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Don't Treat Investigational Cancer Drugs Like Other Medications
Don't Treat Investigational Cancer Drugs Like Other Medications
PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.
Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.
A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.
Here are things to know about the use of investigational cancer drugs:
Drug Interactions Are Common
Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions:
• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism.
• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.
• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.
• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.
• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”
To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said.
Naming and Labeling May Not Be Standard
Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients.
In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said.
Information Distribution is Key
“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”
Precautions May Be Needed to Maintain Blinding Protocols
Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration.
“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.”
It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”
Education for Patients Can Be Useful
Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.
She also suggested creating treatment calendars/reminders for patients and discussing
Hennes reported no disclosures.
PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.
Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.
A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.
Here are things to know about the use of investigational cancer drugs:
Drug Interactions Are Common
Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions:
• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism.
• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.
• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.
• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.
• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”
To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said.
Naming and Labeling May Not Be Standard
Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients.
In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said.
Information Distribution is Key
“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”
Precautions May Be Needed to Maintain Blinding Protocols
Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration.
“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.”
It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”
Education for Patients Can Be Useful
Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.
She also suggested creating treatment calendars/reminders for patients and discussing
Hennes reported no disclosures.
PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.
Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.
A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.
Here are things to know about the use of investigational cancer drugs:
Drug Interactions Are Common
Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions:
• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism.
• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.
• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.
• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.
• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”
To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said.
Naming and Labeling May Not Be Standard
Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients.
In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said.
Information Distribution is Key
“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”
Precautions May Be Needed to Maintain Blinding Protocols
Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration.
“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.”
It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”
Education for Patients Can Be Useful
Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.
She also suggested creating treatment calendars/reminders for patients and discussing
Hennes reported no disclosures.
Don't Treat Investigational Cancer Drugs Like Other Medications
Don't Treat Investigational Cancer Drugs Like Other Medications
Does Ethnicity Affect Skin Cancer Risk?
Does Ethnicity Affect Skin Cancer Risk?
TOPLINE:
The incidence of skin cancer in England varied by ethnicity: White individuals had higher rates of melanoma, cutaneous squamous cell carcinoma, and basal cell carcinoma than Asian or Black individuals. In contrast, acral lentiginous melanoma was most common among Black individuals, whereas cutaneous T-cell lymphoma and Kaposi sarcoma were highest among those in the "Other" ethnic group.
METHODOLOGY:
- Researchers analysed all cases of cutaneous melanoma (melanoma and acral lentiginous melanoma), basal cell carcinoma, cutaneous squamous cell carcinoma, cutaneous T-cell lymphoma, and Kaposi sarcoma using data from the NHS National Disease Registration Service cancer registry between 2013 and 2020.
- Data collection incorporated ethnicity information from multiple health care datasets, including Clinical Outcomes and Services Dataset, Patient Administration System, Radiotherapy Dataset, Diagnostic Imaging Dataset, and Hospital Episode Statistics.
- A population analysis categorised patients into 7 standardised ethnic groups (on the basis of Office for National Statistics classifications): White, Asian, Chinese, Black, mixed, other, and unknown groups, with ethnicity data being self-reported by patients.
- Outcomes included European age-standardised rates calculated using the 2013 European Standard Population and reported per 100,000 person-years (PYs).
TAKEAWAY:
- White Individuals had 13-fold higher rates of cutaneous squamous cell carcinoma (61.75 per 100,000 PYs), 26-fold and 27-fold higher rates of basal cell carcinoma (153.69 per 100,000 PYs), and 33-fold and 16-fold higher rates of cutaneous melanoma (27.29 per 100,000 PYs) than Asian and Black individuals, respectively.
- Black individuals had the highest incidence of acral lentiginous melanoma (0.85 per 100,000 PYs), and those in the other ethnic group had the highest incidence of cutaneous T-cell lymphoma (1.74 per 100,000 PYs) and Kaposi sarcoma (1.57 per 100,000 PYs).
- The presentation of early-stage melanoma was low among Asian (53.5%), Black (62.4%), mixed (62.5%), and other (76.4%) ethnic groups compared to that among White ethnicities (79.8%).
- Acral lentiginous melanomas were less likely to get urgent suspected cancer pathway referrals than overall melanoma (40.1% vs 44.6%; P < .001) and more likely to be diagnosed late than overall melanoma (stage I/II at diagnosis; 72% vs 80%; P < .0001).
IN PRACTICE:
"The findings emphasise the need for better, targeted ethnicity data collection strategies to address incidence, outcomes and health care equity for not just skin cancer but all health conditions in underserved populations," the authors wrote. "While projects like the Global Burden of Disease have improved global health care reporting, continuous audit and improvement of collected data are essential to provide better care across people of all ethnicities."
SOURCE:
This study was led by Shehnaz Ahmed, British Association of Dermatologists, London, England. It was published online on September 10, 2025, in the British Journal of Dermatology.
LIMITATIONS:
Census data collection after every 10 years could have contributed to inaccurate population estimates and incidence rates. Small sample sizes in certain ethnic groups could have led to potential confounders, requiring a cautious interpretation of relative incidence. The NHS data included only self-reported ethnicity data with no available details of skin phototypes, skin tones, or racial ancestry. This study lacked granular ethnicity census data and stage data for basal cell carcinoma, cutaneous small cell carcinoma, and Kaposi sarcoma.
DISCLOSURES:
This research was supported through a partnership between the British Association of Dermatologists and NHS England's National Disease Registration Service. Two authors reported being employees of the British Association of Dermatologists.
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:
The incidence of skin cancer in England varied by ethnicity: White individuals had higher rates of melanoma, cutaneous squamous cell carcinoma, and basal cell carcinoma than Asian or Black individuals. In contrast, acral lentiginous melanoma was most common among Black individuals, whereas cutaneous T-cell lymphoma and Kaposi sarcoma were highest among those in the "Other" ethnic group.
METHODOLOGY:
- Researchers analysed all cases of cutaneous melanoma (melanoma and acral lentiginous melanoma), basal cell carcinoma, cutaneous squamous cell carcinoma, cutaneous T-cell lymphoma, and Kaposi sarcoma using data from the NHS National Disease Registration Service cancer registry between 2013 and 2020.
- Data collection incorporated ethnicity information from multiple health care datasets, including Clinical Outcomes and Services Dataset, Patient Administration System, Radiotherapy Dataset, Diagnostic Imaging Dataset, and Hospital Episode Statistics.
- A population analysis categorised patients into 7 standardised ethnic groups (on the basis of Office for National Statistics classifications): White, Asian, Chinese, Black, mixed, other, and unknown groups, with ethnicity data being self-reported by patients.
- Outcomes included European age-standardised rates calculated using the 2013 European Standard Population and reported per 100,000 person-years (PYs).
