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VIDEO: Checkpoint inhibitors show few efficacy, safety differences
VIENNA – The two subclasses of immune checkpoint inhibitor drugs showed very little basis for choosing between them by either efficacy or toxicity in a systematic review of 23 trials run in patients with non–small cell lung cancer during 2013-2016.
For efficacy, inhibitors of the programmed death (PD-1) receptors had a 19% overall response rate when averaged from 12 different trials with 3,284 patients on one of these drugs. The PD-ligand 1 (PD-L1) inhibitors produced a 17% overall response rate in 11 trials with 2,615 patients on one of the drugs, a between-class efficacy difference that was not statistically significant, Rathi N. Pillai, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
Immune-related adverse events were significantly more common in the patients treated with PD-1 inhibitors: 16%, compared with 11% in the PD-L1 inhibitor-treated patients (P = .04). The two subclasses also showed a trend toward a difference in the most common immune-related adverse event, hypothyroidism, with an incidence of 6.7% with PD-1 inhibitors and 4.2% with PD-L1 inhibitors (P = .07). The two sets of patients showed a statistically significant difference in the next most common immune-related adverse event, pneunomitis, 4.0% with PD-1 inhibitors and 2.0% with PD-L1 inhibitors (P = .02).
The trials with PD-1 inhibitors included nivolumab (Opdivo) and pembrolizumab (Keytruda). The trials with PD-L1 inhibitors included atezolizumab (Tecentriq), durvalumab, and avelumab. The total rate of all adverse events was highest among patients on nivolumab, 76%, and lowest among patients on durvalumab, 61%.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
This very important systematic review with data from a total of nearly 6,000 patients shows that severe toxicity is unusual with the PD-1 and PD-L1 inhibitors, and they result in no meaningful difference in response rates. The toxicities seen with these drugs are milder and less frequent than we see with standard chemotherapy drugs. The severe autoimmune toxicities seen are a major concern but are manageable and occurred at low rates.
In general, efficacy and toxicity does not appear to form a basis by which to choose among these drugs. Fatigue was the most common adverse event, which is surprising to see with these drugs although we are accustomed to seeing it in patients on standard chemotherapy. Fatigue can be a major issue for patients, even if it is relatively mild, because they remain on these drugs for periods as long as 2 years.
If the PD-1 and PD-L1 inhibitors continue to perform with similar efficacy and safety profiles, clinicians will be forced to turn to other parameters when trying to decide which drug specifically to prescribe. This can include issues of cost, reimbursement, and dosing convenience. Nivolumab, for example, has been administered more often, every 2 weeks, than the other drugs in these classes. Oncologists are trying to develop effective regimens with these drugs that can be given once every 3 or every 4 weeks. Future investigations may also look at the possibility of treating patients with these drugs initially for 6 months, and then scaling back to retreatment only when there is disease progression. If this approach is successful, it would obviate concerns about causing long-term fatigue or the inconvenience of more frequent treatment schedules.
We also need to continue to monitor and compare the toxicities of these immune checkpoint inhibitors as we move into using them in combination regimens.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Merck/MSD, Merck Serono, and Roche, and he has received honoraria from Merck and Roche, and he has received travel grants from BMS and Roche. He made these comments as the designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
This very important systematic review with data from a total of nearly 6,000 patients shows that severe toxicity is unusual with the PD-1 and PD-L1 inhibitors, and they result in no meaningful difference in response rates. The toxicities seen with these drugs are milder and less frequent than we see with standard chemotherapy drugs. The severe autoimmune toxicities seen are a major concern but are manageable and occurred at low rates.
In general, efficacy and toxicity does not appear to form a basis by which to choose among these drugs. Fatigue was the most common adverse event, which is surprising to see with these drugs although we are accustomed to seeing it in patients on standard chemotherapy. Fatigue can be a major issue for patients, even if it is relatively mild, because they remain on these drugs for periods as long as 2 years.
If the PD-1 and PD-L1 inhibitors continue to perform with similar efficacy and safety profiles, clinicians will be forced to turn to other parameters when trying to decide which drug specifically to prescribe. This can include issues of cost, reimbursement, and dosing convenience. Nivolumab, for example, has been administered more often, every 2 weeks, than the other drugs in these classes. Oncologists are trying to develop effective regimens with these drugs that can be given once every 3 or every 4 weeks. Future investigations may also look at the possibility of treating patients with these drugs initially for 6 months, and then scaling back to retreatment only when there is disease progression. If this approach is successful, it would obviate concerns about causing long-term fatigue or the inconvenience of more frequent treatment schedules.
