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Dr. Rogers’ Neighborhood: Guinea Pigs and Groundbreaking Cancer Care
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home.
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home.
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home.
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Survival Outcomes in Hepatocellular Carcinoma Patients Show Improvement Over Time
TOPLINE:
Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.
METHODOLOGY:
- Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
- The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
- Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
- Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.
TAKEAWAY:
- Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
- Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
- Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
- Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.
IN PRACTICE:
“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.
SOURCE:
The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.
LIMITATIONS:
The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.
DISCLOSURES:
The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.
METHODOLOGY:
- Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
- The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
- Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
- Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.
TAKEAWAY:
- Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
- Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
- Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
- Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.
IN PRACTICE:
“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.
SOURCE:
The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.
LIMITATIONS:
The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.
DISCLOSURES:
The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.
METHODOLOGY:
- Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
- The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
- Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
- Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.
TAKEAWAY:
- Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
- Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
- Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
- Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.
IN PRACTICE:
“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.
SOURCE:
The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.
LIMITATIONS:
The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.
DISCLOSURES:
The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Does Medicare Advantage Offer Higher-Value Chemotherapy?
TOPLINE:
METHODOLOGY:
- Private Medicare Advantage plans enroll more than half of the Medicare population, but it is unknown if or how the cost restrictions they impose affect chemotherapy, which accounts for a large portion of cancer care costs.
- Researchers conducted a cohort study using national Medicare data from January 2015 to December 2019 to look at Medicare Advantage enrollment and treatment patterns for patients with cancer receiving chemotherapy.
- The study included 96,501 Medicare Advantage enrollees and 206,274 traditional Medicare beneficiaries who initiated chemotherapy between January 2016 and December 2019 (mean age, ~73 years; ~56% women; Hispanic individuals, 15% and 8%; Black individuals, 15% and 8%; and White individuals, 75% and 86%, respectively).
- Resource use and care quality were measured during a 6-month period following chemotherapy initiation, and survival days were measured 18 months after beginning chemotherapy.
- Resource use measures included hospital inpatient services, outpatient care, prescription drugs, hospice services, and chemotherapy services. Quality measures included chemotherapy-related emergency visits and hospital admissions, as well as avoidable emergency visits and preventable hospitalizations.
TAKEAWAY:
- Medicare Advantage plans had lower resource use than traditional Medicare per enrollee with cancer undergoing chemotherapy ($8718 lower; 95% CI, $8343-$9094).
- The lower resource use was largely caused by fewer chemotherapy visits and less expensive chemotherapy per visit in Medicare Advantage plans ($5032 lower; 95% CI, $4772-$5293).
- Medicare Advantage enrollees had 2.5 percentage points fewer chemotherapy-related emergency department visits and 0.7 percentage points fewer chemotherapy-related hospitalizations than traditional Medicare beneficiaries.
- There was no clinically meaningful difference in survival between Medicare Advantage and traditional Medicare beneficiaries during the 18 months following chemotherapy initiation.
IN PRACTICE:
“Our new finding is that MA [Medicare Advantage] plans had lower resource use than TM [traditional Medicare] among enrollees with cancer undergoing chemotherapy — a serious condition managed by specialists and requiring expensive treatments. This suggests that MA’s cost advantages over TM are not limited to conditions for which low-cost primary care management can avoid costly services,” the authors wrote.
SOURCE:
The study was led by Yamini Kalidindi, PhD, McDermott+ Consulting, Washington, DC. It was published online on September 20, 2024, in JAMA Network Open (doi: 10.1001/jamanetworkopen.2024.34707), with a commentary.
LIMITATIONS:
The study’s findings may be affected by unobserved patient characteristics despite the use of inverse-probability weighting. The exclusion of Medicare Advantage enrollees in contracts with incomplete encounter data limits the generalizability of the results. The study does not apply to beneficiaries without Part D drug coverage. Quality measures were limited to those available from claims and encounter data, lacking information on patients’ cancer stage. The 18-month measure of survival might not adequately capture survival differences associated with early-stage cancers. The study did not measure whether patient care followed recommended guidelines.
DISCLOSURES:
Various authors reported grants from the National Institute on Aging, the National Institutes of Health, The Commonwealth Fund, Arnold Ventures, the National Cancer Institute, the Department of Defense, and the National Institute of Health Care Management. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Private Medicare Advantage plans enroll more than half of the Medicare population, but it is unknown if or how the cost restrictions they impose affect chemotherapy, which accounts for a large portion of cancer care costs.
