Jim Kling

Long-term results from the Dutch PREOPANC randomized, controlled trial confirm that neoadjuvant chemoradiotherapy conveys a survival advantage to patients with resectable and borderline resectable pancreatic cancer.

Neoadjuvant therapy remains controversial in this patient population, which makes up 15% of pancreatic cancer cases. Historically, these patients have been treated with surgery followed by adjuvant chemotherapy, but only about half of patients ever receive adjuvant chemotherapy due to early recurrence, surgical complication, or worsening disease. Neoadjuvant chemoradiotherapy is thought to increase the fraction of patients who receive chemotherapy. Improved exposure to chemotherapy could increase survival, and may also increase the rate of microscopically margin-negative resections.

Neoadjuvant chemoradiotherapy has become increasingly common, but the practice is based on retrospective analysis and small, phase II trials.

“This phase III, randomized trial demonstrates a long-term survival benefit with neoadjuvant treatment compared with upfront surgery in patients with resectable and borderline resectable pancreatic cancer,” the researchers wrote in the study, published online Jan. 27 in the Journal of Clinical Oncology. “The effect of neoadjuvant chemoradiotherapy was consistent across subgroups, including resectable and borderline resectable disease,” they added.

The new data represent long-term follow-up of 246 patients who had been randomized to neoadjuvant chemoradiotherapy or upfront surgery. Short-term data, published in 2020, showed trends toward improved survival but no statistically significant difference at a median of 27 months of follow-up. In the update, after a median follow-up of 59 months, patients in the neoadjuvant chemoradiotherapy group had better overall survival (hazard ratio [HR], 0.73; P = .025) and the 5-year overall survival was higher in the neoadjuvant chemoradiotherapy group (20.5%; 95% confidence interval [CI], 14.2%-29.8%) than the upfront surgery group (6.5%; 95% CI, 3.1%-13.7%).

Subgroup analyses found a survival advantage for upfront chemoradiotherapy among patients with borderline resectable tumors (HR, 0.67; P = .045), and a trend toward improved survival among patients with resectable tumors (HR, 0.79; P = .23). There was a trend toward more serious adverse events in the upfront chemoradiotherapy group (52% versus 41%; P = .096). There was no difference in major surgical complications or postoperative mortality.

The study found high progression rates within the first year in both the neoadjuvant chemoradiotherapy group and the upfront surgery group. “Apparently, our neoadjuvant schedule was not able to prevent many of these early progressions, and more effective schedules are warranted,” the authors wrote.

The survival outcomes were lower than those found in adjuvant trials, likely because of differences in patient populations. Adjuvant studies generally recruit patients who have recovered well from resection and have no early signs of recurrence, and therefore have a more favorable prognosis.

The long-term results from PREOPANC are in agreement with four previous studies that compared neoadjuvant chemoradiotherapy to upfront surgery.

A limitation of the study was that gemcitabine monotherapy was used in the adjuvant setting, and this regimen is now considered out of date.

The study was funded by the Dutch Cancer Foundation.

Long-term results from the Dutch PREOPANC randomized, controlled trial confirm that neoadjuvant chemoradiotherapy conveys a survival advantage to patients with resectable and borderline resectable pancreatic cancer.

Neoadjuvant therapy remains controversial in this patient population, which makes up 15% of pancreatic cancer cases. Historically, these patients have been treated with surgery followed by adjuvant chemotherapy, but only about half of patients ever receive adjuvant chemotherapy due to early recurrence, surgical complication, or worsening disease. Neoadjuvant chemoradiotherapy is thought to increase the fraction of patients who receive chemotherapy. Improved exposure to chemotherapy could increase survival, and may also increase the rate of microscopically margin-negative resections.

Neoadjuvant chemoradiotherapy has become increasingly common, but the practice is based on retrospective analysis and small, phase II trials.

“This phase III, randomized trial demonstrates a long-term survival benefit with neoadjuvant treatment compared with upfront surgery in patients with resectable and borderline resectable pancreatic cancer,” the researchers wrote in the study, published online Jan. 27 in the Journal of Clinical Oncology. “The effect of neoadjuvant chemoradiotherapy was consistent across subgroups, including resectable and borderline resectable disease,” they added.

The new data represent long-term follow-up of 246 patients who had been randomized to neoadjuvant chemoradiotherapy or upfront surgery. Short-term data, published in 2020, showed trends toward improved survival but no statistically significant difference at a median of 27 months of follow-up. In the update, after a median follow-up of 59 months, patients in the neoadjuvant chemoradiotherapy group had better overall survival (hazard ratio [HR], 0.73; P = .025) and the 5-year overall survival was higher in the neoadjuvant chemoradiotherapy group (20.5%; 95% confidence interval [CI], 14.2%-29.8%) than the upfront surgery group (6.5%; 95% CI, 3.1%-13.7%).

Subgroup analyses found a survival advantage for upfront chemoradiotherapy among patients with borderline resectable tumors (HR, 0.67; P = .045), and a trend toward improved survival among patients with resectable tumors (HR, 0.79; P = .23). There was a trend toward more serious adverse events in the upfront chemoradiotherapy group (52% versus 41%; P = .096). There was no difference in major surgical complications or postoperative mortality.

The study found high progression rates within the first year in both the neoadjuvant chemoradiotherapy group and the upfront surgery group. “Apparently, our neoadjuvant schedule was not able to prevent many of these early progressions, and more effective schedules are warranted,” the authors wrote.

The survival outcomes were lower than those found in adjuvant trials, likely because of differences in patient populations. Adjuvant studies generally recruit patients who have recovered well from resection and have no early signs of recurrence, and therefore have a more favorable prognosis.

The long-term results from PREOPANC are in agreement with four previous studies that compared neoadjuvant chemoradiotherapy to upfront surgery.

A limitation of the study was that gemcitabine monotherapy was used in the adjuvant setting, and this regimen is now considered out of date.

The study was funded by the Dutch Cancer Foundation.

Long-term results from the Dutch PREOPANC randomized, controlled trial confirm that neoadjuvant chemoradiotherapy conveys a survival advantage to patients with resectable and borderline resectable pancreatic cancer.

Neoadjuvant therapy remains controversial in this patient population, which makes up 15% of pancreatic cancer cases. Historically, these patients have been treated with surgery followed by adjuvant chemotherapy, but only about half of patients ever receive adjuvant chemotherapy due to early recurrence, surgical complication, or worsening disease. Neoadjuvant chemoradiotherapy is thought to increase the fraction of patients who receive chemotherapy. Improved exposure to chemotherapy could increase survival, and may also increase the rate of microscopically margin-negative resections.

Neoadjuvant chemoradiotherapy has become increasingly common, but the practice is based on retrospective analysis and small, phase II trials.

“This phase III, randomized trial demonstrates a long-term survival benefit with neoadjuvant treatment compared with upfront surgery in patients with resectable and borderline resectable pancreatic cancer,” the researchers wrote in the study, published online Jan. 27 in the Journal of Clinical Oncology. “The effect of neoadjuvant chemoradiotherapy was consistent across subgroups, including resectable and borderline resectable disease,” they added.

The new data represent long-term follow-up of 246 patients who had been randomized to neoadjuvant chemoradiotherapy or upfront surgery. Short-term data, published in 2020, showed trends toward improved survival but no statistically significant difference at a median of 27 months of follow-up. In the update, after a median follow-up of 59 months, patients in the neoadjuvant chemoradiotherapy group had better overall survival (hazard ratio [HR], 0.73; P = .025) and the 5-year overall survival was higher in the neoadjuvant chemoradiotherapy group (20.5%; 95% confidence interval [CI], 14.2%-29.8%) than the upfront surgery group (6.5%; 95% CI, 3.1%-13.7%).

Subgroup analyses found a survival advantage for upfront chemoradiotherapy among patients with borderline resectable tumors (HR, 0.67; P = .045), and a trend toward improved survival among patients with resectable tumors (HR, 0.79; P = .23). There was a trend toward more serious adverse events in the upfront chemoradiotherapy group (52% versus 41%; P = .096). There was no difference in major surgical complications or postoperative mortality.

The study found high progression rates within the first year in both the neoadjuvant chemoradiotherapy group and the upfront surgery group. “Apparently, our neoadjuvant schedule was not able to prevent many of these early progressions, and more effective schedules are warranted,” the authors wrote.