We also need to continue to monitor and compare the toxicities of these immune checkpoint inhibitors as we move into using them in combination regimens.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Merck/MSD, Merck Serono, and Roche, and he has received honoraria from Merck and Roche, and he has received travel grants from BMS and Roche. He made these comments as the designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
This very important systematic review with data from a total of nearly 6,000 patients shows that severe toxicity is unusual with the PD-1 and PD-L1 inhibitors, and they result in no meaningful difference in response rates. The toxicities seen with these drugs are milder and less frequent than we see with standard chemotherapy drugs. The severe autoimmune toxicities seen are a major concern but are manageable and occurred at low rates.
In general, efficacy and toxicity does not appear to form a basis by which to choose among these drugs. Fatigue was the most common adverse event, which is surprising to see with these drugs although we are accustomed to seeing it in patients on standard chemotherapy. Fatigue can be a major issue for patients, even if it is relatively mild, because they remain on these drugs for periods as long as 2 years.
If the PD-1 and PD-L1 inhibitors continue to perform with similar efficacy and safety profiles, clinicians will be forced to turn to other parameters when trying to decide which drug specifically to prescribe. This can include issues of cost, reimbursement, and dosing convenience. Nivolumab, for example, has been administered more often, every 2 weeks, than the other drugs in these classes. Oncologists are trying to develop effective regimens with these drugs that can be given once every 3 or every 4 weeks. Future investigations may also look at the possibility of treating patients with these drugs initially for 6 months, and then scaling back to retreatment only when there is disease progression. If this approach is successful, it would obviate concerns about causing long-term fatigue or the inconvenience of more frequent treatment schedules.
We also need to continue to monitor and compare the toxicities of these immune checkpoint inhibitors as we move into using them in combination regimens.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Merck/MSD, Merck Serono, and Roche, and he has received honoraria from Merck and Roche, and he has received travel grants from BMS and Roche. He made these comments as the designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VIENNA – The two subclasses of immune checkpoint inhibitor drugs showed very little basis for choosing between them by either efficacy or toxicity in a systematic review of 23 trials run in patients with non–small cell lung cancer during 2013-2016.
For efficacy, inhibitors of the programmed death (PD-1) receptors had a 19% overall response rate when averaged from 12 different trials with 3,284 patients on one of these drugs. The PD-ligand 1 (PD-L1) inhibitors produced a 17% overall response rate in 11 trials with 2,615 patients on one of the drugs, a between-class efficacy difference that was not statistically significant, Rathi N. Pillai, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
Immune-related adverse events were significantly more common in the patients treated with PD-1 inhibitors: 16%, compared with 11% in the PD-L1 inhibitor-treated patients (P = .04). The two subclasses also showed a trend toward a difference in the most common immune-related adverse event, hypothyroidism, with an incidence of 6.7% with PD-1 inhibitors and 4.2% with PD-L1 inhibitors (P = .07). The two sets of patients showed a statistically significant difference in the next most common immune-related adverse event, pneunomitis, 4.0% with PD-1 inhibitors and 2.0% with PD-L1 inhibitors (P = .02).
The trials with PD-1 inhibitors included nivolumab (Opdivo) and pembrolizumab (Keytruda). The trials with PD-L1 inhibitors included atezolizumab (Tecentriq), durvalumab, and avelumab. The total rate of all adverse events was highest among patients on nivolumab, 76%, and lowest among patients on durvalumab, 61%.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
VIENNA – The two subclasses of immune checkpoint inhibitor drugs showed very little basis for choosing between them by either efficacy or toxicity in a systematic review of 23 trials run in patients with non–small cell lung cancer during 2013-2016.
