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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
Optimizing Symptom Management in VA Oncology: A Workflow-Based Quality Improvement Initiative
Background
Enhancing symptom assessment and management of patients undergoing cancer treatment presents several challenges, ranging from workflow integration to application of evidenced-based interventions (Minteer, et al., 2023). Previously, our team conducted a VA mixed-methods study and identified a lack of standardized approaches for symptom assessment, lack of technology support to optimize workflows, and the need for adaptable workflows that reflect both facility and patient preferences. In response, the National Oncology Program Office at Palo Alto VA (PAVA) launched the Proactive Patient-Centered Care Program (PPP) to address these care gaps and develop a feasible, replicable, sustainable workflow to guide broader VA-wide implementation based on prior work conducted by the PAVA team (Banks, et al., 2024).
Methods
Prior to launch, the PPP team engaged oncology leadership in VISN21 and VISN22. Long Beach VA (LBVA) was selected as the initial pilot implementation site. A multidisciplinary group from PAVA and LBVA comprised of oncology and palliative care clinicians, nurses, pharmacists, a lay health worker, and project manager guided the workflow adaptations. To support scalability and sustainability, the Empowering Learning, Innovation, and experiences through Implementation of health Informatics (ELIXIR) team designed an electronic health record agnostic technology-enabled tool to support workflow. The group met weekly to bi-monthly over 5 months, virtually and two in-person sessions, to map current practices, co-develop workflows, and identify key decisions regarding patient eligibility criteria, frequency of symptom assessments, triage responsibilities, escalation protocols, and closed-loop communication processes.
Results
A technology-enabled workflow was developed to deploy proactive symptom assessment and management across VA oncology sites with streamlined coordination between peer support staff and clinicians along with technology to support timely interventions.
Conclusions
Process improvement for symptom management requires on the ground adaptation even within an integrated health system like the VA. This initiative underscores the need for multidisciplinary collaboration, sustainability, and technology integration to support long-term intervention fidelity and scalability. The workflow developed will guide the PPP program’s expansion to LBVA, with patient enrollment beginning May 2025. The approach used to develop this workflow will serve as a model for standardizing supportive care processes across the VA to account for local needs.
Background
Enhancing symptom assessment and management of patients undergoing cancer treatment presents several challenges, ranging from workflow integration to application of evidenced-based interventions (Minteer, et al., 2023). Previously, our team conducted a VA mixed-methods study and identified a lack of standardized approaches for symptom assessment, lack of technology support to optimize workflows, and the need for adaptable workflows that reflect both facility and patient preferences. In response, the National Oncology Program Office at Palo Alto VA (PAVA) launched the Proactive Patient-Centered Care Program (PPP) to address these care gaps and develop a feasible, replicable, sustainable workflow to guide broader VA-wide implementation based on prior work conducted by the PAVA team (Banks, et al., 2024).
Methods
Prior to launch, the PPP team engaged oncology leadership in VISN21 and VISN22. Long Beach VA (LBVA) was selected as the initial pilot implementation site. A multidisciplinary group from PAVA and LBVA comprised of oncology and palliative care clinicians, nurses, pharmacists, a lay health worker, and project manager guided the workflow adaptations. To support scalability and sustainability, the Empowering Learning, Innovation, and experiences through Implementation of health Informatics (ELIXIR) team designed an electronic health record agnostic technology-enabled tool to support workflow. The group met weekly to bi-monthly over 5 months, virtually and two in-person sessions, to map current practices, co-develop workflows, and identify key decisions regarding patient eligibility criteria, frequency of symptom assessments, triage responsibilities, escalation protocols, and closed-loop communication processes.
Results
A technology-enabled workflow was developed to deploy proactive symptom assessment and management across VA oncology sites with streamlined coordination between peer support staff and clinicians along with technology to support timely interventions.
Conclusions
Process improvement for symptom management requires on the ground adaptation even within an integrated health system like the VA. This initiative underscores the need for multidisciplinary collaboration, sustainability, and technology integration to support long-term intervention fidelity and scalability. The workflow developed will guide the PPP program’s expansion to LBVA, with patient enrollment beginning May 2025. The approach used to develop this workflow will serve as a model for standardizing supportive care processes across the VA to account for local needs.
Background
Enhancing symptom assessment and management of patients undergoing cancer treatment presents several challenges, ranging from workflow integration to application of evidenced-based interventions (Minteer, et al., 2023). Previously, our team conducted a VA mixed-methods study and identified a lack of standardized approaches for symptom assessment, lack of technology support to optimize workflows, and the need for adaptable workflows that reflect both facility and patient preferences. In response, the National Oncology Program Office at Palo Alto VA (PAVA) launched the Proactive Patient-Centered Care Program (PPP) to address these care gaps and develop a feasible, replicable, sustainable workflow to guide broader VA-wide implementation based on prior work conducted by the PAVA team (Banks, et al., 2024).
Methods
Prior to launch, the PPP team engaged oncology leadership in VISN21 and VISN22. Long Beach VA (LBVA) was selected as the initial pilot implementation site. A multidisciplinary group from PAVA and LBVA comprised of oncology and palliative care clinicians, nurses, pharmacists, a lay health worker, and project manager guided the workflow adaptations. To support scalability and sustainability, the Empowering Learning, Innovation, and experiences through Implementation of health Informatics (ELIXIR) team designed an electronic health record agnostic technology-enabled tool to support workflow. The group met weekly to bi-monthly over 5 months, virtually and two in-person sessions, to map current practices, co-develop workflows, and identify key decisions regarding patient eligibility criteria, frequency of symptom assessments, triage responsibilities, escalation protocols, and closed-loop communication processes.
