken into account when weighing the risks and benefits of checkpoint inhibitors given the magnitude of benefit was sex-dependent. They also called for future immunotherapy studies to include more women.
No funding or conflicts of interest were declared.
SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.
Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.
In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.
They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).
Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.
“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.
This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.
However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.
The authors also looked at whether the studies that compared immunotherapies with nonimmunological therapies might show a different effect, but they still found a significantly higher benefit in men, compared with women.
The overall study population was two-thirds male and one-third female. The checkpoint inhibitors used were ipilimumab, tremelimumab, nivolumab, and pembrolizumab, and the trials were conducted in patients with melanoma, non–small cell lung cancer, head and neck cancer, renal cell carcinoma, urothelial tumors, gastric tumors, and mesothelioma.
Men have almost double the risk of mortality from cancer than do women, the authors said, with the greatest differences seen in melanoma, lung cancer, larynx cancer, esophagus cancer, and bladder cancer.
“This male-biased mortality is hypothesized to reflect differences not only in behavioral and biological factors, including causes of cancer and hormonal regulation, but also in the immune system.”
Despite this, sex is rarely taken into account when new therapeutic approaches are tested, the authors said.
They also commented on the fact that there was a relatively low number of women included in each trial, an issue that was recognized as far back as the 1990s as a major problem in medical trials.
“Our results further highlight this problem, showing clinically relevant differences in the efficacy of two important classes of immunological drugs, namely anti–CTLA-4 and anti–PD-1 antibodies, when compared with controls in male and female patients with advanced solid tumors,” they wrote.
They noted that they couldn’t exclude the possibility that the effect may be the result of other variables that were distributed differently between the sexes. However, they also qualified this by saying that variables known to affect the efficacy of immune checkpoint inhibitors, such as PD-L1 expression and mutation status, were not likely to explain the results.
Given their findings, the authors said a patient’s sex should be taken into account when weighing the risks and benefits of checkpoint inhibitors given the magnitude of benefit was sex-dependent. They also called for future immunotherapy studies to include more women.
No funding or conflicts of interest were declared.
SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.
FROM LANCET ONCOLOGY
Key clinical point: Checkpoint inhibitors are linked with greater mortality reductions in men than in women.
Major finding: Checkpoint inhibitors are associated with a 28% reduction in cancer mortality in men and 14% in women.
Study details: Systematic review and meta-analysis of 20 randomized, controlled trials involving 11,351 patients.
Disclosures: No funding or conflicts of interest were declared.
Source: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.
E-cigarette usage has changed
, according to a study published online on May 15 by JAMA.
The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.
None of the investigators reported any conflicts of interest.
SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.
, according to a study published online on May 15 by JAMA.
The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.
None of the investigators reported any conflicts of interest.
SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.
, according to a study published online on May 15 by JAMA.
The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.
None of the investigators reported any conflicts of interest.
SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.
FROM JAMA
Delay of NSCLC surgery can lead to worse prognosis
SAN DIEGO – Delaying
“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”
An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.
“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”
For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.
Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.
“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”
The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.
In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”
No disclosures and no study funding are reported.
SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.
SAN DIEGO – Delaying
“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”
An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.
“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”
For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.
Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.
“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”
The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.
In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”
No disclosures and no study funding are reported.
SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.
SAN DIEGO – Delaying
“There is significant upstaging with time from completion of clinical staging to surgical resection, with a 4% increase of upstaging per week for the overall study population,” said study coauthor Harmik J. Soukiasian, MD, FACS, of Cedars-Sinai Medical Center, Los Angeles, in an interview. “Upstaging impacts lung cancer prognosis as more advanced stages portend to a poorer prognosis.”
An estimated 80%-85% of lung cancer patients have NSCLC, according to the American Cancer Society, and Dr. Soukiasian said surgery offers a chance at a cure for those diagnosed at stage I.
“National Cancer Comprehensive Network (NCCN) Guidelines recommend surgery within 8 weeks of completed clinical staging for NSCLC to limit cancer progression or upstaging,” Dr. Soukiasian said. “Although these guidelines are well established and widely adopted, our study performs a more granular analysis, studying time as a predictor of upstaging for those patients diagnosed with stage I NSCLC.”
For the new study, Dr. Soukiasian and colleagues tracked 52,406 patients in a cancer database who had stage I NSCLC but had not undergone preoperative chemotherapy. The researchers tracked their clinical stages for up to 12 weeks from initial staging.
Researchers found that, while staging levels rose with each successive week, just 25% of patients underwent surgery by 1 week, and only 79% had surgery in accordance with NSCLC guidelines by week 8. At 12 weeks, 9% had still not undergone surgery.
