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Sponge-on-a-string could move Barrett’s screening from GI lab to primary care
SAN DIEGO – A quick, inexpensive, and well-tolerated sponge-on-a-string esophageal biopsy, combined with methylated DNA analysis, discriminated Barrett’s esophagus from normal tissue with perfect accuracy in a pilot study at the Mayo Clinic in Rochester, Minn.
The investigators used tissue samples from over 100 patients to identify methylated DNA markers that discriminated Barrett’s esophagitis from healthy tissue with an area under the curve (AUC) of more than 0.9. They then had 19 patients with endoscopically confirmed Barrett’s and 20 controls who had Barrett’s ruled out on previous endoscopies swallow a polyurethane foam sponge that expanded to 25 mm after its surrounding gelatin capsule dissolved.
After 10 minutes, the sponge was pulled out by its cord. Methylation-specific polymerase chain reaction (PCR) testing was performed on DNA extracted from the sponge. The results were checked against follow-up endoscopies in the 39 subjects.
When taken together, two DNA markers – methylation of the vav guanine nucleotide exchange factor 3 (VAV3) and zinc finger protein 682 (ZNF682) genes – were 100% specific and 100% sensitive for Barrett’s esophagus, with an AUC of 1.0.
“We achieved perfect discrimination between Barrett’s and non-Barrett’s tissue. We are at the threshold of developing an accurate, minimally invasive tool for Barrett’s and Barrett’s dysplasia screening,” said lead investigator Prasad G. Iyer, M.D., a gastroenterology professor at Mayo.
His team didn’t use the Cytosponge, which is being developed for similar purposes and has been in the medical news lately. Instead, they used the EsophaCap from Capnostics, which was approved by the Food and Drug Administration in the 1990s.
“This technique would allow us to take” Barrett’s screening out of “the GI lab and into a primary care office, where it can be performed by a nurse or even a technician, without the expense and side effects of endoscopy” he said. After the sponge is retrieved, staff would just have to process it a bit and send it off for methylation-specific PCR. The ease and accuracy could increase screening: “That’s where I think a tool like this” – which might cost $200 – “could substitute for endoscopy, which costs a couple thousand.” Endoscopies could be limited to patients who are sponge-positive for Barrett’s, Dr. Iyer said at the annual Digestive Disease Week.
“Our next goal is to identify markers which will tell us who amongst those with Barrett’s have dysplasia. At this point in time, we are doing” endoscopic surveillance for dysplasia and early cancer, Dr. Iyer said, and the sponge-and-marker approach might have significant advantages. A prospective trial is in the works with almost 250 patients.
Barrett’s patients were a median of 66 years old, their lesion lengths were 4-7.5 cm, and about 80% were men. Half had no dysplasia, and about a quarter each had low-grade dysplasia and high-grade disease/esophageal adenocarcinoma. The controls were somewhat younger, with a median age of 61 years, and half were men.
The study was funded by Exact Science, which performed the methylated DNA analysis. Dr. Iyer and other investigators are involved with the company, and the Mayo Clinic is an equity investor.
SAN DIEGO – A quick, inexpensive, and well-tolerated sponge-on-a-string esophageal biopsy, combined with methylated DNA analysis, discriminated Barrett’s esophagus from normal tissue with perfect accuracy in a pilot study at the Mayo Clinic in Rochester, Minn.
The investigators used tissue samples from over 100 patients to identify methylated DNA markers that discriminated Barrett’s esophagitis from healthy tissue with an area under the curve (AUC) of more than 0.9. They then had 19 patients with endoscopically confirmed Barrett’s and 20 controls who had Barrett’s ruled out on previous endoscopies swallow a polyurethane foam sponge that expanded to 25 mm after its surrounding gelatin capsule dissolved.
After 10 minutes, the sponge was pulled out by its cord. Methylation-specific polymerase chain reaction (PCR) testing was performed on DNA extracted from the sponge. The results were checked against follow-up endoscopies in the 39 subjects.
When taken together, two DNA markers – methylation of the vav guanine nucleotide exchange factor 3 (VAV3) and zinc finger protein 682 (ZNF682) genes – were 100% specific and 100% sensitive for Barrett’s esophagus, with an AUC of 1.0.
“We achieved perfect discrimination between Barrett’s and non-Barrett’s tissue. We are at the threshold of developing an accurate, minimally invasive tool for Barrett’s and Barrett’s dysplasia screening,” said lead investigator Prasad G. Iyer, M.D., a gastroenterology professor at Mayo.
His team didn’t use the Cytosponge, which is being developed for similar purposes and has been in the medical news lately. Instead, they used the EsophaCap from Capnostics, which was approved by the Food and Drug Administration in the 1990s.
“This technique would allow us to take” Barrett’s screening out of “the GI lab and into a primary care office, where it can be performed by a nurse or even a technician, without the expense and side effects of endoscopy” he said. After the sponge is retrieved, staff would just have to process it a bit and send it off for methylation-specific PCR. The ease and accuracy could increase screening: “That’s where I think a tool like this” – which might cost $200 – “could substitute for endoscopy, which costs a couple thousand.” Endoscopies could be limited to patients who are sponge-positive for Barrett’s, Dr. Iyer said at the annual Digestive Disease Week.
“Our next goal is to identify markers which will tell us who amongst those with Barrett’s have dysplasia. At this point in time, we are doing” endoscopic surveillance for dysplasia and early cancer, Dr. Iyer said, and the sponge-and-marker approach might have significant advantages. A prospective trial is in the works with almost 250 patients.
Barrett’s patients were a median of 66 years old, their lesion lengths were 4-7.5 cm, and about 80% were men. Half had no dysplasia, and about a quarter each had low-grade dysplasia and high-grade disease/esophageal adenocarcinoma. The controls were somewhat younger, with a median age of 61 years, and half were men.
The study was funded by Exact Science, which performed the methylated DNA analysis. Dr. Iyer and other investigators are involved with the company, and the Mayo Clinic is an equity investor.
