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FDA Expands Dupilumab for EoE to Younger Children
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
How to Motivate Pain Patients to Try Nondrug Options
This transcript has been edited for clarity.
Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.
How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?
Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.
If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.
As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.
Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.
Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?
Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.
There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.
I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.
The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?
You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.
Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.
Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?
I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.
Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.
If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.
There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.
Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.
How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?
Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.
If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.
As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.
Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.
Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?
Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.
There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.
I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.
The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?
You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.
Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.
Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?
I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.
Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.
If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.
There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.
Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.
How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?
Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.
If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.
As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.
Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.
Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?
Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.
There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.
I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.
The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?
You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.
Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.
Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?
I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.
Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.
If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.
There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.
Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.
A version of this article appeared on Medscape.com.
e-Cigarettes Best Nicotine Gum for Smoking Cessation
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
HPV Vaccine Shown to Be Highly Effective in Girls Years Later
TOPLINE:
METHODOLOGY:
- Cervical cancer is the fourth most common cancer among women worldwide.
- Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
- After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
- Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
- They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.
TAKEAWAY:
- No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received.
- Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000).
IN PRACTICE:
“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”
SOURCE:
The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.
LIMITATIONS:
Only 14,645 women had received just one or two doses, which may have affected the statistical analysis.
DISCLOSURES:
The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Cervical cancer is the fourth most common cancer among women worldwide.
- Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
- After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
- Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
- They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.
TAKEAWAY:
- No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received.
- Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000).
IN PRACTICE:
“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”
SOURCE:
The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.
LIMITATIONS:
Only 14,645 women had received just one or two doses, which may have affected the statistical analysis.
DISCLOSURES:
The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Cervical cancer is the fourth most common cancer among women worldwide.
- Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
- After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
- Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
- They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.
TAKEAWAY:
- No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received.
- Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000).
IN PRACTICE:
“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”
SOURCE:
The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.
LIMITATIONS:
Only 14,645 women had received just one or two doses, which may have affected the statistical analysis.
DISCLOSURES:
The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
A version of this article appeared on Medscape.com.
Chemo-Free Maintenance Strategies May Boost Survival in TNBC
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
- The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
- The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
- The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.
TAKEAWAY:
- After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
- Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
- Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
- Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.
IN PRACTICE:
“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.
SOURCE:
This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.
LIMITATIONS:
The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.
DISCLOSURES:
AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
A version of this article appeared on Medscape.com.
The Amygdala Know
In a recent issue of Pediatric News, the Child Psychiatry Consult column featured an excellent discussion by Dr. David Rettew of some new research into a possible association between excessive crying in infancy and emotional problems later in childhood. This longitudinal study of almost 5,000 children included an assessment at 3 months and an MRI at age 10, which found that the infants who were excessive criers also had smaller amygdala. While the orders of magnitude of the researchers’ observations is small, it is interesting that the mothers of excessive criers were slightly more likely to experience mental health problems.
Dr. Rettew wisely cautions us to take note of this study’s findings but avoid overreacting. If indeed excessive crying in infancy is a marker for future problems, at the moment we may want to increase our efforts in helping parents improve their parenting skills using a nonjudgmental approach.
Using Dr. Rettew’s sage advice as a leaping off point, I will add the reminder that we must continue to meet head on the venerable myth that “colic” is a gastrointestinal problem. We must promise to never code out a parental complaint as “colic.” If we want to label it “excessive crying of infancy,” that’s one thing, but using “colic” only serves to perpetuate the myth and all the old, and sometimes dangerous, remedies that continue to cling to it.
Whether we use the term “colicky behavior” or call it “excessive crying,” we must remember these are merely descriptive terms. We have not made a diagnosis and are obligated to keep our minds open to serious and life-threatening conditions that make infants cry excessively — aberrant coronary arteries and urinary obstructions to name just two.
I can’t leave the phenomenon of colic without adding a nickel to the two cents I have already gifted you. When I was in medical school, I am sure I was told something about the amygdala. But, I suspect that I was only expected to recall where it lived. In the 50+ years since that brief encounter, other folks have learned much more. Prompted by this study, I searched what is known about small amygdala. Turns out that sleep deprivation has been associated with smaller amygdala, as has episodic migraine headaches, both in adults.
Regular readers of Letters from Maine can already smell where this is going. For decades I have believed that both excessive crying in infancy and episodic migraine in children are associated with, and my bias would say “caused” by, sleep deprivation. We learned from this study that mothers of excessively crying infants are more likely to have mental health problems. And, I will add that at least one study has shown that mothers and fathers of excessively crying infants are more likely to suffer from migraines.
Whether you join me in my biased interpretation isn’t important. What this study tells us is that there is likely to be something going on in infancy that may be a marker for future mental health problems. Were these children born with small or vulnerable amygdala? Did poor sleep hygiene contribute to the problem by interfering with the growth of their amygdala? I can envision studies that could provide some clarity. I’m not sure many parents would agree to have their happy and well-slept 3-month-olds slid into an MRI tube to serve as controls. But, I wouldn’t be surprised that we could find a sizable number of sleep deprived and frazzled parents of colicky infants who would agree if we told them it might help find an answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
In a recent issue of Pediatric News, the Child Psychiatry Consult column featured an excellent discussion by Dr. David Rettew of some new research into a possible association between excessive crying in infancy and emotional problems later in childhood. This longitudinal study of almost 5,000 children included an assessment at 3 months and an MRI at age 10, which found that the infants who were excessive criers also had smaller amygdala. While the orders of magnitude of the researchers’ observations is small, it is interesting that the mothers of excessive criers were slightly more likely to experience mental health problems.