Upstaging was common: 22% at 1 week, 32% after 8 weeks, and 33% after 12 weeks.
“We demonstrate that patients diagnosed with stage I NSCLC benefit from surgery sooner than the 8-week window recommended by the NCCN guidelines,” Dr. Soukiasian said. “Exclusive of the rate of progression and in addition to time to surgery, our study also demonstrated academic centers, higher lymph node yield during surgery, and left-sided tumors to be independent predictors of upstaging.”
The study design doesn’t provide insight into why surgery is often delayed. However, “we can theorize factors associated with delays to surgery may be due to patient factors (personal scheduling, availability of support systems, etc.), delays in follow up, operating room availability or scheduling, and issues with insurance approval,” Dr. Soukiasian said.
In his presentation, Dr. Soukiasian emphasized the role of the mediastinum. “Given the clinical impact of stage III disease, we analyzed upstaging rates of stage I NSCLC to stage IIIA and revealed a 1.3% increase per week of upstaging specifically to stage IIIA. Additionally, almost 5% of patients initially diagnosed with stage I NSCLC upstaged to IIIA disease. The significant rate of upstaging to IIIA disease makes the case for more accurate and aggressive mediastinal staging prior to surgical resection.”
No disclosures and no study funding are reported.
SOURCE: Soukiasian HJ et al. AATS 2018, Abstract 67.
AT THE AATS ANNUAL MEETING
Key clinical point: Clinical staging levels worsen in each successive surgery-free week after initial staging in certain NSCLC patients.
Major finding: There was a 1.3% increase per week of upstaging to stage IIIA.
Study details: Analysis of 52,406 patients with stage I NSCLC who were tracked for up to 12 weeks.
Disclosures: No disclosures and no funding were reported.
Source: Soukiasian HJ et al. AATS 2018, Abstract 67.
Checkpoint inhibitors get to patients quickly
Checkpoint inhibitors got to melanoma, non–small cell lung cancer, and renal cell carcinoma patients quickly in clinical practice after Food and Drug Administration approval – usually within 4 months – but the patients treated in clinical settings tended to be older than those treated in trials, which has caused concern about whether real-world efficacy will prove to be the same, according to a study in JAMA Oncology.
“Such rapid adoption stands in contrast to older estimates that suggest it takes years or even decades for new treatments to be adopted,” wrote lead author Cary Gross, MD, professor of medicine at Yale University, New Haven, and his coauthors. “We found significant differences in age between patients treated in practice and those treated in trials, which highlights the need to clarify the risks and benefits of checkpoint inhibitors in general populations of patients.”
Researchers drew data on nivolumab and pembrolizumab use from the Flatiron Health longitudinal EHR database, which included 233 academic and community oncology practices. In each of the three disease cohorts, adoption was seen within 4 months for at least 60% of patients. Uptake was quickest for the melanoma patients, 76% of whom received a checkpoint inhibitor within 4 months, investigators wrote. Factors for the fast adoption could include high disease severity, a preference for novelty, perceived gains over existing treatments, and promotional activities, such as media reports and advertising directly to consumers, they wrote.
More patients in real-world practice were aged 65 years or older, ranging from as little as 61% at the lowest end of the range at one center to as much as 64% at the highest end at another. In the clinical trials, the percentage of patients aged 65 years or older ranged from 32% in one trial to 41% in another. Researchers wrote that these higher real-world rates are concerning because there are still questions regarding whether differences in immune responses will cause differences in efficacy between older and younger patients, as well as safety considerations among different age groups.
“Although data suggest that outcomes are similar between older and younger patients receiving anti–PD-1 agents for melanoma, there is little evidence to guide anti–PD-1 treatment of older patients with NSCLC [non–small cell lung cancer],” Dr. Gross and his coinvestigators wrote.
Investigators wrote that the findings are cause for caution.
“As FDA officials develop more flexible standards for approval, which the 21st Century Cures Act requires them to do, it is possible that many patients will receive drugs before much is known about clinical outcomes,” Dr. Gross said. “Further integrations of real-world evidence might allow the FDA to better assess the drugs that they approve on the basis of nonrepresentative trial participants.”
SOURCE: Gross C et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0798.
Checkpoint inhibitors got to melanoma, non–small cell lung cancer, and renal cell carcinoma patients quickly in clinical practice after Food and Drug Administration approval – usually within 4 months – but the patients treated in clinical settings tended to be older than those treated in trials, which has caused concern about whether real-world efficacy will prove to be the same, according to a study in JAMA Oncology.
“Such rapid adoption stands in contrast to older estimates that suggest it takes years or even decades for new treatments to be adopted,” wrote lead author Cary Gross, MD, professor of medicine at Yale University, New Haven, and his coauthors. “We found significant differences in age between patients treated in practice and those treated in trials, which highlights the need to clarify the risks and benefits of checkpoint inhibitors in general populations of patients.”
