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Celiac disease: Can biopsy be avoided?
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
VIDEO: Postpartum care gets a new look
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
REPORTING FROM ACOG 2018
Psoriasis duration reflects cardiovascular event risk
KAUAI, HAWAII – The recent report that the risk of a major adverse cardiovascular event increases by 1% more than in the general population for each additional year of psoriasis duration is sobering news for physicians who treat pediatric psoriasis.
“If I have a 16-year-old who has a 5-year history of psoriasis, what does that mean for when she’s 30 or 40? And should we be intervening more aggressively?” Lawrence F. Eichenfield, MD, asked at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even though there’s not a great deal of evidence, there’s some evidence to rationalize early screening in psoriasis,” according to Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at the University of California, San Diego.
Psoriasis develops during childhood in almost one-third of patients.
The pediatric psoriasis screening guidelines describe a simple routine screening program and timeline for early identification of overweight or obesity, type 2 diabetes, hypertension, nonalcoholic fatty liver disease, anxiety, depression, substance abuse, inflammatory bowel disease, and quality of life issues, all of which are encountered with increased frequency in pediatric psoriasis patients. A fasting lipid panel is recommended in children aged 9-11 years with psoriasis and again at age 17-21 years.
“Don’t forget arthritis. For a kid with psoriasis, at every office visit, I ask about morning stiffness or limp. Those are probably the two most sensitive questions in screening for psoriatic arthritis,” according to Dr. Eichenfield.
It has been clear for some time that the skin is not the only organ affected by psoriatic inflammation. The study that quantified the relationship between psoriasis duration and cardiovascular risk – a 1% increase for each year of psoriasis – was a collaboration between investigators at the University of Copenhagen and the University of Pennsylvania, Philadelphia.
The two-part project included aortal imaging of 190 psoriasis patients using fludeoxyglucose F 18 PET/CT scan, which showed a strong relationship between duration of psoriasis and the degree of vascular inflammation. This was bolstered by a population-based study using Danish national registry data on 87,161 psoriasis patients and 4.2 million controls from the general Danish population (J Am Acad Dermatol. 2017 Oct;77[4]:650-56.e3).
Dr. Eichenfield reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – The recent report that the risk of a major adverse cardiovascular event increases by 1% more than in the general population for each additional year of psoriasis duration is sobering news for physicians who treat pediatric psoriasis.
“If I have a 16-year-old who has a 5-year history of psoriasis, what does that mean for when she’s 30 or 40? And should we be intervening more aggressively?” Lawrence F. Eichenfield, MD, asked at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even though there’s not a great deal of evidence, there’s some evidence to rationalize early screening in psoriasis,” according to Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at the University of California, San Diego.
Psoriasis develops during childhood in almost one-third of patients.
The pediatric psoriasis screening guidelines describe a simple routine screening program and timeline for early identification of overweight or obesity, type 2 diabetes, hypertension, nonalcoholic fatty liver disease, anxiety, depression, substance abuse, inflammatory bowel disease, and quality of life issues, all of which are encountered with increased frequency in pediatric psoriasis patients. A fasting lipid panel is recommended in children aged 9-11 years with psoriasis and again at age 17-21 years.
“Don’t forget arthritis. For a kid with psoriasis, at every office visit, I ask about morning stiffness or limp. Those are probably the two most sensitive questions in screening for psoriatic arthritis,” according to Dr. Eichenfield.
It has been clear for some time that the skin is not the only organ affected by psoriatic inflammation. The study that quantified the relationship between psoriasis duration and cardiovascular risk – a 1% increase for each year of psoriasis – was a collaboration between investigators at the University of Copenhagen and the University of Pennsylvania, Philadelphia.
The two-part project included aortal imaging of 190 psoriasis patients using fludeoxyglucose F 18 PET/CT scan, which showed a strong relationship between duration of psoriasis and the degree of vascular inflammation. This was bolstered by a population-based study using Danish national registry data on 87,161 psoriasis patients and 4.2 million controls from the general Danish population (J Am Acad Dermatol. 2017 Oct;77[4]:650-56.e3).
Dr. Eichenfield reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – The recent report that the risk of a major adverse cardiovascular event increases by 1% more than in the general population for each additional year of psoriasis duration is sobering news for physicians who treat pediatric psoriasis.
“If I have a 16-year-old who has a 5-year history of psoriasis, what does that mean for when she’s 30 or 40? And should we be intervening more aggressively?” Lawrence F. Eichenfield, MD, asked at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even though there’s not a great deal of evidence, there’s some evidence to rationalize early screening in psoriasis,” according to Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at the University of California, San Diego.
Psoriasis develops during childhood in almost one-third of patients.
The pediatric psoriasis screening guidelines describe a simple routine screening program and timeline for early identification of overweight or obesity, type 2 diabetes, hypertension, nonalcoholic fatty liver disease, anxiety, depression, substance abuse, inflammatory bowel disease, and quality of life issues, all of which are encountered with increased frequency in pediatric psoriasis patients. A fasting lipid panel is recommended in children aged 9-11 years with psoriasis and again at age 17-21 years.
“Don’t forget arthritis. For a kid with psoriasis, at every office visit, I ask about morning stiffness or limp. Those are probably the two most sensitive questions in screening for psoriatic arthritis,” according to Dr. Eichenfield.
It has been clear for some time that the skin is not the only organ affected by psoriatic inflammation. The study that quantified the relationship between psoriasis duration and cardiovascular risk – a 1% increase for each year of psoriasis – was a collaboration between investigators at the University of Copenhagen and the University of Pennsylvania, Philadelphia.
The two-part project included aortal imaging of 190 psoriasis patients using fludeoxyglucose F 18 PET/CT scan, which showed a strong relationship between duration of psoriasis and the degree of vascular inflammation. This was bolstered by a population-based study using Danish national registry data on 87,161 psoriasis patients and 4.2 million controls from the general Danish population (J Am Acad Dermatol. 2017 Oct;77[4]:650-56.e3).
Dr. Eichenfield reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: AAN MS guidelines aim to help clinicians weigh expanding drug choices
LOS ANGELES – A new clinical guideline for adults with multiple sclerosis is designed to help clinicians navigate an increasingly complex landscape of treatment options, its authors say.
The new American Academy of Neurology (AAN) guideline includes some 30 recommendations related to starting a disease-modifying therapy (DMT), switching therapies, or stopping treatment. The guideline, presented April 23 at the AAN annual meeting and published online simultaneously in Neurology, is the first full MS practice guideline issued by AAN since 2002, when only a handful of medications were licensed for use in MS.
