Narine Sargsyan, MD, recently was named the 2021 Alton Memorial Hospital (Alton, Ill.) Chairman’s Award winner. Serving as BJC Medical Group’s hospitalist medical director and hospital department chief of medicine, Dr. Sargsyan won the award based on the nominations of her fellow physicians.

The Chairman’s Award goes to an Alton Memorial staff member acknowledged for contributions to the facility and the community, including promotion and execution of outstanding customer service. Dr. Sargsyan has been a point person for Alton’s treatment of patients during the COVID-19 pandemic, recruiting new hospitalists to treat hospital inpatients. She also served on a committee selecting the inaugural resident class for the Southern Illinois University School of Medicine’s Family Residency program.
 

Alice Tang, DO, recently was named chief medical officer at Sentara Northern Virginia Medical Center (Woodbridge, Va.). The former medical director at Sentara Lake Ridge Hospital also directed the stroke program at Sentara Northern Virginia Medical Center, so she is familiar with her new facility.

The hospital medicine veteran specialized in emergency medicine and earned her health care MBA from George Washington University. Dr. Tang said her goal as CMO is to enhance the care environment while simultaneously raising the level of the care given by Sentara providers.
 

Faisal Keen, MD, has been named 2021 Physician of the Year at Sarasota Memorial Hospital’s Sarasota (Fla.) campus. The award winner was selected by a panel of SMH physician leaders.

Dr. Keen has been a hospitalist at SMH Sarasota for the past 6 years.

In presenting Dr. Keen with the award, the staff paid particular compliment to the care he provided to the facility’s hundreds of COVID-19 patients throughout the pandemic. At one point during the surge, Dr. Keen worked 30 shifts during a single month. Among the praises he received during the award presentation were those for his efforts in hurricane preparedness and helping physicians at SMH utilize technology in their patient care.
 

Jeffrey Crowder, MSPA, PA-C, recently became the first physician assistant to be named chief of hospitalist service at Maine Veterans Affairs Medical Center (Augusta, Me.). He is the first PA to hold the position at any Maine VA hospital. Mr. Crowder held the role in an acting position for the previous year, helping Maine VA Augusta navigate the COVID-19 pandemic.

Mr. Crowder will oversee 13 physicians and 9 PAs in providing care to Maine’s veterans. Included in the facility are intensive care and medical surgery units. Mr. Crowder’s group is responsible for part-time coverage at the 60-bed Togus Community Living Center.
 

Southeast Iowa Regional Medical Center (West Burlington, Iowa) has expanded its hospitalist program, adding the service to its Fort Madison campus. The health system’s hospitalist program was initiated at SEIRMC’s West Burlington campus back in 2010. That facility now includes 12 full-time and five part-time hospitalist physicians.

OB Hospitalist Group (Greenville, S.C.) has been acquired by Kohlberg & Company LLC (Mount Kisco, N.Y.), giving the nation’s largest dedicated obstetric hospitalist provider a new stakeholder. OBHG hopes to expand its services, which already include 200 hospital partners across 34 states.

OBHG’s network of providers includes more than 1,100 clinicians, with sites normally featuring an OB emergency department with a practicing ob.gyn. on site around the clock. Kohlberg & Company was founded in 1987 and has organized nine private equity funds, raising $12 billion of equity capital.

Narine Sargsyan, MD, recently was named the 2021 Alton Memorial Hospital (Alton, Ill.) Chairman’s Award winner. Serving as BJC Medical Group’s hospitalist medical director and hospital department chief of medicine, Dr. Sargsyan won the award based on the nominations of her fellow physicians.

The Chairman’s Award goes to an Alton Memorial staff member acknowledged for contributions to the facility and the community, including promotion and execution of outstanding customer service. Dr. Sargsyan has been a point person for Alton’s treatment of patients during the COVID-19 pandemic, recruiting new hospitalists to treat hospital inpatients. She also served on a committee selecting the inaugural resident class for the Southern Illinois University School of Medicine’s Family Residency program.
 

Alice Tang, DO, recently was named chief medical officer at Sentara Northern Virginia Medical Center (Woodbridge, Va.). The former medical director at Sentara Lake Ridge Hospital also directed the stroke program at Sentara Northern Virginia Medical Center, so she is familiar with her new facility.

The hospital medicine veteran specialized in emergency medicine and earned her health care MBA from George Washington University. Dr. Tang said her goal as CMO is to enhance the care environment while simultaneously raising the level of the care given by Sentara providers.
 

Faisal Keen, MD, has been named 2021 Physician of the Year at Sarasota Memorial Hospital’s Sarasota (Fla.) campus. The award winner was selected by a panel of SMH physician leaders.

Dr. Keen has been a hospitalist at SMH Sarasota for the past 6 years.

In presenting Dr. Keen with the award, the staff paid particular compliment to the care he provided to the facility’s hundreds of COVID-19 patients throughout the pandemic. At one point during the surge, Dr. Keen worked 30 shifts during a single month. Among the praises he received during the award presentation were those for his efforts in hurricane preparedness and helping physicians at SMH utilize technology in their patient care.
 

Jeffrey Crowder, MSPA, PA-C, recently became the first physician assistant to be named chief of hospitalist service at Maine Veterans Affairs Medical Center (Augusta, Me.). He is the first PA to hold the position at any Maine VA hospital. Mr. Crowder held the role in an acting position for the previous year, helping Maine VA Augusta navigate the COVID-19 pandemic.

Mr. Crowder will oversee 13 physicians and 9 PAs in providing care to Maine’s veterans. Included in the facility are intensive care and medical surgery units. Mr. Crowder’s group is responsible for part-time coverage at the 60-bed Togus Community Living Center.
 

Southeast Iowa Regional Medical Center (West Burlington, Iowa) has expanded its hospitalist program, adding the service to its Fort Madison campus. The health system’s hospitalist program was initiated at SEIRMC’s West Burlington campus back in 2010. That facility now includes 12 full-time and five part-time hospitalist physicians.

OB Hospitalist Group (Greenville, S.C.) has been acquired by Kohlberg & Company LLC (Mount Kisco, N.Y.), giving the nation’s largest dedicated obstetric hospitalist provider a new stakeholder. OBHG hopes to expand its services, which already include 200 hospital partners across 34 states.

OBHG’s network of providers includes more than 1,100 clinicians, with sites normally featuring an OB emergency department with a practicing ob.gyn. on site around the clock. Kohlberg & Company was founded in 1987 and has organized nine private equity funds, raising $12 billion of equity capital.

Narine Sargsyan, MD, recently was named the 2021 Alton Memorial Hospital (Alton, Ill.) Chairman’s Award winner. Serving as BJC Medical Group’s hospitalist medical director and hospital department chief of medicine, Dr. Sargsyan won the award based on the nominations of her fellow physicians.

The Chairman’s Award goes to an Alton Memorial staff member acknowledged for contributions to the facility and the community, including promotion and execution of outstanding customer service. Dr. Sargsyan has been a point person for Alton’s treatment of patients during the COVID-19 pandemic, recruiting new hospitalists to treat hospital inpatients. She also served on a committee selecting the inaugural resident class for the Southern Illinois University School of Medicine’s Family Residency program.
 

Alice Tang, DO, recently was named chief medical officer at Sentara Northern Virginia Medical Center (Woodbridge, Va.). The former medical director at Sentara Lake Ridge Hospital also directed the stroke program at Sentara Northern Virginia Medical Center, so she is familiar with her new facility.

The hospital medicine veteran specialized in emergency medicine and earned her health care MBA from George Washington University. Dr. Tang said her goal as CMO is to enhance the care environment while simultaneously raising the level of the care given by Sentara providers.
 

Faisal Keen, MD, has been named 2021 Physician of the Year at Sarasota Memorial Hospital’s Sarasota (Fla.) campus. The award winner was selected by a panel of SMH physician leaders.

Dr. Keen has been a hospitalist at SMH Sarasota for the past 6 years.

In presenting Dr. Keen with the award, the staff paid particular compliment to the care he provided to the facility’s hundreds of COVID-19 patients throughout the pandemic. At one point during the surge, Dr. Keen worked 30 shifts during a single month. Among the praises he received during the award presentation were those for his efforts in hurricane preparedness and helping physicians at SMH utilize technology in their patient care.
 

Jeffrey Crowder, MSPA, PA-C, recently became the first physician assistant to be named chief of hospitalist service at Maine Veterans Affairs Medical Center (Augusta, Me.). He is the first PA to hold the position at any Maine VA hospital. Mr. Crowder held the role in an acting position for the previous year, helping Maine VA Augusta navigate the COVID-19 pandemic.

Mr. Crowder will oversee 13 physicians and 9 PAs in providing care to Maine’s veterans. Included in the facility are intensive care and medical surgery units. Mr. Crowder’s group is responsible for part-time coverage at the 60-bed Togus Community Living Center.
 

Southeast Iowa Regional Medical Center (West Burlington, Iowa) has expanded its hospitalist program, adding the service to its Fort Madison campus. The health system’s hospitalist program was initiated at SEIRMC’s West Burlington campus back in 2010. That facility now includes 12 full-time and five part-time hospitalist physicians.

OB Hospitalist Group (Greenville, S.C.) has been acquired by Kohlberg & Company LLC (Mount Kisco, N.Y.), giving the nation’s largest dedicated obstetric hospitalist provider a new stakeholder. OBHG hopes to expand its services, which already include 200 hospital partners across 34 states.

