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Privacy and maternal records
At the undergraduate level, classes on medical ethics tend to focus on the big ticket items like abortion, euthanasia, and social justice. Personally, I find the more interesting clinical cases involve relatively minor issues that accumulate to create problems. Privacy is one example.
A large amount of information in the mother’s prenatal records potentially impacts a newborn’s care. Ideally, the EHR is transferring data to the newborn’s chart, but not everything automatically populates in the newborn record, so there will be times when a pediatrician needs to review the mother’s chart.
- The criteria for selecting which mothers’ charts to review involve racial profiling.
- Access to mental health records involving addiction treatment requires special authorization. State laws and hospital policies will vary.
- Mom is a Hollywood celebrity and, while reviewing her chart, prurient curiosity extends the search to records of her cosmetic surgeries.
In my opinion, most of what is and isn’t permissible is determined by medical custom and not by statutes. The judiciary reserves the power to intervene, so medical custom should be informed by laws and by legal principles. But, the primary basis for these decisions should be a commitment to patient advocacy and to common sense, which in this situation means, “Would the typical reasonable person be upset if she learned I had done something without telling her?” If the answer to that question is yes, or in any way equivocal, I think ethics would dictate obtaining consent or at least assent.
Opiate addiction has quadrupled in the past 15 years. Almost all states now have prescription registries to help detect doctor shopping, multiple prescribers, and misdirection. If you are prescribing an opiate, it is ethically reasonable (and now the law) for you to make writing the prescription contingent on your patient agreeing to your consulting the registry. No consent, no prescription.
I think the facts of that case (writing a prescription) can be distinguished (a legal term) from the case of a neonatologist accessing the narcotic registry of the mother while on a fishing expedition to find evidence that might help the baby. Perhaps it is okay with the mother’s uncoerced consent, but otherwise I think that practice reeks as an unreasonable search. Ethically and legally, it has parallels to Ferguson v. City of Charleston (SCOTUS 2001).
That was a 6-3 Supreme Court decision, so, while I agree with the majority, you may find hospital lawyers who disagree. Overall, I assert that consent and privacy are best considered ethically as advocacy for the patient and not as legalistic forms that the physician must complete.
The reverse situation also occurs. Sometimes maternal health information is placed into the newborn’s chart that doesn’t need to be there. For example, common practice has been to designate mom, after delivery, as G4P2022. This contains the information that mother has had two therapeutic abortions. Does that information belong in a newborn’s chart? Especially in the era of the EHR where this information will hang around forever and will be easily obtained by the baby 16 years later when she can access all her medical information online. Will the mother be upset for her teenage daughter to learn that mom has had two abortions? Is that private information, belonging to the mother, that was given in confidence to her obstetrician? I advocate respecting privacy.
I have similar concerns about STD information being transferred from maternal charts to the newborn’s EHR. A maternal history of gonorrhea treated 8 years previously is unlikely to be relevant and should not populate the newborn’s EHR. I can make an argument that chlamydia detected and treated during the pregnancy might be useful to the baby’s pediatrician because neither treatment nor tests of cure are perfect. Perhaps, it could exist as a Snapchat-type record and disappear from the newborn’s record in a year if no respiratory symptoms occur.
I’m aware of efforts to destigmatize abortion and STDs, but, until that occurs, sensitive information should be handled delicately to preserve privacy. That is a major component of the Hippocratic Oath.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
At the undergraduate level, classes on medical ethics tend to focus on the big ticket items like abortion, euthanasia, and social justice. Personally, I find the more interesting clinical cases involve relatively minor issues that accumulate to create problems. Privacy is one example.
A large amount of information in the mother’s prenatal records potentially impacts a newborn’s care. Ideally, the EHR is transferring data to the newborn’s chart, but not everything automatically populates in the newborn record, so there will be times when a pediatrician needs to review the mother’s chart.
- The criteria for selecting which mothers’ charts to review involve racial profiling.
- Access to mental health records involving addiction treatment requires special authorization. State laws and hospital policies will vary.
- Mom is a Hollywood celebrity and, while reviewing her chart, prurient curiosity extends the search to records of her cosmetic surgeries.
In my opinion, most of what is and isn’t permissible is determined by medical custom and not by statutes. The judiciary reserves the power to intervene, so medical custom should be informed by laws and by legal principles. But, the primary basis for these decisions should be a commitment to patient advocacy and to common sense, which in this situation means, “Would the typical reasonable person be upset if she learned I had done something without telling her?” If the answer to that question is yes, or in any way equivocal, I think ethics would dictate obtaining consent or at least assent.
Opiate addiction has quadrupled in the past 15 years. Almost all states now have prescription registries to help detect doctor shopping, multiple prescribers, and misdirection. If you are prescribing an opiate, it is ethically reasonable (and now the law) for you to make writing the prescription contingent on your patient agreeing to your consulting the registry. No consent, no prescription.
I think the facts of that case (writing a prescription) can be distinguished (a legal term) from the case of a neonatologist accessing the narcotic registry of the mother while on a fishing expedition to find evidence that might help the baby. Perhaps it is okay with the mother’s uncoerced consent, but otherwise I think that practice reeks as an unreasonable search. Ethically and legally, it has parallels to Ferguson v. City of Charleston (SCOTUS 2001).
That was a 6-3 Supreme Court decision, so, while I agree with the majority, you may find hospital lawyers who disagree. Overall, I assert that consent and privacy are best considered ethically as advocacy for the patient and not as legalistic forms that the physician must complete.
The reverse situation also occurs. Sometimes maternal health information is placed into the newborn’s chart that doesn’t need to be there. For example, common practice has been to designate mom, after delivery, as G4P2022. This contains the information that mother has had two therapeutic abortions. Does that information belong in a newborn’s chart? Especially in the era of the EHR where this information will hang around forever and will be easily obtained by the baby 16 years later when she can access all her medical information online. Will the mother be upset for her teenage daughter to learn that mom has had two abortions? Is that private information, belonging to the mother, that was given in confidence to her obstetrician? I advocate respecting privacy.
I have similar concerns about STD information being transferred from maternal charts to the newborn’s EHR. A maternal history of gonorrhea treated 8 years previously is unlikely to be relevant and should not populate the newborn’s EHR. I can make an argument that chlamydia detected and treated during the pregnancy might be useful to the baby’s pediatrician because neither treatment nor tests of cure are perfect. Perhaps, it could exist as a Snapchat-type record and disappear from the newborn’s record in a year if no respiratory symptoms occur.
I’m aware of efforts to destigmatize abortion and STDs, but, until that occurs, sensitive information should be handled delicately to preserve privacy. That is a major component of the Hippocratic Oath.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
At the undergraduate level, classes on medical ethics tend to focus on the big ticket items like abortion, euthanasia, and social justice. Personally, I find the more interesting clinical cases involve relatively minor issues that accumulate to create problems. Privacy is one example.
A large amount of information in the mother’s prenatal records potentially impacts a newborn’s care. Ideally, the EHR is transferring data to the newborn’s chart, but not everything automatically populates in the newborn record, so there will be times when a pediatrician needs to review the mother’s chart.
- The criteria for selecting which mothers’ charts to review involve racial profiling.
- Access to mental health records involving addiction treatment requires special authorization. State laws and hospital policies will vary.
- Mom is a Hollywood celebrity and, while reviewing her chart, prurient curiosity extends the search to records of her cosmetic surgeries.
In my opinion, most of what is and isn’t permissible is determined by medical custom and not by statutes. The judiciary reserves the power to intervene, so medical custom should be informed by laws and by legal principles. But, the primary basis for these decisions should be a commitment to patient advocacy and to common sense, which in this situation means, “Would the typical reasonable person be upset if she learned I had done something without telling her?” If the answer to that question is yes, or in any way equivocal, I think ethics would dictate obtaining consent or at least assent.
Opiate addiction has quadrupled in the past 15 years. Almost all states now have prescription registries to help detect doctor shopping, multiple prescribers, and misdirection. If you are prescribing an opiate, it is ethically reasonable (and now the law) for you to make writing the prescription contingent on your patient agreeing to your consulting the registry. No consent, no prescription.
I think the facts of that case (writing a prescription) can be distinguished (a legal term) from the case of a neonatologist accessing the narcotic registry of the mother while on a fishing expedition to find evidence that might help the baby. Perhaps it is okay with the mother’s uncoerced consent, but otherwise I think that practice reeks as an unreasonable search. Ethically and legally, it has parallels to Ferguson v. City of Charleston (SCOTUS 2001).
That was a 6-3 Supreme Court decision, so, while I agree with the majority, you may find hospital lawyers who disagree. Overall, I assert that consent and privacy are best considered ethically as advocacy for the patient and not as legalistic forms that the physician must complete.
The reverse situation also occurs. Sometimes maternal health information is placed into the newborn’s chart that doesn’t need to be there. For example, common practice has been to designate mom, after delivery, as G4P2022. This contains the information that mother has had two therapeutic abortions. Does that information belong in a newborn’s chart? Especially in the era of the EHR where this information will hang around forever and will be easily obtained by the baby 16 years later when she can access all her medical information online. Will the mother be upset for her teenage daughter to learn that mom has had two abortions? Is that private information, belonging to the mother, that was given in confidence to her obstetrician? I advocate respecting privacy.
I have similar concerns about STD information being transferred from maternal charts to the newborn’s EHR. A maternal history of gonorrhea treated 8 years previously is unlikely to be relevant and should not populate the newborn’s EHR. I can make an argument that chlamydia detected and treated during the pregnancy might be useful to the baby’s pediatrician because neither treatment nor tests of cure are perfect. Perhaps, it could exist as a Snapchat-type record and disappear from the newborn’s record in a year if no respiratory symptoms occur.
I’m aware of efforts to destigmatize abortion and STDs, but, until that occurs, sensitive information should be handled delicately to preserve privacy. That is a major component of the Hippocratic Oath.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
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Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
NONESTROGEN PRODUCT FOR DYSPAREUNIA
FOR MORE INFORMATION, VISIT: http://www.amagpharma.com
ORAL MAINTENANCE TX FOR RECURRENT CANCER
FOR MORE INFORMATION, VISIT: http://www.zejula.com
MIGS STAPLING SYSTEM WITH REAL-TIME FEEDBACK
FOR MORE INFORMATION, VISIT: http://www.medtronic.com
BONE BUILDING AGENT
FOR MORE INFORMATION, VISIT: http://www.radiuspharm.com
PROTEOMIC BREAST CANCER ASSAY
FOR MORE INFORMATION, VISIT: http://www.provistadx.com
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
NONESTROGEN PRODUCT FOR DYSPAREUNIA
FOR MORE INFORMATION, VISIT: http://www.amagpharma.com
ORAL MAINTENANCE TX FOR RECURRENT CANCER
FOR MORE INFORMATION, VISIT: http://www.zejula.com
MIGS STAPLING SYSTEM WITH REAL-TIME FEEDBACK
FOR MORE INFORMATION, VISIT: http://www.medtronic.com
BONE BUILDING AGENT
FOR MORE INFORMATION, VISIT: http://www.radiuspharm.com
PROTEOMIC BREAST CANCER ASSAY
FOR MORE INFORMATION, VISIT: http://www.provistadx.com
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Therapeutic patient education is a new way to approach atopic dermatitis
(AD) resulting from poor adherence to treatment.
The aim of TPE, a multidisciplinary approach to caring for and managing AD, is to improve patient and caregiver adherence to physician-directed treatments through education and to improve quality of life, according to several presenters who spoke at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and University of California, San Diego. They reviewed the approach to using TPE in chronic disease states, demonstrating this state-of-the-art approach to educating patients, families, and health care providers about AD management, and allowing for the exchange of ideas for best practices on AD therapeutic education programs and use in the U.S. health care environment.
