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Fungal infection can mimic lung cancer metastases
A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.
In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.
The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.
However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
Mistaken identity
Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.
Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.
Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.
“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
Challenging case
In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.
“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.
The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.
A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.
“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.
The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.
Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.
Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.
“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.
Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.
A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.
In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.
The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.
However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
Mistaken identity
Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.
Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.
Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.
“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
Challenging case
In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.
“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.
The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.
A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.
“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.
The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.
Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.
Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.
“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.
Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.
A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.
In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.
The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.
However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
Mistaken identity
Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.
Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.
Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.
“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
Challenging case
In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.
“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.
The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.
A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.
“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.
The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.
Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.
Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.
“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.
Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.
REPORTING FROM CHEST 2021
Pfizer offers refund if drug ‘doesn’t work’
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
Could your patient benefit? New trials in lung cancer
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Case report: Lung cancer shrinks in patient using CBD oil
A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.
The patient was an 80-year-old woman.
At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.
The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.
After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.
It was taken orally about two to three times a day.
Details of the case were published on October 14 in BMJ Case Reports.
“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.
“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.
The team also notes that there are similar case reports in the medical literature.
Both points were emphasized by experts reacting to the publication via the UK Science Media Center.
“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”
He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”
Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.
“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.
Patient declined recommended treatment
The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.
After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.
A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.
The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.
The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.
Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.
“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.
The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.
“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”
The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.
“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”
The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.
The patient was an 80-year-old woman.
At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.
The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.
After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.
It was taken orally about two to three times a day.
Details of the case were published on October 14 in BMJ Case Reports.
“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.
“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.
The team also notes that there are similar case reports in the medical literature.
Both points were emphasized by experts reacting to the publication via the UK Science Media Center.
“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”
He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”
Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.
“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.
Patient declined recommended treatment
The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.
After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.
A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.
The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.
The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.
Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.
“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.
The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.
“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”
The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.
“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”
The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.
The patient was an 80-year-old woman.
At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.
The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.
After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.
It was taken orally about two to three times a day.
Details of the case were published on October 14 in BMJ Case Reports.
“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.
“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.
The team also notes that there are similar case reports in the medical literature.
Both points were emphasized by experts reacting to the publication via the UK Science Media Center.
“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”
He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”
Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.
“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.
Patient declined recommended treatment
The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.
After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.
A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.
The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.
The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.
Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.
“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.
The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.
“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”
The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.
“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”
The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Early-Stage NSCLC Highlights From ESMO 2021
Benjamin Cooper, MD, director of Proton Therapy services at NYU Langone Health, shares key findings from early-stage non-small cell lung cancer (NSCLC) trials presented at the 2021 ESMO Congress.
Dr Cooper begins with the LungART trial, which evaluated whether postoperative radiotherapy (PORT) would benefit patients with completely resected NSCLC and mediastinal N2 involvement. Use of PORT reduced the risk of mediastinal relapse but did not show significant impact on disease-free survival (DFS).
Next, he turns to findings from the COAST trial, which compared durvalumab monotherapy, durvalumab plus oleclumab, and durvalumab plus monalizumab in patients with locally advanced, unresectable stage III NSCLC. Both combination regimens increased the objective response rate and significantly improved progression-free survival (PFS) vs durvalumab alone.
Dr Cooper also reviews sites of disease relapse and post-relapse treatment from IMpower010, which evaluated atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage IB-IIIA NSCLC. Similar patterns of relapse were seen across study arms, but patients with PD-L1 levels of 50% or higher experienced greatest DFS benefits.
Lastly, Dr Cooper highlights GEMSTONE-301, which tested the novel anti-PD-L1 drug sugemalimab in patients with unresectable, stage III NSCLC who did not progress after concurrent or sequential radiotherapy. There was a statistically significant and clinically meaningful PFS improvement in patients receiving sugemalimab compared to placebo.
--
Benjamin Cooper, MD, Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine, New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Benjamin Cooper, MD, director of Proton Therapy services at NYU Langone Health, shares key findings from early-stage non-small cell lung cancer (NSCLC) trials presented at the 2021 ESMO Congress.
Dr Cooper begins with the LungART trial, which evaluated whether postoperative radiotherapy (PORT) would benefit patients with completely resected NSCLC and mediastinal N2 involvement. Use of PORT reduced the risk of mediastinal relapse but did not show significant impact on disease-free survival (DFS).