The survival outcomes were lower than those found in adjuvant trials, likely because of differences in patient populations. Adjuvant studies generally recruit patients who have recovered well from resection and have no early signs of recurrence, and therefore have a more favorable prognosis.

The long-term results from PREOPANC are in agreement with four previous studies that compared neoadjuvant chemoradiotherapy to upfront surgery.

A limitation of the study was that gemcitabine monotherapy was used in the adjuvant setting, and this regimen is now considered out of date.

The study was funded by the Dutch Cancer Foundation.

An interim analysis of the DAYBREAK open-label extension trial found that the sphingosine-1-phosphate receptor agonist ozanimod achieved sustained control of disease activity in people with relapsing multiple sclerosis (RMS) even during the pandemic. The study began in 2020 and also captured data on COVID-19 infections, and found that most were mild and resembled the profile of COVID-19 infections in the broader MS population.

Ozanimod is approved for the treatment of relapsing MS (RMS) and moderately to severe ulcerative colitis.

The DAYBREAK trial revealed a safety profile that broadly matched what was seen in the pivotal studies, with the exception that one case of progressive multifocal leukoencephalopathy (PML) emerged in the study population.

“So now we do know that ozanimod can cause PML, just as fingolimod can cause PML. I think some of us were hoping that perhaps the extent of immune suppression was going to be somewhat different in ozanimod and that PML might not occur. It’s a rare complication, but one that we now know can occur with this drug,” Bruce Cree, MD, PhD, said in an interview.

Ozanimod is a more selective drug than fingolimod. It affects only cell surface expression of the S1P1 and S1P5 receptors, and not other known S1P receptors. Ozanimod does not require first-dose observation and cardiac monitoring in most patients, and it can be taken at home.

“The two products have not been compared head-to-head. This is all comparison of data from different studies, and one has to take those considerations in mind as important caveats. But generally speaking, the safety profile and tolerability profile of ozanimod seems to be a little bit better, in my opinion, compared to that of fingolimod,” said Dr. Cree, who presented the results of the study at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). He is professor of neurology at the University of California, San Francisco.
 

Stable efficacy and no worsening of COVID-19 outcomes

Among 2,181 participants in DAYBREAK who were at risk of COVID-19, 8.7% had confirmed or suspected cases of COVID-19 during the study period. All were unvaccinated. Fourteen cases were considered serious, and there were two COVID-19–related deaths, and a third death caused by a pulmonary abscess related to an earlier COVID-19 infection. “When you look at this data and compare it to other datasets, this is not too dissimilar from rates of mortality that we would expect or serious infection that we see in other MS cohorts. So there doesn’t seem to be a striking worsening of COVID outcomes with ozanimod,” said Dr. Cree.

The benefit of the drug appeared to remain stable over multiple years. The annualized relapse rate was low and the relapse rate appeared to decline further over time. “It’s not an absolutely flat line, there is some curvature to it. So that that’s good news as well. And then the objective observation of lesion formation also is attenuated over time. We see a therapeutic effect on new radiographic lesions as well, and very low rates of disability worsening in ozanimod patients,” said Dr. Cree.

Overall, the study included 2,494 patients who entered the open-label extension study of the phase 1-3 trials. The study began in November 2019, and the current data extend through May 10, 2021. A total of 736 patients started out with interferon beta-1a and later switched to 0.92 mg ozanimod, 877 patients started at 0.46 mg ozanimod and switched to 0.92 mg ozanimod, and 881 were on a continuous dose of 0.92 mg ozanimod.

Three-quarters of the patients were relapse free at 36 months, 71% at 48 months. Among those who were on 0.92 mg ozanimod continuously, 64% were relapse-free through 60 months of treatment.

Among the cohort, 7.6% experienced severe treatment-emergent adverse events (TEAEs), 11.9% experienced serious TEAEs, and 3.0% discontinued ozanimod because of TEAEs. Common TEAEs included nasopharyngitis (59.3%), headache (46.1%), upper respiratory tract infection (31.5%), lymphopenia (29.4%), decreased absolute lymphocyte count (ALC, 24.5%), back pain (22.7%), and hypertension (20.7%).

Furthermore, 1.4% of patients developed treatment-emergent malignancies, 0.4% developed macular edema, 2.8% had cardiac TEAEs, and 9.8% had ALC levels below 0.2 x 109/L.
 

Encouraging data

The COVID-19 data were encouraging, according to Patricia Coyle, MD, who was asked to comment on the study. “190 individuals out of 2,181 seems quite reasonable, and they had three deaths. It certainly didn’t look like any excessive numbers of COVID, or excessive numbers of deaths,” said Dr. Coyle, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center.

She noted that other database studies have shown an association between increased risk and anti-CD20 agents, but they haven’t really seen that with the other disease-modifying therapies. “I think this is some long-term data that says that ozanimod appears to be well tolerated without having any surprising late toxicity,” said Dr. Coyle.

The study was funded by Celgene International II. Dr. Cree has consulted for Alexion, Atara, Autobahn, Avotres, Biogen, EMD Serono, Novartis, Sanofi, TG Therapeutics, and Therini, and received grant support from Genentech. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

An interim analysis of the DAYBREAK open-label extension trial found that the sphingosine-1-phosphate receptor agonist ozanimod achieved sustained control of disease activity in people with relapsing multiple sclerosis (RMS) even during the pandemic. The study began in 2020 and also captured data on COVID-19 infections, and found that most were mild and resembled the profile of COVID-19 infections in the broader MS population.

Ozanimod is approved for the treatment of relapsing MS (RMS) and moderately to severe ulcerative colitis.

The DAYBREAK trial revealed a safety profile that broadly matched what was seen in the pivotal studies, with the exception that one case of progressive multifocal leukoencephalopathy (PML) emerged in the study population.

“So now we do know that ozanimod can cause PML, just as fingolimod can cause PML. I think some of us were hoping that perhaps the extent of immune suppression was going to be somewhat different in ozanimod and that PML might not occur. It’s a rare complication, but one that we now know can occur with this drug,” Bruce Cree, MD, PhD, said in an interview.

Ozanimod is a more selective drug than fingolimod. It affects only cell surface expression of the S1P1 and S1P5 receptors, and not other known S1P receptors. Ozanimod does not require first-dose observation and cardiac monitoring in most patients, and it can be taken at home.

“The two products have not been compared head-to-head. This is all comparison of data from different studies, and one has to take those considerations in mind as important caveats. But generally speaking, the safety profile and tolerability profile of ozanimod seems to be a little bit better, in my opinion, compared to that of fingolimod,” said Dr. Cree, who presented the results of the study at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). He is professor of neurology at the University of California, San Francisco.
 

Stable efficacy and no worsening of COVID-19 outcomes

Among 2,181 participants in DAYBREAK who were at risk of COVID-19, 8.7% had confirmed or suspected cases of COVID-19 during the study period. All were unvaccinated. Fourteen cases were considered serious, and there were two COVID-19–related deaths, and a third death caused by a pulmonary abscess related to an earlier COVID-19 infection. “When you look at this data and compare it to other datasets, this is not too dissimilar from rates of mortality that we would expect or serious infection that we see in other MS cohorts. So there doesn’t seem to be a striking worsening of COVID outcomes with ozanimod,” said Dr. Cree.

The benefit of the drug appeared to remain stable over multiple years. The annualized relapse rate was low and the relapse rate appeared to decline further over time. “It’s not an absolutely flat line, there is some curvature to it. So that that’s good news as well. And then the objective observation of lesion formation also is attenuated over time. We see a therapeutic effect on new radiographic lesions as well, and very low rates of disability worsening in ozanimod patients,” said Dr. Cree.

Overall, the study included 2,494 patients who entered the open-label extension study of the phase 1-3 trials. The study began in November 2019, and the current data extend through May 10, 2021. A total of 736 patients started out with interferon beta-1a and later switched to 0.92 mg ozanimod, 877 patients started at 0.46 mg ozanimod and switched to 0.92 mg ozanimod, and 881 were on a continuous dose of 0.92 mg ozanimod.

Three-quarters of the patients were relapse free at 36 months, 71% at 48 months. Among those who were on 0.92 mg ozanimod continuously, 64% were relapse-free through 60 months of treatment.