- Researchers conducted a cohort study using national Medicare data from January 2015 to December 2019 to look at Medicare Advantage enrollment and treatment patterns for patients with cancer receiving chemotherapy.
- The study included 96,501 Medicare Advantage enrollees and 206,274 traditional Medicare beneficiaries who initiated chemotherapy between January 2016 and December 2019 (mean age, ~73 years; ~56% women; Hispanic individuals, 15% and 8%; Black individuals, 15% and 8%; and White individuals, 75% and 86%, respectively).
- Resource use and care quality were measured during a 6-month period following chemotherapy initiation, and survival days were measured 18 months after beginning chemotherapy.
- Resource use measures included hospital inpatient services, outpatient care, prescription drugs, hospice services, and chemotherapy services. Quality measures included chemotherapy-related emergency visits and hospital admissions, as well as avoidable emergency visits and preventable hospitalizations.
TAKEAWAY:
- Medicare Advantage plans had lower resource use than traditional Medicare per enrollee with cancer undergoing chemotherapy ($8718 lower; 95% CI, $8343-$9094).
- The lower resource use was largely caused by fewer chemotherapy visits and less expensive chemotherapy per visit in Medicare Advantage plans ($5032 lower; 95% CI, $4772-$5293).
- Medicare Advantage enrollees had 2.5 percentage points fewer chemotherapy-related emergency department visits and 0.7 percentage points fewer chemotherapy-related hospitalizations than traditional Medicare beneficiaries.
- There was no clinically meaningful difference in survival between Medicare Advantage and traditional Medicare beneficiaries during the 18 months following chemotherapy initiation.
IN PRACTICE:
“Our new finding is that MA [Medicare Advantage] plans had lower resource use than TM [traditional Medicare] among enrollees with cancer undergoing chemotherapy — a serious condition managed by specialists and requiring expensive treatments. This suggests that MA’s cost advantages over TM are not limited to conditions for which low-cost primary care management can avoid costly services,” the authors wrote.
SOURCE:
The study was led by Yamini Kalidindi, PhD, McDermott+ Consulting, Washington, DC. It was published online on September 20, 2024, in JAMA Network Open (doi: 10.1001/jamanetworkopen.2024.34707), with a commentary.
LIMITATIONS:
The study’s findings may be affected by unobserved patient characteristics despite the use of inverse-probability weighting. The exclusion of Medicare Advantage enrollees in contracts with incomplete encounter data limits the generalizability of the results. The study does not apply to beneficiaries without Part D drug coverage. Quality measures were limited to those available from claims and encounter data, lacking information on patients’ cancer stage. The 18-month measure of survival might not adequately capture survival differences associated with early-stage cancers. The study did not measure whether patient care followed recommended guidelines.
DISCLOSURES:
Various authors reported grants from the National Institute on Aging, the National Institutes of Health, The Commonwealth Fund, Arnold Ventures, the National Cancer Institute, the Department of Defense, and the National Institute of Health Care Management. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Private Medicare Advantage plans enroll more than half of the Medicare population, but it is unknown if or how the cost restrictions they impose affect chemotherapy, which accounts for a large portion of cancer care costs.
- Researchers conducted a cohort study using national Medicare data from January 2015 to December 2019 to look at Medicare Advantage enrollment and treatment patterns for patients with cancer receiving chemotherapy.
- The study included 96,501 Medicare Advantage enrollees and 206,274 traditional Medicare beneficiaries who initiated chemotherapy between January 2016 and December 2019 (mean age, ~73 years; ~56% women; Hispanic individuals, 15% and 8%; Black individuals, 15% and 8%; and White individuals, 75% and 86%, respectively).
- Resource use and care quality were measured during a 6-month period following chemotherapy initiation, and survival days were measured 18 months after beginning chemotherapy.
- Resource use measures included hospital inpatient services, outpatient care, prescription drugs, hospice services, and chemotherapy services. Quality measures included chemotherapy-related emergency visits and hospital admissions, as well as avoidable emergency visits and preventable hospitalizations.
