Gowning up: Is it necessary when examining patients with atopic dermatitis?

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When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

Dr. Jonathan I. Silverberg

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”



Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

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When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

Dr. Jonathan I. Silverberg

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”



Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

Dr. Jonathan I. Silverberg

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”



Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

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Perception of atopic dermatitis severity often differs between patients, physicians

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It’s no secret that atopic dermatitis (AD) is associated with a high burden of disease, with an impact on sleep disturbance, increased anxiety, depression, reduced function and productivity at work and school, and overall decreased quality of life.

But to complicate matters, how patients rate the severity of their AD often differs from that of treating clinicians, according to Zelma Chiesa Fuxench, MD, a dermatologist at the University of Pennsylvania, Philadelphia. For example, a cross-sectional study of 678 patients with AD, which assessed disease severity based on self-reports and physician-reported disease severity using components of the Eczema Area and Severity Index score, found that the level of agreement matched in about 68% of the cases. However, in about 32% of cases, there was a mismatch between how patients and physicians rated disease severity. In about 11% of the cases, patients reported a higher degree of disease severity, compared with physicians, while in about 20% of cases, patients reported lower disease severity, compared with the physician assessment.

“This has potential implications for overestimating or underestimating disease burden and could impact our treatment of AD patients,” Dr. Chiesa Fuxench said at the Revolutionizing Atopic Dermatitis symposium.

The study also found that, while the pattern of agreement was not affected by the extent of AD in terms of the body surface area, the use of immunomodulatory drugs, or the Eczema Area and Severity Index (EASI) score, increased sleep disturbance did have an influence. Also, quality of life was lower and a higher impact on work productivity was observed when patients rated their disease severity higher than the rating of physicians.
 

Measures to assess disease severity

“If we understand that there is mismatch between how a patient experiences their disease and how physicians rate it, what can we do to be better at assessing disease severity in AD to truly capture the full disease burden in patients with AD?” Dr. Chiesa Fuxench asked. She noted that different validated measures have been described in the literature, and objective assessment tools often used in clinical trials include the EASI and the SCORing Atopic Dermatitis (SCORAD). “These are measures that are done by the physician that take into account the extent of the body surface area involvement and also the intensity of the lesions such as how red or thick they are,” she said. “In addition, the SCORAD will also take into account the patient-reported intensity level of itch and sleep loss.”

The Patient-Oriented SCORAD (PO-SCORAD) is similar to the SCORAD except that it is completed by the patient or the patient’s caregiver. In all three outcome measures, a higher score indicates a higher level of disease severity. Other measures that have been frequently described in the literature include the Patient-Oriented Eczema Measure (POEM), which takes into account seven symptoms scored over the last week (itch, sleep, weeping/oozing, cracking, flaking, and dryness/roughness), with higher scores indicating increased disease severity, and the Dermatology Life Quality Index (DLQI), which is a generic measure to assess the burden of skin diseases including AD. The DLQI “asks 10 questions as they relate to the impact of health-related quality of life over the last week, with higher scores indicating more severe disease,” Dr. Chiesa Fuxench said.

There are also symptom-specific scales such as the Pruritus Numerical Rating Scale (Pruritus-NRS) that measures the impact of itch on a scale of 0 to 10, and the Three-Item Severity Scale (TIS) and the Validated Investigator Global Assessment (v-IGA) that are used to assess different measures in terms of intensity of the lesions.”

However, the study that looked at the discordance between AD severity reported by physicians and patients also found that awareness and use of clinical and patient-reported measures for assessing AD disease severity among physicians was low. The authors further divided their findings among primary care physicians, dermatologists, and allergists/immunologists. “While dermatologists and allergists/immunologists reported being more aware of these outcome measures, a high proportion of physicians within this group were not using these outcomes measures in daily clinical practice,” Dr. Chiesa Fuxench said.

“Is there a need for us to use more than one outcome measure instrument when trying to assess the impact of AD, understanding that many of us practice in a very busy clinical setting? The answer is probably yes. The use of multiple assessment tools that measure different domains could potentially help better capture the broad manifestations of AD, because of the complex nature of disease burden in this population. In addition, there are studies showing poor correlation between patient-reported and physician-assessed disease severity for various instruments, emphasizing the point that these measures may be capturing very different things.”



With so many measures to choose from and limited time in the office, which ones should clinicians use? Harmonizing Outcome Measures for Eczema (HOME), based at the Center of Evidence-based Dermatology, at the University of Nottingham (England), is a consortium of patients and other key stakeholders in AD aiming to develop a consensus-based core outcome set for clinical trials and clinical practice. At a consensus meeting in 2018, the consortium reported that the PO-SCORAD and the POEM could be used in the clinical setting to better capture the true level of disease severity and burden in patients with AD.

The PO-SCORAD is also available as an App. A PO-SCORAD of less than 25 is associated with mild disease; a PO-SCORAD between 25 and 50 is associated with moderate disease, and a PO-SCORAD of greater than 50 is associated with severe disease.

“It’s recommended that patients capture the PO-SCORAD once or twice a week,” Dr. Chiesa Fuxench said, noting that the newer version of the App includes photos of different skin types to make it more relevant for a larger number of patients.

Another advantage of using the App is that a patient can track their disease severity through time. They can upload photographs, or they can send you a graphical input of their disease severity either through e-mail or print it out and bring it to their office visit to share the results with you.”

A prospective observational European study of 471 adult and pediatric patients with AD found a statistically significant correlation between SCORAD and PO-SCORAD results at day 0 and day 28. A separate large study conducted in 12 countries found that PO-SCORAD was the only self-assessment score to be highly correlated with the SCORAD index and POEM (A Spearman’s correlation coefficient of greater than or equal to 0.70). In that study, PO-SCORAD also correlated most closely with the results of the DLQI (r = 0.67) and the Dermatitis Family Questionnaire Impact DFQI (r = 0.56).

A more recent study of almost 300 adults with AD that examined the correlations between PO-SCORAD, POEM, and DLQI yielded similar findings.

Other researchers are aiming to assess the full burden of AD at the patient level. Drawing from a cross-sectional study called AWARE (Adults With Atopic Dermatitis Reporting on their Experience), an international observational study, investigators sought to identify what terms AD patients were using to describe their disease. The most commonly used terms were itch (37%), embarrassed (37%), annoyed (35%), pain (25%), and frustration (22%). “Although our study did not identify all patient-reported consequences of AD, such as the known impact of AD on sexual health, our qualitative approach has provided an understanding of patient perceptions and the underlying range of physical and emotional consequences of AD, which can inform shared decision-making,” the authors wrote. “These findings suggest the need for broader assessment of the impact of AD on patients’ lives,” they added.

Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.

The study on AD severity reported by physicians and patients was funded by Sanofi and Regeneron Pharmaceuticals, and several authors were employees of those companies.

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It’s no secret that atopic dermatitis (AD) is associated with a high burden of disease, with an impact on sleep disturbance, increased anxiety, depression, reduced function and productivity at work and school, and overall decreased quality of life.

But to complicate matters, how patients rate the severity of their AD often differs from that of treating clinicians, according to Zelma Chiesa Fuxench, MD, a dermatologist at the University of Pennsylvania, Philadelphia. For example, a cross-sectional study of 678 patients with AD, which assessed disease severity based on self-reports and physician-reported disease severity using components of the Eczema Area and Severity Index score, found that the level of agreement matched in about 68% of the cases. However, in about 32% of cases, there was a mismatch between how patients and physicians rated disease severity. In about 11% of the cases, patients reported a higher degree of disease severity, compared with physicians, while in about 20% of cases, patients reported lower disease severity, compared with the physician assessment.

“This has potential implications for overestimating or underestimating disease burden and could impact our treatment of AD patients,” Dr. Chiesa Fuxench said at the Revolutionizing Atopic Dermatitis symposium.

The study also found that, while the pattern of agreement was not affected by the extent of AD in terms of the body surface area, the use of immunomodulatory drugs, or the Eczema Area and Severity Index (EASI) score, increased sleep disturbance did have an influence. Also, quality of life was lower and a higher impact on work productivity was observed when patients rated their disease severity higher than the rating of physicians.
 

Measures to assess disease severity

“If we understand that there is mismatch between how a patient experiences their disease and how physicians rate it, what can we do to be better at assessing disease severity in AD to truly capture the full disease burden in patients with AD?” Dr. Chiesa Fuxench asked. She noted that different validated measures have been described in the literature, and objective assessment tools often used in clinical trials include the EASI and the SCORing Atopic Dermatitis (SCORAD). “These are measures that are done by the physician that take into account the extent of the body surface area involvement and also the intensity of the lesions such as how red or thick they are,” she said. “In addition, the SCORAD will also take into account the patient-reported intensity level of itch and sleep loss.”

The Patient-Oriented SCORAD (PO-SCORAD) is similar to the SCORAD except that it is completed by the patient or the patient’s caregiver. In all three outcome measures, a higher score indicates a higher level of disease severity. Other measures that have been frequently described in the literature include the Patient-Oriented Eczema Measure (POEM), which takes into account seven symptoms scored over the last week (itch, sleep, weeping/oozing, cracking, flaking, and dryness/roughness), with higher scores indicating increased disease severity, and the Dermatology Life Quality Index (DLQI), which is a generic measure to assess the burden of skin diseases including AD. The DLQI “asks 10 questions as they relate to the impact of health-related quality of life over the last week, with higher scores indicating more severe disease,” Dr. Chiesa Fuxench said.

There are also symptom-specific scales such as the Pruritus Numerical Rating Scale (Pruritus-NRS) that measures the impact of itch on a scale of 0 to 10, and the Three-Item Severity Scale (TIS) and the Validated Investigator Global Assessment (v-IGA) that are used to assess different measures in terms of intensity of the lesions.”

However, the study that looked at the discordance between AD severity reported by physicians and patients also found that awareness and use of clinical and patient-reported measures for assessing AD disease severity among physicians was low. The authors further divided their findings among primary care physicians, dermatologists, and allergists/immunologists. “While dermatologists and allergists/immunologists reported being more aware of these outcome measures, a high proportion of physicians within this group were not using these outcomes measures in daily clinical practice,” Dr. Chiesa Fuxench said.