Dr. Rettew wisely cautions us to take note of this study’s findings but avoid overreacting. If indeed excessive crying in infancy is a marker for future problems, at the moment we may want to increase our efforts in helping parents improve their parenting skills using a nonjudgmental approach.
Using Dr. Rettew’s sage advice as a leaping off point, I will add the reminder that we must continue to meet head on the venerable myth that “colic” is a gastrointestinal problem. We must promise to never code out a parental complaint as “colic.” If we want to label it “excessive crying of infancy,” that’s one thing, but using “colic” only serves to perpetuate the myth and all the old, and sometimes dangerous, remedies that continue to cling to it.
Whether we use the term “colicky behavior” or call it “excessive crying,” we must remember these are merely descriptive terms. We have not made a diagnosis and are obligated to keep our minds open to serious and life-threatening conditions that make infants cry excessively — aberrant coronary arteries and urinary obstructions to name just two.
I can’t leave the phenomenon of colic without adding a nickel to the two cents I have already gifted you. When I was in medical school, I am sure I was told something about the amygdala. But, I suspect that I was only expected to recall where it lived. In the 50+ years since that brief encounter, other folks have learned much more. Prompted by this study, I searched what is known about small amygdala. Turns out that sleep deprivation has been associated with smaller amygdala, as has episodic migraine headaches, both in adults.
Regular readers of Letters from Maine can already smell where this is going. For decades I have believed that both excessive crying in infancy and episodic migraine in children are associated with, and my bias would say “caused” by, sleep deprivation. We learned from this study that mothers of excessively crying infants are more likely to have mental health problems. And, I will add that at least one study has shown that mothers and fathers of excessively crying infants are more likely to suffer from migraines.
Whether you join me in my biased interpretation isn’t important. What this study tells us is that there is likely to be something going on in infancy that may be a marker for future mental health problems. Were these children born with small or vulnerable amygdala? Did poor sleep hygiene contribute to the problem by interfering with the growth of their amygdala? I can envision studies that could provide some clarity. I’m not sure many parents would agree to have their happy and well-slept 3-month-olds slid into an MRI tube to serve as controls. But, I wouldn’t be surprised that we could find a sizable number of sleep deprived and frazzled parents of colicky infants who would agree if we told them it might help find an answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
In a recent issue of Pediatric News, the Child Psychiatry Consult column featured an excellent discussion by Dr. David Rettew of some new research into a possible association between excessive crying in infancy and emotional problems later in childhood. This longitudinal study of almost 5,000 children included an assessment at 3 months and an MRI at age 10, which found that the infants who were excessive criers also had smaller amygdala. While the orders of magnitude of the researchers’ observations is small, it is interesting that the mothers of excessive criers were slightly more likely to experience mental health problems.
Dr. Rettew wisely cautions us to take note of this study’s findings but avoid overreacting. If indeed excessive crying in infancy is a marker for future problems, at the moment we may want to increase our efforts in helping parents improve their parenting skills using a nonjudgmental approach.
Using Dr. Rettew’s sage advice as a leaping off point, I will add the reminder that we must continue to meet head on the venerable myth that “colic” is a gastrointestinal problem. We must promise to never code out a parental complaint as “colic.” If we want to label it “excessive crying of infancy,” that’s one thing, but using “colic” only serves to perpetuate the myth and all the old, and sometimes dangerous, remedies that continue to cling to it.
Whether we use the term “colicky behavior” or call it “excessive crying,” we must remember these are merely descriptive terms. We have not made a diagnosis and are obligated to keep our minds open to serious and life-threatening conditions that make infants cry excessively — aberrant coronary arteries and urinary obstructions to name just two.
I can’t leave the phenomenon of colic without adding a nickel to the two cents I have already gifted you. When I was in medical school, I am sure I was told something about the amygdala. But, I suspect that I was only expected to recall where it lived. In the 50+ years since that brief encounter, other folks have learned much more. Prompted by this study, I searched what is known about small amygdala. Turns out that sleep deprivation has been associated with smaller amygdala, as has episodic migraine headaches, both in adults.
Regular readers of Letters from Maine can already smell where this is going. For decades I have believed that both excessive crying in infancy and episodic migraine in children are associated with, and my bias would say “caused” by, sleep deprivation. We learned from this study that mothers of excessively crying infants are more likely to have mental health problems. And, I will add that at least one study has shown that mothers and fathers of excessively crying infants are more likely to suffer from migraines.
Whether you join me in my biased interpretation isn’t important. What this study tells us is that there is likely to be something going on in infancy that may be a marker for future mental health problems. Were these children born with small or vulnerable amygdala? Did poor sleep hygiene contribute to the problem by interfering with the growth of their amygdala? I can envision studies that could provide some clarity. I’m not sure many parents would agree to have their happy and well-slept 3-month-olds slid into an MRI tube to serve as controls. But, I wouldn’t be surprised that we could find a sizable number of sleep deprived and frazzled parents of colicky infants who would agree if we told them it might help find an answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Adequate Transition of Epilepsy Care from Pediatric to Adult Is Often Lacking
, according to a recent survey. Many respondents received little to no information regarding the process, and many adults were still receiving care from family physicians or pediatric neurologists. The study was published online in Epilepsy & Behavior.