The new guideline does not present a hierarchy of DMTs to start but instead weighs evidence for 21 medications or formulations, including 8 used off label, with the idea that clinicians will tailor their choices by considering patient needs, preferences, potential adverse affects, cost of medicines, comorbidities (including depression), and likelihood of adherence, among other factors addressed.
“It’s a dramatically different landscape of the choices clinicians have,” guideline lead author Alexander Rae-Grant, MD, of the Cleveland Clinic, said at a press conference announcing the guideline.
The guideline encourages clinicians and patients “to have a detailed discussion of the risks and benefits of different therapies,” guideline coauthor Ruth Ann Marrie, MD, PhD, of the University of Manitoba, Winnipeg, said at the press conference. “You need to have that informed ... discussion to share decision making – the guideline provides information for each provider-patient dyad to make decisions specific to that patient.”
The guideline incorporates findings from nearly 50 randomized trials, although few of these were head-to-head comparisons of therapies. The authors graded evidence for each DMT as compared with placebo or other DMTs in lowering relapse rate, taking into consideration study design and size. The guideline reflects changes to diagnostic criteria made in 2010, and a classification scheme issued in 2014 for MS subtypes, both of which have complicated the extension of clinical trial findings to some patient groups. It stresses early treatment, recommending that clinicians start DMTs in people with a single clinical demyelinating event and two or more brain lesions characteristic of MS.
Several drugs used off label in MS, including azathioprine and cladribine, were included in the evidence review, with cladribine described as a cost-effective option for patients without the resources to obtain approved agents.
Patients with a new diagnosis of MS should be counseled on starting DMTs not at the time of diagnosis but in a dedicated follow-up visit, the guideline says. Dr. Rae-Grant said that there’s a reasonable amount of “literature to suggest that at the time of diagnosis, what people hear after diagnosis is zero – and that deciding what medication to use is such a weighty decision, we did feel it was important to do that at a different time.”
Dr. Marrie said the AAN guideline “shares some strong similarities” with guidelines released in 2017 by the European Academy of Neurology, including recommendations for early initiation of therapy, for maintaining therapies, and for switching DMTs in individuals not responding or who have breakthrough relapses or changes on MRI.
Dr. Marrie disclosed no conflicts of interest related to her work on the guidelines. Dr. Rae-Grant disclosed income from textbooks on neurology and MS, and no other financial conflicts of interest.
SOURCE: Rae-Grant A et al. Neurology. 2018;90:777-88.
LOS ANGELES – A new clinical guideline for adults with multiple sclerosis is designed to help clinicians navigate an increasingly complex landscape of treatment options, its authors say.
The new American Academy of Neurology (AAN) guideline includes some 30 recommendations related to starting a disease-modifying therapy (DMT), switching therapies, or stopping treatment. The guideline, presented April 23 at the AAN annual meeting and published online simultaneously in Neurology, is the first full MS practice guideline issued by AAN since 2002, when only a handful of medications were licensed for use in MS.
The new guideline does not present a hierarchy of DMTs to start but instead weighs evidence for 21 medications or formulations, including 8 used off label, with the idea that clinicians will tailor their choices by considering patient needs, preferences, potential adverse affects, cost of medicines, comorbidities (including depression), and likelihood of adherence, among other factors addressed.
“It’s a dramatically different landscape of the choices clinicians have,” guideline lead author Alexander Rae-Grant, MD, of the Cleveland Clinic, said at a press conference announcing the guideline.
The guideline encourages clinicians and patients “to have a detailed discussion of the risks and benefits of different therapies,” guideline coauthor Ruth Ann Marrie, MD, PhD, of the University of Manitoba, Winnipeg, said at the press conference. “You need to have that informed ... discussion to share decision making – the guideline provides information for each provider-patient dyad to make decisions specific to that patient.”
The guideline incorporates findings from nearly 50 randomized trials, although few of these were head-to-head comparisons of therapies. The authors graded evidence for each DMT as compared with placebo or other DMTs in lowering relapse rate, taking into consideration study design and size. The guideline reflects changes to diagnostic criteria made in 2010, and a classification scheme issued in 2014 for MS subtypes, both of which have complicated the extension of clinical trial findings to some patient groups. It stresses early treatment, recommending that clinicians start DMTs in people with a single clinical demyelinating event and two or more brain lesions characteristic of MS.
Several drugs used off label in MS, including azathioprine and cladribine, were included in the evidence review, with cladribine described as a cost-effective option for patients without the resources to obtain approved agents.
Patients with a new diagnosis of MS should be counseled on starting DMTs not at the time of diagnosis but in a dedicated follow-up visit, the guideline says. Dr. Rae-Grant said that there’s a reasonable amount of “literature to suggest that at the time of diagnosis, what people hear after diagnosis is zero – and that deciding what medication to use is such a weighty decision, we did feel it was important to do that at a different time.”
Dr. Marrie said the AAN guideline “shares some strong similarities” with guidelines released in 2017 by the European Academy of Neurology, including recommendations for early initiation of therapy, for maintaining therapies, and for switching DMTs in individuals not responding or who have breakthrough relapses or changes on MRI.
Dr. Marrie disclosed no conflicts of interest related to her work on the guidelines. Dr. Rae-Grant disclosed income from textbooks on neurology and MS, and no other financial conflicts of interest.
SOURCE: Rae-Grant A et al. Neurology. 2018;90:777-88.
LOS ANGELES – A new clinical guideline for adults with multiple sclerosis is designed to help clinicians navigate an increasingly complex landscape of treatment options, its authors say.
The new American Academy of Neurology (AAN) guideline includes some 30 recommendations related to starting a disease-modifying therapy (DMT), switching therapies, or stopping treatment. The guideline, presented April 23 at the AAN annual meeting and published online simultaneously in Neurology, is the first full MS practice guideline issued by AAN since 2002, when only a handful of medications were licensed for use in MS.
The new guideline does not present a hierarchy of DMTs to start but instead weighs evidence for 21 medications or formulations, including 8 used off label, with the idea that clinicians will tailor their choices by considering patient needs, preferences, potential adverse affects, cost of medicines, comorbidities (including depression), and likelihood of adherence, among other factors addressed.
“It’s a dramatically different landscape of the choices clinicians have,” guideline lead author Alexander Rae-Grant, MD, of the Cleveland Clinic, said at a press conference announcing the guideline.
The guideline encourages clinicians and patients “to have a detailed discussion of the risks and benefits of different therapies,” guideline coauthor Ruth Ann Marrie, MD, PhD, of the University of Manitoba, Winnipeg, said at the press conference. “You need to have that informed ... discussion to share decision making – the guideline provides information for each provider-patient dyad to make decisions specific to that patient.”