For efficacy, inhibitors of the programmed death (PD-1) receptors had a 19% overall response rate when averaged from 12 different trials with 3,284 patients on one of these drugs. The PD-ligand 1 (PD-L1) inhibitors produced a 17% overall response rate in 11 trials with 2,615 patients on one of the drugs, a between-class efficacy difference that was not statistically significant, Rathi N. Pillai, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
Immune-related adverse events were significantly more common in the patients treated with PD-1 inhibitors: 16%, compared with 11% in the PD-L1 inhibitor-treated patients (P = .04). The two subclasses also showed a trend toward a difference in the most common immune-related adverse event, hypothyroidism, with an incidence of 6.7% with PD-1 inhibitors and 4.2% with PD-L1 inhibitors (P = .07). The two sets of patients showed a statistically significant difference in the next most common immune-related adverse event, pneunomitis, 4.0% with PD-1 inhibitors and 2.0% with PD-L1 inhibitors (P = .02).
The trials with PD-1 inhibitors included nivolumab (Opdivo) and pembrolizumab (Keytruda). The trials with PD-L1 inhibitors included atezolizumab (Tecentriq), durvalumab, and avelumab. The total rate of all adverse events was highest among patients on nivolumab, 76%, and lowest among patients on durvalumab, 61%.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT WCLC 2016
Key clinical point:
Major finding: Overall response rates were 19% using a PD-1 inhibitor and 17% when using a PD-L1 inhibitor.
Data source: A systematic review of 23 trials in patients with non–small cell lung cancer published during 2013-2016.
Disclosures: Dr. Pillai had no disclosures.
Nivolumab plus ipilimumab shines as first-line in advanced NSCLC
VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.
This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.
CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.
Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.
The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.
The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.
The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.
Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.
There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.
Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.
“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.
He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.
“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.
Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.
Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.
VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.
This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.
CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.
Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.
The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.
The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.
The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.
Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.
There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.
Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.
“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.
He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.
“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.
Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.
Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.
VIENNA – The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.
This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.
CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.
Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.
The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.
The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.
The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.
Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.
There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.
Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.
“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.
He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.
“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.
Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.
Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.
AT WCLC 2016
Key clinical point: A combination of two immunotherapy agents with different mechanisms of action produced impressive efficacy and acceptable toxicities as first-line therapy in patients with chemotherapy-naive advanced non–small cell lung cancer.
Major finding: in patients with any detectable tumor PD-L1 expression.
Data source: This analysis from a larger phase I study included 127 patients with no prior chemotherapy for advanced NSCLC.
Disclosures: The study presenter is a consultant to Bristol-Myers Squibb, which sponsored the CheckMate 012 trial.
VIDEO: Decision aids can relay relative risks to lung cancer patients
VIENNA – Many lung cancer patients would like to work with their physicians to reach a shared decision about their care, but often feel inadequately informed to comfortably participate in the decision process.
Patient decision aids offer a way to address this knowledge and participation gap, Laurie E. Gaspar, MD, said in a video interview at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
She and her associates have run an online survey that so far has received responses from 196 lung cancer patients, caregivers of patients, or significant others of patients. One hundred seventeen (60%) said that they faced a difficult management decision, but more than half these patients said they felt they had inadequate information to make their decision. The most popular form of decision making was a shared decision with their physician, favored by 73% of the respondents, but only about half the patients believed they had actually participated in a shared-decision process with their physician, reported Dr. Gaspar, professor of radiation oncology at the University of Colorado in Aurora.
“A majority of the patients felt there was a problem in not having sufficient information, and a majority want to make decisions in a shared way,” she explained.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
VIENNA – Many lung cancer patients would like to work with their physicians to reach a shared decision about their care, but often feel inadequately informed to comfortably participate in the decision process.
Patient decision aids offer a way to address this knowledge and participation gap, Laurie E. Gaspar, MD, said in a video interview at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
She and her associates have run an online survey that so far has received responses from 196 lung cancer patients, caregivers of patients, or significant others of patients. One hundred seventeen (60%) said that they faced a difficult management decision, but more than half these patients said they felt they had inadequate information to make their decision. The most popular form of decision making was a shared decision with their physician, favored by 73% of the respondents, but only about half the patients believed they had actually participated in a shared-decision process with their physician, reported Dr. Gaspar, professor of radiation oncology at the University of Colorado in Aurora.
“A majority of the patients felt there was a problem in not having sufficient information, and a majority want to make decisions in a shared way,” she explained.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
VIENNA – Many lung cancer patients would like to work with their physicians to reach a shared decision about their care, but often feel inadequately informed to comfortably participate in the decision process.