Other successful meetings on TPE in Europe, Asia, and South America inspired this meeting, the first in the United States aimed to train health care professionals in TPE principles for AD. The meeting was sponsored by the Fondation Dermatite Atopique (Atopic Dermatitis Foundation for Research and Education), Rady’s Eczema and Inflammatory Skin Disease Center, and UCSD.
TPE is defined by the World Health Organization as an approach to help patients with chronic illness acquire or maintain the skills necessary to manage their life and illness in the best way possible. TPE involves patient preferences, shared decision-making, organized activities, psychosocial support, hospital organization and procedures, and health- and disease-related behaviors.
Sébastien Barbarot, MD, of the departments of dermatology and pediatric dermatology, Nantes (France) University Hospital, said that there are four main components to the TPE process:
• Assessing and understanding the patient’s knowledge and values.
• Developing age-appropriate personalized educational objectives.
• Transferring the necessary skills to the patient or caregiver.
• Assessing the effectiveness of the educational program.
Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at UCSD, discussed how to conduct the initial visit with potential candidates for TPE. At the new patient visit, the pediatric patient and their caregivers should first be presented with the concept of TPE, which includes proposing a personalized education approach. Next, explain the goals and benefits of TPE (with a time and location for the sessions), provide educational materials, allow time for questions, and establish the patient’s consent to participate.
The certain skills that patients should acquire fall under three main categories: knowledge of the disease, practical skills, and relational skills.
Alain Golay, MD, professor and chief of the department of therapeutic education in chronic diseases at the Geneva University Hospital, said that patients and caregivers should be familiar with the pathophysiology and natural history of the disease, as well as with aggravating factors and the rationale behind elements of the treatment plan – and they should understand a reasonable timeline for treatment responses.
Learning how to properly apply the treatment is among the practical skills that the patient needs to acquire. In terms of relational skills, patients should know enough about their disease to be able to explain it to others. Educational methods can include interactive presentations, case studies, roundtable meetings, workshops, and role play. Other tools that can be used as a resource include written action plans, posters, informational videos, reminders, and booklets. Nurse-led educational sessions that increase teaching time is another modality. Multidisciplinary clinics should include an allergist, dermatologist, psychologist, dietitian, and nurse. These clinics also can form workshops or teaching groups. This allows for smaller groups where ideas can be exchanged, and can be targeted specifically based on the audiences’ needs, he said.
Dr. Barbarot outlined the fourth step of TPE, which involves assessment of effectiveness. Several outcome measures can be used, including clinical outcomes, quality of life, patient global assessment, and knowledge questionnaires.
(AD) resulting from poor adherence to treatment.
The aim of TPE, a multidisciplinary approach to caring for and managing AD, is to improve patient and caregiver adherence to physician-directed treatments through education and to improve quality of life, according to several presenters who spoke at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and University of California, San Diego. They reviewed the approach to using TPE in chronic disease states, demonstrating this state-of-the-art approach to educating patients, families, and health care providers about AD management, and allowing for the exchange of ideas for best practices on AD therapeutic education programs and use in the U.S. health care environment.
Other successful meetings on TPE in Europe, Asia, and South America inspired this meeting, the first in the United States aimed to train health care professionals in TPE principles for AD. The meeting was sponsored by the Fondation Dermatite Atopique (Atopic Dermatitis Foundation for Research and Education), Rady’s Eczema and Inflammatory Skin Disease Center, and UCSD.
TPE is defined by the World Health Organization as an approach to help patients with chronic illness acquire or maintain the skills necessary to manage their life and illness in the best way possible. TPE involves patient preferences, shared decision-making, organized activities, psychosocial support, hospital organization and procedures, and health- and disease-related behaviors.
Sébastien Barbarot, MD, of the departments of dermatology and pediatric dermatology, Nantes (France) University Hospital, said that there are four main components to the TPE process:
• Assessing and understanding the patient’s knowledge and values.
• Developing age-appropriate personalized educational objectives.
• Transferring the necessary skills to the patient or caregiver.
• Assessing the effectiveness of the educational program.
Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at UCSD, discussed how to conduct the initial visit with potential candidates for TPE. At the new patient visit, the pediatric patient and their caregivers should first be presented with the concept of TPE, which includes proposing a personalized education approach. Next, explain the goals and benefits of TPE (with a time and location for the sessions), provide educational materials, allow time for questions, and establish the patient’s consent to participate.
The certain skills that patients should acquire fall under three main categories: knowledge of the disease, practical skills, and relational skills.
Alain Golay, MD, professor and chief of the department of therapeutic education in chronic diseases at the Geneva University Hospital, said that patients and caregivers should be familiar with the pathophysiology and natural history of the disease, as well as with aggravating factors and the rationale behind elements of the treatment plan – and they should understand a reasonable timeline for treatment responses.
Learning how to properly apply the treatment is among the practical skills that the patient needs to acquire. In terms of relational skills, patients should know enough about their disease to be able to explain it to others. Educational methods can include interactive presentations, case studies, roundtable meetings, workshops, and role play. Other tools that can be used as a resource include written action plans, posters, informational videos, reminders, and booklets. Nurse-led educational sessions that increase teaching time is another modality. Multidisciplinary clinics should include an allergist, dermatologist, psychologist, dietitian, and nurse. These clinics also can form workshops or teaching groups. This allows for smaller groups where ideas can be exchanged, and can be targeted specifically based on the audiences’ needs, he said.
Dr. Barbarot outlined the fourth step of TPE, which involves assessment of effectiveness. Several outcome measures can be used, including clinical outcomes, quality of life, patient global assessment, and knowledge questionnaires.
(AD) resulting from poor adherence to treatment.
The aim of TPE, a multidisciplinary approach to caring for and managing AD, is to improve patient and caregiver adherence to physician-directed treatments through education and to improve quality of life, according to several presenters who spoke at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and University of California, San Diego. They reviewed the approach to using TPE in chronic disease states, demonstrating this state-of-the-art approach to educating patients, families, and health care providers about AD management, and allowing for the exchange of ideas for best practices on AD therapeutic education programs and use in the U.S. health care environment.
Other successful meetings on TPE in Europe, Asia, and South America inspired this meeting, the first in the United States aimed to train health care professionals in TPE principles for AD. The meeting was sponsored by the Fondation Dermatite Atopique (Atopic Dermatitis Foundation for Research and Education), Rady’s Eczema and Inflammatory Skin Disease Center, and UCSD.
TPE is defined by the World Health Organization as an approach to help patients with chronic illness acquire or maintain the skills necessary to manage their life and illness in the best way possible. TPE involves patient preferences, shared decision-making, organized activities, psychosocial support, hospital organization and procedures, and health- and disease-related behaviors.
Sébastien Barbarot, MD, of the departments of dermatology and pediatric dermatology, Nantes (France) University Hospital, said that there are four main components to the TPE process:
• Assessing and understanding the patient’s knowledge and values.
• Developing age-appropriate personalized educational objectives.
• Transferring the necessary skills to the patient or caregiver.
• Assessing the effectiveness of the educational program.
Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego and professor of dermatology and pediatrics at UCSD, discussed how to conduct the initial visit with potential candidates for TPE. At the new patient visit, the pediatric patient and their caregivers should first be presented with the concept of TPE, which includes proposing a personalized education approach. Next, explain the goals and benefits of TPE (with a time and location for the sessions), provide educational materials, allow time for questions, and establish the patient’s consent to participate.
The certain skills that patients should acquire fall under three main categories: knowledge of the disease, practical skills, and relational skills.
Alain Golay, MD, professor and chief of the department of therapeutic education in chronic diseases at the Geneva University Hospital, said that patients and caregivers should be familiar with the pathophysiology and natural history of the disease, as well as with aggravating factors and the rationale behind elements of the treatment plan – and they should understand a reasonable timeline for treatment responses.
Learning how to properly apply the treatment is among the practical skills that the patient needs to acquire. In terms of relational skills, patients should know enough about their disease to be able to explain it to others. Educational methods can include interactive presentations, case studies, roundtable meetings, workshops, and role play. Other tools that can be used as a resource include written action plans, posters, informational videos, reminders, and booklets. Nurse-led educational sessions that increase teaching time is another modality. Multidisciplinary clinics should include an allergist, dermatologist, psychologist, dietitian, and nurse. These clinics also can form workshops or teaching groups. This allows for smaller groups where ideas can be exchanged, and can be targeted specifically based on the audiences’ needs, he said.
Dr. Barbarot outlined the fourth step of TPE, which involves assessment of effectiveness. Several outcome measures can be used, including clinical outcomes, quality of life, patient global assessment, and knowledge questionnaires.
VIDEO: Cancer immunotherapies activate rheumatologic adverse effects
MADRID – The introduction of immune checkpoint inhibitor drugs has “been great for cancer but bad for rheumatology.”
That’s the gist of the immunologic adverse effect fallout from the immunomodulatory revolution that’s recently swept oncology, Leonard Calabrese, DO, said in a video interview during the European Congress of Rheumatology.
Results from a recent survey of U.S. rheumatologists run by Dr. Calabrese and his associates showed that “more than a quarter” now have seen at least one patient who experienced activation of a rheumatologic disease after starting treatment with an immune checkpoint inhibitor, said Dr. Calabrese, head of the section of clinical immunology at the Cleveland Clinic in Ohio.
Unlike most other immunological adverse effects caused by immune checkpoint inhibitors, the rheumatologic complications usually don’t resolve when treatment stops, he added.
These adverse effects represent a new wrinkle for the practice of rheumatology and are now something that clinicians must familiarize themselves with, Dr. Calabrese advised.
Dr. Calabrese reported that he is a consultant to Bristol-Myers Squibb.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
MADRID – The introduction of immune checkpoint inhibitor drugs has “been great for cancer but bad for rheumatology.”
That’s the gist of the immunologic adverse effect fallout from the immunomodulatory revolution that’s recently swept oncology, Leonard Calabrese, DO, said in a video interview during the European Congress of Rheumatology.
Results from a recent survey of U.S. rheumatologists run by Dr. Calabrese and his associates showed that “more than a quarter” now have seen at least one patient who experienced activation of a rheumatologic disease after starting treatment with an immune checkpoint inhibitor, said Dr. Calabrese, head of the section of clinical immunology at the Cleveland Clinic in Ohio.
Unlike most other immunological adverse effects caused by immune checkpoint inhibitors, the rheumatologic complications usually don’t resolve when treatment stops, he added.
These adverse effects represent a new wrinkle for the practice of rheumatology and are now something that clinicians must familiarize themselves with, Dr. Calabrese advised.
Dr. Calabrese reported that he is a consultant to Bristol-Myers Squibb.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
MADRID – The introduction of immune checkpoint inhibitor drugs has “been great for cancer but bad for rheumatology.”
That’s the gist of the immunologic adverse effect fallout from the immunomodulatory revolution that’s recently swept oncology, Leonard Calabrese, DO, said in a video interview during the European Congress of Rheumatology.
Results from a recent survey of U.S. rheumatologists run by Dr. Calabrese and his associates showed that “more than a quarter” now have seen at least one patient who experienced activation of a rheumatologic disease after starting treatment with an immune checkpoint inhibitor, said Dr. Calabrese, head of the section of clinical immunology at the Cleveland Clinic in Ohio.
Unlike most other immunological adverse effects caused by immune checkpoint inhibitors, the rheumatologic complications usually don’t resolve when treatment stops, he added.
