Breast Cancer ICYMI

Breast and cervical cancer screenings declined sharply in the early months of the COVID-19 pandemic, particularly among certain racial and ethnic minority groups and rural populations, notes the U.S. Centers for Disease Control and Prevention.

The new data come from the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), a program that provides cancer screening services to women with low income and inadequate health insurance.

The data show that the total number of screenings funded by the NBCCEDP declined by 87% for breast cancer screening and by 84% for cervical cancer screening in April 2020 in comparison with the previous 5-year averages for that month.

The declines in breast cancer screening varied from 84% among Hispanic women to 98% among American Indian/Alaskan Native women. The declines in cervical cancer screening varied from 82% among Black women to 92% among Asian Pacific Islander women.

In April 2020, breast cancer screening declined by 86% in metro areas, 88% in urban areas, and 89% in rural areas in comparison with respective 5-year averages. For cervical cancer screenings, the corresponding declines were 85%, 77%, and 82%.

The findings are consistent with those from studies conducted in insured populations, note the authors, led by the Amy DeGroff, PhD, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion.

“Prolonged delays in screening related to the COVID-19 pandemic may lead to delayed diagnoses, poor health consequences, and an increase in cancer disparities among women already experiencing health inequities,” the CDC states in a press release.

Women from racial and ethnic minority groups already face a disproportionate burden of cervical and breast cancers in the United States: Black women and Hispanic women have the highest rates of cervical cancer incidence (8.3 and 8.9 per 100,000 women, respectively, vs. 7.3 per 100,000 among White women) and the highest rates of cervical cancer deaths. Black women have the highest rate of breast cancer death (26.9 per 100,000 women, vs. 19.4 per 100,000 among White women), the study authors explain.

Although the volume of screening began to recover in May 2020 – test volumes for breast and cervical cancer were 39% and 40% below the 5-year average by June 2020 – breast cancer screening in rural areas remained 52% below the 5-year average, they report.

The findings were published online June 30 in Preventive Medicine.

“This study highlights a decline in cancer screening among women of racial and ethnic minority groups with low incomes when their access to medical services decreased at the beginning of the pandemic,” Dr. DeGroff comments in the CDC press release.

The findings “reinforce the need to safely maintain routine health care services during the pandemic, especially when the health care environment meets COVID-19 safety guidelines,” she adds.

The investigators used NBCCEDP administrative and program data reported to the CDC by awardees – organizations that receive funding to implement the NBCCEDP – to assess the impact of COVID-19 on the number of breast and cervical cancer screening tests administered through the program and the effects of COVID-19 on the availability of screening services and NBCCEDP awardees’ capacity to support partner clinics.

A total of 630,264 breast and 594,566 cervical cancer screening tests were conducted during the review period of January-June 2015-2020.

Despite COVID-related challenges, “a large number of awardees reported flexibility and creative efforts to reach women and support clinics’ resumption of clinical care, including screening, during the COVID-19 pandemic,” the authors write.

“[The] CDC encourages health care professionals to help minimize delays in testing by continuing routine cancer screening for women having symptoms or at high risk for breast or cervical cancer,” Dr. DeGroff commented. “The Early Detection Program can help women overcome barriers to health equity by educating them about the importance of routine screening, addressing their concerns about COVID-19 transmission, and helping them to safely access screening through interventions like patient navigation.”

Future studies will examine the effect of the pandemic on screening during the second half of 2020, when surges of COVID-19 and their timing varied geographically, they note.

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

Breast and cervical cancer screenings declined sharply in the early months of the COVID-19 pandemic, particularly among certain racial and ethnic minority groups and rural populations, notes the U.S. Centers for Disease Control and Prevention.

The new data come from the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), a program that provides cancer screening services to women with low income and inadequate health insurance.

The data show that the total number of screenings funded by the NBCCEDP declined by 87% for breast cancer screening and by 84% for cervical cancer screening in April 2020 in comparison with the previous 5-year averages for that month.

The declines in breast cancer screening varied from 84% among Hispanic women to 98% among American Indian/Alaskan Native women. The declines in cervical cancer screening varied from 82% among Black women to 92% among Asian Pacific Islander women.