OBHG’s network of providers includes more than 1,100 clinicians, with sites normally featuring an OB emergency department with a practicing ob.gyn. on site around the clock. Kohlberg & Company was founded in 1987 and has organized nine private equity funds, raising $12 billion of equity capital.

A majority of U.S. Supreme Court Justices on Dec. 1 seemed receptive to the idea that there is no constitutional right to abortion, or, at a minimum, that states have the ability to determine when a pregnancy can be terminated.

The justices heard from lawyers arguing for and against a 2018 Mississippi law that, with few exceptions, bans abortion after 15 weeks, claiming that a fetus is viable outside the womb at that age. The Supreme Court’s 1973 Roe v. Wade decision and legal rulings in the decades since, including the 1992 decision in Planned Parenthood v. Casey, have said that abortion should be available to the point of viability – established as about 23 weeks.

The court also ruled in Casey that state laws could not present an “undue burden” on a woman’s ability to obtain an abortion.

The Mississippi attorney general did not initially seek to overturn Roe and Casey, but later argued in Dobbs v. Jackson Women’s Health Organization  that both cases were erroneously decided and should be completely thrown out.

“It is an egregiously wrong decision that has inflicted tremendous damage on our country and will continue to do so and take innumerable human lives unless and until this court overrules it,” said Scott G. Stewart, Mississippi’s solicitor general.

When it accepted the Mississippi case, the Supreme Court did not agree to weigh in on overturning Roe or Casey, but the justices’ leanings were evident during the hearing, and it is possible they would throw out those landmark cases.

Justice Clarence Thomas asked repeatedly for the law’s challengers to point out where the right to an abortion was written in the Constitution, as did Justice Samuel Alito.

“If we were talking about the Second Amendment, I know exactly what we’re talking about, if we’re talking about the Fourth Amendment, I know what we’re talking about, because it’s written, it’s there,” said Justice Thomas. “What specifically is the right here that we’re talking about?” he asked U.S. Solicitor General Elizabeth Prelogar.

She said the right to abortion was embedded in the 14th amendment’s guarantee of the pursuit of liberty.

“If this Court renounces the liberty interest recognized in Roe and reaffirmed in Casey, it would be an unprecedented contraction of individual rights,” and a departure from court doctrine of upholding precedent, known as stare decisis, she said.

Chief Justice John Roberts seemed to be against throwing out either of the landmark abortion cases, but instead wanted to focus on whether the 15 weeks was a reasonable time point. But he seemed to be alone in honing-in on that issue.

“Roberts seem desperate for some limiting principle that isn’t reversing Roe, and none of the other conservative justices are biting,” tweeted Mary Ziegler, a historian who has written about abortion.

But justices Neil Gorsuch, Amy Coney Barrett, and Brett Kavanaugh all appeared to be receptive to the idea that the prior precedent set by Roe and Casey could be overturned.

Neil Katyal, the former U.S. acting solicitor general and a Supreme Court lawyer, tweeted during the arguments that he saw “nothing so far sympathetic to the challengers. And a lot that has been very hostile.”

He cautioned that questions during oral arguments “often are just trying to understand a lawyer’s position,” adding, “But the tea leaves here are ominous.”

If Roe v. Wade is overturned, 22 states have laws already on the books that could be used to restrict abortion, according to the Guttmacher Institute. Almost all abortions would be banned in 12 states that have so-called “trigger” laws: Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Utah.

Seventeen states have abortion restrictions that have been unenforced or blocked by courts that would go back into effect if Roe is nullified. An additional seven states have laws that intend to restrict abortion in the absence of Roe and four states have passed constitutional amendments to specifically not protect the right to abortion.

Guttmacher reports that 15 states and the District of Columbia have passed laws that protect the right to abortion.

Jackson Women’s Health – the state’s sole abortion provider – sued to block the Mississippi law soon after it passed. A federal judge ruled against the state and that decision was upheld by the U.S. Fifth Circuit Court of Appeals, which also issued a permanent injunction against the law. The Supreme Court in May 2021 agreed to take Mississippi’s appeal.

Earlier in November, the Supreme Court heard arguments in two cases challenging a restrictive Texas law, Whole Woman’s Health v. Jackson and U.S. v. Texas. The justices seemed receptive to the idea that the law, SB 8, was unconstitutional. But the court did not grant a request by the Biden administration to halt the law while the challenges made their way through the courts.

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

A majority of U.S. Supreme Court Justices on Dec. 1 seemed receptive to the idea that there is no constitutional right to abortion, or, at a minimum, that states have the ability to determine when a pregnancy can be terminated.

The justices heard from lawyers arguing for and against a 2018 Mississippi law that, with few exceptions, bans abortion after 15 weeks, claiming that a fetus is viable outside the womb at that age. The Supreme Court’s 1973 Roe v. Wade decision and legal rulings in the decades since, including the 1992 decision in Planned Parenthood v. Casey, have said that abortion should be available to the point of viability – established as about 23 weeks.

The court also ruled in Casey that state laws could not present an “undue burden” on a woman’s ability to obtain an abortion.

The Mississippi attorney general did not initially seek to overturn Roe and Casey, but later argued in Dobbs v. Jackson Women’s Health Organization  that both cases were erroneously decided and should be completely thrown out.

“It is an egregiously wrong decision that has inflicted tremendous damage on our country and will continue to do so and take innumerable human lives unless and until this court overrules it,” said Scott G. Stewart, Mississippi’s solicitor general.

When it accepted the Mississippi case, the Supreme Court did not agree to weigh in on overturning Roe or Casey, but the justices’ leanings were evident during the hearing, and it is possible they would throw out those landmark cases.

Justice Clarence Thomas asked repeatedly for the law’s challengers to point out where the right to an abortion was written in the Constitution, as did Justice Samuel Alito.

“If we were talking about the Second Amendment, I know exactly what we’re talking about, if we’re talking about the Fourth Amendment, I know what we’re talking about, because it’s written, it’s there,” said Justice Thomas. “What specifically is the right here that we’re talking about?” he asked U.S. Solicitor General Elizabeth Prelogar.

She said the right to abortion was embedded in the 14th amendment’s guarantee of the pursuit of liberty.

“If this Court renounces the liberty interest recognized in Roe and reaffirmed in Casey, it would be an unprecedented contraction of individual rights,” and a departure from court doctrine of upholding precedent, known as stare decisis, she said.

Chief Justice John Roberts seemed to be against throwing out either of the landmark abortion cases, but instead wanted to focus on whether the 15 weeks was a reasonable time point. But he seemed to be alone in honing-in on that issue.

“Roberts seem desperate for some limiting principle that isn’t reversing Roe, and none of the other conservative justices are biting,” tweeted Mary Ziegler, a historian who has written about abortion.

But justices Neil Gorsuch, Amy Coney Barrett, and Brett Kavanaugh all appeared to be receptive to the idea that the prior precedent set by Roe and Casey could be overturned.

Neil Katyal, the former U.S. acting solicitor general and a Supreme Court lawyer, tweeted during the arguments that he saw “nothing so far sympathetic to the challengers. And a lot that has been very hostile.”

He cautioned that questions during oral arguments “often are just trying to understand a lawyer’s position,” adding, “But the tea leaves here are ominous.”

If Roe v. Wade is overturned, 22 states have laws already on the books that could be used to restrict abortion, according to the Guttmacher Institute. Almost all abortions would be banned in 12 states that have so-called “trigger” laws: Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Utah.

Seventeen states have abortion restrictions that have been unenforced or blocked by courts that would go back into effect if Roe is nullified. An additional seven states have laws that intend to restrict abortion in the absence of Roe and four states have passed constitutional amendments to specifically not protect the right to abortion.

Guttmacher reports that 15 states and the District of Columbia have passed laws that protect the right to abortion.

Jackson Women’s Health – the state’s sole abortion provider – sued to block the Mississippi law soon after it passed. A federal judge ruled against the state and that decision was upheld by the U.S. Fifth Circuit Court of Appeals, which also issued a permanent injunction against the law. The Supreme Court in May 2021 agreed to take Mississippi’s appeal.

Earlier in November, the Supreme Court heard arguments in two cases challenging a restrictive Texas law, Whole Woman’s Health v. Jackson and U.S. v. Texas. The justices seemed receptive to the idea that the law, SB 8, was unconstitutional. But the court did not grant a request by the Biden administration to halt the law while the challenges made their way through the courts.

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

A majority of U.S. Supreme Court Justices on Dec. 1 seemed receptive to the idea that there is no constitutional right to abortion, or, at a minimum, that states have the ability to determine when a pregnancy can be terminated.

The justices heard from lawyers arguing for and against a 2018 Mississippi law that, with few exceptions, bans abortion after 15 weeks, claiming that a fetus is viable outside the womb at that age. The Supreme Court’s 1973 Roe v. Wade decision and legal rulings in the decades since, including the 1992 decision in Planned Parenthood v. Casey, have said that abortion should be available to the point of viability – established as about 23 weeks.

The court also ruled in Casey that state laws could not present an “undue burden” on a woman’s ability to obtain an abortion.

The Mississippi attorney general did not initially seek to overturn Roe and Casey, but later argued in Dobbs v. Jackson Women’s Health Organization  that both cases were erroneously decided and should be completely thrown out.

“It is an egregiously wrong decision that has inflicted tremendous damage on our country and will continue to do so and take innumerable human lives unless and until this court overrules it,” said Scott G. Stewart, Mississippi’s solicitor general.