These adverse effects represent a new wrinkle for the practice of rheumatology and are now something that clinicians must familiarize themselves with, Dr. Calabrese advised.
Dr. Calabrese reported that he is a consultant to Bristol-Myers Squibb.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE EULAR 2017 CONGRESS
SUNSHINE: High-dose vitamin D boosts PFS in metastatic CRC
CHICAGO – High-dose vitamin D supplementation is a simple, safe approach for improving on the efficacy of first-line chemotherapy for metastatic colorectal cancer, suggest findings of the SUNSHINE trial reported at the annual meeting of the American Society of Clinical Oncology.
“Vitamin D has shown anti-neoplastic properties in the laboratory, including inhibition of cell proliferation and angiogenesis, induction of cell differentiation and apoptosis, as well as anti-inflammatory and immunomodulatory effects,” said lead author Kimmie Ng, MD, director of clinical research and a Gastrointestinal Cancer Center physician at the Dana-Farber Cancer Institute in Boston.
“The vitamin D hypothesis is also supported by a large body of epidemiologic evidence, both from our group as well as from others, that have shown that higher plasma 25-hydroxyvitamin D levels are associated with improved survival in patients with colorectal cancer,” she added.
Notably, in the CALGB/SWOG 80405 trial of first-line therapy for colorectal cancer, patients’ median 25-hydroxy vitamin D level at baseline fell below the cutoff for deficiency (ASCO 2015 meeting, Abstract 3503). Moreover, those having higher levels ultimately had better overall survival even after other factors were taken into account.
In the SUNSHINE trial, the investigators studied 139 patients with untreated metastatic colorectal cancer. Results showed that those given FOLFOX chemotherapy and the antiangiogenic agent bevacizumab (Avastin) plus high-dose vitamin D had a one-third lower risk of progression or death compared with counterparts given the same regimen plus low-dose vitamin D.
High-dose supplementation was not associated with greater toxicity. In fact, patients in that group had a much lower incidence of grade 3 or 4 diarrhea.
“After a decade of observational data linking higher vitamin D status with improved outcomes in colorectal cancer patients, SUNSHINE is the first completed randomized double-blind controlled clinical trial of vitamin D supplementation for treatment of colorectal cancer,” Dr. Ng said. “The trial met its primary endpoint. Given this data, a larger, confirmatory phase III trial is warranted.”
The investigators are performing subgroup analyses and analyzing overall survival, and will measure patients’ 25-hydroxyvitamin D levels in plasma samples collected serially throughout the study to determine whether they correlate with outcomes.
In addition, “to help understand and elucidate underlying mechanisms and biology, we have planned several correlative studies looking at tumoral and plasma biomarkers related to the vitamin D pathway, inflammation, and tumor immunity, among other pathways,” she further noted. “We will also be conducting next-generation sequencing and gene expression analyses.”
Expert perspective
“It will be interesting to know [patients’ vitamin D levels] as the majority of patients were enrolled in New England, where I think there is a little less sunshine than in other parts of the United States, so perhaps the vitamin D levels will reflect that,” said invited discussant Andrea Cercek, MD, of Memorial Sloan Kettering Cancer Center in New York.
Data on vitamin D pertaining to chemoprevention and to outcomes in other malignancies have been mixed, she cautioned. For example, supplementation did not reduce the risk of recurrent colorectal adenomas in one study (N Engl J Med. 2015;373:1519-30), and benefit or harm in terms of developing advanced colorectal adenomas in another study hinged on vitamin D receptor genotype (JAMA Oncol. 2017;3:628-35). Among patients with prostate cancer, addition of vitamin D to chemotherapy was actually associated with poorer overall survival (J Clin Oncol. 2011;29:2191-8).
“SUNSHINE was a positive study. It was a very well carried out phase II trial with a significant progression-free survival benefit. Correlative analyses are ongoing, and these will be critical, looking at biomarkers, perhaps helping us identify those patients who will benefit,” Dr. Cercek summarized. “I agree 100% with the investigators that a phase III study is warranted, and I look forward to it.”
Study details
Patients in SUNSHINE were randomized to receive first-line modified FOLFOX chemotherapy and bevacizumab plus either high-dose vitamin D (oral vitamin D3 8,000 IU/day for 2 weeks as a loading dose, followed by 4,000 IU/day) or low-dose vitamin D (oral vitamin D3 400 IU/day) on a double-blind basis. The latter “is an amount you would find in a multivitamin and only increases plasma levels by about 3 ng/mL, thus serving as a useful active control” Dr. Ng noted.
Receipt of chemotherapy and bevacizumab was generally similar between groups. “It is interesting to note that more patients receiving high-dose vitamin D discontinued treatment to undergo potentially curative surgery compared to those in the control arm, though this was not statistically different,” she noted.
In intent-to-treat analysis conducted at a median follow-up of 17-18 months, progression-free survival, the trial’s primary endpoint, was a median of 13.1 months in the high-dose group and 11.2 months in the low-dose group (P = .04). The difference in favor of high-dose vitamin D remained significant in multivariate analysis (hazard ratio, 0.67; P = .02).
The groups were statistically indistinguishable with respect to overall response rate, but the disease control rate was marginally better with high-dose versus low-dose vitamin D (96% vs. 84%, P = .05).
Rates of most grade 3 or 4 adverse events did not differ significantly between groups. However, diarrhea of these grades was less common in the high-dose vitamin D group (1% vs. 12%; P = .02). With respect to grade 3 or 4 events possibly related to the vitamin therapy, there was one case of hyperphosphatemia in the high-dose group and one case of kidney stones in the low-dose group.
Dr. Ng disclosed that she receives honoraria from Prime Oncology and Sage Publications; has a consulting or advisory role with Defined Health and Genentech/Roche; and receives research funding from Celgene, Genentech/Roche (institutional), Gilead Sciences, Pharmavite (institutional), and Trovagene.
CHICAGO – High-dose vitamin D supplementation is a simple, safe approach for improving on the efficacy of first-line chemotherapy for metastatic colorectal cancer, suggest findings of the SUNSHINE trial reported at the annual meeting of the American Society of Clinical Oncology.
“Vitamin D has shown anti-neoplastic properties in the laboratory, including inhibition of cell proliferation and angiogenesis, induction of cell differentiation and apoptosis, as well as anti-inflammatory and immunomodulatory effects,” said lead author Kimmie Ng, MD, director of clinical research and a Gastrointestinal Cancer Center physician at the Dana-Farber Cancer Institute in Boston.
“The vitamin D hypothesis is also supported by a large body of epidemiologic evidence, both from our group as well as from others, that have shown that higher plasma 25-hydroxyvitamin D levels are associated with improved survival in patients with colorectal cancer,” she added.
Notably, in the CALGB/SWOG 80405 trial of first-line therapy for colorectal cancer, patients’ median 25-hydroxy vitamin D level at baseline fell below the cutoff for deficiency (ASCO 2015 meeting, Abstract 3503). Moreover, those having higher levels ultimately had better overall survival even after other factors were taken into account.
In the SUNSHINE trial, the investigators studied 139 patients with untreated metastatic colorectal cancer. Results showed that those given FOLFOX chemotherapy and the antiangiogenic agent bevacizumab (Avastin) plus high-dose vitamin D had a one-third lower risk of progression or death compared with counterparts given the same regimen plus low-dose vitamin D.
High-dose supplementation was not associated with greater toxicity. In fact, patients in that group had a much lower incidence of grade 3 or 4 diarrhea.
“After a decade of observational data linking higher vitamin D status with improved outcomes in colorectal cancer patients, SUNSHINE is the first completed randomized double-blind controlled clinical trial of vitamin D supplementation for treatment of colorectal cancer,” Dr. Ng said. “The trial met its primary endpoint. Given this data, a larger, confirmatory phase III trial is warranted.”
The investigators are performing subgroup analyses and analyzing overall survival, and will measure patients’ 25-hydroxyvitamin D levels in plasma samples collected serially throughout the study to determine whether they correlate with outcomes.
In addition, “to help understand and elucidate underlying mechanisms and biology, we have planned several correlative studies looking at tumoral and plasma biomarkers related to the vitamin D pathway, inflammation, and tumor immunity, among other pathways,” she further noted. “We will also be conducting next-generation sequencing and gene expression analyses.”
Expert perspective
“It will be interesting to know [patients’ vitamin D levels] as the majority of patients were enrolled in New England, where I think there is a little less sunshine than in other parts of the United States, so perhaps the vitamin D levels will reflect that,” said invited discussant Andrea Cercek, MD, of Memorial Sloan Kettering Cancer Center in New York.
Data on vitamin D pertaining to chemoprevention and to outcomes in other malignancies have been mixed, she cautioned. For example, supplementation did not reduce the risk of recurrent colorectal adenomas in one study (N Engl J Med. 2015;373:1519-30), and benefit or harm in terms of developing advanced colorectal adenomas in another study hinged on vitamin D receptor genotype (JAMA Oncol. 2017;3:628-35). Among patients with prostate cancer, addition of vitamin D to chemotherapy was actually associated with poorer overall survival (J Clin Oncol. 2011;29:2191-8).
“SUNSHINE was a positive study. It was a very well carried out phase II trial with a significant progression-free survival benefit. Correlative analyses are ongoing, and these will be critical, looking at biomarkers, perhaps helping us identify those patients who will benefit,” Dr. Cercek summarized. “I agree 100% with the investigators that a phase III study is warranted, and I look forward to it.”
Study details
Patients in SUNSHINE were randomized to receive first-line modified FOLFOX chemotherapy and bevacizumab plus either high-dose vitamin D (oral vitamin D3 8,000 IU/day for 2 weeks as a loading dose, followed by 4,000 IU/day) or low-dose vitamin D (oral vitamin D3 400 IU/day) on a double-blind basis. The latter “is an amount you would find in a multivitamin and only increases plasma levels by about 3 ng/mL, thus serving as a useful active control” Dr. Ng noted.
Receipt of chemotherapy and bevacizumab was generally similar between groups. “It is interesting to note that more patients receiving high-dose vitamin D discontinued treatment to undergo potentially curative surgery compared to those in the control arm, though this was not statistically different,” she noted.
In intent-to-treat analysis conducted at a median follow-up of 17-18 months, progression-free survival, the trial’s primary endpoint, was a median of 13.1 months in the high-dose group and 11.2 months in the low-dose group (P = .04). The difference in favor of high-dose vitamin D remained significant in multivariate analysis (hazard ratio, 0.67; P = .02).
The groups were statistically indistinguishable with respect to overall response rate, but the disease control rate was marginally better with high-dose versus low-dose vitamin D (96% vs. 84%, P = .05).
Rates of most grade 3 or 4 adverse events did not differ significantly between groups. However, diarrhea of these grades was less common in the high-dose vitamin D group (1% vs. 12%; P = .02). With respect to grade 3 or 4 events possibly related to the vitamin therapy, there was one case of hyperphosphatemia in the high-dose group and one case of kidney stones in the low-dose group.
Dr. Ng disclosed that she receives honoraria from Prime Oncology and Sage Publications; has a consulting or advisory role with Defined Health and Genentech/Roche; and receives research funding from Celgene, Genentech/Roche (institutional), Gilead Sciences, Pharmavite (institutional), and Trovagene.
CHICAGO – High-dose vitamin D supplementation is a simple, safe approach for improving on the efficacy of first-line chemotherapy for metastatic colorectal cancer, suggest findings of the SUNSHINE trial reported at the annual meeting of the American Society of Clinical Oncology.