Patient decision aids offer a way to address this knowledge and participation gap, Laurie E. Gaspar, MD, said in a video interview at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
She and her associates have run an online survey that so far has received responses from 196 lung cancer patients, caregivers of patients, or significant others of patients. One hundred seventeen (60%) said that they faced a difficult management decision, but more than half these patients said they felt they had inadequate information to make their decision. The most popular form of decision making was a shared decision with their physician, favored by 73% of the respondents, but only about half the patients believed they had actually participated in a shared-decision process with their physician, reported Dr. Gaspar, professor of radiation oncology at the University of Colorado in Aurora.
“A majority of the patients felt there was a problem in not having sufficient information, and a majority want to make decisions in a shared way,” she explained.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
At WCLC 2016
Key clinical point:
Major finding: A shared-decision process received support from 73% of patients, but just half believed they participated in shared decision making.
Data source: Online survey completed by 196 lung cancer patients, caregivers or significant others.
Disclosures: Dr. Gaspar had no disclosures.
Centers of excellence program raises quality bar in lung cancer management
VIENNA – A grassroots, patient-centric program aimed at encouraging U.S. community hospitals in underserved areas to adopt a comprehensive centers-of-excellence model for treatment of lung cancer has demonstrated that community cancer centers can achieve quality of care comparable to that found in academic medical centers, Raymond Osarogiagbon, MD, declared at the World Congress on Lung Cancer.
One major reason why aggregate lung cancer survival in the United States has barely inched upward during the past 3 decades is there is often a huge gap between the quality of care patients get at academic research centers – including access to clinical trials – and what they can get in community hospitals. Eighty percent of lung cancer patients receive their care in these community cancer centers, where not all physicians and surgeons may be up to speed with guideline-recommended best practices, observed Dr. Osarogiagbon, a medical oncologist and director of the multidisciplinary thoracic oncology program at Baptist Cancer Center in Memphis.
The centers of excellence program, supported by the Bonnie J. Addario Lung Cancer Foundation, is an attempt to address this disparity. In 3 years, 13 hospitals in areas with large underserved patient populations in nine states have qualified. Dr. Osarogiagbon anticipates that the competitive advantage this designation provides will spur more and more community hospitals with cancer centers to get on board.
To qualify, community cancer centers have to commit to following specific best practices as standards of care in accord with guidelines issued by groups including the National Comprehensive Cancer Network and the American Society of Clinical Oncology. Requirements include the use of multidisciplinary teams for treatment decisions, routine use of molecular diagnostics and targeted therapies, patient access to clinical trials, longitudinal institutional data tracking, patient and caregiver education programs, and minimally invasive surgical and staging techniques. A lung cancer screening program is required. So is a systematic program for management of all incidentally detected lung nodules, many of which today fall between the cracks.
In an interview, Dr. Osarogiagbon shared several examples of how achieving the foundation’s center of excellence designation enables community cancer centers to achieve top-quality care on a par with academic medical centers. At Memorial Cancer Institute in Hollywood, Fla., which serves large Hispanic and black populations, implementation of a lung cancer screening program and other measures has resulted in 40% of patients with lung cancer being diagnosed with stage 1 or 2 disease amenable to curative surgery. The overall U.S. rate is significantly lower at 29%.
And in an area composed of western Tennessee, northern Mississippi, and eastern Arkansas, Dr. Osarogiagbon and coinvestigators at the Baptist Cancer Center conducted a study demonstrating that the use of two complementary surgical staging interventions resulted in improved rates of guideline-recommended surgical staging quality.
The observational study, presented elsewhere at the world congress by Nicholas Faris, MD, of the Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, entailed analysis of curative-intent resections in 2,094 patients with non–small-cell lung cancer during 2004-2016. A novel anatomically sound gross dissection protocol was provided to assist pathologists in retrieving the intrapulmonary lymph nodes required for staging in 161 patients undergoing curative resection. A special lymph node specimen collection kit was utilized in 152. Another 289 resections utilized both interventions. And 1,492 patients received neither intervention.
Use of the interventions was associated with higher rates of adherence to various professional organizations’ guidelines for high-quality surgical staging. For example, the American College of Surgeons Commission on Cancer recommends that at least 10 lymph nodes be examined in patients with stage 1a-2b NSCLC. This was achieved in 71% of patients who had both interventions, 56% of those where the lymph node specimen collection kit was utilized but not the pathology intervention, 48% of patients where the pathology intervention but not the kit was employed, and in only 25% of patients where neither was used.
