Will Pass

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.

Altering the gut microbiome may reduce the tumor-promoting effects of cigarette smoking, based on a preclinical study.

Mice treated with microbiome-depleting antibiotics or genetically modified to lack an adaptive immune response did not show increased rates of cancer growth when exposed to cigarette smoke, reported lead author Prateek Sharma, MBBS, of the University of Miami, and colleagues.

Although previous research has shown that the gut microbiome plays a role in the progression of cancer and that smoking alters the gut microbiome, the collective effects of these changes have not been studied, the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

“There is information that smoking changes the gut microbiome ... but the impact of this change is not known,” Dr. Sharma said in a virtual press conference.

To learn more, the investigators first performed an experiment using wild-type mice. All mice were injected with a cancer cell line from the pancreas, colon, or bladder. Mice were then sorted into four groups, in which they were given microbiome-depleting antibiotics and exposed to smoke, given antibiotics alone, exposed to smoke alone, or left untreated and unexposed to serve as controls. Tumor size was then measured over the course of 2 months.

The experiment revealed that mice exposed to smoke but not treated with antibiotics had increased rates of tumor growth regardless of cancer type. But in mice treated with antibiotics, the tumor-promoting effects of smoke exposure were completely lost; the mice had rates of tumor growth even lower than controls.

This experiment was repeated with mice genetically engineered to lack an adaptive immune response. Regardless of smoke or antibiotic exposure, all mice had comparable rates of tumor growth.

Dr. Sharma offered a summary of the findings and their possible implications for human medicine.

“Cigarette smoking changes the gut microbiome, and this changed gut microbiome interacts with the immune system to affect cancer progression,” he said. “If we can target this changed microbiome with modulation strategies like antibiotics, probiotics, or administration of good bacteria, we can alter this process. And if the same results are found in human studies, it could go a long way to affect cancer outcomes in smokers.”

In addition to human studies, Dr. Sharma said that future research should aim to uncover the underlying mechanisms involved in this process, including the types of bacteria that play a role.

When asked if the study might lessen concerns about the negative impacts of smoking among cancer patients, Dr. Sharma suggested that, even if the findings do translate to humans, smoking would still carry significant health risks.

“Even if gut microbiome modulation strategies do work in these patients, it may help a little, but it’s not going to bring it down to the level of nonsmokers, so it’s no way an excuse to not fear or continue [smoking],” he said.

The study was funded by the Florida Department of Health. The investigators reported no conflicts of interest.

Altering the gut microbiome may reduce the tumor-promoting effects of cigarette smoking, based on a preclinical study.

Mice treated with microbiome-depleting antibiotics or genetically modified to lack an adaptive immune response did not show increased rates of cancer growth when exposed to cigarette smoke, reported lead author Prateek Sharma, MBBS, of the University of Miami, and colleagues.

Although previous research has shown that the gut microbiome plays a role in the progression of cancer and that smoking alters the gut microbiome, the collective effects of these changes have not been studied, the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

“There is information that smoking changes the gut microbiome ... but the impact of this change is not known,” Dr. Sharma said in a virtual press conference.

To learn more, the investigators first performed an experiment using wild-type mice. All mice were injected with a cancer cell line from the pancreas, colon, or bladder. Mice were then sorted into four groups, in which they were given microbiome-depleting antibiotics and exposed to smoke, given antibiotics alone, exposed to smoke alone, or left untreated and unexposed to serve as controls. Tumor size was then measured over the course of 2 months.

The experiment revealed that mice exposed to smoke but not treated with antibiotics had increased rates of tumor growth regardless of cancer type. But in mice treated with antibiotics, the tumor-promoting effects of smoke exposure were completely lost; the mice had rates of tumor growth even lower than controls.

This experiment was repeated with mice genetically engineered to lack an adaptive immune response. Regardless of smoke or antibiotic exposure, all mice had comparable rates of tumor growth.

Dr. Sharma offered a summary of the findings and their possible implications for human medicine.

“Cigarette smoking changes the gut microbiome, and this changed gut microbiome interacts with the immune system to affect cancer progression,” he said. “If we can target this changed microbiome with modulation strategies like antibiotics, probiotics, or administration of good bacteria, we can alter this process. And if the same results are found in human studies, it could go a long way to affect cancer outcomes in smokers.”