TAKEAWAY:
- Medicare Advantage plans had lower resource use than traditional Medicare per enrollee with cancer undergoing chemotherapy ($8718 lower; 95% CI, $8343-$9094).
- The lower resource use was largely caused by fewer chemotherapy visits and less expensive chemotherapy per visit in Medicare Advantage plans ($5032 lower; 95% CI, $4772-$5293).
- Medicare Advantage enrollees had 2.5 percentage points fewer chemotherapy-related emergency department visits and 0.7 percentage points fewer chemotherapy-related hospitalizations than traditional Medicare beneficiaries.
- There was no clinically meaningful difference in survival between Medicare Advantage and traditional Medicare beneficiaries during the 18 months following chemotherapy initiation.
IN PRACTICE:
“Our new finding is that MA [Medicare Advantage] plans had lower resource use than TM [traditional Medicare] among enrollees with cancer undergoing chemotherapy — a serious condition managed by specialists and requiring expensive treatments. This suggests that MA’s cost advantages over TM are not limited to conditions for which low-cost primary care management can avoid costly services,” the authors wrote.
SOURCE:
The study was led by Yamini Kalidindi, PhD, McDermott+ Consulting, Washington, DC. It was published online on September 20, 2024, in JAMA Network Open (doi: 10.1001/jamanetworkopen.2024.34707), with a commentary.
LIMITATIONS:
The study’s findings may be affected by unobserved patient characteristics despite the use of inverse-probability weighting. The exclusion of Medicare Advantage enrollees in contracts with incomplete encounter data limits the generalizability of the results. The study does not apply to beneficiaries without Part D drug coverage. Quality measures were limited to those available from claims and encounter data, lacking information on patients’ cancer stage. The 18-month measure of survival might not adequately capture survival differences associated with early-stage cancers. The study did not measure whether patient care followed recommended guidelines.
DISCLOSURES:
Various authors reported grants from the National Institute on Aging, the National Institutes of Health, The Commonwealth Fund, Arnold Ventures, the National Cancer Institute, the Department of Defense, and the National Institute of Health Care Management. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
AACR Cancer Progress Report: Big Strides and Big Gaps
The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted.
One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.
These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
Inside the Report: Big Progress
Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives.
According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.
The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.
“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.”
The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.
“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
The Gaps
Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.
“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.
The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.
Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.
Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.
The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.
Financial toxicity remains prevalent as well.
The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.
For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.
On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
The Path Forward
Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.
“I am excited about what the future holds for cancer research, and especially for patient care,” she said.
However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.
Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.
The AACR report specifically calls on Congress to:
- Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
- Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
- Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
- Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.
By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”
A version of this article first appeared on Medscape.com.
The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted.
One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.
These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
Inside the Report: Big Progress
Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives.
According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.
The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.
“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.”
The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.
“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
The Gaps
Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.
“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.
The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.
Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.
Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.
The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.
Financial toxicity remains prevalent as well.
The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.
For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.
On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
The Path Forward
Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.
“I am excited about what the future holds for cancer research, and especially for patient care,” she said.
However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.
Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.
The AACR report specifically calls on Congress to:
- Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
- Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
- Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
- Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.
By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”
A version of this article first appeared on Medscape.com.
The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted.
One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.
These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
Inside the Report: Big Progress
Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives.
According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.
The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.
“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.”
The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.
“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
The Gaps
Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.
“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.
The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.
Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.
Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.
The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.
Financial toxicity remains prevalent as well.
The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.
For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.
On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
The Path Forward
Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.
“I am excited about what the future holds for cancer research, and especially for patient care,” she said.
However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.
Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.
The AACR report specifically calls on Congress to:
- Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
- Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
- Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
- Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.
By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”
A version of this article first appeared on Medscape.com.
Black Women Have a Higher Risk for Death in BC Subtypes
TOPLINE:
The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.
METHODOLOGY:
- US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
- Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
- The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
- Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
- The primary outcome was BC-specific survival, with overall survival as a secondary analysis.
TAKEAWAY:
- Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
- The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
- Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
- In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.
IN PRACTICE:
“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.
SOURCE:
The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.
DISCLOSURES:
Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.
METHODOLOGY:
- US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
- Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
- The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
- Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
- The primary outcome was BC-specific survival, with overall survival as a secondary analysis.
TAKEAWAY:
- Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
- The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
- Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
- In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.
IN PRACTICE:
“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.