Similarly, more than three mediastinal lymph node stations were sampled in accord with National Comprehensive Cancer Network guidelines in 96% of patients with both interventions, 90% with the lymph node collection kit, 54% with the pathology intervention, and only 44% with neither, Dr. Osarogiagbon said in the interview.
Dr. Osarogiagbon reported serving as a consultant to Eli Lilly, Genentech, and the Association of Community Cancer Centers.
VIENNA – A grassroots, patient-centric program aimed at encouraging U.S. community hospitals in underserved areas to adopt a comprehensive centers-of-excellence model for treatment of lung cancer has demonstrated that community cancer centers can achieve quality of care comparable to that found in academic medical centers, Raymond Osarogiagbon, MD, declared at the World Congress on Lung Cancer.
One major reason why aggregate lung cancer survival in the United States has barely inched upward during the past 3 decades is there is often a huge gap between the quality of care patients get at academic research centers – including access to clinical trials – and what they can get in community hospitals. Eighty percent of lung cancer patients receive their care in these community cancer centers, where not all physicians and surgeons may be up to speed with guideline-recommended best practices, observed Dr. Osarogiagbon, a medical oncologist and director of the multidisciplinary thoracic oncology program at Baptist Cancer Center in Memphis.
The centers of excellence program, supported by the Bonnie J. Addario Lung Cancer Foundation, is an attempt to address this disparity. In 3 years, 13 hospitals in areas with large underserved patient populations in nine states have qualified. Dr. Osarogiagbon anticipates that the competitive advantage this designation provides will spur more and more community hospitals with cancer centers to get on board.
To qualify, community cancer centers have to commit to following specific best practices as standards of care in accord with guidelines issued by groups including the National Comprehensive Cancer Network and the American Society of Clinical Oncology. Requirements include the use of multidisciplinary teams for treatment decisions, routine use of molecular diagnostics and targeted therapies, patient access to clinical trials, longitudinal institutional data tracking, patient and caregiver education programs, and minimally invasive surgical and staging techniques. A lung cancer screening program is required. So is a systematic program for management of all incidentally detected lung nodules, many of which today fall between the cracks.
In an interview, Dr. Osarogiagbon shared several examples of how achieving the foundation’s center of excellence designation enables community cancer centers to achieve top-quality care on a par with academic medical centers. At Memorial Cancer Institute in Hollywood, Fla., which serves large Hispanic and black populations, implementation of a lung cancer screening program and other measures has resulted in 40% of patients with lung cancer being diagnosed with stage 1 or 2 disease amenable to curative surgery. The overall U.S. rate is significantly lower at 29%.
And in an area composed of western Tennessee, northern Mississippi, and eastern Arkansas, Dr. Osarogiagbon and coinvestigators at the Baptist Cancer Center conducted a study demonstrating that the use of two complementary surgical staging interventions resulted in improved rates of guideline-recommended surgical staging quality.
The observational study, presented elsewhere at the world congress by Nicholas Faris, MD, of the Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, entailed analysis of curative-intent resections in 2,094 patients with non–small-cell lung cancer during 2004-2016. A novel anatomically sound gross dissection protocol was provided to assist pathologists in retrieving the intrapulmonary lymph nodes required for staging in 161 patients undergoing curative resection. A special lymph node specimen collection kit was utilized in 152. Another 289 resections utilized both interventions. And 1,492 patients received neither intervention.
Use of the interventions was associated with higher rates of adherence to various professional organizations’ guidelines for high-quality surgical staging. For example, the American College of Surgeons Commission on Cancer recommends that at least 10 lymph nodes be examined in patients with stage 1a-2b NSCLC. This was achieved in 71% of patients who had both interventions, 56% of those where the lymph node specimen collection kit was utilized but not the pathology intervention, 48% of patients where the pathology intervention but not the kit was employed, and in only 25% of patients where neither was used.
Similarly, more than three mediastinal lymph node stations were sampled in accord with National Comprehensive Cancer Network guidelines in 96% of patients with both interventions, 90% with the lymph node collection kit, 54% with the pathology intervention, and only 44% with neither, Dr. Osarogiagbon said in the interview.
Dr. Osarogiagbon reported serving as a consultant to Eli Lilly, Genentech, and the Association of Community Cancer Centers.