Among the cohort, 7.6% experienced severe treatment-emergent adverse events (TEAEs), 11.9% experienced serious TEAEs, and 3.0% discontinued ozanimod because of TEAEs. Common TEAEs included nasopharyngitis (59.3%), headache (46.1%), upper respiratory tract infection (31.5%), lymphopenia (29.4%), decreased absolute lymphocyte count (ALC, 24.5%), back pain (22.7%), and hypertension (20.7%).

Furthermore, 1.4% of patients developed treatment-emergent malignancies, 0.4% developed macular edema, 2.8% had cardiac TEAEs, and 9.8% had ALC levels below 0.2 x 109/L.
 

Encouraging data

The COVID-19 data were encouraging, according to Patricia Coyle, MD, who was asked to comment on the study. “190 individuals out of 2,181 seems quite reasonable, and they had three deaths. It certainly didn’t look like any excessive numbers of COVID, or excessive numbers of deaths,” said Dr. Coyle, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center.

She noted that other database studies have shown an association between increased risk and anti-CD20 agents, but they haven’t really seen that with the other disease-modifying therapies. “I think this is some long-term data that says that ozanimod appears to be well tolerated without having any surprising late toxicity,” said Dr. Coyle.

The study was funded by Celgene International II. Dr. Cree has consulted for Alexion, Atara, Autobahn, Avotres, Biogen, EMD Serono, Novartis, Sanofi, TG Therapeutics, and Therini, and received grant support from Genentech. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

An interim analysis of the DAYBREAK open-label extension trial found that the sphingosine-1-phosphate receptor agonist ozanimod achieved sustained control of disease activity in people with relapsing multiple sclerosis (RMS) even during the pandemic. The study began in 2020 and also captured data on COVID-19 infections, and found that most were mild and resembled the profile of COVID-19 infections in the broader MS population.

Ozanimod is approved for the treatment of relapsing MS (RMS) and moderately to severe ulcerative colitis.

The DAYBREAK trial revealed a safety profile that broadly matched what was seen in the pivotal studies, with the exception that one case of progressive multifocal leukoencephalopathy (PML) emerged in the study population.

“So now we do know that ozanimod can cause PML, just as fingolimod can cause PML. I think some of us were hoping that perhaps the extent of immune suppression was going to be somewhat different in ozanimod and that PML might not occur. It’s a rare complication, but one that we now know can occur with this drug,” Bruce Cree, MD, PhD, said in an interview.

Ozanimod is a more selective drug than fingolimod. It affects only cell surface expression of the S1P1 and S1P5 receptors, and not other known S1P receptors. Ozanimod does not require first-dose observation and cardiac monitoring in most patients, and it can be taken at home.

“The two products have not been compared head-to-head. This is all comparison of data from different studies, and one has to take those considerations in mind as important caveats. But generally speaking, the safety profile and tolerability profile of ozanimod seems to be a little bit better, in my opinion, compared to that of fingolimod,” said Dr. Cree, who presented the results of the study at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). He is professor of neurology at the University of California, San Francisco.
 

Stable efficacy and no worsening of COVID-19 outcomes

Among 2,181 participants in DAYBREAK who were at risk of COVID-19, 8.7% had confirmed or suspected cases of COVID-19 during the study period. All were unvaccinated. Fourteen cases were considered serious, and there were two COVID-19–related deaths, and a third death caused by a pulmonary abscess related to an earlier COVID-19 infection. “When you look at this data and compare it to other datasets, this is not too dissimilar from rates of mortality that we would expect or serious infection that we see in other MS cohorts. So there doesn’t seem to be a striking worsening of COVID outcomes with ozanimod,” said Dr. Cree.

The benefit of the drug appeared to remain stable over multiple years. The annualized relapse rate was low and the relapse rate appeared to decline further over time. “It’s not an absolutely flat line, there is some curvature to it. So that that’s good news as well. And then the objective observation of lesion formation also is attenuated over time. We see a therapeutic effect on new radiographic lesions as well, and very low rates of disability worsening in ozanimod patients,” said Dr. Cree.

Overall, the study included 2,494 patients who entered the open-label extension study of the phase 1-3 trials. The study began in November 2019, and the current data extend through May 10, 2021. A total of 736 patients started out with interferon beta-1a and later switched to 0.92 mg ozanimod, 877 patients started at 0.46 mg ozanimod and switched to 0.92 mg ozanimod, and 881 were on a continuous dose of 0.92 mg ozanimod.

Three-quarters of the patients were relapse free at 36 months, 71% at 48 months. Among those who were on 0.92 mg ozanimod continuously, 64% were relapse-free through 60 months of treatment.

Among the cohort, 7.6% experienced severe treatment-emergent adverse events (TEAEs), 11.9% experienced serious TEAEs, and 3.0% discontinued ozanimod because of TEAEs. Common TEAEs included nasopharyngitis (59.3%), headache (46.1%), upper respiratory tract infection (31.5%), lymphopenia (29.4%), decreased absolute lymphocyte count (ALC, 24.5%), back pain (22.7%), and hypertension (20.7%).

Furthermore, 1.4% of patients developed treatment-emergent malignancies, 0.4% developed macular edema, 2.8% had cardiac TEAEs, and 9.8% had ALC levels below 0.2 x 109/L.
 

Encouraging data

The COVID-19 data were encouraging, according to Patricia Coyle, MD, who was asked to comment on the study. “190 individuals out of 2,181 seems quite reasonable, and they had three deaths. It certainly didn’t look like any excessive numbers of COVID, or excessive numbers of deaths,” said Dr. Coyle, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center.

She noted that other database studies have shown an association between increased risk and anti-CD20 agents, but they haven’t really seen that with the other disease-modifying therapies. “I think this is some long-term data that says that ozanimod appears to be well tolerated without having any surprising late toxicity,” said Dr. Coyle.

The study was funded by Celgene International II. Dr. Cree has consulted for Alexion, Atara, Autobahn, Avotres, Biogen, EMD Serono, Novartis, Sanofi, TG Therapeutics, and Therini, and received grant support from Genentech. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

Among individuals with multiple sclerosis (MS), disease modifying therapies (DMTs) are associated with a reduced humoral response to SARS-CoV-2 vaccines, according to a new retrospective analysis. The link is particularly strong among B-cell depleting drugs.

“A lot of patients ask us if having MS by itself affects the vaccine response. We did not find that, but it’s about the disease-modifying therapy that a patient is being treated with,” Tirisham Gyang, MD, said in an interview. Dr. Gyang presented the study at a poster session during the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

“These patients (on DMTs) had decreased neutralizing antibody levels to the vaccine after they received it. We also saw a similar marker in drugs that modulate the sphingosine S-1 receptor. These patients also had a lower titer. It wasn’t statistically significant, but we think it’s positive. It was underpowered because there was a small number of patients in that subgroup,” said Dr. Gyang, assistant professor of neurology at The Ohio State University.

The results can inform vaccine strategies among people with MS, but the issue remains complex. “I don’t know that we could do a blanket statement and say, if you wait this amount of time, everybody will be okay. It’s a very individualized approach, and patients need to discuss timing of vaccines with their providers, because we know that waiting is better. It’s preferable to wait until towards the end of the dosing cycle. The other factor is making sure that the MS is well treated,” said Dr. Gyang.

The researchers prospectively followed 83 MS patients at the The Ohio State University Wexner Medical Center. Among the cohort, 71% were female. Fifty-one subjects had serum samples analyzed following mRNA COVID-19 vaccination, and they were compared with 38 health care worker controls.

After vaccination, people with MS had about 2.4-fold lower levels of half-maximal neutralization titer (NT50) values compared with health care worker controls. This appeared to be driven primarily by DMTs. There was a more than ninefold reduction in the neutralizing antibody (nAb) response among 13 patients on B-cell depleting agents, compared with no therapy or other therapies (P < .001). Among of individuals on these agents, 61.5% had no detectable nAb.

The researchers also found an association between postvaccine NT50 values and when the vaccine was received compared with the last infusion of B-cell depleting agents. Every additional day since the previous infusion was associated with a 3.7% increase in NT50 value (P = .0032).

The average length of exposure to B-cell depleting agents was 24 months and the median was 25 months. There was no association between length of time on a B-cell depleting agent and NT50 values after vaccination (Spearman correlation 0.35, P = .24).

Subanalyses by sex and vaccine type revealed no differences in nAb levels.