TAKEAWAY:
- White Individuals had 13-fold higher rates of cutaneous squamous cell carcinoma (61.75 per 100,000 PYs), 26-fold and 27-fold higher rates of basal cell carcinoma (153.69 per 100,000 PYs), and 33-fold and 16-fold higher rates of cutaneous melanoma (27.29 per 100,000 PYs) than Asian and Black individuals, respectively.
- Black individuals had the highest incidence of acral lentiginous melanoma (0.85 per 100,000 PYs), and those in the other ethnic group had the highest incidence of cutaneous T-cell lymphoma (1.74 per 100,000 PYs) and Kaposi sarcoma (1.57 per 100,000 PYs).
- The presentation of early-stage melanoma was low among Asian (53.5%), Black (62.4%), mixed (62.5%), and other (76.4%) ethnic groups compared to that among White ethnicities (79.8%).
- Acral lentiginous melanomas were less likely to get urgent suspected cancer pathway referrals than overall melanoma (40.1% vs 44.6%; P < .001) and more likely to be diagnosed late than overall melanoma (stage I/II at diagnosis; 72% vs 80%; P < .0001).
IN PRACTICE:
"The findings emphasise the need for better, targeted ethnicity data collection strategies to address incidence, outcomes and health care equity for not just skin cancer but all health conditions in underserved populations," the authors wrote. "While projects like the Global Burden of Disease have improved global health care reporting, continuous audit and improvement of collected data are essential to provide better care across people of all ethnicities."
SOURCE:
This study was led by Shehnaz Ahmed, British Association of Dermatologists, London, England. It was published online on September 10, 2025, in the British Journal of Dermatology.
LIMITATIONS:
Census data collection after every 10 years could have contributed to inaccurate population estimates and incidence rates. Small sample sizes in certain ethnic groups could have led to potential confounders, requiring a cautious interpretation of relative incidence. The NHS data included only self-reported ethnicity data with no available details of skin phototypes, skin tones, or racial ancestry. This study lacked granular ethnicity census data and stage data for basal cell carcinoma, cutaneous small cell carcinoma, and Kaposi sarcoma.
DISCLOSURES:
This research was supported through a partnership between the British Association of Dermatologists and NHS England's National Disease Registration Service. Two authors reported being employees of the British Association of Dermatologists.
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:
The incidence of skin cancer in England varied by ethnicity: White individuals had higher rates of melanoma, cutaneous squamous cell carcinoma, and basal cell carcinoma than Asian or Black individuals. In contrast, acral lentiginous melanoma was most common among Black individuals, whereas cutaneous T-cell lymphoma and Kaposi sarcoma were highest among those in the "Other" ethnic group.
METHODOLOGY:
- Researchers analysed all cases of cutaneous melanoma (melanoma and acral lentiginous melanoma), basal cell carcinoma, cutaneous squamous cell carcinoma, cutaneous T-cell lymphoma, and Kaposi sarcoma using data from the NHS National Disease Registration Service cancer registry between 2013 and 2020.
- Data collection incorporated ethnicity information from multiple health care datasets, including Clinical Outcomes and Services Dataset, Patient Administration System, Radiotherapy Dataset, Diagnostic Imaging Dataset, and Hospital Episode Statistics.
- A population analysis categorised patients into 7 standardised ethnic groups (on the basis of Office for National Statistics classifications): White, Asian, Chinese, Black, mixed, other, and unknown groups, with ethnicity data being self-reported by patients.
- Outcomes included European age-standardised rates calculated using the 2013 European Standard Population and reported per 100,000 person-years (PYs).
TAKEAWAY:
- White Individuals had 13-fold higher rates of cutaneous squamous cell carcinoma (61.75 per 100,000 PYs), 26-fold and 27-fold higher rates of basal cell carcinoma (153.69 per 100,000 PYs), and 33-fold and 16-fold higher rates of cutaneous melanoma (27.29 per 100,000 PYs) than Asian and Black individuals, respectively.
- Black individuals had the highest incidence of acral lentiginous melanoma (0.85 per 100,000 PYs), and those in the other ethnic group had the highest incidence of cutaneous T-cell lymphoma (1.74 per 100,000 PYs) and Kaposi sarcoma (1.57 per 100,000 PYs).
- The presentation of early-stage melanoma was low among Asian (53.5%), Black (62.4%), mixed (62.5%), and other (76.4%) ethnic groups compared to that among White ethnicities (79.8%).
- Acral lentiginous melanomas were less likely to get urgent suspected cancer pathway referrals than overall melanoma (40.1% vs 44.6%; P < .001) and more likely to be diagnosed late than overall melanoma (stage I/II at diagnosis; 72% vs 80%; P < .0001).
IN PRACTICE:
"The findings emphasise the need for better, targeted ethnicity data collection strategies to address incidence, outcomes and health care equity for not just skin cancer but all health conditions in underserved populations," the authors wrote. "While projects like the Global Burden of Disease have improved global health care reporting, continuous audit and improvement of collected data are essential to provide better care across people of all ethnicities."
SOURCE:
This study was led by Shehnaz Ahmed, British Association of Dermatologists, London, England. It was published online on September 10, 2025, in the British Journal of Dermatology.
LIMITATIONS:
Census data collection after every 10 years could have contributed to inaccurate population estimates and incidence rates. Small sample sizes in certain ethnic groups could have led to potential confounders, requiring a cautious interpretation of relative incidence. The NHS data included only self-reported ethnicity data with no available details of skin phototypes, skin tones, or racial ancestry. This study lacked granular ethnicity census data and stage data for basal cell carcinoma, cutaneous small cell carcinoma, and Kaposi sarcoma.
DISCLOSURES:
This research was supported through a partnership between the British Association of Dermatologists and NHS England's National Disease Registration Service. Two authors reported being employees of the British Association of Dermatologists.
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.
Does Ethnicity Affect Skin Cancer Risk?
Does Ethnicity Affect Skin Cancer Risk?
Architect of VA Transformation Urges Innovation Amid Uncertainty
Architect of VA Transformation Urges Innovation Amid Uncertainty
PHOENIX – Three decades after he initiated the transformation of the Veterans Health Administration (VHA) into a model research and clinical health care system, former US Department of Veterans Affairs (VA) Under Secretary of Health Kenneth W. Kizer, MD, MPH, urged cancer specialists to embrace this challenging moment as an opportunity for bold innovation.
At the annual meeting of the Association of VA Hematology/Oncology (AVAHO), Kizer acknowledged that the VA faces an “uncertain and turbulent time” in areas such as funding, staffing, community care implementation, and the rollout of a new electronic health record system.
He also noted the grim rise of global instability, economic turmoil, climate change, infectious diseases, political violence, and mass shootings.
