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Searching for the Optimal CRC Surveillance Test
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
Giving the Smallest GI Transplant Patients a New Lease On Life
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
In a Parallel Universe, “I’d Be a Concert Pianist” Says Tennessee GI
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
Cannabis May Ease Symptoms in Advanced Pancreatic Cancer
Cannabis May Ease Symptoms in Advanced Pancreatic Cancer
TOPLINE:
A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.
METHODOLOGY:
- Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
- Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
- Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
- Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.
TAKEAWAY:
- At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
- The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
- At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
- Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”
IN PRACTICE:
“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.
“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.
SOURCE:
The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.
LIMITATIONS:
The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.
DISCLOSURES:
The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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:
A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.
METHODOLOGY:
- Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
- Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
- Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
- Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.
TAKEAWAY:
- At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
- The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
- At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
- Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”
IN PRACTICE:
“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.
“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.
SOURCE:
The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.
LIMITATIONS:
The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.
DISCLOSURES:
The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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:
A randomized trial of 32 patients with advanced pancreatic cancer found that early access to medical cannabis patients' symptom burden, with minimal side effects.
METHODOLOGY:
- Patients with pancreatic cancer commonly experience moderate-to-severe pain, nausea, insomnia, and other symptoms that significantly affect their quality of life. Current management approaches are insufficient. Preliminary evidence suggests that medical cannabis has efficacy against multiple cancer-related symptoms, but high-quality data remain limited due to regulatory barriers.
- Researchers conducted a pilot randomized, waitlist-controlled trial involving 32 patients (median age, 71 years) with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma and at least one burdensome symptom.
- Patients were randomly assigned in a 1:1 ratio to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention through the Minnesota Medical Cannabis Program, which provided cannabis products and education in how to use them.
- Primary outcomes focused on feasibility, while secondary outcomes examined acceptability, changes in symptom burden, and quality of life in exploratory efficacy analyses.
TAKEAWAY:
- At baseline, patients reported a substantial moderate-to-severe symptom burden — most commonly insomnia (85%), pain (77%), and appetite loss (69%); 10 patients (31%) were using opioids.
- The study met all of its feasibility metrics, with 74% of the patients meeting enrollment eligibility and 81% complying with their random assignment. Patients in the arm with early cannabis access typically picked up their products 3 days after starting chemotherapy. Most used tablets or other oral cannabis formulations.
- At 8 weeks, patients in the early-access arm experienced numerically higher rates of improvement in pain (44% vs 20%; P = .35), appetite (56% vs 30%; P = .37), and insomnia (67% vs 30%; P = .18), as well as a reduction in opioid use. Their rates of potential cannabis side effects, including dry mouth, dizziness, and concentration problems, were lower compared with the waitlist group — possibly, the authors noted, due to their education to “start low, go slow.”
- Patients made a median of two trips to a cannabis dispensary during the study period, and most said that using cannabis was “easy” and “practical.”
IN PRACTICE:
“Early access to medical cannabis was associated with improvement in certain symptoms, such as insomnia, with minimal harms,” the authors wrote, adding that the research design offers a model collaboration between investigators and state cannabis programs.
“The encouraging preliminary efficacy and safety of cannabis in managing symptoms supports further exploration," they concluded.
SOURCE:
The study was led by Dylan Zylla, MD, MS, of HealthPartners Institute, Cancer Research Center, Minneapolis, Minnesota. It was presented on January 9 at the ASCO Gastrointestinal Cancers Symposium 2026 and simultaneously published in JCO Oncology Practice.
LIMITATIONS:
The trial was small and the 8-week primary study period precluded conclusions about longer-term benefits and safety. Generalizability may be limited as the trial was conducted in a single state with a predominantly urban and White patient population. Additionally, heterogeneity in state cannabis programs and laws may limit national applicability.
DISCLOSURES:
The study was supported by philanthropic support to the HealthPartners Cancer Research Center. Cannabis products were provided by Vireo Health (GreenGoods, Minnesota). 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.
Cannabis May Ease Symptoms in Advanced Pancreatic Cancer
Cannabis May Ease Symptoms in Advanced Pancreatic Cancer
Home Screening Cost-Effective for Anal Cancer
Home Screening Cost-Effective for Anal Cancer
TOPLINE:
A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.