The study did not look at T-cell responses after vaccination or the effect of T-cell depleting agents, and T cells likely still provide some protection, according to Dr. Gyang. “Even though the vaccine response may not be as robust as it would have been if they were not on the drug, there is still some degree of protection,” she said.
 

Some answers, more questions

The study is important, even though it was presented at the time that the COVID-19 Omicron variant surge was waning. “COVID still remains a major concern. Even though it seems to be on the wane at the moment, that doesn’t mean it will be on the wane next week,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates (Patchogue, N.Y.), who was asked to comment on the study.

He noted that about 21% of patients in the study who received a vaccination had no detectable antibodies. “That’s a problem. You need to pick a medication that works, but not if the medication puts you at risk for other problems, especially in the world of now, where we know there are viral pandemics that occur. And that calls into question: What if you’re immunocompromised and you get a flu vaccine or a tetanus vaccine? How much do we know about the vaccination response to most of these? No one really considers [vaccine response] when choosing a medication,” said Dr. Gudesblatt.

The results broadly confirm what has been seen in other studies, though its focus on the humoral response is a limitation, according to Patricia Coyle, MD, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center. “For example, there have been independent studies with the (anti-CD-20 therapies) that indicate that they have a normal cell-mediated vaccine response to the COVID vaccine, even though the antibody response may be impaired in a significant number of individuals, though as you continue to vaccinate the antibody response seems to get better,” Dr. Coyle said in an interview.

Dr. Gyang has served as consultant for Genentech, Horizon Therapeutics, Greenwich Biosciences and EMD Serono. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

Among individuals with multiple sclerosis (MS), disease modifying therapies (DMTs) are associated with a reduced humoral response to SARS-CoV-2 vaccines, according to a new retrospective analysis. The link is particularly strong among B-cell depleting drugs.

“A lot of patients ask us if having MS by itself affects the vaccine response. We did not find that, but it’s about the disease-modifying therapy that a patient is being treated with,” Tirisham Gyang, MD, said in an interview. Dr. Gyang presented the study at a poster session during the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

“These patients (on DMTs) had decreased neutralizing antibody levels to the vaccine after they received it. We also saw a similar marker in drugs that modulate the sphingosine S-1 receptor. These patients also had a lower titer. It wasn’t statistically significant, but we think it’s positive. It was underpowered because there was a small number of patients in that subgroup,” said Dr. Gyang, assistant professor of neurology at The Ohio State University.

The results can inform vaccine strategies among people with MS, but the issue remains complex. “I don’t know that we could do a blanket statement and say, if you wait this amount of time, everybody will be okay. It’s a very individualized approach, and patients need to discuss timing of vaccines with their providers, because we know that waiting is better. It’s preferable to wait until towards the end of the dosing cycle. The other factor is making sure that the MS is well treated,” said Dr. Gyang.

The researchers prospectively followed 83 MS patients at the The Ohio State University Wexner Medical Center. Among the cohort, 71% were female. Fifty-one subjects had serum samples analyzed following mRNA COVID-19 vaccination, and they were compared with 38 health care worker controls.

After vaccination, people with MS had about 2.4-fold lower levels of half-maximal neutralization titer (NT50) values compared with health care worker controls. This appeared to be driven primarily by DMTs. There was a more than ninefold reduction in the neutralizing antibody (nAb) response among 13 patients on B-cell depleting agents, compared with no therapy or other therapies (P < .001). Among of individuals on these agents, 61.5% had no detectable nAb.

The researchers also found an association between postvaccine NT50 values and when the vaccine was received compared with the last infusion of B-cell depleting agents. Every additional day since the previous infusion was associated with a 3.7% increase in NT50 value (P = .0032).

The average length of exposure to B-cell depleting agents was 24 months and the median was 25 months. There was no association between length of time on a B-cell depleting agent and NT50 values after vaccination (Spearman correlation 0.35, P = .24).

Subanalyses by sex and vaccine type revealed no differences in nAb levels.

The study did not look at T-cell responses after vaccination or the effect of T-cell depleting agents, and T cells likely still provide some protection, according to Dr. Gyang. “Even though the vaccine response may not be as robust as it would have been if they were not on the drug, there is still some degree of protection,” she said.
 

Some answers, more questions

The study is important, even though it was presented at the time that the COVID-19 Omicron variant surge was waning. “COVID still remains a major concern. Even though it seems to be on the wane at the moment, that doesn’t mean it will be on the wane next week,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates (Patchogue, N.Y.), who was asked to comment on the study.

He noted that about 21% of patients in the study who received a vaccination had no detectable antibodies. “That’s a problem. You need to pick a medication that works, but not if the medication puts you at risk for other problems, especially in the world of now, where we know there are viral pandemics that occur. And that calls into question: What if you’re immunocompromised and you get a flu vaccine or a tetanus vaccine? How much do we know about the vaccination response to most of these? No one really considers [vaccine response] when choosing a medication,” said Dr. Gudesblatt.

The results broadly confirm what has been seen in other studies, though its focus on the humoral response is a limitation, according to Patricia Coyle, MD, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center. “For example, there have been independent studies with the (anti-CD-20 therapies) that indicate that they have a normal cell-mediated vaccine response to the COVID vaccine, even though the antibody response may be impaired in a significant number of individuals, though as you continue to vaccinate the antibody response seems to get better,” Dr. Coyle said in an interview.

Dr. Gyang has served as consultant for Genentech, Horizon Therapeutics, Greenwich Biosciences and EMD Serono. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

Among individuals with multiple sclerosis (MS), disease modifying therapies (DMTs) are associated with a reduced humoral response to SARS-CoV-2 vaccines, according to a new retrospective analysis. The link is particularly strong among B-cell depleting drugs.

“A lot of patients ask us if having MS by itself affects the vaccine response. We did not find that, but it’s about the disease-modifying therapy that a patient is being treated with,” Tirisham Gyang, MD, said in an interview. Dr. Gyang presented the study at a poster session during the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

“These patients (on DMTs) had decreased neutralizing antibody levels to the vaccine after they received it. We also saw a similar marker in drugs that modulate the sphingosine S-1 receptor. These patients also had a lower titer. It wasn’t statistically significant, but we think it’s positive. It was underpowered because there was a small number of patients in that subgroup,” said Dr. Gyang, assistant professor of neurology at The Ohio State University.

The results can inform vaccine strategies among people with MS, but the issue remains complex. “I don’t know that we could do a blanket statement and say, if you wait this amount of time, everybody will be okay. It’s a very individualized approach, and patients need to discuss timing of vaccines with their providers, because we know that waiting is better. It’s preferable to wait until towards the end of the dosing cycle. The other factor is making sure that the MS is well treated,” said Dr. Gyang.

The researchers prospectively followed 83 MS patients at the The Ohio State University Wexner Medical Center. Among the cohort, 71% were female. Fifty-one subjects had serum samples analyzed following mRNA COVID-19 vaccination, and they were compared with 38 health care worker controls.

After vaccination, people with MS had about 2.4-fold lower levels of half-maximal neutralization titer (NT50) values compared with health care worker controls. This appeared to be driven primarily by DMTs. There was a more than ninefold reduction in the neutralizing antibody (nAb) response among 13 patients on B-cell depleting agents, compared with no therapy or other therapies (P < .001). Among of individuals on these agents, 61.5% had no detectable nAb.

The researchers also found an association between postvaccine NT50 values and when the vaccine was received compared with the last infusion of B-cell depleting agents. Every additional day since the previous infusion was associated with a 3.7% increase in NT50 value (P = .0032).

The average length of exposure to B-cell depleting agents was 24 months and the median was 25 months. There was no association between length of time on a B-cell depleting agent and NT50 values after vaccination (Spearman correlation 0.35, P = .24).

Subanalyses by sex and vaccine type revealed no differences in nAb levels.

The study did not look at T-cell responses after vaccination or the effect of T-cell depleting agents, and T cells likely still provide some protection, according to Dr. Gyang. “Even though the vaccine response may not be as robust as it would have been if they were not on the drug, there is still some degree of protection,” she said.
 

Some answers, more questions

The study is important, even though it was presented at the time that the COVID-19 Omicron variant surge was waning. “COVID still remains a major concern. Even though it seems to be on the wane at the moment, that doesn’t mean it will be on the wane next week,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates (Patchogue, N.Y.), who was asked to comment on the study.