Next, he turns to findings from the COAST trial, which compared durvalumab monotherapy, durvalumab plus oleclumab, and durvalumab plus monalizumab in patients with locally advanced, unresectable stage III NSCLC. Both combination regimens increased the objective response rate and significantly improved progression-free survival (PFS) vs durvalumab alone.
Dr Cooper also reviews sites of disease relapse and post-relapse treatment from IMpower010, which evaluated atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage IB-IIIA NSCLC. Similar patterns of relapse were seen across study arms, but patients with PD-L1 levels of 50% or higher experienced greatest DFS benefits.
Lastly, Dr Cooper highlights GEMSTONE-301, which tested the novel anti-PD-L1 drug sugemalimab in patients with unresectable, stage III NSCLC who did not progress after concurrent or sequential radiotherapy. There was a statistically significant and clinically meaningful PFS improvement in patients receiving sugemalimab compared to placebo.
--
Benjamin Cooper, MD, Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine, New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Benjamin Cooper, MD, director of Proton Therapy services at NYU Langone Health, shares key findings from early-stage non-small cell lung cancer (NSCLC) trials presented at the 2021 ESMO Congress.
Dr Cooper begins with the LungART trial, which evaluated whether postoperative radiotherapy (PORT) would benefit patients with completely resected NSCLC and mediastinal N2 involvement. Use of PORT reduced the risk of mediastinal relapse but did not show significant impact on disease-free survival (DFS).
Next, he turns to findings from the COAST trial, which compared durvalumab monotherapy, durvalumab plus oleclumab, and durvalumab plus monalizumab in patients with locally advanced, unresectable stage III NSCLC. Both combination regimens increased the objective response rate and significantly improved progression-free survival (PFS) vs durvalumab alone.
Dr Cooper also reviews sites of disease relapse and post-relapse treatment from IMpower010, which evaluated atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage IB-IIIA NSCLC. Similar patterns of relapse were seen across study arms, but patients with PD-L1 levels of 50% or higher experienced greatest DFS benefits.
Lastly, Dr Cooper highlights GEMSTONE-301, which tested the novel anti-PD-L1 drug sugemalimab in patients with unresectable, stage III NSCLC who did not progress after concurrent or sequential radiotherapy. There was a statistically significant and clinically meaningful PFS improvement in patients receiving sugemalimab compared to placebo.
--
Benjamin Cooper, MD, Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine, New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Many patients, doctors unaware of advancements in cancer care
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
‘Unprecedented’ 3-year sustained survival with lung cancer combo treatment
The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).
At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.
This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.
The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.
Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).
Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.
At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).
Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.
Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.
Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.
The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.
“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.
The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.
The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).
At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.
This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.
The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.
Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).
Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.
At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).
Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.
Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.
Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.
The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.
“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.
The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.
The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).
At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.
This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.
The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.
Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).
Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.
At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).
Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.
Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.
Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.
The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.
“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.
The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.
FROM ESMO 2021
Use of Biomarkers to Optimize Treatment of NSCLC
Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials.
Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease.
Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy.
Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials.
--
Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,
New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials.
Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease.
Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy.
Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials.
--
Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,
New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Benjamin Cooper, MD, Director of Proton Therapy at NYU Langone Health, discusses how physicians who treat patients with non-small cell lung cancer (NSCLC) can use genetic profiling results to select effective therapy. Although the current list of therapies is not applicable to all genetic mutations, there are approved treatments for several biomarkers and agents targeting other biomarkers are in clinical trials.
Dr. Cooper explains that biomarkers in NSCLC either boost the immune system’s capability to destroy oncogenes or they block driver and escape mutations that advance disease.
Immunotherapies that target either PD-1 or PD-L1 are now mainstays of NSCLC treatment. To gauge whether these therapies have potential effectiveness for a given patient, oncologists test for the presence of PD-L1 in the tumor. Higher expression of PD-L1 indicates stronger potential response to therapy.
Dr. Cooper then turns to a discussion of oncogenic driver mutations, focusing on EGFR, ALK, ROS1, BRAF, NTRK, RET, MET, KRAS, and HER2. Although there are hundreds of oncogenic driver mutations, not all are currently actionable. Effective therapy options have been available for EGFR, ALK, and BRAF for more than a decade, and treatments for other drivers such as NTRK, MET, KRAS, and HER2 have shown promising results in recent trials.
--
Benjamin Cooper, MD is an Assistant Professor, Department of Radiation Oncology, Director, Proton Therapy Services, NYU Grossman School of Medicine,
New York, New York
Benjamin Cooper, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca.