“This can be stressful. It can create negative energy. But this uncertainty can also be liberating, and it can prompt positive energy and innovation, depending on choices that we make,” said Kizer, who also has served as California’s top health official prior to leading the VHA from 1994 to 1999.
From “Bloated Bureaucracy’ to High-Quality Health Care System
Kizer has been credited with revitalizing VHA care through a greater commitment to quality, and harkened to his work with the VA as an example of how bold goals can lead to bold innovation.
“What were the perceptions of VA health care in 1994? Well, they weren’t very good, frankly,” Kizer recalled. He described the VA as having a reputation at that time as “highly dysfunctional” with “a very bloated and entrenched bureaucracy.” As for quality of care, it “wasn’t viewed as very good.”
The system’s problems were so severe that patients would park motorhomes in VA medical center parking lots as they waited for care. “While they might have an appointment for one day, they may not be seen for 3 or 4 or 5 days. So they would stay in their motorhome until they finally got into their clinic appointment,” Kizer said.
Overall, “the public viewed the VA as this bleak backwater of incompetence and difference and inefficiency, and there were very strong calls to privatize the VA,” Kizer said.
Kizer asked colleagues about what he should do after he was asked to take the under secretary job. “With one exception, they all said, don’t go near it. Don’t touch it. Walk away. That it’s impossible to change the organization.
“I looked at the VA and I saw an opportunity. When I told [members of the President Bill] Clinton [Administration] yes, my bold aim was that I would like to pursue this was to make VHA a model of excellent health care, an exemplary health care system. Most everyone else thought that I was totally delusional, but sometimes it’s good to be delusional.”
Revolutionary Changes Despite Opposition
Kizer sought reforms in 5 major strategic objectives, all without explicit congressional approval: creating an accountable management structure, decentralizing decision-making, integrating care, implementing universal primary care, and pursuing eligibility reform to create the current 8-tier VA system.
One major innovation was the implementation of community-based outpatient clinics (CBOCs): “Those were strongly opposed initially,” Kizer said. “Everyone, the veteran community in particular, had been led to believe that the only good care was in the hospital.”
The resistance was substantial. “There was a lot of opposition when we said we’re going to move out into the community where you live to make [care] easier to access,” Kizer said.
To make things more difficult, Congress wouldn’t fund the project: “For the first 3 years, every CBOC had to be funded by redirected savings from other things that we could do within the system,” he said. “All of this was through redirected savings and finding ways to save and reinvest.”
Innovation From the Ground Up
Kizer emphasized that many breakthrough innovations came from frontline staff rather than executive mandates. He cited the example of Barcode Medication Administration, which originated from a nurse in Topeka, Kan.
The nurse saw a barcode scanner put to work at a rental car company where it was used to check cars in and out. She wondered, “Why can’t we do this with medications when they’re given on the floor? We followed up on it, pursued those things, tested it out, it worked.”
The results were dramatic. “I was told at a meeting that they had achieved close to 80% reduction in medication errors,” Kizer said. After verifying the results personally, he “authorized $20 million, and we moved forward with it systemwide.”
This experience reinforced his belief in harvesting ideas from staff at all levels.
Innovation remains part of the VA’s culture “despite what some people would have you believe,” Kizer said. Recently, the VA has made major advances in areas such as patient transportation and the climate crisis, he said.
Inside the Recipe for Innovation
Boldness, persistence, adaptability, and tolerance for risk are necessary ingredients for high-risk goals, Kizer said. Ambition is also part of the picture.
He highlighted examples such as the Apollo moon landing, the first sub-4-minute mile, and the first swim across the English Channel by a woman.
In medicine, Kizer pointed to a national patient safety campaign that saved an estimated 122,000 lives. He also mentioned recent progress in organ transplantation such as recommendations from the National Academies of Sciences, Engineering, and Medicine to establish national performance goals and the Organ Procurement and Transplantation Network’s target of 60,000 deceased donor transplants by 2026.
Bold doesn’t mean being reckless or careless, Kizer said. “But it does require innovation. And it does require that you try some new things, some of which aren’t going to work out.”
The key mindset, he explained, is to “embrace the unknown” because “you often really don’t know how you will accomplish the aim when you start. But you’ll figure it out as you go.”
Kizer highlighted 2 opposing strategies to handling challenging times.
According to him, the “negative energy” approach focuses on frustrations, limitations, and asking “Why is this happening to me?”
In contrast, a “positive energy” approach expects problems, focuses on available resources and capabilities, and asks, “What are the opportunities that these changes are creating for me?”
Kizer made it crystal clear which option he prefers.
Dr. Kizer disclosed that his comments represent his opinions only, and he noted his ongoing connections to the VA.
PHOENIX – Three decades after he initiated the transformation of the Veterans Health Administration (VHA) into a model research and clinical health care system, former US Department of Veterans Affairs (VA) Under Secretary of Health Kenneth W. Kizer, MD, MPH, urged cancer specialists to embrace this challenging moment as an opportunity for bold innovation.
At the annual meeting of the Association of VA Hematology/Oncology (AVAHO), Kizer acknowledged that the VA faces an “uncertain and turbulent time” in areas such as funding, staffing, community care implementation, and the rollout of a new electronic health record system.
He also noted the grim rise of global instability, economic turmoil, climate change, infectious diseases, political violence, and mass shootings.
“This can be stressful. It can create negative energy. But this uncertainty can also be liberating, and it can prompt positive energy and innovation, depending on choices that we make,” said Kizer, who also has served as California’s top health official prior to leading the VHA from 1994 to 1999.
From “Bloated Bureaucracy’ to High-Quality Health Care System
Kizer has been credited with revitalizing VHA care through a greater commitment to quality, and harkened to his work with the VA as an example of how bold goals can lead to bold innovation.
“What were the perceptions of VA health care in 1994? Well, they weren’t very good, frankly,” Kizer recalled. He described the VA as having a reputation at that time as “highly dysfunctional” with “a very bloated and entrenched bureaucracy.” As for quality of care, it “wasn’t viewed as very good.”
The system’s problems were so severe that patients would park motorhomes in VA medical center parking lots as they waited for care. “While they might have an appointment for one day, they may not be seen for 3 or 4 or 5 days. So they would stay in their motorhome until they finally got into their clinic appointment,” Kizer said.
Overall, “the public viewed the VA as this bleak backwater of incompetence and difference and inefficiency, and there were very strong calls to privatize the VA,” Kizer said.
Kizer asked colleagues about what he should do after he was asked to take the under secretary job. “With one exception, they all said, don’t go near it. Don’t touch it. Walk away. That it’s impossible to change the organization.