In addition to human studies, Dr. Sharma said that future research should aim to uncover the underlying mechanisms involved in this process, including the types of bacteria that play a role.

When asked if the study might lessen concerns about the negative impacts of smoking among cancer patients, Dr. Sharma suggested that, even if the findings do translate to humans, smoking would still carry significant health risks.

“Even if gut microbiome modulation strategies do work in these patients, it may help a little, but it’s not going to bring it down to the level of nonsmokers, so it’s no way an excuse to not fear or continue [smoking],” he said.

The study was funded by the Florida Department of Health. The investigators reported no conflicts of interest.

Altering the gut microbiome may reduce the tumor-promoting effects of cigarette smoking, based on a preclinical study.

Mice treated with microbiome-depleting antibiotics or genetically modified to lack an adaptive immune response did not show increased rates of cancer growth when exposed to cigarette smoke, reported lead author Prateek Sharma, MBBS, of the University of Miami, and colleagues.

Although previous research has shown that the gut microbiome plays a role in the progression of cancer and that smoking alters the gut microbiome, the collective effects of these changes have not been studied, the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

“There is information that smoking changes the gut microbiome ... but the impact of this change is not known,” Dr. Sharma said in a virtual press conference.

To learn more, the investigators first performed an experiment using wild-type mice. All mice were injected with a cancer cell line from the pancreas, colon, or bladder. Mice were then sorted into four groups, in which they were given microbiome-depleting antibiotics and exposed to smoke, given antibiotics alone, exposed to smoke alone, or left untreated and unexposed to serve as controls. Tumor size was then measured over the course of 2 months.

The experiment revealed that mice exposed to smoke but not treated with antibiotics had increased rates of tumor growth regardless of cancer type. But in mice treated with antibiotics, the tumor-promoting effects of smoke exposure were completely lost; the mice had rates of tumor growth even lower than controls.

This experiment was repeated with mice genetically engineered to lack an adaptive immune response. Regardless of smoke or antibiotic exposure, all mice had comparable rates of tumor growth.

Dr. Sharma offered a summary of the findings and their possible implications for human medicine.

“Cigarette smoking changes the gut microbiome, and this changed gut microbiome interacts with the immune system to affect cancer progression,” he said. “If we can target this changed microbiome with modulation strategies like antibiotics, probiotics, or administration of good bacteria, we can alter this process. And if the same results are found in human studies, it could go a long way to affect cancer outcomes in smokers.”

In addition to human studies, Dr. Sharma said that future research should aim to uncover the underlying mechanisms involved in this process, including the types of bacteria that play a role.

When asked if the study might lessen concerns about the negative impacts of smoking among cancer patients, Dr. Sharma suggested that, even if the findings do translate to humans, smoking would still carry significant health risks.

“Even if gut microbiome modulation strategies do work in these patients, it may help a little, but it’s not going to bring it down to the level of nonsmokers, so it’s no way an excuse to not fear or continue [smoking],” he said.

The study was funded by the Florida Department of Health. The investigators reported no conflicts of interest.

First responders to the site of the 2001 World Trade Center attack may have an elevated risk of nonalcoholic fatty liver disease (NAFLD), according to investigators.

In a retrospective look at 236 first responders presenting with gastrointestinal symptoms to the World Trade Center Health Program, 195 (82.6%) had NAFLD, compared with 24%-45% of the general population, reported lead author Mishal Reja, MD, of Robert Wood Johnson University Hospital, New Brunswick, N.J.

The increased rate of NAFLD among first responders is likely because of toxin exposure at ground zero, which can cause a subtype of NAFLD known as toxin-associated fatty liver disease (TAFLD), Dr. Reja wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

“I was not surprised [by these findings],” Dr. Reja said during a virtual press conference. “In the prior literature that did examine TAFLD, it did show that populations exposed to these specific chemicals ... at the ground zero site had extremely high rates – consistent with the rates we found in our study – of fatty liver disease.”

Dr. Reja said that 9/11 first responders were exposed to “many common toxins that are consistently in occupational and environmental toxicant literature.” In particular, he named polycyclic aromatic hydrocarbons and vinyl chloride.

“A lot of these toxins are ... included in industrial solvents as well as building demolition,” Dr. Reja said. “So they’ve been around for so long, and they’ve been studied for so long, [that we have] literature that shows these toxins are associated with fatty liver disease, which is how we arrived at the hypothesis in the first place.”

