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Five Reasons to Update Your Will
You have a will, so you can rest easy, right? Not necessarily. If your will is outdated, it can cause more harm than good.
Even though it can provide for some contingencies, an old will can’t cover every change that may have occurred since it was first drawn. Professionals advise that you review your will every few years and more often if situations such as the following five have occurred since you last updated your will.
1. Family Changes
If you’ve had any changes in your family situation, you will probably need to update your will. Events such as marriage, divorce, death, birth, adoption, or a falling out with a loved one may affect how your estate will be distributed, who should act as guardian for your dependents, and who should be named as executor of your estate.
2. Relocating to a New State
The laws among the states vary. Moving to a new state or purchasing property in another state can affect your estate plan and how property in that state will be taxed and distributed.
3. Tax Law Changes
Federal and state legislatures are continually tinkering with federal estate and state inheritance tax laws. An old will may fail to take advantage of strategies that will minimize estate taxes.
4. You Want to Support a Favorite Cause
If you have developed a connection to a cause, you may want to benefit a particular charity with a gift in your estate. Contact us for sample language you can share with your attorney to include a gift to us in your will.
5. Changes in Your Estate’s Value
When you made your will, your assets may have been relatively modest. Now the value may be larger and your will no longer reflects how you would like your estate divided.
You will help spark future discoveries in GI. Visit our website at https://gastro.planmylegacy.org or contact us at [email protected].
You have a will, so you can rest easy, right? Not necessarily. If your will is outdated, it can cause more harm than good.
Even though it can provide for some contingencies, an old will can’t cover every change that may have occurred since it was first drawn. Professionals advise that you review your will every few years and more often if situations such as the following five have occurred since you last updated your will.
1. Family Changes
If you’ve had any changes in your family situation, you will probably need to update your will. Events such as marriage, divorce, death, birth, adoption, or a falling out with a loved one may affect how your estate will be distributed, who should act as guardian for your dependents, and who should be named as executor of your estate.
2. Relocating to a New State
The laws among the states vary. Moving to a new state or purchasing property in another state can affect your estate plan and how property in that state will be taxed and distributed.
3. Tax Law Changes
Federal and state legislatures are continually tinkering with federal estate and state inheritance tax laws. An old will may fail to take advantage of strategies that will minimize estate taxes.
4. You Want to Support a Favorite Cause
If you have developed a connection to a cause, you may want to benefit a particular charity with a gift in your estate. Contact us for sample language you can share with your attorney to include a gift to us in your will.
5. Changes in Your Estate’s Value
When you made your will, your assets may have been relatively modest. Now the value may be larger and your will no longer reflects how you would like your estate divided.
You will help spark future discoveries in GI. Visit our website at https://gastro.planmylegacy.org or contact us at [email protected].
You have a will, so you can rest easy, right? Not necessarily. If your will is outdated, it can cause more harm than good.
Even though it can provide for some contingencies, an old will can’t cover every change that may have occurred since it was first drawn. Professionals advise that you review your will every few years and more often if situations such as the following five have occurred since you last updated your will.
1. Family Changes
If you’ve had any changes in your family situation, you will probably need to update your will. Events such as marriage, divorce, death, birth, adoption, or a falling out with a loved one may affect how your estate will be distributed, who should act as guardian for your dependents, and who should be named as executor of your estate.
2. Relocating to a New State
The laws among the states vary. Moving to a new state or purchasing property in another state can affect your estate plan and how property in that state will be taxed and distributed.
3. Tax Law Changes
Federal and state legislatures are continually tinkering with federal estate and state inheritance tax laws. An old will may fail to take advantage of strategies that will minimize estate taxes.
4. You Want to Support a Favorite Cause
If you have developed a connection to a cause, you may want to benefit a particular charity with a gift in your estate. Contact us for sample language you can share with your attorney to include a gift to us in your will.
5. Changes in Your Estate’s Value
When you made your will, your assets may have been relatively modest. Now the value may be larger and your will no longer reflects how you would like your estate divided.
You will help spark future discoveries in GI. Visit our website at https://gastro.planmylegacy.org or contact us at [email protected].