“I looked at the VA and I saw an opportunity. When I told [members of the President Bill] Clinton [Administration] yes, my bold aim was that I would like to pursue this was to make VHA a model of excellent health care, an exemplary health care system. Most everyone else thought that I was totally delusional, but sometimes it’s good to be delusional.”
Revolutionary Changes Despite Opposition
Kizer sought reforms in 5 major strategic objectives, all without explicit congressional approval: creating an accountable management structure, decentralizing decision-making, integrating care, implementing universal primary care, and pursuing eligibility reform to create the current 8-tier VA system.
One major innovation was the implementation of community-based outpatient clinics (CBOCs): “Those were strongly opposed initially,” Kizer said. “Everyone, the veteran community in particular, had been led to believe that the only good care was in the hospital.”
The resistance was substantial. “There was a lot of opposition when we said we’re going to move out into the community where you live to make [care] easier to access,” Kizer said.
To make things more difficult, Congress wouldn’t fund the project: “For the first 3 years, every CBOC had to be funded by redirected savings from other things that we could do within the system,” he said. “All of this was through redirected savings and finding ways to save and reinvest.”
Innovation From the Ground Up
Kizer emphasized that many breakthrough innovations came from frontline staff rather than executive mandates. He cited the example of Barcode Medication Administration, which originated from a nurse in Topeka, Kan.
The nurse saw a barcode scanner put to work at a rental car company where it was used to check cars in and out. She wondered, “Why can’t we do this with medications when they’re given on the floor? We followed up on it, pursued those things, tested it out, it worked.”
The results were dramatic. “I was told at a meeting that they had achieved close to 80% reduction in medication errors,” Kizer said. After verifying the results personally, he “authorized $20 million, and we moved forward with it systemwide.”
This experience reinforced his belief in harvesting ideas from staff at all levels.
Innovation remains part of the VA’s culture “despite what some people would have you believe,” Kizer said. Recently, the VA has made major advances in areas such as patient transportation and the climate crisis, he said.
Inside the Recipe for Innovation
Boldness, persistence, adaptability, and tolerance for risk are necessary ingredients for high-risk goals, Kizer said. Ambition is also part of the picture.
He highlighted examples such as the Apollo moon landing, the first sub-4-minute mile, and the first swim across the English Channel by a woman.
In medicine, Kizer pointed to a national patient safety campaign that saved an estimated 122,000 lives. He also mentioned recent progress in organ transplantation such as recommendations from the National Academies of Sciences, Engineering, and Medicine to establish national performance goals and the Organ Procurement and Transplantation Network’s target of 60,000 deceased donor transplants by 2026.
Bold doesn’t mean being reckless or careless, Kizer said. “But it does require innovation. And it does require that you try some new things, some of which aren’t going to work out.”
The key mindset, he explained, is to “embrace the unknown” because “you often really don’t know how you will accomplish the aim when you start. But you’ll figure it out as you go.”
Kizer highlighted 2 opposing strategies to handling challenging times.
According to him, the “negative energy” approach focuses on frustrations, limitations, and asking “Why is this happening to me?”
In contrast, a “positive energy” approach expects problems, focuses on available resources and capabilities, and asks, “What are the opportunities that these changes are creating for me?”
Kizer made it crystal clear which option he prefers.
Dr. Kizer disclosed that his comments represent his opinions only, and he noted his ongoing connections to the VA.
PHOENIX – Three decades after he initiated the transformation of the Veterans Health Administration (VHA) into a model research and clinical health care system, former US Department of Veterans Affairs (VA) Under Secretary of Health Kenneth W. Kizer, MD, MPH, urged cancer specialists to embrace this challenging moment as an opportunity for bold innovation.
At the annual meeting of the Association of VA Hematology/Oncology (AVAHO), Kizer acknowledged that the VA faces an “uncertain and turbulent time” in areas such as funding, staffing, community care implementation, and the rollout of a new electronic health record system.
He also noted the grim rise of global instability, economic turmoil, climate change, infectious diseases, political violence, and mass shootings.
“This can be stressful. It can create negative energy. But this uncertainty can also be liberating, and it can prompt positive energy and innovation, depending on choices that we make,” said Kizer, who also has served as California’s top health official prior to leading the VHA from 1994 to 1999.
From “Bloated Bureaucracy’ to High-Quality Health Care System
Kizer has been credited with revitalizing VHA care through a greater commitment to quality, and harkened to his work with the VA as an example of how bold goals can lead to bold innovation.
“What were the perceptions of VA health care in 1994? Well, they weren’t very good, frankly,” Kizer recalled. He described the VA as having a reputation at that time as “highly dysfunctional” with “a very bloated and entrenched bureaucracy.” As for quality of care, it “wasn’t viewed as very good.”
The system’s problems were so severe that patients would park motorhomes in VA medical center parking lots as they waited for care. “While they might have an appointment for one day, they may not be seen for 3 or 4 or 5 days. So they would stay in their motorhome until they finally got into their clinic appointment,” Kizer said.
Overall, “the public viewed the VA as this bleak backwater of incompetence and difference and inefficiency, and there were very strong calls to privatize the VA,” Kizer said.
Kizer asked colleagues about what he should do after he was asked to take the under secretary job. “With one exception, they all said, don’t go near it. Don’t touch it. Walk away. That it’s impossible to change the organization.
“I looked at the VA and I saw an opportunity. When I told [members of the President Bill] Clinton [Administration] yes, my bold aim was that I would like to pursue this was to make VHA a model of excellent health care, an exemplary health care system. Most everyone else thought that I was totally delusional, but sometimes it’s good to be delusional.”
Revolutionary Changes Despite Opposition
Kizer sought reforms in 5 major strategic objectives, all without explicit congressional approval: creating an accountable management structure, decentralizing decision-making, integrating care, implementing universal primary care, and pursuing eligibility reform to create the current 8-tier VA system.
One major innovation was the implementation of community-based outpatient clinics (CBOCs): “Those were strongly opposed initially,” Kizer said. “Everyone, the veteran community in particular, had been led to believe that the only good care was in the hospital.”
The resistance was substantial. “There was a lot of opposition when we said we’re going to move out into the community where you live to make [care] easier to access,” Kizer said.
To make things more difficult, Congress wouldn’t fund the project: “For the first 3 years, every CBOC had to be funded by redirected savings from other things that we could do within the system,” he said. “All of this was through redirected savings and finding ways to save and reinvest.”
Innovation From the Ground Up
Kizer emphasized that many breakthrough innovations came from frontline staff rather than executive mandates. He cited the example of Barcode Medication Administration, which originated from a nurse in Topeka, Kan.
The nurse saw a barcode scanner put to work at a rental car company where it was used to check cars in and out. She wondered, “Why can’t we do this with medications when they’re given on the floor? We followed up on it, pursued those things, tested it out, it worked.”