The first responders were stratified by roles, which were associated with varying levels of exposure. About 40% of individuals in the study were involved in moving debris from the site, a small group (4%) were involved in clean-up and maintenance, while approximately 30%-40% worked in more protected, administrative roles.

Comparing individuals in the study with TAFLD versus those without TAFLD revealed additional risk factors. Multivariate logistical regression analysis showed that obese individuals had a significantly increased risk of fatty liver disease, suggesting a synergistic effect.

“If you were exposed to these toxins in the World Trade Center, and you were obese, [then] you are actually between two to three times more likely to get [TAFLD],” Dr. Reja said, noting that hypertension and diabetes were also identified as independent risk factors.

Dr. Reja and colleagues are planning a prospective trial to investigate further. The study will likely involve 100-200 first responders with TAFLD, a similar number of individuals with NAFLD, and another group without liver disease.

The investigators reported no outside funding or conflicts of interest.

SOURCE: Reja M et al. DDW 2020, Abstracts available online May 2.

First responders to the site of the 2001 World Trade Center attack may have an elevated risk of nonalcoholic fatty liver disease (NAFLD), according to investigators.

In a retrospective look at 236 first responders presenting with gastrointestinal symptoms to the World Trade Center Health Program, 195 (82.6%) had NAFLD, compared with 24%-45% of the general population, reported lead author Mishal Reja, MD, of Robert Wood Johnson University Hospital, New Brunswick, N.J.

The increased rate of NAFLD among first responders is likely because of toxin exposure at ground zero, which can cause a subtype of NAFLD known as toxin-associated fatty liver disease (TAFLD), Dr. Reja wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

“I was not surprised [by these findings],” Dr. Reja said during a virtual press conference. “In the prior literature that did examine TAFLD, it did show that populations exposed to these specific chemicals ... at the ground zero site had extremely high rates – consistent with the rates we found in our study – of fatty liver disease.”

Dr. Reja said that 9/11 first responders were exposed to “many common toxins that are consistently in occupational and environmental toxicant literature.” In particular, he named polycyclic aromatic hydrocarbons and vinyl chloride.

“A lot of these toxins are ... included in industrial solvents as well as building demolition,” Dr. Reja said. “So they’ve been around for so long, and they’ve been studied for so long, [that we have] literature that shows these toxins are associated with fatty liver disease, which is how we arrived at the hypothesis in the first place.”

The first responders were stratified by roles, which were associated with varying levels of exposure. About 40% of individuals in the study were involved in moving debris from the site, a small group (4%) were involved in clean-up and maintenance, while approximately 30%-40% worked in more protected, administrative roles.

Comparing individuals in the study with TAFLD versus those without TAFLD revealed additional risk factors. Multivariate logistical regression analysis showed that obese individuals had a significantly increased risk of fatty liver disease, suggesting a synergistic effect.

“If you were exposed to these toxins in the World Trade Center, and you were obese, [then] you are actually between two to three times more likely to get [TAFLD],” Dr. Reja said, noting that hypertension and diabetes were also identified as independent risk factors.

Dr. Reja and colleagues are planning a prospective trial to investigate further. The study will likely involve 100-200 first responders with TAFLD, a similar number of individuals with NAFLD, and another group without liver disease.

The investigators reported no outside funding or conflicts of interest.

SOURCE: Reja M et al. DDW 2020, Abstracts available online May 2.

First responders to the site of the 2001 World Trade Center attack may have an elevated risk of nonalcoholic fatty liver disease (NAFLD), according to investigators.

In a retrospective look at 236 first responders presenting with gastrointestinal symptoms to the World Trade Center Health Program, 195 (82.6%) had NAFLD, compared with 24%-45% of the general population, reported lead author Mishal Reja, MD, of Robert Wood Johnson University Hospital, New Brunswick, N.J.

The increased rate of NAFLD among first responders is likely because of toxin exposure at ground zero, which can cause a subtype of NAFLD known as toxin-associated fatty liver disease (TAFLD), Dr. Reja wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

“I was not surprised [by these findings],” Dr. Reja said during a virtual press conference. “In the prior literature that did examine TAFLD, it did show that populations exposed to these specific chemicals ... at the ground zero site had extremely high rates – consistent with the rates we found in our study – of fatty liver disease.”