“Is there a need for us to use more than one outcome measure instrument when trying to assess the impact of AD, understanding that many of us practice in a very busy clinical setting? The answer is probably yes. The use of multiple assessment tools that measure different domains could potentially help better capture the broad manifestations of AD, because of the complex nature of disease burden in this population. In addition, there are studies showing poor correlation between patient-reported and physician-assessed disease severity for various instruments, emphasizing the point that these measures may be capturing very different things.”



With so many measures to choose from and limited time in the office, which ones should clinicians use? Harmonizing Outcome Measures for Eczema (HOME), based at the Center of Evidence-based Dermatology, at the University of Nottingham (England), is a consortium of patients and other key stakeholders in AD aiming to develop a consensus-based core outcome set for clinical trials and clinical practice. At a consensus meeting in 2018, the consortium reported that the PO-SCORAD and the POEM could be used in the clinical setting to better capture the true level of disease severity and burden in patients with AD.

The PO-SCORAD is also available as an App. A PO-SCORAD of less than 25 is associated with mild disease; a PO-SCORAD between 25 and 50 is associated with moderate disease, and a PO-SCORAD of greater than 50 is associated with severe disease.

“It’s recommended that patients capture the PO-SCORAD once or twice a week,” Dr. Chiesa Fuxench said, noting that the newer version of the App includes photos of different skin types to make it more relevant for a larger number of patients.

Another advantage of using the App is that a patient can track their disease severity through time. They can upload photographs, or they can send you a graphical input of their disease severity either through e-mail or print it out and bring it to their office visit to share the results with you.”

A prospective observational European study of 471 adult and pediatric patients with AD found a statistically significant correlation between SCORAD and PO-SCORAD results at day 0 and day 28. A separate large study conducted in 12 countries found that PO-SCORAD was the only self-assessment score to be highly correlated with the SCORAD index and POEM (A Spearman’s correlation coefficient of greater than or equal to 0.70). In that study, PO-SCORAD also correlated most closely with the results of the DLQI (r = 0.67) and the Dermatitis Family Questionnaire Impact DFQI (r = 0.56).

A more recent study of almost 300 adults with AD that examined the correlations between PO-SCORAD, POEM, and DLQI yielded similar findings.

Other researchers are aiming to assess the full burden of AD at the patient level. Drawing from a cross-sectional study called AWARE (Adults With Atopic Dermatitis Reporting on their Experience), an international observational study, investigators sought to identify what terms AD patients were using to describe their disease. The most commonly used terms were itch (37%), embarrassed (37%), annoyed (35%), pain (25%), and frustration (22%). “Although our study did not identify all patient-reported consequences of AD, such as the known impact of AD on sexual health, our qualitative approach has provided an understanding of patient perceptions and the underlying range of physical and emotional consequences of AD, which can inform shared decision-making,” the authors wrote. “These findings suggest the need for broader assessment of the impact of AD on patients’ lives,” they added.

Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.

The study on AD severity reported by physicians and patients was funded by Sanofi and Regeneron Pharmaceuticals, and several authors were employees of those companies.

It’s no secret that atopic dermatitis (AD) is associated with a high burden of disease, with an impact on sleep disturbance, increased anxiety, depression, reduced function and productivity at work and school, and overall decreased quality of life.

But to complicate matters, how patients rate the severity of their AD often differs from that of treating clinicians, according to Zelma Chiesa Fuxench, MD, a dermatologist at the University of Pennsylvania, Philadelphia. For example, a cross-sectional study of 678 patients with AD, which assessed disease severity based on self-reports and physician-reported disease severity using components of the Eczema Area and Severity Index score, found that the level of agreement matched in about 68% of the cases. However, in about 32% of cases, there was a mismatch between how patients and physicians rated disease severity. In about 11% of the cases, patients reported a higher degree of disease severity, compared with physicians, while in about 20% of cases, patients reported lower disease severity, compared with the physician assessment.

“This has potential implications for overestimating or underestimating disease burden and could impact our treatment of AD patients,” Dr. Chiesa Fuxench said at the Revolutionizing Atopic Dermatitis symposium.

The study also found that, while the pattern of agreement was not affected by the extent of AD in terms of the body surface area, the use of immunomodulatory drugs, or the Eczema Area and Severity Index (EASI) score, increased sleep disturbance did have an influence. Also, quality of life was lower and a higher impact on work productivity was observed when patients rated their disease severity higher than the rating of physicians.
 

Measures to assess disease severity

“If we understand that there is mismatch between how a patient experiences their disease and how physicians rate it, what can we do to be better at assessing disease severity in AD to truly capture the full disease burden in patients with AD?” Dr. Chiesa Fuxench asked. She noted that different validated measures have been described in the literature, and objective assessment tools often used in clinical trials include the EASI and the SCORing Atopic Dermatitis (SCORAD). “These are measures that are done by the physician that take into account the extent of the body surface area involvement and also the intensity of the lesions such as how red or thick they are,” she said. “In addition, the SCORAD will also take into account the patient-reported intensity level of itch and sleep loss.”

The Patient-Oriented SCORAD (PO-SCORAD) is similar to the SCORAD except that it is completed by the patient or the patient’s caregiver. In all three outcome measures, a higher score indicates a higher level of disease severity. Other measures that have been frequently described in the literature include the Patient-Oriented Eczema Measure (POEM), which takes into account seven symptoms scored over the last week (itch, sleep, weeping/oozing, cracking, flaking, and dryness/roughness), with higher scores indicating increased disease severity, and the Dermatology Life Quality Index (DLQI), which is a generic measure to assess the burden of skin diseases including AD. The DLQI “asks 10 questions as they relate to the impact of health-related quality of life over the last week, with higher scores indicating more severe disease,” Dr. Chiesa Fuxench said.

There are also symptom-specific scales such as the Pruritus Numerical Rating Scale (Pruritus-NRS) that measures the impact of itch on a scale of 0 to 10, and the Three-Item Severity Scale (TIS) and the Validated Investigator Global Assessment (v-IGA) that are used to assess different measures in terms of intensity of the lesions.”

However, the study that looked at the discordance between AD severity reported by physicians and patients also found that awareness and use of clinical and patient-reported measures for assessing AD disease severity among physicians was low. The authors further divided their findings among primary care physicians, dermatologists, and allergists/immunologists. “While dermatologists and allergists/immunologists reported being more aware of these outcome measures, a high proportion of physicians within this group were not using these outcomes measures in daily clinical practice,” Dr. Chiesa Fuxench said.

“Is there a need for us to use more than one outcome measure instrument when trying to assess the impact of AD, understanding that many of us practice in a very busy clinical setting? The answer is probably yes. The use of multiple assessment tools that measure different domains could potentially help better capture the broad manifestations of AD, because of the complex nature of disease burden in this population. In addition, there are studies showing poor correlation between patient-reported and physician-assessed disease severity for various instruments, emphasizing the point that these measures may be capturing very different things.”



With so many measures to choose from and limited time in the office, which ones should clinicians use? Harmonizing Outcome Measures for Eczema (HOME), based at the Center of Evidence-based Dermatology, at the University of Nottingham (England), is a consortium of patients and other key stakeholders in AD aiming to develop a consensus-based core outcome set for clinical trials and clinical practice. At a consensus meeting in 2018, the consortium reported that the PO-SCORAD and the POEM could be used in the clinical setting to better capture the true level of disease severity and burden in patients with AD.

The PO-SCORAD is also available as an App. A PO-SCORAD of less than 25 is associated with mild disease; a PO-SCORAD between 25 and 50 is associated with moderate disease, and a PO-SCORAD of greater than 50 is associated with severe disease.

“It’s recommended that patients capture the PO-SCORAD once or twice a week,” Dr. Chiesa Fuxench said, noting that the newer version of the App includes photos of different skin types to make it more relevant for a larger number of patients.

Another advantage of using the App is that a patient can track their disease severity through time. They can upload photographs, or they can send you a graphical input of their disease severity either through e-mail or print it out and bring it to their office visit to share the results with you.”

A prospective observational European study of 471 adult and pediatric patients with AD found a statistically significant correlation between SCORAD and PO-SCORAD results at day 0 and day 28. A separate large study conducted in 12 countries found that PO-SCORAD was the only self-assessment score to be highly correlated with the SCORAD index and POEM (A Spearman’s correlation coefficient of greater than or equal to 0.70). In that study, PO-SCORAD also correlated most closely with the results of the DLQI (r = 0.67) and the Dermatitis Family Questionnaire Impact DFQI (r = 0.56).

A more recent study of almost 300 adults with AD that examined the correlations between PO-SCORAD, POEM, and DLQI yielded similar findings.

Other researchers are aiming to assess the full burden of AD at the patient level. Drawing from a cross-sectional study called AWARE (Adults With Atopic Dermatitis Reporting on their Experience), an international observational study, investigators sought to identify what terms AD patients were using to describe their disease. The most commonly used terms were itch (37%), embarrassed (37%), annoyed (35%), pain (25%), and frustration (22%). “Although our study did not identify all patient-reported consequences of AD, such as the known impact of AD on sexual health, our qualitative approach has provided an understanding of patient perceptions and the underlying range of physical and emotional consequences of AD, which can inform shared decision-making,” the authors wrote. “These findings suggest the need for broader assessment of the impact of AD on patients’ lives,” they added.

Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.

The study on AD severity reported by physicians and patients was funded by Sanofi and Regeneron Pharmaceuticals, and several authors were employees of those companies.

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Pruritus in elderly patients: Not a diagnosis

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Once they reach retirement age, increasing numbers of patients come to Eric L. Simpson, MD, complaining of an itchy rash that has appeared seemingly out of the blue.

“They ask: ‘What happened? Why did I get this? Everything was going so well and all of a sudden, I get this itchy rash that keeps me up every night,’ ” Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland, said during the Revolutionizing Atopic Dermatitis symposium. “Is this elderly atopic dermatitis? Is that a real thing?”

But such patients often lack flexural involvement, which is a telltale sign of atopic dermatitis, “so I really struggle with making the diagnosis of new onset AD in the elderly,” he said, adding that existing medical literature on the topic is variable, with the use of terms that include chronic eczematous eruption of the elderly, chronic “eczematiform” eruption in the elderly, chronic eczematous eruption of the aged, eczematous dermatitis not otherwise specified, dermal hypersensitivity reaction, urticarial dermatitis, and eczematous drug eruptions.