The guideline incorporates findings from nearly 50 randomized trials, although few of these were head-to-head comparisons of therapies. The authors graded evidence for each DMT as compared with placebo or other DMTs in lowering relapse rate, taking into consideration study design and size. The guideline reflects changes to diagnostic criteria made in 2010, and a classification scheme issued in 2014 for MS subtypes, both of which have complicated the extension of clinical trial findings to some patient groups. It stresses early treatment, recommending that clinicians start DMTs in people with a single clinical demyelinating event and two or more brain lesions characteristic of MS.
Several drugs used off label in MS, including azathioprine and cladribine, were included in the evidence review, with cladribine described as a cost-effective option for patients without the resources to obtain approved agents.
Patients with a new diagnosis of MS should be counseled on starting DMTs not at the time of diagnosis but in a dedicated follow-up visit, the guideline says. Dr. Rae-Grant said that there’s a reasonable amount of “literature to suggest that at the time of diagnosis, what people hear after diagnosis is zero – and that deciding what medication to use is such a weighty decision, we did feel it was important to do that at a different time.”
Dr. Marrie said the AAN guideline “shares some strong similarities” with guidelines released in 2017 by the European Academy of Neurology, including recommendations for early initiation of therapy, for maintaining therapies, and for switching DMTs in individuals not responding or who have breakthrough relapses or changes on MRI.
Dr. Marrie disclosed no conflicts of interest related to her work on the guidelines. Dr. Rae-Grant disclosed income from textbooks on neurology and MS, and no other financial conflicts of interest.
SOURCE: Rae-Grant A et al. Neurology. 2018;90:777-88.
REPORTING FROM AAN 2018
ACOG advises earlier, more comprehensive postpartum care
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: New recommendations on postpartum care advise earlier and more comprehensive follow-up visits and propose a new paradigm for ensuring the physical, emotional, and mental health of women in the first 12 weeks after giving birth.
Major finding: Women should have a follow-up visit within 3 weeks post partum – earlier if they have chronic conditions or had pregnancy complications – and an additional comprehensive visit no later than 12 weeks post partum.
Data source: The findings are based on an assessment of existing evidence on postpartum care, postpartum risks, and currently unfulfilled needs that ob.gyns. can and should fulfill, according to ACOG.
Disclosures: The committee opinion did not require external funding, and the authors did not report any disclosures.
Source: Obstet Gynecol 2018;131:e140-50.
New JIA guidelines emphasize treating to target
– a strategy made possible with new therapies that have transformed treatment in recent years, including earlier treatment with methotrexate, expanding use of intra-articular glucocorticoids, and especially disease-modifying antibodies.
The guidelines, published online April 11 in the Annals of the Rheumatic Diseases, are a departure from some others in that there is very little research supporting the approach they advocate. But there is precedent in adult disease. Research in adults with rheumatoid arthritis has shown that achievement of low levels of disease activity through frequent adjustments of therapy improves patient outcomes, no matter the treatment used.
Nevertheless, the time for aggressive treatment in children has come, according to Karen Onel, MD, chief of the division of pediatric rheumatology at the Hospital for Special Surgery, New York. She pointed out that joint and organ damage resulting from JIA can be permanent. “These guidelines are meant to be fluid, but we need to be committed to getting patients into remission as quickly as possible. Anything less than that is not OK,” said Dr. Onel, who did not participate in drafting the guidelines.
The guidelines make almost no mention of specific treatments, with the exception of an admonition to avoid long-term systemic glucocorticoid therapy. “It’s addressing a philosophy of care that is different than what most of us do in our daily practice,” Dr. Lovell said. The lack of medication specifics also ensures that the guidelines will be useful in a wide range of settings, since specific drugs may be unavailable in some countries, or unaffordable due to insurance considerations.
The guidelines and the community at large are battling a historical perception of JIA as a childhood disease that patients outgrow. That has led to conservative approaches to therapy in an attempt to spare children from toxicity. But with new treatment options, that approach is outdated. “We have an issue in pediatrics where many people feel, including families, that you should wait until the child is old enough to make these decisions on their own. But the reality is that if [JIA] is not fixed in childhood, it won’t be fixed in adulthood,” Dr. Onel said.
About half of JIA cases are handled by rheumatologists who primarily work with adults, and they tend to favor toxicity-sparing regimens. These practitioners must be convinced to be more aggressive in their treatment, but parents are critical as well. The guidelines emphasize communicating with parents the rationale behind a chosen treatment target, along with information on the disease and the benefits and risks of the medications to be prescribed. Parents may struggle to understand the need for aggressive treatment, especially those with young children.
Parents may even be socially stigmatized by peers who think dietary change and exercise should be sufficient. “It’s really unfair. Nobody says to a parent of a child with cancer that they are treating their children with poison. The same holds true for other childhood chronic diseases. For whatever reason, the risk of permanent disability from childhood arthritis is understated,” Dr. Onel said.
A call for research
The primary target called for in the guidelines is clinically inactive disease (CID), defined as an absence of signs and symptoms of inflammatory disease activity, including extra-articular manifestations. An alternative target is minimal or low disease activity (LDA), which may be a more appropriate goal in patients with long-standing disease. Whatever the target, patients should be tracked at each clinical visit using a validated composite instrument, though the committee did not recommend one specifically.
Frequency of assessments may range from weekly to monthly or every 3 months, depending on the disease state. Within 3 months, the guidelines call for a minimum 50% improvement in disease activity, and by 6 months, clinicians should aim to achieve the target of clinical remission or LDA.
“It’s really important that clinicians systematically collect information on disease activity at every encounter. The next step is making sure we have some way of measuring outcomes. That might require a registry. It’s not easy to just start doing this. You need to have a plan in place,” said Esi Morgan, MD, of the department of rheumatology at Cincinnati Children’s Hospital Medical Center, and also a member of the guideline committee.
It remains to be seen how effective treatment to target will be, but Dr. Lovell hopes the guidelines will encourage research to provide definitive answers. “I think the recommendation is to just get on with it. Start doing trials utilizing a treat-to-target approach, and do them in a formal enough fashion that you can compare it to routine care in kids with JIA so you can assess the impact,” Dr. Lovell said.
Confidence is high. “There are many examples [of treating to target], so we can be confident this will work. What’s slightly different is applying this across the many subtypes of JIA. There are many categories, so it makes it a little more complex in terms of telling people what to do. But it’s definitely worth doing. We just need to solve the problem of how to address those issues,” Dr. Morgan said.
One key question is whether CID or LDA is the best target for functional outcomes. The UK Childhood Arthritis Prospective Study examined this question among 832 JIA patients and found that only achievement of CID on the clinical Juvenile Arthritis Disease Activity Score (cJADAS) was associated with an improvement in functional ability and psychosocial health at 1 year. Both endpoints were associated with greater absence of limited joints.