Researchers drew data on nivolumab and pembrolizumab use from the Flatiron Health longitudinal EHR database, which included 233 academic and community oncology practices. In each of the three disease cohorts, adoption was seen within 4 months for at least 60% of patients. Uptake was quickest for the melanoma patients, 76% of whom received a checkpoint inhibitor within 4 months, investigators wrote. Factors for the fast adoption could include high disease severity, a preference for novelty, perceived gains over existing treatments, and promotional activities, such as media reports and advertising directly to consumers, they wrote.
More patients in real-world practice were aged 65 years or older, ranging from as little as 61% at the lowest end of the range at one center to as much as 64% at the highest end at another. In the clinical trials, the percentage of patients aged 65 years or older ranged from 32% in one trial to 41% in another. Researchers wrote that these higher real-world rates are concerning because there are still questions regarding whether differences in immune responses will cause differences in efficacy between older and younger patients, as well as safety considerations among different age groups.
“Although data suggest that outcomes are similar between older and younger patients receiving anti–PD-1 agents for melanoma, there is little evidence to guide anti–PD-1 treatment of older patients with NSCLC [non–small cell lung cancer],” Dr. Gross and his coinvestigators wrote.
Investigators wrote that the findings are cause for caution.
“As FDA officials develop more flexible standards for approval, which the 21st Century Cures Act requires them to do, it is possible that many patients will receive drugs before much is known about clinical outcomes,” Dr. Gross said. “Further integrations of real-world evidence might allow the FDA to better assess the drugs that they approve on the basis of nonrepresentative trial participants.”
SOURCE: Gross C et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0798.
Checkpoint inhibitors got to melanoma, non–small cell lung cancer, and renal cell carcinoma patients quickly in clinical practice after Food and Drug Administration approval – usually within 4 months – but the patients treated in clinical settings tended to be older than those treated in trials, which has caused concern about whether real-world efficacy will prove to be the same, according to a study in JAMA Oncology.
“Such rapid adoption stands in contrast to older estimates that suggest it takes years or even decades for new treatments to be adopted,” wrote lead author Cary Gross, MD, professor of medicine at Yale University, New Haven, and his coauthors. “We found significant differences in age between patients treated in practice and those treated in trials, which highlights the need to clarify the risks and benefits of checkpoint inhibitors in general populations of patients.”
Researchers drew data on nivolumab and pembrolizumab use from the Flatiron Health longitudinal EHR database, which included 233 academic and community oncology practices. In each of the three disease cohorts, adoption was seen within 4 months for at least 60% of patients. Uptake was quickest for the melanoma patients, 76% of whom received a checkpoint inhibitor within 4 months, investigators wrote. Factors for the fast adoption could include high disease severity, a preference for novelty, perceived gains over existing treatments, and promotional activities, such as media reports and advertising directly to consumers, they wrote.
More patients in real-world practice were aged 65 years or older, ranging from as little as 61% at the lowest end of the range at one center to as much as 64% at the highest end at another. In the clinical trials, the percentage of patients aged 65 years or older ranged from 32% in one trial to 41% in another. Researchers wrote that these higher real-world rates are concerning because there are still questions regarding whether differences in immune responses will cause differences in efficacy between older and younger patients, as well as safety considerations among different age groups.
“Although data suggest that outcomes are similar between older and younger patients receiving anti–PD-1 agents for melanoma, there is little evidence to guide anti–PD-1 treatment of older patients with NSCLC [non–small cell lung cancer],” Dr. Gross and his coinvestigators wrote.
Investigators wrote that the findings are cause for caution.
“As FDA officials develop more flexible standards for approval, which the 21st Century Cures Act requires them to do, it is possible that many patients will receive drugs before much is known about clinical outcomes,” Dr. Gross said. “Further integrations of real-world evidence might allow the FDA to better assess the drugs that they approve on the basis of nonrepresentative trial participants.”
SOURCE: Gross C et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0798.
FROM JAMA ONCOLOGY
Key clinical point: Fast adoption but older patient age is seen in clinical use of checkpoint inhibitors.
Major finding: About 60% of patients were aged 65 years and older in clinical settings, compared with about 30%-40% in trials.
Study details: A retrospective study of data from the Flatiron Health longitudinal EHR database, which includes 233 academic and community practices.
Disclosures: The study was sponsored by the National Institutes of Health. Investigators reported receiving financial support from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, and other companies.
Source: Gross C et al. JAMA Oncology. 2018 May 10. doi: 10.1001/jamaoncol.2018.0798.