Simple Score Predicts Advanced Colorectal Neoplasia in Young Adults
While colorectal cancer (CRC) incidence has declined overall due to screening, early-onset CRC is on the rise, particularly in individuals younger than 45 years — an age group not currently recommended for CRC screening.
Studies have shown that the risk for early-onset advanced neoplasia varies based on several factors, including sex, race, family history of CRC, smoking, alcohol consumption, diabetes, hyperlipidemia, obesity, and diet.
A score that incorporates some of these factors to identify which younger adults are at higher risk for advanced neoplasia, a precursor to CRC, could support earlier, more targeted screening interventions.
The simple clinical score can be easily calculated by primary care providers in the office, Carole Macaron, MD, lead author of the study and a gastroenterologist at Cleveland Clinic, told GI & Hepatology News. “Patients with a high-risk score would be referred for colorectal cancer screening.”
The study was published in Digestive Diseases and Sciences.
To develop and validate their risk score, Macaron and colleagues did a retrospective cross-sectional analysis of 9446 individuals aged 18-44 years (mean age, 36.8 years; 61% women) who underwent colonoscopy at their center.
Advanced neoplasia was defined as a tubular adenoma ≥ 10 mm or any adenoma with villous features or high-grade dysplasia, sessile serrated polyp ≥ 10 mm, sessile serrated polyp with dysplasia, traditional serrated adenoma, or invasive adenocarcinoma.
The 346 (3.7%) individuals found to have advanced neoplasia served as the case group, and the remainder with normal colonoscopy or non-advanced neoplasia served as controls.
A multivariate logistic regression model identified three independent risk factors significantly associated with advanced neoplasia: Higher body mass index (BMI; P = .0157), former and current tobacco use (P = .0009 and P = .0015, respectively), and having a first-degree relative with CRC < 60 years (P < .0001) or other family history of CRC (P = .0117).
The researchers used these risk factors to develop a risk prediction score to estimate the likelihood of detecting advanced neoplasia, which ranged from a risk of 1.8% for patients with a score of 1 to 22.2% for those with a score of 12. Individuals with a score of ≥ 9 had a 14% or higher risk for advanced neoplasia.
Based on the risk model, the likelihood of detecting advanced neoplasia in an asymptomatic 32-year-old overweight individual, with a history of previous tobacco use and a first-degree relative younger than age 60 with CRC would be 20.3%, Macaron and colleagues noted.
The model demonstrated “moderate” discriminatory power in the validation set (C-statistic: 0.645), indicating that it can effectively differentiate between individuals at a higher and lower risk for advanced neoplasia.
Additionally, the authors are exploring ways to improve the discriminatory power of the score, possibly by including additional risk factors.
Given the score is calculated using easily obtainable risk factors for individuals younger than 45 who are at risk for early-onset colorectal neoplasia, it could help guide individualized screening decisions for those in whom screening is not currently offered, Macaron said. It could also serve as a tool for risk communication and shared decision-making.
Integration into electronic health records or online calculators may enhance its accessibility and clinical utility.
The authors noted that this retrospective study was conducted at a single center caring mainly for White non-Hispanic adults, limiting generalizability to the general population and to other races and ethnicities.
Validation in Real-World Setting Needed
“There are no currently accepted advanced colorectal neoplasia risk scores that are used in general practice,” said Steven H. Itzkowitz, MD, AGAF, professor of medicine, oncological sciences, and medical education, Icahn School of Medicine at Mount Sinai in New York City. “If these lesions can be predicted, it would enable these young individuals to undergo screening colonoscopy, which could detect and remove these lesions, thereby preventing CRC.”
Many of the known risk factors (family history, high BMI, or smoking) for CRC development at any age are incorporated within this tool, so it should be feasible to collect these data,” said Itzkowitz, who was not involved with the study.
But he cautioned that accurate and adequate family histories are not always performed. Clinicians also may not have considered combining these factors into an actionable risk score.
“If this score can be externally validated in a real-world setting, it could be a useful addition in our efforts to lower CRC rates among young individuals,” Itzkowitz said.
The study did not receive any funding. Macaron and Itzkowitz reported no competing interests.
A version of this article first appeared on Medscape.com.