SAN DIEGO – A quick, inexpensive, and well-tolerated sponge-on-a-string esophageal biopsy, combined with methylated DNA analysis, discriminated Barrett’s esophagus from normal tissue with perfect accuracy in a pilot study at the Mayo Clinic in Rochester, Minn.
The investigators used tissue samples from over 100 patients to identify methylated DNA markers that discriminated Barrett’s esophagitis from healthy tissue with an area under the curve (AUC) of more than 0.9. They then had 19 patients with endoscopically confirmed Barrett’s and 20 controls who had Barrett’s ruled out on previous endoscopies swallow a polyurethane foam sponge that expanded to 25 mm after its surrounding gelatin capsule dissolved.
After 10 minutes, the sponge was pulled out by its cord. Methylation-specific polymerase chain reaction (PCR) testing was performed on DNA extracted from the sponge. The results were checked against follow-up endoscopies in the 39 subjects.
When taken together, two DNA markers – methylation of the vav guanine nucleotide exchange factor 3 (VAV3) and zinc finger protein 682 (ZNF682) genes – were 100% specific and 100% sensitive for Barrett’s esophagus, with an AUC of 1.0.
“We achieved perfect discrimination between Barrett’s and non-Barrett’s tissue. We are at the threshold of developing an accurate, minimally invasive tool for Barrett’s and Barrett’s dysplasia screening,” said lead investigator Prasad G. Iyer, M.D., a gastroenterology professor at Mayo.
His team didn’t use the Cytosponge, which is being developed for similar purposes and has been in the medical news lately. Instead, they used the EsophaCap from Capnostics, which was approved by the Food and Drug Administration in the 1990s.
“This technique would allow us to take” Barrett’s screening out of “the GI lab and into a primary care office, where it can be performed by a nurse or even a technician, without the expense and side effects of endoscopy” he said. After the sponge is retrieved, staff would just have to process it a bit and send it off for methylation-specific PCR. The ease and accuracy could increase screening: “That’s where I think a tool like this” – which might cost $200 – “could substitute for endoscopy, which costs a couple thousand.” Endoscopies could be limited to patients who are sponge-positive for Barrett’s, Dr. Iyer said at the annual Digestive Disease Week.
“Our next goal is to identify markers which will tell us who amongst those with Barrett’s have dysplasia. At this point in time, we are doing” endoscopic surveillance for dysplasia and early cancer, Dr. Iyer said, and the sponge-and-marker approach might have significant advantages. A prospective trial is in the works with almost 250 patients.
Barrett’s patients were a median of 66 years old, their lesion lengths were 4-7.5 cm, and about 80% were men. Half had no dysplasia, and about a quarter each had low-grade dysplasia and high-grade disease/esophageal adenocarcinoma. The controls were somewhat younger, with a median age of 61 years, and half were men.
The study was funded by Exact Science, which performed the methylated DNA analysis. Dr. Iyer and other investigators are involved with the company, and the Mayo Clinic is an equity investor.
AT DDW® 2016
Key clinical point: A quick, inexpensive, and well-tolerated sponge-on-a-string esophageal biopsy, combined with methylated DNA analysis, discriminated Barrett’s esophagus from normal tissue with perfect accuracy.
Major finding: When taken together, two methylated DNA markers were 100% specific and 100% sensitive for Barrett’s esophagus, with an AUC of 1.0.
Data source: Pilot study of 19 Barrett’s patients and 20 controls.
Disclosures: The study was funded by Exact Science, which performed the methylated DNA analysis. The presenter and other investigators are involved with the company, and the Mayo Clinic is an equity investor.
Colorectal cancer threatens younger people
The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.
Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.
More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.
“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”
The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.
In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).
As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).
Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).
These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.
Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.
Dr. Sutton had no relevant financial disclosures.
The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.
Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.
More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.
“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”
The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.
In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).
As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).
Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).
These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.
Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.
Dr. Sutton had no relevant financial disclosures.
The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.
Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.
More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.
“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”
The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.
In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).
As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).
Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).
These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.
Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.
Dr. Sutton had no relevant financial disclosures.
FROM DDW® 2016
Key clinical point: The incidence of colorectal cancer is declining overall in the United States, but is increasing in people under age 50.
Major finding: Over a period of a decade, the number of young-onset cases of colorectal cancer increased by 11.4%, while the number of cases in patients over age 50 fell by 2.5%.
Data source: A retrospective study of more than 1 million colorectal cancer cases in the National Cancer Database from 2004 to 2013.
Disclosures: Dr. Sutton had no relevant financial disclosures
Gas-filled gastric balloons achieve weight loss
A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.
The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m2 at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.
The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).
A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.
The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.
The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.
Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.
“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.
“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”
The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.
Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.
Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.
“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.
Dr. Sullivan received funding for this study from Obalon Therapeutics.
A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.
The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m2 at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.
The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).
A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.
The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.
The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.
Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.
“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.
“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”
The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.
Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.
Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.
“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.
Dr. Sullivan received funding for this study from Obalon Therapeutics.
A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.
The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m2 at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.
The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).
A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.
The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.
The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.
Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.
“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.
“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”
The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.
Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.
Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.
“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.
Dr. Sullivan received funding for this study from Obalon Therapeutics.
FROM DDW® 2016
Key clinical point: Gas-filled gastric balloons achieve more weight loss than lifestyle changes and are quite tolerable.
Major finding: Gas-filled balloons achieved nearly 7% loss of weight in obese people, compared with 3.59% in obese controls.
Data source: Randomized multicenter study that enrolled 387 obese people.
Disclosures: Dr. Sullivan received funding for this study from Obalon Therapeutics.
Low-residue diet enables clean colonoscopy
There is good news for people who avoid colonoscopies because of the day-long preparation with a clear liquid cleansing diet. New research shows that consuming small portions of low-residue (low-fiber) solid foods on the day before colonoscopy led to improved colonoscopies, compared with a clear liquid diet.
In addition, people who consumed low-residue foods had more energy on the day before and the day of the procedure, compared with those on a clear liquid diet.