Another challenge is to determine what instrument to use to track disease activity and treatment response. Instruments include Wallace’s preliminary criteria, the American College of Rheumatology preliminary criteria, the Childhood Health Assessment Questionnaire (CHAQ), and the JADAS. All can be time consuming, which is a problem in a busy clinic. “That’s the work we need to do now: Figuring out what the best, easiest, most predictive instrument is going to be,” Dr. Onel said.
Dr. Lovell and Dr. Onel have no financial disclosures. Dr. Morgan is chair of the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN), which has received grants from Novartis and Medac Pharma.
SOURCE: Ravelli A et al. Ann Rheum Dis. 2018 Apr 11. doi: 10.1136/annrheumdis-2018-213030.
– a strategy made possible with new therapies that have transformed treatment in recent years, including earlier treatment with methotrexate, expanding use of intra-articular glucocorticoids, and especially disease-modifying antibodies.
The guidelines, published online April 11 in the Annals of the Rheumatic Diseases, are a departure from some others in that there is very little research supporting the approach they advocate. But there is precedent in adult disease. Research in adults with rheumatoid arthritis has shown that achievement of low levels of disease activity through frequent adjustments of therapy improves patient outcomes, no matter the treatment used.
Nevertheless, the time for aggressive treatment in children has come, according to Karen Onel, MD, chief of the division of pediatric rheumatology at the Hospital for Special Surgery, New York. She pointed out that joint and organ damage resulting from JIA can be permanent. “These guidelines are meant to be fluid, but we need to be committed to getting patients into remission as quickly as possible. Anything less than that is not OK,” said Dr. Onel, who did not participate in drafting the guidelines.
The guidelines make almost no mention of specific treatments, with the exception of an admonition to avoid long-term systemic glucocorticoid therapy. “It’s addressing a philosophy of care that is different than what most of us do in our daily practice,” Dr. Lovell said. The lack of medication specifics also ensures that the guidelines will be useful in a wide range of settings, since specific drugs may be unavailable in some countries, or unaffordable due to insurance considerations.
The guidelines and the community at large are battling a historical perception of JIA as a childhood disease that patients outgrow. That has led to conservative approaches to therapy in an attempt to spare children from toxicity. But with new treatment options, that approach is outdated. “We have an issue in pediatrics where many people feel, including families, that you should wait until the child is old enough to make these decisions on their own. But the reality is that if [JIA] is not fixed in childhood, it won’t be fixed in adulthood,” Dr. Onel said.
About half of JIA cases are handled by rheumatologists who primarily work with adults, and they tend to favor toxicity-sparing regimens. These practitioners must be convinced to be more aggressive in their treatment, but parents are critical as well. The guidelines emphasize communicating with parents the rationale behind a chosen treatment target, along with information on the disease and the benefits and risks of the medications to be prescribed. Parents may struggle to understand the need for aggressive treatment, especially those with young children.
Parents may even be socially stigmatized by peers who think dietary change and exercise should be sufficient. “It’s really unfair. Nobody says to a parent of a child with cancer that they are treating their children with poison. The same holds true for other childhood chronic diseases. For whatever reason, the risk of permanent disability from childhood arthritis is understated,” Dr. Onel said.
A call for research
The primary target called for in the guidelines is clinically inactive disease (CID), defined as an absence of signs and symptoms of inflammatory disease activity, including extra-articular manifestations. An alternative target is minimal or low disease activity (LDA), which may be a more appropriate goal in patients with long-standing disease. Whatever the target, patients should be tracked at each clinical visit using a validated composite instrument, though the committee did not recommend one specifically.
Frequency of assessments may range from weekly to monthly or every 3 months, depending on the disease state. Within 3 months, the guidelines call for a minimum 50% improvement in disease activity, and by 6 months, clinicians should aim to achieve the target of clinical remission or LDA.
“It’s really important that clinicians systematically collect information on disease activity at every encounter. The next step is making sure we have some way of measuring outcomes. That might require a registry. It’s not easy to just start doing this. You need to have a plan in place,” said Esi Morgan, MD, of the department of rheumatology at Cincinnati Children’s Hospital Medical Center, and also a member of the guideline committee.
It remains to be seen how effective treatment to target will be, but Dr. Lovell hopes the guidelines will encourage research to provide definitive answers. “I think the recommendation is to just get on with it. Start doing trials utilizing a treat-to-target approach, and do them in a formal enough fashion that you can compare it to routine care in kids with JIA so you can assess the impact,” Dr. Lovell said.
Confidence is high. “There are many examples [of treating to target], so we can be confident this will work. What’s slightly different is applying this across the many subtypes of JIA. There are many categories, so it makes it a little more complex in terms of telling people what to do. But it’s definitely worth doing. We just need to solve the problem of how to address those issues,” Dr. Morgan said.
One key question is whether CID or LDA is the best target for functional outcomes. The UK Childhood Arthritis Prospective Study examined this question among 832 JIA patients and found that only achievement of CID on the clinical Juvenile Arthritis Disease Activity Score (cJADAS) was associated with an improvement in functional ability and psychosocial health at 1 year. Both endpoints were associated with greater absence of limited joints.
Another challenge is to determine what instrument to use to track disease activity and treatment response. Instruments include Wallace’s preliminary criteria, the American College of Rheumatology preliminary criteria, the Childhood Health Assessment Questionnaire (CHAQ), and the JADAS. All can be time consuming, which is a problem in a busy clinic. “That’s the work we need to do now: Figuring out what the best, easiest, most predictive instrument is going to be,” Dr. Onel said.
Dr. Lovell and Dr. Onel have no financial disclosures. Dr. Morgan is chair of the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN), which has received grants from Novartis and Medac Pharma.
SOURCE: Ravelli A et al. Ann Rheum Dis. 2018 Apr 11. doi: 10.1136/annrheumdis-2018-213030.
– a strategy made possible with new therapies that have transformed treatment in recent years, including earlier treatment with methotrexate, expanding use of intra-articular glucocorticoids, and especially disease-modifying antibodies.
The guidelines, published online April 11 in the Annals of the Rheumatic Diseases, are a departure from some others in that there is very little research supporting the approach they advocate. But there is precedent in adult disease. Research in adults with rheumatoid arthritis has shown that achievement of low levels of disease activity through frequent adjustments of therapy improves patient outcomes, no matter the treatment used.
Nevertheless, the time for aggressive treatment in children has come, according to Karen Onel, MD, chief of the division of pediatric rheumatology at the Hospital for Special Surgery, New York. She pointed out that joint and organ damage resulting from JIA can be permanent. “These guidelines are meant to be fluid, but we need to be committed to getting patients into remission as quickly as possible. Anything less than that is not OK,” said Dr. Onel, who did not participate in drafting the guidelines.