When it accepted the Mississippi case, the Supreme Court did not agree to weigh in on overturning Roe or Casey, but the justices’ leanings were evident during the hearing, and it is possible they would throw out those landmark cases.

Justice Clarence Thomas asked repeatedly for the law’s challengers to point out where the right to an abortion was written in the Constitution, as did Justice Samuel Alito.

“If we were talking about the Second Amendment, I know exactly what we’re talking about, if we’re talking about the Fourth Amendment, I know what we’re talking about, because it’s written, it’s there,” said Justice Thomas. “What specifically is the right here that we’re talking about?” he asked U.S. Solicitor General Elizabeth Prelogar.

She said the right to abortion was embedded in the 14th amendment’s guarantee of the pursuit of liberty.

“If this Court renounces the liberty interest recognized in Roe and reaffirmed in Casey, it would be an unprecedented contraction of individual rights,” and a departure from court doctrine of upholding precedent, known as stare decisis, she said.

Chief Justice John Roberts seemed to be against throwing out either of the landmark abortion cases, but instead wanted to focus on whether the 15 weeks was a reasonable time point. But he seemed to be alone in honing-in on that issue.

“Roberts seem desperate for some limiting principle that isn’t reversing Roe, and none of the other conservative justices are biting,” tweeted Mary Ziegler, a historian who has written about abortion.

But justices Neil Gorsuch, Amy Coney Barrett, and Brett Kavanaugh all appeared to be receptive to the idea that the prior precedent set by Roe and Casey could be overturned.

Neil Katyal, the former U.S. acting solicitor general and a Supreme Court lawyer, tweeted during the arguments that he saw “nothing so far sympathetic to the challengers. And a lot that has been very hostile.”

He cautioned that questions during oral arguments “often are just trying to understand a lawyer’s position,” adding, “But the tea leaves here are ominous.”

If Roe v. Wade is overturned, 22 states have laws already on the books that could be used to restrict abortion, according to the Guttmacher Institute. Almost all abortions would be banned in 12 states that have so-called “trigger” laws: Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Utah.

Seventeen states have abortion restrictions that have been unenforced or blocked by courts that would go back into effect if Roe is nullified. An additional seven states have laws that intend to restrict abortion in the absence of Roe and four states have passed constitutional amendments to specifically not protect the right to abortion.

Guttmacher reports that 15 states and the District of Columbia have passed laws that protect the right to abortion.

Jackson Women’s Health – the state’s sole abortion provider – sued to block the Mississippi law soon after it passed. A federal judge ruled against the state and that decision was upheld by the U.S. Fifth Circuit Court of Appeals, which also issued a permanent injunction against the law. The Supreme Court in May 2021 agreed to take Mississippi’s appeal.

Earlier in November, the Supreme Court heard arguments in two cases challenging a restrictive Texas law, Whole Woman’s Health v. Jackson and U.S. v. Texas. The justices seemed receptive to the idea that the law, SB 8, was unconstitutional. But the court did not grant a request by the Biden administration to halt the law while the challenges made their way through the courts.

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

To the Editor:

Minocycline is a commonly prescribed semisynthetic tetracycline derivative used for long-term treatment of acne vulgaris.¹ Given the continued popularity of minocycline and other tetracyclines in treating acne, more adverse side effects are being reported. We report a patient who experienced acute severe urticaria with angioedema from minocycline.

A 35-year-old woman with a history of acne vulgaris presented to the emergency department with urticaria and associated angioedema. Fifteen days after starting minocycline, she awoke with diffuse hives sparing only the abdomen that resolved with diphenhydramine. Later that day, she developed generalized pruritus, hives, and lip swelling. She received intravenous methylprednisolone, diphenhydramine, and famotidine in the emergency department. She returned to the emergency department the next day due to facial and lip swelling, diffuse urticaria that was most pronounced on the arms, and throat irritation. Intramuscular epinephrine was administered first followed by methylprednisolone, famotidine, and cetirizine. She was discharged and advised to start daily prednisone 50 mg and cetirizine 20 mg every evening.

She returned to the emergency department the following morning due to worsening generalized urticaria and angioedema of the lips. She denied any associated respiratory, joint, or gastrointestinal tract symptoms. She had several urticarial plaques on the scalp, face, and body (Figure), only sparing the abdomen. Her hives were erythematous, raised, pruritic, and blanching. There was no residual purpura, ecchymosis, or hyperpigmentation associated with the urticaria, and each lesion was present for less than 24 hours. There was no swelling on examination. Additionally, she was afebrile. The C4 level was 18 mg/dL (reference range, 15–45 mg/dL). She did not develop eosinophilia (absolute eosinophil count, 0/µL [reference range, 50–500/µL]), lymphocytosis (absolute lymphocyte count, 1300/µL [reference range, 1000–4800/µL]), or abnormal liver or renal function. She was hospitalized for 3 days with severe urticaria and required 7 days of prednisone 40 to 50 mg, fexofenadine 360 mg, and cetirizine 20 mg. A viral infection was considered as a possible etiology; however, she had no supporting signs or symptoms of an upper respiratory illness or other viral illness.

The patient’s minocycline use was considered the most likely etiology, as an oral contraceptive was the only other medication. She was labelled allergic to minocycline and discharged with intramuscular epinephrine. She was evaluated in the outpatient allergy immunology clinic 9 days later, and all her symptoms had resolved. Due to the severity of our patient’s reaction and the possibility of further severe reactions, an oral challenge was not carried out. Our patient was not interested in pursuing any further minocycline or other tetracycline-based therapy for her acne. She also was not interested in pursuing any minocycline skin-prick testing or oral challenge. One limitation to this case is our patient declining a confirmatory drug challenge; however, given the severity of the symptoms, the physicians involved agreed the patient's safety outweighed the benefits of confirmatory testing.

A PubMed search of articles indexed for MEDLINE and a Google Scholar search using the terms minocycline, drug hypersensitivity, urticaria, anaphylaxis, minocycline allergy, and angioedema yielded only 16 articles and correspondences. Reported adverse effects of minocycline included drug-induced lupus erythematosus, vasculitis, nausea, photosensitivity, and DRESS-like (drug reaction with eosinophilia and systemic symptoms syndrome) conditions. Three case reports of anaphylaxis/anaphylactoid reactions have been published,^2-4 but cases of urticaria attributable to minocycline appear to be exceedingly rare.^2,3 Reports of serum sickness in patients aged 15 to 62 years were rare. Women were noted to experience a higher frequency of adverse effects compared to men.⁵ Symptoms typically presented 3 to 28 days after initiation of minocycline. Data currently suggest that the pathogenesis of hypersensitivity reactions to minocycline remains unknown⁶; however, one hypothesis is that minocycline or its metabolites act as a superantigen, resulting in lymphocyte overactivation and massive cytokine release.⁷

Minocycline generally is well tolerated by patients. Physicians should be aware that minocycline is a possible causative agent of allergic drug reactions. Our patient’s presentation of severe acute urticaria with angioedema of the face and lips is a rarity.

To the Editor:

Minocycline is a commonly prescribed semisynthetic tetracycline derivative used for long-term treatment of acne vulgaris.¹ Given the continued popularity of minocycline and other tetracyclines in treating acne, more adverse side effects are being reported. We report a patient who experienced acute severe urticaria with angioedema from minocycline.

A 35-year-old woman with a history of acne vulgaris presented to the emergency department with urticaria and associated angioedema. Fifteen days after starting minocycline, she awoke with diffuse hives sparing only the abdomen that resolved with diphenhydramine. Later that day, she developed generalized pruritus, hives, and lip swelling. She received intravenous methylprednisolone, diphenhydramine, and famotidine in the emergency department. She returned to the emergency department the next day due to facial and lip swelling, diffuse urticaria that was most pronounced on the arms, and throat irritation. Intramuscular epinephrine was administered first followed by methylprednisolone, famotidine, and cetirizine. She was discharged and advised to start daily prednisone 50 mg and cetirizine 20 mg every evening.

She returned to the emergency department the following morning due to worsening generalized urticaria and angioedema of the lips. She denied any associated respiratory, joint, or gastrointestinal tract symptoms. She had several urticarial plaques on the scalp, face, and body (Figure), only sparing the abdomen. Her hives were erythematous, raised, pruritic, and blanching. There was no residual purpura, ecchymosis, or hyperpigmentation associated with the urticaria, and each lesion was present for less than 24 hours. There was no swelling on examination. Additionally, she was afebrile. The C4 level was 18 mg/dL (reference range, 15–45 mg/dL). She did not develop eosinophilia (absolute eosinophil count, 0/µL [reference range, 50–500/µL]), lymphocytosis (absolute lymphocyte count, 1300/µL [reference range, 1000–4800/µL]), or abnormal liver or renal function. She was hospitalized for 3 days with severe urticaria and required 7 days of prednisone 40 to 50 mg, fexofenadine 360 mg, and cetirizine 20 mg. A viral infection was considered as a possible etiology; however, she had no supporting signs or symptoms of an upper respiratory illness or other viral illness.

The patient’s minocycline use was considered the most likely etiology, as an oral contraceptive was the only other medication. She was labelled allergic to minocycline and discharged with intramuscular epinephrine. She was evaluated in the outpatient allergy immunology clinic 9 days later, and all her symptoms had resolved. Due to the severity of our patient’s reaction and the possibility of further severe reactions, an oral challenge was not carried out. Our patient was not interested in pursuing any further minocycline or other tetracycline-based therapy for her acne. She also was not interested in pursuing any minocycline skin-prick testing or oral challenge. One limitation to this case is our patient declining a confirmatory drug challenge; however, given the severity of the symptoms, the physicians involved agreed the patient's safety outweighed the benefits of confirmatory testing.