Room for Improvement
“We are not doing as good a job with planning for transition as we should,” said Elaine C. Wirrell, MD, who was not involved with the study. “It is not just a simple issue of sending your patient to an adult neurologist. Transition is a process that happens over time, so we need to do a better job getting our families ready for moving on to an adult provider.” Dr. Wirrell is director of pediatric epilepsy and professor of neurology at the Mayo Clinic in Rochester, Minnesota.
Clumsy Transitions
Investigators distributed a 25-question survey to patients and caregivers who attended the 2019 Epilepsy Awareness Day at Disneyland, and through online support groups in North America. Among 58 responses, 32 came from patients between ages 12 and 17 years or their caregivers.
Despite attempts to recruit a diverse cross-section of respondents, most patients had severe epilepsy and comorbidities: 43% had daily or weekly seizures; 45% were on three or more antiseizure medications; and 74% had intellectual disabilities.
Many children with early-life epilepsies suffer from developmental and epileptic encephalopathy, which has associated non-seizure symptoms including learning challenges, behavioral issues, and other medical concerns, Dr. Wirrell said. Therefore, she said, finding a neurologist who treats adults — and has the expertise and interest to care for such patients — can be difficult.
“We’re seeing many patients not making that transition, or maybe not making it appropriately, so they’re not necessarily getting to the providers who have the most expertise in managing their epilepsy.” Among adults surveyed, 27% were still being followed by pediatric neurologists, and 35% were visiting family doctors for epilepsy-related treatment.
Because the needs of children with complex epilepsy can extend well beyond neurology, Dr. Wirrell added, managing such cases often requires multidisciplinary pediatric teams. “Finding that team on the adult side is more challenging.” As a result, she said, patients may transfer their neurology care without getting additional support for comorbidities such as mood disorders and learning disabilities.
The foregoing challenges are complicated by the fact that pediatric neurologists often lack the time (and in the United States, reimbursement) to adequately address the transition process, said Dr. Wirrell. Providers in freestanding children’s hospitals may face additional challenges coordinating with adult-care providers outside their facilities, she said.
“There’s also potentially a reluctance of both families and physicians to transition the patient on, because there’s concern that maybe there isn’t anybody on the adult side who is able to do as good a job as what they have on the pediatric side.”
Well-Coordinated Transitions Should Have No Surprises
Transition should be a planned, independence-promoting process that results in smooth, well-coordinated movement of pediatric patients into adult care — one without surprises or disconnections, the authors wrote. However, 55% of respondents never heard the term “transition” from any provider, even though 69% of patients were being treated in academic specialty centers.
Among 12- to 17-year-olds, 72% had never discussed transition with their healthcare team. That figure includes no 17-year-olds. Approximately 90% of respondents said they received sufficient time during healthcare visits, but 54% reported feeling stressed when moving from pediatric to adult care.
Given resource constraints in many pediatric epilepsy programs, the study authors recommended patient-empowerment tools such as a transition toolkit to help patients and families navigate the transition process even in places without formal transition programs.
“Many of these children are coming over with boatloads of medical records,” Dr. Wirrell said. “It’s not fair to the adult provider, who then has to go through all those records.” Instead, she said, pediatric teams should provide succinct summaries of relevant test results, medication side effects, prior treatments tried, and the like. “Those summaries are critically important so that we can get information to the person who needs it.”
Although successful transition requires significant coordination, she added, much of the process can often be handled by nonphysicians. “There are some very good nurse-led transition programs. Often, we can have a nurse providing education to the family and even potentially having a joint visit with an adult epilepsy nurse for complex patients.”
Pediatric providers also must know when to begin the transition process, Dr. Wirrell said. As soon as patients are 13 or 14 years old, she suggested discussing the process with them and their families every 6 to 12 months, covering specifics ranging from how to order medications to why adult patients may need power of attorney designees.
On a broader scale, said Dr. Wirrell, a smooth handoff requires planning. Fortunately, she said, the topic is becoming a significant priority for a growing number of children’s hospitals specific not only to epilepsy, but also to other chronic illnesses.
Dr. Wirrell is co–editor-in-chief for epilepsy.com. She reports no relevant financial interests.
, according to a recent survey. Many respondents received little to no information regarding the process, and many adults were still receiving care from family physicians or pediatric neurologists. The study was published online in Epilepsy & Behavior.
Room for Improvement
“We are not doing as good a job with planning for transition as we should,” said Elaine C. Wirrell, MD, who was not involved with the study. “It is not just a simple issue of sending your patient to an adult neurologist. Transition is a process that happens over time, so we need to do a better job getting our families ready for moving on to an adult provider.” Dr. Wirrell is director of pediatric epilepsy and professor of neurology at the Mayo Clinic in Rochester, Minnesota.
Clumsy Transitions
Investigators distributed a 25-question survey to patients and caregivers who attended the 2019 Epilepsy Awareness Day at Disneyland, and through online support groups in North America. Among 58 responses, 32 came from patients between ages 12 and 17 years or their caregivers.
Despite attempts to recruit a diverse cross-section of respondents, most patients had severe epilepsy and comorbidities: 43% had daily or weekly seizures; 45% were on three or more antiseizure medications; and 74% had intellectual disabilities.
Many children with early-life epilepsies suffer from developmental and epileptic encephalopathy, which has associated non-seizure symptoms including learning challenges, behavioral issues, and other medical concerns, Dr. Wirrell said. Therefore, she said, finding a neurologist who treats adults — and has the expertise and interest to care for such patients — can be difficult.