METHODOLOGY:
- Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
- Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
- Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
- Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
- The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.
TAKEAWAY:
- Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
- The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
- With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
- From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.
IN PRACTICE:
"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.
SOURCE:
The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.
LIMITATIONS:
The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.
DISCLOSURES:
Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.
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:
A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.
METHODOLOGY:
- Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
- Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
- Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
- Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
- The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.
TAKEAWAY:
- Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
- The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
- With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
- From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.
IN PRACTICE:
"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.
SOURCE:
The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.
LIMITATIONS:
The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.
DISCLOSURES:
Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.
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:
A recent analysis suggested that home-based screening for anal cancer is a cost-effective way to increase screening compared to clinic-based screening. The study found that a home-based approach led to higher participation rates (89.2% vs 74.2% for a clinic-based approach) among sexual and gender minority individuals and was cost-effective, costing $25.19 per additional individual screened when accounting for both direct and indirect costs and $132.36 per additional individual screened when only accounting for direct medical costs.
METHODOLOGY:
- Anal cancer screening is recommended for high-risk populations, such as sexual and gender minority individuals. However, it's unclear how cost-effective home-based self-sampling is compared to clinic-based screening.
- Researchers conducted an economic evaluation using data from a randomized clinical trial that included 240 sexual and gender minority individuals in Milwaukee from January 2020 to August 2022.
- Participants, aged ≥ 25 years, were randomized to either home-based self-sampling or clinic-based screening.
- Researchers evaluated direct home-based screening costs from the trial, and sourced clinic-based costs from the Medicare reimbursement schedule. Travel and time costs were determined from participant self-reports.
- The primary outcome was the incremental cost-effectiveness ratio (ICER), which was the additional cost needed to increase screening participation by one person. The researchers calculated ICERs from both a healthcare payer and societal perspective. The healthcare perspective included only direct medical costs and the societal perspective accounted for direct medical costs as well as indirect time and travel costs.
TAKEAWAY:
- Home-based screening led to higher participation rates than clinic-based screening—89.2% vs 74.2%—with 107 participants completing home-based screening compared with 89 participants doing clinic-based screening.
- The cost per participant was $64.18 for home-based screening and $60.40 for clinic-based screening from the societal perspective, and $61.91 for home-based screening and $42.06 for clinic-based screening from the healthcare payer perspective.
- With home-based screening, the ICER per additional screened participant was $25.19 from a societal perspective and $132.36 from a healthcare payer perspective.
- From the societal perspective, the probability that home-based screening was cost-effective compared with clinic-based screening was nearly 50% at a willingness-to-pay threshold of $25 and 99.99% at a threshold of $100. From the healthcare perspective, the probability was 3.8% at a threshold of $100 and 90.9% at a threshold of $200.
IN PRACTICE:
"These findings suggest that home-based screening promises to be a cost-effective option to enhance anal cancer screening participation," the study authors concluded.
SOURCE:
The study, led by Haluk Damgacioglu, PhD, Department of Public Health Sciences, Medical University of South Carolina in Charleston, South Carolina, was published online in JAMA Network Open.
LIMITATIONS:
The study was conducted in an urban setting where proximity to clinics may reduce structural barriers, potentially limiting generalizability to rural areas where longer travel distances and limited clinician availability could affect participation rates. The analysis did not include downstream steps such as follow-up clinic visits, confirmatory testing, treatment of precancerous lesions, or cancer prevention outcomes. While home-based screening participants were required to visit clinics for digital anal rectal examination to exclude prevalent anal cancer, these follow-up visit costs were not included in the cost-effectiveness analysis.
DISCLOSURES:
Elizabeth Chiao, PhD, reported receiving grants from the National Institutes of Health during the study. Jennifer S. Smith, PhD, MPH, disclosed receiving personal fees from Hologic, Inc., and materials for research purposes from Rovers Medical Devices. Ashish A. Deshmukh, PhD, MPH, reported receiving personal fees from Value Analytics Lab. Alan G. Nyitray, PhD, reported receiving grants from the National Cancer Institute and test kits from Copan Diagnostics.
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.