Results
A technology-enabled workflow was developed to deploy proactive symptom assessment and management across VA oncology sites with streamlined coordination between peer support staff and clinicians along with technology to support timely interventions.
Conclusions
Process improvement for symptom management requires on the ground adaptation even within an integrated health system like the VA. This initiative underscores the need for multidisciplinary collaboration, sustainability, and technology integration to support long-term intervention fidelity and scalability. The workflow developed will guide the PPP program’s expansion to LBVA, with patient enrollment beginning May 2025. The approach used to develop this workflow will serve as a model for standardizing supportive care processes across the VA to account for local needs.
Virtual Reality: An Innovative Approach to Cancer Distress Management
Objective
To assess the impact of virtual reality on the distress and pain levels of oncology patients in a VA outpatient infusion clinic.
Background
It is known that distress in cancer care leads to several problems including decreased survival, decreased treatment adherence, and inability to make treatment decisions. Virtual reality (VR) has proven to be beneficial to Veterans suffering from stress, anxiety, and other mental health ailments. This VA Oncology Infusion clinic is assessing the impact of VR on its Veterans’ distress and pain levels.
Methods
The pilot phase will last from 3/5/25- 9/5/25. Prior to each VR session, Veterans are administered an NCCN cancer distress screening tool and a numerical pain assessment. Post-VR session, Veterans are reassessed for distress and pain. The veterans are asked the following questions after each session: 1) Would you recommend VR to other veterans? and 2) Was the VR headset easy to use? Each VR session is approximately 10-15 minutes long, and the Veterans choose to engage in mindfulness activities, breathing exercises, or view scenery of their choice.
Results
Preliminary results indicate receptiveness and positive experiences amongst Veterans. 66% of Veterans who have used the VR headset have demonstrated a decrease in Cancer Distress by at least 2 points after a 10–15-minute VR session. 92% of Veterans that have used the VR headset report that it is easy to use and that they would recommend it to other Veterans.
Feasibility
The VA has created the Extended Reality Network (XR) to support the implementation of VR at the local site level. Resources and training are widely available to ensure program success.
Sustainability and Impact
A clearly developed standard of work and protocol that is tailored to the local site’s workflow, including a VR champion is needed to ensure sustainability. Preliminary data shows that veterans are engaged and responding positively to this innovative approach to cancer distress management, as evidenced by decreased distress levels and anxiety.
Objective
To assess the impact of virtual reality on the distress and pain levels of oncology patients in a VA outpatient infusion clinic.
Background
It is known that distress in cancer care leads to several problems including decreased survival, decreased treatment adherence, and inability to make treatment decisions. Virtual reality (VR) has proven to be beneficial to Veterans suffering from stress, anxiety, and other mental health ailments. This VA Oncology Infusion clinic is assessing the impact of VR on its Veterans’ distress and pain levels.
Methods
The pilot phase will last from 3/5/25- 9/5/25. Prior to each VR session, Veterans are administered an NCCN cancer distress screening tool and a numerical pain assessment. Post-VR session, Veterans are reassessed for distress and pain. The veterans are asked the following questions after each session: 1) Would you recommend VR to other veterans? and 2) Was the VR headset easy to use? Each VR session is approximately 10-15 minutes long, and the Veterans choose to engage in mindfulness activities, breathing exercises, or view scenery of their choice.
Results
Preliminary results indicate receptiveness and positive experiences amongst Veterans. 66% of Veterans who have used the VR headset have demonstrated a decrease in Cancer Distress by at least 2 points after a 10–15-minute VR session. 92% of Veterans that have used the VR headset report that it is easy to use and that they would recommend it to other Veterans.
Feasibility
The VA has created the Extended Reality Network (XR) to support the implementation of VR at the local site level. Resources and training are widely available to ensure program success.
Sustainability and Impact
A clearly developed standard of work and protocol that is tailored to the local site’s workflow, including a VR champion is needed to ensure sustainability. Preliminary data shows that veterans are engaged and responding positively to this innovative approach to cancer distress management, as evidenced by decreased distress levels and anxiety.
Objective
To assess the impact of virtual reality on the distress and pain levels of oncology patients in a VA outpatient infusion clinic.
Background
It is known that distress in cancer care leads to several problems including decreased survival, decreased treatment adherence, and inability to make treatment decisions. Virtual reality (VR) has proven to be beneficial to Veterans suffering from stress, anxiety, and other mental health ailments. This VA Oncology Infusion clinic is assessing the impact of VR on its Veterans’ distress and pain levels.
Methods
The pilot phase will last from 3/5/25- 9/5/25. Prior to each VR session, Veterans are administered an NCCN cancer distress screening tool and a numerical pain assessment. Post-VR session, Veterans are reassessed for distress and pain. The veterans are asked the following questions after each session: 1) Would you recommend VR to other veterans? and 2) Was the VR headset easy to use? Each VR session is approximately 10-15 minutes long, and the Veterans choose to engage in mindfulness activities, breathing exercises, or view scenery of their choice.
Results
Preliminary results indicate receptiveness and positive experiences amongst Veterans. 66% of Veterans who have used the VR headset have demonstrated a decrease in Cancer Distress by at least 2 points after a 10–15-minute VR session. 92% of Veterans that have used the VR headset report that it is easy to use and that they would recommend it to other Veterans.