The results were dramatic. “I was told at a meeting that they had achieved close to 80% reduction in medication errors,” Kizer said. After verifying the results personally, he “authorized $20 million, and we moved forward with it systemwide.”
This experience reinforced his belief in harvesting ideas from staff at all levels.
Innovation remains part of the VA’s culture “despite what some people would have you believe,” Kizer said. Recently, the VA has made major advances in areas such as patient transportation and the climate crisis, he said.
Inside the Recipe for Innovation
Boldness, persistence, adaptability, and tolerance for risk are necessary ingredients for high-risk goals, Kizer said. Ambition is also part of the picture.
He highlighted examples such as the Apollo moon landing, the first sub-4-minute mile, and the first swim across the English Channel by a woman.
In medicine, Kizer pointed to a national patient safety campaign that saved an estimated 122,000 lives. He also mentioned recent progress in organ transplantation such as recommendations from the National Academies of Sciences, Engineering, and Medicine to establish national performance goals and the Organ Procurement and Transplantation Network’s target of 60,000 deceased donor transplants by 2026.
Bold doesn’t mean being reckless or careless, Kizer said. “But it does require innovation. And it does require that you try some new things, some of which aren’t going to work out.”
The key mindset, he explained, is to “embrace the unknown” because “you often really don’t know how you will accomplish the aim when you start. But you’ll figure it out as you go.”
Kizer highlighted 2 opposing strategies to handling challenging times.
According to him, the “negative energy” approach focuses on frustrations, limitations, and asking “Why is this happening to me?”
In contrast, a “positive energy” approach expects problems, focuses on available resources and capabilities, and asks, “What are the opportunities that these changes are creating for me?”
Kizer made it crystal clear which option he prefers.
Dr. Kizer disclosed that his comments represent his opinions only, and he noted his ongoing connections to the VA.
Architect of VA Transformation Urges Innovation Amid Uncertainty
Architect of VA Transformation Urges Innovation Amid Uncertainty
ERCC2, KDM6A, and TERT as Key Prognostic Factors in Bladder Cancer: Insights from the AACR Project GENIE Database
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Communication Modality (CM) Among Veterans Using National TeleOncology (NTO) Services
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.
Organs of Metastasis Predominate with Age in Non-Small Cell Lung Cancer Subtypes: National Cancer Database Analysis
Background
Patients diagnosed with lung cancer are predominantly non-small cell lung cancer (NSCLC), a leading cause of cancer-related deaths. Thus, it is imperative to investigate and distinguish the differences present at diagnosis to possibly improve survival outcomes. NSCLC commonly metastasizes within older patients near the mean age of 71 years, but also in early onset patients which represents the patients younger than the earliest lung cancer screening age of 50.
Objective
To reveal differences in ratios of metastasis locations in squamous cell carcinoma (SCC), adenocarcinoma (ACC), and adenosquamous carcinoma (ASC).
Methods
The National Cancer Database (NCDB) was utilized to identify patients diagnosed with SCC, ACC, and ASC using the histology codes 8070, 8140, and 8560 from the ICD-O-3.2 from 2004 to 2022. Age groups were 70 years. Metastases located to the brain, liver, bone, and lung were included. Chi-Square tests were performed. The data was analyzed using R version 4.4.2 and statistical significance was set to α = 0.05.
Results
In this study, 1,445,119 patients were analyzed. Chi-Square tests identified significant differences in the ratios of organ metastasis locations between age groups in each subtype (p < 0.001). SCC in each age group similarly metastasized most to bone (36.3%, 34.7%, 34.5%), but notably more local lung metastasis was observed in the oldest group (33.6%). In ACC and ASC, the oldest group also had greater ratios of spread within the lungs (28.0%, 27.2%). Overall, the younger the age group, distant spread to the brain increased (ex. 29.0%, 24.4%, 17.5%). This suggests a widely heterogenous distribution of metastases at diagnosis of NSCLC subtypes and patient age.
Conclusions
This study demonstrated that patients with SCC, ACC, or ASC subtypes of NSCLC share similar predominant locations based in part on patient age, irrespective of cancer origin. NSCLC may more distantly metastasize in younger patients to the brain, while older patients may have locally metastatic cancer. Further analysis of key demographic variables as well as common undertaken treatment options may prove informative and reveal existing differences in survival outcomes.
Background
Patients diagnosed with lung cancer are predominantly non-small cell lung cancer (NSCLC), a leading cause of cancer-related deaths. Thus, it is imperative to investigate and distinguish the differences present at diagnosis to possibly improve survival outcomes. NSCLC commonly metastasizes within older patients near the mean age of 71 years, but also in early onset patients which represents the patients younger than the earliest lung cancer screening age of 50.
Objective
To reveal differences in ratios of metastasis locations in squamous cell carcinoma (SCC), adenocarcinoma (ACC), and adenosquamous carcinoma (ASC).
Methods
The National Cancer Database (NCDB) was utilized to identify patients diagnosed with SCC, ACC, and ASC using the histology codes 8070, 8140, and 8560 from the ICD-O-3.2 from 2004 to 2022. Age groups were 70 years. Metastases located to the brain, liver, bone, and lung were included. Chi-Square tests were performed. The data was analyzed using R version 4.4.2 and statistical significance was set to α = 0.05.
Results
In this study, 1,445,119 patients were analyzed. Chi-Square tests identified significant differences in the ratios of organ metastasis locations between age groups in each subtype (p < 0.001). SCC in each age group similarly metastasized most to bone (36.3%, 34.7%, 34.5%), but notably more local lung metastasis was observed in the oldest group (33.6%). In ACC and ASC, the oldest group also had greater ratios of spread within the lungs (28.0%, 27.2%). Overall, the younger the age group, distant spread to the brain increased (ex. 29.0%, 24.4%, 17.5%). This suggests a widely heterogenous distribution of metastases at diagnosis of NSCLC subtypes and patient age.
Conclusions
This study demonstrated that patients with SCC, ACC, or ASC subtypes of NSCLC share similar predominant locations based in part on patient age, irrespective of cancer origin. NSCLC may more distantly metastasize in younger patients to the brain, while older patients may have locally metastatic cancer. Further analysis of key demographic variables as well as common undertaken treatment options may prove informative and reveal existing differences in survival outcomes.
Background
Patients diagnosed with lung cancer are predominantly non-small cell lung cancer (NSCLC), a leading cause of cancer-related deaths. Thus, it is imperative to investigate and distinguish the differences present at diagnosis to possibly improve survival outcomes. NSCLC commonly metastasizes within older patients near the mean age of 71 years, but also in early onset patients which represents the patients younger than the earliest lung cancer screening age of 50.
Objective
To reveal differences in ratios of metastasis locations in squamous cell carcinoma (SCC), adenocarcinoma (ACC), and adenosquamous carcinoma (ASC).