“Colonoscopies prevent death from colorectal cancer, yet millions of people avoid this screening. Many cite dietary restrictions as a deterrent. The clear liquid diet is standard of care [for colonoscopy preparation] in the U.S. We found that low-residue foods led to a better colonoscopy compared to a liquid diet. Also, patients were more comfortable, less hungry, and less fatigued on the morning of colonoscopy,” said lead author Dr. Jason Samarasena, associate professor at the University of California, Irvine. He presented this research at a teleconference at the annual Digestive Disease Week.
In this single-center, randomized trial, people assigned to the low-residue diet could eat small portions of protein, carbohydrate, and fat at three meals on the day before colonoscopy. The group assigned to the clear liquid diet could drink only broth, black coffee, tea, and other clear liquids. Both groups drank standard bowel-cleansing liquid on the night before and the morning of the procedure.
Dr. Samarasena explained that low-residue foods, such as eggs, yogurt, cheese, bread, cottage cheese, chicken nuggets, and macaroni and cheese, are easily broken down in the stomach and cleaned out by the bowel preparation.
“High-residue foods, such as fruit, nuts, or vegetables, don’t break down as much and make it more difficult to visualize the colon,” he said.
The study included 83 patients who underwent colonoscopies at two sites over a 1-year period from 2014 to 2015. An adequate bowel preparation was defined as a Boston Bowel Preparation Scale (BBPS) score greater than 6. All endoscopists were blinded and all colonoscopies were video recorded.
In an interim blinded analysis, the low-residue diet allowed a significantly higher number of adequate bowel preparations, compared with the clear liquid diet group: mean BBPS was 7.98 for the low-residue diet group and 7.54 for the clear liquid diet group (P = .05).
People assigned to the low-residue diet expressed a much higher level of satisfaction for the diet: 97% versus 46% who rated the clear liquid diet satisfactory.
In addition, people assigned to the low-residue group had significantly lower hunger scores on a scale from 1 to 10, with 10 being most hungry on the evening before the colonoscopy (3.5 for the low-residue diet versus 6.9 for the clear liquid diet, P = .001), and lower fatigue scores (3.5 versus 6, respectively, P = .01) on a 10-point scale on the morning of the procedure, compared with the clear liquid diet group.
There was no significant difference between the two groups for mean symptom scores for nausea, vomiting, bloating, abdominal cramping, and overall discomfort.
“Patients slated to undergo colonoscopy often have to miss at least a day of work. A low-residue diet may allow patients to work on the day before the procedure,” Dr. Samarasena noted.
Dr. Samarasena and his coinvestigators plan to enroll more patients for a larger sample size to compare both diets.
“This will be one of the largest studies in the U.S. to evaluate a low-residue diet. We hope this will encourage gastroenterologists in the U.S. to use a low-residue diet and that more patients will then undergo colonoscopy screening,“ he said.
There is good news for people who avoid colonoscopies because of the day-long preparation with a clear liquid cleansing diet. New research shows that consuming small portions of low-residue (low-fiber) solid foods on the day before colonoscopy led to improved colonoscopies, compared with a clear liquid diet.
In addition, people who consumed low-residue foods had more energy on the day before and the day of the procedure, compared with those on a clear liquid diet.
“Colonoscopies prevent death from colorectal cancer, yet millions of people avoid this screening. Many cite dietary restrictions as a deterrent. The clear liquid diet is standard of care [for colonoscopy preparation] in the U.S. We found that low-residue foods led to a better colonoscopy compared to a liquid diet. Also, patients were more comfortable, less hungry, and less fatigued on the morning of colonoscopy,” said lead author Dr. Jason Samarasena, associate professor at the University of California, Irvine. He presented this research at a teleconference at the annual Digestive Disease Week.
In this single-center, randomized trial, people assigned to the low-residue diet could eat small portions of protein, carbohydrate, and fat at three meals on the day before colonoscopy. The group assigned to the clear liquid diet could drink only broth, black coffee, tea, and other clear liquids. Both groups drank standard bowel-cleansing liquid on the night before and the morning of the procedure.
Dr. Samarasena explained that low-residue foods, such as eggs, yogurt, cheese, bread, cottage cheese, chicken nuggets, and macaroni and cheese, are easily broken down in the stomach and cleaned out by the bowel preparation.
“High-residue foods, such as fruit, nuts, or vegetables, don’t break down as much and make it more difficult to visualize the colon,” he said.
The study included 83 patients who underwent colonoscopies at two sites over a 1-year period from 2014 to 2015. An adequate bowel preparation was defined as a Boston Bowel Preparation Scale (BBPS) score greater than 6. All endoscopists were blinded and all colonoscopies were video recorded.
In an interim blinded analysis, the low-residue diet allowed a significantly higher number of adequate bowel preparations, compared with the clear liquid diet group: mean BBPS was 7.98 for the low-residue diet group and 7.54 for the clear liquid diet group (P = .05).
People assigned to the low-residue diet expressed a much higher level of satisfaction for the diet: 97% versus 46% who rated the clear liquid diet satisfactory.
In addition, people assigned to the low-residue group had significantly lower hunger scores on a scale from 1 to 10, with 10 being most hungry on the evening before the colonoscopy (3.5 for the low-residue diet versus 6.9 for the clear liquid diet, P = .001), and lower fatigue scores (3.5 versus 6, respectively, P = .01) on a 10-point scale on the morning of the procedure, compared with the clear liquid diet group.
There was no significant difference between the two groups for mean symptom scores for nausea, vomiting, bloating, abdominal cramping, and overall discomfort.
“Patients slated to undergo colonoscopy often have to miss at least a day of work. A low-residue diet may allow patients to work on the day before the procedure,” Dr. Samarasena noted.
Dr. Samarasena and his coinvestigators plan to enroll more patients for a larger sample size to compare both diets.
“This will be one of the largest studies in the U.S. to evaluate a low-residue diet. We hope this will encourage gastroenterologists in the U.S. to use a low-residue diet and that more patients will then undergo colonoscopy screening,“ he said.