“We’re seeing many patients not making that transition, or maybe not making it appropriately, so they’re not necessarily getting to the providers who have the most expertise in managing their epilepsy.” Among adults surveyed, 27% were still being followed by pediatric neurologists, and 35% were visiting family doctors for epilepsy-related treatment.
Because the needs of children with complex epilepsy can extend well beyond neurology, Dr. Wirrell added, managing such cases often requires multidisciplinary pediatric teams. “Finding that team on the adult side is more challenging.” As a result, she said, patients may transfer their neurology care without getting additional support for comorbidities such as mood disorders and learning disabilities.
The foregoing challenges are complicated by the fact that pediatric neurologists often lack the time (and in the United States, reimbursement) to adequately address the transition process, said Dr. Wirrell. Providers in freestanding children’s hospitals may face additional challenges coordinating with adult-care providers outside their facilities, she said.
“There’s also potentially a reluctance of both families and physicians to transition the patient on, because there’s concern that maybe there isn’t anybody on the adult side who is able to do as good a job as what they have on the pediatric side.”
Well-Coordinated Transitions Should Have No Surprises
Transition should be a planned, independence-promoting process that results in smooth, well-coordinated movement of pediatric patients into adult care — one without surprises or disconnections, the authors wrote. However, 55% of respondents never heard the term “transition” from any provider, even though 69% of patients were being treated in academic specialty centers.
Among 12- to 17-year-olds, 72% had never discussed transition with their healthcare team. That figure includes no 17-year-olds. Approximately 90% of respondents said they received sufficient time during healthcare visits, but 54% reported feeling stressed when moving from pediatric to adult care.
Given resource constraints in many pediatric epilepsy programs, the study authors recommended patient-empowerment tools such as a transition toolkit to help patients and families navigate the transition process even in places without formal transition programs.
“Many of these children are coming over with boatloads of medical records,” Dr. Wirrell said. “It’s not fair to the adult provider, who then has to go through all those records.” Instead, she said, pediatric teams should provide succinct summaries of relevant test results, medication side effects, prior treatments tried, and the like. “Those summaries are critically important so that we can get information to the person who needs it.”
Although successful transition requires significant coordination, she added, much of the process can often be handled by nonphysicians. “There are some very good nurse-led transition programs. Often, we can have a nurse providing education to the family and even potentially having a joint visit with an adult epilepsy nurse for complex patients.”
Pediatric providers also must know when to begin the transition process, Dr. Wirrell said. As soon as patients are 13 or 14 years old, she suggested discussing the process with them and their families every 6 to 12 months, covering specifics ranging from how to order medications to why adult patients may need power of attorney designees.
On a broader scale, said Dr. Wirrell, a smooth handoff requires planning. Fortunately, she said, the topic is becoming a significant priority for a growing number of children’s hospitals specific not only to epilepsy, but also to other chronic illnesses.
Dr. Wirrell is co–editor-in-chief for epilepsy.com. She reports no relevant financial interests.
, according to a recent survey. Many respondents received little to no information regarding the process, and many adults were still receiving care from family physicians or pediatric neurologists. The study was published online in Epilepsy & Behavior.
Room for Improvement
“We are not doing as good a job with planning for transition as we should,” said Elaine C. Wirrell, MD, who was not involved with the study. “It is not just a simple issue of sending your patient to an adult neurologist. Transition is a process that happens over time, so we need to do a better job getting our families ready for moving on to an adult provider.” Dr. Wirrell is director of pediatric epilepsy and professor of neurology at the Mayo Clinic in Rochester, Minnesota.
Clumsy Transitions
Investigators distributed a 25-question survey to patients and caregivers who attended the 2019 Epilepsy Awareness Day at Disneyland, and through online support groups in North America. Among 58 responses, 32 came from patients between ages 12 and 17 years or their caregivers.
Despite attempts to recruit a diverse cross-section of respondents, most patients had severe epilepsy and comorbidities: 43% had daily or weekly seizures; 45% were on three or more antiseizure medications; and 74% had intellectual disabilities.
Many children with early-life epilepsies suffer from developmental and epileptic encephalopathy, which has associated non-seizure symptoms including learning challenges, behavioral issues, and other medical concerns, Dr. Wirrell said. Therefore, she said, finding a neurologist who treats adults — and has the expertise and interest to care for such patients — can be difficult.
“We’re seeing many patients not making that transition, or maybe not making it appropriately, so they’re not necessarily getting to the providers who have the most expertise in managing their epilepsy.” Among adults surveyed, 27% were still being followed by pediatric neurologists, and 35% were visiting family doctors for epilepsy-related treatment.
Because the needs of children with complex epilepsy can extend well beyond neurology, Dr. Wirrell added, managing such cases often requires multidisciplinary pediatric teams. “Finding that team on the adult side is more challenging.” As a result, she said, patients may transfer their neurology care without getting additional support for comorbidities such as mood disorders and learning disabilities.
The foregoing challenges are complicated by the fact that pediatric neurologists often lack the time (and in the United States, reimbursement) to adequately address the transition process, said Dr. Wirrell. Providers in freestanding children’s hospitals may face additional challenges coordinating with adult-care providers outside their facilities, she said.
“There’s also potentially a reluctance of both families and physicians to transition the patient on, because there’s concern that maybe there isn’t anybody on the adult side who is able to do as good a job as what they have on the pediatric side.”
Well-Coordinated Transitions Should Have No Surprises
Transition should be a planned, independence-promoting process that results in smooth, well-coordinated movement of pediatric patients into adult care — one without surprises or disconnections, the authors wrote. However, 55% of respondents never heard the term “transition” from any provider, even though 69% of patients were being treated in academic specialty centers.