Response to preop immunotherapy predicts survival in early NSCLC
Although major pathological response after neoadjuvant cisplatin-based chemotherapy has been shown to predict survival in patients with early-stage NSCLC, this is the first time a similar association has been demonstrated with neoadjuvant immune checkpoint inhibition, Marie Wislez, MD, PhD, a researcher at Hopital Cochin, Paris, reported at the 2021 European Society of Medical Oncology Congress.
Primary outcomes of the multicenter trial showed 12- and 18-month OS of 89.1%, and 12- and 18-month DFS of 78.3% and 73.7%, respectively, in 46 patients treated with preoperative durvalumab. Median OS and DFS were not reached.
Major pathological response was observed in eight patients (18.6%), with three patients experiencing complete pathological response. No deaths or recurrences were observed in patients in this group. A significant association was observed between major pathological response and DFS. However, the study was stopped early because of excessive 90-day postoperative mortality, which the authors said were most likely related to comorbidities.
The current post hoc analysis of data from the study showed poorer overall survival and disease-free survival with increasing percentage of residual viable tumor (RVT) cells on multivariate prognostic analysis (hazard ratio, 1.05 and 1.06; P = .04 and .02, respectively), Dr. Wislez said in her presentation made on Sept. 18 (abstract 1151MO).
“For each 10% increase of RVT, you have an increased risk of death of 64% and increased risk of recurrence of 71%,” she said.
Study subjects, who were enrolled between April 2017 and August 2019, had a median age of 61 years, 67.4% were men, 98% were smokers or former smokes, and all had Eastern Cooperative Oncology Group performance status scores of 0-1. The median percentage of RVT cells was 36.11.
Of the 50 patients enrolled, 46 were eligible for and received durvalumab and 43 underwent surgery. Those with stages IB and 4 cm or greater tumor size to stage IIIA non-N2 NSCLC received three cycles of durvalumab before surgery. Durvalumab was given intravenously at a dose of 750 mg on days 1, 15, and 29, and surgery was performed 2-14 days after the last infusion.
Tissue specimens from patients who underwent neoadjuvant durvalumab and complete surgical resection were retrospectively evaluated by two pathologists blinded to patient outcomes, Dr. Wislez noted.
Session chair Michael Thomas, MD, of Thoraxklinik-Heidelberg at Heidelberg (Germany) University Hospital, described the study as “hypotheses generating,” and noted that it suggests incremental step-wise assessment of pathological response could be an additional tool for subgrouping of patients in upcoming trials.
Indeed, this novel finding suggests that the extent of pathological response could be considered as a surrogate marker for neoadjuvant treatment trials, although the use of a continuous variable would be challenging in the trial setting, Dr. Wislez agreed.
“But it’s a demonstration that [with] immunotherapy monotherapy ... the extent of pathological response is associated with overall survival,” she said.
This study was funded by AstraZeneca. Dr. Wislez reported honoraria from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche, Novartis, Merck, and MSD.
Although major pathological response after neoadjuvant cisplatin-based chemotherapy has been shown to predict survival in patients with early-stage NSCLC, this is the first time a similar association has been demonstrated with neoadjuvant immune checkpoint inhibition, Marie Wislez, MD, PhD, a researcher at Hopital Cochin, Paris, reported at the 2021 European Society of Medical Oncology Congress.
Primary outcomes of the multicenter trial showed 12- and 18-month OS of 89.1%, and 12- and 18-month DFS of 78.3% and 73.7%, respectively, in 46 patients treated with preoperative durvalumab. Median OS and DFS were not reached.
Major pathological response was observed in eight patients (18.6%), with three patients experiencing complete pathological response. No deaths or recurrences were observed in patients in this group. A significant association was observed between major pathological response and DFS. However, the study was stopped early because of excessive 90-day postoperative mortality, which the authors said were most likely related to comorbidities.
The current post hoc analysis of data from the study showed poorer overall survival and disease-free survival with increasing percentage of residual viable tumor (RVT) cells on multivariate prognostic analysis (hazard ratio, 1.05 and 1.06; P = .04 and .02, respectively), Dr. Wislez said in her presentation made on Sept. 18 (abstract 1151MO).
“For each 10% increase of RVT, you have an increased risk of death of 64% and increased risk of recurrence of 71%,” she said.