The guidelines make almost no mention of specific treatments, with the exception of an admonition to avoid long-term systemic glucocorticoid therapy. “It’s addressing a philosophy of care that is different than what most of us do in our daily practice,” Dr. Lovell said. The lack of medication specifics also ensures that the guidelines will be useful in a wide range of settings, since specific drugs may be unavailable in some countries, or unaffordable due to insurance considerations.
The guidelines and the community at large are battling a historical perception of JIA as a childhood disease that patients outgrow. That has led to conservative approaches to therapy in an attempt to spare children from toxicity. But with new treatment options, that approach is outdated. “We have an issue in pediatrics where many people feel, including families, that you should wait until the child is old enough to make these decisions on their own. But the reality is that if [JIA] is not fixed in childhood, it won’t be fixed in adulthood,” Dr. Onel said.
About half of JIA cases are handled by rheumatologists who primarily work with adults, and they tend to favor toxicity-sparing regimens. These practitioners must be convinced to be more aggressive in their treatment, but parents are critical as well. The guidelines emphasize communicating with parents the rationale behind a chosen treatment target, along with information on the disease and the benefits and risks of the medications to be prescribed. Parents may struggle to understand the need for aggressive treatment, especially those with young children.
Parents may even be socially stigmatized by peers who think dietary change and exercise should be sufficient. “It’s really unfair. Nobody says to a parent of a child with cancer that they are treating their children with poison. The same holds true for other childhood chronic diseases. For whatever reason, the risk of permanent disability from childhood arthritis is understated,” Dr. Onel said.
A call for research
The primary target called for in the guidelines is clinically inactive disease (CID), defined as an absence of signs and symptoms of inflammatory disease activity, including extra-articular manifestations. An alternative target is minimal or low disease activity (LDA), which may be a more appropriate goal in patients with long-standing disease. Whatever the target, patients should be tracked at each clinical visit using a validated composite instrument, though the committee did not recommend one specifically.
Frequency of assessments may range from weekly to monthly or every 3 months, depending on the disease state. Within 3 months, the guidelines call for a minimum 50% improvement in disease activity, and by 6 months, clinicians should aim to achieve the target of clinical remission or LDA.
“It’s really important that clinicians systematically collect information on disease activity at every encounter. The next step is making sure we have some way of measuring outcomes. That might require a registry. It’s not easy to just start doing this. You need to have a plan in place,” said Esi Morgan, MD, of the department of rheumatology at Cincinnati Children’s Hospital Medical Center, and also a member of the guideline committee.
It remains to be seen how effective treatment to target will be, but Dr. Lovell hopes the guidelines will encourage research to provide definitive answers. “I think the recommendation is to just get on with it. Start doing trials utilizing a treat-to-target approach, and do them in a formal enough fashion that you can compare it to routine care in kids with JIA so you can assess the impact,” Dr. Lovell said.
Confidence is high. “There are many examples [of treating to target], so we can be confident this will work. What’s slightly different is applying this across the many subtypes of JIA. There are many categories, so it makes it a little more complex in terms of telling people what to do. But it’s definitely worth doing. We just need to solve the problem of how to address those issues,” Dr. Morgan said.
One key question is whether CID or LDA is the best target for functional outcomes. The UK Childhood Arthritis Prospective Study examined this question among 832 JIA patients and found that only achievement of CID on the clinical Juvenile Arthritis Disease Activity Score (cJADAS) was associated with an improvement in functional ability and psychosocial health at 1 year. Both endpoints were associated with greater absence of limited joints.
Another challenge is to determine what instrument to use to track disease activity and treatment response. Instruments include Wallace’s preliminary criteria, the American College of Rheumatology preliminary criteria, the Childhood Health Assessment Questionnaire (CHAQ), and the JADAS. All can be time consuming, which is a problem in a busy clinic. “That’s the work we need to do now: Figuring out what the best, easiest, most predictive instrument is going to be,” Dr. Onel said.
Dr. Lovell and Dr. Onel have no financial disclosures. Dr. Morgan is chair of the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN), which has received grants from Novartis and Medac Pharma.
SOURCE: Ravelli A et al. Ann Rheum Dis. 2018 Apr 11. doi: 10.1136/annrheumdis-2018-213030.
FROM ANNALS OF THE RHEUMATIC DISEASES
Updated CLL guidelines incorporate a decade of advances
include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.
The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.
Major changes or additions include:
Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.
“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.
IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.
Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.
Biomarkers: The guidelines call for standardization and use in prospective clinical trials of assays for serum markers such as soluble CD23, thymidine kinase, and beta-2-microglobulin. These markers have been shown in several studies to be associated with overall survival or progression-free survival, and of these markers, beta-2-microglobulin “has retained independent prognostic value in several multiparameter scores,” the guidelines state.
The authors also tip their hats to recently developed or improved prognostic scores, especially the CLL International Prognostic Index (CLL-IPI), which incorporates clinical stage, age, IGHV mutational status, beta-2-microglobulin, and del(17p) and/or TP53 mutations.
Organ function assessment: Not new, but improved in the current version of the guidelines, are recommendations for evaluation of splenomegaly, hepatomegaly, and lymphadenopathy in response assessment. These recommendations were harmonized with the relevant sections of the updated lymphoma response guidelines.
Continuous therapy: The guidelines panel recommends assessment of response duration during continuous therapy with oral agents and after the end of therapy, especially after chemotherapy or chemoimmunotherapy.
“Study protocols should provide detailed specifications of the planned time points for the assessment of the treatment response under continuous therapy. Response durations of less than six months are not considered clinically relevant,” the panel cautioned.
Response assessments for treatments with a maintenance phase should be performed at a minimum of 2 months after patients achieve their best responses.
MRD: The guidelines call for minimal residual disease (MRD) assessment in clinical trials aimed at maximizing remission depth, with emphasis on reporting the sensitivity of the MRD evaluation method used, and the type of tissue assessed.
Antiviral prophylaxis: The guidelines caution that because patients treated with anti-CD20 antibodies, such as rituximab or obinutuzumab, could have reactivation of hepatitis B virus (HBV) infections, patients should be tested for HBV serological status before starting on an anti-CD20 agent.
“Progressive multifocal leukoencephalopathy has been reported in a few CLL patients treated with anti-CD20 antibodies; therefore, infections with John Cunningham (JC) virus should be ruled out in situations of unclear neurological symptoms,” the panel recommended.
They note that patients younger than 65 treated with fludarabine-based therapy in the first line do not require routine monitoring or infection prophylaxis, due to the low reported incidence of infections in this group.
The authors reported having no financial disclosures related to the guidelines.
include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.