“Pruritus of the elderly is not a diagnosis,” Dr. Simpson said. “That’s just a symptom with a million etiologies. Never put that as your assessment. You could put pruritic eruption or pruritus, but try to look for the cause.”

More than 50% of older patients have xerosis, according to a 2013 clinical review on pruritus in the elderly, by Timothy G. Berger, MD, and colleagues at the University of California, San Francisco, which includes advice on the evaluation and management of pruritus in this group of patients based on whether they have a rash or not. For a patient with no rash, Dr. Simpson said, the workup “includes ruling out xerosis, scabies, and effects of medications that could cause rash such as narcotics and Adderall; as well as a generalized pruritus workup including renal and hepatic function, blood count, and thyroid levels.”



In a separate analysis of pruritic elderly patients by the same authors, five rash-related diagnoses accounted for 75% of cases: eczematous dermatitis, lichen simplex/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disorder. “Morphology of pruritus with rash is also important,” Dr. Simpson added. “Is it eczematous? Papular? Prurigo nodularis? This helps lead you in the right direction.”

Some case-control studies have shown that calcium channel blockers could be related to eczema in older patients.

“But there aren’t a lot of studies out there that show that when you stop your calcium channel blocker, your eczema gets better,” Dr. Simpson said. “I’m reluctant to stop medications to try to help their eczema. I haven’t had many good results doing that.”

In an abstract presented during the 2021 annual meeting of the Society of Investigative Dermatology, he and his colleagues prospectively reviewed 89 patients over age 65 who had been referred with new-onset eczema. Of these, 34 underwent drug cessation trials for 1-3 months. “Not one patient improved when they stopped medications,” Dr. Simpson said, but “multiple patients were hospitalized for discontinuing their cardiac and antihypertensive medications.” While this was a biased sample of patients coming to him with chronic eczema, “in my experience, if you have chronic eczema in an older patient, stopping medications is likely not going to help.”

Other diagnostic tips he offered included asking patients what skin products they’re using, considering patch testing, and considering biopsy to rule out cutaneous T-cell lymphoma or bullous pemphigoid. “If you’re not sure there’s a rash, you might need to do a pruritus workup,” he said. If an eczematous rash is present and no other cause is found, try treating it like AD, he added. 

Dr. Simpson reported serving as an investigator for and consultant to numerous pharmaceutical companies.

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Once they reach retirement age, increasing numbers of patients come to Eric L. Simpson, MD, complaining of an itchy rash that has appeared seemingly out of the blue.

“They ask: ‘What happened? Why did I get this? Everything was going so well and all of a sudden, I get this itchy rash that keeps me up every night,’ ” Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland, said during the Revolutionizing Atopic Dermatitis symposium. “Is this elderly atopic dermatitis? Is that a real thing?”

But such patients often lack flexural involvement, which is a telltale sign of atopic dermatitis, “so I really struggle with making the diagnosis of new onset AD in the elderly,” he said, adding that existing medical literature on the topic is variable, with the use of terms that include chronic eczematous eruption of the elderly, chronic “eczematiform” eruption in the elderly, chronic eczematous eruption of the aged, eczematous dermatitis not otherwise specified, dermal hypersensitivity reaction, urticarial dermatitis, and eczematous drug eruptions.

“Pruritus of the elderly is not a diagnosis,” Dr. Simpson said. “That’s just a symptom with a million etiologies. Never put that as your assessment. You could put pruritic eruption or pruritus, but try to look for the cause.”

More than 50% of older patients have xerosis, according to a 2013 clinical review on pruritus in the elderly, by Timothy G. Berger, MD, and colleagues at the University of California, San Francisco, which includes advice on the evaluation and management of pruritus in this group of patients based on whether they have a rash or not. For a patient with no rash, Dr. Simpson said, the workup “includes ruling out xerosis, scabies, and effects of medications that could cause rash such as narcotics and Adderall; as well as a generalized pruritus workup including renal and hepatic function, blood count, and thyroid levels.”



In a separate analysis of pruritic elderly patients by the same authors, five rash-related diagnoses accounted for 75% of cases: eczematous dermatitis, lichen simplex/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disorder. “Morphology of pruritus with rash is also important,” Dr. Simpson added. “Is it eczematous? Papular? Prurigo nodularis? This helps lead you in the right direction.”

Some case-control studies have shown that calcium channel blockers could be related to eczema in older patients.

“But there aren’t a lot of studies out there that show that when you stop your calcium channel blocker, your eczema gets better,” Dr. Simpson said. “I’m reluctant to stop medications to try to help their eczema. I haven’t had many good results doing that.”

In an abstract presented during the 2021 annual meeting of the Society of Investigative Dermatology, he and his colleagues prospectively reviewed 89 patients over age 65 who had been referred with new-onset eczema. Of these, 34 underwent drug cessation trials for 1-3 months. “Not one patient improved when they stopped medications,” Dr. Simpson said, but “multiple patients were hospitalized for discontinuing their cardiac and antihypertensive medications.” While this was a biased sample of patients coming to him with chronic eczema, “in my experience, if you have chronic eczema in an older patient, stopping medications is likely not going to help.”

Other diagnostic tips he offered included asking patients what skin products they’re using, considering patch testing, and considering biopsy to rule out cutaneous T-cell lymphoma or bullous pemphigoid. “If you’re not sure there’s a rash, you might need to do a pruritus workup,” he said. If an eczematous rash is present and no other cause is found, try treating it like AD, he added. 

Dr. Simpson reported serving as an investigator for and consultant to numerous pharmaceutical companies.

Once they reach retirement age, increasing numbers of patients come to Eric L. Simpson, MD, complaining of an itchy rash that has appeared seemingly out of the blue.

“They ask: ‘What happened? Why did I get this? Everything was going so well and all of a sudden, I get this itchy rash that keeps me up every night,’ ” Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland, said during the Revolutionizing Atopic Dermatitis symposium. “Is this elderly atopic dermatitis? Is that a real thing?”

But such patients often lack flexural involvement, which is a telltale sign of atopic dermatitis, “so I really struggle with making the diagnosis of new onset AD in the elderly,” he said, adding that existing medical literature on the topic is variable, with the use of terms that include chronic eczematous eruption of the elderly, chronic “eczematiform” eruption in the elderly, chronic eczematous eruption of the aged, eczematous dermatitis not otherwise specified, dermal hypersensitivity reaction, urticarial dermatitis, and eczematous drug eruptions.

“Pruritus of the elderly is not a diagnosis,” Dr. Simpson said. “That’s just a symptom with a million etiologies. Never put that as your assessment. You could put pruritic eruption or pruritus, but try to look for the cause.”

More than 50% of older patients have xerosis, according to a 2013 clinical review on pruritus in the elderly, by Timothy G. Berger, MD, and colleagues at the University of California, San Francisco, which includes advice on the evaluation and management of pruritus in this group of patients based on whether they have a rash or not. For a patient with no rash, Dr. Simpson said, the workup “includes ruling out xerosis, scabies, and effects of medications that could cause rash such as narcotics and Adderall; as well as a generalized pruritus workup including renal and hepatic function, blood count, and thyroid levels.”



In a separate analysis of pruritic elderly patients by the same authors, five rash-related diagnoses accounted for 75% of cases: eczematous dermatitis, lichen simplex/prurigo nodularis, subacute prurigo, transient acantholytic dermatosis, and neuropathic disorder. “Morphology of pruritus with rash is also important,” Dr. Simpson added. “Is it eczematous? Papular? Prurigo nodularis? This helps lead you in the right direction.”

Some case-control studies have shown that calcium channel blockers could be related to eczema in older patients.

“But there aren’t a lot of studies out there that show that when you stop your calcium channel blocker, your eczema gets better,” Dr. Simpson said. “I’m reluctant to stop medications to try to help their eczema. I haven’t had many good results doing that.”

In an abstract presented during the 2021 annual meeting of the Society of Investigative Dermatology, he and his colleagues prospectively reviewed 89 patients over age 65 who had been referred with new-onset eczema. Of these, 34 underwent drug cessation trials for 1-3 months. “Not one patient improved when they stopped medications,” Dr. Simpson said, but “multiple patients were hospitalized for discontinuing their cardiac and antihypertensive medications.” While this was a biased sample of patients coming to him with chronic eczema, “in my experience, if you have chronic eczema in an older patient, stopping medications is likely not going to help.”

Other diagnostic tips he offered included asking patients what skin products they’re using, considering patch testing, and considering biopsy to rule out cutaneous T-cell lymphoma or bullous pemphigoid. “If you’re not sure there’s a rash, you might need to do a pruritus workup,” he said. If an eczematous rash is present and no other cause is found, try treating it like AD, he added. 

Dr. Simpson reported serving as an investigator for and consultant to numerous pharmaceutical companies.

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FROM REVOLUTIONIZING AD 2021

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Novel treatment shows early promise for gastric cancer

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Chinese researchers reporting at the 2022 Gastrointestinal Cancers Symposium shared new results from a phase 1b/2 study showing that combination treatment with the antibody AK104 shows promise for patients with gastric and gastroesophageal junction cancer.

“AK-104 plus chemo presents a potential new first line treatment option for these patients,” said Jiafu Ji, MD, PhD, of Peking University Cancer Hospital and Institute Gastrointestinal Cancer Center, Beijing.

AK104 is a PD-1/CTLA4 antibody manufactured by Akeso Biopharma, which in 2020 received fast-track designation for the drug’s use as monotherapy for patients with recurrent or chemotherapy-resistant metastatic squamous cervical cancer.

The new trial was a multicenter, open-label study that combined chemotherapy (XELOX – capecitabine combined with oxaliplatin) with AK104 for use as first-line therapy for patients with gastric and gastroesophageal junction cancer.

Two previous studies showed that combination treatment with an anti–PD-1 and anti-CTLA4 AK104 produced a higher response rate and better long-term overall survival than anti–PD-1 therapy alone, but at a cost of greater toxicity.