“Vitamin D has shown anti-neoplastic properties in the laboratory, including inhibition of cell proliferation and angiogenesis, induction of cell differentiation and apoptosis, as well as anti-inflammatory and immunomodulatory effects,” said lead author Kimmie Ng, MD, director of clinical research and a Gastrointestinal Cancer Center physician at the Dana-Farber Cancer Institute in Boston.
“The vitamin D hypothesis is also supported by a large body of epidemiologic evidence, both from our group as well as from others, that have shown that higher plasma 25-hydroxyvitamin D levels are associated with improved survival in patients with colorectal cancer,” she added.
Notably, in the CALGB/SWOG 80405 trial of first-line therapy for colorectal cancer, patients’ median 25-hydroxy vitamin D level at baseline fell below the cutoff for deficiency (ASCO 2015 meeting, Abstract 3503). Moreover, those having higher levels ultimately had better overall survival even after other factors were taken into account.
In the SUNSHINE trial, the investigators studied 139 patients with untreated metastatic colorectal cancer. Results showed that those given FOLFOX chemotherapy and the antiangiogenic agent bevacizumab (Avastin) plus high-dose vitamin D had a one-third lower risk of progression or death compared with counterparts given the same regimen plus low-dose vitamin D.
High-dose supplementation was not associated with greater toxicity. In fact, patients in that group had a much lower incidence of grade 3 or 4 diarrhea.
“After a decade of observational data linking higher vitamin D status with improved outcomes in colorectal cancer patients, SUNSHINE is the first completed randomized double-blind controlled clinical trial of vitamin D supplementation for treatment of colorectal cancer,” Dr. Ng said. “The trial met its primary endpoint. Given this data, a larger, confirmatory phase III trial is warranted.”
The investigators are performing subgroup analyses and analyzing overall survival, and will measure patients’ 25-hydroxyvitamin D levels in plasma samples collected serially throughout the study to determine whether they correlate with outcomes.
In addition, “to help understand and elucidate underlying mechanisms and biology, we have planned several correlative studies looking at tumoral and plasma biomarkers related to the vitamin D pathway, inflammation, and tumor immunity, among other pathways,” she further noted. “We will also be conducting next-generation sequencing and gene expression analyses.”
Expert perspective
“It will be interesting to know [patients’ vitamin D levels] as the majority of patients were enrolled in New England, where I think there is a little less sunshine than in other parts of the United States, so perhaps the vitamin D levels will reflect that,” said invited discussant Andrea Cercek, MD, of Memorial Sloan Kettering Cancer Center in New York.
Data on vitamin D pertaining to chemoprevention and to outcomes in other malignancies have been mixed, she cautioned. For example, supplementation did not reduce the risk of recurrent colorectal adenomas in one study (N Engl J Med. 2015;373:1519-30), and benefit or harm in terms of developing advanced colorectal adenomas in another study hinged on vitamin D receptor genotype (JAMA Oncol. 2017;3:628-35). Among patients with prostate cancer, addition of vitamin D to chemotherapy was actually associated with poorer overall survival (J Clin Oncol. 2011;29:2191-8).
“SUNSHINE was a positive study. It was a very well carried out phase II trial with a significant progression-free survival benefit. Correlative analyses are ongoing, and these will be critical, looking at biomarkers, perhaps helping us identify those patients who will benefit,” Dr. Cercek summarized. “I agree 100% with the investigators that a phase III study is warranted, and I look forward to it.”
Study details
Patients in SUNSHINE were randomized to receive first-line modified FOLFOX chemotherapy and bevacizumab plus either high-dose vitamin D (oral vitamin D3 8,000 IU/day for 2 weeks as a loading dose, followed by 4,000 IU/day) or low-dose vitamin D (oral vitamin D3 400 IU/day) on a double-blind basis. The latter “is an amount you would find in a multivitamin and only increases plasma levels by about 3 ng/mL, thus serving as a useful active control” Dr. Ng noted.
Receipt of chemotherapy and bevacizumab was generally similar between groups. “It is interesting to note that more patients receiving high-dose vitamin D discontinued treatment to undergo potentially curative surgery compared to those in the control arm, though this was not statistically different,” she noted.
In intent-to-treat analysis conducted at a median follow-up of 17-18 months, progression-free survival, the trial’s primary endpoint, was a median of 13.1 months in the high-dose group and 11.2 months in the low-dose group (P = .04). The difference in favor of high-dose vitamin D remained significant in multivariate analysis (hazard ratio, 0.67; P = .02).
The groups were statistically indistinguishable with respect to overall response rate, but the disease control rate was marginally better with high-dose versus low-dose vitamin D (96% vs. 84%, P = .05).
Rates of most grade 3 or 4 adverse events did not differ significantly between groups. However, diarrhea of these grades was less common in the high-dose vitamin D group (1% vs. 12%; P = .02). With respect to grade 3 or 4 events possibly related to the vitamin therapy, there was one case of hyperphosphatemia in the high-dose group and one case of kidney stones in the low-dose group.
Dr. Ng disclosed that she receives honoraria from Prime Oncology and Sage Publications; has a consulting or advisory role with Defined Health and Genentech/Roche; and receives research funding from Celgene, Genentech/Roche (institutional), Gilead Sciences, Pharmavite (institutional), and Trovagene.
AT ASCO 2017
Key clinical point:
Major finding: Compared with chemotherapy plus low-dose vitamin D, chemotherapy plus high-dose vitamin D was associated with a reduced risk of progression or death (hazard ratio, 0.67).
Data source: A phase II randomized trial (SUNSHINE) among 139 patients with untreated metastatic colorectal cancer.
Disclosures: Dr. Ng disclosed that she receives honoraria from Prime Oncology and Sage Publications; has a consulting or advisory role with Defined Health and Genentech/Roche; and receives research funding from Celgene, Genentech/Roche (institutional), Gilead Sciences, Pharmavite (institutional), and Trovagene.
New drug choices emerging to battle antibiotic resistance
SAN FRANCISCO – When the Infectious Diseases Society of America released the “Bad Bugs, No Drugs” report in 2004, its authors warned that effective antibiotics may not be available to treat seriously ill patients in the near future.
It also proposed legislative, regulatory, and funding solutions with a goal of developing and licensing 10 new antibiotics by the year 2020.
One such advancement was the Generating Antibiotics Incentives Now Act, which was signed into law in 2012 and created a designation for new antibiotics that are used to treat serious and/or life-threatening diseases due to certain pathogens. It also extends the patent life of these antibiotics and allows for fast-track Food and Drug Administration approval.
According to Dr. Erlich, chief of staff and medical director of infection control and antibiotic stewardship at Mills Peninsula Medical Center, Burlingame, Calif., increasingly common antibiotic-resistant pathogens besides MRSA and VRE include penicillin-resistant Streptococcus pneumoniae, extended-spectrum beta-lactamase–producing gram-negative rods, carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Mycobacterium tuberculosis, Salmonella enterica serotype Typhimurium DT 104, and drug-resistant Candida species.
Since 2010, several new antibiotics have been introduced to the market, including three second-generation lipoglycopeptide antibiotics with gram-positive coverage that are approved primarily for skin and soft tissue infections: dalbavancin (Dalvance), telavancin (Vibativ), and oritavancin (Orbactiv).
Compared with vancomycin, these new agents have more convenient dosing and a longer half life, “but they’re also more expensive,” said Dr. Erlich. Dalbavancin can be dosed once a week intravenously, telavancin can be dosed once daily intravenously, and oritavancin requires just one dose.
Another new agent is tedizolid phosphate (Sivextro), a second-generation oxazolidinone that is in the same drug class as linezolid (Zyvox). Tedizolid phosphate has gram-positive coverage including MRSA, but it is not approved for VRE. “It’s FDA approved for skin and soft-tissue infections (SSTI) but can be used for other locations as well,” Dr. Erlich said. “It features once-daily dosing IV or PO.”
Ceftaroline fosamil (Teflaro), ceftolozane/tazobactam (Zerbaxa), and ceftazidime/avibactam (Avycaz) are broad-spectrum cephalosporins with or without beta-lactamase inhibitors resulting in extended gram-negative coverage. FDA-approved indications include complicated urinary tract infections, complicated abdominal infections, SSTI, and pneumonia.
The primary advantage of these drugs, compared with other agents, is for multidrug-resistant gram-negative bacteria such as extended-spectrum beta-lactamase producers and CRE. “We’re not using a lot of these drugs in clinical practice, but they are available for patients with multidrug-resistant gram-negative rods who have no other options,” Dr. Erlich said.
Practical ways that clinicians can prevent antibiotic resistance include prescribing antibiotics only when necessary. “Be aware of local resistance patterns, avoid antibiotics for probable viral infections, use narrow-spectrum choices when possible, use shorter durations when appropriate, and consult published guidelines for optimal empiric antibiotic therapy,” Dr. Erlich advised.
In addition, “advocate infection control measures to keep patients from developing infections, including proper wound care, hand washing, respiratory etiquette, vaccinations, and social isolation for symptomatic individuals,” he noted.
Dr. Erlich reported having no relevant financial disclosures.
SAN FRANCISCO – When the Infectious Diseases Society of America released the “Bad Bugs, No Drugs” report in 2004, its authors warned that effective antibiotics may not be available to treat seriously ill patients in the near future.
It also proposed legislative, regulatory, and funding solutions with a goal of developing and licensing 10 new antibiotics by the year 2020.
One such advancement was the Generating Antibiotics Incentives Now Act, which was signed into law in 2012 and created a designation for new antibiotics that are used to treat serious and/or life-threatening diseases due to certain pathogens. It also extends the patent life of these antibiotics and allows for fast-track Food and Drug Administration approval.
According to Dr. Erlich, chief of staff and medical director of infection control and antibiotic stewardship at Mills Peninsula Medical Center, Burlingame, Calif., increasingly common antibiotic-resistant pathogens besides MRSA and VRE include penicillin-resistant Streptococcus pneumoniae, extended-spectrum beta-lactamase–producing gram-negative rods, carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Mycobacterium tuberculosis, Salmonella enterica serotype Typhimurium DT 104, and drug-resistant Candida species.
Since 2010, several new antibiotics have been introduced to the market, including three second-generation lipoglycopeptide antibiotics with gram-positive coverage that are approved primarily for skin and soft tissue infections: dalbavancin (Dalvance), telavancin (Vibativ), and oritavancin (Orbactiv).
Compared with vancomycin, these new agents have more convenient dosing and a longer half life, “but they’re also more expensive,” said Dr. Erlich. Dalbavancin can be dosed once a week intravenously, telavancin can be dosed once daily intravenously, and oritavancin requires just one dose.
Another new agent is tedizolid phosphate (Sivextro), a second-generation oxazolidinone that is in the same drug class as linezolid (Zyvox). Tedizolid phosphate has gram-positive coverage including MRSA, but it is not approved for VRE. “It’s FDA approved for skin and soft-tissue infections (SSTI) but can be used for other locations as well,” Dr. Erlich said. “It features once-daily dosing IV or PO.”
Ceftaroline fosamil (Teflaro), ceftolozane/tazobactam (Zerbaxa), and ceftazidime/avibactam (Avycaz) are broad-spectrum cephalosporins with or without beta-lactamase inhibitors resulting in extended gram-negative coverage. FDA-approved indications include complicated urinary tract infections, complicated abdominal infections, SSTI, and pneumonia.
The primary advantage of these drugs, compared with other agents, is for multidrug-resistant gram-negative bacteria such as extended-spectrum beta-lactamase producers and CRE. “We’re not using a lot of these drugs in clinical practice, but they are available for patients with multidrug-resistant gram-negative rods who have no other options,” Dr. Erlich said.