In April 2020, breast cancer screening declined by 86% in metro areas, 88% in urban areas, and 89% in rural areas in comparison with respective 5-year averages. For cervical cancer screenings, the corresponding declines were 85%, 77%, and 82%.

The findings are consistent with those from studies conducted in insured populations, note the authors, led by the Amy DeGroff, PhD, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion.

“Prolonged delays in screening related to the COVID-19 pandemic may lead to delayed diagnoses, poor health consequences, and an increase in cancer disparities among women already experiencing health inequities,” the CDC states in a press release.

Women from racial and ethnic minority groups already face a disproportionate burden of cervical and breast cancers in the United States: Black women and Hispanic women have the highest rates of cervical cancer incidence (8.3 and 8.9 per 100,000 women, respectively, vs. 7.3 per 100,000 among White women) and the highest rates of cervical cancer deaths. Black women have the highest rate of breast cancer death (26.9 per 100,000 women, vs. 19.4 per 100,000 among White women), the study authors explain.

Although the volume of screening began to recover in May 2020 – test volumes for breast and cervical cancer were 39% and 40% below the 5-year average by June 2020 – breast cancer screening in rural areas remained 52% below the 5-year average, they report.

The findings were published online June 30 in Preventive Medicine.

“This study highlights a decline in cancer screening among women of racial and ethnic minority groups with low incomes when their access to medical services decreased at the beginning of the pandemic,” Dr. DeGroff comments in the CDC press release.

The findings “reinforce the need to safely maintain routine health care services during the pandemic, especially when the health care environment meets COVID-19 safety guidelines,” she adds.

The investigators used NBCCEDP administrative and program data reported to the CDC by awardees – organizations that receive funding to implement the NBCCEDP – to assess the impact of COVID-19 on the number of breast and cervical cancer screening tests administered through the program and the effects of COVID-19 on the availability of screening services and NBCCEDP awardees’ capacity to support partner clinics.

A total of 630,264 breast and 594,566 cervical cancer screening tests were conducted during the review period of January-June 2015-2020.

Despite COVID-related challenges, “a large number of awardees reported flexibility and creative efforts to reach women and support clinics’ resumption of clinical care, including screening, during the COVID-19 pandemic,” the authors write.

“[The] CDC encourages health care professionals to help minimize delays in testing by continuing routine cancer screening for women having symptoms or at high risk for breast or cervical cancer,” Dr. DeGroff commented. “The Early Detection Program can help women overcome barriers to health equity by educating them about the importance of routine screening, addressing their concerns about COVID-19 transmission, and helping them to safely access screening through interventions like patient navigation.”

Future studies will examine the effect of the pandemic on screening during the second half of 2020, when surges of COVID-19 and their timing varied geographically, they note.

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

Breast and cervical cancer screenings declined sharply in the early months of the COVID-19 pandemic, particularly among certain racial and ethnic minority groups and rural populations, notes the U.S. Centers for Disease Control and Prevention.

The new data come from the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), a program that provides cancer screening services to women with low income and inadequate health insurance.

The data show that the total number of screenings funded by the NBCCEDP declined by 87% for breast cancer screening and by 84% for cervical cancer screening in April 2020 in comparison with the previous 5-year averages for that month.

The declines in breast cancer screening varied from 84% among Hispanic women to 98% among American Indian/Alaskan Native women. The declines in cervical cancer screening varied from 82% among Black women to 92% among Asian Pacific Islander women.

In April 2020, breast cancer screening declined by 86% in metro areas, 88% in urban areas, and 89% in rural areas in comparison with respective 5-year averages. For cervical cancer screenings, the corresponding declines were 85%, 77%, and 82%.

The findings are consistent with those from studies conducted in insured populations, note the authors, led by the Amy DeGroff, PhD, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion.

“Prolonged delays in screening related to the COVID-19 pandemic may lead to delayed diagnoses, poor health consequences, and an increase in cancer disparities among women already experiencing health inequities,” the CDC states in a press release.