Among 12- to 17-year-olds, 72% had never discussed transition with their healthcare team. That figure includes no 17-year-olds. Approximately 90% of respondents said they received sufficient time during healthcare visits, but 54% reported feeling stressed when moving from pediatric to adult care.
Given resource constraints in many pediatric epilepsy programs, the study authors recommended patient-empowerment tools such as a transition toolkit to help patients and families navigate the transition process even in places without formal transition programs.
“Many of these children are coming over with boatloads of medical records,” Dr. Wirrell said. “It’s not fair to the adult provider, who then has to go through all those records.” Instead, she said, pediatric teams should provide succinct summaries of relevant test results, medication side effects, prior treatments tried, and the like. “Those summaries are critically important so that we can get information to the person who needs it.”
Although successful transition requires significant coordination, she added, much of the process can often be handled by nonphysicians. “There are some very good nurse-led transition programs. Often, we can have a nurse providing education to the family and even potentially having a joint visit with an adult epilepsy nurse for complex patients.”
Pediatric providers also must know when to begin the transition process, Dr. Wirrell said. As soon as patients are 13 or 14 years old, she suggested discussing the process with them and their families every 6 to 12 months, covering specifics ranging from how to order medications to why adult patients may need power of attorney designees.
On a broader scale, said Dr. Wirrell, a smooth handoff requires planning. Fortunately, she said, the topic is becoming a significant priority for a growing number of children’s hospitals specific not only to epilepsy, but also to other chronic illnesses.
Dr. Wirrell is co–editor-in-chief for epilepsy.com. She reports no relevant financial interests.
FROM EPILEPSY & BEHAVIOR
Bone Mineral Density Higher in Children Living Near Green Areas
A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.
The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.
To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.
Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.
The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.
“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.
The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.
One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.
According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.
The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.
To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.
Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.
The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.
“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.
The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.
One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.
According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.
The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.
To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.
Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.
The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.
“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.
The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.
One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.
According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
Treatment Sequence May Impact Pancreatic Cancer Survival
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
- In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
- To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
- The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).
TAKEAWAY:
- Overall, progression occurred in 90% of patients, and the median overall survival was 12.0 months, with only 48% of patients able to start a third-line therapy.
- The researchers focused on three common therapy sequences: nab-paclitaxel plus gemcitabine or nab-paclitaxel combination therapy as first-line and FOLFIRINOX as second-line (line A); nab-paclitaxel combination therapy to gemcitabine combination therapy to FOLFIRINOX (line B); and nab-paclitaxel combination therapy, to gemcitabine combination therapy, to oxaliplatin or irinotecan combination therapy (line C).
- Overall, the researchers observed a median overall survival of 14 months among patients receiving line A and C sequences and 18 months with line B.
- Patients receiving line B therapy demonstrated a 52% lower risk for death compared with those receiving line A treatment (hazard ratio [HR], 0.48; P = .018) and a 75% reduced risk for death compared with those on the line C sequence (HR, 0.25; P = .040).
IN PRACTICE:
“Our study provides real-world evidence for the effectiveness of different treatment sequences and underscores the [impact of] treatment sequences on survival outcome when considering the entire management in advanced pancreatic ductal adenocarcinoma,” the authors concluded.
SOURCE:
The study, led by Guanghai Dai, MD, from the Chinese People’s Liberation Army General Hospital, Beijing, was published in BMC Cancer on January 12, 2024.
LIMITATIONS:
The study was a single-center, retrospective analysis.
DISCLOSURES:
The paper was funded by Beijing natural science foundation. The authors did not declare any relevant financial relationships.
A version of this article appeared on Medscape.com.
Ob.Gyns. Face ‘Occupational Crisis’ Navigating Abortion Ban
A 14-year-old girl arrived at a South Carolina clinic just one day after the state’s anti-abortion law would have allowed her to terminate a pregnancy in instances of rape or incest.
Angela Dempsey-Fanning, MD, MPH, an ob.gyn. in Charleston, had to inform the teenager, a victim of incest, that she could not legally provide abortion care, so the girl and her mother decided to seek treatment in a different state.
“I couldn’t shake the sense that so many principles of medical ethics were being violated in denying care to her,” said Dr. Dempsey-Fanning, president of the Society of Family Planning, a nonprofit that advocates for abortion access. “When I interact with patients in these situations ... I carry the emotional and mental burden for weeks.”
South Carolina is one of 16 states to put in place severe abortion restrictions in the wake of the US Supreme Court ruling in June 2022 on the Dobbs v. Jackson Women’s Health Organization case that overturned Roe v. Wade.
according to a study recently published in the JAMA Network Open.
Public discourse on the Dobbs v. Jackson ruling has mostly centered on the impact to patients, according to Mara Buchbinder, PhD, professor and vice chair in the Department of Social Medicine at University of North Carolina Chapel Hill School of Medicine, and a coauthor of the study.
“We were interested in what the impacts would be for the obstetric workforce as well,” she said.
In 2022 and 2023, Dr. Buchbinder and her colleagues interviewed 54 ob.gyns. practicing in 13 states where abortion had become illegal with limited exceptions, including Texas, West Virginia, and South Dakota.
Clinicians who participated in the study described instances in which the state restrictions on abortion forced them to delay what they deemed to be medically necessary care until a patient faced severe complications or even death. More than 90% reported moral distress concerning situations where legal constraints prevented them or their colleagues from following clinical standards.