Practical ways that clinicians can prevent antibiotic resistance include prescribing antibiotics only when necessary. “Be aware of local resistance patterns, avoid antibiotics for probable viral infections, use narrow-spectrum choices when possible, use shorter durations when appropriate, and consult published guidelines for optimal empiric antibiotic therapy,” Dr. Erlich advised.
In addition, “advocate infection control measures to keep patients from developing infections, including proper wound care, hand washing, respiratory etiquette, vaccinations, and social isolation for symptomatic individuals,” he noted.
Dr. Erlich reported having no relevant financial disclosures.
SAN FRANCISCO – When the Infectious Diseases Society of America released the “Bad Bugs, No Drugs” report in 2004, its authors warned that effective antibiotics may not be available to treat seriously ill patients in the near future.
It also proposed legislative, regulatory, and funding solutions with a goal of developing and licensing 10 new antibiotics by the year 2020.
One such advancement was the Generating Antibiotics Incentives Now Act, which was signed into law in 2012 and created a designation for new antibiotics that are used to treat serious and/or life-threatening diseases due to certain pathogens. It also extends the patent life of these antibiotics and allows for fast-track Food and Drug Administration approval.
According to Dr. Erlich, chief of staff and medical director of infection control and antibiotic stewardship at Mills Peninsula Medical Center, Burlingame, Calif., increasingly common antibiotic-resistant pathogens besides MRSA and VRE include penicillin-resistant Streptococcus pneumoniae, extended-spectrum beta-lactamase–producing gram-negative rods, carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Mycobacterium tuberculosis, Salmonella enterica serotype Typhimurium DT 104, and drug-resistant Candida species.
Since 2010, several new antibiotics have been introduced to the market, including three second-generation lipoglycopeptide antibiotics with gram-positive coverage that are approved primarily for skin and soft tissue infections: dalbavancin (Dalvance), telavancin (Vibativ), and oritavancin (Orbactiv).
Compared with vancomycin, these new agents have more convenient dosing and a longer half life, “but they’re also more expensive,” said Dr. Erlich. Dalbavancin can be dosed once a week intravenously, telavancin can be dosed once daily intravenously, and oritavancin requires just one dose.
Another new agent is tedizolid phosphate (Sivextro), a second-generation oxazolidinone that is in the same drug class as linezolid (Zyvox). Tedizolid phosphate has gram-positive coverage including MRSA, but it is not approved for VRE. “It’s FDA approved for skin and soft-tissue infections (SSTI) but can be used for other locations as well,” Dr. Erlich said. “It features once-daily dosing IV or PO.”
Ceftaroline fosamil (Teflaro), ceftolozane/tazobactam (Zerbaxa), and ceftazidime/avibactam (Avycaz) are broad-spectrum cephalosporins with or without beta-lactamase inhibitors resulting in extended gram-negative coverage. FDA-approved indications include complicated urinary tract infections, complicated abdominal infections, SSTI, and pneumonia.
The primary advantage of these drugs, compared with other agents, is for multidrug-resistant gram-negative bacteria such as extended-spectrum beta-lactamase producers and CRE. “We’re not using a lot of these drugs in clinical practice, but they are available for patients with multidrug-resistant gram-negative rods who have no other options,” Dr. Erlich said.
Practical ways that clinicians can prevent antibiotic resistance include prescribing antibiotics only when necessary. “Be aware of local resistance patterns, avoid antibiotics for probable viral infections, use narrow-spectrum choices when possible, use shorter durations when appropriate, and consult published guidelines for optimal empiric antibiotic therapy,” Dr. Erlich advised.
In addition, “advocate infection control measures to keep patients from developing infections, including proper wound care, hand washing, respiratory etiquette, vaccinations, and social isolation for symptomatic individuals,” he noted.
Dr. Erlich reported having no relevant financial disclosures.
AT THE ANNUAL ADVANCES IN INTERNAL MEDICINE
Ibrutinib/buparlisib looks good for relapsed mantle cell lymphoma
LUGANO, SWITZERLAND – A combination of the Bruton’s tyrosine kinase (BTK) ibrutinib (Imbruvica) and the pan-phosphoinositide 3-kinase (PI3K) inhibitor buparlisib showed clinical activity superior to that of single-agent ibrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL).
In a phase I/IB dose escalation study and expansion cohort testing the combination in patients with diffuse large B cell lymphoma (DLBCL), follicular lymphoma, and MCL, the overall response rate (ORR) among patients with MCL was 100%, consisting of complete responses (CR) in 8 of 11 patients, and partial responses (PR) in 3 patients, reported Connie Lee Batlevi, MD, of Memorial Sloan Kettering Cancer Center in New York.
In contrast, the response rate to ibrutinib monotherapy among patients with relapsed MCL is around 20%, she said.
Preclinical studies have demonstrated synergism between BTK inhibitors and PI3K inhibitors in B-cell non-Hodgkin lymphoma (NHL), prompting the investigators to look into the combination in patients with relapsed or refractory DLBCL, follicular lymphoma (FL), and MCL.
They enrolled 25 patients (9 with DLBCL, 5 with FL, and 11 with MCL). The patients received escalating doses of once daily ibrutinib and buparlisib in three dose levels (ibrutinib 420-560 mg; buparlisib 80-100 mg). Dose level 3, consisting of ibrutinib 560 mg and buparlisib 100 mg, was selected for dose expansion based on one of six patients developing a dose-limiting toxicity.
Using the Lugano Response Criteria, the overall ORR (all histologies) was 52%. Among nine patients with DLBCL, the ORR was 11%, with one CR and no PR. Among five patients with FL, the ORR was 20%, consisting of one CR and no PR.
Among 11 patients with MCL, however, the ORR was far more impressive, at 100%, including eight CR and three PR. No patients with MCL had either stable or progressive disease.
Under the RECIL (International Working Group) criteria, the ORR was 48% including one CR each for DLBCL and FL, and eight CR and two PR for patients with MCL.
In the safety analysis, there were two dose-limiting toxicities in the lowest and highest dose groups, but none at dose level 2 (ibrutinib 560 mg and buparlisib 80 mg).
Grade 3 or greater adverse events occurred in 63% of patients. The most common events were hyperglycemia and rash in 19% each, and diarrhea, anorexia, and neurologic changes in 11% each,
The grade 3 neurologic changes included depression, agitation, mood swings, confusion and memory impairment, all of which resolved after buparlisib was withdrawn.
Dr. Batlevi showed scans of two patients with representative clinical responses in MCL. One 55-year-old man with blastoid MCL who had relapsed 18 months after frontline therapy with ofatumumab and bendamustine had near total clearance of lesions after two cycles of ibrutinib and buparlisib. He remains in CR after 12 months on the combination.
A second patient, a 77-year-old man with MCL that relapsed 10 years after R-CHOP and rituximab maintenance followed by autologous stem cell transplant, showed a complete response upon restaging after two cycles of ibrutinib/buparlisib.
The investigators are currently enrolling patients for phase IB expansions, with the goal of better estimating the safety and efficacy of the combination.
Memorial Sloan Kettering Cancer Center sponsored the study, with support from Janssen and Novartis. Dr. Batlevi reported no conflicts of interest.
LUGANO, SWITZERLAND – A combination of the Bruton’s tyrosine kinase (BTK) ibrutinib (Imbruvica) and the pan-phosphoinositide 3-kinase (PI3K) inhibitor buparlisib showed clinical activity superior to that of single-agent ibrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL).
In a phase I/IB dose escalation study and expansion cohort testing the combination in patients with diffuse large B cell lymphoma (DLBCL), follicular lymphoma, and MCL, the overall response rate (ORR) among patients with MCL was 100%, consisting of complete responses (CR) in 8 of 11 patients, and partial responses (PR) in 3 patients, reported Connie Lee Batlevi, MD, of Memorial Sloan Kettering Cancer Center in New York.
In contrast, the response rate to ibrutinib monotherapy among patients with relapsed MCL is around 20%, she said.
Preclinical studies have demonstrated synergism between BTK inhibitors and PI3K inhibitors in B-cell non-Hodgkin lymphoma (NHL), prompting the investigators to look into the combination in patients with relapsed or refractory DLBCL, follicular lymphoma (FL), and MCL.
They enrolled 25 patients (9 with DLBCL, 5 with FL, and 11 with MCL). The patients received escalating doses of once daily ibrutinib and buparlisib in three dose levels (ibrutinib 420-560 mg; buparlisib 80-100 mg). Dose level 3, consisting of ibrutinib 560 mg and buparlisib 100 mg, was selected for dose expansion based on one of six patients developing a dose-limiting toxicity.
Using the Lugano Response Criteria, the overall ORR (all histologies) was 52%. Among nine patients with DLBCL, the ORR was 11%, with one CR and no PR. Among five patients with FL, the ORR was 20%, consisting of one CR and no PR.
Among 11 patients with MCL, however, the ORR was far more impressive, at 100%, including eight CR and three PR. No patients with MCL had either stable or progressive disease.
Under the RECIL (International Working Group) criteria, the ORR was 48% including one CR each for DLBCL and FL, and eight CR and two PR for patients with MCL.
In the safety analysis, there were two dose-limiting toxicities in the lowest and highest dose groups, but none at dose level 2 (ibrutinib 560 mg and buparlisib 80 mg).
Grade 3 or greater adverse events occurred in 63% of patients. The most common events were hyperglycemia and rash in 19% each, and diarrhea, anorexia, and neurologic changes in 11% each,
The grade 3 neurologic changes included depression, agitation, mood swings, confusion and memory impairment, all of which resolved after buparlisib was withdrawn.
Dr. Batlevi showed scans of two patients with representative clinical responses in MCL. One 55-year-old man with blastoid MCL who had relapsed 18 months after frontline therapy with ofatumumab and bendamustine had near total clearance of lesions after two cycles of ibrutinib and buparlisib. He remains in CR after 12 months on the combination.
A second patient, a 77-year-old man with MCL that relapsed 10 years after R-CHOP and rituximab maintenance followed by autologous stem cell transplant, showed a complete response upon restaging after two cycles of ibrutinib/buparlisib.
The investigators are currently enrolling patients for phase IB expansions, with the goal of better estimating the safety and efficacy of the combination.
Memorial Sloan Kettering Cancer Center sponsored the study, with support from Janssen and Novartis. Dr. Batlevi reported no conflicts of interest.
LUGANO, SWITZERLAND – A combination of the Bruton’s tyrosine kinase (BTK) ibrutinib (Imbruvica) and the pan-phosphoinositide 3-kinase (PI3K) inhibitor buparlisib showed clinical activity superior to that of single-agent ibrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL).
In a phase I/IB dose escalation study and expansion cohort testing the combination in patients with diffuse large B cell lymphoma (DLBCL), follicular lymphoma, and MCL, the overall response rate (ORR) among patients with MCL was 100%, consisting of complete responses (CR) in 8 of 11 patients, and partial responses (PR) in 3 patients, reported Connie Lee Batlevi, MD, of Memorial Sloan Kettering Cancer Center in New York.
In contrast, the response rate to ibrutinib monotherapy among patients with relapsed MCL is around 20%, she said.
Preclinical studies have demonstrated synergism between BTK inhibitors and PI3K inhibitors in B-cell non-Hodgkin lymphoma (NHL), prompting the investigators to look into the combination in patients with relapsed or refractory DLBCL, follicular lymphoma (FL), and MCL.