There is good news for people who avoid colonoscopies because of the day-long preparation with a clear liquid cleansing diet. New research shows that consuming small portions of low-residue (low-fiber) solid foods on the day before colonoscopy led to improved colonoscopies, compared with a clear liquid diet.
In addition, people who consumed low-residue foods had more energy on the day before and the day of the procedure, compared with those on a clear liquid diet.
“Colonoscopies prevent death from colorectal cancer, yet millions of people avoid this screening. Many cite dietary restrictions as a deterrent. The clear liquid diet is standard of care [for colonoscopy preparation] in the U.S. We found that low-residue foods led to a better colonoscopy compared to a liquid diet. Also, patients were more comfortable, less hungry, and less fatigued on the morning of colonoscopy,” said lead author Dr. Jason Samarasena, associate professor at the University of California, Irvine. He presented this research at a teleconference at the annual Digestive Disease Week.
In this single-center, randomized trial, people assigned to the low-residue diet could eat small portions of protein, carbohydrate, and fat at three meals on the day before colonoscopy. The group assigned to the clear liquid diet could drink only broth, black coffee, tea, and other clear liquids. Both groups drank standard bowel-cleansing liquid on the night before and the morning of the procedure.
Dr. Samarasena explained that low-residue foods, such as eggs, yogurt, cheese, bread, cottage cheese, chicken nuggets, and macaroni and cheese, are easily broken down in the stomach and cleaned out by the bowel preparation.
“High-residue foods, such as fruit, nuts, or vegetables, don’t break down as much and make it more difficult to visualize the colon,” he said.
The study included 83 patients who underwent colonoscopies at two sites over a 1-year period from 2014 to 2015. An adequate bowel preparation was defined as a Boston Bowel Preparation Scale (BBPS) score greater than 6. All endoscopists were blinded and all colonoscopies were video recorded.
In an interim blinded analysis, the low-residue diet allowed a significantly higher number of adequate bowel preparations, compared with the clear liquid diet group: mean BBPS was 7.98 for the low-residue diet group and 7.54 for the clear liquid diet group (P = .05).
People assigned to the low-residue diet expressed a much higher level of satisfaction for the diet: 97% versus 46% who rated the clear liquid diet satisfactory.
In addition, people assigned to the low-residue group had significantly lower hunger scores on a scale from 1 to 10, with 10 being most hungry on the evening before the colonoscopy (3.5 for the low-residue diet versus 6.9 for the clear liquid diet, P = .001), and lower fatigue scores (3.5 versus 6, respectively, P = .01) on a 10-point scale on the morning of the procedure, compared with the clear liquid diet group.
There was no significant difference between the two groups for mean symptom scores for nausea, vomiting, bloating, abdominal cramping, and overall discomfort.
“Patients slated to undergo colonoscopy often have to miss at least a day of work. A low-residue diet may allow patients to work on the day before the procedure,” Dr. Samarasena noted.
Dr. Samarasena and his coinvestigators plan to enroll more patients for a larger sample size to compare both diets.
“This will be one of the largest studies in the U.S. to evaluate a low-residue diet. We hope this will encourage gastroenterologists in the U.S. to use a low-residue diet and that more patients will then undergo colonoscopy screening,“ he said.
FROM DDW® 2016
Key clinical point: A low-residue diet led to improved preparation for colonoscopy, compared with a clear liquid diet.
Major finding: A low-residue diet allowed a significantly higher number of adequate bowel preparations, compared with the clear liquid diet group: mean BBPS was 7.98 for the low-residue diet group and 7.54 for the clear liquid diet group (P = .05).
Data source: Interim analysis of a multicenter, single-center, randomized, single blinded trial of 83 patients.
Disclosures: Dr. Samarasena received funding from Medtronic, Medivators, Olympus, and Pentax.
Naldemedine improves opioid-induced constipation
SAN DIEGO – The investigational oral drug, naldemedine, was found effective in treating opioid-induced constipation (OIC) in patients with noncancer chronic pain, according to results of two identically designed phase III trials (COMPOSE I and II). Naldemedine achieved durable efficacy and consistent safety, with a low incidence of gastrointestinal side effects, and importantly did not compromise or interfere with the analgesic effect of opioids.
In both studies, the drug met the primary endpoint and significantly improved all secondary endpoints. Improved frequency of spontaneous bowel movements (SBMs) was observed for at least 9 weeks out of the 12 weeks (the primary endpoint) in 47.6% of naldemedine-treated patients, compared with 34.6% of placebo patients in COMPOSE I. In COMPOSE II, 52.5% versus 33.6%, respectively, had improved frequency of SMB for at least 9 out of 12 weeks.
“Improvement with naldemedine was seen early and was durable, with no evidence of opiate withdrawal. This is good news for patients with OIC, given the significant impact this condition can have and the difficulty they can have in finding a safe and effective treatment,” said presenting author Dr. Martin Hale, an orthopedic surgeon and pain management specialist. He presented results of both trials at the annual Digestive Disease Week.
Naldemedine is a naltrexone-based, once-daily, oral, peripherally acting mu-opioid–receptor antagonist being developed by Shionogi. The fact that it is not centrally acting suggests that its side effect profile would be acceptable. Opiates work on mu receptors, reducing GI motility and fluid secretion, resulting in OIC.
“Laxatives have limited efficacy for OIC and do not address the underlying problem,” Dr. Hale of Gold Coast Research, Plantation, Fla., said. Thus, better treatments are needed.
Study details
Both studies were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. COMPOSE I included 547 patients, and COMPOSE II, 553 patients. To be included, patients had to be on opioid therapy for at least 3 months and on a stable dose of opioids for at least 4 weeks. They had to have noncancer pain accompanied by OIC.
Patients were randomized in a 1:1 ratio to oral naldemedine 0.2 mg with or without food versus placebo. “Being able to take the drug with food makes it more acceptable to patients,” Dr. Hale noted.