“You have somebody hemorrhaging with an intrauterine pregnancy with a heartbeat ... I [didn’t yet] have legal coverage for that, but there’s only so many times you can transfuse somebody and they’re begging for their life before you say, ‘This is unconscionable,’ ” one clinician reported to researchers.
Another clinician said, “Is a 5% risk of death enough? Does it take 20%? Does it take 50%? What is enough legally?”
The US Department of Health and Human Services has announced a new team to ensure hospitals in all states comply with the Emergency Medical Treatment and Labor Act, which, according to the Biden administration, includes emergency abortions. Still, some hospitals may not have clear policies that define pregnancy-related emergencies, making it challenging for clinicians to feel protected in clinically complex situations.
The study also highlighted aiding and abetting clauses, which prevent ob.gyns. from providing referrals for abortions or discussing the option with patients. Participants described the limitations as undermining their medical expertise.
“Some of the harm that is done to these ob.gyns. is not only from the laws themselves, but from their own institutions,” Dr. Buchbinder said. “Hospitals have to decide, ‘what does this law mean and how are we going to put it to practice here?’ ”
Angela Hawkins, MD, a hospitalist practicing in Oklahoma, encountered a patient who was experiencing an obvious miscarriage. But because the situation could not yet be established as life-threatening, Dr. Hawkins felt that she could not intervene.
“There are things I know are straightforward and I would’ve handled them completely differently in the past,” Dr. Hawkins said, adding that she needed to seek reassurance from her hospital employer that she would not face legal ramifications if she provided care.
“It’s frustrating to know that this is medicine and I can’t practice it without calling legal and ethics in the middle of the night,” said Dr. Hawkins, chair of the Oklahoma section of the American College of Obstetrics and Gynecology.
Still, more than half of Oklahoma’s 77 counties are considered maternity care deserts, meaning they have little to no obstetric services available for pregnant patients. Dr. Hawkins recently completed her own survey of practicing ob.gyns. in the state. In soon-to-be published research, almost 60% of the 63 respondents reported thinking about leaving or were planning to leave the state to practice in areas that are less restrictive.
“That’s very concerning to the ob.gyns. that are left,” she said. “I feel like, if everyone leaves, who is left to take care of the patients?”
The study in JAMA Network Open also highlighted that 11% of participants had moved their practices to less restrictive states with stronger abortion protections.
In addition to losing existing clinicians, the laws have made it difficult for medical centers to recruit new ones, according to Kavita Shah Arora, MD, MBE, MS, director for Division of General Obstetrics, Gynecology, and Midwifery at the University of North Carolina at Chapel Hill, and a coauthor of the study. North Carolina enacted a new law in July 2023 that reduced the time allowed for an abortion from 20 weeks to 12 weeks under most circumstances.
“Our department faces new challenges in recruitment and retention being in a restrictive state that we haven’t had to deal with before,” Dr. Arora said. “It’s impacting how medical students choose which residency programs to apply to.”
Ob.gyns. may not be the only clinicians who feel the effect of laws restricting abortion, according to Deborah Nucatola, MD, chief medical officer of Planned Parenthood Great Northwest, Hawai’i, Alaska, Indiana, Kentucky.
Patients who live in areas with limited access to obstetrics services often present to urgent care facilities or emergency departments for medical care that are staffed with family, internal medicine, and emergency physicians, Dr. Nucatola said.
“I don’t want anyone by any means to think this is isolated to one specialty,” said Dr. Nucatola, who was not involved with the study. “It’s going to affect everyone who cares for these patients; you lose the ability to use your medical knowledge and then have to navigate this legal restriction that doesn’t correlate with anything that happens in medicine.”
Dr. Dempsey-Fanning’s 14-year-old patient did eventually receive abortion care outside of South Carolina. Dr. Dempsey-Fanning said that she and her colleagues have spent hours coordinating for patients to receive care in a different state. Then, patients and their families must come up with the money for travel and any missed work to get to another clinician working where abortion is legal.
Despite this, she said, “You are left still feeling as though you abandoned this patient in many practical ways.
“I know I weigh the decision about my future practice almost daily, wondering how long I can stay and keep fighting for patients in an environment ripe with fear, worry, and an overriding sense of injustice,” said Dr. Dempsey-Fanning.
The study authors and experts quoted in the story report no relevant disclosures.
A version of this article appeared on Medscape.com.
A 14-year-old girl arrived at a South Carolina clinic just one day after the state’s anti-abortion law would have allowed her to terminate a pregnancy in instances of rape or incest.
Angela Dempsey-Fanning, MD, MPH, an ob.gyn. in Charleston, had to inform the teenager, a victim of incest, that she could not legally provide abortion care, so the girl and her mother decided to seek treatment in a different state.
“I couldn’t shake the sense that so many principles of medical ethics were being violated in denying care to her,” said Dr. Dempsey-Fanning, president of the Society of Family Planning, a nonprofit that advocates for abortion access. “When I interact with patients in these situations ... I carry the emotional and mental burden for weeks.”
South Carolina is one of 16 states to put in place severe abortion restrictions in the wake of the US Supreme Court ruling in June 2022 on the Dobbs v. Jackson Women’s Health Organization case that overturned Roe v. Wade.
according to a study recently published in the JAMA Network Open.
Public discourse on the Dobbs v. Jackson ruling has mostly centered on the impact to patients, according to Mara Buchbinder, PhD, professor and vice chair in the Department of Social Medicine at University of North Carolina Chapel Hill School of Medicine, and a coauthor of the study.