VIENNA – A grassroots, patient-centric program aimed at encouraging U.S. community hospitals in underserved areas to adopt a comprehensive centers-of-excellence model for treatment of lung cancer has demonstrated that community cancer centers can achieve quality of care comparable to that found in academic medical centers, Raymond Osarogiagbon, MD, declared at the World Congress on Lung Cancer.
One major reason why aggregate lung cancer survival in the United States has barely inched upward during the past 3 decades is there is often a huge gap between the quality of care patients get at academic research centers – including access to clinical trials – and what they can get in community hospitals. Eighty percent of lung cancer patients receive their care in these community cancer centers, where not all physicians and surgeons may be up to speed with guideline-recommended best practices, observed Dr. Osarogiagbon, a medical oncologist and director of the multidisciplinary thoracic oncology program at Baptist Cancer Center in Memphis.
The centers of excellence program, supported by the Bonnie J. Addario Lung Cancer Foundation, is an attempt to address this disparity. In 3 years, 13 hospitals in areas with large underserved patient populations in nine states have qualified. Dr. Osarogiagbon anticipates that the competitive advantage this designation provides will spur more and more community hospitals with cancer centers to get on board.
To qualify, community cancer centers have to commit to following specific best practices as standards of care in accord with guidelines issued by groups including the National Comprehensive Cancer Network and the American Society of Clinical Oncology. Requirements include the use of multidisciplinary teams for treatment decisions, routine use of molecular diagnostics and targeted therapies, patient access to clinical trials, longitudinal institutional data tracking, patient and caregiver education programs, and minimally invasive surgical and staging techniques. A lung cancer screening program is required. So is a systematic program for management of all incidentally detected lung nodules, many of which today fall between the cracks.
In an interview, Dr. Osarogiagbon shared several examples of how achieving the foundation’s center of excellence designation enables community cancer centers to achieve top-quality care on a par with academic medical centers. At Memorial Cancer Institute in Hollywood, Fla., which serves large Hispanic and black populations, implementation of a lung cancer screening program and other measures has resulted in 40% of patients with lung cancer being diagnosed with stage 1 or 2 disease amenable to curative surgery. The overall U.S. rate is significantly lower at 29%.
And in an area composed of western Tennessee, northern Mississippi, and eastern Arkansas, Dr. Osarogiagbon and coinvestigators at the Baptist Cancer Center conducted a study demonstrating that the use of two complementary surgical staging interventions resulted in improved rates of guideline-recommended surgical staging quality.
The observational study, presented elsewhere at the world congress by Nicholas Faris, MD, of the Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, entailed analysis of curative-intent resections in 2,094 patients with non–small-cell lung cancer during 2004-2016. A novel anatomically sound gross dissection protocol was provided to assist pathologists in retrieving the intrapulmonary lymph nodes required for staging in 161 patients undergoing curative resection. A special lymph node specimen collection kit was utilized in 152. Another 289 resections utilized both interventions. And 1,492 patients received neither intervention.
Use of the interventions was associated with higher rates of adherence to various professional organizations’ guidelines for high-quality surgical staging. For example, the American College of Surgeons Commission on Cancer recommends that at least 10 lymph nodes be examined in patients with stage 1a-2b NSCLC. This was achieved in 71% of patients who had both interventions, 56% of those where the lymph node specimen collection kit was utilized but not the pathology intervention, 48% of patients where the pathology intervention but not the kit was employed, and in only 25% of patients where neither was used.
Similarly, more than three mediastinal lymph node stations were sampled in accord with National Comprehensive Cancer Network guidelines in 96% of patients with both interventions, 90% with the lymph node collection kit, 54% with the pathology intervention, and only 44% with neither, Dr. Osarogiagbon said in the interview.
Dr. Osarogiagbon reported serving as a consultant to Eli Lilly, Genentech, and the Association of Community Cancer Centers.
EXPERT ANALYSIS FROM WCLC 2016
Checkpoint inhibitors for lung cancer figure prominently at WCLC 2016
Oncology Practice will be on-site this coming week at the 17th World Conference on Lung Cancer in Vienna with the latest on checkpoint inhibitors and other treatments for lung cancer. Look for coverage of the best clinical presentations at the conference, hosted by the International Association for the Study of Lung Cancer, including the following and more, beginning Sunday, Dec. 4.