“The toxicity can be really significant with the combination ... you see some severe immune related events. So with the bispecific antibody, the hope is that we can minimize that additive toxicity by bringing the CTLA4 inhibitor to antigen-experienced PD-1–positive T cells, and hopefully enhance the effect of blocking CTLA4 at the tumor-immune interface, rather than nonspecifically,” said Katherine Bever, MD, who was asked to comment on the study. Dr. Bever is an assistant professor of oncology at Johns Hopkins University, Baltimore, and moderated the panel where the study was presented.

The new results are encouraging, Dr. Bever said. “The data looks promising in terms of the survival that they reported. It compares very favorably to our other first-line studies. But we need randomized data to show exactly what the contribution of the bispecific antibody is to the chemotherapy that it’s being combined with, and how that compares to combination with anti–PD-1 alone, and also to understand more about what they saw in terms of immune toxicities.”

Dr. Bever said the combination of chemotherapy and the PD-1 inhibitor nivolumab is now a first-line treatment for gastric and gastroesophageal junction cancer based on results from the CheckMate 649 study, but relatively few patients appear to benefit from the PD-1 inhibitor compared to chemotherapy alone.

“I think there’s the potential that by incorporating PD-1 and CTLA4 targeting in the first line, we might further improve outcomes for these patients, but you need randomized data to show that,” she said.

Dr. Ji said that there is an ongoing phase 3 study of AK104 in combination with chemotherapy for first-line treatment of gastric or gastroesophageal junction cancer.

The phase 1b/2 clinical trial included 96 patients (median age, 62.7 years; 70.8% male) who were treated with AK-104 every 2-3 weeks, plus XELOX (capecitabine plus oxaliplatin) or modified XELOX.

After a median follow-up of 9.95 months the overall response rate was 65.9% (2.3% complete, 63.6% partial). The disease control rate was 92.0%. The median duration of response was 6.93 months, the median progression-free survival was 7.10 months, and median overall survival was 17.41 months. Treatment-related adverse events included reductions in platelet count (60.4%), white blood cells (58.3%), and neutrophils (56.3%), anemia (47.9%), nausea (30.2%), vomiting (30.2%), and increase in AST (30.2%); 62.5% had at least one grade 3 or higher TRAE.

The study was funded by Akeso Biopharma. Dr. Ji and Dr. Bever have no relevant financial disclosures.

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Chinese researchers reporting at the 2022 Gastrointestinal Cancers Symposium shared new results from a phase 1b/2 study showing that combination treatment with the antibody AK104 shows promise for patients with gastric and gastroesophageal junction cancer.

“AK-104 plus chemo presents a potential new first line treatment option for these patients,” said Jiafu Ji, MD, PhD, of Peking University Cancer Hospital and Institute Gastrointestinal Cancer Center, Beijing.

AK104 is a PD-1/CTLA4 antibody manufactured by Akeso Biopharma, which in 2020 received fast-track designation for the drug’s use as monotherapy for patients with recurrent or chemotherapy-resistant metastatic squamous cervical cancer.

The new trial was a multicenter, open-label study that combined chemotherapy (XELOX – capecitabine combined with oxaliplatin) with AK104 for use as first-line therapy for patients with gastric and gastroesophageal junction cancer.

Two previous studies showed that combination treatment with an anti–PD-1 and anti-CTLA4 AK104 produced a higher response rate and better long-term overall survival than anti–PD-1 therapy alone, but at a cost of greater toxicity.

“The toxicity can be really significant with the combination ... you see some severe immune related events. So with the bispecific antibody, the hope is that we can minimize that additive toxicity by bringing the CTLA4 inhibitor to antigen-experienced PD-1–positive T cells, and hopefully enhance the effect of blocking CTLA4 at the tumor-immune interface, rather than nonspecifically,” said Katherine Bever, MD, who was asked to comment on the study. Dr. Bever is an assistant professor of oncology at Johns Hopkins University, Baltimore, and moderated the panel where the study was presented.

The new results are encouraging, Dr. Bever said. “The data looks promising in terms of the survival that they reported. It compares very favorably to our other first-line studies. But we need randomized data to show exactly what the contribution of the bispecific antibody is to the chemotherapy that it’s being combined with, and how that compares to combination with anti–PD-1 alone, and also to understand more about what they saw in terms of immune toxicities.”

Dr. Bever said the combination of chemotherapy and the PD-1 inhibitor nivolumab is now a first-line treatment for gastric and gastroesophageal junction cancer based on results from the CheckMate 649 study, but relatively few patients appear to benefit from the PD-1 inhibitor compared to chemotherapy alone.

“I think there’s the potential that by incorporating PD-1 and CTLA4 targeting in the first line, we might further improve outcomes for these patients, but you need randomized data to show that,” she said.

Dr. Ji said that there is an ongoing phase 3 study of AK104 in combination with chemotherapy for first-line treatment of gastric or gastroesophageal junction cancer.

The phase 1b/2 clinical trial included 96 patients (median age, 62.7 years; 70.8% male) who were treated with AK-104 every 2-3 weeks, plus XELOX (capecitabine plus oxaliplatin) or modified XELOX.

After a median follow-up of 9.95 months the overall response rate was 65.9% (2.3% complete, 63.6% partial). The disease control rate was 92.0%. The median duration of response was 6.93 months, the median progression-free survival was 7.10 months, and median overall survival was 17.41 months. Treatment-related adverse events included reductions in platelet count (60.4%), white blood cells (58.3%), and neutrophils (56.3%), anemia (47.9%), nausea (30.2%), vomiting (30.2%), and increase in AST (30.2%); 62.5% had at least one grade 3 or higher TRAE.

The study was funded by Akeso Biopharma. Dr. Ji and Dr. Bever have no relevant financial disclosures.

Chinese researchers reporting at the 2022 Gastrointestinal Cancers Symposium shared new results from a phase 1b/2 study showing that combination treatment with the antibody AK104 shows promise for patients with gastric and gastroesophageal junction cancer.

“AK-104 plus chemo presents a potential new first line treatment option for these patients,” said Jiafu Ji, MD, PhD, of Peking University Cancer Hospital and Institute Gastrointestinal Cancer Center, Beijing.

AK104 is a PD-1/CTLA4 antibody manufactured by Akeso Biopharma, which in 2020 received fast-track designation for the drug’s use as monotherapy for patients with recurrent or chemotherapy-resistant metastatic squamous cervical cancer.

The new trial was a multicenter, open-label study that combined chemotherapy (XELOX – capecitabine combined with oxaliplatin) with AK104 for use as first-line therapy for patients with gastric and gastroesophageal junction cancer.

Two previous studies showed that combination treatment with an anti–PD-1 and anti-CTLA4 AK104 produced a higher response rate and better long-term overall survival than anti–PD-1 therapy alone, but at a cost of greater toxicity.

“The toxicity can be really significant with the combination ... you see some severe immune related events. So with the bispecific antibody, the hope is that we can minimize that additive toxicity by bringing the CTLA4 inhibitor to antigen-experienced PD-1–positive T cells, and hopefully enhance the effect of blocking CTLA4 at the tumor-immune interface, rather than nonspecifically,” said Katherine Bever, MD, who was asked to comment on the study. Dr. Bever is an assistant professor of oncology at Johns Hopkins University, Baltimore, and moderated the panel where the study was presented.

The new results are encouraging, Dr. Bever said. “The data looks promising in terms of the survival that they reported. It compares very favorably to our other first-line studies. But we need randomized data to show exactly what the contribution of the bispecific antibody is to the chemotherapy that it’s being combined with, and how that compares to combination with anti–PD-1 alone, and also to understand more about what they saw in terms of immune toxicities.”

Dr. Bever said the combination of chemotherapy and the PD-1 inhibitor nivolumab is now a first-line treatment for gastric and gastroesophageal junction cancer based on results from the CheckMate 649 study, but relatively few patients appear to benefit from the PD-1 inhibitor compared to chemotherapy alone.

“I think there’s the potential that by incorporating PD-1 and CTLA4 targeting in the first line, we might further improve outcomes for these patients, but you need randomized data to show that,” she said.

Dr. Ji said that there is an ongoing phase 3 study of AK104 in combination with chemotherapy for first-line treatment of gastric or gastroesophageal junction cancer.

The phase 1b/2 clinical trial included 96 patients (median age, 62.7 years; 70.8% male) who were treated with AK-104 every 2-3 weeks, plus XELOX (capecitabine plus oxaliplatin) or modified XELOX.

After a median follow-up of 9.95 months the overall response rate was 65.9% (2.3% complete, 63.6% partial). The disease control rate was 92.0%. The median duration of response was 6.93 months, the median progression-free survival was 7.10 months, and median overall survival was 17.41 months. Treatment-related adverse events included reductions in platelet count (60.4%), white blood cells (58.3%), and neutrophils (56.3%), anemia (47.9%), nausea (30.2%), vomiting (30.2%), and increase in AST (30.2%); 62.5% had at least one grade 3 or higher TRAE.

The study was funded by Akeso Biopharma. Dr. Ji and Dr. Bever have no relevant financial disclosures.

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FROM GI CANCERS SYMPOSIUM 2022

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Endoscopic mucosal resection valuable for cancer diagnosis

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Surgeons should perform endoscopic mucosal resection (EMR) for all visible lesions in the presence of neoplasia to make an accurate histopathologic diagnosis of early-stage esophageal cancer, said a physician presenting at the 2022 Gastrointestinal Cancers Symposium.

Vani Konda, MD, a gastroenterologist with Baylor Scott and White Center for Esophageal Diseases, Dallas, participated in an educational session on approaches for treating localized gastroesophageal cancer. In her presentation, she addressed the advantages and disadvantages of EMR and endoscopic submucosal dissection (ESD) for esophageal neoplasia for both diagnosis and treatment.

Esophageal neoplasia therapy includes tissue-acquiring (lesion removal and histopathologic samples) and non–tissue-acquiring therapies (which include radiofrequency ablation, cryotherapy and hybrid-argon plasma coagulation.

The optimal therapy may vary with the esophageal cancer, and the cancer may vary with geography. Worldwide, squamous cell carcinoma is predominant, while in Western countries, esophageal adenocarcinoma is most prevalent. The incidence and mortality of esophageal adenocarcinoma has been rising for several decades, Dr. Konda said.
 