Methods
The National Cancer Database (NCDB) was utilized to identify patients diagnosed with SCC, ACC, and ASC using the histology codes 8070, 8140, and 8560 from the ICD-O-3.2 from 2004 to 2022. Age groups were 70 years. Metastases located to the brain, liver, bone, and lung were included. Chi-Square tests were performed. The data was analyzed using R version 4.4.2 and statistical significance was set to α = 0.05.
Results
In this study, 1,445,119 patients were analyzed. Chi-Square tests identified significant differences in the ratios of organ metastasis locations between age groups in each subtype (p < 0.001). SCC in each age group similarly metastasized most to bone (36.3%, 34.7%, 34.5%), but notably more local lung metastasis was observed in the oldest group (33.6%). In ACC and ASC, the oldest group also had greater ratios of spread within the lungs (28.0%, 27.2%). Overall, the younger the age group, distant spread to the brain increased (ex. 29.0%, 24.4%, 17.5%). This suggests a widely heterogenous distribution of metastases at diagnosis of NSCLC subtypes and patient age.
Conclusions
This study demonstrated that patients with SCC, ACC, or ASC subtypes of NSCLC share similar predominant locations based in part on patient age, irrespective of cancer origin. NSCLC may more distantly metastasize in younger patients to the brain, while older patients may have locally metastatic cancer. Further analysis of key demographic variables as well as common undertaken treatment options may prove informative and reveal existing differences in survival outcomes.
Shifting Demographics: A Temporal Analysis of the Alarming Rise in Rectal Adenocarcinoma Among Young Adults
Background
Rectal adenocarcinoma has long been associated with older adults, with routine screening typically beginning at age 45 or older. However, recent data reveal a concerning rise in rectal cancer incidence among adults under 40. These early-onset cases often present at later stages and may have distinct biological features. While some research attributes this trend to genetic or environmental factors, the contribution of socioeconomic disparities and healthcare access has not been fully explored. Identifying these influences is essential to shaping targeted prevention and early detection strategies for younger populations.
Objective
To evaluate temporal trends in rectal adenocarcinoma among young adults and assess demographic and socioeconomic predictors of early-onset diagnosis.
Methods
Data were drawn from the National Cancer Database (NCDB) for patients diagnosed with rectal adenocarcinoma from 2004 to 2022. Among 440,316 cases, 17,842 (4.1%) occurred in individuals under 40. Linear regression assessed temporal trends, while logistic regression evaluated associations between early-onset diagnosis and variables including sex, race, insurance status, income level, Charlson-Deyo comorbidity score, and tumor stage. Statistical significance was defined as α = 0.05.
Results
The number of young adults diagnosed rose from 424 in 2004 to 937 in 2022—an increase of over 120%. Each year was associated with a 1.7% rise in odds of early diagnosis (OR = 1.017, p < 0.001). Male patients had 24.7% higher odds (OR = 1.247, p < 0.001), and Black patients had 59.3% higher odds compared to White patients (OR = 1.593, p < 0.001). Non-private insurance was linked to a 41.6% decrease in early diagnosis (OR = 0.584, p < 0.001). Income level was not significant (p = 0.426). Lower Charlson-Deyo scores and higher tumor stages were also associated with early-onset cases.
Conclusions
Rectal adenocarcinoma is increasingly affecting younger adults, with significant associations across demographic and insurance variables. These findings call for improved awareness, early diagnostic strategies, and further research into underlying causes to mitigate this growing public health concern.
Background
Rectal adenocarcinoma has long been associated with older adults, with routine screening typically beginning at age 45 or older. However, recent data reveal a concerning rise in rectal cancer incidence among adults under 40. These early-onset cases often present at later stages and may have distinct biological features. While some research attributes this trend to genetic or environmental factors, the contribution of socioeconomic disparities and healthcare access has not been fully explored. Identifying these influences is essential to shaping targeted prevention and early detection strategies for younger populations.
Objective
To evaluate temporal trends in rectal adenocarcinoma among young adults and assess demographic and socioeconomic predictors of early-onset diagnosis.
Methods
Data were drawn from the National Cancer Database (NCDB) for patients diagnosed with rectal adenocarcinoma from 2004 to 2022. Among 440,316 cases, 17,842 (4.1%) occurred in individuals under 40. Linear regression assessed temporal trends, while logistic regression evaluated associations between early-onset diagnosis and variables including sex, race, insurance status, income level, Charlson-Deyo comorbidity score, and tumor stage. Statistical significance was defined as α = 0.05.
Results
The number of young adults diagnosed rose from 424 in 2004 to 937 in 2022—an increase of over 120%. Each year was associated with a 1.7% rise in odds of early diagnosis (OR = 1.017, p < 0.001). Male patients had 24.7% higher odds (OR = 1.247, p < 0.001), and Black patients had 59.3% higher odds compared to White patients (OR = 1.593, p < 0.001). Non-private insurance was linked to a 41.6% decrease in early diagnosis (OR = 0.584, p < 0.001). Income level was not significant (p = 0.426). Lower Charlson-Deyo scores and higher tumor stages were also associated with early-onset cases.
Conclusions
Rectal adenocarcinoma is increasingly affecting younger adults, with significant associations across demographic and insurance variables. These findings call for improved awareness, early diagnostic strategies, and further research into underlying causes to mitigate this growing public health concern.
Background
Rectal adenocarcinoma has long been associated with older adults, with routine screening typically beginning at age 45 or older. However, recent data reveal a concerning rise in rectal cancer incidence among adults under 40. These early-onset cases often present at later stages and may have distinct biological features. While some research attributes this trend to genetic or environmental factors, the contribution of socioeconomic disparities and healthcare access has not been fully explored. Identifying these influences is essential to shaping targeted prevention and early detection strategies for younger populations.
Objective
To evaluate temporal trends in rectal adenocarcinoma among young adults and assess demographic and socioeconomic predictors of early-onset diagnosis.
Methods
Data were drawn from the National Cancer Database (NCDB) for patients diagnosed with rectal adenocarcinoma from 2004 to 2022. Among 440,316 cases, 17,842 (4.1%) occurred in individuals under 40. Linear regression assessed temporal trends, while logistic regression evaluated associations between early-onset diagnosis and variables including sex, race, insurance status, income level, Charlson-Deyo comorbidity score, and tumor stage. Statistical significance was defined as α = 0.05.
Results
The number of young adults diagnosed rose from 424 in 2004 to 937 in 2022—an increase of over 120%. Each year was associated with a 1.7% rise in odds of early diagnosis (OR = 1.017, p < 0.001). Male patients had 24.7% higher odds (OR = 1.247, p < 0.001), and Black patients had 59.3% higher odds compared to White patients (OR = 1.593, p < 0.001). Non-private insurance was linked to a 41.6% decrease in early diagnosis (OR = 0.584, p < 0.001). Income level was not significant (p = 0.426). Lower Charlson-Deyo scores and higher tumor stages were also associated with early-onset cases.