He noted that about 21% of patients in the study who received a vaccination had no detectable antibodies. “That’s a problem. You need to pick a medication that works, but not if the medication puts you at risk for other problems, especially in the world of now, where we know there are viral pandemics that occur. And that calls into question: What if you’re immunocompromised and you get a flu vaccine or a tetanus vaccine? How much do we know about the vaccination response to most of these? No one really considers [vaccine response] when choosing a medication,” said Dr. Gudesblatt.

The results broadly confirm what has been seen in other studies, though its focus on the humoral response is a limitation, according to Patricia Coyle, MD, professor of neurology and director of Stony Brook (N.Y.) MS Comprehensive Care Center. “For example, there have been independent studies with the (anti-CD-20 therapies) that indicate that they have a normal cell-mediated vaccine response to the COVID vaccine, even though the antibody response may be impaired in a significant number of individuals, though as you continue to vaccinate the antibody response seems to get better,” Dr. Coyle said in an interview.

Dr. Gyang has served as consultant for Genentech, Horizon Therapeutics, Greenwich Biosciences and EMD Serono. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accordant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alkermes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

Aspirin use failed to reduce recurrence rates among women with breast cancer in a phase 3, randomized, controlled trial that was halted following a planned futility analysis. The aspirin group actually had greater risk of recurrence, though the result did not reach statistical significance. Aspirin has proven effective in reducing recurrence rates in colon cancer.

Despite the disappointment of the results, Wendy Chen, MD, of Dana-Farber Cancer Institute, Boston, emphasized the value of the study. “Negative studies provide important data. You don’t want people doing something that’s not going to be helping them. There have been a lot of negative studies that have still provided important clinical information,” said Dr. Chen, who presented the results of the study at the ASCO Plenary Series.

Even study participants took the news with equanimity. “What has really been gratifying is that the patients, when we did tell them about the results, all of them [said] ‘I’m really glad I participated in the study anyway. I think it was an important question.’ And this is why we do studies. You don’t do studies because every single one of them is going to show a benefit. We do studies knowing that some of them are going to show no benefit,” said Dr. Chen.

The study included 3,021 women under age 70, recruited from 338 sites between 2017 and 2020, who were randomized to 300 mg daily aspirin or placebo. The median follow-up was 24.0 months. Dropout was high, with only 56% of patients still taking aspirin or placebo at the end of the study. The percentage was nearly identical in both arms. That low treatment rate could potentially explain the lack of an apparent effect, but Dr. Chen noted that the incidence of recurrence was actually higher in the aspirin group (hazard ratio, 1.25), though the result was not statistically significant (P = .1258). “The amount that it would need to flip in the second half [of the study] would really be of such a large magnitude to flip it. That biologically would not be plausible,” Dr. Chen said.

Previous epidemiological and even post hoc analyses of other clinical trials had suggested that aspirin might be effective at reducing recurrence in breast cancer, including data from 39,876 participants in the Women’s Health Study suggesting a reduction in risk of metastatic adenocarcinoma, but this isn’t the first time such evidence has led researchers and physicians astray. Dr. Chen pointed to hormone replacement therapy, which was prescribed for the prevention of breast cancer recurrence on the basis of similar evidence, but was shown to be harmful in a randomized, controlled trial.

“It was a very similar situation. Fortunately, the aspirin in this population was not causing harm, but it is possible that there are a lot of people who are just taking aspirin on their own, and they may be over 70, or they may have have other risk factors for adverse events that are different from our population,” Dr. Chen said.

The study was funded by the U.S. Department of Defense and the National Cancer Institute. Bayer provided aspirin and placebo for the study.

Aspirin use failed to reduce recurrence rates among women with breast cancer in a phase 3, randomized, controlled trial that was halted following a planned futility analysis. The aspirin group actually had greater risk of recurrence, though the result did not reach statistical significance. Aspirin has proven effective in reducing recurrence rates in colon cancer.

Despite the disappointment of the results, Wendy Chen, MD, of Dana-Farber Cancer Institute, Boston, emphasized the value of the study. “Negative studies provide important data. You don’t want people doing something that’s not going to be helping them. There have been a lot of negative studies that have still provided important clinical information,” said Dr. Chen, who presented the results of the study at the ASCO Plenary Series.

Even study participants took the news with equanimity. “What has really been gratifying is that the patients, when we did tell them about the results, all of them [said] ‘I’m really glad I participated in the study anyway. I think it was an important question.’ And this is why we do studies. You don’t do studies because every single one of them is going to show a benefit. We do studies knowing that some of them are going to show no benefit,” said Dr. Chen.

The study included 3,021 women under age 70, recruited from 338 sites between 2017 and 2020, who were randomized to 300 mg daily aspirin or placebo. The median follow-up was 24.0 months. Dropout was high, with only 56% of patients still taking aspirin or placebo at the end of the study. The percentage was nearly identical in both arms. That low treatment rate could potentially explain the lack of an apparent effect, but Dr. Chen noted that the incidence of recurrence was actually higher in the aspirin group (hazard ratio, 1.25), though the result was not statistically significant (P = .1258). “The amount that it would need to flip in the second half [of the study] would really be of such a large magnitude to flip it. That biologically would not be plausible,” Dr. Chen said.

Previous epidemiological and even post hoc analyses of other clinical trials had suggested that aspirin might be effective at reducing recurrence in breast cancer, including data from 39,876 participants in the Women’s Health Study suggesting a reduction in risk of metastatic adenocarcinoma, but this isn’t the first time such evidence has led researchers and physicians astray. Dr. Chen pointed to hormone replacement therapy, which was prescribed for the prevention of breast cancer recurrence on the basis of similar evidence, but was shown to be harmful in a randomized, controlled trial.

“It was a very similar situation. Fortunately, the aspirin in this population was not causing harm, but it is possible that there are a lot of people who are just taking aspirin on their own, and they may be over 70, or they may have have other risk factors for adverse events that are different from our population,” Dr. Chen said.

The study was funded by the U.S. Department of Defense and the National Cancer Institute. Bayer provided aspirin and placebo for the study.

Aspirin use failed to reduce recurrence rates among women with breast cancer in a phase 3, randomized, controlled trial that was halted following a planned futility analysis. The aspirin group actually had greater risk of recurrence, though the result did not reach statistical significance. Aspirin has proven effective in reducing recurrence rates in colon cancer.

Despite the disappointment of the results, Wendy Chen, MD, of Dana-Farber Cancer Institute, Boston, emphasized the value of the study. “Negative studies provide important data. You don’t want people doing something that’s not going to be helping them. There have been a lot of negative studies that have still provided important clinical information,” said Dr. Chen, who presented the results of the study at the ASCO Plenary Series.

Even study participants took the news with equanimity. “What has really been gratifying is that the patients, when we did tell them about the results, all of them [said] ‘I’m really glad I participated in the study anyway. I think it was an important question.’ And this is why we do studies. You don’t do studies because every single one of them is going to show a benefit. We do studies knowing that some of them are going to show no benefit,” said Dr. Chen.

The study included 3,021 women under age 70, recruited from 338 sites between 2017 and 2020, who were randomized to 300 mg daily aspirin or placebo. The median follow-up was 24.0 months. Dropout was high, with only 56% of patients still taking aspirin or placebo at the end of the study. The percentage was nearly identical in both arms. That low treatment rate could potentially explain the lack of an apparent effect, but Dr. Chen noted that the incidence of recurrence was actually higher in the aspirin group (hazard ratio, 1.25), though the result was not statistically significant (P = .1258). “The amount that it would need to flip in the second half [of the study] would really be of such a large magnitude to flip it. That biologically would not be plausible,” Dr. Chen said.

Previous epidemiological and even post hoc analyses of other clinical trials had suggested that aspirin might be effective at reducing recurrence in breast cancer, including data from 39,876 participants in the Women’s Health Study suggesting a reduction in risk of metastatic adenocarcinoma, but this isn’t the first time such evidence has led researchers and physicians astray. Dr. Chen pointed to hormone replacement therapy, which was prescribed for the prevention of breast cancer recurrence on the basis of similar evidence, but was shown to be harmful in a randomized, controlled trial.