Considering risk factors

Barrett’s esophagus is a known risk factor for esophageal adenocarcinoma. It can be seen endoscopically as salmon-colored lining, and histologically as specialized intestinal metaplasia.

A lesion extending beyond the basement membrane into the lamina propria is an intramucosal carcinoma, or T1a lesion. A lesion extending beyond the muscularis mucosa into the submucosa is a submucosal carcinoma, or T1b tumor, Dr. Konda said.

“The difference between T1a and T1b is important in the selection of treatment approaches due to the risk of [lymph node] metastasis,” she said. She equated a T1a lesion with a 2% or smaller risk of lymph node metastasis, and a T1b tumor with a 20% risk.*

Endoscopic therapy is more reasonable for a T1a lesion, especially since the alternative, esophagectomy, may have a mortality rate of 2% or higher, she said, while for T1b tumors, surgical or systemic treatments are warranted.

A diagnosis of high-grade dysplasia by biopsy is associated with a 40% risk of prevalent cancer, mostly intramucosal carcinoma. On the other hand, submucosal carcinoma is rare in the absence of endoscopically visible lesions. “This risk of prevalent cancer, especially in visible lesions, is the reason that we should address all visible lesions with endoscopic resection, especially in the setting of dysplasia,” Dr. Konda said.

EMR is more accurate than biopsies; diagnoses change up to half the time when EMR is done after a preresection biopsy, and there’s a higher interobserver agreement among pathologists with EMR, she said.

The goal of therapy in Barrett’s esophagus is total Barrett’s eradication to treat not only the known neoplasia, but also the rest of the at-risk epithelium.

Piecemeal EMR for the entire Barrett’s epithelium can bring about a 96% or greater neoplasia eradication rate. But the stricture rate may reach 37%, and bleeding and perforation are also common.

Combining endoscopic mucosal resection for visible lesions with ablation for the rest of the at-risk lining can achieve an eradication rate of 93% with a more favorable complication profile.
 

Weighing the benefits of ESD

In contrast to EMR, ESD has been practiced more frequently in Asia. It provides an en bloc specimen.

A 2014 systematic review of 380 EMR procedures and 333 ESD procedures for Barret’s associated neoplasia indicated that ESD takes longer. The recurrence rate was 0.7% for ESD versus 2.6% for EMR, but this difference fell just short of statistical significance (P = .06). Bleeding and perforation rates were similar, but stricture rates reached 22.3% with wide-field EMR, 3.4% with ESD and 0.7% with focal EMR.

In a 2016 head-to-head trial, researchers assigned 20 patients each to EMR or ESD. They found the procedure longer, but the en bloc resection was higher in ESD. Complete remission of the neoplasia was not statistically different between the two groups, with 15 of 16 patients achieving this goal with ESD and 16 of 17 with EMR. All the patients had complete remission after one retreatment of residual neoplasia. There were two severe adverse events in the ESD group, and none in the EMR group.

Weighing the pros and cons, Dr. Konda concluded that EMR is technically easier and adequate in most cases of Barrett’s esophagus, while ESD may be preferred in select cases with concern for submucosal carcinoma or nonlifting lesions.

She advocated taking patient characteristics, disease characteristics, and available expertise into account.

Dr. Konda reported financial relationships with Ambu, Cernostics, Exact Sciences, Medtronic, and Lucid Sciences. 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.

*Correction, 1/28/22: An earlier version of this article mischaracterized lymph node metastasis.

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Surgeons should perform endoscopic mucosal resection (EMR) for all visible lesions in the presence of neoplasia to make an accurate histopathologic diagnosis of early-stage esophageal cancer, said a physician presenting at the 2022 Gastrointestinal Cancers Symposium.

Vani Konda, MD, a gastroenterologist with Baylor Scott and White Center for Esophageal Diseases, Dallas, participated in an educational session on approaches for treating localized gastroesophageal cancer. In her presentation, she addressed the advantages and disadvantages of EMR and endoscopic submucosal dissection (ESD) for esophageal neoplasia for both diagnosis and treatment.

Esophageal neoplasia therapy includes tissue-acquiring (lesion removal and histopathologic samples) and non–tissue-acquiring therapies (which include radiofrequency ablation, cryotherapy and hybrid-argon plasma coagulation.

The optimal therapy may vary with the esophageal cancer, and the cancer may vary with geography. Worldwide, squamous cell carcinoma is predominant, while in Western countries, esophageal adenocarcinoma is most prevalent. The incidence and mortality of esophageal adenocarcinoma has been rising for several decades, Dr. Konda said.
 

Considering risk factors

Barrett’s esophagus is a known risk factor for esophageal adenocarcinoma. It can be seen endoscopically as salmon-colored lining, and histologically as specialized intestinal metaplasia.

A lesion extending beyond the basement membrane into the lamina propria is an intramucosal carcinoma, or T1a lesion. A lesion extending beyond the muscularis mucosa into the submucosa is a submucosal carcinoma, or T1b tumor, Dr. Konda said.

“The difference between T1a and T1b is important in the selection of treatment approaches due to the risk of [lymph node] metastasis,” she said. She equated a T1a lesion with a 2% or smaller risk of lymph node metastasis, and a T1b tumor with a 20% risk.*

Endoscopic therapy is more reasonable for a T1a lesion, especially since the alternative, esophagectomy, may have a mortality rate of 2% or higher, she said, while for T1b tumors, surgical or systemic treatments are warranted.

A diagnosis of high-grade dysplasia by biopsy is associated with a 40% risk of prevalent cancer, mostly intramucosal carcinoma. On the other hand, submucosal carcinoma is rare in the absence of endoscopically visible lesions. “This risk of prevalent cancer, especially in visible lesions, is the reason that we should address all visible lesions with endoscopic resection, especially in the setting of dysplasia,” Dr. Konda said.

EMR is more accurate than biopsies; diagnoses change up to half the time when EMR is done after a preresection biopsy, and there’s a higher interobserver agreement among pathologists with EMR, she said.

The goal of therapy in Barrett’s esophagus is total Barrett’s eradication to treat not only the known neoplasia, but also the rest of the at-risk epithelium.

Piecemeal EMR for the entire Barrett’s epithelium can bring about a 96% or greater neoplasia eradication rate. But the stricture rate may reach 37%, and bleeding and perforation are also common.

Combining endoscopic mucosal resection for visible lesions with ablation for the rest of the at-risk lining can achieve an eradication rate of 93% with a more favorable complication profile.
 

Weighing the benefits of ESD

In contrast to EMR, ESD has been practiced more frequently in Asia. It provides an en bloc specimen.

A 2014 systematic review of 380 EMR procedures and 333 ESD procedures for Barret’s associated neoplasia indicated that ESD takes longer. The recurrence rate was 0.7% for ESD versus 2.6% for EMR, but this difference fell just short of statistical significance (P = .06). Bleeding and perforation rates were similar, but stricture rates reached 22.3% with wide-field EMR, 3.4% with ESD and 0.7% with focal EMR.

In a 2016 head-to-head trial, researchers assigned 20 patients each to EMR or ESD. They found the procedure longer, but the en bloc resection was higher in ESD. Complete remission of the neoplasia was not statistically different between the two groups, with 15 of 16 patients achieving this goal with ESD and 16 of 17 with EMR. All the patients had complete remission after one retreatment of residual neoplasia. There were two severe adverse events in the ESD group, and none in the EMR group.

Weighing the pros and cons, Dr. Konda concluded that EMR is technically easier and adequate in most cases of Barrett’s esophagus, while ESD may be preferred in select cases with concern for submucosal carcinoma or nonlifting lesions.

She advocated taking patient characteristics, disease characteristics, and available expertise into account.

Dr. Konda reported financial relationships with Ambu, Cernostics, Exact Sciences, Medtronic, and Lucid Sciences. 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.

*Correction, 1/28/22: An earlier version of this article mischaracterized lymph node metastasis.

Surgeons should perform endoscopic mucosal resection (EMR) for all visible lesions in the presence of neoplasia to make an accurate histopathologic diagnosis of early-stage esophageal cancer, said a physician presenting at the 2022 Gastrointestinal Cancers Symposium.

Vani Konda, MD, a gastroenterologist with Baylor Scott and White Center for Esophageal Diseases, Dallas, participated in an educational session on approaches for treating localized gastroesophageal cancer. In her presentation, she addressed the advantages and disadvantages of EMR and endoscopic submucosal dissection (ESD) for esophageal neoplasia for both diagnosis and treatment.

Esophageal neoplasia therapy includes tissue-acquiring (lesion removal and histopathologic samples) and non–tissue-acquiring therapies (which include radiofrequency ablation, cryotherapy and hybrid-argon plasma coagulation.

The optimal therapy may vary with the esophageal cancer, and the cancer may vary with geography. Worldwide, squamous cell carcinoma is predominant, while in Western countries, esophageal adenocarcinoma is most prevalent. The incidence and mortality of esophageal adenocarcinoma has been rising for several decades, Dr. Konda said.
 

Considering risk factors

Barrett’s esophagus is a known risk factor for esophageal adenocarcinoma. It can be seen endoscopically as salmon-colored lining, and histologically as specialized intestinal metaplasia.

A lesion extending beyond the basement membrane into the lamina propria is an intramucosal carcinoma, or T1a lesion. A lesion extending beyond the muscularis mucosa into the submucosa is a submucosal carcinoma, or T1b tumor, Dr. Konda said.

“The difference between T1a and T1b is important in the selection of treatment approaches due to the risk of [lymph node] metastasis,” she said. She equated a T1a lesion with a 2% or smaller risk of lymph node metastasis, and a T1b tumor with a 20% risk.*

Endoscopic therapy is more reasonable for a T1a lesion, especially since the alternative, esophagectomy, may have a mortality rate of 2% or higher, she said, while for T1b tumors, surgical or systemic treatments are warranted.

A diagnosis of high-grade dysplasia by biopsy is associated with a 40% risk of prevalent cancer, mostly intramucosal carcinoma. On the other hand, submucosal carcinoma is rare in the absence of endoscopically visible lesions. “This risk of prevalent cancer, especially in visible lesions, is the reason that we should address all visible lesions with endoscopic resection, especially in the setting of dysplasia,” Dr. Konda said.