Conclusions
Rectal adenocarcinoma is increasingly affecting younger adults, with significant associations across demographic and insurance variables. These findings call for improved awareness, early diagnostic strategies, and further research into underlying causes to mitigate this growing public health concern.
Epidemiology and Survival of Parotid Gland Malignancies With Brain Metastases: A Population- Based Study
Background
Parotid gland malignancies are a rare subset of salivary gland tumors, comprising approximately 1–3% of all head and neck cancers. While distant metastases commonly involve the lungs, brain metastases are exceedingly rare and remain poorly characterized. Management typically includes stereotactic radiosurgery or whole-brain radiation. This study evaluates the incidence, clinicopathologic features, and survival outcomes of patients with parotid gland tumors and brain metastases using data from Surveillance, Epidemiology, and End Results (SEER) database.
Methods
SEER database (2010–2022) was queried for patients diagnosed with primary malignant neoplasms of the parotid gland (ICD-O-3 site code C07.9). Cases of brain metastases were identified using SEER metastatic site variables. Age-adjusted incidence rates (IR) per 100,000 population were calculated using SEER*Stat 8.4.5. Kaplan-Meier survival analyses were conducted using GraphPad Prism, and survival differences were assessed using the log-rank test.
Results
Among 12,951 patients diagnosed with parotid malignancy, 47 (0.36%) had brain metastases. The median age at diagnosis was 67 years, and 77.5% were male. The overall incidence rate (IR) of brain metastases was 0.00235 per 100,000 population, with a significantly higher rate observed in males compared to females (p < 0.0001). The most common histologic subtype associated with brain involvement was squamous cell carcinoma (SCC, n=10), followed by adenocarcinoma. Median overall survival (mOS) for patients with brain metastases was 2 months (hazard ratio [HR] 6.28; 95% CI: 2.71–14.55), compared to 131 months for those without brain involvement (p < 0.001). 1-year cancer-specific survival for patients with brain metastases was 38%. Among patients with parotid SCC and brain metastases, mOS was 3 months, compared to 39 months in those without brain involvement (HR 5.70; 95% CI: 1.09–29.68; p < 0.0001).
Conclusions
Brain metastases from parotid gland cancers, though rare, are associated with markedly poor outcomes. This highlights the importance of early neurologic assessment and brain imaging in high-risk patients, particularly with SCC histology. Prior studies have shown that TP53 mutations are common in parotid SCC, but their role in CNS spread remains unclear. Future research should explore molecular pathways underlying neurotropism in parotid cancers and investigate targeted systemic therapies with CNS penetration to improve outcomes.
Background
Parotid gland malignancies are a rare subset of salivary gland tumors, comprising approximately 1–3% of all head and neck cancers. While distant metastases commonly involve the lungs, brain metastases are exceedingly rare and remain poorly characterized. Management typically includes stereotactic radiosurgery or whole-brain radiation. This study evaluates the incidence, clinicopathologic features, and survival outcomes of patients with parotid gland tumors and brain metastases using data from Surveillance, Epidemiology, and End Results (SEER) database.
Methods
SEER database (2010–2022) was queried for patients diagnosed with primary malignant neoplasms of the parotid gland (ICD-O-3 site code C07.9). Cases of brain metastases were identified using SEER metastatic site variables. Age-adjusted incidence rates (IR) per 100,000 population were calculated using SEER*Stat 8.4.5. Kaplan-Meier survival analyses were conducted using GraphPad Prism, and survival differences were assessed using the log-rank test.
Results
Among 12,951 patients diagnosed with parotid malignancy, 47 (0.36%) had brain metastases. The median age at diagnosis was 67 years, and 77.5% were male. The overall incidence rate (IR) of brain metastases was 0.00235 per 100,000 population, with a significantly higher rate observed in males compared to females (p < 0.0001). The most common histologic subtype associated with brain involvement was squamous cell carcinoma (SCC, n=10), followed by adenocarcinoma. Median overall survival (mOS) for patients with brain metastases was 2 months (hazard ratio [HR] 6.28; 95% CI: 2.71–14.55), compared to 131 months for those without brain involvement (p < 0.001). 1-year cancer-specific survival for patients with brain metastases was 38%. Among patients with parotid SCC and brain metastases, mOS was 3 months, compared to 39 months in those without brain involvement (HR 5.70; 95% CI: 1.09–29.68; p < 0.0001).
Conclusions
Brain metastases from parotid gland cancers, though rare, are associated with markedly poor outcomes. This highlights the importance of early neurologic assessment and brain imaging in high-risk patients, particularly with SCC histology. Prior studies have shown that TP53 mutations are common in parotid SCC, but their role in CNS spread remains unclear. Future research should explore molecular pathways underlying neurotropism in parotid cancers and investigate targeted systemic therapies with CNS penetration to improve outcomes.
Background
Parotid gland malignancies are a rare subset of salivary gland tumors, comprising approximately 1–3% of all head and neck cancers. While distant metastases commonly involve the lungs, brain metastases are exceedingly rare and remain poorly characterized. Management typically includes stereotactic radiosurgery or whole-brain radiation. This study evaluates the incidence, clinicopathologic features, and survival outcomes of patients with parotid gland tumors and brain metastases using data from Surveillance, Epidemiology, and End Results (SEER) database.
Methods
SEER database (2010–2022) was queried for patients diagnosed with primary malignant neoplasms of the parotid gland (ICD-O-3 site code C07.9). Cases of brain metastases were identified using SEER metastatic site variables. Age-adjusted incidence rates (IR) per 100,000 population were calculated using SEER*Stat 8.4.5. Kaplan-Meier survival analyses were conducted using GraphPad Prism, and survival differences were assessed using the log-rank test.
Results
Among 12,951 patients diagnosed with parotid malignancy, 47 (0.36%) had brain metastases. The median age at diagnosis was 67 years, and 77.5% were male. The overall incidence rate (IR) of brain metastases was 0.00235 per 100,000 population, with a significantly higher rate observed in males compared to females (p < 0.0001). The most common histologic subtype associated with brain involvement was squamous cell carcinoma (SCC, n=10), followed by adenocarcinoma. Median overall survival (mOS) for patients with brain metastases was 2 months (hazard ratio [HR] 6.28; 95% CI: 2.71–14.55), compared to 131 months for those without brain involvement (p < 0.001). 1-year cancer-specific survival for patients with brain metastases was 38%. Among patients with parotid SCC and brain metastases, mOS was 3 months, compared to 39 months in those without brain involvement (HR 5.70; 95% CI: 1.09–29.68; p < 0.0001).