A PubMed search of articles indexed for MEDLINE and a Google Scholar search using the terms minocycline, drug hypersensitivity, urticaria, anaphylaxis, minocycline allergy, and angioedema yielded only 16 articles and correspondences. Reported adverse effects of minocycline included drug-induced lupus erythematosus, vasculitis, nausea, photosensitivity, and DRESS-like (drug reaction with eosinophilia and systemic symptoms syndrome) conditions. Three case reports of anaphylaxis/anaphylactoid reactions have been published,^2-4 but cases of urticaria attributable to minocycline appear to be exceedingly rare.^2,3 Reports of serum sickness in patients aged 15 to 62 years were rare. Women were noted to experience a higher frequency of adverse effects compared to men.⁵ Symptoms typically presented 3 to 28 days after initiation of minocycline. Data currently suggest that the pathogenesis of hypersensitivity reactions to minocycline remains unknown⁶; however, one hypothesis is that minocycline or its metabolites act as a superantigen, resulting in lymphocyte overactivation and massive cytokine release.⁷

Minocycline generally is well tolerated by patients. Physicians should be aware that minocycline is a possible causative agent of allergic drug reactions. Our patient’s presentation of severe acute urticaria with angioedema of the face and lips is a rarity.

To the Editor:

Minocycline is a commonly prescribed semisynthetic tetracycline derivative used for long-term treatment of acne vulgaris.¹ Given the continued popularity of minocycline and other tetracyclines in treating acne, more adverse side effects are being reported. We report a patient who experienced acute severe urticaria with angioedema from minocycline.

A 35-year-old woman with a history of acne vulgaris presented to the emergency department with urticaria and associated angioedema. Fifteen days after starting minocycline, she awoke with diffuse hives sparing only the abdomen that resolved with diphenhydramine. Later that day, she developed generalized pruritus, hives, and lip swelling. She received intravenous methylprednisolone, diphenhydramine, and famotidine in the emergency department. She returned to the emergency department the next day due to facial and lip swelling, diffuse urticaria that was most pronounced on the arms, and throat irritation. Intramuscular epinephrine was administered first followed by methylprednisolone, famotidine, and cetirizine. She was discharged and advised to start daily prednisone 50 mg and cetirizine 20 mg every evening.

She returned to the emergency department the following morning due to worsening generalized urticaria and angioedema of the lips. She denied any associated respiratory, joint, or gastrointestinal tract symptoms. She had several urticarial plaques on the scalp, face, and body (Figure), only sparing the abdomen. Her hives were erythematous, raised, pruritic, and blanching. There was no residual purpura, ecchymosis, or hyperpigmentation associated with the urticaria, and each lesion was present for less than 24 hours. There was no swelling on examination. Additionally, she was afebrile. The C4 level was 18 mg/dL (reference range, 15–45 mg/dL). She did not develop eosinophilia (absolute eosinophil count, 0/µL [reference range, 50–500/µL]), lymphocytosis (absolute lymphocyte count, 1300/µL [reference range, 1000–4800/µL]), or abnormal liver or renal function. She was hospitalized for 3 days with severe urticaria and required 7 days of prednisone 40 to 50 mg, fexofenadine 360 mg, and cetirizine 20 mg. A viral infection was considered as a possible etiology; however, she had no supporting signs or symptoms of an upper respiratory illness or other viral illness.

The patient’s minocycline use was considered the most likely etiology, as an oral contraceptive was the only other medication. She was labelled allergic to minocycline and discharged with intramuscular epinephrine. She was evaluated in the outpatient allergy immunology clinic 9 days later, and all her symptoms had resolved. Due to the severity of our patient’s reaction and the possibility of further severe reactions, an oral challenge was not carried out. Our patient was not interested in pursuing any further minocycline or other tetracycline-based therapy for her acne. She also was not interested in pursuing any minocycline skin-prick testing or oral challenge. One limitation to this case is our patient declining a confirmatory drug challenge; however, given the severity of the symptoms, the physicians involved agreed the patient's safety outweighed the benefits of confirmatory testing.

A PubMed search of articles indexed for MEDLINE and a Google Scholar search using the terms minocycline, drug hypersensitivity, urticaria, anaphylaxis, minocycline allergy, and angioedema yielded only 16 articles and correspondences. Reported adverse effects of minocycline included drug-induced lupus erythematosus, vasculitis, nausea, photosensitivity, and DRESS-like (drug reaction with eosinophilia and systemic symptoms syndrome) conditions. Three case reports of anaphylaxis/anaphylactoid reactions have been published,^2-4 but cases of urticaria attributable to minocycline appear to be exceedingly rare.^2,3 Reports of serum sickness in patients aged 15 to 62 years were rare. Women were noted to experience a higher frequency of adverse effects compared to men.⁵ Symptoms typically presented 3 to 28 days after initiation of minocycline. Data currently suggest that the pathogenesis of hypersensitivity reactions to minocycline remains unknown⁶; however, one hypothesis is that minocycline or its metabolites act as a superantigen, resulting in lymphocyte overactivation and massive cytokine release.⁷

Minocycline generally is well tolerated by patients. Physicians should be aware that minocycline is a possible causative agent of allergic drug reactions. Our patient’s presentation of severe acute urticaria with angioedema of the face and lips is a rarity.

The first case of the Omicron variant of the coronavirus in the United States was confirmed by officials today in an individual in California who had recently traveled to South Africa. He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said. 

The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.

“All close contacts have been contacted and have tested negative,” officials said. 

The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”

Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.

The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.

It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.

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

The first case of the Omicron variant of the coronavirus in the United States was confirmed by officials today in an individual in California who had recently traveled to South Africa. He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said. 

The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.

“All close contacts have been contacted and have tested negative,” officials said. 

The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”

Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.

The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.

It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.

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

The first case of the Omicron variant of the coronavirus in the United States was confirmed by officials today in an individual in California who had recently traveled to South Africa. He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said. 

The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.

“All close contacts have been contacted and have tested negative,” officials said. 

The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”

Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.

The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.

It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.

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

Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.

Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.

Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.

Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

Aspirin use was associated with longer overall survival in people with inoperable non–small cell lung cancer (NSCLC), according to a new study from Taiwan.

copyright Darren Hester/Fotolia.com

The analysis, published online Nov. 22 in BMC Cancer , adds another data point to a small and inconsistent evidence base.

“Despite the need for future prospective randomized clinical trials, aspirin may be considered as an additional treatment for inoperable NSCLC patients,” Ming-Szu Hung, MD, of Chang-Gung University, Taoyuan City, and colleagues write.

The current literature suggests that the over-the-counter medication may help ward off various types of cancer, including lung cancer, but the various study findings do not always align. For lung-cancer survival, in particular, a few observational studies have found increased survival among aspirin users while others have not.

To help bring clarity to the literature, Dr. Hung’s team examined data from Taiwan’s National Health Insurance Research Database on more than 38,000 patients diagnosed with NSCLC between 2000 and 2012, almost 5,000 of whom were taking aspirin at the time of diagnosis.

The researchers found that aspirin users survived for a median of 1.73 years, compared with 1.30 years for nonusers. Taking the drug was associated with longer overall survival in time-varying covariate analysis (hazard ratio, 0.83; 95% CI, 0.80-0.86). This finding was confirmed in a propensity-score analysis of 4,932 matched pairs (HR, 0.79; 95% CI, 0.75-0.83).

“These results warrant further randomized clinical trials to evaluate the actual role of aspirin in the treatment of NSCLC patients,” the researchers conclude.

But Úna McMenamin, PhD, a cancer epidemiologist at Queen’s University Belfast, Ireland, was not convinced by the study’s methods.

While she praised its large size and use of population-based health registers, she expressed concern about the potential for reverse causation, “as it is unclear whether authors lagged the aspirin exposure in the cohort of lung cancer patients.”

There is evidence that common medications such as aspirin may be withdrawn from patients who are thought to be near the end of their life, Dr. McMenamin told this news organization. When not factored into the statistical analysis, aspirin may appear “to be spuriously associated with a reduced risk of death when, in fact, no association may be present.”

Previous studies of aspirin use in lung cancer patients that have included a lag, such as one Dr. McMenamin and colleagues conducted in 2015, have found no evidence of a protective effect.

That is why, according to Dr. McMenamin, “additional population-based studies, in diverse populations, are required to investigate the association between aspirin use and survival outcomes in lung-cancer patients to determine whether randomized controlled trials are warranted in this patient group.”

In addition, she noted, “any potential benefit of aspirin in lung cancer patients needs to be balanced against known adverse events associated with prolonged aspirin use, such as gastrointestinal bleeding.”

Dr. Hung did not reply to requests for comment.

The study had no funding, and the researchers report no conflicts of interest.

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

Aspirin use was associated with longer overall survival in people with inoperable non–small cell lung cancer (NSCLC), according to a new study from Taiwan.

copyright Darren Hester/Fotolia.com

The analysis, published online Nov. 22 in BMC Cancer , adds another data point to a small and inconsistent evidence base.

“Despite the need for future prospective randomized clinical trials, aspirin may be considered as an additional treatment for inoperable NSCLC patients,” Ming-Szu Hung, MD, of Chang-Gung University, Taoyuan City, and colleagues write.