“We were interested in what the impacts would be for the obstetric workforce as well,” she said.
In 2022 and 2023, Dr. Buchbinder and her colleagues interviewed 54 ob.gyns. practicing in 13 states where abortion had become illegal with limited exceptions, including Texas, West Virginia, and South Dakota.
Clinicians who participated in the study described instances in which the state restrictions on abortion forced them to delay what they deemed to be medically necessary care until a patient faced severe complications or even death. More than 90% reported moral distress concerning situations where legal constraints prevented them or their colleagues from following clinical standards.
“You have somebody hemorrhaging with an intrauterine pregnancy with a heartbeat ... I [didn’t yet] have legal coverage for that, but there’s only so many times you can transfuse somebody and they’re begging for their life before you say, ‘This is unconscionable,’ ” one clinician reported to researchers.
Another clinician said, “Is a 5% risk of death enough? Does it take 20%? Does it take 50%? What is enough legally?”
The US Department of Health and Human Services has announced a new team to ensure hospitals in all states comply with the Emergency Medical Treatment and Labor Act, which, according to the Biden administration, includes emergency abortions. Still, some hospitals may not have clear policies that define pregnancy-related emergencies, making it challenging for clinicians to feel protected in clinically complex situations.
The study also highlighted aiding and abetting clauses, which prevent ob.gyns. from providing referrals for abortions or discussing the option with patients. Participants described the limitations as undermining their medical expertise.
“Some of the harm that is done to these ob.gyns. is not only from the laws themselves, but from their own institutions,” Dr. Buchbinder said. “Hospitals have to decide, ‘what does this law mean and how are we going to put it to practice here?’ ”
Angela Hawkins, MD, a hospitalist practicing in Oklahoma, encountered a patient who was experiencing an obvious miscarriage. But because the situation could not yet be established as life-threatening, Dr. Hawkins felt that she could not intervene.
“There are things I know are straightforward and I would’ve handled them completely differently in the past,” Dr. Hawkins said, adding that she needed to seek reassurance from her hospital employer that she would not face legal ramifications if she provided care.
“It’s frustrating to know that this is medicine and I can’t practice it without calling legal and ethics in the middle of the night,” said Dr. Hawkins, chair of the Oklahoma section of the American College of Obstetrics and Gynecology.
Still, more than half of Oklahoma’s 77 counties are considered maternity care deserts, meaning they have little to no obstetric services available for pregnant patients. Dr. Hawkins recently completed her own survey of practicing ob.gyns. in the state. In soon-to-be published research, almost 60% of the 63 respondents reported thinking about leaving or were planning to leave the state to practice in areas that are less restrictive.
“That’s very concerning to the ob.gyns. that are left,” she said. “I feel like, if everyone leaves, who is left to take care of the patients?”
The study in JAMA Network Open also highlighted that 11% of participants had moved their practices to less restrictive states with stronger abortion protections.
In addition to losing existing clinicians, the laws have made it difficult for medical centers to recruit new ones, according to Kavita Shah Arora, MD, MBE, MS, director for Division of General Obstetrics, Gynecology, and Midwifery at the University of North Carolina at Chapel Hill, and a coauthor of the study. North Carolina enacted a new law in July 2023 that reduced the time allowed for an abortion from 20 weeks to 12 weeks under most circumstances.
“Our department faces new challenges in recruitment and retention being in a restrictive state that we haven’t had to deal with before,” Dr. Arora said. “It’s impacting how medical students choose which residency programs to apply to.”
Ob.gyns. may not be the only clinicians who feel the effect of laws restricting abortion, according to Deborah Nucatola, MD, chief medical officer of Planned Parenthood Great Northwest, Hawai’i, Alaska, Indiana, Kentucky.
Patients who live in areas with limited access to obstetrics services often present to urgent care facilities or emergency departments for medical care that are staffed with family, internal medicine, and emergency physicians, Dr. Nucatola said.
“I don’t want anyone by any means to think this is isolated to one specialty,” said Dr. Nucatola, who was not involved with the study. “It’s going to affect everyone who cares for these patients; you lose the ability to use your medical knowledge and then have to navigate this legal restriction that doesn’t correlate with anything that happens in medicine.”
Dr. Dempsey-Fanning’s 14-year-old patient did eventually receive abortion care outside of South Carolina. Dr. Dempsey-Fanning said that she and her colleagues have spent hours coordinating for patients to receive care in a different state. Then, patients and their families must come up with the money for travel and any missed work to get to another clinician working where abortion is legal.
Despite this, she said, “You are left still feeling as though you abandoned this patient in many practical ways.
“I know I weigh the decision about my future practice almost daily, wondering how long I can stay and keep fighting for patients in an environment ripe with fear, worry, and an overriding sense of injustice,” said Dr. Dempsey-Fanning.
The study authors and experts quoted in the story report no relevant disclosures.
A version of this article appeared on Medscape.com.
A 14-year-old girl arrived at a South Carolina clinic just one day after the state’s anti-abortion law would have allowed her to terminate a pregnancy in instances of rape or incest.
Angela Dempsey-Fanning, MD, MPH, an ob.gyn. in Charleston, had to inform the teenager, a victim of incest, that she could not legally provide abortion care, so the girl and her mother decided to seek treatment in a different state.
“I couldn’t shake the sense that so many principles of medical ethics were being violated in denying care to her,” said Dr. Dempsey-Fanning, president of the Society of Family Planning, a nonprofit that advocates for abortion access. “When I interact with patients in these situations ... I carry the emotional and mental burden for weeks.”