The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.
Major changes or additions include:
Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.
“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.
IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.
Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.
Biomarkers: The guidelines call for standardization and use in prospective clinical trials of assays for serum markers such as soluble CD23, thymidine kinase, and beta-2-microglobulin. These markers have been shown in several studies to be associated with overall survival or progression-free survival, and of these markers, beta-2-microglobulin “has retained independent prognostic value in several multiparameter scores,” the guidelines state.
The authors also tip their hats to recently developed or improved prognostic scores, especially the CLL International Prognostic Index (CLL-IPI), which incorporates clinical stage, age, IGHV mutational status, beta-2-microglobulin, and del(17p) and/or TP53 mutations.
Organ function assessment: Not new, but improved in the current version of the guidelines, are recommendations for evaluation of splenomegaly, hepatomegaly, and lymphadenopathy in response assessment. These recommendations were harmonized with the relevant sections of the updated lymphoma response guidelines.
Continuous therapy: The guidelines panel recommends assessment of response duration during continuous therapy with oral agents and after the end of therapy, especially after chemotherapy or chemoimmunotherapy.
“Study protocols should provide detailed specifications of the planned time points for the assessment of the treatment response under continuous therapy. Response durations of less than six months are not considered clinically relevant,” the panel cautioned.
Response assessments for treatments with a maintenance phase should be performed at a minimum of 2 months after patients achieve their best responses.
MRD: The guidelines call for minimal residual disease (MRD) assessment in clinical trials aimed at maximizing remission depth, with emphasis on reporting the sensitivity of the MRD evaluation method used, and the type of tissue assessed.
Antiviral prophylaxis: The guidelines caution that because patients treated with anti-CD20 antibodies, such as rituximab or obinutuzumab, could have reactivation of hepatitis B virus (HBV) infections, patients should be tested for HBV serological status before starting on an anti-CD20 agent.
“Progressive multifocal leukoencephalopathy has been reported in a few CLL patients treated with anti-CD20 antibodies; therefore, infections with John Cunningham (JC) virus should be ruled out in situations of unclear neurological symptoms,” the panel recommended.
They note that patients younger than 65 treated with fludarabine-based therapy in the first line do not require routine monitoring or infection prophylaxis, due to the low reported incidence of infections in this group.
The authors reported having no financial disclosures related to the guidelines.
include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.
The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.
Major changes or additions include:
Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.
“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.
IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.
Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.
Biomarkers: The guidelines call for standardization and use in prospective clinical trials of assays for serum markers such as soluble CD23, thymidine kinase, and beta-2-microglobulin. These markers have been shown in several studies to be associated with overall survival or progression-free survival, and of these markers, beta-2-microglobulin “has retained independent prognostic value in several multiparameter scores,” the guidelines state.
The authors also tip their hats to recently developed or improved prognostic scores, especially the CLL International Prognostic Index (CLL-IPI), which incorporates clinical stage, age, IGHV mutational status, beta-2-microglobulin, and del(17p) and/or TP53 mutations.
Organ function assessment: Not new, but improved in the current version of the guidelines, are recommendations for evaluation of splenomegaly, hepatomegaly, and lymphadenopathy in response assessment. These recommendations were harmonized with the relevant sections of the updated lymphoma response guidelines.
Continuous therapy: The guidelines panel recommends assessment of response duration during continuous therapy with oral agents and after the end of therapy, especially after chemotherapy or chemoimmunotherapy.
“Study protocols should provide detailed specifications of the planned time points for the assessment of the treatment response under continuous therapy. Response durations of less than six months are not considered clinically relevant,” the panel cautioned.
Response assessments for treatments with a maintenance phase should be performed at a minimum of 2 months after patients achieve their best responses.
MRD: The guidelines call for minimal residual disease (MRD) assessment in clinical trials aimed at maximizing remission depth, with emphasis on reporting the sensitivity of the MRD evaluation method used, and the type of tissue assessed.
Antiviral prophylaxis: The guidelines caution that because patients treated with anti-CD20 antibodies, such as rituximab or obinutuzumab, could have reactivation of hepatitis B virus (HBV) infections, patients should be tested for HBV serological status before starting on an anti-CD20 agent.
“Progressive multifocal leukoencephalopathy has been reported in a few CLL patients treated with anti-CD20 antibodies; therefore, infections with John Cunningham (JC) virus should be ruled out in situations of unclear neurological symptoms,” the panel recommended.
They note that patients younger than 65 treated with fludarabine-based therapy in the first line do not require routine monitoring or infection prophylaxis, due to the low reported incidence of infections in this group.
The authors reported having no financial disclosures related to the guidelines.
FROM BLOOD
Cancer groups offer guidance on musculoskeletal adverse events related to checkpoint inhibitors
Recently released guidelines from two major cancer organizations have provided some of the most comprehensive guidance to date on management of musculoskeletal side effects associated with cancer immunotherapy.
The guidelines, published in February, are a “sorely needed” reference point for the rheumatology community and others who will be encountering patients who experience immune-related adverse events (irAEs), according to Leonard H. Calabrese, DO, the R.J. Fasenmyer Chair of Clinical Immunology at the Cleveland Clinic in Ohio.
“They’re a good first start, given the fact that up until 4 or 5 months ago, there were no endorsed guidelines that included oncologists and rheumatologists,” Dr. Calabrese said of the guidelines, which were collaboratively developed and recently released by both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).
Rheumatologists can add value
“We talk a lot about rheumatologists being aware of these diseases, but it’s been pointed out by some oncologists that unless they’re really knowledgeable and can add considerably to the management, it doesn’t do any good just to be aware of it,” Dr. Calabrese explained. “You need to actually have some procedural knowledge.”
ASCO guidelines also describe a polymyalgia-like syndrome seen in some patients on immune checkpoint inhibitors that according to the guideline authors is characterized by pain, but not true muscle weakness.
In general, the guidelines endorse a stepwise approach, in which milder irAEs can be managed with conservative treatments and without the need to stop the immune checkpoint inhibitor therapy. In contrast, more serious side effects may require more intensive management and either temporary or permanent discontinuation of cancer immunotherapy.
One good example is NCCN’s take on managing inflammatory arthritis.
Mild cases of inflammatory arthritis can be treated with NSAIDs, low-dose prednisone, or intra-articular steroids with no need to stop immune checkpoint inhibitor treatment, according to NCCN guideline authors.
Moderate cases, by contrast, may require holding immunotherapy and treating with prednisone. A rheumatology consult by week 4 is “strongly recommended” if the immune arthritis doesn’t improve, the authors added.