They enrolled 25 patients (9 with DLBCL, 5 with FL, and 11 with MCL). The patients received escalating doses of once daily ibrutinib and buparlisib in three dose levels (ibrutinib 420-560 mg; buparlisib 80-100 mg). Dose level 3, consisting of ibrutinib 560 mg and buparlisib 100 mg, was selected for dose expansion based on one of six patients developing a dose-limiting toxicity.
Using the Lugano Response Criteria, the overall ORR (all histologies) was 52%. Among nine patients with DLBCL, the ORR was 11%, with one CR and no PR. Among five patients with FL, the ORR was 20%, consisting of one CR and no PR.
Among 11 patients with MCL, however, the ORR was far more impressive, at 100%, including eight CR and three PR. No patients with MCL had either stable or progressive disease.
Under the RECIL (International Working Group) criteria, the ORR was 48% including one CR each for DLBCL and FL, and eight CR and two PR for patients with MCL.
In the safety analysis, there were two dose-limiting toxicities in the lowest and highest dose groups, but none at dose level 2 (ibrutinib 560 mg and buparlisib 80 mg).
Grade 3 or greater adverse events occurred in 63% of patients. The most common events were hyperglycemia and rash in 19% each, and diarrhea, anorexia, and neurologic changes in 11% each,
The grade 3 neurologic changes included depression, agitation, mood swings, confusion and memory impairment, all of which resolved after buparlisib was withdrawn.
Dr. Batlevi showed scans of two patients with representative clinical responses in MCL. One 55-year-old man with blastoid MCL who had relapsed 18 months after frontline therapy with ofatumumab and bendamustine had near total clearance of lesions after two cycles of ibrutinib and buparlisib. He remains in CR after 12 months on the combination.
A second patient, a 77-year-old man with MCL that relapsed 10 years after R-CHOP and rituximab maintenance followed by autologous stem cell transplant, showed a complete response upon restaging after two cycles of ibrutinib/buparlisib.
The investigators are currently enrolling patients for phase IB expansions, with the goal of better estimating the safety and efficacy of the combination.
Memorial Sloan Kettering Cancer Center sponsored the study, with support from Janssen and Novartis. Dr. Batlevi reported no conflicts of interest.
AT 14-ICML
Key clinical point: The combination of ibrutinib and buparlisib showed efficacy against mantle cell lymphoma in a dose-escalation and safety study,
Major finding: The overall response rate to the combination among 11 patients with relapsed MCL was 100%.
Data source: Open label phase I/IB study of 25 patients with B-cell lymphomas.
Disclosures: Memorial Sloan Kettering Cancer Center sponsored the study, with support from Janssen and Novartis. Dr. Batlevi reported no conflicts of interest.
Knee bone density improved in osteoarthritis with load-reducing shoe
LAS VEGAS – Patients with medial compartment knee osteoarthritis who wore a patented flexible mobility shoe experienced a favorable reduction in medial tibial bone mineral density that directly correlated with their improved gait biomechanics and reduced peak knee adduction moment, Najia Shakoor, MD, reported at the World Congress on Osteoarthritis.
“Our results suggest that bone can be modified with sustained load reduction and that evaluation of tibial bone density may be an inexpensive tool for evaluating the consequences of load-reducing interventions,” said Dr. Shakoor, a rheumatologist at Rush University in Chicago.
Indeed, measuring changes in medial tibial bone density over time via serial dual x-ray absorptiometry is an attractive surrogate anatomic marker of a patient’s response to a biomechanical load-reducing intervention such as a special shoe or knee brace, Dr. Shakoor noted at the meeting sponsored by the Osteoarthritis Research Society International.
After all, she added, bone density measurement is simpler than sending a patient to a motion analysis laboratory for multicamera gait analysis using a force plate to evaluate changes in the peak external knee adduction moment (a validated marker of load distribution across the tibial plateau).
Studies suggest that bone, not cartilage, bears the bulk of the load burden across the knee joint. That’s why patients with knee osteoarthritis have increased proximal tibial bone mineral density. Dr. Shakoor presented evidence that sustained reduction in dynamic knee loading results in a proportionate reduction in medial tibial bone density over the course of 6 months.
She reported on 51 patients with mild to moderate radiographic and symptomatic medial compartment knee osteoarthritis who were randomized to wear a commercially available flexible mobility shoe or a similar-looking but nonflexible control shoe for 6 hours per day for at least 6 days per week for 6 months. At baseline and again at 6 months, the participants underwent knee bone density measurement and formal gait analysis.
Peak knee adduction moment decreased by 14% over the course of 6 months in the flexible shoe group, significantly greater than the 6% reduction in the controls. Moreover, Dr. Shakoor and her coinvestigators documented a significant reduction in medial tibial bone density in the flexible shoe group. The greater the improvement in knee adduction moment, the larger the reduction in bone density.
In contrast, medial tibial bone density didn’t change significantly in the controls.
Dr. Shakoor said that she had also expected to see a reduction in the ratio of medial to lateral tibial bone density in the flexible shoe group. However, there was no statistically significant change, although there was a trend in that direction.
Asked if reduction in knee adduction moment and/or medial tibial bone density correlated with improved knee pain scores, Dr. Shakoor replied that almost everyone in the study reported improvement in pain, suggesting a placebo effect for that endpoint. In any event, the relatively small study wasn’t powered to evaluate change in pain over time.
The Arthritis Foundation funded the study. Dr. Shakoor is coinventor of the flexible shoe used in the study. The patent, owned by Rush University, has been licensed to Dr. Comfort, which markets the shoe as the Dr. Comfort Flex-OA Mobility Shoe. A percentage of the proceeds from shoe sales is distributed to the university and the coinventors.
LAS VEGAS – Patients with medial compartment knee osteoarthritis who wore a patented flexible mobility shoe experienced a favorable reduction in medial tibial bone mineral density that directly correlated with their improved gait biomechanics and reduced peak knee adduction moment, Najia Shakoor, MD, reported at the World Congress on Osteoarthritis.
“Our results suggest that bone can be modified with sustained load reduction and that evaluation of tibial bone density may be an inexpensive tool for evaluating the consequences of load-reducing interventions,” said Dr. Shakoor, a rheumatologist at Rush University in Chicago.
Indeed, measuring changes in medial tibial bone density over time via serial dual x-ray absorptiometry is an attractive surrogate anatomic marker of a patient’s response to a biomechanical load-reducing intervention such as a special shoe or knee brace, Dr. Shakoor noted at the meeting sponsored by the Osteoarthritis Research Society International.
After all, she added, bone density measurement is simpler than sending a patient to a motion analysis laboratory for multicamera gait analysis using a force plate to evaluate changes in the peak external knee adduction moment (a validated marker of load distribution across the tibial plateau).
Studies suggest that bone, not cartilage, bears the bulk of the load burden across the knee joint. That’s why patients with knee osteoarthritis have increased proximal tibial bone mineral density. Dr. Shakoor presented evidence that sustained reduction in dynamic knee loading results in a proportionate reduction in medial tibial bone density over the course of 6 months.
She reported on 51 patients with mild to moderate radiographic and symptomatic medial compartment knee osteoarthritis who were randomized to wear a commercially available flexible mobility shoe or a similar-looking but nonflexible control shoe for 6 hours per day for at least 6 days per week for 6 months. At baseline and again at 6 months, the participants underwent knee bone density measurement and formal gait analysis.
Peak knee adduction moment decreased by 14% over the course of 6 months in the flexible shoe group, significantly greater than the 6% reduction in the controls. Moreover, Dr. Shakoor and her coinvestigators documented a significant reduction in medial tibial bone density in the flexible shoe group. The greater the improvement in knee adduction moment, the larger the reduction in bone density.
In contrast, medial tibial bone density didn’t change significantly in the controls.
Dr. Shakoor said that she had also expected to see a reduction in the ratio of medial to lateral tibial bone density in the flexible shoe group. However, there was no statistically significant change, although there was a trend in that direction.
Asked if reduction in knee adduction moment and/or medial tibial bone density correlated with improved knee pain scores, Dr. Shakoor replied that almost everyone in the study reported improvement in pain, suggesting a placebo effect for that endpoint. In any event, the relatively small study wasn’t powered to evaluate change in pain over time.
The Arthritis Foundation funded the study. Dr. Shakoor is coinventor of the flexible shoe used in the study. The patent, owned by Rush University, has been licensed to Dr. Comfort, which markets the shoe as the Dr. Comfort Flex-OA Mobility Shoe. A percentage of the proceeds from shoe sales is distributed to the university and the coinventors.
LAS VEGAS – Patients with medial compartment knee osteoarthritis who wore a patented flexible mobility shoe experienced a favorable reduction in medial tibial bone mineral density that directly correlated with their improved gait biomechanics and reduced peak knee adduction moment, Najia Shakoor, MD, reported at the World Congress on Osteoarthritis.
“Our results suggest that bone can be modified with sustained load reduction and that evaluation of tibial bone density may be an inexpensive tool for evaluating the consequences of load-reducing interventions,” said Dr. Shakoor, a rheumatologist at Rush University in Chicago.
Indeed, measuring changes in medial tibial bone density over time via serial dual x-ray absorptiometry is an attractive surrogate anatomic marker of a patient’s response to a biomechanical load-reducing intervention such as a special shoe or knee brace, Dr. Shakoor noted at the meeting sponsored by the Osteoarthritis Research Society International.
After all, she added, bone density measurement is simpler than sending a patient to a motion analysis laboratory for multicamera gait analysis using a force plate to evaluate changes in the peak external knee adduction moment (a validated marker of load distribution across the tibial plateau).
Studies suggest that bone, not cartilage, bears the bulk of the load burden across the knee joint. That’s why patients with knee osteoarthritis have increased proximal tibial bone mineral density. Dr. Shakoor presented evidence that sustained reduction in dynamic knee loading results in a proportionate reduction in medial tibial bone density over the course of 6 months.
She reported on 51 patients with mild to moderate radiographic and symptomatic medial compartment knee osteoarthritis who were randomized to wear a commercially available flexible mobility shoe or a similar-looking but nonflexible control shoe for 6 hours per day for at least 6 days per week for 6 months. At baseline and again at 6 months, the participants underwent knee bone density measurement and formal gait analysis.
Peak knee adduction moment decreased by 14% over the course of 6 months in the flexible shoe group, significantly greater than the 6% reduction in the controls. Moreover, Dr. Shakoor and her coinvestigators documented a significant reduction in medial tibial bone density in the flexible shoe group. The greater the improvement in knee adduction moment, the larger the reduction in bone density.
In contrast, medial tibial bone density didn’t change significantly in the controls.
Dr. Shakoor said that she had also expected to see a reduction in the ratio of medial to lateral tibial bone density in the flexible shoe group. However, there was no statistically significant change, although there was a trend in that direction.
Asked if reduction in knee adduction moment and/or medial tibial bone density correlated with improved knee pain scores, Dr. Shakoor replied that almost everyone in the study reported improvement in pain, suggesting a placebo effect for that endpoint. In any event, the relatively small study wasn’t powered to evaluate change in pain over time.
The Arthritis Foundation funded the study. Dr. Shakoor is coinventor of the flexible shoe used in the study. The patent, owned by Rush University, has been licensed to Dr. Comfort, which markets the shoe as the Dr. Comfort Flex-OA Mobility Shoe. A percentage of the proceeds from shoe sales is distributed to the university and the coinventors.
AT OARSI 2017
Key clinical point:
Major finding: Knee osteoarthritis patients who wore a flexible mobility shoe designed to reduce dynamic loading of the joint had a 14% reduction in peak external knee adduction moment over a 6-month period, with a parallel decrease in medial tibial bone density.