OA03.01 - First-Line Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Patients With Advanced NSCLC: Long-Term Outcomes from CheckMate 012.
OA03.02 - Atezolizumab as 1L Therapy for Advanced NSCLC in PD-L1–Selected Patients: Updated ORR, PFS, and OS Data From the BIRCH Study.
OA03.03 - JAVELIN Solid Tumor: Safety and Clinical Activity of Avelumab (Anti–PD-L1) as First-Line Treatment in Patients With Advanced NSCLC.
OA03.05 - Analysis of Early Survival in Patients With Advanced Nonsquamous NSCLC Treated With Nivolumab vs. Docetaxel in CheckMate 057.
OA03.07 - KEYNOTE-010: Durable Clinical Benefit in Patients With Previously Treated, PD-L1–Expressing NSCLC Who Completed Pembrolizumab.
OA05.01 - Pembrolizumab in Patients With Extensive-Stage Small Cell Lung Cancer: Updated Survival Results from KEYNOTE-028.
OA13.03 - Long-Term Overall Survival for Patients With Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028.
PL03.03 - Randomised Phase III Study of Osimertinib vs. Platinum-Pemetrexed for EGFR T790M-Positive Advanced NSCLC (AURA3).
PL03.05 - BRAIN: A Phase III Trial Comparing WBI and Chemotherapy With Icotinib in NSCLC With Brain Metastases Harboring EGFR Mutations (CTONG 1201).
PL03.07 - First-line Ceritinib Versus Chemotherapy in Patients With ALK-Rearranged (ALK+) NSCLC: A Randomized, Phase III Study (ASCEND-4).
PL03.09 - Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel versus Docetaxel in Advanced Non–Small Cell Lung Cancer (GALAXY-2).
PL04a.01 - Health-Related Quality of Life for Pembrolizumab vs. Chemotherapy in Advanced NSCLC With PD-L1 TPS Greater Than or Equal to 50%: Data From KEYNOTE-024.
PL04a.02 - OAK, a Randomized Phase III Study of Atezolizumab vs. Docetaxel in Patients With Advanced NSCLC: Results From Subgroup Analyses.
PL04a.03 - Durvalumab in 3rd-Line Locally Advanced or Metastatic, EGFR/ALK Wild-Type NSCLC: Results from the Phase II ATLANTIC Study.
MA09.02 - Pembrolizumab + Carboplatin and Pemetrexed as 1st-Line Therapy for Advanced Non–Small Cell Lung Cancer: KEYNOTE-021.
MA09.11 - Efficacy and Safety of Necitumumab and Pembrolizumab Combination Therapy in Stage IV Nonsquamous Non–Small Cell Lung Cancer.
Oncology Practice will be on-site this coming week at the 17th World Conference on Lung Cancer in Vienna with the latest on checkpoint inhibitors and other treatments for lung cancer. Look for coverage of the best clinical presentations at the conference, hosted by the International Association for the Study of Lung Cancer, including the following and more, beginning Sunday, Dec. 4.
OA03.01 - First-Line Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Patients With Advanced NSCLC: Long-Term Outcomes from CheckMate 012.
OA03.02 - Atezolizumab as 1L Therapy for Advanced NSCLC in PD-L1–Selected Patients: Updated ORR, PFS, and OS Data From the BIRCH Study.
OA03.03 - JAVELIN Solid Tumor: Safety and Clinical Activity of Avelumab (Anti–PD-L1) as First-Line Treatment in Patients With Advanced NSCLC.
OA03.05 - Analysis of Early Survival in Patients With Advanced Nonsquamous NSCLC Treated With Nivolumab vs. Docetaxel in CheckMate 057.
OA03.07 - KEYNOTE-010: Durable Clinical Benefit in Patients With Previously Treated, PD-L1–Expressing NSCLC Who Completed Pembrolizumab.
OA05.01 - Pembrolizumab in Patients With Extensive-Stage Small Cell Lung Cancer: Updated Survival Results from KEYNOTE-028.
OA13.03 - Long-Term Overall Survival for Patients With Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028.
PL03.03 - Randomised Phase III Study of Osimertinib vs. Platinum-Pemetrexed for EGFR T790M-Positive Advanced NSCLC (AURA3).
PL03.05 - BRAIN: A Phase III Trial Comparing WBI and Chemotherapy With Icotinib in NSCLC With Brain Metastases Harboring EGFR Mutations (CTONG 1201).