While colorectal cancer (CRC) incidence has declined overall due to screening, early-onset CRC is on the rise, particularly in individuals younger than 45 years — an age group not currently recommended for CRC screening.
Studies have shown that the risk for early-onset advanced neoplasia varies based on several factors, including sex, race, family history of CRC, smoking, alcohol consumption, diabetes, hyperlipidemia, obesity, and diet.
A score that incorporates some of these factors to identify which younger adults are at higher risk for advanced neoplasia, a precursor to CRC, could support earlier, more targeted screening interventions.
The simple clinical score can be easily calculated by primary care providers in the office, Carole Macaron, MD, lead author of the study and a gastroenterologist at Cleveland Clinic, told GI & Hepatology News. “Patients with a high-risk score would be referred for colorectal cancer screening.”
The study was published in Digestive Diseases and Sciences.
To develop and validate their risk score, Macaron and colleagues did a retrospective cross-sectional analysis of 9446 individuals aged 18-44 years (mean age, 36.8 years; 61% women) who underwent colonoscopy at their center.
Advanced neoplasia was defined as a tubular adenoma ≥ 10 mm or any adenoma with villous features or high-grade dysplasia, sessile serrated polyp ≥ 10 mm, sessile serrated polyp with dysplasia, traditional serrated adenoma, or invasive adenocarcinoma.
The 346 (3.7%) individuals found to have advanced neoplasia served as the case group, and the remainder with normal colonoscopy or non-advanced neoplasia served as controls.
A multivariate logistic regression model identified three independent risk factors significantly associated with advanced neoplasia: Higher body mass index (BMI; P = .0157), former and current tobacco use (P = .0009 and P = .0015, respectively), and having a first-degree relative with CRC < 60 years (P < .0001) or other family history of CRC (P = .0117).
The researchers used these risk factors to develop a risk prediction score to estimate the likelihood of detecting advanced neoplasia, which ranged from a risk of 1.8% for patients with a score of 1 to 22.2% for those with a score of 12. Individuals with a score of ≥ 9 had a 14% or higher risk for advanced neoplasia.
Based on the risk model, the likelihood of detecting advanced neoplasia in an asymptomatic 32-year-old overweight individual, with a history of previous tobacco use and a first-degree relative younger than age 60 with CRC would be 20.3%, Macaron and colleagues noted.
The model demonstrated “moderate” discriminatory power in the validation set (C-statistic: 0.645), indicating that it can effectively differentiate between individuals at a higher and lower risk for advanced neoplasia.
Additionally, the authors are exploring ways to improve the discriminatory power of the score, possibly by including additional risk factors.
Given the score is calculated using easily obtainable risk factors for individuals younger than 45 who are at risk for early-onset colorectal neoplasia, it could help guide individualized screening decisions for those in whom screening is not currently offered, Macaron said. It could also serve as a tool for risk communication and shared decision-making.
Integration into electronic health records or online calculators may enhance its accessibility and clinical utility.
The authors noted that this retrospective study was conducted at a single center caring mainly for White non-Hispanic adults, limiting generalizability to the general population and to other races and ethnicities.
Validation in Real-World Setting Needed
“There are no currently accepted advanced colorectal neoplasia risk scores that are used in general practice,” said Steven H. Itzkowitz, MD, AGAF, professor of medicine, oncological sciences, and medical education, Icahn School of Medicine at Mount Sinai in New York City. “If these lesions can be predicted, it would enable these young individuals to undergo screening colonoscopy, which could detect and remove these lesions, thereby preventing CRC.”
Many of the known risk factors (family history, high BMI, or smoking) for CRC development at any age are incorporated within this tool, so it should be feasible to collect these data,” said Itzkowitz, who was not involved with the study.
But he cautioned that accurate and adequate family histories are not always performed. Clinicians also may not have considered combining these factors into an actionable risk score.
“If this score can be externally validated in a real-world setting, it could be a useful addition in our efforts to lower CRC rates among young individuals,” Itzkowitz said.
The study did not receive any funding. Macaron and Itzkowitz reported no competing interests.
A version of this article first appeared on Medscape.com.