SOURCE:
The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.
DISCLOSURES:
Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.
METHODOLOGY:
- US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
- Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
- The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
- Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
- The primary outcome was BC-specific survival, with overall survival as a secondary analysis.
TAKEAWAY:
- Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
- The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
- Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
- In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.
IN PRACTICE:
“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.
SOURCE:
The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.
DISCLOSURES:
Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.
A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.
There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.
The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.
The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery.
Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.
At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.
Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.
There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.
Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.
Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
A version of this article appeared on Medscape.com.
FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.
A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.
There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.
The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.
The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery.
Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.
At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.
Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.
There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.
Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.
Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
A version of this article appeared on Medscape.com.
FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.
A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.
There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.
The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.
The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery.
Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.
At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.
Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.
There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.
Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.
Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
A version of this article appeared on Medscape.com.
Cancer Risk: Are Pesticides the New Smoking?
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Is Minimal Access Nipple-Sparing Mastectomy a Safer Option?
TOPLINE:
Given that both procedures appear safe overall, the choice may be guided by patients’ preference.
METHODOLOGY:
- Compared with a conventional mastectomy, a nipple-sparing mastectomy offers superior esthetic outcomes in patients with breast cancer. However, even the typical nipple-sparing approach often results in visible scarring and a high risk for nipple or areola necrosis. A minimal access approach, using endoscopic or robotic techniques, offers the potential to minimize scarring and better outcomes, but the complication risks are not well understood.
- Researchers performed a retrospective study that included 1583 patients with breast cancer who underwent conventional nipple-sparing mastectomy (n = 1356) or minimal access nipple-sparing mastectomy (n = 227) between 2018 and 2020 across 21 institutions in the Republic of Korea.
- Postoperative complications, categorized as short term (< 30 days) and long term (< 90 days), were compared between the two groups.
- The minimal access group had a higher percentage of premenopausal patients (73.57% vs 66.67%) and women with firm breasts (66.08% vs 31.27%).
TAKEAWAY:
- In total, 72 individuals (5.31%) in the conventional nipple-sparing mastectomy group and 7 (3.08%) in the minimal access nipple-sparing mastectomy group developed postoperative complications of grade IIIb or higher.
- The rate of complications between the conventional and minimal access nipple-sparing mastectomy groups in the short term (34.29% for conventional vs 32.16% for minimal access; P = .53) and long term (38.72% vs 32.16%, respectively; P = .06) was not significantly different.
- The conventional group experienced significantly fewer wound infections — both in the short term (1.62% vs 7.49%) and long term (4.28% vs 7.93%) — but a significantly higher rate of seroma (14.23% vs 9.25%), likely because of the variations in surgical instruments used during the procedures.
- Necrosis of the nipple or areola occurred more often in the minimal access group in the short term (8.81% vs 3.91%) but occurred more frequently in the conventional group in the long term (6.71% vs 2.20%).
IN PRACTICE:
“The similar complication rates suggest that both C-NSM [conventional nipple-sparing mastectomy] and M-NSM [minimal access nipple-sparing mastectomy] may be equally safe options,” the authors wrote. “Therefore, the choice of surgical approach should be tailored to patient preferences and individual needs.”
SOURCE:
The study, led by Joo Heung Kim, MD, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea, was published online on August 14, 2024, in JAMA Surgery.
LIMITATIONS:
The retrospective design comes with inherent biases. The nonrandom assignment of the participants to the two groups and the relatively small number of cases of minimal access nipple-sparing mastectomy may have affected the findings. The involvement of different surgeons and use of early robotic surgery techniques may have introduced bias as well.
DISCLOSURES:
This study was supported by Yonsei University College of Medicine and the National Research Foundation of Korea. Two authors reported receiving grants and consulting fees outside of this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Given that both procedures appear safe overall, the choice may be guided by patients’ preference.
METHODOLOGY:
- Compared with a conventional mastectomy, a nipple-sparing mastectomy offers superior esthetic outcomes in patients with breast cancer. However, even the typical nipple-sparing approach often results in visible scarring and a high risk for nipple or areola necrosis. A minimal access approach, using endoscopic or robotic techniques, offers the potential to minimize scarring and better outcomes, but the complication risks are not well understood.