The current literature suggests that the over-the-counter medication may help ward off various types of cancer, including lung cancer, but the various study findings do not always align. For lung-cancer survival, in particular, a few observational studies have found increased survival among aspirin users while others have not.

To help bring clarity to the literature, Dr. Hung’s team examined data from Taiwan’s National Health Insurance Research Database on more than 38,000 patients diagnosed with NSCLC between 2000 and 2012, almost 5,000 of whom were taking aspirin at the time of diagnosis.

The researchers found that aspirin users survived for a median of 1.73 years, compared with 1.30 years for nonusers. Taking the drug was associated with longer overall survival in time-varying covariate analysis (hazard ratio, 0.83; 95% CI, 0.80-0.86). This finding was confirmed in a propensity-score analysis of 4,932 matched pairs (HR, 0.79; 95% CI, 0.75-0.83).

“These results warrant further randomized clinical trials to evaluate the actual role of aspirin in the treatment of NSCLC patients,” the researchers conclude.

But Úna McMenamin, PhD, a cancer epidemiologist at Queen’s University Belfast, Ireland, was not convinced by the study’s methods.

While she praised its large size and use of population-based health registers, she expressed concern about the potential for reverse causation, “as it is unclear whether authors lagged the aspirin exposure in the cohort of lung cancer patients.”

There is evidence that common medications such as aspirin may be withdrawn from patients who are thought to be near the end of their life, Dr. McMenamin told this news organization. When not factored into the statistical analysis, aspirin may appear “to be spuriously associated with a reduced risk of death when, in fact, no association may be present.”

Previous studies of aspirin use in lung cancer patients that have included a lag, such as one Dr. McMenamin and colleagues conducted in 2015, have found no evidence of a protective effect.

That is why, according to Dr. McMenamin, “additional population-based studies, in diverse populations, are required to investigate the association between aspirin use and survival outcomes in lung-cancer patients to determine whether randomized controlled trials are warranted in this patient group.”

In addition, she noted, “any potential benefit of aspirin in lung cancer patients needs to be balanced against known adverse events associated with prolonged aspirin use, such as gastrointestinal bleeding.”

Dr. Hung did not reply to requests for comment.

The study had no funding, and the researchers report no conflicts of interest.

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

Aspirin use was associated with longer overall survival in people with inoperable non–small cell lung cancer (NSCLC), according to a new study from Taiwan.

copyright Darren Hester/Fotolia.com

The analysis, published online Nov. 22 in BMC Cancer , adds another data point to a small and inconsistent evidence base.

“Despite the need for future prospective randomized clinical trials, aspirin may be considered as an additional treatment for inoperable NSCLC patients,” Ming-Szu Hung, MD, of Chang-Gung University, Taoyuan City, and colleagues write.

The current literature suggests that the over-the-counter medication may help ward off various types of cancer, including lung cancer, but the various study findings do not always align. For lung-cancer survival, in particular, a few observational studies have found increased survival among aspirin users while others have not.

To help bring clarity to the literature, Dr. Hung’s team examined data from Taiwan’s National Health Insurance Research Database on more than 38,000 patients diagnosed with NSCLC between 2000 and 2012, almost 5,000 of whom were taking aspirin at the time of diagnosis.

The researchers found that aspirin users survived for a median of 1.73 years, compared with 1.30 years for nonusers. Taking the drug was associated with longer overall survival in time-varying covariate analysis (hazard ratio, 0.83; 95% CI, 0.80-0.86). This finding was confirmed in a propensity-score analysis of 4,932 matched pairs (HR, 0.79; 95% CI, 0.75-0.83).

“These results warrant further randomized clinical trials to evaluate the actual role of aspirin in the treatment of NSCLC patients,” the researchers conclude.

But Úna McMenamin, PhD, a cancer epidemiologist at Queen’s University Belfast, Ireland, was not convinced by the study’s methods.

While she praised its large size and use of population-based health registers, she expressed concern about the potential for reverse causation, “as it is unclear whether authors lagged the aspirin exposure in the cohort of lung cancer patients.”

There is evidence that common medications such as aspirin may be withdrawn from patients who are thought to be near the end of their life, Dr. McMenamin told this news organization. When not factored into the statistical analysis, aspirin may appear “to be spuriously associated with a reduced risk of death when, in fact, no association may be present.”

Previous studies of aspirin use in lung cancer patients that have included a lag, such as one Dr. McMenamin and colleagues conducted in 2015, have found no evidence of a protective effect.

That is why, according to Dr. McMenamin, “additional population-based studies, in diverse populations, are required to investigate the association between aspirin use and survival outcomes in lung-cancer patients to determine whether randomized controlled trials are warranted in this patient group.”

In addition, she noted, “any potential benefit of aspirin in lung cancer patients needs to be balanced against known adverse events associated with prolonged aspirin use, such as gastrointestinal bleeding.”

Dr. Hung did not reply to requests for comment.

The study had no funding, and the researchers report no conflicts of interest.

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

The Moderna CEO says existing COVID-19 vaccines will likely be less effective against the new Omicron variant.

“There is no world, I think, where [the effectiveness] is the same level … we had with Delta,” Stephane Bancel told the Financial Times .

“I think it’s going to be a material drop,” he said. “I just don’t know how much, because we need to wait for the data. But all the scientists I’ve talked to … are like, ‘This is not going to be good.’”

Vaccine companies are now studying whether the new Omicron variant could evade the current shots. Some data is expected in about 2 weeks.

Mr. Bancel said that if a new vaccine is needed, it could take several months to produce at scale. He estimated that Moderna could make billions of vaccine doses in 2022.

“[Moderna] and Pfizer cannot get a billion doses next week. The math doesn’t work,” he said. “But could we get the billion doses out by the summer? Sure.”

The news caused some panic on Nov. 30, prompting financial markets to fall sharply, according to Reuters. But the markets recovered after European officials gave a more reassuring outlook.

“Even if the new variant becomes more widespread, the vaccines we have will continue to provide protection,” Emer Cooke, executive director of the European Medicines Agency, told the European Parliament.

Mr. Cooke said the agency could approve new vaccines that target the Omicron variant within 3 to 4 months, if needed. Moderna and Pfizer have announced they are beginning to tailor a shot to address the Omicron variant in case the data shows they are necessary.

Also on Nov. 30, the European Centre for Disease Prevention and Control announced that 42 Omicron cases had been identified in 10 European Union countries, according to Reuters.

The cases were mild or had no symptoms, although they were found in younger people who may have mild or no symptoms anyway.

“For the assessment of whether [Omicron] escapes immunity, we still have to wait until investigations in the laboratories with [blood samples] from people who have recovered have been carried out,” Andrea Ammon, MD, chair of the agency, said during an online conference.

The University of Oxford, which developed a COVID-19 vaccine with AstraZeneca, said Nov. 30 that there’s no evidence that vaccines won’t prevent severe disease from the Omicron variant, according to Reuters.

“Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different,” the university said in a statement. “However, we have the necessary tools and processes in place for rapid development of an updated COVID-19 vaccine if it should be necessary.”

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

The Moderna CEO says existing COVID-19 vaccines will likely be less effective against the new Omicron variant.

“There is no world, I think, where [the effectiveness] is the same level … we had with Delta,” Stephane Bancel told the Financial Times .

“I think it’s going to be a material drop,” he said. “I just don’t know how much, because we need to wait for the data. But all the scientists I’ve talked to … are like, ‘This is not going to be good.’”

Vaccine companies are now studying whether the new Omicron variant could evade the current shots. Some data is expected in about 2 weeks.

Mr. Bancel said that if a new vaccine is needed, it could take several months to produce at scale. He estimated that Moderna could make billions of vaccine doses in 2022.

“[Moderna] and Pfizer cannot get a billion doses next week. The math doesn’t work,” he said. “But could we get the billion doses out by the summer? Sure.”

The news caused some panic on Nov. 30, prompting financial markets to fall sharply, according to Reuters. But the markets recovered after European officials gave a more reassuring outlook.

“Even if the new variant becomes more widespread, the vaccines we have will continue to provide protection,” Emer Cooke, executive director of the European Medicines Agency, told the European Parliament.

Mr. Cooke said the agency could approve new vaccines that target the Omicron variant within 3 to 4 months, if needed. Moderna and Pfizer have announced they are beginning to tailor a shot to address the Omicron variant in case the data shows they are necessary.

Also on Nov. 30, the European Centre for Disease Prevention and Control announced that 42 Omicron cases had been identified in 10 European Union countries, according to Reuters.

The cases were mild or had no symptoms, although they were found in younger people who may have mild or no symptoms anyway.

“For the assessment of whether [Omicron] escapes immunity, we still have to wait until investigations in the laboratories with [blood samples] from people who have recovered have been carried out,” Andrea Ammon, MD, chair of the agency, said during an online conference.

The University of Oxford, which developed a COVID-19 vaccine with AstraZeneca, said Nov. 30 that there’s no evidence that vaccines won’t prevent severe disease from the Omicron variant, according to Reuters.

“Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different,” the university said in a statement. “However, we have the necessary tools and processes in place for rapid development of an updated COVID-19 vaccine if it should be necessary.”

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

The Moderna CEO says existing COVID-19 vaccines will likely be less effective against the new Omicron variant.

“There is no world, I think, where [the effectiveness] is the same level … we had with Delta,” Stephane Bancel told the Financial Times .

“I think it’s going to be a material drop,” he said. “I just don’t know how much, because we need to wait for the data. But all the scientists I’ve talked to … are like, ‘This is not going to be good.’”

Vaccine companies are now studying whether the new Omicron variant could evade the current shots. Some data is expected in about 2 weeks.

Mr. Bancel said that if a new vaccine is needed, it could take several months to produce at scale. He estimated that Moderna could make billions of vaccine doses in 2022.

“[Moderna] and Pfizer cannot get a billion doses next week. The math doesn’t work,” he said. “But could we get the billion doses out by the summer? Sure.”

The news caused some panic on Nov. 30, prompting financial markets to fall sharply, according to Reuters. But the markets recovered after European officials gave a more reassuring outlook.

“Even if the new variant becomes more widespread, the vaccines we have will continue to provide protection,” Emer Cooke, executive director of the European Medicines Agency, told the European Parliament.

Mr. Cooke said the agency could approve new vaccines that target the Omicron variant within 3 to 4 months, if needed. Moderna and Pfizer have announced they are beginning to tailor a shot to address the Omicron variant in case the data shows they are necessary.

Also on Nov. 30, the European Centre for Disease Prevention and Control announced that 42 Omicron cases had been identified in 10 European Union countries, according to Reuters.

The cases were mild or had no symptoms, although they were found in younger people who may have mild or no symptoms anyway.

“For the assessment of whether [Omicron] escapes immunity, we still have to wait until investigations in the laboratories with [blood samples] from people who have recovered have been carried out,” Andrea Ammon, MD, chair of the agency, said during an online conference.

The University of Oxford, which developed a COVID-19 vaccine with AstraZeneca, said Nov. 30 that there’s no evidence that vaccines won’t prevent severe disease from the Omicron variant, according to Reuters.

“Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different,” the university said in a statement. “However, we have the necessary tools and processes in place for rapid development of an updated COVID-19 vaccine if it should be necessary.”

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

New cases of COVID-19 were down in children during the week leading up to Thanksgiving, but not by as much as vaccinations, which dropped by 71% in the days before and after the holiday, according to new data.

States reported 131,828 new pediatric cases for the week of Nov. 19-25, a decline of 7.1% over the previous week but still enough to surpass 100,000 for the 16th consecutive week. The weekly count had risen for 3 straight weeks since the last decrease in late October, the American Academy of Pediatrics and the Children’s Hospital Association said Nov. 30 in their weekly COVID report.

The AAP/CHA analysis, based on data from state and territorial health departments, puts the total number of cases in children at 6.9 million since the pandemic began, representing 17.0% of cases in Americans of all ages. The Centers for Disease Control and Prevention, which uses an age limit of 18 years to define a child, unlike some states, reports numbers of 6.1 million and 15.5%.

New vaccinations among the youngest eligible children, those aged 5-11 years, were down for the second week in a row after reaching almost 1.7 million during the first full week after approval on Nov. 2. Since then, the vaccination counts have been 1.2 million (Nov. 16-22) and 333,000 (Nov. 23-29), the CDC said on its COVID Data Tracker. A similar drop in the last week – from 127,000 to just 50,000 – also was seen for those aged 12-17 years.

Altogether, 14.2% of children aged 5-11, almost 4.1 million individuals, have received at least one dose of the vaccine, compared with 59.0% (10 million) of the 12- to 15-year-olds and 65.2% (5.5 million) of those aged 16-17. Just under 1% of the youngest group has been fully vaccinated, versus 49.0% and 55.8% for the older children, the CDC said.

It has been reported that Pfizer and BioNTech, which produce the only COVID vaccine approved for children, are planning to apply to the Food and Drug Administration during the first week of December for authorization for a booster dose for 16- and 17-year-olds.

rfranki@mdedge.com

New cases of COVID-19 were down in children during the week leading up to Thanksgiving, but not by as much as vaccinations, which dropped by 71% in the days before and after the holiday, according to new data.

States reported 131,828 new pediatric cases for the week of Nov. 19-25, a decline of 7.1% over the previous week but still enough to surpass 100,000 for the 16th consecutive week. The weekly count had risen for 3 straight weeks since the last decrease in late October, the American Academy of Pediatrics and the Children’s Hospital Association said Nov. 30 in their weekly COVID report.

The AAP/CHA analysis, based on data from state and territorial health departments, puts the total number of cases in children at 6.9 million since the pandemic began, representing 17.0% of cases in Americans of all ages. The Centers for Disease Control and Prevention, which uses an age limit of 18 years to define a child, unlike some states, reports numbers of 6.1 million and 15.5%.

New vaccinations among the youngest eligible children, those aged 5-11 years, were down for the second week in a row after reaching almost 1.7 million during the first full week after approval on Nov. 2. Since then, the vaccination counts have been 1.2 million (Nov. 16-22) and 333,000 (Nov. 23-29), the CDC said on its COVID Data Tracker. A similar drop in the last week – from 127,000 to just 50,000 – also was seen for those aged 12-17 years.

Altogether, 14.2% of children aged 5-11, almost 4.1 million individuals, have received at least one dose of the vaccine, compared with 59.0% (10 million) of the 12- to 15-year-olds and 65.2% (5.5 million) of those aged 16-17. Just under 1% of the youngest group has been fully vaccinated, versus 49.0% and 55.8% for the older children, the CDC said.

It has been reported that Pfizer and BioNTech, which produce the only COVID vaccine approved for children, are planning to apply to the Food and Drug Administration during the first week of December for authorization for a booster dose for 16- and 17-year-olds.

rfranki@mdedge.com

New cases of COVID-19 were down in children during the week leading up to Thanksgiving, but not by as much as vaccinations, which dropped by 71% in the days before and after the holiday, according to new data.

States reported 131,828 new pediatric cases for the week of Nov. 19-25, a decline of 7.1% over the previous week but still enough to surpass 100,000 for the 16th consecutive week. The weekly count had risen for 3 straight weeks since the last decrease in late October, the American Academy of Pediatrics and the Children’s Hospital Association said Nov. 30 in their weekly COVID report.

The AAP/CHA analysis, based on data from state and territorial health departments, puts the total number of cases in children at 6.9 million since the pandemic began, representing 17.0% of cases in Americans of all ages. The Centers for Disease Control and Prevention, which uses an age limit of 18 years to define a child, unlike some states, reports numbers of 6.1 million and 15.5%.

New vaccinations among the youngest eligible children, those aged 5-11 years, were down for the second week in a row after reaching almost 1.7 million during the first full week after approval on Nov. 2. Since then, the vaccination counts have been 1.2 million (Nov. 16-22) and 333,000 (Nov. 23-29), the CDC said on its COVID Data Tracker. A similar drop in the last week – from 127,000 to just 50,000 – also was seen for those aged 12-17 years.

Altogether, 14.2% of children aged 5-11, almost 4.1 million individuals, have received at least one dose of the vaccine, compared with 59.0% (10 million) of the 12- to 15-year-olds and 65.2% (5.5 million) of those aged 16-17. Just under 1% of the youngest group has been fully vaccinated, versus 49.0% and 55.8% for the older children, the CDC said.

It has been reported that Pfizer and BioNTech, which produce the only COVID vaccine approved for children, are planning to apply to the Food and Drug Administration during the first week of December for authorization for a booster dose for 16- and 17-year-olds.

rfranki@mdedge.com

The San Antonio Breast Cancer Symposium (SABCS) 2021 will “be a great meeting,” according to Carlos Arteaga, MD, director of Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, Dallas.

Dr. Arteaga, the meeting’s codirector, said the first-ever hybrid symposium will take place virtually from Dec. 7 to 10 as well as in person. Online availability appears to be a boon to attendance, with a record 9,325 registrants for the 2020 symposium, held only virtually because of the COVID-19 pandemic.

The meeting will have an app available, which can be accessed by searching “San Antonio Breast Cancer Symposium” (Google Play for Android, Apple for iOS) and downloading, or by going to www.core-apps.com/dl/sabcs from a desktop computer.

Dr. Arteaga provided a sneak peek of the most exciting research being presented at the upcoming meeting.
 

On the horizon for advanced breast cancer

A “very important” study of an investigational oral agent employed in heavily pretreated postmenopausal women with estrogen receptor–positive (ER+) advanced breast cancer headlines the meeting.

This international, multicenter trial could have “practice-changing implications,” Dr. Arteaga said in an interview.

The phase 3 EMERALD trial (abstract GS2-02) pits elacestrant, a selective estrogen receptor degrader (SERD), against standard endocrine therapy (fulvestrant or an aromatase inhibitor) in patients with metastatic breast cancer whose disease has progressed after treatment with at least one endocrine therapy and a CDK4/6 inhibitor.

The trial is important because many patients with breast cancer have estrogen receptor mutations, which are a “major mechanism of [drug] resistance” and thus progression on earlier therapy, Dr. Arteaga said.

Elacestrant is in good company among a plethora of oral SERDs under investigation in advanced breast cancer; however, currently, fulvestrant – which requires an intramuscular injection in the buttocks every month – is the only approved SERD.

“There’s plenty of preclinical data that suggest that these drugs [SERDs] may have activity against these mutant forms of the receptor, which occur in up to 40% of patients with advanced ER+ breast cancer,” he explained.

Researchers will present data on two primary outcome measures from the phase 3 trial: progression-free survival (PFS) based on mutations of the estrogen receptor 1 gene (ESR1-mut) and PFS in all subjects regardless of ESR1 status.

In addition to the EMERALD trial, PADA-1 (abstract GS3-05) is another important randomized, phase 3 trial focused on treating estrogen receptor mutations in patients with metastatic disease, said Dr. Arteaga.

The trial has enrolled patients with ER+ metastatic breast cancer who received an aromatase inhibitor (letrozole, anastrozole, or exemestane) and the CDK4/6 inhibitor palbociclib as first-line therapy.

In step 1 of the trial, approximately 1,000 patients were screened for circulating blood ESR1 mutation detection at regular intervals while being treated with palbociclib and an aromatase inhibitor in a continuous scheme until tumor progression or ESR1 mutation detection.

In step 2, up to 200 patients with a rising circulating ESR1 mutation and no tumor progression were randomized 1:1 to no change in therapy until tumor progression or to receive palbociclib plus fulvestrant until tumor progression.

The trial examines the safety and efficacy of “a clinical conundrum that we face” in this setting: whether or not to switch treatment from an aromatase inhibitor to fulvestrant while continuing a CDK4/6 inhibitor at the sign of mutation detection, Dr. Arteaga explained.
 

Refining who gets the ‘kitchen sink’

Dr. Arteaga highlighted two trials focused on the immune checkpoint inhibitor pembrolizumab.

The phase 3 KEYNOTE-522 study led to the approval of neoadjuvant pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer (TNBC) in July 2021. At this year’s SABCS, researchers will present new data from KEYNOTE-522 (abstract GS1-01), representing final results from the trial’s event-free survival (EFS) outcome.

Previously, investigators reported a statistically significant and clinically meaningful improvement in EFS. These data suggest “that deploying immunotherapy early before surgery ... may be curative in some patients,” Dr. Arteaga said. The new data will allow the “robustness and consistency” of the earlier findings to be assessed.

But, he added, this is a “tough” treatment, which includes five drugs. “It’s the kitchen sink, and not everybody needs the kitchen sink. It’s important to refine these findings. Some patients may not need pembrolizumab, but some do.”

The second trial exploring pembrolizumab – KEYNOTE-355 (abstract GS1-02) – mirrors KEYNOTE-522 but in patients with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1.

Previously, investigators reported that pembrolizumab combined with chemotherapy showed statistically significant improvements in overall survival and PFS compared to placebo plus chemotherapy. At the 2021 SABCS, researchers will provide final study results, including outcomes in subgroups of patients by additional combined positive score cutoffs.
 

Metformin trial: ‘This is it’

Dr. Arteaga highlighted CCTGMA.32 (abstract GS1-08), a phase 3 randomized, placebo-controlled adjuvant trial of the diabetes drug metformin versus placebo in early breast cancer. Results of the primary efficacy analysis of the trial will be presented at the meeting.

The Canadian-led study seeks to determine if metformin can decrease breast cancer cell growth and work with cancer therapies to prevent disease recurrence. The study design calls for patients to take twice-daily oral metformin or placebo pills for up to 5 years in the absence of disease progression.

The primary outcome of the 3,500-plus patient trial is invasive disease-free survival in hormone receptor (ER and PgR) negative and positive (ER and/or PgR) subgroups.

“Metformin has actually been associated with improved survival [in breast cancer] in patients on chemotherapy. But we don’t know exactly how,” he said. “There’s never been a head-to-head comparison in the adjuvant setting [before]. This is it.”
 

TKI for breast cancer with brain mets

The SABCS codirector spotlighted an updated overall survival analysis of the randomized phase 3 PHOEBE trial (abstract GS3-02).

Previous research confirmed the superiority of pyrotinib, a novel TKI targeting HER1, HER2, and HER4, over lapatinib when given in combination with capecitabine in HER2-positive metastatic breast cancer.

In the United States, the lapatinib-capecitabine combination is “mostly used” in patients with HER2 metastatic disease and brain metastases who also undergo stereotactic radiation, Dr. Arteaga said.

This use has continued despite groundbreaking results from the HER2CLIMB trial, featuring the TKI tucatinib, he said.

As reported last year, adding tucatinib to trastuzumab and capecitabine in patients with HER2-positive breast cancer and brain metastases increased median overall survival from 12 months to 18.1 months. The results were called the first of their kind at that time.

The pyrotinib study may matter to American clinicians because pyrotinib is used mostly in China, not the United States, and this analysis suggests that pyrotinib could be part of the armamentarium in the United States, alongside tucatinib.

TKIs are like Coke and Pepsi, Dr. Arteaga said: “Similar but not identical.” Therefore, it is worth taking a look at the new study, he said. “There may be some benefit in having more than one [TKI] in the therapeutic armamentarium.”

Dr. Arteaga receives or has received grant support from Pfizer and Lilly and serves or has served in a scientific advisory role with Novartis, Lilly, TAIHO Oncology, Daiichi Sankyo, Merck, AstraZeneca, OrigiMed, Immunomedics, ARVINAS, Sanofi, Athenex, and the Susan G. Komen Foundation. He also holds minor stock options from Provista.

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

The San Antonio Breast Cancer Symposium (SABCS) 2021 will “be a great meeting,” according to Carlos Arteaga, MD, director of Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, Dallas.

Dr. Arteaga, the meeting’s codirector, said the first-ever hybrid symposium will take place virtually from Dec. 7 to 10 as well as in person. Online availability appears to be a boon to attendance, with a record 9,325 registrants for the 2020 symposium, held only virtually because of the COVID-19 pandemic.

The meeting will have an app available, which can be accessed by searching “San Antonio Breast Cancer Symposium” (Google Play for Android, Apple for iOS) and downloading, or by going to www.core-apps.com/dl/sabcs from a desktop computer.

Dr. Arteaga provided a sneak peek of the most exciting research being presented at the upcoming meeting.
 

On the horizon for advanced breast cancer

A “very important” study of an investigational oral agent employed in heavily pretreated postmenopausal women with estrogen receptor–positive (ER+) advanced breast cancer headlines the meeting.

This international, multicenter trial could have “practice-changing implications,” Dr. Arteaga said in an interview.

The phase 3 EMERALD trial (abstract GS2-02) pits elacestrant, a selective estrogen receptor degrader (SERD), against standard endocrine therapy (fulvestrant or an aromatase inhibitor) in patients with metastatic breast cancer whose disease has progressed after treatment with at least one endocrine therapy and a CDK4/6 inhibitor.

The trial is important because many patients with breast cancer have estrogen receptor mutations, which are a “major mechanism of [drug] resistance” and thus progression on earlier therapy, Dr. Arteaga said.

Elacestrant is in good company among a plethora of oral SERDs under investigation in advanced breast cancer; however, currently, fulvestrant – which requires an intramuscular injection in the buttocks every month – is the only approved SERD.

“There’s plenty of preclinical data that suggest that these drugs [SERDs] may have activity against these mutant forms of the receptor, which occur in up to 40% of patients with advanced ER+ breast cancer,” he explained.

Researchers will present data on two primary outcome measures from the phase 3 trial: progression-free survival (PFS) based on mutations of the estrogen receptor 1 gene (ESR1-mut) and PFS in all subjects regardless of ESR1 status.

In addition to the EMERALD trial, PADA-1 (abstract GS3-05) is another important randomized, phase 3 trial focused on treating estrogen receptor mutations in patients with metastatic disease, said Dr. Arteaga.

The trial has enrolled patients with ER+ metastatic breast cancer who received an aromatase inhibitor (letrozole, anastrozole, or exemestane) and the CDK4/6 inhibitor palbociclib as first-line therapy.

In step 1 of the trial, approximately 1,000 patients were screened for circulating blood ESR1 mutation detection at regular intervals while being treated with palbociclib and an aromatase inhibitor in a continuous scheme until tumor progression or ESR1 mutation detection.

In step 2, up to 200 patients with a rising circulating ESR1 mutation and no tumor progression were randomized 1:1 to no change in therapy until tumor progression or to receive palbociclib plus fulvestrant until tumor progression.

The trial examines the safety and efficacy of “a clinical conundrum that we face” in this setting: whether or not to switch treatment from an aromatase inhibitor to fulvestrant while continuing a CDK4/6 inhibitor at the sign of mutation detection, Dr. Arteaga explained.
 

Refining who gets the ‘kitchen sink’

Dr. Arteaga highlighted two trials focused on the immune checkpoint inhibitor pembrolizumab.

The phase 3 KEYNOTE-522 study led to the approval of neoadjuvant pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer (TNBC) in July 2021. At this year’s SABCS, researchers will present new data from KEYNOTE-522 (abstract GS1-01), representing final results from the trial’s event-free survival (EFS) outcome.

Previously, investigators reported a statistically significant and clinically meaningful improvement in EFS. These data suggest “that deploying immunotherapy early before surgery ... may be curative in some patients,” Dr. Arteaga said. The new data will allow the “robustness and consistency” of the earlier findings to be assessed.

But, he added, this is a “tough” treatment, which includes five drugs. “It’s the kitchen sink, and not everybody needs the kitchen sink. It’s important to refine these findings. Some patients may not need pembrolizumab, but some do.”

The second trial exploring pembrolizumab – KEYNOTE-355 (abstract GS1-02) – mirrors KEYNOTE-522 but in patients with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1.

Previously, investigators reported that pembrolizumab combined with chemotherapy showed statistically significant improvements in overall survival and PFS compared to placebo plus chemotherapy. At the 2021 SABCS, researchers will provide final study results, including outcomes in subgroups of patients by additional combined positive score cutoffs.
 

Metformin trial: ‘This is it’

Dr. Arteaga highlighted CCTGMA.32 (abstract GS1-08), a phase 3 randomized, placebo-controlled adjuvant trial of the diabetes drug metformin versus placebo in early breast cancer. Results of the primary efficacy analysis of the trial will be presented at the meeting.

The Canadian-led study seeks to determine if metformin can decrease breast cancer cell growth and work with cancer therapies to prevent disease recurrence. The study design calls for patients to take twice-daily oral metformin or placebo pills for up to 5 years in the absence of disease progression.

The primary outcome of the 3,500-plus patient trial is invasive disease-free survival in hormone receptor (ER and PgR) negative and positive (ER and/or PgR) subgroups.

“Metformin has actually been associated with improved survival [in breast cancer] in patients on chemotherapy. But we don’t know exactly how,” he said. “There’s never been a head-to-head comparison in the adjuvant setting [before]. This is it.”
 

TKI for breast cancer with brain mets

The SABCS codirector spotlighted an updated overall survival analysis of the randomized phase 3 PHOEBE trial (abstract GS3-02).

Previous research confirmed the superiority of pyrotinib, a novel TKI targeting HER1, HER2, and HER4, over lapatinib when given in combination with capecitabine in HER2-positive metastatic breast cancer.

In the United States, the lapatinib-capecitabine combination is “mostly used” in patients with HER2 metastatic disease and brain metastases who also undergo stereotactic radiation, Dr. Arteaga said.

This use has continued despite groundbreaking results from the HER2CLIMB trial, featuring the TKI tucatinib, he said.

As reported last year, adding tucatinib to trastuzumab and capecitabine in patients with HER2-positive breast cancer and brain metastases increased median overall survival from 12 months to 18.1 months. The results were called the first of their kind at that time.

The pyrotinib study may matter to American clinicians because pyrotinib is used mostly in China, not the United States, and this analysis suggests that pyrotinib could be part of the armamentarium in the United States, alongside tucatinib.

TKIs are like Coke and Pepsi, Dr. Arteaga said: “Similar but not identical.” Therefore, it is worth taking a look at the new study, he said. “There may be some benefit in having more than one [TKI] in the therapeutic armamentarium.”

Dr. Arteaga receives or has received grant support from Pfizer and Lilly and serves or has served in a scientific advisory role with Novartis, Lilly, TAIHO Oncology, Daiichi Sankyo, Merck, AstraZeneca, OrigiMed, Immunomedics, ARVINAS, Sanofi, Athenex, and the Susan G. Komen Foundation. He also holds minor stock options from Provista.

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

The San Antonio Breast Cancer Symposium (SABCS) 2021 will “be a great meeting,” according to Carlos Arteaga, MD, director of Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, Dallas.

Dr. Arteaga, the meeting’s codirector, said the first-ever hybrid symposium will take place virtually from Dec. 7 to 10 as well as in person. Online availability appears to be a boon to attendance, with a record 9,325 registrants for the 2020 symposium, held only virtually because of the COVID-19 pandemic.

The meeting will have an app available, which can be accessed by searching “San Antonio Breast Cancer Symposium” (Google Play for Android, Apple for iOS) and downloading, or by going to www.core-apps.com/dl/sabcs from a desktop computer.

Dr. Arteaga provided a sneak peek of the most exciting research being presented at the upcoming meeting.
 

On the horizon for advanced breast cancer

A “very important” study of an investigational oral agent employed in heavily pretreated postmenopausal women with estrogen receptor–positive (ER+) advanced breast cancer headlines the meeting.

This international, multicenter trial could have “practice-changing implications,” Dr. Arteaga said in an interview.

The phase 3 EMERALD trial (abstract GS2-02) pits elacestrant, a selective estrogen receptor degrader (SERD), against standard endocrine therapy (fulvestrant or an aromatase inhibitor) in patients with metastatic breast cancer whose disease has progressed after treatment with at least one endocrine therapy and a CDK4/6 inhibitor.

The trial is important because many patients with breast cancer have estrogen receptor mutations, which are a “major mechanism of [drug] resistance” and thus progression on earlier therapy, Dr. Arteaga said.

Elacestrant is in good company among a plethora of oral SERDs under investigation in advanced breast cancer; however, currently, fulvestrant – which requires an intramuscular injection in the buttocks every month – is the only approved SERD.

“There’s plenty of preclinical data that suggest that these drugs [SERDs] may have activity against these mutant forms of the receptor, which occur in up to 40% of patients with advanced ER+ breast cancer,” he explained.

Researchers will present data on two primary outcome measures from the phase 3 trial: progression-free survival (PFS) based on mutations of the estrogen receptor 1 gene (ESR1-mut) and PFS in all subjects regardless of ESR1 status.

In addition to the EMERALD trial, PADA-1 (abstract GS3-05) is another important randomized, phase 3 trial focused on treating estrogen receptor mutations in patients with metastatic disease, said Dr. Arteaga.

The trial has enrolled patients with ER+ metastatic breast cancer who received an aromatase inhibitor (letrozole, anastrozole, or exemestane) and the CDK4/6 inhibitor palbociclib as first-line therapy.

In step 1 of the trial, approximately 1,000 patients were screened for circulating blood ESR1 mutation detection at regular intervals while being treated with palbociclib and an aromatase inhibitor in a continuous scheme until tumor progression or ESR1 mutation detection.

In step 2, up to 200 patients with a rising circulating ESR1 mutation and no tumor progression were randomized 1:1 to no change in therapy until tumor progression or to receive palbociclib plus fulvestrant until tumor progression.

The trial examines the safety and efficacy of “a clinical conundrum that we face” in this setting: whether or not to switch treatment from an aromatase inhibitor to fulvestrant while continuing a CDK4/6 inhibitor at the sign of mutation detection, Dr. Arteaga explained.
 

Refining who gets the ‘kitchen sink’

Dr. Arteaga highlighted two trials focused on the immune checkpoint inhibitor pembrolizumab.

The phase 3 KEYNOTE-522 study led to the approval of neoadjuvant pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer (TNBC) in July 2021. At this year’s SABCS, researchers will present new data from KEYNOTE-522 (abstract GS1-01), representing final results from the trial’s event-free survival (EFS) outcome.

Previously, investigators reported a statistically significant and clinically meaningful improvement in EFS. These data suggest “that deploying immunotherapy early before surgery ... may be curative in some patients,” Dr. Arteaga said. The new data will allow the “robustness and consistency” of the earlier findings to be assessed.

But, he added, this is a “tough” treatment, which includes five drugs. “It’s the kitchen sink, and not everybody needs the kitchen sink. It’s important to refine these findings. Some patients may not need pembrolizumab, but some do.”

The second trial exploring pembrolizumab – KEYNOTE-355 (abstract GS1-02) – mirrors KEYNOTE-522 but in patients with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1.

Previously, investigators reported that pembrolizumab combined with chemotherapy showed statistically significant improvements in overall survival and PFS compared to placebo plus chemotherapy. At the 2021 SABCS, researchers will provide final study results, including outcomes in subgroups of patients by additional combined positive score cutoffs.
 

Metformin trial: ‘This is it’

Dr. Arteaga highlighted CCTGMA.32 (abstract GS1-08), a phase 3 randomized, placebo-controlled adjuvant trial of the diabetes drug metformin versus placebo in early breast cancer. Results of the primary efficacy analysis of the trial will be presented at the meeting.

The Canadian-led study seeks to determine if metformin can decrease breast cancer cell growth and work with cancer therapies to prevent disease recurrence. The study design calls for patients to take twice-daily oral metformin or placebo pills for up to 5 years in the absence of disease progression.

The primary outcome of the 3,500-plus patient trial is invasive disease-free survival in hormone receptor (ER and PgR) negative and positive (ER and/or PgR) subgroups.

“Metformin has actually been associated with improved survival [in breast cancer] in patients on chemotherapy. But we don’t know exactly how,” he said. “There’s never been a head-to-head comparison in the adjuvant setting [before]. This is it.”
 

TKI for breast cancer with brain mets

The SABCS codirector spotlighted an updated overall survival analysis of the randomized phase 3 PHOEBE trial (abstract GS3-02).

Previous research confirmed the superiority of pyrotinib, a novel TKI targeting HER1, HER2, and HER4, over lapatinib when given in combination with capecitabine in HER2-positive metastatic breast cancer.

In the United States, the lapatinib-capecitabine combination is “mostly used” in patients with HER2 metastatic disease and brain metastases who also undergo stereotactic radiation, Dr. Arteaga said.

This use has continued despite groundbreaking results from the HER2CLIMB trial, featuring the TKI tucatinib, he said.

As reported last year, adding tucatinib to trastuzumab and capecitabine in patients with HER2-positive breast cancer and brain metastases increased median overall survival from 12 months to 18.1 months. The results were called the first of their kind at that time.

The pyrotinib study may matter to American clinicians because pyrotinib is used mostly in China, not the United States, and this analysis suggests that pyrotinib could be part of the armamentarium in the United States, alongside tucatinib.

TKIs are like Coke and Pepsi, Dr. Arteaga said: “Similar but not identical.” Therefore, it is worth taking a look at the new study, he said. “There may be some benefit in having more than one [TKI] in the therapeutic armamentarium.”

Dr. Arteaga receives or has received grant support from Pfizer and Lilly and serves or has served in a scientific advisory role with Novartis, Lilly, TAIHO Oncology, Daiichi Sankyo, Merck, AstraZeneca, OrigiMed, Immunomedics, ARVINAS, Sanofi, Athenex, and the Susan G. Komen Foundation. He also holds minor stock options from Provista.

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