Responses were observed early in the course of the 12-week trial and remained durable. Naldemedine treatment significantly improved the frequency of SBMs per week, compared with placebo (P less than .0001 in both studies), and SBMs without straining per week from baseline to the last 2 weeks of the study (P = .0003 in COMPOSE I and P = .0011 in COMPOSE II).
Adverse events were similar across all four arms of both studies. Treatment-related adverse events were reported in about 48% of patients across both trials. Major adverse cardiovascular events (MACE) of concern occurred in 1 patient in treated with naldemedine and 1 in the placebo group. “MACE is not relevant with this drug,” Dr Hale told listeners.
Abdominal pain and diarrhea were the only treatment-related adverse events reported in greater than 5% of patients treated with naldemedine versus placebo. Abdominal pain was reported in 6.3% of the treated groups in COMPOSE I and 5.2% of the treated group in COMPOSE II versus 1.8% and 2.9%, respectively, in the placebo groups. Diarrhea was reported in 6.6% of the naldemedine patients in COMPOSE I and in 8.9% in COMPOSE II, compared with 2.9% and 1.8%, respectively, on placebo. Nausea was reported in 4.8% of naldemedine-treated patients in both trials, compared with 2.6% and 3.3%, respectively, in the placebo arms.
“Most treatment-emergent adverse events were mild or moderate. Back pain and flatulence were rare,” he commented.
Two scales were used to measure opiate withdrawal: Clinical Opiate Withdrawal Scale (COWS) and Subjective Opiate Withdrawal Score (SOWS). The graph curves were superimposable for naldemedine and placebo at all time points, showing that naldemedine did not interfere with the analgesic effect of opioids.
The study was funded by Shionogi, Florham Park, N.J.
SAN DIEGO – The investigational oral drug, naldemedine, was found effective in treating opioid-induced constipation (OIC) in patients with noncancer chronic pain, according to results of two identically designed phase III trials (COMPOSE I and II). Naldemedine achieved durable efficacy and consistent safety, with a low incidence of gastrointestinal side effects, and importantly did not compromise or interfere with the analgesic effect of opioids.
In both studies, the drug met the primary endpoint and significantly improved all secondary endpoints. Improved frequency of spontaneous bowel movements (SBMs) was observed for at least 9 weeks out of the 12 weeks (the primary endpoint) in 47.6% of naldemedine-treated patients, compared with 34.6% of placebo patients in COMPOSE I. In COMPOSE II, 52.5% versus 33.6%, respectively, had improved frequency of SMB for at least 9 out of 12 weeks.
“Improvement with naldemedine was seen early and was durable, with no evidence of opiate withdrawal. This is good news for patients with OIC, given the significant impact this condition can have and the difficulty they can have in finding a safe and effective treatment,” said presenting author Dr. Martin Hale, an orthopedic surgeon and pain management specialist. He presented results of both trials at the annual Digestive Disease Week.
Naldemedine is a naltrexone-based, once-daily, oral, peripherally acting mu-opioid–receptor antagonist being developed by Shionogi. The fact that it is not centrally acting suggests that its side effect profile would be acceptable. Opiates work on mu receptors, reducing GI motility and fluid secretion, resulting in OIC.
“Laxatives have limited efficacy for OIC and do not address the underlying problem,” Dr. Hale of Gold Coast Research, Plantation, Fla., said. Thus, better treatments are needed.
Study details
Both studies were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. COMPOSE I included 547 patients, and COMPOSE II, 553 patients. To be included, patients had to be on opioid therapy for at least 3 months and on a stable dose of opioids for at least 4 weeks. They had to have noncancer pain accompanied by OIC.
Patients were randomized in a 1:1 ratio to oral naldemedine 0.2 mg with or without food versus placebo. “Being able to take the drug with food makes it more acceptable to patients,” Dr. Hale noted.
Responses were observed early in the course of the 12-week trial and remained durable. Naldemedine treatment significantly improved the frequency of SBMs per week, compared with placebo (P less than .0001 in both studies), and SBMs without straining per week from baseline to the last 2 weeks of the study (P = .0003 in COMPOSE I and P = .0011 in COMPOSE II).
Adverse events were similar across all four arms of both studies. Treatment-related adverse events were reported in about 48% of patients across both trials. Major adverse cardiovascular events (MACE) of concern occurred in 1 patient in treated with naldemedine and 1 in the placebo group. “MACE is not relevant with this drug,” Dr Hale told listeners.
Abdominal pain and diarrhea were the only treatment-related adverse events reported in greater than 5% of patients treated with naldemedine versus placebo. Abdominal pain was reported in 6.3% of the treated groups in COMPOSE I and 5.2% of the treated group in COMPOSE II versus 1.8% and 2.9%, respectively, in the placebo groups. Diarrhea was reported in 6.6% of the naldemedine patients in COMPOSE I and in 8.9% in COMPOSE II, compared with 2.9% and 1.8%, respectively, on placebo. Nausea was reported in 4.8% of naldemedine-treated patients in both trials, compared with 2.6% and 3.3%, respectively, in the placebo arms.
“Most treatment-emergent adverse events were mild or moderate. Back pain and flatulence were rare,” he commented.
Two scales were used to measure opiate withdrawal: Clinical Opiate Withdrawal Scale (COWS) and Subjective Opiate Withdrawal Score (SOWS). The graph curves were superimposable for naldemedine and placebo at all time points, showing that naldemedine did not interfere with the analgesic effect of opioids.
The study was funded by Shionogi, Florham Park, N.J.
SAN DIEGO – The investigational oral drug, naldemedine, was found effective in treating opioid-induced constipation (OIC) in patients with noncancer chronic pain, according to results of two identically designed phase III trials (COMPOSE I and II). Naldemedine achieved durable efficacy and consistent safety, with a low incidence of gastrointestinal side effects, and importantly did not compromise or interfere with the analgesic effect of opioids.