While colorectal cancer (CRC) incidence has declined overall due to screening, early-onset CRC is on the rise, particularly in individuals younger than 45 years — an age group not currently recommended for CRC screening.
Studies have shown that the risk for early-onset advanced neoplasia varies based on several factors, including sex, race, family history of CRC, smoking, alcohol consumption, diabetes, hyperlipidemia, obesity, and diet.
A score that incorporates some of these factors to identify which younger adults are at higher risk for advanced neoplasia, a precursor to CRC, could support earlier, more targeted screening interventions.
The simple clinical score can be easily calculated by primary care providers in the office, Carole Macaron, MD, lead author of the study and a gastroenterologist at Cleveland Clinic, told GI & Hepatology News. “Patients with a high-risk score would be referred for colorectal cancer screening.”
The study was published in Digestive Diseases and Sciences.
To develop and validate their risk score, Macaron and colleagues did a retrospective cross-sectional analysis of 9446 individuals aged 18-44 years (mean age, 36.8 years; 61% women) who underwent colonoscopy at their center.
Advanced neoplasia was defined as a tubular adenoma ≥ 10 mm or any adenoma with villous features or high-grade dysplasia, sessile serrated polyp ≥ 10 mm, sessile serrated polyp with dysplasia, traditional serrated adenoma, or invasive adenocarcinoma.
The 346 (3.7%) individuals found to have advanced neoplasia served as the case group, and the remainder with normal colonoscopy or non-advanced neoplasia served as controls.
A multivariate logistic regression model identified three independent risk factors significantly associated with advanced neoplasia: Higher body mass index (BMI; P = .0157), former and current tobacco use (P = .0009 and P = .0015, respectively), and having a first-degree relative with CRC < 60 years (P < .0001) or other family history of CRC (P = .0117).
The researchers used these risk factors to develop a risk prediction score to estimate the likelihood of detecting advanced neoplasia, which ranged from a risk of 1.8% for patients with a score of 1 to 22.2% for those with a score of 12. Individuals with a score of ≥ 9 had a 14% or higher risk for advanced neoplasia.
Based on the risk model, the likelihood of detecting advanced neoplasia in an asymptomatic 32-year-old overweight individual, with a history of previous tobacco use and a first-degree relative younger than age 60 with CRC would be 20.3%, Macaron and colleagues noted.
The model demonstrated “moderate” discriminatory power in the validation set (C-statistic: 0.645), indicating that it can effectively differentiate between individuals at a higher and lower risk for advanced neoplasia.
Additionally, the authors are exploring ways to improve the discriminatory power of the score, possibly by including additional risk factors.
Given the score is calculated using easily obtainable risk factors for individuals younger than 45 who are at risk for early-onset colorectal neoplasia, it could help guide individualized screening decisions for those in whom screening is not currently offered, Macaron said. It could also serve as a tool for risk communication and shared decision-making.
Integration into electronic health records or online calculators may enhance its accessibility and clinical utility.
The authors noted that this retrospective study was conducted at a single center caring mainly for White non-Hispanic adults, limiting generalizability to the general population and to other races and ethnicities.
Validation in Real-World Setting Needed
“There are no currently accepted advanced colorectal neoplasia risk scores that are used in general practice,” said Steven H. Itzkowitz, MD, AGAF, professor of medicine, oncological sciences, and medical education, Icahn School of Medicine at Mount Sinai in New York City. “If these lesions can be predicted, it would enable these young individuals to undergo screening colonoscopy, which could detect and remove these lesions, thereby preventing CRC.”
Many of the known risk factors (family history, high BMI, or smoking) for CRC development at any age are incorporated within this tool, so it should be feasible to collect these data,” said Itzkowitz, who was not involved with the study.
But he cautioned that accurate and adequate family histories are not always performed. Clinicians also may not have considered combining these factors into an actionable risk score.
“If this score can be externally validated in a real-world setting, it could be a useful addition in our efforts to lower CRC rates among young individuals,” Itzkowitz said.
The study did not receive any funding. Macaron and Itzkowitz reported no competing interests.
A version of this article first appeared on Medscape.com.
HHS Cuts Thousands of Jobs, Eliminates Entire Services
On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind.
Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.”
"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.
The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them.
Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”
Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.
The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy
“This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”
US Food and Drug Administration
An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors.
Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.”
Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.
Centers for Disease Control and Prevention
About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.
Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC.
A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care.
National Institutes of Health
NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.
In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”
Deep Cuts at Other HHS Agencies
As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said.
About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.
More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.
Indian Health Service
The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.
“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”
March layoffs that had been announced for 1000 IHS employees were rescinded.
“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.
In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position.
"Streamline the Agency"
The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”
“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated.
“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.”
But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.
Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”
Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”
On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind.
Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.”
"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.
The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them.
Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”
Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.
The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy
“This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”
US Food and Drug Administration
An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors.
Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.”
Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.
Centers for Disease Control and Prevention
About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.
Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC.
A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care.
National Institutes of Health
NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.
In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”
Deep Cuts at Other HHS Agencies
As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said.
About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.
More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.
Indian Health Service
The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.
“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”
March layoffs that had been announced for 1000 IHS employees were rescinded.
“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.
In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position.
"Streamline the Agency"
The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”
“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated.
“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.”
But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.
Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”
Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”
On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind.
Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.”
"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.
The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them.
Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”
Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.
The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy
“This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”
US Food and Drug Administration
An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors.
Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.”
Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.
Centers for Disease Control and Prevention
About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.
Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC.
A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care.
National Institutes of Health
NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.
In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”
Deep Cuts at Other HHS Agencies
As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said.
About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.
More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.
Indian Health Service
The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.
“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”
March layoffs that had been announced for 1000 IHS employees were rescinded.
“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.
In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position.
"Streamline the Agency"
The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”
“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated.
“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.”
But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.
Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”
Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”
A ‘Fool’s Errand’? Picking a Winner for Treating Early-Stage NSCLC
For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.
Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.
More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.
“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.
Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.
What may ultimately matter most is carefully selecting operable patients who undergo SBRT.
Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.
The Pros and Cons of SBRT
SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.
SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.
The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.
One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.
Latest Data in Large Cohort
A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.
In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.
Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.
The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.
While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).
Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).
However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.
Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.
Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.
Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.
What Do Experts Say?
So, is SBRT an option for patients with stage I NSCLC?
Opinions vary.
“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.
Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.
In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.
The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”
Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”
Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.
“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”
In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.
Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”
Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.
While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.
These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.
A Winner?
Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.
STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.
But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.
“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.
Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”
Aggarwal, Robinson, and Flores had no relevant disclosures.
A version of this article first appeared on Medscape.com.
For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.
Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.
More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.
“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.
Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.
What may ultimately matter most is carefully selecting operable patients who undergo SBRT.
Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.
The Pros and Cons of SBRT
SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.
SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.
The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.
One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.
Latest Data in Large Cohort
A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.
In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.
Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.
The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.
While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).
Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).
However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.
Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.
Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.
Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.
What Do Experts Say?
So, is SBRT an option for patients with stage I NSCLC?
Opinions vary.
“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.
Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.
In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.
The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”
Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”
Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.
“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”
In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.
Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”
Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.
While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.
These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.
A Winner?
Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.
STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.
But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.
“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.
Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”
Aggarwal, Robinson, and Flores had no relevant disclosures.
A version of this article first appeared on Medscape.com.
For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.
Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.
More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.
“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.
Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.
What may ultimately matter most is carefully selecting operable patients who undergo SBRT.
Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.
The Pros and Cons of SBRT
SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.
SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.
The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.
One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.
Latest Data in Large Cohort
A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.
In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.
Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.
The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.
While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).
Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).
However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.
Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.
Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.
Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.
What Do Experts Say?
So, is SBRT an option for patients with stage I NSCLC?
Opinions vary.
“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.
Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.
In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.
The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”
Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”
Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.
“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”
In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.
Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”
Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.
While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.
These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.
A Winner?
Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.
STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.
But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.
“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.
Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”
Aggarwal, Robinson, and Flores had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FDA Approves Pluvicto for Earlier Use in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.
Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.
Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.
Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.
Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.
The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.
“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”
A version of this article first appeared on Medscape.com.
The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.
Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.
Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.
Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.
Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.
The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.
“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”
A version of this article first appeared on Medscape.com.