Dr. Reja said that 9/11 first responders were exposed to “many common toxins that are consistently in occupational and environmental toxicant literature.” In particular, he named polycyclic aromatic hydrocarbons and vinyl chloride.

“A lot of these toxins are ... included in industrial solvents as well as building demolition,” Dr. Reja said. “So they’ve been around for so long, and they’ve been studied for so long, [that we have] literature that shows these toxins are associated with fatty liver disease, which is how we arrived at the hypothesis in the first place.”

The first responders were stratified by roles, which were associated with varying levels of exposure. About 40% of individuals in the study were involved in moving debris from the site, a small group (4%) were involved in clean-up and maintenance, while approximately 30%-40% worked in more protected, administrative roles.

Comparing individuals in the study with TAFLD versus those without TAFLD revealed additional risk factors. Multivariate logistical regression analysis showed that obese individuals had a significantly increased risk of fatty liver disease, suggesting a synergistic effect.

“If you were exposed to these toxins in the World Trade Center, and you were obese, [then] you are actually between two to three times more likely to get [TAFLD],” Dr. Reja said, noting that hypertension and diabetes were also identified as independent risk factors.

Dr. Reja and colleagues are planning a prospective trial to investigate further. The study will likely involve 100-200 first responders with TAFLD, a similar number of individuals with NAFLD, and another group without liver disease.

The investigators reported no outside funding or conflicts of interest.

SOURCE: Reja M et al. DDW 2020, Abstracts available online May 2.

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

Help your patients understand their Crohn’s disease treatment options by sharing AGA patient education content at https://www.gastro.org/practice-guidance/gi-patient-center/topic/crohn-s-disease.  

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

Help your patients understand their Crohn’s disease treatment options by sharing AGA patient education content at https://www.gastro.org/practice-guidance/gi-patient-center/topic/crohn-s-disease.  

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

Help your patients understand their Crohn’s disease treatment options by sharing AGA patient education content at https://www.gastro.org/practice-guidance/gi-patient-center/topic/crohn-s-disease.  

Risk models that incorporate genetic and circulating biomarker data in addition to established risk factors may improve risk modeling for pancreatic cancer in the general population, according to investigators.

Identifying high-risk individuals could facilitate earlier disease detection, which is essential for curing pancreatic cancer, reported lead author Jihye Kim, PhD, of Harvard School of Public Health, Boston, and colleagues.

“Given the late stage at presentation for most patients with pancreatic cancer, earlier detection approaches are worthy of significant investment as a critical means to reduce mortality from pancreatic cancer, soon to be the second-leading cause of cancer death in the United States,” the investigators wrote in Cancer Epidemiology, Biomarkers & Prevention.

According to the investigators, a variety of risk factors for pancreatic cancer are well established and include clinical, demographic, and lifestyle factors, while recent studies have reported associations with genetic and circulating biomarkers.

“Although risk factors have been investigated individually, their joint contribution to risk discrimination remains largely unknown,” the investigators wrote.

To learn more, Dr. Kim and colleagues performed a nested case-control study in which 500 patients with primary pancreatic adenocarcinoma were matched with 1,091 healthy controls. Data were drawn from four prospective studies: the Nurses’ Health Study, the Health Professionals Follow-up Study, the Women’s Health Initiative Observational Study, and the Physicians’ Health Study I. Via these studies, cases provided blood samples prior to diagnosis with pancreatic cancer.

“Importantly, because all our subjects were enrolled in prospective cohorts, all risk factor data and circulating markers were measured before the cases’ diagnosis of pancreatic cancer,” the investigators wrote. “This design faithfully recapitulates the situation faced by primary care physicians, where decisions related to disease screening are made in the prediagnostic setting using data collected in the several years prior to cancer diagnosis.”

In the present study, the investigators collected patient data for a variety of risk factors, including clinical and lifestyle characteristics, circulating biomarkers such as interleukin-6 and proinsulin, and 22 single-nucleotide polymorphisms. Frequencies and distributions of these factors were used to develop three multivariate risk models: a clinical model, a clinical/genetic model, and a clinical/genetic/biomarker model. To determine absolute risk of pancreatic cancer, these three models were combined with U.S. epidemiologic data, including incidence and mortality rates.