In both studies, the drug met the primary endpoint and significantly improved all secondary endpoints. Improved frequency of spontaneous bowel movements (SBMs) was observed for at least 9 weeks out of the 12 weeks (the primary endpoint) in 47.6% of naldemedine-treated patients, compared with 34.6% of placebo patients in COMPOSE I. In COMPOSE II, 52.5% versus 33.6%, respectively, had improved frequency of SMB for at least 9 out of 12 weeks.
“Improvement with naldemedine was seen early and was durable, with no evidence of opiate withdrawal. This is good news for patients with OIC, given the significant impact this condition can have and the difficulty they can have in finding a safe and effective treatment,” said presenting author Dr. Martin Hale, an orthopedic surgeon and pain management specialist. He presented results of both trials at the annual Digestive Disease Week.
Naldemedine is a naltrexone-based, once-daily, oral, peripherally acting mu-opioid–receptor antagonist being developed by Shionogi. The fact that it is not centrally acting suggests that its side effect profile would be acceptable. Opiates work on mu receptors, reducing GI motility and fluid secretion, resulting in OIC.
“Laxatives have limited efficacy for OIC and do not address the underlying problem,” Dr. Hale of Gold Coast Research, Plantation, Fla., said. Thus, better treatments are needed.
Study details
Both studies were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. COMPOSE I included 547 patients, and COMPOSE II, 553 patients. To be included, patients had to be on opioid therapy for at least 3 months and on a stable dose of opioids for at least 4 weeks. They had to have noncancer pain accompanied by OIC.
Patients were randomized in a 1:1 ratio to oral naldemedine 0.2 mg with or without food versus placebo. “Being able to take the drug with food makes it more acceptable to patients,” Dr. Hale noted.
Responses were observed early in the course of the 12-week trial and remained durable. Naldemedine treatment significantly improved the frequency of SBMs per week, compared with placebo (P less than .0001 in both studies), and SBMs without straining per week from baseline to the last 2 weeks of the study (P = .0003 in COMPOSE I and P = .0011 in COMPOSE II).
Adverse events were similar across all four arms of both studies. Treatment-related adverse events were reported in about 48% of patients across both trials. Major adverse cardiovascular events (MACE) of concern occurred in 1 patient in treated with naldemedine and 1 in the placebo group. “MACE is not relevant with this drug,” Dr Hale told listeners.
Abdominal pain and diarrhea were the only treatment-related adverse events reported in greater than 5% of patients treated with naldemedine versus placebo. Abdominal pain was reported in 6.3% of the treated groups in COMPOSE I and 5.2% of the treated group in COMPOSE II versus 1.8% and 2.9%, respectively, in the placebo groups. Diarrhea was reported in 6.6% of the naldemedine patients in COMPOSE I and in 8.9% in COMPOSE II, compared with 2.9% and 1.8%, respectively, on placebo. Nausea was reported in 4.8% of naldemedine-treated patients in both trials, compared with 2.6% and 3.3%, respectively, in the placebo arms.
“Most treatment-emergent adverse events were mild or moderate. Back pain and flatulence were rare,” he commented.
Two scales were used to measure opiate withdrawal: Clinical Opiate Withdrawal Scale (COWS) and Subjective Opiate Withdrawal Score (SOWS). The graph curves were superimposable for naldemedine and placebo at all time points, showing that naldemedine did not interfere with the analgesic effect of opioids.
The study was funded by Shionogi, Florham Park, N.J.
AT DDW® 2016
Key clinical point: Naldemedine was safe and effective in opioid-induced constipation in patients with chronic noncancer pain.
Major finding: Naldemedine improved frequency of spontaneous bowel movements for at least 9 weeks out of the 12 weeks (the primary endpoint) in 47.6% of patients, compared with 34.6% of placebo patients in COMPOSE I. In COMPOSE II, 52.5% versus 33.6%, respectively, had improved frequency of SMB for at least 9 out of 12 weeks.
Data source: Two identically designed phase III, randomized, controlled, double-blind clinical trials that included 547 and 553 patients, respectively.
Disclosures: The study was funded by Shionogi, Florham Park, N.J.
Methylated DNA markers hold promise for Lynch syndrome
SAN DIEGO – It has been challenging to identify reliable biomarkers for Lynch syndrome colorectal neoplasms, but that may be about to change. Researchers have identified 10 discriminant methylated DNA markers (MDMs) for detection of Lynch syndrome colorectal neoplasia.
In particular, OPLAH was the most discriminant MDM across all Lynch syndrome and sporadic colorectal neoplasias, according to a study reported at the annual Digestive Disease Week.
OPLAH had 100% specificity for both Lynch neoplasms and sporadic neoplasms, and sensitivity was 85% for Lynch syndrome neoplasms and 97% in sporadic patients. For adenocarcinoma, specificity and sensitivity were 100% with OPLAH.
“We found some highly discriminating and promising markers for detection of Lynch-associated neoplasms, which could complement current approaches for colorectal cancer,” said presenting author Dr. Veroushka Ballester-Vargas.
Lynch syndrome is the most common hereditary colorectal cancer (CRC), accounting for up to 5% of all CRC. Detection of Lynch neoplasms is currently challenging for several reasons, she explained.
Although there are at least three different sets of criteria for Lynch neoplasms, up to one-third of patients don’t fulfill those criteria. Moreover, 60% to 80% of Lynch tumors arise in the right colon, which is challenging to visualize on colonoscopy. Cologuard is a good test for sporadic CRC, but suboptimal for Lynch syndrome neoplasms.
Dr. Ballester-Vargas, an assistant professor at Columbia University, New York, and her colleagues have previously shown that MDMs may be advantageous as biomarkers. “These markers have one target site per gene, are highly informative and easy to assay,” she said. “Specific discovery of MDMs for Lynch-colorectal neoplasms has not been previously reported.”
Most biomarker discovery efforts have focused on sporadic colorectal neoplasia.
For discovery, the investigators evaluated 54 paraffin-embedded tissues for Lynch syndrome patients (18 normal mucosa, 18 adenoma larger than 1 cm, and 18 adenocarcinoma). Unbiased whole methylome method identified 21 top candidate MDMs from differentially methylated regions. Subsequent biological validation was performed for these 21 top candidates on 218 independent paraffin-embedded samples, 103 Lynch and 115 sporadic.