Data source: A 6-month randomized trial involving 51 patients with symptomatic radiographic medial compartment knee osteoarthritis, who were assigned to wear a shoe designed to reduce dynamic knee loading or a similar-looking control shoe.
Disclosures: The Arthritis Foundation funded the study. Dr. Shakoor is coinventor of the flexible shoe used in the study. The patent, owned by Rush University, has been licensed to Dr. Comfort, which markets the shoe as the Dr. Comfort Flex-OA Mobility Shoe. A percentage of the proceeds from shoe sales is distributed to the university and the coinventors.
Female genital mutilation is seen by most ob.gyns.
SAN DIEGO – Nearly 60% of ob.gyns. have seen patients who have experienced female genital mutilation (FGM), according to the results of a survey of 288 fellows of the American College of Obstetricians and Gynecologists.
Additionally, the survey found that there are few guidelines for care of these patients. Among fellows who had seen patients with FGM, 80.1% said their institutions had no policies or guidelines for management of these patients. Additionally, just 56.7% of fellows who had treated these women were aware that federal laws prohibit FGM.
The findings came as a surprise to the study’s senior author, Alireza Shamshirsaz, MD, a maternal-fetal medicine specialist at Baylor College of Medicine, Houston. “I really see the gap of knowledge of [ob.gyns.] in the States, and the emergent need for guidelines and regulation.”
Ob.gyns. who cared for women who had experienced FGM reported that they used a combination of approaches in treating these patients. Nearly half of physicians (45.8%) said they generally treated FGM patients the same as their other patients, but nearly three-quarters said they also discuss potential complications of FGM procedures. About 28% of physicians reported providing information about surgical repair options, while less than 5% provided mental health referrals.
For minors who had experienced FGM, low numbers of survey respondents made law enforcement referrals (7.7%) or social service referrals (7.7%). There were a few respondents (5.4%) who said they didn’t feel comfortable managing patients who had experienced FGM.
In another surprise to the researchers, genital mutilation procedures were not all performed abroad. Three ob.gyns. reported caring for patients who had previously undergone FGM in the United States.
The findings highlight the need for structured education in ob.gyn. residency training programs regarding how to approach at-risk patients and those who have experienced FGM, Dr. Shamshirsaz said in an interview. He also called for specific guidelines from ACOG regarding virginity testing and hymenoplasty and for clearer statutes to guide physicians when patients request FGM or virginity testing procedures.
“All [ob.gyns.] should be aware that their at-risk patients may have a history of honor-related practices and should obtain a full history in a culturally sensitive and professionally responsible manner so that they may respond to and address the unique needs of these patients,” the researchers wrote.
The researchers reported having no relevant financial disclosures. The study was supported by a grant from ACOG.
koakes@frontlinemedcom.com
On Twitter @karioakes
SAN DIEGO – Nearly 60% of ob.gyns. have seen patients who have experienced female genital mutilation (FGM), according to the results of a survey of 288 fellows of the American College of Obstetricians and Gynecologists.
Additionally, the survey found that there are few guidelines for care of these patients. Among fellows who had seen patients with FGM, 80.1% said their institutions had no policies or guidelines for management of these patients. Additionally, just 56.7% of fellows who had treated these women were aware that federal laws prohibit FGM.
The findings came as a surprise to the study’s senior author, Alireza Shamshirsaz, MD, a maternal-fetal medicine specialist at Baylor College of Medicine, Houston. “I really see the gap of knowledge of [ob.gyns.] in the States, and the emergent need for guidelines and regulation.”
Ob.gyns. who cared for women who had experienced FGM reported that they used a combination of approaches in treating these patients. Nearly half of physicians (45.8%) said they generally treated FGM patients the same as their other patients, but nearly three-quarters said they also discuss potential complications of FGM procedures. About 28% of physicians reported providing information about surgical repair options, while less than 5% provided mental health referrals.
For minors who had experienced FGM, low numbers of survey respondents made law enforcement referrals (7.7%) or social service referrals (7.7%). There were a few respondents (5.4%) who said they didn’t feel comfortable managing patients who had experienced FGM.
In another surprise to the researchers, genital mutilation procedures were not all performed abroad. Three ob.gyns. reported caring for patients who had previously undergone FGM in the United States.
The findings highlight the need for structured education in ob.gyn. residency training programs regarding how to approach at-risk patients and those who have experienced FGM, Dr. Shamshirsaz said in an interview. He also called for specific guidelines from ACOG regarding virginity testing and hymenoplasty and for clearer statutes to guide physicians when patients request FGM or virginity testing procedures.
“All [ob.gyns.] should be aware that their at-risk patients may have a history of honor-related practices and should obtain a full history in a culturally sensitive and professionally responsible manner so that they may respond to and address the unique needs of these patients,” the researchers wrote.
The researchers reported having no relevant financial disclosures. The study was supported by a grant from ACOG.
koakes@frontlinemedcom.com
On Twitter @karioakes
SAN DIEGO – Nearly 60% of ob.gyns. have seen patients who have experienced female genital mutilation (FGM), according to the results of a survey of 288 fellows of the American College of Obstetricians and Gynecologists.
Additionally, the survey found that there are few guidelines for care of these patients. Among fellows who had seen patients with FGM, 80.1% said their institutions had no policies or guidelines for management of these patients. Additionally, just 56.7% of fellows who had treated these women were aware that federal laws prohibit FGM.
The findings came as a surprise to the study’s senior author, Alireza Shamshirsaz, MD, a maternal-fetal medicine specialist at Baylor College of Medicine, Houston. “I really see the gap of knowledge of [ob.gyns.] in the States, and the emergent need for guidelines and regulation.”
Ob.gyns. who cared for women who had experienced FGM reported that they used a combination of approaches in treating these patients. Nearly half of physicians (45.8%) said they generally treated FGM patients the same as their other patients, but nearly three-quarters said they also discuss potential complications of FGM procedures. About 28% of physicians reported providing information about surgical repair options, while less than 5% provided mental health referrals.
For minors who had experienced FGM, low numbers of survey respondents made law enforcement referrals (7.7%) or social service referrals (7.7%). There were a few respondents (5.4%) who said they didn’t feel comfortable managing patients who had experienced FGM.
In another surprise to the researchers, genital mutilation procedures were not all performed abroad. Three ob.gyns. reported caring for patients who had previously undergone FGM in the United States.
The findings highlight the need for structured education in ob.gyn. residency training programs regarding how to approach at-risk patients and those who have experienced FGM, Dr. Shamshirsaz said in an interview. He also called for specific guidelines from ACOG regarding virginity testing and hymenoplasty and for clearer statutes to guide physicians when patients request FGM or virginity testing procedures.
“All [ob.gyns.] should be aware that their at-risk patients may have a history of honor-related practices and should obtain a full history in a culturally sensitive and professionally responsible manner so that they may respond to and address the unique needs of these patients,” the researchers wrote.
The researchers reported having no relevant financial disclosures. The study was supported by a grant from ACOG.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Of the 288 ACOG fellows surveyed, 58.6% have seen patients who have experienced female genital mutilation.
Data source: An anonymous online survey of 288 randomly-selected and stratified ACOG fellows.
Disclosures: The study was supported by a grant from ACOG. The researchers reported having no relevant financial disclosures.
Hepatitis C is a pediatric disease now
The baby looked perfect: healthy term male, weight at the 60th percentile, normal exam. The mother, a 26-year-old diagnosed with hepatitis C virus (HCV) infection during her pregnancy, looked alternately hopeful and horrified as I explained what implications her infection could have for her baby.
“Most babies will be fine,” I explained. “Of all mothers with hepatitis C infection, just under 6% will pass the infection on to their babies.” Transmission rates are twice as high in infants born to women with high HCV viral loads or those coinfected with HIV. The risk of transmission from women with undetectable HCV RNA is almost zero. Unfortunately, this mother did not fall into that category.
At that moment, however, I didn’t have time to be concerned about the numbers. My focus was one mother and her newborn baby.
“What if my baby is one of the unlucky ones who gets infected?” the mother asked, cuddling her infant. “What then?”
We know a lot about the course of hepatitis C in adults. An estimated 75%-86% of those infected will go on to develop chronic infection. Long-term sequelae include cirrhosis, liver failure, and hepatocellular carcinoma.
The course of HCV in children appears to be different. Twenty-five percent to 40% of vertically infected children will spontaneously clear their infection, most by 2 years of age. Occasionally, that might not happen until 7 years of age. Most who are chronically infected experience few symptoms, and fortunately cirrhosis and liver failure rarely present in childhood. In a large cohort of Italian children, half of whom were thought to be infected perinatally, less than 2% progressed to decompensated cirrhosis after 10 years of infection. According to the CDC, most children infected at birth “do well during childhood,” but more research is needed to understand the long-term effects of perinatal hepatitis C in children.
New antivirals have revolutionized the care of HCV-infected adults and now offer the hope of cure for up to 90%. None of these drugs are currently approved for use in children younger than 12 years, although clinical trials are underway. Because most cases of HCV in children are indolent, some children may not require treatment until adulthood.
July 28th was World Hepatitis Day and this year’s theme was Eliminate Hepatitis. To eliminate the problem of hepatitis C in children, pediatricians and others involved in the care of children need to get involved.
We need to know the scope of the problem
Since 2015, Kentucky has mandated reporting of all HCV-infected pregnant women and children through age 60 months, as well as all infants born to all HCV-infected women. At present though, there is substantial variability in state reporting requirements. We likely need a standardized case definition for perinatal HCV and national reporting criteria.
We need some clear guidance about testing during pregnancy
This should come from public health authorities, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
Jonathan Mermin, MD, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, has said, “Women are screened throughout pregnancy for many conditions that threaten their health. An expectant mother at risk for hepatitis C deserves to be tested. Knowing her status is the only way she can access the best hepatitis care and treatment – both for herself and her baby.” Yet, routine hepatitis C testing is not recommended during pregnancy, in part because there are no established interventions to prevent mother-to-child transmission of HCV. Instead, women are to be screened for risk factors and tested if they are present. As we learned with hepatitis B and HIV, risk factor screening is hard and misses individuals who are infected.
We need to ensure that HCV-exposed infants are identified and followed appropriately.
In a study of HCV-exposed infants born to women in Philadelphia, 84% did not receive adequate testing for HCV infection. In human terms, 537 children were born to HCV-positive mothers during the study period and 4 of 84 (5%) children tested were found to be infected. Assuming that 5% of HCV-exposed infants will develop chronic infection, 23 additional children were undiagnosed and, therefore, were not being followed for potential sequelae.
HCV-infected mothers in this study were more likely than non-infected mothers to be socioeconomically disadvantaged – specifically, unmarried, less educated, and publicly insured – suggesting that access to care may have played a role. When you add in drug use as a common risk factor for HCV infection, it is easy to understand why some at-risk infants are lost to follow-up.
Investigators in the Philadelphia study suggested that there might be more to the story. They proposed that pediatricians might be unaware of the need for testing because they had not been alerted to the mother’s HCV status by the obstetrician, the birthing hospital, or the mother herself. Finally, they theorized that many pediatricians “may be unaware or skeptical of the guidelines for testing children exposed to HCV.” This is a problem that we can solve.