EMR is more accurate than biopsies; diagnoses change up to half the time when EMR is done after a preresection biopsy, and there’s a higher interobserver agreement among pathologists with EMR, she said.

The goal of therapy in Barrett’s esophagus is total Barrett’s eradication to treat not only the known neoplasia, but also the rest of the at-risk epithelium.

Piecemeal EMR for the entire Barrett’s epithelium can bring about a 96% or greater neoplasia eradication rate. But the stricture rate may reach 37%, and bleeding and perforation are also common.

Combining endoscopic mucosal resection for visible lesions with ablation for the rest of the at-risk lining can achieve an eradication rate of 93% with a more favorable complication profile.
 

Weighing the benefits of ESD

In contrast to EMR, ESD has been practiced more frequently in Asia. It provides an en bloc specimen.

A 2014 systematic review of 380 EMR procedures and 333 ESD procedures for Barret’s associated neoplasia indicated that ESD takes longer. The recurrence rate was 0.7% for ESD versus 2.6% for EMR, but this difference fell just short of statistical significance (P = .06). Bleeding and perforation rates were similar, but stricture rates reached 22.3% with wide-field EMR, 3.4% with ESD and 0.7% with focal EMR.

In a 2016 head-to-head trial, researchers assigned 20 patients each to EMR or ESD. They found the procedure longer, but the en bloc resection was higher in ESD. Complete remission of the neoplasia was not statistically different between the two groups, with 15 of 16 patients achieving this goal with ESD and 16 of 17 with EMR. All the patients had complete remission after one retreatment of residual neoplasia. There were two severe adverse events in the ESD group, and none in the EMR group.

Weighing the pros and cons, Dr. Konda concluded that EMR is technically easier and adequate in most cases of Barrett’s esophagus, while ESD may be preferred in select cases with concern for submucosal carcinoma or nonlifting lesions.

She advocated taking patient characteristics, disease characteristics, and available expertise into account.

Dr. Konda reported financial relationships with Ambu, Cernostics, Exact Sciences, Medtronic, and Lucid Sciences. 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.

*Correction, 1/28/22: An earlier version of this article mischaracterized lymph node metastasis.

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Decades of research fail to resolve disparities in gastrointestinal cancer care

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Men and White people receive better treatment for gastroesophageal cancer than women, Blacks, and Latinos despite years of studies highlighting disparities in care, researchers say.

The problem is complex because it stems from both biological and socioeconomic factors, but some signs of improvement are beginning to show, said Nathaniel R. Evans III, MD, a professor of surgery at Thomas Jefferson University in Philadelphia.

“Repeatedly, we see that, although we know how patients should be treated, there are oftentimes subsets of patients who don’t receive that same level of care,” said Dr. Evans in a general session talk at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

Black patients with esophageal cancer are 38% more likely to die from the condition than White patients, he said, citing a 2013 study (Ann Surg Oncol. 2013 doi: 10.1245/s10434-012-2807-3). For Latino patients, mortality is 20% higher than for White patients.

The difference can mostly be explained by the rate of esophagectomy, which is 52% lower for Black patients and 29% lower for Latino patients, compared with White patients, the study found.

Besides race and gender, insurance status also influences who gets surgery, Dr. Evans said, citing data from the National Cancer Database. Black patients are less likely to get surgery and more likely to die at all stages and histologies, he said. They wait longer for treatment and are more likely to receive no treatment at all.

Women also suffer from disparities, said Anna Dorothea Wagner, MD, head of the gastrointestinal cancer clinic at Lausanne University Hospital in Lausanne (Switzerland), who spoke at the symposium with Dr Evans.

Seventy-five percent of men with esophageal and gastric adenocarcinoma get curative treatments, compared with only 60% of women, Dr. Wagner said, citing a 2020 study on which she is an author. Women are more likely to get palliative care. As a result, only 30% of women survive the condition for 5 years or more compared to 34% of men, she said. “At the moment we don’t know whether this is due to either patient preferences or cognitive or bias of physicians.”

Disparities in treatment outcomes because of biological differences

For women, some disparities also arise out of clear biological differences, Dr. Wagner said. Sex hormone signaling affects cancer susceptibility, and sex-biased gene expression signatures have been detected in multiple cancer types.

Women with poorly differentiated and signet-cell pathology are less likely to survive their cancer than men with the same histology, she said.

Many studies have shown that chemotherapy is more toxic to women than men without being more efficacious, she added. This suggests that the optimal doses might be different for women and men.

Responding to a question from the audience, Dr. Wagner said more research is needed on transgender patients to understand how these factors affect them.

Dr. Evans attributed the racial and ethnic disparities to some combination of differential histology, stage at diagnosis, access to care, socioeconomics, and inherent bias.

“The problem is not new,” Dr. Evans said. He described studies that found disparities in the 1970s. “But the good news is that things do seem to be getting better.”

Between 2000 and 2011, the number of esophagectomies being performed at high-volume hospitals increased, he said. The overall mortality after esophagectomy has consequently decreased over this time, and the gap in this rate between White and Black people has closed, he said. “Specialization and centralization clearly improve outcomes for certain surgical procedures.”

To address the problem everyone should acknowledge the disparities, particularly in the access to surgery. “I think one of the best tools we have to try to address the disparity is education, both for patients and providers,” Dr. Evans said.

Care teams must become more diverse and culturally competent to combat longstanding distrust and improve communication, he said.

In December, ASCO announced an “action plan” to address equity, diversity and inclusion in cancer care. The organization promised to improve clinical trial eligibility, and train researchers about inherent bias in order to make the trials more representative of the cancer population.

It vowed to increase participation of underrepresented groups in its professional development programs and leadership roles, and educate its members about equity. And, it resolved to provide resources to providers so they could advocate for better quality of care, especially in rural and disadvantaged settings.

Dr. Wagner disclosed relationships with Alligator Bioscience, BMS, Dragonfly Therapeutics, Lilly, Merck KGaA, MSD Oncology, Servier/Pfizer, and Abbvie. Dr. Evans disclosed relationships with Bristol Myers Squibb Foundation and Intuitive Surgical.

This article was updated 1/28/22.

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Men and White people receive better treatment for gastroesophageal cancer than women, Blacks, and Latinos despite years of studies highlighting disparities in care, researchers say.

The problem is complex because it stems from both biological and socioeconomic factors, but some signs of improvement are beginning to show, said Nathaniel R. Evans III, MD, a professor of surgery at Thomas Jefferson University in Philadelphia.

“Repeatedly, we see that, although we know how patients should be treated, there are oftentimes subsets of patients who don’t receive that same level of care,” said Dr. Evans in a general session talk at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

Black patients with esophageal cancer are 38% more likely to die from the condition than White patients, he said, citing a 2013 study (Ann Surg Oncol. 2013 doi: 10.1245/s10434-012-2807-3). For Latino patients, mortality is 20% higher than for White patients.

The difference can mostly be explained by the rate of esophagectomy, which is 52% lower for Black patients and 29% lower for Latino patients, compared with White patients, the study found.

Besides race and gender, insurance status also influences who gets surgery, Dr. Evans said, citing data from the National Cancer Database. Black patients are less likely to get surgery and more likely to die at all stages and histologies, he said. They wait longer for treatment and are more likely to receive no treatment at all.

Women also suffer from disparities, said Anna Dorothea Wagner, MD, head of the gastrointestinal cancer clinic at Lausanne University Hospital in Lausanne (Switzerland), who spoke at the symposium with Dr Evans.

Seventy-five percent of men with esophageal and gastric adenocarcinoma get curative treatments, compared with only 60% of women, Dr. Wagner said, citing a 2020 study on which she is an author. Women are more likely to get palliative care. As a result, only 30% of women survive the condition for 5 years or more compared to 34% of men, she said. “At the moment we don’t know whether this is due to either patient preferences or cognitive or bias of physicians.”

Disparities in treatment outcomes because of biological differences

For women, some disparities also arise out of clear biological differences, Dr. Wagner said. Sex hormone signaling affects cancer susceptibility, and sex-biased gene expression signatures have been detected in multiple cancer types.

Women with poorly differentiated and signet-cell pathology are less likely to survive their cancer than men with the same histology, she said.

Many studies have shown that chemotherapy is more toxic to women than men without being more efficacious, she added. This suggests that the optimal doses might be different for women and men.

Responding to a question from the audience, Dr. Wagner said more research is needed on transgender patients to understand how these factors affect them.

Dr. Evans attributed the racial and ethnic disparities to some combination of differential histology, stage at diagnosis, access to care, socioeconomics, and inherent bias.

“The problem is not new,” Dr. Evans said. He described studies that found disparities in the 1970s. “But the good news is that things do seem to be getting better.”

Between 2000 and 2011, the number of esophagectomies being performed at high-volume hospitals increased, he said. The overall mortality after esophagectomy has consequently decreased over this time, and the gap in this rate between White and Black people has closed, he said. “Specialization and centralization clearly improve outcomes for certain surgical procedures.”

To address the problem everyone should acknowledge the disparities, particularly in the access to surgery. “I think one of the best tools we have to try to address the disparity is education, both for patients and providers,” Dr. Evans said.

Care teams must become more diverse and culturally competent to combat longstanding distrust and improve communication, he said.

In December, ASCO announced an “action plan” to address equity, diversity and inclusion in cancer care. The organization promised to improve clinical trial eligibility, and train researchers about inherent bias in order to make the trials more representative of the cancer population.

It vowed to increase participation of underrepresented groups in its professional development programs and leadership roles, and educate its members about equity. And, it resolved to provide resources to providers so they could advocate for better quality of care, especially in rural and disadvantaged settings.

Dr. Wagner disclosed relationships with Alligator Bioscience, BMS, Dragonfly Therapeutics, Lilly, Merck KGaA, MSD Oncology, Servier/Pfizer, and Abbvie. Dr. Evans disclosed relationships with Bristol Myers Squibb Foundation and Intuitive Surgical.

This article was updated 1/28/22.

 

Men and White people receive better treatment for gastroesophageal cancer than women, Blacks, and Latinos despite years of studies highlighting disparities in care, researchers say.