Severe cases may warrant permanent discontinuation of immunotherapy and treatment with methylprednisolone/prednisone, infliximab, or tocilizumab, they added. If the irAE doesn’t improve after 2 weeks, a rheumatology consult should be considered for additional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, or sulfasalazine.
irAEs on the rise
These guidelines are particularly useful for rheumatologists to familiarize themselves with the six Food and Drug Administration–approved immune checkpoint inhibitors, their spectrum of side effects, and how oncologists use the severity of presentation to guide therapy, according to Laura Cappelli, MD.
Understanding irAEs will be increasingly important for rheumatologist as the use of immune checkpoint inhibitors continues to increase, said Dr. Cappelli, who has started a research program at Johns Hopkins to evaluate the rheumatologic adverse effects of these therapies.
Dr. Cappelli said her division sees at least one suspected irAE case per week, most commonly the immune arthritis associated with checkpoint inhibitor therapy.
Likewise, Dr. Calabrese said he is already seeing approximately two new referrals per week for adverse events related to these relatively new therapies.
“It’s far outstripped our notion of what we thought we would be doing,” he said in an interview.
Systems have been set up to encourage interprofessional collaborations, he added, including a “virtual referral clinic” where advanced practitioners working with oncologists communicate with advanced practitioners in each of the specialty areas that are most frequently consulted in order to help facilitate care and triage patients.
In addition, a monthly irAE tumor board was set up to include only cases that have manifest autoimmune or autoinflammatory complications.
“We have a growing group of people who come to this from each area involved, whether it be nephrology, neurology, ophthalmology, gastroenterology, rheumatology, or something else,” Dr. Calabrese said. “That’s been a great learning experience for all of us to talk about these adverse events in real time.”
Critical need for guidance
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Rheumatologists and those with particular expertise in rheumatologic side effects participated in the development of the ASCO and NCCN guidelines. They include Maria E. Suarez-Almazor, MD, PhD, chief of rheumatology and clinical immunology at the University of Texas MD Anderson Cancer Center, Houston, who served on the ASCO expert panel; Jarushka Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, provided expertise in the rheumatologic side effects that were considered by the NCCN panel, according to Dr. Schneider.
Rheumatologist input also informed another set of recommendations on immune checkpoint inhibitor toxicities published several months before the ASCO and NCCN guidelines. The working group for the September 2017 guidelines from the Society for Immunotherapy of Cancer (doi: 10.1186/s40425-017-0300-z) included Dr. Suarez-Almazor, as well as Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center.
Vigilance required
Checkpoint inhibitors have been approved by the FDA to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because irAE symptoms can be subtle, according to Julie Brahmer, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focus specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
Recently released guidelines from two major cancer organizations have provided some of the most comprehensive guidance to date on management of musculoskeletal side effects associated with cancer immunotherapy.
The guidelines, published in February, are a “sorely needed” reference point for the rheumatology community and others who will be encountering patients who experience immune-related adverse events (irAEs), according to Leonard H. Calabrese, DO, the R.J. Fasenmyer Chair of Clinical Immunology at the Cleveland Clinic in Ohio.
“They’re a good first start, given the fact that up until 4 or 5 months ago, there were no endorsed guidelines that included oncologists and rheumatologists,” Dr. Calabrese said of the guidelines, which were collaboratively developed and recently released by both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).
Rheumatologists can add value
“We talk a lot about rheumatologists being aware of these diseases, but it’s been pointed out by some oncologists that unless they’re really knowledgeable and can add considerably to the management, it doesn’t do any good just to be aware of it,” Dr. Calabrese explained. “You need to actually have some procedural knowledge.”
ASCO guidelines also describe a polymyalgia-like syndrome seen in some patients on immune checkpoint inhibitors that according to the guideline authors is characterized by pain, but not true muscle weakness.
In general, the guidelines endorse a stepwise approach, in which milder irAEs can be managed with conservative treatments and without the need to stop the immune checkpoint inhibitor therapy. In contrast, more serious side effects may require more intensive management and either temporary or permanent discontinuation of cancer immunotherapy.
One good example is NCCN’s take on managing inflammatory arthritis.
Mild cases of inflammatory arthritis can be treated with NSAIDs, low-dose prednisone, or intra-articular steroids with no need to stop immune checkpoint inhibitor treatment, according to NCCN guideline authors.
Moderate cases, by contrast, may require holding immunotherapy and treating with prednisone. A rheumatology consult by week 4 is “strongly recommended” if the immune arthritis doesn’t improve, the authors added.
Severe cases may warrant permanent discontinuation of immunotherapy and treatment with methylprednisolone/prednisone, infliximab, or tocilizumab, they added. If the irAE doesn’t improve after 2 weeks, a rheumatology consult should be considered for additional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, or sulfasalazine.
irAEs on the rise
These guidelines are particularly useful for rheumatologists to familiarize themselves with the six Food and Drug Administration–approved immune checkpoint inhibitors, their spectrum of side effects, and how oncologists use the severity of presentation to guide therapy, according to Laura Cappelli, MD.
Understanding irAEs will be increasingly important for rheumatologist as the use of immune checkpoint inhibitors continues to increase, said Dr. Cappelli, who has started a research program at Johns Hopkins to evaluate the rheumatologic adverse effects of these therapies.
Dr. Cappelli said her division sees at least one suspected irAE case per week, most commonly the immune arthritis associated with checkpoint inhibitor therapy.
Likewise, Dr. Calabrese said he is already seeing approximately two new referrals per week for adverse events related to these relatively new therapies.
“It’s far outstripped our notion of what we thought we would be doing,” he said in an interview.
Systems have been set up to encourage interprofessional collaborations, he added, including a “virtual referral clinic” where advanced practitioners working with oncologists communicate with advanced practitioners in each of the specialty areas that are most frequently consulted in order to help facilitate care and triage patients.
In addition, a monthly irAE tumor board was set up to include only cases that have manifest autoimmune or autoinflammatory complications.
“We have a growing group of people who come to this from each area involved, whether it be nephrology, neurology, ophthalmology, gastroenterology, rheumatology, or something else,” Dr. Calabrese said. “That’s been a great learning experience for all of us to talk about these adverse events in real time.”
Critical need for guidance
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Rheumatologists and those with particular expertise in rheumatologic side effects participated in the development of the ASCO and NCCN guidelines. They include Maria E. Suarez-Almazor, MD, PhD, chief of rheumatology and clinical immunology at the University of Texas MD Anderson Cancer Center, Houston, who served on the ASCO expert panel; Jarushka Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, provided expertise in the rheumatologic side effects that were considered by the NCCN panel, according to Dr. Schneider.
Rheumatologist input also informed another set of recommendations on immune checkpoint inhibitor toxicities published several months before the ASCO and NCCN guidelines. The working group for the September 2017 guidelines from the Society for Immunotherapy of Cancer (doi: 10.1186/s40425-017-0300-z) included Dr. Suarez-Almazor, as well as Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center.