- Researchers performed a retrospective study that included 1583 patients with breast cancer who underwent conventional nipple-sparing mastectomy (n = 1356) or minimal access nipple-sparing mastectomy (n = 227) between 2018 and 2020 across 21 institutions in the Republic of Korea.
- Postoperative complications, categorized as short term (< 30 days) and long term (< 90 days), were compared between the two groups.
- The minimal access group had a higher percentage of premenopausal patients (73.57% vs 66.67%) and women with firm breasts (66.08% vs 31.27%).
TAKEAWAY:
- In total, 72 individuals (5.31%) in the conventional nipple-sparing mastectomy group and 7 (3.08%) in the minimal access nipple-sparing mastectomy group developed postoperative complications of grade IIIb or higher.
- The rate of complications between the conventional and minimal access nipple-sparing mastectomy groups in the short term (34.29% for conventional vs 32.16% for minimal access; P = .53) and long term (38.72% vs 32.16%, respectively; P = .06) was not significantly different.
- The conventional group experienced significantly fewer wound infections — both in the short term (1.62% vs 7.49%) and long term (4.28% vs 7.93%) — but a significantly higher rate of seroma (14.23% vs 9.25%), likely because of the variations in surgical instruments used during the procedures.
- Necrosis of the nipple or areola occurred more often in the minimal access group in the short term (8.81% vs 3.91%) but occurred more frequently in the conventional group in the long term (6.71% vs 2.20%).
IN PRACTICE:
“The similar complication rates suggest that both C-NSM [conventional nipple-sparing mastectomy] and M-NSM [minimal access nipple-sparing mastectomy] may be equally safe options,” the authors wrote. “Therefore, the choice of surgical approach should be tailored to patient preferences and individual needs.”
SOURCE:
The study, led by Joo Heung Kim, MD, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea, was published online on August 14, 2024, in JAMA Surgery.
LIMITATIONS:
The retrospective design comes with inherent biases. The nonrandom assignment of the participants to the two groups and the relatively small number of cases of minimal access nipple-sparing mastectomy may have affected the findings. The involvement of different surgeons and use of early robotic surgery techniques may have introduced bias as well.
DISCLOSURES:
This study was supported by Yonsei University College of Medicine and the National Research Foundation of Korea. Two authors reported receiving grants and consulting fees outside of this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Given that both procedures appear safe overall, the choice may be guided by patients’ preference.
METHODOLOGY:
- Compared with a conventional mastectomy, a nipple-sparing mastectomy offers superior esthetic outcomes in patients with breast cancer. However, even the typical nipple-sparing approach often results in visible scarring and a high risk for nipple or areola necrosis. A minimal access approach, using endoscopic or robotic techniques, offers the potential to minimize scarring and better outcomes, but the complication risks are not well understood.
- Researchers performed a retrospective study that included 1583 patients with breast cancer who underwent conventional nipple-sparing mastectomy (n = 1356) or minimal access nipple-sparing mastectomy (n = 227) between 2018 and 2020 across 21 institutions in the Republic of Korea.
- Postoperative complications, categorized as short term (< 30 days) and long term (< 90 days), were compared between the two groups.
- The minimal access group had a higher percentage of premenopausal patients (73.57% vs 66.67%) and women with firm breasts (66.08% vs 31.27%).
TAKEAWAY:
- In total, 72 individuals (5.31%) in the conventional nipple-sparing mastectomy group and 7 (3.08%) in the minimal access nipple-sparing mastectomy group developed postoperative complications of grade IIIb or higher.
- The rate of complications between the conventional and minimal access nipple-sparing mastectomy groups in the short term (34.29% for conventional vs 32.16% for minimal access; P = .53) and long term (38.72% vs 32.16%, respectively; P = .06) was not significantly different.
- The conventional group experienced significantly fewer wound infections — both in the short term (1.62% vs 7.49%) and long term (4.28% vs 7.93%) — but a significantly higher rate of seroma (14.23% vs 9.25%), likely because of the variations in surgical instruments used during the procedures.
- Necrosis of the nipple or areola occurred more often in the minimal access group in the short term (8.81% vs 3.91%) but occurred more frequently in the conventional group in the long term (6.71% vs 2.20%).
IN PRACTICE:
“The similar complication rates suggest that both C-NSM [conventional nipple-sparing mastectomy] and M-NSM [minimal access nipple-sparing mastectomy] may be equally safe options,” the authors wrote. “Therefore, the choice of surgical approach should be tailored to patient preferences and individual needs.”