Home Screening Cost-Effective for Anal Cancer
Home Screening Cost-Effective for Anal Cancer
Simple Steps: Walking May Ease Colorectal Cancer Fatigue
Simple Steps: Walking May Ease Colorectal Cancer Fatigue
Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.
The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.
The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.
“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.
The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”
Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.
This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.
That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.
“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”
Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.
“Yet,” Liu said, “our toolbox of effective interventions remains limited.”
Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.
In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.
“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.
To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.
Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.
Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).
Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.
Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.
Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.
Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.
Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.
So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”
Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.
“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”
The study had no commercial funding. Liu and Saltzman had no disclosures.
A version of this article first appeared on Medscape.com.
Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.
The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.
The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.
“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.
The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”
Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.
This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.
That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.
“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”
Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.
“Yet,” Liu said, “our toolbox of effective interventions remains limited.”
Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.
In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.
“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.
To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.
Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.
Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).
Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.
Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.
Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.
Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.
Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.
So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”
Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.
“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”
The study had no commercial funding. Liu and Saltzman had no disclosures.
A version of this article first appeared on Medscape.com.
Regular physical activity—especially walking—may improve fatigue and boost quality of life for people with nonmetastatic colorectal cancer during the first 2 years after diagnosis, according to research presented at ASCO Gastrointestinal Cancers Symposium 2026.
The study, which tracked over 1700 patients with colorectal cancer, found that those with nonmetastatic disease who walked for exercise 6-12 months after their diagnosis showed significant improvement in their fatigue scores over time. Their quality-of-life ratings rose in tandem.
The findings suggest that simple, sustained movement may play a meaningful role in long-term survivorship care, lead investigator Louisa Liu, MD, of Cedars-Sinai Medical Center in Los Angeles, said during a press briefing.
“Fatigue is one of the most common and debilitating symptoms our patients experience, often long after treatment ends,” Liu noted.
The new data, she said, show that an accessible form of exercise, especially when maintained over time, “can make a real difference in how patients feel and function during recovery.”
Joel Saltzman, MD, an ASCO expert in gastrointestinal cancers based at Taussig Cancer Center, Cleveland Clinic, Cleveland, agreed.
This is a “super-important study for all of us in the cancer community,” Saltzman told the briefing, especially in light of the CHALLENGE trial.
That study demonstrated that a structured exercise program can actually improve overall survival for patients with early-stage colon cancer who completed surgery and adjuvant chemotherapy.
“When you couple that with how patients feel, it really begs the question: Are we as a society doing enough cancer rehabilitation?” Saltzman said. “Everyone’s familiar with cardiac rehab, but oncologic rehabilitation is really something that really should be thought about in the future.”
Among long-term colorectal cancer survivors, nearly 40% continue to experience moderate-to-severe fatigue years after treatment — a challenge that affects functional recovery, daily activity, and quality of life.
“Yet,” Liu said, “our toolbox of effective interventions remains limited.”
Growing evidence supports physical activity as a nonpharmacologic approach for managing cancer-related fatigue. The mechanisms, Liu noted, may be multiple and include reductions in systemic inflammation, preserved muscle mass, better sleep quality and improvements in psychological stress.
In fact, current clinical guidelines recommend physical activity as part of survivorship care, but some key questions remain unanswered, Liu said.
“We still don’t fully understand when during recovery activity is most beneficial, what types of activity are best for different patients, or how these effects play out in real-world longitudinal settings, especially in colorectal cancer survivors,” she explained.
To address some of those gaps, Liu and colleagues analyzed data from 1718 patients with colorectal cancer (mean age, 67 years; 48% women) enrolled in the International ColoCare prospective cohort study. Nearly 1 in 5 had metastatic disease at diagnosis.
Physical activity was assessed at baseline and at 6, 12, and 24 months after diagnosis using a validated questionnaire. Participants’ total number of metabolic equivalent of task (MET) minutes per week — a measurement of energy spent during physical activity — were calculated for walking, moderate activities, and vigorous activities.
Total physical activity was categorized as low (fewer than 600 MET min/wk), moderate (600-3000 MET min/wk), or high (over 3000 MET min/wk).
Cancer-related fatigue and quality of life were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 scale.
Overall, patients who were more physically active reported less fatigue and better quality of life as they moved further into recovery. And walking, Liu said, showed the “clearest and most consistent” association with these improved outcomes.