Conclusions
Brain metastases from parotid gland cancers, though rare, are associated with markedly poor outcomes. This highlights the importance of early neurologic assessment and brain imaging in high-risk patients, particularly with SCC histology. Prior studies have shown that TP53 mutations are common in parotid SCC, but their role in CNS spread remains unclear. Future research should explore molecular pathways underlying neurotropism in parotid cancers and investigate targeted systemic therapies with CNS penetration to improve outcomes.
Augmenting DNA Damage by Chemotherapy With CDK7 Inhibition to Disrupt PARP Expression in Cholangiocarcinoma
Assessing Geographical Trends in End-of-Life Cancer Care Using CDC WONDER’s Place of Death Data
Background
19.8% of all deaths in the US in 2023 were due to cancer. Despite its prevalence, there is minimal literature analyzing geographical trends in end-of-life care in cancer patients. This study aims to assess the evolution of end-of-life preferences in cancer patients, particularly during the COVID-19 pandemic, and account for geographical disparities to optimize palliative care delivery.
Methods
The CDC WONDER database was used to collect data on place of death (home, hospice, medical facilities, nursing homes) in patients over 25 years old that died with malignant neoplasms (ICD 10: C00- C97) in the US from 2003-2023. Deaths were stratified by region and urbanization. Proportional mortality was calculated, and statistically significant trends in mortality over time were identified using Joinpoint regression.
Results
There were 13,654,631 total deaths from malignant neoplasms over the study period. Home (40.3%) was the most common place of death followed by medical facilities (30.4%), nursing homes (14.3%), and hospice (8.9%). In 2020, all places experienced a decreased in proportion except for home which rose 7.0% from 41.7% to 48.7%. The South had the highest hospice rates (11.3%); 5.0% greater than the next highest region (Northeast; 8.3%). The West had the highest home rates (47.1%); 6.2% greater than the next closest region (South; 40.9%). The Northeast had the highest medical facility rates (36.0%); 5.5% higher than the next highest region (South, 30.5%). Nonmetro areas (< 50,000 population) had the lowest hospice (4.9%) and highest nursing home rates (15.8%). They also saw a substantial jump (+15.4%) in home deaths from 2019-21. All urbanizations saw a drop in medical facility deaths in 2020 but all have since climbed to surpass their 2019 rates except for nonmetro areas which have dropped 7.3% from 2020-2023.
Conclusion
Hospice and home deaths have increased in frequency with home deaths spiking during the COVID-19 pandemic. Geographical disparities persist in end-of-life care, particularly in nonmetro areas. This highlights the need to increase education and access to palliative care. Further research should aim at why the rural populations have failed to revert to pre-COVID trends like the other urbanization groups.
Background
19.8% of all deaths in the US in 2023 were due to cancer. Despite its prevalence, there is minimal literature analyzing geographical trends in end-of-life care in cancer patients. This study aims to assess the evolution of end-of-life preferences in cancer patients, particularly during the COVID-19 pandemic, and account for geographical disparities to optimize palliative care delivery.
Methods
The CDC WONDER database was used to collect data on place of death (home, hospice, medical facilities, nursing homes) in patients over 25 years old that died with malignant neoplasms (ICD 10: C00- C97) in the US from 2003-2023. Deaths were stratified by region and urbanization. Proportional mortality was calculated, and statistically significant trends in mortality over time were identified using Joinpoint regression.
Results
There were 13,654,631 total deaths from malignant neoplasms over the study period. Home (40.3%) was the most common place of death followed by medical facilities (30.4%), nursing homes (14.3%), and hospice (8.9%). In 2020, all places experienced a decreased in proportion except for home which rose 7.0% from 41.7% to 48.7%. The South had the highest hospice rates (11.3%); 5.0% greater than the next highest region (Northeast; 8.3%). The West had the highest home rates (47.1%); 6.2% greater than the next closest region (South; 40.9%). The Northeast had the highest medical facility rates (36.0%); 5.5% higher than the next highest region (South, 30.5%). Nonmetro areas (< 50,000 population) had the lowest hospice (4.9%) and highest nursing home rates (15.8%). They also saw a substantial jump (+15.4%) in home deaths from 2019-21. All urbanizations saw a drop in medical facility deaths in 2020 but all have since climbed to surpass their 2019 rates except for nonmetro areas which have dropped 7.3% from 2020-2023.
Conclusion
Hospice and home deaths have increased in frequency with home deaths spiking during the COVID-19 pandemic. Geographical disparities persist in end-of-life care, particularly in nonmetro areas. This highlights the need to increase education and access to palliative care. Further research should aim at why the rural populations have failed to revert to pre-COVID trends like the other urbanization groups.
Background
19.8% of all deaths in the US in 2023 were due to cancer. Despite its prevalence, there is minimal literature analyzing geographical trends in end-of-life care in cancer patients. This study aims to assess the evolution of end-of-life preferences in cancer patients, particularly during the COVID-19 pandemic, and account for geographical disparities to optimize palliative care delivery.
Methods
The CDC WONDER database was used to collect data on place of death (home, hospice, medical facilities, nursing homes) in patients over 25 years old that died with malignant neoplasms (ICD 10: C00- C97) in the US from 2003-2023. Deaths were stratified by region and urbanization. Proportional mortality was calculated, and statistically significant trends in mortality over time were identified using Joinpoint regression.
Results
There were 13,654,631 total deaths from malignant neoplasms over the study period. Home (40.3%) was the most common place of death followed by medical facilities (30.4%), nursing homes (14.3%), and hospice (8.9%). In 2020, all places experienced a decreased in proportion except for home which rose 7.0% from 41.7% to 48.7%. The South had the highest hospice rates (11.3%); 5.0% greater than the next highest region (Northeast; 8.3%). The West had the highest home rates (47.1%); 6.2% greater than the next closest region (South; 40.9%). The Northeast had the highest medical facility rates (36.0%); 5.5% higher than the next highest region (South, 30.5%). Nonmetro areas (< 50,000 population) had the lowest hospice (4.9%) and highest nursing home rates (15.8%). They also saw a substantial jump (+15.4%) in home deaths from 2019-21. All urbanizations saw a drop in medical facility deaths in 2020 but all have since climbed to surpass their 2019 rates except for nonmetro areas which have dropped 7.3% from 2020-2023.
Conclusion
Hospice and home deaths have increased in frequency with home deaths spiking during the COVID-19 pandemic. Geographical disparities persist in end-of-life care, particularly in nonmetro areas. This highlights the need to increase education and access to palliative care. Further research should aim at why the rural populations have failed to revert to pre-COVID trends like the other urbanization groups.