Study subjects, who were enrolled between April 2017 and August 2019, had a median age of 61 years, 67.4% were men, 98% were smokers or former smokes, and all had Eastern Cooperative Oncology Group performance status scores of 0-1. The median percentage of RVT cells was 36.11.
Of the 50 patients enrolled, 46 were eligible for and received durvalumab and 43 underwent surgery. Those with stages IB and 4 cm or greater tumor size to stage IIIA non-N2 NSCLC received three cycles of durvalumab before surgery. Durvalumab was given intravenously at a dose of 750 mg on days 1, 15, and 29, and surgery was performed 2-14 days after the last infusion.
Tissue specimens from patients who underwent neoadjuvant durvalumab and complete surgical resection were retrospectively evaluated by two pathologists blinded to patient outcomes, Dr. Wislez noted.
Session chair Michael Thomas, MD, of Thoraxklinik-Heidelberg at Heidelberg (Germany) University Hospital, described the study as “hypotheses generating,” and noted that it suggests incremental step-wise assessment of pathological response could be an additional tool for subgrouping of patients in upcoming trials.
Indeed, this novel finding suggests that the extent of pathological response could be considered as a surrogate marker for neoadjuvant treatment trials, although the use of a continuous variable would be challenging in the trial setting, Dr. Wislez agreed.
“But it’s a demonstration that [with] immunotherapy monotherapy ... the extent of pathological response is associated with overall survival,” she said.
This study was funded by AstraZeneca. Dr. Wislez reported honoraria from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche, Novartis, Merck, and MSD.
Although major pathological response after neoadjuvant cisplatin-based chemotherapy has been shown to predict survival in patients with early-stage NSCLC, this is the first time a similar association has been demonstrated with neoadjuvant immune checkpoint inhibition, Marie Wislez, MD, PhD, a researcher at Hopital Cochin, Paris, reported at the 2021 European Society of Medical Oncology Congress.
Primary outcomes of the multicenter trial showed 12- and 18-month OS of 89.1%, and 12- and 18-month DFS of 78.3% and 73.7%, respectively, in 46 patients treated with preoperative durvalumab. Median OS and DFS were not reached.
Major pathological response was observed in eight patients (18.6%), with three patients experiencing complete pathological response. No deaths or recurrences were observed in patients in this group. A significant association was observed between major pathological response and DFS. However, the study was stopped early because of excessive 90-day postoperative mortality, which the authors said were most likely related to comorbidities.
The current post hoc analysis of data from the study showed poorer overall survival and disease-free survival with increasing percentage of residual viable tumor (RVT) cells on multivariate prognostic analysis (hazard ratio, 1.05 and 1.06; P = .04 and .02, respectively), Dr. Wislez said in her presentation made on Sept. 18 (abstract 1151MO).
“For each 10% increase of RVT, you have an increased risk of death of 64% and increased risk of recurrence of 71%,” she said.
Study subjects, who were enrolled between April 2017 and August 2019, had a median age of 61 years, 67.4% were men, 98% were smokers or former smokes, and all had Eastern Cooperative Oncology Group performance status scores of 0-1. The median percentage of RVT cells was 36.11.
Of the 50 patients enrolled, 46 were eligible for and received durvalumab and 43 underwent surgery. Those with stages IB and 4 cm or greater tumor size to stage IIIA non-N2 NSCLC received three cycles of durvalumab before surgery. Durvalumab was given intravenously at a dose of 750 mg on days 1, 15, and 29, and surgery was performed 2-14 days after the last infusion.
Tissue specimens from patients who underwent neoadjuvant durvalumab and complete surgical resection were retrospectively evaluated by two pathologists blinded to patient outcomes, Dr. Wislez noted.
Session chair Michael Thomas, MD, of Thoraxklinik-Heidelberg at Heidelberg (Germany) University Hospital, described the study as “hypotheses generating,” and noted that it suggests incremental step-wise assessment of pathological response could be an additional tool for subgrouping of patients in upcoming trials.
Indeed, this novel finding suggests that the extent of pathological response could be considered as a surrogate marker for neoadjuvant treatment trials, although the use of a continuous variable would be challenging in the trial setting, Dr. Wislez agreed.
“But it’s a demonstration that [with] immunotherapy monotherapy ... the extent of pathological response is associated with overall survival,” she said.
This study was funded by AstraZeneca. Dr. Wislez reported honoraria from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche, Novartis, Merck, and MSD.
FROM ESMO 2021