The problem is complex because it stems from both biological and socioeconomic factors, but some signs of improvement are beginning to show, said Nathaniel R. Evans III, MD, a professor of surgery at Thomas Jefferson University in Philadelphia.

“Repeatedly, we see that, although we know how patients should be treated, there are oftentimes subsets of patients who don’t receive that same level of care,” said Dr. Evans in a general session talk at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

Black patients with esophageal cancer are 38% more likely to die from the condition than White patients, he said, citing a 2013 study (Ann Surg Oncol. 2013 doi: 10.1245/s10434-012-2807-3). For Latino patients, mortality is 20% higher than for White patients.

The difference can mostly be explained by the rate of esophagectomy, which is 52% lower for Black patients and 29% lower for Latino patients, compared with White patients, the study found.

Besides race and gender, insurance status also influences who gets surgery, Dr. Evans said, citing data from the National Cancer Database. Black patients are less likely to get surgery and more likely to die at all stages and histologies, he said. They wait longer for treatment and are more likely to receive no treatment at all.

Women also suffer from disparities, said Anna Dorothea Wagner, MD, head of the gastrointestinal cancer clinic at Lausanne University Hospital in Lausanne (Switzerland), who spoke at the symposium with Dr Evans.

Seventy-five percent of men with esophageal and gastric adenocarcinoma get curative treatments, compared with only 60% of women, Dr. Wagner said, citing a 2020 study on which she is an author. Women are more likely to get palliative care. As a result, only 30% of women survive the condition for 5 years or more compared to 34% of men, she said. “At the moment we don’t know whether this is due to either patient preferences or cognitive or bias of physicians.”

Disparities in treatment outcomes because of biological differences

For women, some disparities also arise out of clear biological differences, Dr. Wagner said. Sex hormone signaling affects cancer susceptibility, and sex-biased gene expression signatures have been detected in multiple cancer types.

Women with poorly differentiated and signet-cell pathology are less likely to survive their cancer than men with the same histology, she said.

Many studies have shown that chemotherapy is more toxic to women than men without being more efficacious, she added. This suggests that the optimal doses might be different for women and men.

Responding to a question from the audience, Dr. Wagner said more research is needed on transgender patients to understand how these factors affect them.

Dr. Evans attributed the racial and ethnic disparities to some combination of differential histology, stage at diagnosis, access to care, socioeconomics, and inherent bias.

“The problem is not new,” Dr. Evans said. He described studies that found disparities in the 1970s. “But the good news is that things do seem to be getting better.”

Between 2000 and 2011, the number of esophagectomies being performed at high-volume hospitals increased, he said. The overall mortality after esophagectomy has consequently decreased over this time, and the gap in this rate between White and Black people has closed, he said. “Specialization and centralization clearly improve outcomes for certain surgical procedures.”

To address the problem everyone should acknowledge the disparities, particularly in the access to surgery. “I think one of the best tools we have to try to address the disparity is education, both for patients and providers,” Dr. Evans said.

Care teams must become more diverse and culturally competent to combat longstanding distrust and improve communication, he said.

In December, ASCO announced an “action plan” to address equity, diversity and inclusion in cancer care. The organization promised to improve clinical trial eligibility, and train researchers about inherent bias in order to make the trials more representative of the cancer population.

It vowed to increase participation of underrepresented groups in its professional development programs and leadership roles, and educate its members about equity. And, it resolved to provide resources to providers so they could advocate for better quality of care, especially in rural and disadvantaged settings.

Dr. Wagner disclosed relationships with Alligator Bioscience, BMS, Dragonfly Therapeutics, Lilly, Merck KGaA, MSD Oncology, Servier/Pfizer, and Abbvie. Dr. Evans disclosed relationships with Bristol Myers Squibb Foundation and Intuitive Surgical.

This article was updated 1/28/22.

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Can immunotherapy replace surgery for stomach cancer?

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A new French study raises the possibility that immunotherapy can help some people with stomach cancer avoid surgery.

GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.

Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.

After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.

If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.

The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.

At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.

They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.

Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.

Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.

Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.

There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.

The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.

Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.

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A new French study raises the possibility that immunotherapy can help some people with stomach cancer avoid surgery.

GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.

Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.

After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.

If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.

The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.

At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.

They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.

Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.

Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.

Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.

There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.

The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.

Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.

 

A new French study raises the possibility that immunotherapy can help some people with stomach cancer avoid surgery.

GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.

Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.

After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.

If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.

The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.

At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.

They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.

Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.

Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.

Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.

There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.

The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.

Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.

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Oxaliplatin add-on not recommended for elderly with colon cancer

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A Japanese study finds that the addition of oxaliplatin (Eloxatin, Sanofi-Aventis) to fluoropyrimidine with bevacizumab, does not extend progression-free survival in elderly patients with metastatic colorectal cancer and in fact, can lead to more severe adverse events.

The results of the trial were presented by Tetsuya Hamaguchi, MD, PhD, at the 2022 Gastrointestinal Cancers Symposium.

Fluoropyrimidine with oxaliplatin and bevacizumab is a standard intensive initial therapy for metastatic colorectal cancer, but how well this combination works in elderly patients isn’t known because few clinical trials include senior-aged patients. It is known that the combination of fluoropyrimidine and bevacizumab can lead to significantly longer progression-free survival in elderly patients with metastatic colorectal cancer.

Dr. Hamaguchi, an oncologist with Saitama Medical University International Medical Center in Hidaka, Japan, included 251 patients (93% were at least 75 years old) with newly diagnosed metastatic colorectal cancer in a randomized, phase 3 trial of modified FOLFOX7 (folinic acid, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) plus bevacizumab versus 5-fluorouracil/l-LV or capecitabine plus bevacizumab.

The patients were treated between September 2012 and March 2019. 125 patients received combination therapy and 126 received the addition of oxaliplatin. Researchers found the addition of oxaliplatin to fluoropyrimidine with bevacizumab did not extend progression-free survival and it was associated with more frequent and severe adverse events, including neutropenia, nausea, stomatitis, diarrhea, fatigue, sensory neuropathy, and hypertension.
 

Triggering sensory neuropathy

At issue is neuropathy caused by oxaliplatin. Grade 3 neuropathy can occur in 25% of patients after 12 cycles of FOLFOX. It has also been recorded in more than 20% of patients at 18 months, according to Gabriel Brooks, MD, an oncologist with the Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, N.H., who served as the discussant for the oral abstract session featuring the study presented by Dr. Hamaguchi.

“Even if we carefully ask our patients about their symptoms, and even if we stop oxaliplatin as soon as they have evidence of grade 2 neuropathy, many of those patients who didn’t have any neuropathy when the oxaliplatin is stopped will go on to develop it. And many of those patients who have grade 2 neuropathy will have worsening of their neuropathy and it will become a grade 3 neuropathy, even if we try to stop conscientiously,” Dr. Brooks said during his presentation.

The MOSAIC trial demonstrated that oxaliplatin improved disease-free and overall survival when added to 5-fluorouracil in the adjuvant treatment of stage II/III colon cancer. However, neuropathy concerns led to studies examining shortened regimens in an effort to reduce neuropathy incidence. In 2018, the IDEA study compared 3 months versus 6 months of oxaliplatin with fluoropyrimidine as adjuvant therapy for stage III colon cancer. The study found that the 6-month regimen was superior with respect to disease-free survival, but the benefit was very small, according to Dr. Brooks.

“What was not small was the difference in the incidence of [grade] 3-4 neuropathy, which was only 2.5% among patients who received 3 months of adjuvant chemotherapy with oxaliplatin, and it was 15.9% among people randomized to 6 months of adjuvant chemotherapy,” he said. The same study suggested that 3 months of the CapeOX regimen is noninferior to 6 months.

The new study included patients aged 70-74 years with Performance Status 2, or 75 or older with PS 0-2. They were randomized to receive fluoropyrimidine plus bevacizumab (arm A) or fluoropyrimidine, bevacizumab, and oxaliplatin (arm B). The study had to be terminated because of poor accrual, and the study was later amended to include a smaller required sample size. After a recruitment of 251 patients and a 2-year minimum follow-up, there was no significant difference in progression-free survival between the two groups (hazard ratio, 0.837; one-sided P = .086), overall survival, or objective response rate.

Adverse events were more common in the oxaliplatin group, including neutropenia (24% vs. 15%), nausea (22% vs. 10%), diarrhea (16% vs. 7%), fatigue (32% vs. 21%), and sensory neuropathy (57% vs. 15%).

Subgroup analyses did identify a subgroup of patients with KRAS wild type benefited from oxaliplatin (HR, 0.578; 95% confidence interval, 0.380-0.879), and Dr. Brooks said that this echoes findings from other studies.

Dr. Brooks advocated for deintensification of oxaliplatin. “The benefits of oxaliplatin are less than are often assumed in multiple settings, and the harms of oxaliplatin are well described. We are probably overly aggressive in our use of oxaliplatin. I submit that we should use oxaliplatin cautiously and sparingly in a couple of situations: We should use it very cautiously and sparingly beyond the third month of adjuvant therapy for colon cancer, and we should use it cautiously and sparingly in elderly or frail patients with metastatic colorectal cancer.”

The study was funded, in part, by the National Cancer Center Research and Development Fund, Grant-in-Aid for Clinical Cancer Research, and the Agency for Medical Research and Development in Japan. Dr. Brooks has consulted for CareCentrix, Ipsen, and UnitedHealthcare and has received research funding from Boston Biomedical and Roche/Genentech. Dr. Hamaguchi has received honoraria from Bayer, Bristol-Myers Squibb Japan, and other pharmaceutical companies. 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.

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A Japanese study finds that the addition of oxaliplatin (Eloxatin, Sanofi-Aventis) to fluoropyrimidine with bevacizumab, does not extend progression-free survival in elderly patients with metastatic colorectal cancer and in fact, can lead to more severe adverse events.

The results of the trial were presented by Tetsuya Hamaguchi, MD, PhD, at the 2022 Gastrointestinal Cancers Symposium.