Among patients with nonmetastatic disease, those who reported regular walking 6-12 months after diagnosis showed significantly lower fatigue and higher quality-of-life scores over 2 years. Fatigue scores in this group improved steadily with time, from 32.5 at diagnosis to 29 at 12 months post-diagnosis and 26.8 at 24 months post-diagnosis.
Patients with metastatic disease also showed reductions in fatigue scores — from 40.7 at diagnosis to 37.1 at 12 months and 36.4 at 24 months — although those differences did not reach statistical significance.
Liu pointed out that patients with metastatic disease, not surprisingly, reported greater fatigue and poorer quality of life across all time points vs those with early-stage disease.
So, she said, “we don’t yet have strong evidence that physical activity changes the fatigue trajectory in the long run for metastatic patients. But this is an area where more targeted research is really needed.”
Looking at patterns of physical activity, the researchers found that activity levels at the time of diagnosis did not reliably predict long-term fatigue and quality-of-life outcomes. Instead, a patient’s activity level maintained between diagnosis and 1 year follow-up was a predictor of better outcomes.
“Short-term increases in physical activity didn’t seem to make a meaningful difference,” Liu said. “This suggests that when it comes to managing cancer-related fatigue, the key is to build steady, lasting habits that patients can stick with throughout their recovery.”
The study had no commercial funding. Liu and Saltzman had no disclosures.
A version of this article first appeared on Medscape.com.
Simple Steps: Walking May Ease Colorectal Cancer Fatigue
Simple Steps: Walking May Ease Colorectal Cancer Fatigue
Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer
Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer
TOPLINE:
Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.
METHODOLOGY:
- Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
- Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
- After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
- The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
- The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.
TAKEAWAY:
- Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
- The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
- Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
- In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).
IN PRACTICE:
“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.
SOURCE:
This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.
LIMITATIONS:
The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.
DISCLOSURES:
No specific funding source was reported. The authors declared having no conflicts of interest.
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:
Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.
METHODOLOGY:
- Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
- Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
- After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
- The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
- The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.
TAKEAWAY:
- Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
- The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
- Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
- In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).
IN PRACTICE:
“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.
SOURCE:
This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.
LIMITATIONS:
The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.
DISCLOSURES:
No specific funding source was reported. The authors declared having no conflicts of interest.
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:
Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.
METHODOLOGY:
- Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
- Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
- After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
- The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
- The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.
TAKEAWAY:
- Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
- The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
- Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
- In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).
IN PRACTICE:
“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.
SOURCE:
This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.
LIMITATIONS:
The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.
DISCLOSURES:
No specific funding source was reported. The authors declared having no conflicts of interest.
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.
Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer
Ulcerative Colitis With Background Mucosal Inflammation Signals Poor Survival in Colorectal Cancer
Is It Safe to Skip Surgery After Malignant Colorectal Polyp Removal?
Is It Safe to Skip Surgery After Malignant Colorectal Polyp Removal?
TOPLINE:
Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.
METHODOLOGY:
- Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
- A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
- The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
- Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.
TAKEAWAY:
- In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
- Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
- Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
- Distant metastases occurred in 2% of all patients across both groups.
IN PRACTICE:
"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.
SOURCE:
The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.
LIMITATIONS:
The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.
DISCLOSURES:
Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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:
Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.
METHODOLOGY:
- Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
- A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
- The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
- Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.
TAKEAWAY:
- In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
- Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
- Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
- Distant metastases occurred in 2% of all patients across both groups.
IN PRACTICE:
"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.
SOURCE:
The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.
LIMITATIONS:
The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.
DISCLOSURES:
Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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:
Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.
METHODOLOGY:
- Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
- A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
- The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
- Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.
TAKEAWAY:
- In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
- Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
- Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
- Distant metastases occurred in 2% of all patients across both groups.
IN PRACTICE:
"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.
SOURCE:
The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.
LIMITATIONS:
The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.
DISCLOSURES:
Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. 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.
Is It Safe to Skip Surgery After Malignant Colorectal Polyp Removal?
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FDA OKs Subcutaneous Mosunetuzumab for Follicular Lymphoma
The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.
The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.
The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.
Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.
SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”
Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.
The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.
Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
A version of this article first appeared on Medscape.com.