Cross-validation showed that the risk models became increasingly accurate with each added dataset; the area under the curve increased from 0.55 for the clinical model to 0.61 for the clinical/genetic model and ultimately to 0.62 for the clinical/genetic/biomarker model. Consequently, each model identified a greater number of individuals with at least a threefold risk of pancreatic cancer over a 10-year period. For example, the clinical model identified 1.5% of women and 0.2% of men with at least threefold risk, whereas the model that also included genetic and biomarker data identified 2.6% of women and 3.7% of men.

Absolute risk modeling allowed for generation of risk stratification percentiles by age. Women in the 99th risk percentile had a 1.7% risk of developing pancreatic cancer by age 70 years, and a 3.6% risk by age 80. For men, the highest-risk group had a 2.0% risk of pancreatic cancer by age 70 years and a 3.8% risk by age 80. Conversely, both men and women in the 10th risk percentile had a 0.2% risk by age 70 years and a 0.4% risk by age 80.

“[T]he addition of genetic variants and circulating markers added discriminatory ability beyond clinical factors that could be solicited in a physician’s office,” the investigators wrote.

“Further refinement and validation in independent samples will be necessary to make these models clinically actionable and impact survival of patients with pancreatic cancer,” they concluded.

The study was supported by the National Institutes of Health. The investigators reported additional relationships with Bayer, Celgene, Eli Lilly, and others.

SOURCE: Kim J et al. Cancer Epidemiol Biomarkers Prev. 2020 Apr 22. doi: 10.1158/1055-9965.EPI-19-1389.

Risk models that incorporate genetic and circulating biomarker data in addition to established risk factors may improve risk modeling for pancreatic cancer in the general population, according to investigators.

Identifying high-risk individuals could facilitate earlier disease detection, which is essential for curing pancreatic cancer, reported lead author Jihye Kim, PhD, of Harvard School of Public Health, Boston, and colleagues.

“Given the late stage at presentation for most patients with pancreatic cancer, earlier detection approaches are worthy of significant investment as a critical means to reduce mortality from pancreatic cancer, soon to be the second-leading cause of cancer death in the United States,” the investigators wrote in Cancer Epidemiology, Biomarkers & Prevention.

According to the investigators, a variety of risk factors for pancreatic cancer are well established and include clinical, demographic, and lifestyle factors, while recent studies have reported associations with genetic and circulating biomarkers.

“Although risk factors have been investigated individually, their joint contribution to risk discrimination remains largely unknown,” the investigators wrote.

To learn more, Dr. Kim and colleagues performed a nested case-control study in which 500 patients with primary pancreatic adenocarcinoma were matched with 1,091 healthy controls. Data were drawn from four prospective studies: the Nurses’ Health Study, the Health Professionals Follow-up Study, the Women’s Health Initiative Observational Study, and the Physicians’ Health Study I. Via these studies, cases provided blood samples prior to diagnosis with pancreatic cancer.

“Importantly, because all our subjects were enrolled in prospective cohorts, all risk factor data and circulating markers were measured before the cases’ diagnosis of pancreatic cancer,” the investigators wrote. “This design faithfully recapitulates the situation faced by primary care physicians, where decisions related to disease screening are made in the prediagnostic setting using data collected in the several years prior to cancer diagnosis.”

In the present study, the investigators collected patient data for a variety of risk factors, including clinical and lifestyle characteristics, circulating biomarkers such as interleukin-6 and proinsulin, and 22 single-nucleotide polymorphisms. Frequencies and distributions of these factors were used to develop three multivariate risk models: a clinical model, a clinical/genetic model, and a clinical/genetic/biomarker model. To determine absolute risk of pancreatic cancer, these three models were combined with U.S. epidemiologic data, including incidence and mortality rates.

Cross-validation showed that the risk models became increasingly accurate with each added dataset; the area under the curve increased from 0.55 for the clinical model to 0.61 for the clinical/genetic model and ultimately to 0.62 for the clinical/genetic/biomarker model. Consequently, each model identified a greater number of individuals with at least a threefold risk of pancreatic cancer over a 10-year period. For example, the clinical model identified 1.5% of women and 0.2% of men with at least threefold risk, whereas the model that also included genetic and biomarker data identified 2.6% of women and 3.7% of men.

