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What the first authorized DNA cancer risk test can and can’t tell you
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
Short-course SBRT: Standard of care in prostate cancer?
SAN DIEGO – delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.
Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.
The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.
“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.
Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.
But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
An international trial
PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.
In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).
At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.
Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.
The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.
At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).
Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.
Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.
Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.
Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”
The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.
In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”
PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.
A version of this article first appeared on Medscape.com.
SAN DIEGO – delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.
Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.
The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.
“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.
Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.
But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
An international trial
PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.
In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).
At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.
Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.
The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.
At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).
Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.
Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.
Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.
Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”
The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.
In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”
PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.
A version of this article first appeared on Medscape.com.
SAN DIEGO – delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.
Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.
The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.
“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.
Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.
But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
An international trial
PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.
In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).
At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.
Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.
The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.
At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).
Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.
Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.
Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.
Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”
The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.
In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”
PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.
A version of this article first appeared on Medscape.com.
AT ASTRO 2023
Cost concerns lead to cancer treatment delays, nonadherence
TOPLINE:
METHODOLOGY:
- Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
- To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
- The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
- Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.
TAKEAWAY:
- Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
- After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
- Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
- Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.
IN PRACTICE:
- “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.
SOURCE:
- The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.
LIMITATIONS:
The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.
DISCLOSURES:
The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
- To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
- The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
- Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.
TAKEAWAY:
- Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
- After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
- Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
- Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.
IN PRACTICE:
- “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.
SOURCE:
- The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.
LIMITATIONS:
The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.
DISCLOSURES:
The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
- To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
- The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
- Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.
TAKEAWAY:
- Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
- After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
- Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
- Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.
IN PRACTICE:
- “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.
SOURCE:
- The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.
LIMITATIONS:
The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.
DISCLOSURES:
The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS AND PREVENTION
Cancer incidence has increased in patients under age 50
Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.
Early-onset cancer
Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.
Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
Increase in deaths
There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.
The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.
“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
Industrialized countries
The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.
In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.
On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
Hypotheses and limitations
How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.
The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.
For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”
They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”
The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
Trend in the United States
Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.
In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.
Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.
Early-onset cancer
Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.
Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
Increase in deaths
There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.
The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.
“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
Industrialized countries
The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.
In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.
On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
Hypotheses and limitations
How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.
The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.
For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”
They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”
The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
Trend in the United States
Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.
In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.
Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.
Early-onset cancer
Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.
Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
Increase in deaths
There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.
The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.
“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
Industrialized countries
The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.
In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.
On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
Hypotheses and limitations
How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.
The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.
For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”
They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”
The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
Trend in the United States
Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.
In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.
from bmj oncology
Survey: Lack of awareness hampers cancer prevention efforts
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
Prostate cancer screening guidelines: To PSA or not to PSA
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
In the United States this year, approximately 288,300 men will be newly diagnosed with prostate cancer and about 34,700 men will die from this disease. It is the second leading cause of cancer in men, and one out of every eight men will be diagnosed with this cancer at some point in their lives.
As primary care physicians, a large part of our role is to prevent or detect cancers early. Patients look to us for this guidance. However, prostate cancer screening has long been a controversial issue. Earlier this year, the American Urological Association along with the Society of Urologic Oncology published updated guidelines.
Clear recommendations that come from this set of guidelines that are relevant to primary care physicians include:
- using PSA as the screening test of choice.
- repeating PSA in patients with newly elevated results before moving on to other test.
- offering PSA screening every 2-4 years in patients aged 50-69 years.
- offering baseline screening in those between 45-50 years of age.
In high-risk patients, screening can be initiated at 40-45 years of age. All of these recommendations come with the caveat that we give the patient all the pros and cons and leave it up to their “values and preferences.”
The guidelines make recommendations regarding PSA screening and biopsy standards. These guidelines are very specific in their recommendations; however, the question about whether to do PSA screening in the first place is left open to debate. While shared decision-making is important with any testing, it is more difficult with prostate cancer screening. Patients need to understand that there are possible adverse events that can result because of an elevated PSA, such as unneeded biopsies that may come with complications.
The authors of this set of guidelines suggest that physicians talk to patients more often about the benefits of the screening than they do about the negative consequences. This assumes that a negative biopsy result is an unnecessary test, which is not a fair assessment. Negative test results can provide useful clinical information. While a PSA result may lead to a biopsy that could have possibly been avoided, we don’t have any better screening tests available. Missing a prostate cancer that could have been detected by PSA screening is also very harmful. Deciding whether to do PSA screening for any given patient then becomes a difficult question.
More research into biomarkers to detect prostate cancer is needed, as suggested by the guideline authors. As primary care doctors, we’re the first ones to order these tests and make decisions regarding the results. While we may not be the ones to do the biopsies, we do need to know when to refer the patients to specialists or when we can just repeat the test.
Population health is often the benchmark used when looking at screening guidelines. But in the primary care setting, we are responsible for individual patients. Applying guidelines that take whole populations into consideration often doesn’t translate well to single patients. We do need to make them responsible for their own health care decisions but, at the same time, we need to offer them some guidance. If the guidelines are clear, this is easy. When they suggest giving patients all the pros and cons and letting them make their own decision, this is hard. Some of them want us to tell them what to do.
Additionally, patients in the primary care setting develop close relationships with their physicians. They are not an elevated PSA test or a negative biopsy result. They have concerns and fears. When they are high risk, the advice is easy. Keeping in mind that prostate cancer is the second leading cause of cancer in men in the United States, we should have clear screening guidelines, such as we do with mammograms in women. Yes, shared decision-making is important, but we also need to know the answer when our patients ask us whether or not they should have a PSA test done.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.
Is this the best screening test for prostate cancer?
In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI.
Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.
Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.
David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”
PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.
The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.
In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.
Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.
Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.
Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.
But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.
Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.
“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.
Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.
But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.
Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.
“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.
The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”
Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.
A version of this article appeared on Medscape.com.
In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI.
Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.
Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.
David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”
PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.
The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.
In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.
Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.
Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.
Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.
But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.
Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.
“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.
Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.
But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.
Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.
“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.
The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”
Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.
A version of this article appeared on Medscape.com.
In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI.
Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.
Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.
David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”
PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.
The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.
In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.
Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.
Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.
Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.
But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.
Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.
“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.
Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.
But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.
Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.
“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.
The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”
Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.
A version of this article appeared on Medscape.com.
Clinically Significant Transition Zone Prostate Cancer Detected by UroNav MRI/TRUS Fusion Biopsy in Active Surveillance Prostate Cancer Patients
OBJECTIVE
UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.
METHODS
We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.
RESULTS
Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.
CONCLUSIONS
The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.
OBJECTIVE
UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.
METHODS
We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.
RESULTS
Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.
CONCLUSIONS
The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.
OBJECTIVE
UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.
METHODS
We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.
RESULTS
Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.
CONCLUSIONS
The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.
Detection of Prostate Cancer in the Transitional Zone by Using a UroNav Biopsy
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
A Novel Prostate Cancer Tracker Program
BACKGROUND
Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.
METHODS
The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.
RESULTS
At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.
CONCLUSIONS
The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.
BACKGROUND
Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.
METHODS
The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.
RESULTS
At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.
CONCLUSIONS
The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.
BACKGROUND
Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.
METHODS
The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.
RESULTS
At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.
CONCLUSIONS
The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.