PL03.07 - First-line Ceritinib Versus Chemotherapy in Patients With ALK-Rearranged (ALK+) NSCLC: A Randomized, Phase III Study (ASCEND-4).
PL03.09 - Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel versus Docetaxel in Advanced Non–Small Cell Lung Cancer (GALAXY-2).
PL04a.01 - Health-Related Quality of Life for Pembrolizumab vs. Chemotherapy in Advanced NSCLC With PD-L1 TPS Greater Than or Equal to 50%: Data From KEYNOTE-024.
PL04a.02 - OAK, a Randomized Phase III Study of Atezolizumab vs. Docetaxel in Patients With Advanced NSCLC: Results From Subgroup Analyses.
PL04a.03 - Durvalumab in 3rd-Line Locally Advanced or Metastatic, EGFR/ALK Wild-Type NSCLC: Results from the Phase II ATLANTIC Study.
MA09.02 - Pembrolizumab + Carboplatin and Pemetrexed as 1st-Line Therapy for Advanced Non–Small Cell Lung Cancer: KEYNOTE-021.
MA09.11 - Efficacy and Safety of Necitumumab and Pembrolizumab Combination Therapy in Stage IV Nonsquamous Non–Small Cell Lung Cancer.
Oncology Practice will be on-site this coming week at the 17th World Conference on Lung Cancer in Vienna with the latest on checkpoint inhibitors and other treatments for lung cancer. Look for coverage of the best clinical presentations at the conference, hosted by the International Association for the Study of Lung Cancer, including the following and more, beginning Sunday, Dec. 4.
OA03.01 - First-Line Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Patients With Advanced NSCLC: Long-Term Outcomes from CheckMate 012.
OA03.02 - Atezolizumab as 1L Therapy for Advanced NSCLC in PD-L1–Selected Patients: Updated ORR, PFS, and OS Data From the BIRCH Study.
OA03.03 - JAVELIN Solid Tumor: Safety and Clinical Activity of Avelumab (Anti–PD-L1) as First-Line Treatment in Patients With Advanced NSCLC.
OA03.05 - Analysis of Early Survival in Patients With Advanced Nonsquamous NSCLC Treated With Nivolumab vs. Docetaxel in CheckMate 057.
OA03.07 - KEYNOTE-010: Durable Clinical Benefit in Patients With Previously Treated, PD-L1–Expressing NSCLC Who Completed Pembrolizumab.
OA05.01 - Pembrolizumab in Patients With Extensive-Stage Small Cell Lung Cancer: Updated Survival Results from KEYNOTE-028.
OA13.03 - Long-Term Overall Survival for Patients With Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028.
PL03.03 - Randomised Phase III Study of Osimertinib vs. Platinum-Pemetrexed for EGFR T790M-Positive Advanced NSCLC (AURA3).
PL03.05 - BRAIN: A Phase III Trial Comparing WBI and Chemotherapy With Icotinib in NSCLC With Brain Metastases Harboring EGFR Mutations (CTONG 1201).
PL03.07 - First-line Ceritinib Versus Chemotherapy in Patients With ALK-Rearranged (ALK+) NSCLC: A Randomized, Phase III Study (ASCEND-4).
PL03.09 - Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel versus Docetaxel in Advanced Non–Small Cell Lung Cancer (GALAXY-2).
PL04a.01 - Health-Related Quality of Life for Pembrolizumab vs. Chemotherapy in Advanced NSCLC With PD-L1 TPS Greater Than or Equal to 50%: Data From KEYNOTE-024.
PL04a.02 - OAK, a Randomized Phase III Study of Atezolizumab vs. Docetaxel in Patients With Advanced NSCLC: Results From Subgroup Analyses.
PL04a.03 - Durvalumab in 3rd-Line Locally Advanced or Metastatic, EGFR/ALK Wild-Type NSCLC: Results from the Phase II ATLANTIC Study.
MA09.02 - Pembrolizumab + Carboplatin and Pemetrexed as 1st-Line Therapy for Advanced Non–Small Cell Lung Cancer: KEYNOTE-021.
MA09.11 - Efficacy and Safety of Necitumumab and Pembrolizumab Combination Therapy in Stage IV Nonsquamous Non–Small Cell Lung Cancer.
FROM WCLC 2016