Absolute risk modeling allowed for generation of risk stratification percentiles by age. Women in the 99th risk percentile had a 1.7% risk of developing pancreatic cancer by age 70 years, and a 3.6% risk by age 80. For men, the highest-risk group had a 2.0% risk of pancreatic cancer by age 70 years and a 3.8% risk by age 80. Conversely, both men and women in the 10th risk percentile had a 0.2% risk by age 70 years and a 0.4% risk by age 80.

“[T]he addition of genetic variants and circulating markers added discriminatory ability beyond clinical factors that could be solicited in a physician’s office,” the investigators wrote.

“Further refinement and validation in independent samples will be necessary to make these models clinically actionable and impact survival of patients with pancreatic cancer,” they concluded.

The study was supported by the National Institutes of Health. The investigators reported additional relationships with Bayer, Celgene, Eli Lilly, and others.

SOURCE: Kim J et al. Cancer Epidemiol Biomarkers Prev. 2020 Apr 22. doi: 10.1158/1055-9965.EPI-19-1389.

Risk models that incorporate genetic and circulating biomarker data in addition to established risk factors may improve risk modeling for pancreatic cancer in the general population, according to investigators.

Identifying high-risk individuals could facilitate earlier disease detection, which is essential for curing pancreatic cancer, reported lead author Jihye Kim, PhD, of Harvard School of Public Health, Boston, and colleagues.

“Given the late stage at presentation for most patients with pancreatic cancer, earlier detection approaches are worthy of significant investment as a critical means to reduce mortality from pancreatic cancer, soon to be the second-leading cause of cancer death in the United States,” the investigators wrote in Cancer Epidemiology, Biomarkers & Prevention.

According to the investigators, a variety of risk factors for pancreatic cancer are well established and include clinical, demographic, and lifestyle factors, while recent studies have reported associations with genetic and circulating biomarkers.

“Although risk factors have been investigated individually, their joint contribution to risk discrimination remains largely unknown,” the investigators wrote.

To learn more, Dr. Kim and colleagues performed a nested case-control study in which 500 patients with primary pancreatic adenocarcinoma were matched with 1,091 healthy controls. Data were drawn from four prospective studies: the Nurses’ Health Study, the Health Professionals Follow-up Study, the Women’s Health Initiative Observational Study, and the Physicians’ Health Study I. Via these studies, cases provided blood samples prior to diagnosis with pancreatic cancer.

“Importantly, because all our subjects were enrolled in prospective cohorts, all risk factor data and circulating markers were measured before the cases’ diagnosis of pancreatic cancer,” the investigators wrote. “This design faithfully recapitulates the situation faced by primary care physicians, where decisions related to disease screening are made in the prediagnostic setting using data collected in the several years prior to cancer diagnosis.”

In the present study, the investigators collected patient data for a variety of risk factors, including clinical and lifestyle characteristics, circulating biomarkers such as interleukin-6 and proinsulin, and 22 single-nucleotide polymorphisms. Frequencies and distributions of these factors were used to develop three multivariate risk models: a clinical model, a clinical/genetic model, and a clinical/genetic/biomarker model. To determine absolute risk of pancreatic cancer, these three models were combined with U.S. epidemiologic data, including incidence and mortality rates.

Cross-validation showed that the risk models became increasingly accurate with each added dataset; the area under the curve increased from 0.55 for the clinical model to 0.61 for the clinical/genetic model and ultimately to 0.62 for the clinical/genetic/biomarker model. Consequently, each model identified a greater number of individuals with at least a threefold risk of pancreatic cancer over a 10-year period. For example, the clinical model identified 1.5% of women and 0.2% of men with at least threefold risk, whereas the model that also included genetic and biomarker data identified 2.6% of women and 3.7% of men.

Absolute risk modeling allowed for generation of risk stratification percentiles by age. Women in the 99th risk percentile had a 1.7% risk of developing pancreatic cancer by age 70 years, and a 3.6% risk by age 80. For men, the highest-risk group had a 2.0% risk of pancreatic cancer by age 70 years and a 3.8% risk by age 80. Conversely, both men and women in the 10th risk percentile had a 0.2% risk by age 70 years and a 0.4% risk by age 80.