The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.
Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.
Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.
Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.
Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.
The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.
“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”
A version of this article first appeared on Medscape.com.
The Physician Associate Advantage: A Vital Solution for Better Patient Care
Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.
Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.
“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”
The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.
Physicians Trust PAs
Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.
“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”
PAs Improve Care Delivery
One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).
This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.
“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.
Autonomy Leads to Access
The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.
“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.
A version of this article first appeared on Medscape.com.
Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.
Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.
“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”
The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.
Physicians Trust PAs
Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.
“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”
PAs Improve Care Delivery
One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).
This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.
“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.
Autonomy Leads to Access
The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.
“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.
A version of this article first appeared on Medscape.com.
Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.
Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.
“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”
The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.
Physicians Trust PAs
Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.
“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”
PAs Improve Care Delivery
One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).
This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.
“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.
Autonomy Leads to Access
The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.
“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.
A version of this article first appeared on Medscape.com.
Study Gives Clinical Edge to Transperineal Prostate Biopsies
In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.
The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).
Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.
“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.
Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.
The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.
Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.
Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.
The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.
Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.
Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.
Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.
Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.
European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.
Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”
The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.
Howard Wolinsky is a Chicago-based freelance writer.
A version of this article appeared at Medscape.com.
In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.
The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).
Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.
“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.
Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.
The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.
Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.
Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.
The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.
Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.
Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.
Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.
Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.
European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.
Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”
The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.
Howard Wolinsky is a Chicago-based freelance writer.
A version of this article appeared at Medscape.com.
In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.
The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).
Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.
“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.
Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.
The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.
Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.
Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.
The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.
Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.
Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.
Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.
Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.
European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.
Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”
The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.
Howard Wolinsky is a Chicago-based freelance writer.
A version of this article appeared at Medscape.com.
A Better Biopsy for Prostate Cancer?
Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.
The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.
“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.
Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.
OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.
The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).
Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.
“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.
The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.
Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available.
“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.
This group is next studying the financial aspects of the technology, he added.
Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.
Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.
Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”
Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.
“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”
The researchers received a grant from Exact Imaging.
A version of this article appeared at Medscape.com.
Howard Wolinsky is a Chicago-based freelance writer.
Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.
The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.
“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.
Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.
OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.
The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).
Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.
“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.
The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.
Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available.
“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.
This group is next studying the financial aspects of the technology, he added.
Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.
Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.
Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”
Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.
“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”
The researchers received a grant from Exact Imaging.
A version of this article appeared at Medscape.com.
Howard Wolinsky is a Chicago-based freelance writer.
Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.
The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.
“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.
Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.
OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.
The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).
Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.
“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.
The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.
Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available.
“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.
This group is next studying the financial aspects of the technology, he added.
Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.
Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.
Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”
Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.
“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”
The researchers received a grant from Exact Imaging.
A version of this article appeared at Medscape.com.
Howard Wolinsky is a Chicago-based freelance writer.
Inadequate Grading of Intraductal Carcinoma of the Prostate
BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.
“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.
Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.
The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.
To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.
The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.
Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.
Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).
Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).
There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.
After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).
Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.
“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.
The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.
“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.
Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.
IDC More Common in Metastases
Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.
In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).
The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.
IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.
IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.
Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).
The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.
“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.
As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.
The take-home message from the collective research should be that “IDC-P matters,” she said.
“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.
The authors had no disclosures to report.
The article first appeared in Medscape.com.
BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.
“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.
Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.
The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.
To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.
The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.
Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.
Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).
Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).
There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.
After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).
Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.
“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.
The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.
“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.
Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.
IDC More Common in Metastases
Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.
In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).
The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.
IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.
IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.
Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).
The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.
“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.
As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.
The take-home message from the collective research should be that “IDC-P matters,” she said.
“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.
The authors had no disclosures to report.
The article first appeared in Medscape.com.
BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.
“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.
Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.
The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.
To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.
The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.
Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.
Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).
Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).
There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.
After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).
Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.
“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.
The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.
“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.
Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.
IDC More Common in Metastases
Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.
In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).
The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.
IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.
IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.
Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).
The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.
“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.
As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.
The take-home message from the collective research should be that “IDC-P matters,” she said.
“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.
The authors had no disclosures to report.
The article first appeared in Medscape.com.
FDA OKs Guselkumab for Crohn’s Disease
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.