From these, the 10 most discriminant markers were selected and their performance was compared with sporadic MDMs.
“These MDMs were highly discriminant for sporadic adenoma, sporadic adenocarcinoma, and Lynch syndrome adenocarcinoma, but many were less so for Lynch,” she noted.
“Of the 10 MDMs, the key observation was that OPLAH had nearly perfect discrimination for both Lynch and sporadic neoplasms, with an area under the curve [AUC] approaching 1 – meaning 100% sensitivity and specificity for both adenoma and cancer,” she reported.
The remaining 9 MDMs were equally discriminant for adenoma and cancer but less discriminant for Lynch neoplasms.
“A closer look at OPLAH alone showed it was a highly discriminant marker, with specificity of 97% for sporadic colorectal cancer and 96% for Lynch neoplasms,” Dr. Ballester-Vargas stated.
“This is an early study. We are discussing the next steps, which will include studying MDMs in blood and stool,” she noted. “The other MDMs we identified are highly discriminant for adenomas and cancers.”
The paucity of Lynch tissues was a limitation of the study.
SAN DIEGO – It has been challenging to identify reliable biomarkers for Lynch syndrome colorectal neoplasms, but that may be about to change. Researchers have identified 10 discriminant methylated DNA markers (MDMs) for detection of Lynch syndrome colorectal neoplasia.
In particular, OPLAH was the most discriminant MDM across all Lynch syndrome and sporadic colorectal neoplasias, according to a study reported at the annual Digestive Disease Week.
OPLAH had 100% specificity for both Lynch neoplasms and sporadic neoplasms, and sensitivity was 85% for Lynch syndrome neoplasms and 97% in sporadic patients. For adenocarcinoma, specificity and sensitivity were 100% with OPLAH.
“We found some highly discriminating and promising markers for detection of Lynch-associated neoplasms, which could complement current approaches for colorectal cancer,” said presenting author Dr. Veroushka Ballester-Vargas.
Lynch syndrome is the most common hereditary colorectal cancer (CRC), accounting for up to 5% of all CRC. Detection of Lynch neoplasms is currently challenging for several reasons, she explained.
Although there are at least three different sets of criteria for Lynch neoplasms, up to one-third of patients don’t fulfill those criteria. Moreover, 60% to 80% of Lynch tumors arise in the right colon, which is challenging to visualize on colonoscopy. Cologuard is a good test for sporadic CRC, but suboptimal for Lynch syndrome neoplasms.
Dr. Ballester-Vargas, an assistant professor at Columbia University, New York, and her colleagues have previously shown that MDMs may be advantageous as biomarkers. “These markers have one target site per gene, are highly informative and easy to assay,” she said. “Specific discovery of MDMs for Lynch-colorectal neoplasms has not been previously reported.”
Most biomarker discovery efforts have focused on sporadic colorectal neoplasia.
For discovery, the investigators evaluated 54 paraffin-embedded tissues for Lynch syndrome patients (18 normal mucosa, 18 adenoma larger than 1 cm, and 18 adenocarcinoma). Unbiased whole methylome method identified 21 top candidate MDMs from differentially methylated regions. Subsequent biological validation was performed for these 21 top candidates on 218 independent paraffin-embedded samples, 103 Lynch and 115 sporadic.
From these, the 10 most discriminant markers were selected and their performance was compared with sporadic MDMs.
“These MDMs were highly discriminant for sporadic adenoma, sporadic adenocarcinoma, and Lynch syndrome adenocarcinoma, but many were less so for Lynch,” she noted.
“Of the 10 MDMs, the key observation was that OPLAH had nearly perfect discrimination for both Lynch and sporadic neoplasms, with an area under the curve [AUC] approaching 1 – meaning 100% sensitivity and specificity for both adenoma and cancer,” she reported.
The remaining 9 MDMs were equally discriminant for adenoma and cancer but less discriminant for Lynch neoplasms.
“A closer look at OPLAH alone showed it was a highly discriminant marker, with specificity of 97% for sporadic colorectal cancer and 96% for Lynch neoplasms,” Dr. Ballester-Vargas stated.
“This is an early study. We are discussing the next steps, which will include studying MDMs in blood and stool,” she noted. “The other MDMs we identified are highly discriminant for adenomas and cancers.”
The paucity of Lynch tissues was a limitation of the study.
SAN DIEGO – It has been challenging to identify reliable biomarkers for Lynch syndrome colorectal neoplasms, but that may be about to change. Researchers have identified 10 discriminant methylated DNA markers (MDMs) for detection of Lynch syndrome colorectal neoplasia.
In particular, OPLAH was the most discriminant MDM across all Lynch syndrome and sporadic colorectal neoplasias, according to a study reported at the annual Digestive Disease Week.
OPLAH had 100% specificity for both Lynch neoplasms and sporadic neoplasms, and sensitivity was 85% for Lynch syndrome neoplasms and 97% in sporadic patients. For adenocarcinoma, specificity and sensitivity were 100% with OPLAH.
“We found some highly discriminating and promising markers for detection of Lynch-associated neoplasms, which could complement current approaches for colorectal cancer,” said presenting author Dr. Veroushka Ballester-Vargas.
Lynch syndrome is the most common hereditary colorectal cancer (CRC), accounting for up to 5% of all CRC. Detection of Lynch neoplasms is currently challenging for several reasons, she explained.
Although there are at least three different sets of criteria for Lynch neoplasms, up to one-third of patients don’t fulfill those criteria. Moreover, 60% to 80% of Lynch tumors arise in the right colon, which is challenging to visualize on colonoscopy. Cologuard is a good test for sporadic CRC, but suboptimal for Lynch syndrome neoplasms.