“It was a very similar situation. Fortunately, the aspirin in this population was not causing harm, but it is possible that there are a lot of people who are just taking aspirin on their own, and they may be over 70, or they may have have other risk factors for adverse events that are different from our population,” Dr. Chen said.

The study was funded by the U.S. Department of Defense and the National Cancer Institute. Bayer provided aspirin and placebo for the study.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

The Rome IV criteria assist physicians in diagnosing functional gastrointestinal disorders (FGID) such as irritable bowel syndrome (IBS), but the wide-ranging symptoms included don’t do a good job of distinguishing all disorders. The Rome Foundation has proposed changes to ROME IV, including reduction in the required duration and frequency of symptoms, and a greater focus on whether symptoms are bothersome.

In a review published in Gastroenterology, researchers suggest that these changes can improve the accuracy of IBS diagnoses. The researchers maintain that Rome IV identifies IBS patients with severe symptoms and a high burden of psychological comorbidity.

The review authors analyzed data from two previous studies. One was a cross-sectional survey of 1,375 self-reported IBS patients in the United Kingdom. When the researchers applied Rome IV criteria versus the earlier Rome III criteria, the proportion of patients identified as having IBS dropped from 79% to 59%. Those identified with IBS by Rome IV had more severe symptoms and worse psychological health. When the researchers applied the modified Rome IV criteria for IBS to the cross-sectional survey, they found that 92.5% met the criteria. Compared to those who did not meet the criteria for IBS by the modified standard, those who did were more likely to have anxiety (49.0% versus 37.3%; P = .001), somatization (47.5% vs. 28.4%; P < .001), and gastrointestinal symptom-specific anxiety (33.8% vs. 15.7%; P < .001). There were no differences in the frequency of depression or severe symptoms.

In a second study, the researchers collected prospective data on 577 consecutive UK patients who visited an IBS clinic. Compared to the reference definition of IBS of lower abdominal pain with altered stool form or frequency, the Rome IV criteria had a sensitivity of 82.4% and a specificity of 82.9%. The positive likelihood ratio was 4.82 (95% confidence interval, 3.30-7.28) and the negative likelihood ratio was 0.21 (95% CI, 0.17-0.16). When the researchers applied the modified Rome IV criteria, 90.6% of patients were identified as having IBS. Compared to the reference standard, the sensitivity of modified Rome IV was 99.1%, and the specificity was 42.7%. The positive LR was 1.73 (95% CI, 1.48-2.02) and the negative LR was 0.02 (95% CI, 0.01-0.06).

Although the new data are of use to specialists, primary care physicians are often only vaguely aware of the Rome criteria, according to John Wilkinson, MD, who was asked to comment on the study. “As important as diagnosing IBS may be, it’s just as important to recognize that the patient has a FGID and does not benefit from continued testing, but rather naming the condition, reassuring the patient, and working together for ongoing self-management using primarily traditional interventions with proven track records,” said Dr. Wilkinson, a consultant in family medicine at the Mayo Clinic, Rochester, Minn.

He noted that physicians may be reluctant to make a diagnosis of IBS, in part because of pushback from patients who may feel that an IBS diagnosis is inadequate. “People have heard of it, usually, and often in a kind of a negative context. ‘Isn’t that the thing where they say that it’s all in your head?’ So, both doctors and patients are [not] particularly happy with the diagnosis.”

Nevertheless, making a diagnosis helps patients begin to manage their condition through diet and lifestyle changes. “I think the most important thing is to not continue to do testing, but talk to people about what they have, and then kind of move on (to management),” said Dr. Wilkinson.

Patients often go through periods of good health, with occasional flareups that result in urgent or emergency care. Tests often return normal results. “So, they are told a variety of things: There’s nothing wrong with you or we can’t find an answer. And this goes on and on over the years, and then finally somebody says, ‘Well, we can’t find an answer, so it must be irritable bowel,’ which is completely unsatisfactory,” said Dr. Wilkinson.

He feels that there is often an over-emphasis on testing and that physicians too often regard IBS as a disease of exclusion. “If it meets some general criteria, and you’ve excluded a few things, you don’t need to do other tests. The diagnosis of exclusion is an idea that is commonly held by a lot of physicians in primary care,” he said.

Dr. Wilkinson called for physicians to become more comfortable making a diagnosis of IBS, “and then be comfortable working with patients and explaining that this is a real thing. It isn’t imaginary. There’s a lot we don’t understand about it. There are things you can do to treat it, but it’s not exactly the model that most people think of where I go to the doctor, do a blood test that confirms that that’s what it is, and then you cure it. It’s a lot of work to have the conversation and work with these patients.”

The authors concluded that the modified criteria, with increased sensitivity even with less specificity, were useful. “The high sensitivity seen with the modified criteria means if these are not met at the outset, then a final diagnosis of IBS is highly unlikely, and further investigation should be pursued.” Further research is required to confirm the results.

The authors and Dr. Wilkinson have no relevant financial disclosures.

The Rome IV criteria assist physicians in diagnosing functional gastrointestinal disorders (FGID) such as irritable bowel syndrome (IBS), but the wide-ranging symptoms included don’t do a good job of distinguishing all disorders. The Rome Foundation has proposed changes to ROME IV, including reduction in the required duration and frequency of symptoms, and a greater focus on whether symptoms are bothersome.

In a review published in Gastroenterology, researchers suggest that these changes can improve the accuracy of IBS diagnoses. The researchers maintain that Rome IV identifies IBS patients with severe symptoms and a high burden of psychological comorbidity.

The review authors analyzed data from two previous studies. One was a cross-sectional survey of 1,375 self-reported IBS patients in the United Kingdom. When the researchers applied Rome IV criteria versus the earlier Rome III criteria, the proportion of patients identified as having IBS dropped from 79% to 59%. Those identified with IBS by Rome IV had more severe symptoms and worse psychological health. When the researchers applied the modified Rome IV criteria for IBS to the cross-sectional survey, they found that 92.5% met the criteria. Compared to those who did not meet the criteria for IBS by the modified standard, those who did were more likely to have anxiety (49.0% versus 37.3%; P = .001), somatization (47.5% vs. 28.4%; P < .001), and gastrointestinal symptom-specific anxiety (33.8% vs. 15.7%; P < .001). There were no differences in the frequency of depression or severe symptoms.

In a second study, the researchers collected prospective data on 577 consecutive UK patients who visited an IBS clinic. Compared to the reference definition of IBS of lower abdominal pain with altered stool form or frequency, the Rome IV criteria had a sensitivity of 82.4% and a specificity of 82.9%. The positive likelihood ratio was 4.82 (95% confidence interval, 3.30-7.28) and the negative likelihood ratio was 0.21 (95% CI, 0.17-0.16). When the researchers applied the modified Rome IV criteria, 90.6% of patients were identified as having IBS. Compared to the reference standard, the sensitivity of modified Rome IV was 99.1%, and the specificity was 42.7%. The positive LR was 1.73 (95% CI, 1.48-2.02) and the negative LR was 0.02 (95% CI, 0.01-0.06).

Although the new data are of use to specialists, primary care physicians are often only vaguely aware of the Rome criteria, according to John Wilkinson, MD, who was asked to comment on the study. “As important as diagnosing IBS may be, it’s just as important to recognize that the patient has a FGID and does not benefit from continued testing, but rather naming the condition, reassuring the patient, and working together for ongoing self-management using primarily traditional interventions with proven track records,” said Dr. Wilkinson, a consultant in family medicine at the Mayo Clinic, Rochester, Minn.

He noted that physicians may be reluctant to make a diagnosis of IBS, in part because of pushback from patients who may feel that an IBS diagnosis is inadequate. “People have heard of it, usually, and often in a kind of a negative context. ‘Isn’t that the thing where they say that it’s all in your head?’ So, both doctors and patients are [not] particularly happy with the diagnosis.”

Nevertheless, making a diagnosis helps patients begin to manage their condition through diet and lifestyle changes. “I think the most important thing is to not continue to do testing, but talk to people about what they have, and then kind of move on (to management),” said Dr. Wilkinson.

Patients often go through periods of good health, with occasional flareups that result in urgent or emergency care. Tests often return normal results. “So, they are told a variety of things: There’s nothing wrong with you or we can’t find an answer. And this goes on and on over the years, and then finally somebody says, ‘Well, we can’t find an answer, so it must be irritable bowel,’ which is completely unsatisfactory,” said Dr. Wilkinson.