“[T]he addition of genetic variants and circulating markers added discriminatory ability beyond clinical factors that could be solicited in a physician’s office,” the investigators wrote.

“Further refinement and validation in independent samples will be necessary to make these models clinically actionable and impact survival of patients with pancreatic cancer,” they concluded.

The study was supported by the National Institutes of Health. The investigators reported additional relationships with Bayer, Celgene, Eli Lilly, and others.

SOURCE: Kim J et al. Cancer Epidemiol Biomarkers Prev. 2020 Apr 22. doi: 10.1158/1055-9965.EPI-19-1389.

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

A novel biomarker may predict early responses to anti–tumor necrosis factor (TNF) therapy in patients with Crohn’s disease, according to investigators.

After 1 week of therapy with adalimumab, serum levels of citrullinated and matrix metalloproteinase-degraded vimentin (VICM) predicted early responses to treatment with an odds ratio of 42.5, reported lead author Joachim H. Mortensen, PhD, of Nordic Bioscience, Herlev, Denmark, and colleagues.

“VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients,” the investigators wrote in the Journal of Clinical Gastroenterology.This is an area of particular need, the investigators explained because 10%-40% of patients with Crohn’s disease have an inadequate response to anti-TNF therapy, yet early detection of treatment failure remains challenging.

According to the investigators, C-reactive protein (CRP) may serve as a reliable biomarker for acute inflammation, but intestinal tissue remodeling in Crohn’s disease is largely caused by chronic inflammation, which is driven by proteases. As these proteases degrade intestinal tissue, protein fragments called neo-epitopes are released into circulation, offering a potential biomarker of disease activity. Previous research showed that VICM, a neo-epitope that correlates with macrophage activity, was highly associated with Crohn’s disease.

“Because anti-TNF reduces the number of activated macrophages, we hypothesized that changes in VICM levels can be applied to monitor the outcome of early response to anti-TNF treatment in Crohn’s disease,” the investigators wrote.

To test this hypothesis, the investigators retrospectively analyzed clinical data and serum samples from 42 patients with Crohn’s disease, of whom 21 were treated with adalimumab at University Medical Center Groningen (the Netherlands) and 21 were treated with infliximab at Aarhus (Denmark) University Hospital. In both cohorts, disease activity was measured by the Harvey-Bradshaw Index, with responders defined by a score of less than 5, which indicates clinical remission. Harvey-Bradshaw Index scores were evaluated at week 8 and week 14 for the adalimumab and infliximab groups, respectively. In the adalimumab group, serum VICM and CRP levels were evaluated at baseline, then at weeks 1 and 8. In the infliximab group, VICM and CRP were measured at baseline, then at weeks 2, 6, and 14.

Patients responding to adalimumab had significantly lower levels of VICM than did nonresponders at week 1 (P = .007) and week 8 (P = .048). Although infliximab responders showed numerical differences in VICM, compared with nonresponders, at week 2 (P = .48), these differences lacked statistical significance until week 6 (P = .046), then lost significance again at week 14 (P = .23). No significant differences in CRP levels between responders and nonresponders were detected at any timepoints.

Using a receiver operating characteristic–curve analysis, the investigators identified a clinically relevant cutoff value for VICM at 12.5 ng/mL. With this cutoff, responders were identifiable as early as week 6 in the infliximab group with an area under the curve (AUC) of 0.89 (specificity, 75%; sensitivity, 88%; P less than .01). In the adalimumab group, responders were identifiable as early as week 1, with an AUC of 0.91 (specificity, 87%; sensitivity, 100%; P less than .01).

In the infliximab group, patients with a serum VICM level less than 12.5 ng/mL at week 6 were 22.5 times more likely to be responders (odds ratio, 22.5). Patients treated with adalimumab were 42 times more likely to be responders if their VICM level fell below the cutoff at week 1. A similar analysis involving CRP had no predictive value.

“In conclusion, the reduction in VICM serum levels, but not reduction in CRP levels, was associated with early response to [anti–TNF-alpha] treatment in patients with Crohn’s disease,” the investigators concluded. “Thus, VICM may help to facilitate early decision-making of the best possible treatment option for Crohn’s disease patients.”

The study was funded by the Danish Research Foundation. The investigators disclosed additional relationships with Nordic Bioscience.

SOURCE: Mortensen JH et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001341.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic