SAN FRANCISCO – In a widely anticipated report, researchers reported that a phase 3 study showed statistically significant improvements in patients with agitation related to Alzheimer’s disease (AD) who took the atypical antipsychotic brexpiprazole (Rexulti).

Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.

“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”

Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.

In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.

Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
 

Three trials

All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.

Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.

The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”

The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).

In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).

In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.

The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.

The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.

Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.

University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”

But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”

What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.

Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
 

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

SAN FRANCISCO – In a widely anticipated report, researchers reported that a phase 3 study showed statistically significant improvements in patients with agitation related to Alzheimer’s disease (AD) who took the atypical antipsychotic brexpiprazole (Rexulti).

Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.

“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”

Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.

In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.

Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
 

Three trials

All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.

Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.

The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”

The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).

In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).

In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.

The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.

The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.

Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.

University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”

But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”

What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.

Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
 

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

SAN FRANCISCO – In a widely anticipated report, researchers reported that a phase 3 study showed statistically significant improvements in patients with agitation related to Alzheimer’s disease (AD) who took the atypical antipsychotic brexpiprazole (Rexulti).

Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.

“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”

Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.

In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.

Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
 

Three trials

All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.

Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.

The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”

The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).

In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).

In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.

The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.

The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.

Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.

University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”

But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”

What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.

Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
 

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

Several adverse infant outcomes were significantly more likely for infants whose mothers had diagnoses of sleep apnea or insomnia, based on data from approximately 5,000 infants.

Sleep disturbance is common during pregnancy, and “sleep disorders during pregnancy can have significant consequences for both the pregnant person and their infant,” write Jennifer N. Felder, PhD, of the University of California, San Francisco, and colleagues.

However, data on the impact of maternal insomnia on specific infant outcomes are limited, they said.

In a study published recently in the journal Sleep Health, the researchers reviewed data from 3,371 pregnant women diagnosed with sleep apnea and 3,213 with insomnia. Of these, 2,357 and 2,212 were matched with controls in a propensity-score analysis. The referent controls were matched for maternal characteristics, obstetric factors, and infant factors among individuals without a sleep disorder. All were singleton pregnancies.

Adverse infant outcomes included the following:

• One- and 5-minute Apgar scores less than 7.
• Respiratory distress syndrome.
• Neonatal intensive care unit admission.
• Hypoglycemia.
• Infant death.
• Hospital stay of longer than 2 days for vaginal delivery or longer than 4 days for cesarean delivery.
• Emergency department visit before 3 months of age.
• Emergency department visit in the first year of life.
• Composite measure of adverse infant outcomes.

Compared with matched controls, the infants born to mothers with sleep apnea had a significantly increased risk for any adverse outcome (50.1% vs. 53.5%) and of the specific outcomes of low 1-minute Apgar scores (6.3% vs. 9.6%), neonatal ICU stays (6.3% vs. 8.4%), and an emergency department visit in the first year of life (33.6% vs. 36.9%).

For infants born to mothers with insomnia, the only significant difference in outcomes compared with controls was an increased likelihood of an emergency department visit (37.2% vs. 32.3%).

“Research on possible mechanisms of the relation between maternal prenatal sleep apnea and poorer birth and infant outcomes associations is small but growing, implicating systemic inflammation and late or prolonged fetal heart rate decelerations,” the researchers write in their discussion.

Research on insomnia during pregnancy and adverse infant outcomes is limited, and the largest studies have been complicated by the effects of insomnia medication; therefore, “our finding that infants born to mothers with an insomnia diagnosis were at increased risk of only emergency room visit, but no other analyzed infant outcomes, is important and novel,” they note.

The findings were limited by several factors, including the reliance on medical records, which may lack details on how routinely health care professionals assessed sleep disorders, the researchers noted. “Consequently, the findings presented here may reflect more severe cases of insomnia and sleep apnea, and may not represent the population of individuals with diagnosed sleep apnea or insomnia during pregnancy generally,” the authors say. Other limitations included a lack of information on treatment of sleep disorders and on the timing of diagnosis (before pregnancy or during pregnancy).

However, the results were strengthened by the large, population-based sample and use of codes to highlight research questions, the researchers said.

In light of the health consequences of sleep disorders in pregnancy, the data suggest that sleep apnea and insomnia in pregnant women may serve as targets for risk assessment of adverse infant outcomes, and more research is needed to determine whether addressing sleep issues reduces these outcomes, they concluded.

The study was supported by the University of California, San Francisco, Preterm Birth Initiative and by grants to lead author Dr. Felder from the National Center for Complementary and Integrative Health and to a coauthor from the National Heart, Lung, and Blood Institute. The researchers reported no relevant financial relationships.

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

Several adverse infant outcomes were significantly more likely for infants whose mothers had diagnoses of sleep apnea or insomnia, based on data from approximately 5,000 infants.

Sleep disturbance is common during pregnancy, and “sleep disorders during pregnancy can have significant consequences for both the pregnant person and their infant,” write Jennifer N. Felder, PhD, of the University of California, San Francisco, and colleagues.

However, data on the impact of maternal insomnia on specific infant outcomes are limited, they said.

In a study published recently in the journal Sleep Health, the researchers reviewed data from 3,371 pregnant women diagnosed with sleep apnea and 3,213 with insomnia. Of these, 2,357 and 2,212 were matched with controls in a propensity-score analysis. The referent controls were matched for maternal characteristics, obstetric factors, and infant factors among individuals without a sleep disorder. All were singleton pregnancies.

Adverse infant outcomes included the following:

• One- and 5-minute Apgar scores less than 7.
• Respiratory distress syndrome.
• Neonatal intensive care unit admission.
• Hypoglycemia.
• Infant death.
• Hospital stay of longer than 2 days for vaginal delivery or longer than 4 days for cesarean delivery.
• Emergency department visit before 3 months of age.
• Emergency department visit in the first year of life.
• Composite measure of adverse infant outcomes.

Compared with matched controls, the infants born to mothers with sleep apnea had a significantly increased risk for any adverse outcome (50.1% vs. 53.5%) and of the specific outcomes of low 1-minute Apgar scores (6.3% vs. 9.6%), neonatal ICU stays (6.3% vs. 8.4%), and an emergency department visit in the first year of life (33.6% vs. 36.9%).

For infants born to mothers with insomnia, the only significant difference in outcomes compared with controls was an increased likelihood of an emergency department visit (37.2% vs. 32.3%).

“Research on possible mechanisms of the relation between maternal prenatal sleep apnea and poorer birth and infant outcomes associations is small but growing, implicating systemic inflammation and late or prolonged fetal heart rate decelerations,” the researchers write in their discussion.

Research on insomnia during pregnancy and adverse infant outcomes is limited, and the largest studies have been complicated by the effects of insomnia medication; therefore, “our finding that infants born to mothers with an insomnia diagnosis were at increased risk of only emergency room visit, but no other analyzed infant outcomes, is important and novel,” they note.

The findings were limited by several factors, including the reliance on medical records, which may lack details on how routinely health care professionals assessed sleep disorders, the researchers noted. “Consequently, the findings presented here may reflect more severe cases of insomnia and sleep apnea, and may not represent the population of individuals with diagnosed sleep apnea or insomnia during pregnancy generally,” the authors say. Other limitations included a lack of information on treatment of sleep disorders and on the timing of diagnosis (before pregnancy or during pregnancy).

However, the results were strengthened by the large, population-based sample and use of codes to highlight research questions, the researchers said.

In light of the health consequences of sleep disorders in pregnancy, the data suggest that sleep apnea and insomnia in pregnant women may serve as targets for risk assessment of adverse infant outcomes, and more research is needed to determine whether addressing sleep issues reduces these outcomes, they concluded.

The study was supported by the University of California, San Francisco, Preterm Birth Initiative and by grants to lead author Dr. Felder from the National Center for Complementary and Integrative Health and to a coauthor from the National Heart, Lung, and Blood Institute. The researchers reported no relevant financial relationships.

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

Several adverse infant outcomes were significantly more likely for infants whose mothers had diagnoses of sleep apnea or insomnia, based on data from approximately 5,000 infants.

Sleep disturbance is common during pregnancy, and “sleep disorders during pregnancy can have significant consequences for both the pregnant person and their infant,” write Jennifer N. Felder, PhD, of the University of California, San Francisco, and colleagues.

However, data on the impact of maternal insomnia on specific infant outcomes are limited, they said.

In a study published recently in the journal Sleep Health, the researchers reviewed data from 3,371 pregnant women diagnosed with sleep apnea and 3,213 with insomnia. Of these, 2,357 and 2,212 were matched with controls in a propensity-score analysis. The referent controls were matched for maternal characteristics, obstetric factors, and infant factors among individuals without a sleep disorder. All were singleton pregnancies.

Adverse infant outcomes included the following:

• One- and 5-minute Apgar scores less than 7.
• Respiratory distress syndrome.
• Neonatal intensive care unit admission.
• Hypoglycemia.
• Infant death.
• Hospital stay of longer than 2 days for vaginal delivery or longer than 4 days for cesarean delivery.
• Emergency department visit before 3 months of age.
• Emergency department visit in the first year of life.
• Composite measure of adverse infant outcomes.

Compared with matched controls, the infants born to mothers with sleep apnea had a significantly increased risk for any adverse outcome (50.1% vs. 53.5%) and of the specific outcomes of low 1-minute Apgar scores (6.3% vs. 9.6%), neonatal ICU stays (6.3% vs. 8.4%), and an emergency department visit in the first year of life (33.6% vs. 36.9%).

For infants born to mothers with insomnia, the only significant difference in outcomes compared with controls was an increased likelihood of an emergency department visit (37.2% vs. 32.3%).

“Research on possible mechanisms of the relation between maternal prenatal sleep apnea and poorer birth and infant outcomes associations is small but growing, implicating systemic inflammation and late or prolonged fetal heart rate decelerations,” the researchers write in their discussion.

Research on insomnia during pregnancy and adverse infant outcomes is limited, and the largest studies have been complicated by the effects of insomnia medication; therefore, “our finding that infants born to mothers with an insomnia diagnosis were at increased risk of only emergency room visit, but no other analyzed infant outcomes, is important and novel,” they note.

The findings were limited by several factors, including the reliance on medical records, which may lack details on how routinely health care professionals assessed sleep disorders, the researchers noted. “Consequently, the findings presented here may reflect more severe cases of insomnia and sleep apnea, and may not represent the population of individuals with diagnosed sleep apnea or insomnia during pregnancy generally,” the authors say. Other limitations included a lack of information on treatment of sleep disorders and on the timing of diagnosis (before pregnancy or during pregnancy).

However, the results were strengthened by the large, population-based sample and use of codes to highlight research questions, the researchers said.

In light of the health consequences of sleep disorders in pregnancy, the data suggest that sleep apnea and insomnia in pregnant women may serve as targets for risk assessment of adverse infant outcomes, and more research is needed to determine whether addressing sleep issues reduces these outcomes, they concluded.

The study was supported by the University of California, San Francisco, Preterm Birth Initiative and by grants to lead author Dr. Felder from the National Center for Complementary and Integrative Health and to a coauthor from the National Heart, Lung, and Blood Institute. The researchers reported no relevant financial relationships.

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

Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively few women with breast cancer who are at risk for lymphedema develop lymph node swelling after receiving an mRNA COVID-19 vaccine.

Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.

“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”

The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.

“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.

The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.

Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.

“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.

Ms. Juhel has no relevant financial disclosures.

Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively few women with breast cancer who are at risk for lymphedema develop lymph node swelling after receiving an mRNA COVID-19 vaccine.

Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.

“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”

The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.

“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.

The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.

Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.

“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.

Ms. Juhel has no relevant financial disclosures.

Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively few women with breast cancer who are at risk for lymphedema develop lymph node swelling after receiving an mRNA COVID-19 vaccine.

Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.

“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”

The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.

“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.

The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.

Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.

“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.

Ms. Juhel has no relevant financial disclosures.

In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.

Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.

“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.

Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.

“The findings confirmed my suspicion that most patients did not get a mammogram during the lockdown. And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.

Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”

Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.

The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.

The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.

The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).

They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.

Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”

Dr. Mazo has no relevant financial disclosures.

In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.

Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.

“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.

Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.

“The findings confirmed my suspicion that most patients did not get a mammogram during the lockdown. And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.

Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”

Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.

The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.

The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.

The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).

They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.

Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”

Dr. Mazo has no relevant financial disclosures.

In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.

Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.

“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.

Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.

“The findings confirmed my suspicion that most patients did not get a mammogram during the lockdown. And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.

Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”

Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.

The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.

The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.

The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).

They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.

Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”

Dr. Mazo has no relevant financial disclosures.

A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.

“Neighborhood economic status and residential segregation can shape cancer outcomes such as later-stage diagnosis through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.

The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.

Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.

The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.

Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).

Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).

The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.

“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.

Dr. Goel has no relevant financial disclosures.

A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.

“Neighborhood economic status and residential segregation can shape cancer outcomes such as later-stage diagnosis through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.

The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.

Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.

The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.

Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).

Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).

The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.

“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.

Dr. Goel has no relevant financial disclosures.

A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.

“Neighborhood economic status and residential segregation can shape cancer outcomes such as later-stage diagnosis through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.

The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.

Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.

The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.

Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).

Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).

The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.

“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.

Dr. Goel has no relevant financial disclosures.

A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.

OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.

RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).

Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.

“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.

The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.

Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.

The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.

Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).

Dr. Kumar has no relevant financial disclosures.

A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.

OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.

RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).

Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.

“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.

The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.

Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.

The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.

Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).

Dr. Kumar has no relevant financial disclosures.

A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.

OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.

RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).

Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.

“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.

The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.

Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.

The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.

Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).

Dr. Kumar has no relevant financial disclosures.

SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”

Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”

Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.

“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”

Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.

Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, Dr. Lee formed her alter ego, “Dr. Pimple Popper,” and became a YouTube sensation, building 7.53 million subscribers over the course of a few years. She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.

About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”

Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:

Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”

Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”

Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”

Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”

Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”

Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.

Dr. Lee reported having no relevant disclosures.

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

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

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

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

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

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

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

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

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

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

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

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

Much attention has been given recently to the idea of detecting many different types of cancer from a single blood test, and a new test claiming to do that has just been reported.

The leader in this field is the Galleri test (from GRAIL) which is already in clinical use in some health care networks across the United States. That test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating tumor (or cell-free) DNA (cfDNA) in a blood sample.

The new test, under development by Swedish biotechnology company Elypta AB, has a different premise. It can detect 14 cancer types based on the analysis of glycosaminoglycans, which are a diverse group of polysaccharides that are altered by the presence of tumors. Using plasma and urine samples, the method had a 41.6%-62.3% sensitivity for detecting stage I cancer at 95% specificity.

In comparison, say the authors, other assays have reported 39%-73% sensitivity to stage I cancers, but these estimates are usually limited to 12 cancer types that are considered “high-signal,” and the assays perform poorly in cancers that emit little cfDNA, such as genitourinary and brain malignancies.

“The main advantage of glycosaminoglycans appears to be that they change in the blood and urine at the earliest stages of cancer,” said study author Francesco Gatto, PhD, founder and chief scientific officer at Elypta. “Consequently, this method showed an impressive detection rate in stage I compared to other emerging methods.”

The study was published online in Proceedings of the National Academy of Sciences.


 

Combine tests?

Dr. Gatto commented that he “could envision that one day we may be able to combine these methods.”

“The same blood specimen could be used to test both glycosaminoglycans and genomic biomarkers,” said Dr. Gatto. “This strategy could hopefully detect even more cancers than with either method alone, and the resulting performance may well be sufficient as a one-stop-shop screening program.”

So how does the new test from Elypta compare with the Galleri test?

“Galleri and similar methods mostly focused on information coming from molecules of DNA naturally floating in the blood,” explained Dr. Gatto. “It makes sense to conduct research there because cancers typically start with events in the DNA.”

He noted that the current study explored a new layer of information, molecules called glycosaminoglycans, that participate in the metabolism of cancer.

“This method detected many cancers that the previous methods missed, and a substantial proportion of these were at stage I,” said Dr. Gatto. “Cancer is a complex disease, so the most layers of information we can probe noninvasively, say with a blood test, the more likely we can catch more cancers at its earliest stage.”

Other platforms typically rely on sequencing and detecting cancer-derived fractions of cfDNA, but these methods have challenges that can interfere with their usage. For example, some cancer types do not shed sufficient cfDNA and it cannot be accurately measured.

“An advantage on focusing on glycosaminoglycans is that the method does not require next-generation sequencing or similarly complex assays because glycosaminoglycans are informative with less than 10 simultaneous measurements as opposed to Galleri that looks at over 1 million DNA methylation sites,” he said.

“This makes the assay behind the test much cheaper and robust – we estimated a 5-10 times lower cost difference,” Dr. Gatto said.
 

Prospective and comparative data needed

In a comment, Eric Klein, MD, emeritus chair of the Glickman Urological and Kidney Institute at the Cleveland Clinic explained that the “only accurate way to know how a test will perform in an intended-use population is to actually test it in that population. It’s not possible to extrapolate results directly from a case-control study.”

Cancers shed many different biologic markers into body fluids, but which of these signals will be best to serve as the basis of an MCED (multi-cancer detection test) that has clinical utility in a screening population has yet to be determined, he noted. “And it’s possible that no single test will be optimum for every clinical situation.”

“The results of this study appear promising, but it is not possible to claim superiority of one test over another based on individual case-control studies because of uncontrolled differences in the selected populations,” Dr. Klein continued. “The only scientifically accurate way to do this is to perform different tests on the same patient samples in a head-to-head comparison.”

There is only one study that he is aware of that has done this recently, in which multiple different assays looking at various signals in cell-free DNA were directly compared on the same samples (Cancer cell. 2022;40:1537-49.e12). “A targeted methylation assay that is the basis for Galleri was best for the lowest limit of detection and for predicting cancer site of origin,” said Dr. Klein.

Another expert agreed that a direct head-to-head study is needed to compare assays. “Based on this data, you cannot say that this method is better than the other one because that requires a comparative study,” said Fred Hirsch, MD, PhD, executive director of the Center for Thoracic Oncology, Tisch Cancer Institute at Mount Sinai, New York.

Metabolomics is interesting, and the data are encouraging, he continued. “But this is a multicancer early detection test and metabolism changes may vary from cancer type to cancer type. I’m not sure that the metabolism of lung cancer is the same as that of a gynecologic cancer.”

Dr. Hirsch also pointed out that there could also be confounding factors. “They have excluded inflammatory disease, but there can be other variables such as smoking,” he said. “Overall it gives some interesting perspectives but I would like to see more prospective validation and studies in specific disease groups, and eventually comparative studies with other methodologies.”
 

Study details

The authors evaluated if plasma and urine free GAGomes (free glycosaminoglycan profiles) deviated from baseline physiological levels in 14 cancer types and could serve as metabolic cancer biomarkers. They also then validated using free GAGomes for MCED in an external population with 2,064 samples obtained from 1,260 patients with cancer and healthy individuals.

In an in vivo cancer progression model, they observed widespread cancer-specific changes in biofluidic free GAGomes and then developed three machine-learning models based on urine (n_urine = 220 cancer vs. 360 healthy) and plasma (n_plasma = 517 cancer vs. 425 healthy) free GAGomes that were able to detect any cancer with an area under the receiver operating characteristic curve of 0.83-0.93 (with up to 62% sensitivity to stage I disease at 95% specificity).

To assess if altered GAGome features associated with cancer suggested more aggressive tumor biology, they correlated each score with overall survival. The median follow-up time was 17 months in the plasma cohort (n = 370 across 13 cancer types), 15 months in the urine cohort (n = 162 across 4 cancer types), and 15 months in the combined cohort (n = 152 across 4 cancer types).

They found that all three scores independently predicted overall survival in a multivariable analysis (hazard ratio, 1.29; P = .0009 for plasma; HR, 1.79; P = .0009 for urine; HR, 1.91; P = .0004 for combined) after adjusting for cancer type, age, sex, and stage IV or high-grade disease.

These findings showed an association of free GAGome alterations with aggressive cancer phenotypes and suggested that scores below the 95% specificity cutoff might have a better prognosis, the authors comment.

In addition, other analyses showed that free GAGomes predicted the putative cancer location with 89% accuracy. And finally, to confirm whether the free GAGome MCED scores could be used for screening, a validation analysis was conducted using a typical “screening population,” which requires at least 99% specificity. The combined free GAGomes were able to predict a poor prognosis of any cancer type within 18 months and with 43% sensitivity (21% in stage I; n = 121 and 49 cases).

Dr. Gatto believes that these results, as well as those from other studies looking at glycosaminoglycans as cancer biomarkers, will lead to the next steps of development. “But I speculate that this test could be most useful to assess in a cheap, practical, and noninvasive manner if a person at increased risk of cancer should be selected for cancer screening as part of established or emerging screening programs.”

The study was sponsored by Elypta. Dr. Gatto is listed as an inventor in patent applications related to the biomarkers described in this study and later assigned to Elypta, and is a shareholder and employed at Elypta. Dr. Hirsch reports no relevant financial relationships. Dr. Klein is a consultant for GRAIL and an investigator for CCGA and Pathfinder.

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

Much attention has been given recently to the idea of detecting many different types of cancer from a single blood test, and a new test claiming to do that has just been reported.

The leader in this field is the Galleri test (from GRAIL) which is already in clinical use in some health care networks across the United States. That test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating tumor (or cell-free) DNA (cfDNA) in a blood sample.

The new test, under development by Swedish biotechnology company Elypta AB, has a different premise. It can detect 14 cancer types based on the analysis of glycosaminoglycans, which are a diverse group of polysaccharides that are altered by the presence of tumors. Using plasma and urine samples, the method had a 41.6%-62.3% sensitivity for detecting stage I cancer at 95% specificity.

In comparison, say the authors, other assays have reported 39%-73% sensitivity to stage I cancers, but these estimates are usually limited to 12 cancer types that are considered “high-signal,” and the assays perform poorly in cancers that emit little cfDNA, such as genitourinary and brain malignancies.

“The main advantage of glycosaminoglycans appears to be that they change in the blood and urine at the earliest stages of cancer,” said study author Francesco Gatto, PhD, founder and chief scientific officer at Elypta. “Consequently, this method showed an impressive detection rate in stage I compared to other emerging methods.”

The study was published online in Proceedings of the National Academy of Sciences.


 

Combine tests?

Dr. Gatto commented that he “could envision that one day we may be able to combine these methods.”

“The same blood specimen could be used to test both glycosaminoglycans and genomic biomarkers,” said Dr. Gatto. “This strategy could hopefully detect even more cancers than with either method alone, and the resulting performance may well be sufficient as a one-stop-shop screening program.”

So how does the new test from Elypta compare with the Galleri test?

“Galleri and similar methods mostly focused on information coming from molecules of DNA naturally floating in the blood,” explained Dr. Gatto. “It makes sense to conduct research there because cancers typically start with events in the DNA.”

He noted that the current study explored a new layer of information, molecules called glycosaminoglycans, that participate in the metabolism of cancer.

“This method detected many cancers that the previous methods missed, and a substantial proportion of these were at stage I,” said Dr. Gatto. “Cancer is a complex disease, so the most layers of information we can probe noninvasively, say with a blood test, the more likely we can catch more cancers at its earliest stage.”

Other platforms typically rely on sequencing and detecting cancer-derived fractions of cfDNA, but these methods have challenges that can interfere with their usage. For example, some cancer types do not shed sufficient cfDNA and it cannot be accurately measured.

“An advantage on focusing on glycosaminoglycans is that the method does not require next-generation sequencing or similarly complex assays because glycosaminoglycans are informative with less than 10 simultaneous measurements as opposed to Galleri that looks at over 1 million DNA methylation sites,” he said.

“This makes the assay behind the test much cheaper and robust – we estimated a 5-10 times lower cost difference,” Dr. Gatto said.
 

Prospective and comparative data needed

In a comment, Eric Klein, MD, emeritus chair of the Glickman Urological and Kidney Institute at the Cleveland Clinic explained that the “only accurate way to know how a test will perform in an intended-use population is to actually test it in that population. It’s not possible to extrapolate results directly from a case-control study.”

Cancers shed many different biologic markers into body fluids, but which of these signals will be best to serve as the basis of an MCED (multi-cancer detection test) that has clinical utility in a screening population has yet to be determined, he noted. “And it’s possible that no single test will be optimum for every clinical situation.”

“The results of this study appear promising, but it is not possible to claim superiority of one test over another based on individual case-control studies because of uncontrolled differences in the selected populations,” Dr. Klein continued. “The only scientifically accurate way to do this is to perform different tests on the same patient samples in a head-to-head comparison.”

There is only one study that he is aware of that has done this recently, in which multiple different assays looking at various signals in cell-free DNA were directly compared on the same samples (Cancer cell. 2022;40:1537-49.e12). “A targeted methylation assay that is the basis for Galleri was best for the lowest limit of detection and for predicting cancer site of origin,” said Dr. Klein.

Another expert agreed that a direct head-to-head study is needed to compare assays. “Based on this data, you cannot say that this method is better than the other one because that requires a comparative study,” said Fred Hirsch, MD, PhD, executive director of the Center for Thoracic Oncology, Tisch Cancer Institute at Mount Sinai, New York.

Metabolomics is interesting, and the data are encouraging, he continued. “But this is a multicancer early detection test and metabolism changes may vary from cancer type to cancer type. I’m not sure that the metabolism of lung cancer is the same as that of a gynecologic cancer.”

Dr. Hirsch also pointed out that there could also be confounding factors. “They have excluded inflammatory disease, but there can be other variables such as smoking,” he said. “Overall it gives some interesting perspectives but I would like to see more prospective validation and studies in specific disease groups, and eventually comparative studies with other methodologies.”
 

Study details

The authors evaluated if plasma and urine free GAGomes (free glycosaminoglycan profiles) deviated from baseline physiological levels in 14 cancer types and could serve as metabolic cancer biomarkers. They also then validated using free GAGomes for MCED in an external population with 2,064 samples obtained from 1,260 patients with cancer and healthy individuals.

In an in vivo cancer progression model, they observed widespread cancer-specific changes in biofluidic free GAGomes and then developed three machine-learning models based on urine (n_urine = 220 cancer vs. 360 healthy) and plasma (n_plasma = 517 cancer vs. 425 healthy) free GAGomes that were able to detect any cancer with an area under the receiver operating characteristic curve of 0.83-0.93 (with up to 62% sensitivity to stage I disease at 95% specificity).

To assess if altered GAGome features associated with cancer suggested more aggressive tumor biology, they correlated each score with overall survival. The median follow-up time was 17 months in the plasma cohort (n = 370 across 13 cancer types), 15 months in the urine cohort (n = 162 across 4 cancer types), and 15 months in the combined cohort (n = 152 across 4 cancer types).

They found that all three scores independently predicted overall survival in a multivariable analysis (hazard ratio, 1.29; P = .0009 for plasma; HR, 1.79; P = .0009 for urine; HR, 1.91; P = .0004 for combined) after adjusting for cancer type, age, sex, and stage IV or high-grade disease.

These findings showed an association of free GAGome alterations with aggressive cancer phenotypes and suggested that scores below the 95% specificity cutoff might have a better prognosis, the authors comment.

In addition, other analyses showed that free GAGomes predicted the putative cancer location with 89% accuracy. And finally, to confirm whether the free GAGome MCED scores could be used for screening, a validation analysis was conducted using a typical “screening population,” which requires at least 99% specificity. The combined free GAGomes were able to predict a poor prognosis of any cancer type within 18 months and with 43% sensitivity (21% in stage I; n = 121 and 49 cases).

Dr. Gatto believes that these results, as well as those from other studies looking at glycosaminoglycans as cancer biomarkers, will lead to the next steps of development. “But I speculate that this test could be most useful to assess in a cheap, practical, and noninvasive manner if a person at increased risk of cancer should be selected for cancer screening as part of established or emerging screening programs.”

The study was sponsored by Elypta. Dr. Gatto is listed as an inventor in patent applications related to the biomarkers described in this study and later assigned to Elypta, and is a shareholder and employed at Elypta. Dr. Hirsch reports no relevant financial relationships. Dr. Klein is a consultant for GRAIL and an investigator for CCGA and Pathfinder.

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

Much attention has been given recently to the idea of detecting many different types of cancer from a single blood test, and a new test claiming to do that has just been reported.

The leader in this field is the Galleri test (from GRAIL) which is already in clinical use in some health care networks across the United States. That test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating tumor (or cell-free) DNA (cfDNA) in a blood sample.

The new test, under development by Swedish biotechnology company Elypta AB, has a different premise. It can detect 14 cancer types based on the analysis of glycosaminoglycans, which are a diverse group of polysaccharides that are altered by the presence of tumors. Using plasma and urine samples, the method had a 41.6%-62.3% sensitivity for detecting stage I cancer at 95% specificity.

In comparison, say the authors, other assays have reported 39%-73% sensitivity to stage I cancers, but these estimates are usually limited to 12 cancer types that are considered “high-signal,” and the assays perform poorly in cancers that emit little cfDNA, such as genitourinary and brain malignancies.

“The main advantage of glycosaminoglycans appears to be that they change in the blood and urine at the earliest stages of cancer,” said study author Francesco Gatto, PhD, founder and chief scientific officer at Elypta. “Consequently, this method showed an impressive detection rate in stage I compared to other emerging methods.”

The study was published online in Proceedings of the National Academy of Sciences.


 

Combine tests?

Dr. Gatto commented that he “could envision that one day we may be able to combine these methods.”

“The same blood specimen could be used to test both glycosaminoglycans and genomic biomarkers,” said Dr. Gatto. “This strategy could hopefully detect even more cancers than with either method alone, and the resulting performance may well be sufficient as a one-stop-shop screening program.”

So how does the new test from Elypta compare with the Galleri test?

“Galleri and similar methods mostly focused on information coming from molecules of DNA naturally floating in the blood,” explained Dr. Gatto. “It makes sense to conduct research there because cancers typically start with events in the DNA.”

He noted that the current study explored a new layer of information, molecules called glycosaminoglycans, that participate in the metabolism of cancer.

“This method detected many cancers that the previous methods missed, and a substantial proportion of these were at stage I,” said Dr. Gatto. “Cancer is a complex disease, so the most layers of information we can probe noninvasively, say with a blood test, the more likely we can catch more cancers at its earliest stage.”

Other platforms typically rely on sequencing and detecting cancer-derived fractions of cfDNA, but these methods have challenges that can interfere with their usage. For example, some cancer types do not shed sufficient cfDNA and it cannot be accurately measured.

“An advantage on focusing on glycosaminoglycans is that the method does not require next-generation sequencing or similarly complex assays because glycosaminoglycans are informative with less than 10 simultaneous measurements as opposed to Galleri that looks at over 1 million DNA methylation sites,” he said.

“This makes the assay behind the test much cheaper and robust – we estimated a 5-10 times lower cost difference,” Dr. Gatto said.
 

Prospective and comparative data needed

In a comment, Eric Klein, MD, emeritus chair of the Glickman Urological and Kidney Institute at the Cleveland Clinic explained that the “only accurate way to know how a test will perform in an intended-use population is to actually test it in that population. It’s not possible to extrapolate results directly from a case-control study.”

Cancers shed many different biologic markers into body fluids, but which of these signals will be best to serve as the basis of an MCED (multi-cancer detection test) that has clinical utility in a screening population has yet to be determined, he noted. “And it’s possible that no single test will be optimum for every clinical situation.”

“The results of this study appear promising, but it is not possible to claim superiority of one test over another based on individual case-control studies because of uncontrolled differences in the selected populations,” Dr. Klein continued. “The only scientifically accurate way to do this is to perform different tests on the same patient samples in a head-to-head comparison.”

There is only one study that he is aware of that has done this recently, in which multiple different assays looking at various signals in cell-free DNA were directly compared on the same samples (Cancer cell. 2022;40:1537-49.e12). “A targeted methylation assay that is the basis for Galleri was best for the lowest limit of detection and for predicting cancer site of origin,” said Dr. Klein.

Another expert agreed that a direct head-to-head study is needed to compare assays. “Based on this data, you cannot say that this method is better than the other one because that requires a comparative study,” said Fred Hirsch, MD, PhD, executive director of the Center for Thoracic Oncology, Tisch Cancer Institute at Mount Sinai, New York.

Metabolomics is interesting, and the data are encouraging, he continued. “But this is a multicancer early detection test and metabolism changes may vary from cancer type to cancer type. I’m not sure that the metabolism of lung cancer is the same as that of a gynecologic cancer.”

Dr. Hirsch also pointed out that there could also be confounding factors. “They have excluded inflammatory disease, but there can be other variables such as smoking,” he said. “Overall it gives some interesting perspectives but I would like to see more prospective validation and studies in specific disease groups, and eventually comparative studies with other methodologies.”
 

Study details

The authors evaluated if plasma and urine free GAGomes (free glycosaminoglycan profiles) deviated from baseline physiological levels in 14 cancer types and could serve as metabolic cancer biomarkers. They also then validated using free GAGomes for MCED in an external population with 2,064 samples obtained from 1,260 patients with cancer and healthy individuals.

In an in vivo cancer progression model, they observed widespread cancer-specific changes in biofluidic free GAGomes and then developed three machine-learning models based on urine (n_urine = 220 cancer vs. 360 healthy) and plasma (n_plasma = 517 cancer vs. 425 healthy) free GAGomes that were able to detect any cancer with an area under the receiver operating characteristic curve of 0.83-0.93 (with up to 62% sensitivity to stage I disease at 95% specificity).

To assess if altered GAGome features associated with cancer suggested more aggressive tumor biology, they correlated each score with overall survival. The median follow-up time was 17 months in the plasma cohort (n = 370 across 13 cancer types), 15 months in the urine cohort (n = 162 across 4 cancer types), and 15 months in the combined cohort (n = 152 across 4 cancer types).

They found that all three scores independently predicted overall survival in a multivariable analysis (hazard ratio, 1.29; P = .0009 for plasma; HR, 1.79; P = .0009 for urine; HR, 1.91; P = .0004 for combined) after adjusting for cancer type, age, sex, and stage IV or high-grade disease.

These findings showed an association of free GAGome alterations with aggressive cancer phenotypes and suggested that scores below the 95% specificity cutoff might have a better prognosis, the authors comment.

In addition, other analyses showed that free GAGomes predicted the putative cancer location with 89% accuracy. And finally, to confirm whether the free GAGome MCED scores could be used for screening, a validation analysis was conducted using a typical “screening population,” which requires at least 99% specificity. The combined free GAGomes were able to predict a poor prognosis of any cancer type within 18 months and with 43% sensitivity (21% in stage I; n = 121 and 49 cases).

Dr. Gatto believes that these results, as well as those from other studies looking at glycosaminoglycans as cancer biomarkers, will lead to the next steps of development. “But I speculate that this test could be most useful to assess in a cheap, practical, and noninvasive manner if a person at increased risk of cancer should be selected for cancer screening as part of established or emerging screening programs.”

The study was sponsored by Elypta. Dr. Gatto is listed as an inventor in patent applications related to the biomarkers described in this study and later assigned to Elypta, and is a shareholder and employed at Elypta. Dr. Hirsch reports no relevant financial relationships. Dr. Klein is a consultant for GRAIL and an investigator for CCGA and Pathfinder.

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