He feels that there is often an over-emphasis on testing and that physicians too often regard IBS as a disease of exclusion. “If it meets some general criteria, and you’ve excluded a few things, you don’t need to do other tests. The diagnosis of exclusion is an idea that is commonly held by a lot of physicians in primary care,” he said.

Dr. Wilkinson called for physicians to become more comfortable making a diagnosis of IBS, “and then be comfortable working with patients and explaining that this is a real thing. It isn’t imaginary. There’s a lot we don’t understand about it. There are things you can do to treat it, but it’s not exactly the model that most people think of where I go to the doctor, do a blood test that confirms that that’s what it is, and then you cure it. It’s a lot of work to have the conversation and work with these patients.”

The authors concluded that the modified criteria, with increased sensitivity even with less specificity, were useful. “The high sensitivity seen with the modified criteria means if these are not met at the outset, then a final diagnosis of IBS is highly unlikely, and further investigation should be pursued.” Further research is required to confirm the results.

The authors and Dr. Wilkinson have no relevant financial disclosures.

The Rome IV criteria assist physicians in diagnosing functional gastrointestinal disorders (FGID) such as irritable bowel syndrome (IBS), but the wide-ranging symptoms included don’t do a good job of distinguishing all disorders. The Rome Foundation has proposed changes to ROME IV, including reduction in the required duration and frequency of symptoms, and a greater focus on whether symptoms are bothersome.

In a review published in Gastroenterology, researchers suggest that these changes can improve the accuracy of IBS diagnoses. The researchers maintain that Rome IV identifies IBS patients with severe symptoms and a high burden of psychological comorbidity.

The review authors analyzed data from two previous studies. One was a cross-sectional survey of 1,375 self-reported IBS patients in the United Kingdom. When the researchers applied Rome IV criteria versus the earlier Rome III criteria, the proportion of patients identified as having IBS dropped from 79% to 59%. Those identified with IBS by Rome IV had more severe symptoms and worse psychological health. When the researchers applied the modified Rome IV criteria for IBS to the cross-sectional survey, they found that 92.5% met the criteria. Compared to those who did not meet the criteria for IBS by the modified standard, those who did were more likely to have anxiety (49.0% versus 37.3%; P = .001), somatization (47.5% vs. 28.4%; P < .001), and gastrointestinal symptom-specific anxiety (33.8% vs. 15.7%; P < .001). There were no differences in the frequency of depression or severe symptoms.

In a second study, the researchers collected prospective data on 577 consecutive UK patients who visited an IBS clinic. Compared to the reference definition of IBS of lower abdominal pain with altered stool form or frequency, the Rome IV criteria had a sensitivity of 82.4% and a specificity of 82.9%. The positive likelihood ratio was 4.82 (95% confidence interval, 3.30-7.28) and the negative likelihood ratio was 0.21 (95% CI, 0.17-0.16). When the researchers applied the modified Rome IV criteria, 90.6% of patients were identified as having IBS. Compared to the reference standard, the sensitivity of modified Rome IV was 99.1%, and the specificity was 42.7%. The positive LR was 1.73 (95% CI, 1.48-2.02) and the negative LR was 0.02 (95% CI, 0.01-0.06).

Although the new data are of use to specialists, primary care physicians are often only vaguely aware of the Rome criteria, according to John Wilkinson, MD, who was asked to comment on the study. “As important as diagnosing IBS may be, it’s just as important to recognize that the patient has a FGID and does not benefit from continued testing, but rather naming the condition, reassuring the patient, and working together for ongoing self-management using primarily traditional interventions with proven track records,” said Dr. Wilkinson, a consultant in family medicine at the Mayo Clinic, Rochester, Minn.

He noted that physicians may be reluctant to make a diagnosis of IBS, in part because of pushback from patients who may feel that an IBS diagnosis is inadequate. “People have heard of it, usually, and often in a kind of a negative context. ‘Isn’t that the thing where they say that it’s all in your head?’ So, both doctors and patients are [not] particularly happy with the diagnosis.”

Nevertheless, making a diagnosis helps patients begin to manage their condition through diet and lifestyle changes. “I think the most important thing is to not continue to do testing, but talk to people about what they have, and then kind of move on (to management),” said Dr. Wilkinson.

Patients often go through periods of good health, with occasional flareups that result in urgent or emergency care. Tests often return normal results. “So, they are told a variety of things: There’s nothing wrong with you or we can’t find an answer. And this goes on and on over the years, and then finally somebody says, ‘Well, we can’t find an answer, so it must be irritable bowel,’ which is completely unsatisfactory,” said Dr. Wilkinson.

He feels that there is often an over-emphasis on testing and that physicians too often regard IBS as a disease of exclusion. “If it meets some general criteria, and you’ve excluded a few things, you don’t need to do other tests. The diagnosis of exclusion is an idea that is commonly held by a lot of physicians in primary care,” he said.

Dr. Wilkinson called for physicians to become more comfortable making a diagnosis of IBS, “and then be comfortable working with patients and explaining that this is a real thing. It isn’t imaginary. There’s a lot we don’t understand about it. There are things you can do to treat it, but it’s not exactly the model that most people think of where I go to the doctor, do a blood test that confirms that that’s what it is, and then you cure it. It’s a lot of work to have the conversation and work with these patients.”

The authors concluded that the modified criteria, with increased sensitivity even with less specificity, were useful. “The high sensitivity seen with the modified criteria means if these are not met at the outset, then a final diagnosis of IBS is highly unlikely, and further investigation should be pursued.” Further research is required to confirm the results.

The authors and Dr. Wilkinson have no relevant financial disclosures.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Two new studies suggest the expansion of Medicaid under the Patient Protection and Affordable Care Act in 2010 may be leading to more frequent diagnosis of colorectal cancer (CRC) among Hispanics.

The studies, presented at the 2022 Gastrointestinal Cancers Symposium, suggest that Medicaid expansion may have a diverse impact on various ethnic groups.

“The take-home message for both physicians and policy makers is that health policy has the capacity to shift health care delivery, yet we need to consider the effects of health policy might influence subgroups of patients differently. This is useful information for providers caring for a diverse group of patients. For policy makers, this study emphasizes the importance of evaluating the impact of health policy among different racial and ethnic subgroups to fully understand the impact of [policy] change,” said study lead author James D. Murphy, MD, MS, assistant vice chair of radiation medicine at the University of California San Diego.

Dr. Murphy and associates cautioned that other factors, not just Medicaid expansion, could be responsible for the uptick in colon cancer diagnoses.

“Our observations could potentially be influenced by other risk factors. Medicaid expansion was not a ‘randomized experiment,’ and states which opted to expand Medicaid might have fundamental differences which could impact colorectal cancer incidence,” he said.

His group’s analysis of the Surveillance, Epidemiology, and End Results database included 21 states where Medicaid was expanded and 16 states where expansion did not occur. Between 2010-2013 and 2014-2018, among patients under 65, overall colorectal cancer incidence rates did not differ by Medicaid expansion status. In nonexpansion states, there was a greater increase in CRC rates among Hispanics (5.4 vs. 1.6 increase per 100,000; P = .002) and Asian/Pacific Islanders (4.3 vs. 0.4 per 100,000; P = .02), but there was no difference among Black or non-Hispanic White individuals.
 

Early-onset colorectal cancer diagnoses increase under Medicaid expansion

In another study presented at the meeting, researchers examined early-onset CRC data from the National Cancer Database. Among Hispanics, the rate of change of incidence of newly diagnosed cases among patients age 40-49 in Medicaid expansion states increased from 4.3% per year between 2010 and 2014 and 9.8% between 2014 and 2017. That compares with the general background increase in incidence of about 2%. In nonexpansion states, the rate of change decreased from 6.4% to 1% (P = .03). There were no statistically significant differences in the change of incidence among Blacks or Whites between expansion and nonexpansion states.

The reduced rate of change among Hispanics in nonexpansion states was a surprise, and the researchers haven’t determined the reason, according to Sanjay Goel, MD, an oncologist with Montefiore Medical Center, New York, and lead author on the National Cancer Database study. Dr. Goel speculated that some people may have migrated from nonexpansion states to states that expanded Medicaid in order to gain health care coverage.