I finished the visit with this mother by reassuring her that she could breastfeed her infant as planned as long as she did not have cracked or bleeding nipples. I also explained the schedule for testing. A 2002 National Institutes of Health consensus statement recommends that infants perinatally exposed to HCV have two HCV RNA tests between 2 and 6 months of age and/or be tested for HCV antibodies after 15 months. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Practice Guidelines for Diagnosis and Management of Hepatitis C Infection in Infants, Children, and Adolescents recommend testing for HCV antibodies at 18 months of age (J Pediatr Gastroenterol Nutr. 2012 Jun;54[6]:838-55). If a family requests earlier testing, a serum HCV RNA test can be done as early as 2 months of age. If positive, NASPGHAN recommends testing after 12 months of age to evaluate for chronic infection.
My practice has adopted the National Institutes of Health consensus statement approach because many of the families we see experience significant anxiety about the diagnosis, and this mother was no exception. As noted in the expert guidelines, this was a situation in which “early exclusion of HCV infection is reassuring and may be worth the added expense.”
“So first test at 2 months?” she asked. “Until then, we can’t do anything but wait?”
It is estimated that there are 23,000 to 46,000 U.S. children living with HCV. The wait for pediatricians is over. , and we need to educate ourselves about diagnosis and management. A first step might be to begin asking expectant mothers and the mothers of newborns if they know their HCV status.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
The baby looked perfect: healthy term male, weight at the 60th percentile, normal exam. The mother, a 26-year-old diagnosed with hepatitis C virus (HCV) infection during her pregnancy, looked alternately hopeful and horrified as I explained what implications her infection could have for her baby.
“Most babies will be fine,” I explained. “Of all mothers with hepatitis C infection, just under 6% will pass the infection on to their babies.” Transmission rates are twice as high in infants born to women with high HCV viral loads or those coinfected with HIV. The risk of transmission from women with undetectable HCV RNA is almost zero. Unfortunately, this mother did not fall into that category.
At that moment, however, I didn’t have time to be concerned about the numbers. My focus was one mother and her newborn baby.
“What if my baby is one of the unlucky ones who gets infected?” the mother asked, cuddling her infant. “What then?”
We know a lot about the course of hepatitis C in adults. An estimated 75%-86% of those infected will go on to develop chronic infection. Long-term sequelae include cirrhosis, liver failure, and hepatocellular carcinoma.
The course of HCV in children appears to be different. Twenty-five percent to 40% of vertically infected children will spontaneously clear their infection, most by 2 years of age. Occasionally, that might not happen until 7 years of age. Most who are chronically infected experience few symptoms, and fortunately cirrhosis and liver failure rarely present in childhood. In a large cohort of Italian children, half of whom were thought to be infected perinatally, less than 2% progressed to decompensated cirrhosis after 10 years of infection. According to the CDC, most children infected at birth “do well during childhood,” but more research is needed to understand the long-term effects of perinatal hepatitis C in children.
New antivirals have revolutionized the care of HCV-infected adults and now offer the hope of cure for up to 90%. None of these drugs are currently approved for use in children younger than 12 years, although clinical trials are underway. Because most cases of HCV in children are indolent, some children may not require treatment until adulthood.
July 28th was World Hepatitis Day and this year’s theme was Eliminate Hepatitis. To eliminate the problem of hepatitis C in children, pediatricians and others involved in the care of children need to get involved.
We need to know the scope of the problem
Since 2015, Kentucky has mandated reporting of all HCV-infected pregnant women and children through age 60 months, as well as all infants born to all HCV-infected women. At present though, there is substantial variability in state reporting requirements. We likely need a standardized case definition for perinatal HCV and national reporting criteria.
We need some clear guidance about testing during pregnancy
This should come from public health authorities, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
Jonathan Mermin, MD, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, has said, “Women are screened throughout pregnancy for many conditions that threaten their health. An expectant mother at risk for hepatitis C deserves to be tested. Knowing her status is the only way she can access the best hepatitis care and treatment – both for herself and her baby.” Yet, routine hepatitis C testing is not recommended during pregnancy, in part because there are no established interventions to prevent mother-to-child transmission of HCV. Instead, women are to be screened for risk factors and tested if they are present. As we learned with hepatitis B and HIV, risk factor screening is hard and misses individuals who are infected.
We need to ensure that HCV-exposed infants are identified and followed appropriately.
In a study of HCV-exposed infants born to women in Philadelphia, 84% did not receive adequate testing for HCV infection. In human terms, 537 children were born to HCV-positive mothers during the study period and 4 of 84 (5%) children tested were found to be infected. Assuming that 5% of HCV-exposed infants will develop chronic infection, 23 additional children were undiagnosed and, therefore, were not being followed for potential sequelae.
HCV-infected mothers in this study were more likely than non-infected mothers to be socioeconomically disadvantaged – specifically, unmarried, less educated, and publicly insured – suggesting that access to care may have played a role. When you add in drug use as a common risk factor for HCV infection, it is easy to understand why some at-risk infants are lost to follow-up.
Investigators in the Philadelphia study suggested that there might be more to the story. They proposed that pediatricians might be unaware of the need for testing because they had not been alerted to the mother’s HCV status by the obstetrician, the birthing hospital, or the mother herself. Finally, they theorized that many pediatricians “may be unaware or skeptical of the guidelines for testing children exposed to HCV.” This is a problem that we can solve.
I finished the visit with this mother by reassuring her that she could breastfeed her infant as planned as long as she did not have cracked or bleeding nipples. I also explained the schedule for testing. A 2002 National Institutes of Health consensus statement recommends that infants perinatally exposed to HCV have two HCV RNA tests between 2 and 6 months of age and/or be tested for HCV antibodies after 15 months. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Practice Guidelines for Diagnosis and Management of Hepatitis C Infection in Infants, Children, and Adolescents recommend testing for HCV antibodies at 18 months of age (J Pediatr Gastroenterol Nutr. 2012 Jun;54[6]:838-55). If a family requests earlier testing, a serum HCV RNA test can be done as early as 2 months of age. If positive, NASPGHAN recommends testing after 12 months of age to evaluate for chronic infection.
My practice has adopted the National Institutes of Health consensus statement approach because many of the families we see experience significant anxiety about the diagnosis, and this mother was no exception. As noted in the expert guidelines, this was a situation in which “early exclusion of HCV infection is reassuring and may be worth the added expense.”
“So first test at 2 months?” she asked. “Until then, we can’t do anything but wait?”
It is estimated that there are 23,000 to 46,000 U.S. children living with HCV. The wait for pediatricians is over. , and we need to educate ourselves about diagnosis and management. A first step might be to begin asking expectant mothers and the mothers of newborns if they know their HCV status.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
The baby looked perfect: healthy term male, weight at the 60th percentile, normal exam. The mother, a 26-year-old diagnosed with hepatitis C virus (HCV) infection during her pregnancy, looked alternately hopeful and horrified as I explained what implications her infection could have for her baby.
“Most babies will be fine,” I explained. “Of all mothers with hepatitis C infection, just under 6% will pass the infection on to their babies.” Transmission rates are twice as high in infants born to women with high HCV viral loads or those coinfected with HIV. The risk of transmission from women with undetectable HCV RNA is almost zero. Unfortunately, this mother did not fall into that category.
At that moment, however, I didn’t have time to be concerned about the numbers. My focus was one mother and her newborn baby.
“What if my baby is one of the unlucky ones who gets infected?” the mother asked, cuddling her infant. “What then?”
We know a lot about the course of hepatitis C in adults. An estimated 75%-86% of those infected will go on to develop chronic infection. Long-term sequelae include cirrhosis, liver failure, and hepatocellular carcinoma.
The course of HCV in children appears to be different. Twenty-five percent to 40% of vertically infected children will spontaneously clear their infection, most by 2 years of age. Occasionally, that might not happen until 7 years of age. Most who are chronically infected experience few symptoms, and fortunately cirrhosis and liver failure rarely present in childhood. In a large cohort of Italian children, half of whom were thought to be infected perinatally, less than 2% progressed to decompensated cirrhosis after 10 years of infection. According to the CDC, most children infected at birth “do well during childhood,” but more research is needed to understand the long-term effects of perinatal hepatitis C in children.
New antivirals have revolutionized the care of HCV-infected adults and now offer the hope of cure for up to 90%. None of these drugs are currently approved for use in children younger than 12 years, although clinical trials are underway. Because most cases of HCV in children are indolent, some children may not require treatment until adulthood.
July 28th was World Hepatitis Day and this year’s theme was Eliminate Hepatitis. To eliminate the problem of hepatitis C in children, pediatricians and others involved in the care of children need to get involved.
We need to know the scope of the problem
Since 2015, Kentucky has mandated reporting of all HCV-infected pregnant women and children through age 60 months, as well as all infants born to all HCV-infected women. At present though, there is substantial variability in state reporting requirements. We likely need a standardized case definition for perinatal HCV and national reporting criteria.
We need some clear guidance about testing during pregnancy
This should come from public health authorities, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
Jonathan Mermin, MD, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, has said, “Women are screened throughout pregnancy for many conditions that threaten their health. An expectant mother at risk for hepatitis C deserves to be tested. Knowing her status is the only way she can access the best hepatitis care and treatment – both for herself and her baby.” Yet, routine hepatitis C testing is not recommended during pregnancy, in part because there are no established interventions to prevent mother-to-child transmission of HCV. Instead, women are to be screened for risk factors and tested if they are present. As we learned with hepatitis B and HIV, risk factor screening is hard and misses individuals who are infected.
We need to ensure that HCV-exposed infants are identified and followed appropriately.
In a study of HCV-exposed infants born to women in Philadelphia, 84% did not receive adequate testing for HCV infection. In human terms, 537 children were born to HCV-positive mothers during the study period and 4 of 84 (5%) children tested were found to be infected. Assuming that 5% of HCV-exposed infants will develop chronic infection, 23 additional children were undiagnosed and, therefore, were not being followed for potential sequelae.
HCV-infected mothers in this study were more likely than non-infected mothers to be socioeconomically disadvantaged – specifically, unmarried, less educated, and publicly insured – suggesting that access to care may have played a role. When you add in drug use as a common risk factor for HCV infection, it is easy to understand why some at-risk infants are lost to follow-up.
Investigators in the Philadelphia study suggested that there might be more to the story. They proposed that pediatricians might be unaware of the need for testing because they had not been alerted to the mother’s HCV status by the obstetrician, the birthing hospital, or the mother herself. Finally, they theorized that many pediatricians “may be unaware or skeptical of the guidelines for testing children exposed to HCV.” This is a problem that we can solve.
I finished the visit with this mother by reassuring her that she could breastfeed her infant as planned as long as she did not have cracked or bleeding nipples. I also explained the schedule for testing. A 2002 National Institutes of Health consensus statement recommends that infants perinatally exposed to HCV have two HCV RNA tests between 2 and 6 months of age and/or be tested for HCV antibodies after 15 months. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Practice Guidelines for Diagnosis and Management of Hepatitis C Infection in Infants, Children, and Adolescents recommend testing for HCV antibodies at 18 months of age (J Pediatr Gastroenterol Nutr. 2012 Jun;54[6]:838-55). If a family requests earlier testing, a serum HCV RNA test can be done as early as 2 months of age. If positive, NASPGHAN recommends testing after 12 months of age to evaluate for chronic infection.
My practice has adopted the National Institutes of Health consensus statement approach because many of the families we see experience significant anxiety about the diagnosis, and this mother was no exception. As noted in the expert guidelines, this was a situation in which “early exclusion of HCV infection is reassuring and may be worth the added expense.”
“So first test at 2 months?” she asked. “Until then, we can’t do anything but wait?”
It is estimated that there are 23,000 to 46,000 U.S. children living with HCV. The wait for pediatricians is over. , and we need to educate ourselves about diagnosis and management. A first step might be to begin asking expectant mothers and the mothers of newborns if they know their HCV status.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.