Vigilance required
Checkpoint inhibitors have been approved by the FDA to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because irAE symptoms can be subtle, according to Julie Brahmer, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focus specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
Recently released guidelines from two major cancer organizations have provided some of the most comprehensive guidance to date on management of musculoskeletal side effects associated with cancer immunotherapy.
The guidelines, published in February, are a “sorely needed” reference point for the rheumatology community and others who will be encountering patients who experience immune-related adverse events (irAEs), according to Leonard H. Calabrese, DO, the R.J. Fasenmyer Chair of Clinical Immunology at the Cleveland Clinic in Ohio.
“They’re a good first start, given the fact that up until 4 or 5 months ago, there were no endorsed guidelines that included oncologists and rheumatologists,” Dr. Calabrese said of the guidelines, which were collaboratively developed and recently released by both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).
Rheumatologists can add value
“We talk a lot about rheumatologists being aware of these diseases, but it’s been pointed out by some oncologists that unless they’re really knowledgeable and can add considerably to the management, it doesn’t do any good just to be aware of it,” Dr. Calabrese explained. “You need to actually have some procedural knowledge.”
ASCO guidelines also describe a polymyalgia-like syndrome seen in some patients on immune checkpoint inhibitors that according to the guideline authors is characterized by pain, but not true muscle weakness.
In general, the guidelines endorse a stepwise approach, in which milder irAEs can be managed with conservative treatments and without the need to stop the immune checkpoint inhibitor therapy. In contrast, more serious side effects may require more intensive management and either temporary or permanent discontinuation of cancer immunotherapy.
One good example is NCCN’s take on managing inflammatory arthritis.
Mild cases of inflammatory arthritis can be treated with NSAIDs, low-dose prednisone, or intra-articular steroids with no need to stop immune checkpoint inhibitor treatment, according to NCCN guideline authors.
Moderate cases, by contrast, may require holding immunotherapy and treating with prednisone. A rheumatology consult by week 4 is “strongly recommended” if the immune arthritis doesn’t improve, the authors added.
Severe cases may warrant permanent discontinuation of immunotherapy and treatment with methylprednisolone/prednisone, infliximab, or tocilizumab, they added. If the irAE doesn’t improve after 2 weeks, a rheumatology consult should be considered for additional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, or sulfasalazine.
irAEs on the rise
These guidelines are particularly useful for rheumatologists to familiarize themselves with the six Food and Drug Administration–approved immune checkpoint inhibitors, their spectrum of side effects, and how oncologists use the severity of presentation to guide therapy, according to Laura Cappelli, MD.
Understanding irAEs will be increasingly important for rheumatologist as the use of immune checkpoint inhibitors continues to increase, said Dr. Cappelli, who has started a research program at Johns Hopkins to evaluate the rheumatologic adverse effects of these therapies.
Dr. Cappelli said her division sees at least one suspected irAE case per week, most commonly the immune arthritis associated with checkpoint inhibitor therapy.
Likewise, Dr. Calabrese said he is already seeing approximately two new referrals per week for adverse events related to these relatively new therapies.
“It’s far outstripped our notion of what we thought we would be doing,” he said in an interview.
Systems have been set up to encourage interprofessional collaborations, he added, including a “virtual referral clinic” where advanced practitioners working with oncologists communicate with advanced practitioners in each of the specialty areas that are most frequently consulted in order to help facilitate care and triage patients.
In addition, a monthly irAE tumor board was set up to include only cases that have manifest autoimmune or autoinflammatory complications.
“We have a growing group of people who come to this from each area involved, whether it be nephrology, neurology, ophthalmology, gastroenterology, rheumatology, or something else,” Dr. Calabrese said. “That’s been a great learning experience for all of us to talk about these adverse events in real time.”
Critical need for guidance
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Rheumatologists and those with particular expertise in rheumatologic side effects participated in the development of the ASCO and NCCN guidelines. They include Maria E. Suarez-Almazor, MD, PhD, chief of rheumatology and clinical immunology at the University of Texas MD Anderson Cancer Center, Houston, who served on the ASCO expert panel; Jarushka Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, provided expertise in the rheumatologic side effects that were considered by the NCCN panel, according to Dr. Schneider.
Rheumatologist input also informed another set of recommendations on immune checkpoint inhibitor toxicities published several months before the ASCO and NCCN guidelines. The working group for the September 2017 guidelines from the Society for Immunotherapy of Cancer (doi: 10.1186/s40425-017-0300-z) included Dr. Suarez-Almazor, as well as Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center.
Vigilance required
Checkpoint inhibitors have been approved by the FDA to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because irAE symptoms can be subtle, according to Julie Brahmer, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focus specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
Accelerated breast irradiation advocated by ASTRO guideline
Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.
A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.
“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.
Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”
Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.
Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.
“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.
Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.
Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.
With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.
As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.
ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).
“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.
“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”
SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.
Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.
A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.
“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.
Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”
Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.
Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.
“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.
Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.
Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.
With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.
As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.
ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).
“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.
“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”
SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.
Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.
A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.
“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.
Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”
Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.
Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.
“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.
Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.
Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.
With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.
As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.
ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).
“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.
“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”
SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.
FROM PRACTICAL RADIATION ONCOLOGY
Key clinical point: For invasive cancer, the preferred scheme is hypofractionated whole breast irradiation (HF-WBI).
Major finding: HF-WBI should be given to a total dose of 4,000 cGy in 15 fractions or 4,250 cGy in 16 fractions.
Study details: A systematic literature review of all relevant studies published during 2009-2016.
Disclosures: The guidelines were sponsored by the American Society for Radiation Oncology.
Source: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.
Medical associations fight American College of Physicians HBA1c recommendations
in a statement released Friday, March 9.
The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.
“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.
“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”
With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.
The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.
While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.
The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”
Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*
At press time the American College of Physicians was unable to provide a statement.
Corrections, 3/12/18: *An earlier version of this article misstated one of the drug classes mentioned.
**An earlier version of this article misstated a reference to the patient group specified.
in a statement released Friday, March 9.
The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.
“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.
“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”
With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.
The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.
While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.
The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”
Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*
At press time the American College of Physicians was unable to provide a statement.
Corrections, 3/12/18: *An earlier version of this article misstated one of the drug classes mentioned.
**An earlier version of this article misstated a reference to the patient group specified.
in a statement released Friday, March 9.
The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.
“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.
“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”
With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.
The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.
While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.
The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”
Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*
At press time the American College of Physicians was unable to provide a statement.
Corrections, 3/12/18: *An earlier version of this article misstated one of the drug classes mentioned.
**An earlier version of this article misstated a reference to the patient group specified.