South Carolina is one of 16 states to put in place severe abortion restrictions in the wake of the US Supreme Court ruling in June 2022 on the Dobbs v. Jackson Women’s Health Organization case that overturned Roe v. Wade.
according to a study recently published in the JAMA Network Open.
Public discourse on the Dobbs v. Jackson ruling has mostly centered on the impact to patients, according to Mara Buchbinder, PhD, professor and vice chair in the Department of Social Medicine at University of North Carolina Chapel Hill School of Medicine, and a coauthor of the study.
“We were interested in what the impacts would be for the obstetric workforce as well,” she said.
In 2022 and 2023, Dr. Buchbinder and her colleagues interviewed 54 ob.gyns. practicing in 13 states where abortion had become illegal with limited exceptions, including Texas, West Virginia, and South Dakota.
Clinicians who participated in the study described instances in which the state restrictions on abortion forced them to delay what they deemed to be medically necessary care until a patient faced severe complications or even death. More than 90% reported moral distress concerning situations where legal constraints prevented them or their colleagues from following clinical standards.
“You have somebody hemorrhaging with an intrauterine pregnancy with a heartbeat ... I [didn’t yet] have legal coverage for that, but there’s only so many times you can transfuse somebody and they’re begging for their life before you say, ‘This is unconscionable,’ ” one clinician reported to researchers.
Another clinician said, “Is a 5% risk of death enough? Does it take 20%? Does it take 50%? What is enough legally?”
The US Department of Health and Human Services has announced a new team to ensure hospitals in all states comply with the Emergency Medical Treatment and Labor Act, which, according to the Biden administration, includes emergency abortions. Still, some hospitals may not have clear policies that define pregnancy-related emergencies, making it challenging for clinicians to feel protected in clinically complex situations.
The study also highlighted aiding and abetting clauses, which prevent ob.gyns. from providing referrals for abortions or discussing the option with patients. Participants described the limitations as undermining their medical expertise.
“Some of the harm that is done to these ob.gyns. is not only from the laws themselves, but from their own institutions,” Dr. Buchbinder said. “Hospitals have to decide, ‘what does this law mean and how are we going to put it to practice here?’ ”
Angela Hawkins, MD, a hospitalist practicing in Oklahoma, encountered a patient who was experiencing an obvious miscarriage. But because the situation could not yet be established as life-threatening, Dr. Hawkins felt that she could not intervene.
“There are things I know are straightforward and I would’ve handled them completely differently in the past,” Dr. Hawkins said, adding that she needed to seek reassurance from her hospital employer that she would not face legal ramifications if she provided care.
“It’s frustrating to know that this is medicine and I can’t practice it without calling legal and ethics in the middle of the night,” said Dr. Hawkins, chair of the Oklahoma section of the American College of Obstetrics and Gynecology.
Still, more than half of Oklahoma’s 77 counties are considered maternity care deserts, meaning they have little to no obstetric services available for pregnant patients. Dr. Hawkins recently completed her own survey of practicing ob.gyns. in the state. In soon-to-be published research, almost 60% of the 63 respondents reported thinking about leaving or were planning to leave the state to practice in areas that are less restrictive.
“That’s very concerning to the ob.gyns. that are left,” she said. “I feel like, if everyone leaves, who is left to take care of the patients?”
The study in JAMA Network Open also highlighted that 11% of participants had moved their practices to less restrictive states with stronger abortion protections.
In addition to losing existing clinicians, the laws have made it difficult for medical centers to recruit new ones, according to Kavita Shah Arora, MD, MBE, MS, director for Division of General Obstetrics, Gynecology, and Midwifery at the University of North Carolina at Chapel Hill, and a coauthor of the study. North Carolina enacted a new law in July 2023 that reduced the time allowed for an abortion from 20 weeks to 12 weeks under most circumstances.
“Our department faces new challenges in recruitment and retention being in a restrictive state that we haven’t had to deal with before,” Dr. Arora said. “It’s impacting how medical students choose which residency programs to apply to.”
Ob.gyns. may not be the only clinicians who feel the effect of laws restricting abortion, according to Deborah Nucatola, MD, chief medical officer of Planned Parenthood Great Northwest, Hawai’i, Alaska, Indiana, Kentucky.
Patients who live in areas with limited access to obstetrics services often present to urgent care facilities or emergency departments for medical care that are staffed with family, internal medicine, and emergency physicians, Dr. Nucatola said.
“I don’t want anyone by any means to think this is isolated to one specialty,” said Dr. Nucatola, who was not involved with the study. “It’s going to affect everyone who cares for these patients; you lose the ability to use your medical knowledge and then have to navigate this legal restriction that doesn’t correlate with anything that happens in medicine.”
Dr. Dempsey-Fanning’s 14-year-old patient did eventually receive abortion care outside of South Carolina. Dr. Dempsey-Fanning said that she and her colleagues have spent hours coordinating for patients to receive care in a different state. Then, patients and their families must come up with the money for travel and any missed work to get to another clinician working where abortion is legal.
Despite this, she said, “You are left still feeling as though you abandoned this patient in many practical ways.
“I know I weigh the decision about my future practice almost daily, wondering how long I can stay and keep fighting for patients in an environment ripe with fear, worry, and an overriding sense of injustice,” said Dr. Dempsey-Fanning.
The study authors and experts quoted in the story report no relevant disclosures.
A version of this article appeared on Medscape.com.