SOURCE:
The study, led by Joo Heung Kim, MD, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea, was published online on August 14, 2024, in JAMA Surgery.
LIMITATIONS:
The retrospective design comes with inherent biases. The nonrandom assignment of the participants to the two groups and the relatively small number of cases of minimal access nipple-sparing mastectomy may have affected the findings. The involvement of different surgeons and use of early robotic surgery techniques may have introduced bias as well.
DISCLOSURES:
This study was supported by Yonsei University College of Medicine and the National Research Foundation of Korea. Two authors reported receiving grants and consulting fees outside of this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Should Genetic Testing Be Routine for Breast Cancer?
TOPLINE:
METHODOLOGY:
- Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
- To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
- All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
- Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.
TAKEAWAY:
- The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
- Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
- Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
- A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.
IN PRACTICE:
These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.
SOURCE:
The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.
LIMITATIONS:
The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.
DISCLOSURES:
The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
- To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
- All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
- Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.
TAKEAWAY:
- The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
- Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
- Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
- A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.
IN PRACTICE:
These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.
SOURCE:
The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.
LIMITATIONS:
The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.
DISCLOSURES:
The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Traditional risk-based criteria, including family history and ancestry, are used to guide genetic testing decisions in women with breast cancer. However, these criteria may overlook patients with actionable genetic variants, particularly those outside the typical risk profile.
- To assess the efficacy of universal genetic testing, researchers conducted a cross-sectional study that included 729 women (median age at diagnosis, 53 years; 65.4% White women) newly diagnosed with invasive breast cancer between September 2019 and April 2022 at three Canadian institutions.
- All patients received genetic counseling followed by testing for the presence of germline pathogenic variants in 17 breast cancer susceptibility genes. The primary gene panel included screening for BRCA1, BRCA2, and PALB2, and the optional secondary panel included 14 additional breast cancer susceptibility genes.
- Of the participants, 659 (90.4%) were tested for both primary and secondary gene panels, whereas 70 (9.6%) underwent testing for only the primary panel. The majority of the cohort (66.8) were diagnosed with estrogen receptor–positive breast cancer, while 15.4% had triple-negative breast cancer.
TAKEAWAY:
- The prevalence of germline pathogenic variants was 7.3% (53 patients) — 5.3% for the primary gene panel and 2.1% for the secondary panel.
- Younger age (< 40 years; odds ratio [OR], 6.83), family history of ovarian cancer (OR, 9.75), high-grade disease (OR, 1.68), and triple-negative breast cancer (OR, 3.19) were independently associated with the presence of pathogenic genetic variants in BRCA1, BRCA2, or PALB2.
- Overall, 34.3% of patients with germline pathogenic variants in BRCA1, BRCA2, or PALB2, and 85.7% of carriers of secondary panel variants would not have qualified for traditional genetic testing according to the current risk factors.
- A total of 13 patients with BRCA1, BRCA2, or PALB2 variants had confirmed pathogenic mutations and were eligible for poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors.
IN PRACTICE:
These findings have “informed our clinical practice, and we now offer mainstream, oncology-led genetic testing to all women diagnosed with incident invasive breast cancer younger than 50 years of age, those with triple-negative breast cancer and/or bilateral breast cancer, those potentially eligible for PARP inhibitors,” as well as to men with breast cancer, the authors wrote.
SOURCE:
The study was led by Zoulikha Rezoug, MSc, Lady Davis Institute of the Jewish General Hospital, McGill University in Montreal, Québec, Canada. It was published online on September 3, 2024, in JAMA Network Open.
LIMITATIONS:
The COVID-19 pandemic resulted in a 6-month recruitment pause. Adjustments in recruitment criteria, focus on younger patients and those with triple-negative breast cancer could have overestimated prevalence of genetic pathogenic variants among women aged ≥ 70 years.
DISCLOSURES:
The study was supported by grants from the Jewish General Hospital Foundation and the Québec Breast Cancer Foundation, as well as an award from the Fonds de Recherche du Québec - Santé. Two authors reported receiving grants or personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FDA OKs Subcutaneous Atezolizumab Formulation for Multiple Cancer Indications
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.