Fluoropyrimidine with oxaliplatin and bevacizumab is a standard intensive initial therapy for metastatic colorectal cancer, but how well this combination works in elderly patients isn’t known because few clinical trials include senior-aged patients. It is known that the combination of fluoropyrimidine and bevacizumab can lead to significantly longer progression-free survival in elderly patients with metastatic colorectal cancer.

Dr. Hamaguchi, an oncologist with Saitama Medical University International Medical Center in Hidaka, Japan, included 251 patients (93% were at least 75 years old) with newly diagnosed metastatic colorectal cancer in a randomized, phase 3 trial of modified FOLFOX7 (folinic acid, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) plus bevacizumab versus 5-fluorouracil/l-LV or capecitabine plus bevacizumab.

The patients were treated between September 2012 and March 2019. 125 patients received combination therapy and 126 received the addition of oxaliplatin. Researchers found the addition of oxaliplatin to fluoropyrimidine with bevacizumab did not extend progression-free survival and it was associated with more frequent and severe adverse events, including neutropenia, nausea, stomatitis, diarrhea, fatigue, sensory neuropathy, and hypertension.
 

Triggering sensory neuropathy

At issue is neuropathy caused by oxaliplatin. Grade 3 neuropathy can occur in 25% of patients after 12 cycles of FOLFOX. It has also been recorded in more than 20% of patients at 18 months, according to Gabriel Brooks, MD, an oncologist with the Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, N.H., who served as the discussant for the oral abstract session featuring the study presented by Dr. Hamaguchi.

“Even if we carefully ask our patients about their symptoms, and even if we stop oxaliplatin as soon as they have evidence of grade 2 neuropathy, many of those patients who didn’t have any neuropathy when the oxaliplatin is stopped will go on to develop it. And many of those patients who have grade 2 neuropathy will have worsening of their neuropathy and it will become a grade 3 neuropathy, even if we try to stop conscientiously,” Dr. Brooks said during his presentation.

The MOSAIC trial demonstrated that oxaliplatin improved disease-free and overall survival when added to 5-fluorouracil in the adjuvant treatment of stage II/III colon cancer. However, neuropathy concerns led to studies examining shortened regimens in an effort to reduce neuropathy incidence. In 2018, the IDEA study compared 3 months versus 6 months of oxaliplatin with fluoropyrimidine as adjuvant therapy for stage III colon cancer. The study found that the 6-month regimen was superior with respect to disease-free survival, but the benefit was very small, according to Dr. Brooks.

“What was not small was the difference in the incidence of [grade] 3-4 neuropathy, which was only 2.5% among patients who received 3 months of adjuvant chemotherapy with oxaliplatin, and it was 15.9% among people randomized to 6 months of adjuvant chemotherapy,” he said. The same study suggested that 3 months of the CapeOX regimen is noninferior to 6 months.

The new study included patients aged 70-74 years with Performance Status 2, or 75 or older with PS 0-2. They were randomized to receive fluoropyrimidine plus bevacizumab (arm A) or fluoropyrimidine, bevacizumab, and oxaliplatin (arm B). The study had to be terminated because of poor accrual, and the study was later amended to include a smaller required sample size. After a recruitment of 251 patients and a 2-year minimum follow-up, there was no significant difference in progression-free survival between the two groups (hazard ratio, 0.837; one-sided P = .086), overall survival, or objective response rate.

Adverse events were more common in the oxaliplatin group, including neutropenia (24% vs. 15%), nausea (22% vs. 10%), diarrhea (16% vs. 7%), fatigue (32% vs. 21%), and sensory neuropathy (57% vs. 15%).

Subgroup analyses did identify a subgroup of patients with KRAS wild type benefited from oxaliplatin (HR, 0.578; 95% confidence interval, 0.380-0.879), and Dr. Brooks said that this echoes findings from other studies.

Dr. Brooks advocated for deintensification of oxaliplatin. “The benefits of oxaliplatin are less than are often assumed in multiple settings, and the harms of oxaliplatin are well described. We are probably overly aggressive in our use of oxaliplatin. I submit that we should use oxaliplatin cautiously and sparingly in a couple of situations: We should use it very cautiously and sparingly beyond the third month of adjuvant therapy for colon cancer, and we should use it cautiously and sparingly in elderly or frail patients with metastatic colorectal cancer.”

The study was funded, in part, by the National Cancer Center Research and Development Fund, Grant-in-Aid for Clinical Cancer Research, and the Agency for Medical Research and Development in Japan. Dr. Brooks has consulted for CareCentrix, Ipsen, and UnitedHealthcare and has received research funding from Boston Biomedical and Roche/Genentech. Dr. Hamaguchi has received honoraria from Bayer, Bristol-Myers Squibb Japan, and other pharmaceutical companies. 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.

A Japanese study finds that the addition of oxaliplatin (Eloxatin, Sanofi-Aventis) to fluoropyrimidine with bevacizumab, does not extend progression-free survival in elderly patients with metastatic colorectal cancer and in fact, can lead to more severe adverse events.

The results of the trial were presented by Tetsuya Hamaguchi, MD, PhD, at the 2022 Gastrointestinal Cancers Symposium.

Fluoropyrimidine with oxaliplatin and bevacizumab is a standard intensive initial therapy for metastatic colorectal cancer, but how well this combination works in elderly patients isn’t known because few clinical trials include senior-aged patients. It is known that the combination of fluoropyrimidine and bevacizumab can lead to significantly longer progression-free survival in elderly patients with metastatic colorectal cancer.

Dr. Hamaguchi, an oncologist with Saitama Medical University International Medical Center in Hidaka, Japan, included 251 patients (93% were at least 75 years old) with newly diagnosed metastatic colorectal cancer in a randomized, phase 3 trial of modified FOLFOX7 (folinic acid, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) plus bevacizumab versus 5-fluorouracil/l-LV or capecitabine plus bevacizumab.

The patients were treated between September 2012 and March 2019. 125 patients received combination therapy and 126 received the addition of oxaliplatin. Researchers found the addition of oxaliplatin to fluoropyrimidine with bevacizumab did not extend progression-free survival and it was associated with more frequent and severe adverse events, including neutropenia, nausea, stomatitis, diarrhea, fatigue, sensory neuropathy, and hypertension.
 

Triggering sensory neuropathy

At issue is neuropathy caused by oxaliplatin. Grade 3 neuropathy can occur in 25% of patients after 12 cycles of FOLFOX. It has also been recorded in more than 20% of patients at 18 months, according to Gabriel Brooks, MD, an oncologist with the Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, N.H., who served as the discussant for the oral abstract session featuring the study presented by Dr. Hamaguchi.

“Even if we carefully ask our patients about their symptoms, and even if we stop oxaliplatin as soon as they have evidence of grade 2 neuropathy, many of those patients who didn’t have any neuropathy when the oxaliplatin is stopped will go on to develop it. And many of those patients who have grade 2 neuropathy will have worsening of their neuropathy and it will become a grade 3 neuropathy, even if we try to stop conscientiously,” Dr. Brooks said during his presentation.

The MOSAIC trial demonstrated that oxaliplatin improved disease-free and overall survival when added to 5-fluorouracil in the adjuvant treatment of stage II/III colon cancer. However, neuropathy concerns led to studies examining shortened regimens in an effort to reduce neuropathy incidence. In 2018, the IDEA study compared 3 months versus 6 months of oxaliplatin with fluoropyrimidine as adjuvant therapy for stage III colon cancer. The study found that the 6-month regimen was superior with respect to disease-free survival, but the benefit was very small, according to Dr. Brooks.

“What was not small was the difference in the incidence of [grade] 3-4 neuropathy, which was only 2.5% among patients who received 3 months of adjuvant chemotherapy with oxaliplatin, and it was 15.9% among people randomized to 6 months of adjuvant chemotherapy,” he said. The same study suggested that 3 months of the CapeOX regimen is noninferior to 6 months.

The new study included patients aged 70-74 years with Performance Status 2, or 75 or older with PS 0-2. They were randomized to receive fluoropyrimidine plus bevacizumab (arm A) or fluoropyrimidine, bevacizumab, and oxaliplatin (arm B). The study had to be terminated because of poor accrual, and the study was later amended to include a smaller required sample size. After a recruitment of 251 patients and a 2-year minimum follow-up, there was no significant difference in progression-free survival between the two groups (hazard ratio, 0.837; one-sided P = .086), overall survival, or objective response rate.

Adverse events were more common in the oxaliplatin group, including neutropenia (24% vs. 15%), nausea (22% vs. 10%), diarrhea (16% vs. 7%), fatigue (32% vs. 21%), and sensory neuropathy (57% vs. 15%).

Subgroup analyses did identify a subgroup of patients with KRAS wild type benefited from oxaliplatin (HR, 0.578; 95% confidence interval, 0.380-0.879), and Dr. Brooks said that this echoes findings from other studies.

Dr. Brooks advocated for deintensification of oxaliplatin. “The benefits of oxaliplatin are less than are often assumed in multiple settings, and the harms of oxaliplatin are well described. We are probably overly aggressive in our use of oxaliplatin. I submit that we should use oxaliplatin cautiously and sparingly in a couple of situations: We should use it very cautiously and sparingly beyond the third month of adjuvant therapy for colon cancer, and we should use it cautiously and sparingly in elderly or frail patients with metastatic colorectal cancer.”

The study was funded, in part, by the National Cancer Center Research and Development Fund, Grant-in-Aid for Clinical Cancer Research, and the Agency for Medical Research and Development in Japan. Dr. Brooks has consulted for CareCentrix, Ipsen, and UnitedHealthcare and has received research funding from Boston Biomedical and Roche/Genentech. Dr. Hamaguchi has received honoraria from Bayer, Bristol-Myers Squibb Japan, and other pharmaceutical companies. 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.

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Hand eczema and atopic dermatitis closely linked

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An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Dr. Jacob P. Thyssen

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.



The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.

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An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Dr. Jacob P. Thyssen

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.



The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.

An estimated 10% of adults report hand eczema each year, but over one’s lifetime, about 15%-20% will experience the condition, which is more common among those with atopic dermatitis (AD), according to Jacob P. Thyssen, MD, PhD.

“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.

Dr. Jacob P. Thyssen

Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.

“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”

He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”

The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.



The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.

Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.

In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”

A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”

Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.

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Virtual reality making progress as depression treatment

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Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

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Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

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