Dr. Ballester-Vargas, an assistant professor at Columbia University, New York, and her colleagues have previously shown that MDMs may be advantageous as biomarkers. “These markers have one target site per gene, are highly informative and easy to assay,” she said. “Specific discovery of MDMs for Lynch-colorectal neoplasms has not been previously reported.”
Most biomarker discovery efforts have focused on sporadic colorectal neoplasia.
For discovery, the investigators evaluated 54 paraffin-embedded tissues for Lynch syndrome patients (18 normal mucosa, 18 adenoma larger than 1 cm, and 18 adenocarcinoma). Unbiased whole methylome method identified 21 top candidate MDMs from differentially methylated regions. Subsequent biological validation was performed for these 21 top candidates on 218 independent paraffin-embedded samples, 103 Lynch and 115 sporadic.
From these, the 10 most discriminant markers were selected and their performance was compared with sporadic MDMs.
“These MDMs were highly discriminant for sporadic adenoma, sporadic adenocarcinoma, and Lynch syndrome adenocarcinoma, but many were less so for Lynch,” she noted.
“Of the 10 MDMs, the key observation was that OPLAH had nearly perfect discrimination for both Lynch and sporadic neoplasms, with an area under the curve [AUC] approaching 1 – meaning 100% sensitivity and specificity for both adenoma and cancer,” she reported.
The remaining 9 MDMs were equally discriminant for adenoma and cancer but less discriminant for Lynch neoplasms.
“A closer look at OPLAH alone showed it was a highly discriminant marker, with specificity of 97% for sporadic colorectal cancer and 96% for Lynch neoplasms,” Dr. Ballester-Vargas stated.
“This is an early study. We are discussing the next steps, which will include studying MDMs in blood and stool,” she noted. “The other MDMs we identified are highly discriminant for adenomas and cancers.”
The paucity of Lynch tissues was a limitation of the study.
AT DDW® 2016
Key clinical point: Methylated DNA markers (MDMs) may prove helpful in identifying Lynch syndrome colorectal neoplasms.
Major finding: OPLAH had 100% specificity for both Lynch neoplasms and sporadic neoplasms, and sensitivity was 85% for Lynch syndrome neoplasms and 97% for sporadic neoplasm.
Data source: Analysis of paraffin-embedded tissues from 54 Lynch patients for discovery and 218 tissue samples (103 Lynch, 115 sporadic) for validation.
Disclosures: The study was funded by the Mayo Clinic and Exact Sciences.
Persistent SIRS, leukocytosis linked to unrecognized necrotizing pancreatitis
SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.
For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.
Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.
To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).
The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.
Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.
The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).
Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.
Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.
SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.
For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.
Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.
To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).
The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.
Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.
The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).
Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.
Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.
SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.
For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.
Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.
To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).
The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.
Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.
The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).
Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.
Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.
AT DDW® 2016
Key clinical point: Persistent leukocytosis (greater than 12 x 109 white blood cells per liter) and SIRS on the day of scheduled laparoscopic cholecystectomy may indicate unrecognized necrotizing pancreatitis.
Major finding: The highest areas under the curve were for SIRS (0.96), followed by a WBC at or above 12 x 109/L (0.92; both P less than .0001).
Data source: A single-center retrospective study of 46 patients with unrecognized pancreatitis who underwent same-admission laparoscopic cholecystectomy, 48 patients with necrotizing pancreatitis who did not undergo SALC, and 48 patients with true mild acute gallstone pancreatitis.
Disclosures: Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.
Fecal transplanting effective in ulcerative colitis
Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.
FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.
“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.
“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.
The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.
Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.
Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.
“The enemas in this trial were as well tolerated as other types of enemas,” he noted.
After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).
At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).
No difference between the two study arms was seen in the rate of adverse events.
Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.
This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.
Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.
“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”
Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.
Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.
Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.
Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.
FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.
“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.
“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.
The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.
Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.
Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.
“The enemas in this trial were as well tolerated as other types of enemas,” he noted.
After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).
At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).
No difference between the two study arms was seen in the rate of adverse events.
Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.
This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.
Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.
“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”
Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.
Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.
Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.
Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.
FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.
“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.
“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.
The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.
Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.
Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.
“The enemas in this trial were as well tolerated as other types of enemas,” he noted.
After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).
At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).
No difference between the two study arms was seen in the rate of adverse events.
Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.
This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.
Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.
“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”
Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.
Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.
Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.
FROM DDW® 2016
Key clinical point: Fecal microbiota transplant is an effective approach for ulcerative colitis in patients resistant to other treatments.
Major finding: 11/41 (27%) of FMT patients responded versus 3/40 (8%) of the control group.
Data source: Double-blind, three-center, randomized study of 81 patients.
Disclosures: Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.
Metabolic factors associated with pancreatic NETs
SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.
Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.
“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.
PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.
“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.
Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.
Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.
Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.
Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).
No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.
Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).
The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.
Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.
Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.
Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).
“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.
SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.
Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.
“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.
PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.
“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.
Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.
Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.
Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.
Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).
No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.
Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).
The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.
Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.
Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.
Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).
“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.
SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.
Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.
“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.
PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.
“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.
Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.
Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.
Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.
Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).
No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.
Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).
The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.
Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.
Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.
Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).
“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.
AT DDW® 2016
Race predicts poor outcomes in people with liver cancer
Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.
Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.
“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.
“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.
The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.
Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.
An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”
After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.
“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.
Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.
Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.
One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.
“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”
Dr. Jones had no relevant financial disclosures.
Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.
Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.
“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.
“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.
The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.
Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.
An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”
After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.
“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.
Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.
Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.
One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.
“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”
Dr. Jones had no relevant financial disclosures.
Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.
Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.
“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.
“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.
The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.
Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.
An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”
After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.
“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.
Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.
Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.
One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.
“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”
Dr. Jones had no relevant financial disclosures.
Key clinical point: Blacks with hepatocellular carcinoma have worse survival and more adverse clinical features than whites.
Major finding: Blacks were 33% more likely to die of hepatocellular carcinoma than were whites. Median survival from time of diagnosis was 301 days for blacks, compared with 534.5 days for non-Hispanic whites.
Data source: A retrospective analysis of 999 patients treated at a single center.
Disclosures: Dr. Jones had no relevant financial disclosures.