The apparent benefit seen in Hispanics, but not Black patients, may be caused by greater susceptibility to early-onset CRC among Hispanics, leading to a stronger effect on that population when Medicaid was expanded, Dr. Goel said.

“At this point, with our available data, we do not have the ability to understand the underlying sources of these disparities, though these are questions which deserve additional research,” Dr. Murphy said.

Regardless of the reason, the message is clear, Dr. Goel said. “The bottom we want to state is that politics aside, providing health care coverage to as many people as possible, ideally to everyone, is the right way of going forward.”

The implications of the findings extend beyond policy. “The general advice I give is that, especially if you treat a Hispanic person, regardless of age, with any symptom or sign that could be suggestive of a malignancy, do not take it lightly. Follow the patient closely. I’m not advocating that you refer everybody with lower abdominal pain or bleeding for a colonoscopy, but do factor it in mind. Call them back in a week or 2, or have them make a follow-up appointment in a month so that they don’t get neglected by the system.”

Dr. Murphy and Dr. Goel have no relevant financial disclosures. The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Two new studies suggest the expansion of Medicaid under the Patient Protection and Affordable Care Act in 2010 may be leading to more frequent diagnosis of colorectal cancer (CRC) among Hispanics.

The studies, presented at the 2022 Gastrointestinal Cancers Symposium, suggest that Medicaid expansion may have a diverse impact on various ethnic groups.

“The take-home message for both physicians and policy makers is that health policy has the capacity to shift health care delivery, yet we need to consider the effects of health policy might influence subgroups of patients differently. This is useful information for providers caring for a diverse group of patients. For policy makers, this study emphasizes the importance of evaluating the impact of health policy among different racial and ethnic subgroups to fully understand the impact of [policy] change,” said study lead author James D. Murphy, MD, MS, assistant vice chair of radiation medicine at the University of California San Diego.

Dr. Murphy and associates cautioned that other factors, not just Medicaid expansion, could be responsible for the uptick in colon cancer diagnoses.

“Our observations could potentially be influenced by other risk factors. Medicaid expansion was not a ‘randomized experiment,’ and states which opted to expand Medicaid might have fundamental differences which could impact colorectal cancer incidence,” he said.

His group’s analysis of the Surveillance, Epidemiology, and End Results database included 21 states where Medicaid was expanded and 16 states where expansion did not occur. Between 2010-2013 and 2014-2018, among patients under 65, overall colorectal cancer incidence rates did not differ by Medicaid expansion status. In nonexpansion states, there was a greater increase in CRC rates among Hispanics (5.4 vs. 1.6 increase per 100,000; P = .002) and Asian/Pacific Islanders (4.3 vs. 0.4 per 100,000; P = .02), but there was no difference among Black or non-Hispanic White individuals.
 

Early-onset colorectal cancer diagnoses increase under Medicaid expansion

In another study presented at the meeting, researchers examined early-onset CRC data from the National Cancer Database. Among Hispanics, the rate of change of incidence of newly diagnosed cases among patients age 40-49 in Medicaid expansion states increased from 4.3% per year between 2010 and 2014 and 9.8% between 2014 and 2017. That compares with the general background increase in incidence of about 2%. In nonexpansion states, the rate of change decreased from 6.4% to 1% (P = .03). There were no statistically significant differences in the change of incidence among Blacks or Whites between expansion and nonexpansion states.

The reduced rate of change among Hispanics in nonexpansion states was a surprise, and the researchers haven’t determined the reason, according to Sanjay Goel, MD, an oncologist with Montefiore Medical Center, New York, and lead author on the National Cancer Database study. Dr. Goel speculated that some people may have migrated from nonexpansion states to states that expanded Medicaid in order to gain health care coverage.

The apparent benefit seen in Hispanics, but not Black patients, may be caused by greater susceptibility to early-onset CRC among Hispanics, leading to a stronger effect on that population when Medicaid was expanded, Dr. Goel said.

“At this point, with our available data, we do not have the ability to understand the underlying sources of these disparities, though these are questions which deserve additional research,” Dr. Murphy said.

Regardless of the reason, the message is clear, Dr. Goel said. “The bottom we want to state is that politics aside, providing health care coverage to as many people as possible, ideally to everyone, is the right way of going forward.”

The implications of the findings extend beyond policy. “The general advice I give is that, especially if you treat a Hispanic person, regardless of age, with any symptom or sign that could be suggestive of a malignancy, do not take it lightly. Follow the patient closely. I’m not advocating that you refer everybody with lower abdominal pain or bleeding for a colonoscopy, but do factor it in mind. Call them back in a week or 2, or have them make a follow-up appointment in a month so that they don’t get neglected by the system.”

Dr. Murphy and Dr. Goel have no relevant financial disclosures. The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Two new studies suggest the expansion of Medicaid under the Patient Protection and Affordable Care Act in 2010 may be leading to more frequent diagnosis of colorectal cancer (CRC) among Hispanics.

The studies, presented at the 2022 Gastrointestinal Cancers Symposium, suggest that Medicaid expansion may have a diverse impact on various ethnic groups.

“The take-home message for both physicians and policy makers is that health policy has the capacity to shift health care delivery, yet we need to consider the effects of health policy might influence subgroups of patients differently. This is useful information for providers caring for a diverse group of patients. For policy makers, this study emphasizes the importance of evaluating the impact of health policy among different racial and ethnic subgroups to fully understand the impact of [policy] change,” said study lead author James D. Murphy, MD, MS, assistant vice chair of radiation medicine at the University of California San Diego.

Dr. Murphy and associates cautioned that other factors, not just Medicaid expansion, could be responsible for the uptick in colon cancer diagnoses.

“Our observations could potentially be influenced by other risk factors. Medicaid expansion was not a ‘randomized experiment,’ and states which opted to expand Medicaid might have fundamental differences which could impact colorectal cancer incidence,” he said.

His group’s analysis of the Surveillance, Epidemiology, and End Results database included 21 states where Medicaid was expanded and 16 states where expansion did not occur. Between 2010-2013 and 2014-2018, among patients under 65, overall colorectal cancer incidence rates did not differ by Medicaid expansion status. In nonexpansion states, there was a greater increase in CRC rates among Hispanics (5.4 vs. 1.6 increase per 100,000; P = .002) and Asian/Pacific Islanders (4.3 vs. 0.4 per 100,000; P = .02), but there was no difference among Black or non-Hispanic White individuals.
 

Early-onset colorectal cancer diagnoses increase under Medicaid expansion

In another study presented at the meeting, researchers examined early-onset CRC data from the National Cancer Database. Among Hispanics, the rate of change of incidence of newly diagnosed cases among patients age 40-49 in Medicaid expansion states increased from 4.3% per year between 2010 and 2014 and 9.8% between 2014 and 2017. That compares with the general background increase in incidence of about 2%. In nonexpansion states, the rate of change decreased from 6.4% to 1% (P = .03). There were no statistically significant differences in the change of incidence among Blacks or Whites between expansion and nonexpansion states.

The reduced rate of change among Hispanics in nonexpansion states was a surprise, and the researchers haven’t determined the reason, according to Sanjay Goel, MD, an oncologist with Montefiore Medical Center, New York, and lead author on the National Cancer Database study. Dr. Goel speculated that some people may have migrated from nonexpansion states to states that expanded Medicaid in order to gain health care coverage.

The apparent benefit seen in Hispanics, but not Black patients, may be caused by greater susceptibility to early-onset CRC among Hispanics, leading to a stronger effect on that population when Medicaid was expanded, Dr. Goel said.

“At this point, with our available data, we do not have the ability to understand the underlying sources of these disparities, though these are questions which deserve additional research,” Dr. Murphy said.

Regardless of the reason, the message is clear, Dr. Goel said. “The bottom we want to state is that politics aside, providing health care coverage to as many people as possible, ideally to everyone, is the right way of going forward.”

The implications of the findings extend beyond policy. “The general advice I give is that, especially if you treat a Hispanic person, regardless of age, with any symptom or sign that could be suggestive of a malignancy, do not take it lightly. Follow the patient closely. I’m not advocating that you refer everybody with lower abdominal pain or bleeding for a colonoscopy, but do factor it in mind. Call them back in a week or 2, or have them make a follow-up appointment in a month so that they don’t get neglected by the system.”

Dr. Murphy and Dr. Goel have no relevant financial disclosures. The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.