Feasibility
The VA has created the Extended Reality Network (XR) to support the implementation of VR at the local site level. Resources and training are widely available to ensure program success.
Sustainability and Impact
A clearly developed standard of work and protocol that is tailored to the local site’s workflow, including a VR champion is needed to ensure sustainability. Preliminary data shows that veterans are engaged and responding positively to this innovative approach to cancer distress management, as evidenced by decreased distress levels and anxiety.
Red Wine May Not Be a Health Tonic, But Is It a Cancer Risk?
Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.
But, when it comes to cancer risk, are all types of alcohol created equal?
For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.
The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.
Although wine’s health halo is dwindling, there might be an exception: Cancer risk.
Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.
“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”
The Knowns About Alcohol and Cancer Risk
Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”
Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)
“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).
Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.
Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.
Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.
As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.
“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”
Hints That Wine Is an Outlier
Still, some studies suggest that how people ingest ethanol could make a difference.
A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).
Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).
The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.
This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.
“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”
Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.
The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.
Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.
In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”
Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.
In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.
“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”
A Conversation Few Are Having
Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.
A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.
“What we know right now is, physicians almost never talk about this,” LoConte said.
That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.
It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.
“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”
Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”
A version of this article appeared on Medscape.com.
Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.
But, when it comes to cancer risk, are all types of alcohol created equal?
For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.
The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.
Although wine’s health halo is dwindling, there might be an exception: Cancer risk.
Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.
“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”
The Knowns About Alcohol and Cancer Risk
Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”
Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)
“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).
Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.
Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.
Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.
As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.
“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”
Hints That Wine Is an Outlier
Still, some studies suggest that how people ingest ethanol could make a difference.
A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).
Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).
The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.
This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.
“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”
Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.
The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.
Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.
In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”
Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.
In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.
“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”
A Conversation Few Are Having
Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.
A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.
“What we know right now is, physicians almost never talk about this,” LoConte said.
That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.
It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.
“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”
Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”
A version of this article appeared on Medscape.com.
Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.
But, when it comes to cancer risk, are all types of alcohol created equal?
For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.
The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.
Although wine’s health halo is dwindling, there might be an exception: Cancer risk.
Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.
“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”
The Knowns About Alcohol and Cancer Risk
Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”
Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)
“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).
Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.
Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.
Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.
As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.
“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”
Hints That Wine Is an Outlier
Still, some studies suggest that how people ingest ethanol could make a difference.
A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).
Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).
The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.
This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.
“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”
Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.
The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.
Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.
In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”
Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.
In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.
“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”
A Conversation Few Are Having
Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.
A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.
“What we know right now is, physicians almost never talk about this,” LoConte said.
That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.
It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.
“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”
Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”
A version of this article appeared on Medscape.com.
CDK 4/6 Blocker Prolongs Survival in HER2+ Metastatic Breast Cancer
according to the results of the phase 3 PATINA study.
This regimen “may represent a new standard of care” for these patients, said principal investigator and presenter Otto Metzger, MD, a medical breast oncologist at the Dana-Farber Cancer Institute in Boston, Massachusetts, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024.
The open-label PATINA trial, which was conducted in Europe, Australia, New Zealand, and the United States, included a total of 518 patients. Patients received first-line treatment of six to eight cycles of induction chemotherapy plus anti-HER2 therapy. Researchers then randomized patients to either palbociclib plus anti-HER2 and endocrine therapy (n = 261) or to anti-HER2 and endocrine therapy alone (n = 257).
Patients did not progress on induction therapy, which likely would have signaled early resistance to anti-HER2 treatment. For anti-HER2 therapy, 97.3% received a combination of trastuzumab and pertuzumab. For endocrine therapy, 90.9% received an aromatase inhibitor.
Metzger and colleagues found that median progression-free survival was 1.3 years longer in patients receiving palbociclib — 3.7 years in the palbociclib arm vs 2.4 years in the control group (hazard ratio [HR], 0.74; P = .0074).
Although overall survival outcomes are immature, 5-year survival rates were slightly better in the palbociclib arm — 74.3% with palbociclib vs 69.8% without it — but the difference was not statistically significant.
Grade 3 neutropenia was the most frequent adverse event in the palbociclib arm (63.2% vs 2%). Grades 2 and 3 fatigue, stomatitis, and diarrhea were also more common with palbociclib. Grade 4 adverse events occurred in 12.3% of those receiving palbociclib and 8.9% of those who did not. There were no treatment-related deaths.
“We’re very impressed with the results,” said Metzger.
On the basis of previous studies, it’s believed that CDK 4/6 inhibition counteracts the development of resistance to anti-HER2 and endocrine therapies, which likely explains the benefit found in the trial.
But even without CDK 4/6 inhibition, the progression-free survival of 2.4 years in the control arm “far exceed[ed] our expectations,” Metzger reported. This may have occurred because the control arm received endocrine therapy, something previous trials of anti-HER2 therapy have avoided because of tolerability and other concerns.
These findings, however, support “the common use of endocrine therapy,” Metzger said.
‘Incredible’ Results
The progression-free survival as well as overall survival results in the trial are “incredible,” said study discussant Sara Hurvitz, MD, a medical breast oncologist at the Fred Hutch Cancer Center in Seattle, Washington. This is “historic and very important data.”
Hurvitz even suggested the results might mean that patients who fit the PATINA criteria can avoid the toxicity of upfront trastuzumab deruxtecan and use the PATINA regimen instead, potentially preserving their quality of life for longer.
Another study discussant, Virginia Kaklamani, MD, a medical breast oncologist at the University of Texas MD Anderson Cancer Center, San Antonio, had a similar thought.
In PATINA, “we’re talking about patients being on a treatment that’s well tolerated, where patients continue to work and continue with their lives despite being on treatment for metastatic breast cancer for 4 years, which is remarkable,” Kaklamani said.
Many of us have dabbled with giving CDK 4/6 inhibitors in triple-positive breast cancer, but “now we have more definitive data,” she said. The approach can help “maintain the quality of life of our patients for a longer period of time” and delay the use of chemotherapy in the second line, she added.
Metzger said Pfizer, the maker of palbociclib, plans to file for a HER2-positive indication with the Food and Drug Administration based on the trial results.
For now, the CDK 4/6 blocker is only indicated in combination with endocrine therapy for HR-positive, HER2-negative metastatic disease.
In response to a question about using the PATINA regimen in patients who don’t get chemotherapy induction, Metzger noted that, “while the study didn’t test this directly, I would argue that this data is quite compelling” for using palbociclib plus anti-HER2 and endocrine therapy, even without chemotherapy induction.
The work was funded by palbociclib maker Pfizer. Metzger had no disclosures. Hurvitz has numerous industry ties, including being a researcher and advisor to Pfizer. Kaklamani also has numerous industry ties, including reporting personal/consulting fees from Pfizer Canada.
A version of this article first appeared on Medscape.com.
according to the results of the phase 3 PATINA study.
This regimen “may represent a new standard of care” for these patients, said principal investigator and presenter Otto Metzger, MD, a medical breast oncologist at the Dana-Farber Cancer Institute in Boston, Massachusetts, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024.
The open-label PATINA trial, which was conducted in Europe, Australia, New Zealand, and the United States, included a total of 518 patients. Patients received first-line treatment of six to eight cycles of induction chemotherapy plus anti-HER2 therapy. Researchers then randomized patients to either palbociclib plus anti-HER2 and endocrine therapy (n = 261) or to anti-HER2 and endocrine therapy alone (n = 257).
Patients did not progress on induction therapy, which likely would have signaled early resistance to anti-HER2 treatment. For anti-HER2 therapy, 97.3% received a combination of trastuzumab and pertuzumab. For endocrine therapy, 90.9% received an aromatase inhibitor.
Metzger and colleagues found that median progression-free survival was 1.3 years longer in patients receiving palbociclib — 3.7 years in the palbociclib arm vs 2.4 years in the control group (hazard ratio [HR], 0.74; P = .0074).
Although overall survival outcomes are immature, 5-year survival rates were slightly better in the palbociclib arm — 74.3% with palbociclib vs 69.8% without it — but the difference was not statistically significant.
Grade 3 neutropenia was the most frequent adverse event in the palbociclib arm (63.2% vs 2%). Grades 2 and 3 fatigue, stomatitis, and diarrhea were also more common with palbociclib. Grade 4 adverse events occurred in 12.3% of those receiving palbociclib and 8.9% of those who did not. There were no treatment-related deaths.
“We’re very impressed with the results,” said Metzger.
On the basis of previous studies, it’s believed that CDK 4/6 inhibition counteracts the development of resistance to anti-HER2 and endocrine therapies, which likely explains the benefit found in the trial.
But even without CDK 4/6 inhibition, the progression-free survival of 2.4 years in the control arm “far exceed[ed] our expectations,” Metzger reported. This may have occurred because the control arm received endocrine therapy, something previous trials of anti-HER2 therapy have avoided because of tolerability and other concerns.
These findings, however, support “the common use of endocrine therapy,” Metzger said.
‘Incredible’ Results
The progression-free survival as well as overall survival results in the trial are “incredible,” said study discussant Sara Hurvitz, MD, a medical breast oncologist at the Fred Hutch Cancer Center in Seattle, Washington. This is “historic and very important data.”
Hurvitz even suggested the results might mean that patients who fit the PATINA criteria can avoid the toxicity of upfront trastuzumab deruxtecan and use the PATINA regimen instead, potentially preserving their quality of life for longer.
Another study discussant, Virginia Kaklamani, MD, a medical breast oncologist at the University of Texas MD Anderson Cancer Center, San Antonio, had a similar thought.
In PATINA, “we’re talking about patients being on a treatment that’s well tolerated, where patients continue to work and continue with their lives despite being on treatment for metastatic breast cancer for 4 years, which is remarkable,” Kaklamani said.
Many of us have dabbled with giving CDK 4/6 inhibitors in triple-positive breast cancer, but “now we have more definitive data,” she said. The approach can help “maintain the quality of life of our patients for a longer period of time” and delay the use of chemotherapy in the second line, she added.
Metzger said Pfizer, the maker of palbociclib, plans to file for a HER2-positive indication with the Food and Drug Administration based on the trial results.
For now, the CDK 4/6 blocker is only indicated in combination with endocrine therapy for HR-positive, HER2-negative metastatic disease.
In response to a question about using the PATINA regimen in patients who don’t get chemotherapy induction, Metzger noted that, “while the study didn’t test this directly, I would argue that this data is quite compelling” for using palbociclib plus anti-HER2 and endocrine therapy, even without chemotherapy induction.
The work was funded by palbociclib maker Pfizer. Metzger had no disclosures. Hurvitz has numerous industry ties, including being a researcher and advisor to Pfizer. Kaklamani also has numerous industry ties, including reporting personal/consulting fees from Pfizer Canada.
A version of this article first appeared on Medscape.com.
according to the results of the phase 3 PATINA study.
This regimen “may represent a new standard of care” for these patients, said principal investigator and presenter Otto Metzger, MD, a medical breast oncologist at the Dana-Farber Cancer Institute in Boston, Massachusetts, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024.
The open-label PATINA trial, which was conducted in Europe, Australia, New Zealand, and the United States, included a total of 518 patients. Patients received first-line treatment of six to eight cycles of induction chemotherapy plus anti-HER2 therapy. Researchers then randomized patients to either palbociclib plus anti-HER2 and endocrine therapy (n = 261) or to anti-HER2 and endocrine therapy alone (n = 257).
Patients did not progress on induction therapy, which likely would have signaled early resistance to anti-HER2 treatment. For anti-HER2 therapy, 97.3% received a combination of trastuzumab and pertuzumab. For endocrine therapy, 90.9% received an aromatase inhibitor.
Metzger and colleagues found that median progression-free survival was 1.3 years longer in patients receiving palbociclib — 3.7 years in the palbociclib arm vs 2.4 years in the control group (hazard ratio [HR], 0.74; P = .0074).
Although overall survival outcomes are immature, 5-year survival rates were slightly better in the palbociclib arm — 74.3% with palbociclib vs 69.8% without it — but the difference was not statistically significant.
Grade 3 neutropenia was the most frequent adverse event in the palbociclib arm (63.2% vs 2%). Grades 2 and 3 fatigue, stomatitis, and diarrhea were also more common with palbociclib. Grade 4 adverse events occurred in 12.3% of those receiving palbociclib and 8.9% of those who did not. There were no treatment-related deaths.
“We’re very impressed with the results,” said Metzger.
On the basis of previous studies, it’s believed that CDK 4/6 inhibition counteracts the development of resistance to anti-HER2 and endocrine therapies, which likely explains the benefit found in the trial.
But even without CDK 4/6 inhibition, the progression-free survival of 2.4 years in the control arm “far exceed[ed] our expectations,” Metzger reported. This may have occurred because the control arm received endocrine therapy, something previous trials of anti-HER2 therapy have avoided because of tolerability and other concerns.
These findings, however, support “the common use of endocrine therapy,” Metzger said.
‘Incredible’ Results
The progression-free survival as well as overall survival results in the trial are “incredible,” said study discussant Sara Hurvitz, MD, a medical breast oncologist at the Fred Hutch Cancer Center in Seattle, Washington. This is “historic and very important data.”
Hurvitz even suggested the results might mean that patients who fit the PATINA criteria can avoid the toxicity of upfront trastuzumab deruxtecan and use the PATINA regimen instead, potentially preserving their quality of life for longer.
Another study discussant, Virginia Kaklamani, MD, a medical breast oncologist at the University of Texas MD Anderson Cancer Center, San Antonio, had a similar thought.
In PATINA, “we’re talking about patients being on a treatment that’s well tolerated, where patients continue to work and continue with their lives despite being on treatment for metastatic breast cancer for 4 years, which is remarkable,” Kaklamani said.
Many of us have dabbled with giving CDK 4/6 inhibitors in triple-positive breast cancer, but “now we have more definitive data,” she said. The approach can help “maintain the quality of life of our patients for a longer period of time” and delay the use of chemotherapy in the second line, she added.
Metzger said Pfizer, the maker of palbociclib, plans to file for a HER2-positive indication with the Food and Drug Administration based on the trial results.
For now, the CDK 4/6 blocker is only indicated in combination with endocrine therapy for HR-positive, HER2-negative metastatic disease.
In response to a question about using the PATINA regimen in patients who don’t get chemotherapy induction, Metzger noted that, “while the study didn’t test this directly, I would argue that this data is quite compelling” for using palbociclib plus anti-HER2 and endocrine therapy, even without chemotherapy induction.
The work was funded by palbociclib maker Pfizer. Metzger had no disclosures. Hurvitz has numerous industry ties, including being a researcher and advisor to Pfizer. Kaklamani also has numerous industry ties, including reporting personal/consulting fees from Pfizer Canada.
A version of this article first appeared on Medscape.com.
FROM SABCS 2024
Dietary Calcium Cuts Colorectal Cancer Risk by 17%
Cancer Research UK (CRUK), which funded the study, said that it demonstrated the benefits of a healthy, balanced diet for lowering cancer risk.
Colorectal cancer is the third most common cancer worldwide. Incidence rates vary markedly, with higher rates observed in high-income countries. The risk increases for individuals who migrate from low- to high-incidence areas, suggesting that lifestyle and environmental factors contribute to its development.
While alcohol and processed meats are established carcinogens, and red meat is classified as probably carcinogenic, there is a lack of consensus regarding the relationships between other dietary factors and colorectal cancer risk. This uncertainty may be due, at least in part, to relatively few studies giving comprehensive results on all food types, as well as dietary measurement errors, and/or small sample sizes.
Study Tracked 97 Dietary Factors
To address these gaps, the research team, led by the University of Oxford in England, tracked the intake of 97 dietary factors in 542,778 women from 2001 for an average of 16.6 years. During this period 12,251 participants developed colorectal cancer. The women completed detailed dietary questionnaires at baseline, with 7% participating in at least one subsequent 24-hour online dietary assessment.
Women diagnosed with colorectal cancer were generally older, taller, more likely to have a family history of bowel cancer, and have more adverse health behaviors, compared with participants overall.
Calcium Intake Showed the Strongest Protective Association
Relative risks (RR) for colorectal cancer were calculated for intakes of all 97 dietary factors, with significant associations found for 17 of them. Calcium intake showed the strongest protective effect, with each additional 300 mg per day – equivalent to a large glass of milk – associated with a 17% reduced RR.
Six dairy-related factors associated with calcium – dairy milk, yogurt, riboflavin, magnesium, phosphorus, and potassium intakes – also demonstrated inverse associations with colorectal cancer risk. Weaker protective effects were noted for breakfast cereal, fruit, wholegrains, carbohydrates, fibre, total sugars, folate, and vitamin C. However, the team commented that these inverse associations might reflect residual confounding from other lifestyle or other dietary factors.
Calcium’s protective role was independent of dairy milk intake. The study, published in Nature Communications, concluded that, while “dairy products help protect against colorectal cancer,” that protection is “driven largely or wholly by calcium.”
Alcohol and Processed Meat Confirmed as Risk Factors
As expected, alcohol showed the reverse association, with each additional 20 g daily – equivalent to one large glass of wine – associated with a 15% RR increase. Weaker associations were seen for the combined category of red and processed meat, with each additional 30 g per day associated with an 8% increased RR for colorectal cancer. This association was minimally affected by diet and lifestyle factors.
Commenting to the Science Media Centre (SMC), Tom Sanders, professor emeritus of nutrition and dietetics at King’s College London, England, said: “One theory is that the calcium may bind to free bile acids in the gut, preventing the harmful effects of free bile acids on gut mucosa.” However, the lactose content in milk also has effects on large bowel microflora, which may in turn affect risk.
Also commenting to the SMC, David Nunan, senior research fellow at the University of Oxford’s Centre for Evidence Based Medicine, who was not involved in the study, cautioned that the findings were subject to the bias inherent in observational studies. “These biases often inflate the estimated associations compared to controlled experiments,” he said. Nunan advised caution in interpreting the findings, as more robust research, such as randomized controlled trials, would be needed to establish causation.
A version of this article first appeared on Medscape.com.
Cancer Research UK (CRUK), which funded the study, said that it demonstrated the benefits of a healthy, balanced diet for lowering cancer risk.
Colorectal cancer is the third most common cancer worldwide. Incidence rates vary markedly, with higher rates observed in high-income countries. The risk increases for individuals who migrate from low- to high-incidence areas, suggesting that lifestyle and environmental factors contribute to its development.
While alcohol and processed meats are established carcinogens, and red meat is classified as probably carcinogenic, there is a lack of consensus regarding the relationships between other dietary factors and colorectal cancer risk. This uncertainty may be due, at least in part, to relatively few studies giving comprehensive results on all food types, as well as dietary measurement errors, and/or small sample sizes.
Study Tracked 97 Dietary Factors
To address these gaps, the research team, led by the University of Oxford in England, tracked the intake of 97 dietary factors in 542,778 women from 2001 for an average of 16.6 years. During this period 12,251 participants developed colorectal cancer. The women completed detailed dietary questionnaires at baseline, with 7% participating in at least one subsequent 24-hour online dietary assessment.
Women diagnosed with colorectal cancer were generally older, taller, more likely to have a family history of bowel cancer, and have more adverse health behaviors, compared with participants overall.
Calcium Intake Showed the Strongest Protective Association
Relative risks (RR) for colorectal cancer were calculated for intakes of all 97 dietary factors, with significant associations found for 17 of them. Calcium intake showed the strongest protective effect, with each additional 300 mg per day – equivalent to a large glass of milk – associated with a 17% reduced RR.
Six dairy-related factors associated with calcium – dairy milk, yogurt, riboflavin, magnesium, phosphorus, and potassium intakes – also demonstrated inverse associations with colorectal cancer risk. Weaker protective effects were noted for breakfast cereal, fruit, wholegrains, carbohydrates, fibre, total sugars, folate, and vitamin C. However, the team commented that these inverse associations might reflect residual confounding from other lifestyle or other dietary factors.
Calcium’s protective role was independent of dairy milk intake. The study, published in Nature Communications, concluded that, while “dairy products help protect against colorectal cancer,” that protection is “driven largely or wholly by calcium.”
Alcohol and Processed Meat Confirmed as Risk Factors
As expected, alcohol showed the reverse association, with each additional 20 g daily – equivalent to one large glass of wine – associated with a 15% RR increase. Weaker associations were seen for the combined category of red and processed meat, with each additional 30 g per day associated with an 8% increased RR for colorectal cancer. This association was minimally affected by diet and lifestyle factors.
Commenting to the Science Media Centre (SMC), Tom Sanders, professor emeritus of nutrition and dietetics at King’s College London, England, said: “One theory is that the calcium may bind to free bile acids in the gut, preventing the harmful effects of free bile acids on gut mucosa.” However, the lactose content in milk also has effects on large bowel microflora, which may in turn affect risk.
Also commenting to the SMC, David Nunan, senior research fellow at the University of Oxford’s Centre for Evidence Based Medicine, who was not involved in the study, cautioned that the findings were subject to the bias inherent in observational studies. “These biases often inflate the estimated associations compared to controlled experiments,” he said. Nunan advised caution in interpreting the findings, as more robust research, such as randomized controlled trials, would be needed to establish causation.
A version of this article first appeared on Medscape.com.
Cancer Research UK (CRUK), which funded the study, said that it demonstrated the benefits of a healthy, balanced diet for lowering cancer risk.
Colorectal cancer is the third most common cancer worldwide. Incidence rates vary markedly, with higher rates observed in high-income countries. The risk increases for individuals who migrate from low- to high-incidence areas, suggesting that lifestyle and environmental factors contribute to its development.
While alcohol and processed meats are established carcinogens, and red meat is classified as probably carcinogenic, there is a lack of consensus regarding the relationships between other dietary factors and colorectal cancer risk. This uncertainty may be due, at least in part, to relatively few studies giving comprehensive results on all food types, as well as dietary measurement errors, and/or small sample sizes.
Study Tracked 97 Dietary Factors
To address these gaps, the research team, led by the University of Oxford in England, tracked the intake of 97 dietary factors in 542,778 women from 2001 for an average of 16.6 years. During this period 12,251 participants developed colorectal cancer. The women completed detailed dietary questionnaires at baseline, with 7% participating in at least one subsequent 24-hour online dietary assessment.
Women diagnosed with colorectal cancer were generally older, taller, more likely to have a family history of bowel cancer, and have more adverse health behaviors, compared with participants overall.
Calcium Intake Showed the Strongest Protective Association
Relative risks (RR) for colorectal cancer were calculated for intakes of all 97 dietary factors, with significant associations found for 17 of them. Calcium intake showed the strongest protective effect, with each additional 300 mg per day – equivalent to a large glass of milk – associated with a 17% reduced RR.
Six dairy-related factors associated with calcium – dairy milk, yogurt, riboflavin, magnesium, phosphorus, and potassium intakes – also demonstrated inverse associations with colorectal cancer risk. Weaker protective effects were noted for breakfast cereal, fruit, wholegrains, carbohydrates, fibre, total sugars, folate, and vitamin C. However, the team commented that these inverse associations might reflect residual confounding from other lifestyle or other dietary factors.
Calcium’s protective role was independent of dairy milk intake. The study, published in Nature Communications, concluded that, while “dairy products help protect against colorectal cancer,” that protection is “driven largely or wholly by calcium.”
Alcohol and Processed Meat Confirmed as Risk Factors
As expected, alcohol showed the reverse association, with each additional 20 g daily – equivalent to one large glass of wine – associated with a 15% RR increase. Weaker associations were seen for the combined category of red and processed meat, with each additional 30 g per day associated with an 8% increased RR for colorectal cancer. This association was minimally affected by diet and lifestyle factors.
Commenting to the Science Media Centre (SMC), Tom Sanders, professor emeritus of nutrition and dietetics at King’s College London, England, said: “One theory is that the calcium may bind to free bile acids in the gut, preventing the harmful effects of free bile acids on gut mucosa.” However, the lactose content in milk also has effects on large bowel microflora, which may in turn affect risk.
Also commenting to the SMC, David Nunan, senior research fellow at the University of Oxford’s Centre for Evidence Based Medicine, who was not involved in the study, cautioned that the findings were subject to the bias inherent in observational studies. “These biases often inflate the estimated associations compared to controlled experiments,” he said. Nunan advised caution in interpreting the findings, as more robust research, such as randomized controlled trials, would be needed to establish causation.
A version of this article first appeared on Medscape.com.
FROM NATURE COMMUNICATIONS
MRI-Invisible Prostate Lesions: Are They Dangerous?
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
KRAS Mutations Linked to Varied Treatment Outcomes in Metastatic Pancreatic Cancer
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Can Glucarpidase Help Reverse Methotrexate Kidney Damage?
TOPLINE:
METHODOLOGY:
- Researchers conducted a multicenter cohort study involving 708 adults with methotrexate-associated acute kidney injury from 28 cancer centers across the United States.
- Analysis utilized a sequential target trial emulation framework to compare outcomes between 209 patients who received glucarpidase within 4 days of methotrexate initiation and 499 patients who did not.
- The primary endpoint was kidney recovery at hospital discharge, defined as survival with serum creatinine < 1.5-fold baseline without dialysis dependence.
- Secondary endpoints included time-to-kidney recovery, neutropenia and transaminitis on day 7, and time-to-death.
TAKEAWAY:
- Glucarpidase administration was associated with adjusted odds ratio [aOR] of 2.70 (95% CI, 1.69-4.31) and adjusted hazard ratio [aHR] of 1.88 (95% CI, 1.18-3.33) for time-to-kidney recovery.
- Treatment with glucarpidase reduced the risk for grade ≥ 2 neutropenia (aOR, 0.50; 95% CI, 0.28-0.91) and grade ≥ 2 transaminitis (aOR, 0.31; 95% CI, 0.13-0.77) on day 7.
- Female patients showed greater benefit from glucarpidase treatment than male patients (P = .02 for interaction).
- No significant difference was observed in time-to-death between glucarpidase-treated and glucarpidase-untreated patients (aHR, 0.76; 95% CI, 0.49-1.18).
IN PRACTICE:
“These data suggest glucarpidase may improve both renal and extrarenal outcomes in patients with MTX-AKI [methotrexate-acute kidney injury],” the authors of the study wrote.
SOURCE:
This study was led by Shruti Gupta, MD, MPH, and David E. Leaf, MD, MMSc, Brigham and Women’s Hospital in Boston, Massachusetts. It was published online in Blood.
LIMITATIONS:
According to the authors, residual confounding cannot be excluded despite adjustment for multiple variables. While glucarpidase-treated patients had similar distributions of most baseline characteristics, they showed greater severity of illness, including more comorbidities, concomitant nephrotoxic medications, higher 24-hour methotrexate levels, and more severe acute kidney injury. This study was limited to patients treated at large, US-based academic centers, potentially affecting generalizability to smaller hospitals or countries where glucarpidase is unavailable.
DISCLOSURES:
This study was funded by BTG International. Gupta disclosed ties with BTG International, Dana-Farber Cancer Institute’s Wong Foundation, Janssen, AstraZeneca, and the National Institute of Diabetes and Digestive and Kidney Diseases (K23DK125672). Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a multicenter cohort study involving 708 adults with methotrexate-associated acute kidney injury from 28 cancer centers across the United States.
- Analysis utilized a sequential target trial emulation framework to compare outcomes between 209 patients who received glucarpidase within 4 days of methotrexate initiation and 499 patients who did not.
- The primary endpoint was kidney recovery at hospital discharge, defined as survival with serum creatinine < 1.5-fold baseline without dialysis dependence.
- Secondary endpoints included time-to-kidney recovery, neutropenia and transaminitis on day 7, and time-to-death.
TAKEAWAY:
- Glucarpidase administration was associated with adjusted odds ratio [aOR] of 2.70 (95% CI, 1.69-4.31) and adjusted hazard ratio [aHR] of 1.88 (95% CI, 1.18-3.33) for time-to-kidney recovery.
- Treatment with glucarpidase reduced the risk for grade ≥ 2 neutropenia (aOR, 0.50; 95% CI, 0.28-0.91) and grade ≥ 2 transaminitis (aOR, 0.31; 95% CI, 0.13-0.77) on day 7.
- Female patients showed greater benefit from glucarpidase treatment than male patients (P = .02 for interaction).
- No significant difference was observed in time-to-death between glucarpidase-treated and glucarpidase-untreated patients (aHR, 0.76; 95% CI, 0.49-1.18).
IN PRACTICE:
“These data suggest glucarpidase may improve both renal and extrarenal outcomes in patients with MTX-AKI [methotrexate-acute kidney injury],” the authors of the study wrote.
SOURCE:
This study was led by Shruti Gupta, MD, MPH, and David E. Leaf, MD, MMSc, Brigham and Women’s Hospital in Boston, Massachusetts. It was published online in Blood.
LIMITATIONS:
According to the authors, residual confounding cannot be excluded despite adjustment for multiple variables. While glucarpidase-treated patients had similar distributions of most baseline characteristics, they showed greater severity of illness, including more comorbidities, concomitant nephrotoxic medications, higher 24-hour methotrexate levels, and more severe acute kidney injury. This study was limited to patients treated at large, US-based academic centers, potentially affecting generalizability to smaller hospitals or countries where glucarpidase is unavailable.
DISCLOSURES:
This study was funded by BTG International. Gupta disclosed ties with BTG International, Dana-Farber Cancer Institute’s Wong Foundation, Janssen, AstraZeneca, and the National Institute of Diabetes and Digestive and Kidney Diseases (K23DK125672). Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a multicenter cohort study involving 708 adults with methotrexate-associated acute kidney injury from 28 cancer centers across the United States.
- Analysis utilized a sequential target trial emulation framework to compare outcomes between 209 patients who received glucarpidase within 4 days of methotrexate initiation and 499 patients who did not.
- The primary endpoint was kidney recovery at hospital discharge, defined as survival with serum creatinine < 1.5-fold baseline without dialysis dependence.
- Secondary endpoints included time-to-kidney recovery, neutropenia and transaminitis on day 7, and time-to-death.
TAKEAWAY:
- Glucarpidase administration was associated with adjusted odds ratio [aOR] of 2.70 (95% CI, 1.69-4.31) and adjusted hazard ratio [aHR] of 1.88 (95% CI, 1.18-3.33) for time-to-kidney recovery.
- Treatment with glucarpidase reduced the risk for grade ≥ 2 neutropenia (aOR, 0.50; 95% CI, 0.28-0.91) and grade ≥ 2 transaminitis (aOR, 0.31; 95% CI, 0.13-0.77) on day 7.
- Female patients showed greater benefit from glucarpidase treatment than male patients (P = .02 for interaction).
- No significant difference was observed in time-to-death between glucarpidase-treated and glucarpidase-untreated patients (aHR, 0.76; 95% CI, 0.49-1.18).
IN PRACTICE:
“These data suggest glucarpidase may improve both renal and extrarenal outcomes in patients with MTX-AKI [methotrexate-acute kidney injury],” the authors of the study wrote.
SOURCE:
This study was led by Shruti Gupta, MD, MPH, and David E. Leaf, MD, MMSc, Brigham and Women’s Hospital in Boston, Massachusetts. It was published online in Blood.
LIMITATIONS:
According to the authors, residual confounding cannot be excluded despite adjustment for multiple variables. While glucarpidase-treated patients had similar distributions of most baseline characteristics, they showed greater severity of illness, including more comorbidities, concomitant nephrotoxic medications, higher 24-hour methotrexate levels, and more severe acute kidney injury. This study was limited to patients treated at large, US-based academic centers, potentially affecting generalizability to smaller hospitals or countries where glucarpidase is unavailable.
DISCLOSURES:
This study was funded by BTG International. Gupta disclosed ties with BTG International, Dana-Farber Cancer Institute’s Wong Foundation, Janssen, AstraZeneca, and the National Institute of Diabetes and Digestive and Kidney Diseases (K23DK125672). Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
PSMA-PET Detects Metastatic Disease in Prostate Cancer Patients With Negative Conventional Imaging
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.