Women from racial and ethnic minority groups already face a disproportionate burden of cervical and breast cancers in the United States: Black women and Hispanic women have the highest rates of cervical cancer incidence (8.3 and 8.9 per 100,000 women, respectively, vs. 7.3 per 100,000 among White women) and the highest rates of cervical cancer deaths. Black women have the highest rate of breast cancer death (26.9 per 100,000 women, vs. 19.4 per 100,000 among White women), the study authors explain.

Although the volume of screening began to recover in May 2020 – test volumes for breast and cervical cancer were 39% and 40% below the 5-year average by June 2020 – breast cancer screening in rural areas remained 52% below the 5-year average, they report.

The findings were published online June 30 in Preventive Medicine.

“This study highlights a decline in cancer screening among women of racial and ethnic minority groups with low incomes when their access to medical services decreased at the beginning of the pandemic,” Dr. DeGroff comments in the CDC press release.

The findings “reinforce the need to safely maintain routine health care services during the pandemic, especially when the health care environment meets COVID-19 safety guidelines,” she adds.

The investigators used NBCCEDP administrative and program data reported to the CDC by awardees – organizations that receive funding to implement the NBCCEDP – to assess the impact of COVID-19 on the number of breast and cervical cancer screening tests administered through the program and the effects of COVID-19 on the availability of screening services and NBCCEDP awardees’ capacity to support partner clinics.

A total of 630,264 breast and 594,566 cervical cancer screening tests were conducted during the review period of January-June 2015-2020.

Despite COVID-related challenges, “a large number of awardees reported flexibility and creative efforts to reach women and support clinics’ resumption of clinical care, including screening, during the COVID-19 pandemic,” the authors write.

“[The] CDC encourages health care professionals to help minimize delays in testing by continuing routine cancer screening for women having symptoms or at high risk for breast or cervical cancer,” Dr. DeGroff commented. “The Early Detection Program can help women overcome barriers to health equity by educating them about the importance of routine screening, addressing their concerns about COVID-19 transmission, and helping them to safely access screening through interventions like patient navigation.”

Future studies will examine the effect of the pandemic on screening during the second half of 2020, when surges of COVID-19 and their timing varied geographically, they note.

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

Higher serum magnesium levels appear to reduce the risk for intracranial aneurysm and aneurysmal subarachnoid hemorrhage. The effects may be partially mediated by magnesium’s influence on systolic blood pressure, new research suggests.

“The modifiable risk factors for intracranial aneurysm are largely unknown. Our findings provided evidence of a causal association between increased serum magnesium levels and reduced risk of intracranial aneurysm,” said Susanna Larsson, PhD, Karolinska Institutet, Stockholm.

These results suggest that raising serum magnesium levels – through a magnesium-rich diet or magnesium supplementation – “may play a role in the primary prevention of intracranial aneurysm and associated hemorrhage,” Dr. Larsson added.

The study was published online June 22 in Neurology.
 

Lower risk for rupture

The researchers leveraged randomly allocated genetic variants related to serum magnesium concentrations in a two-sample Mendelian randomization (MR) study to assess whether higher genetically predicted serum magnesium correlates with reduced risk for intracranial aneurysm. They also performed a multivariable MR analysis to assess the role blood pressure might play in this association.

Source data came from a genome-wide association study (GWAS) involving 23,829 individuals that previously identified five single-nucleotide polymorphisms associated with serum magnesium. Genetic association estimates for intracranial aneurysm were derived from a GWAS in 79,429 people (7,495 case patients and 71,934 control patients), and genetic association estimates for systolic blood pressure were derived from a GWAS of 757,601 individuals.

The researchers found that higher genetically predicted serum magnesium concentrations were associated with lower risk for intracranial aneurysm.

The odds ratios per 0.1 mmol/L increment in genetically predicted serum magnesium concentrations were 0.66 (95% confidence interval, 0.49-0.91) for intracranial aneurysm (unruptured and ruptured combined), 0.57 (95% CI, 0.30-1.06) for unruptured intracranial aneurysm, and 0.67 (95% CI, 0.48-0.92) for aneurysmal subarachnoid hemorrhage.

Adjustment for genetically predicted systolic blood pressure partially attenuated the associations of genetically predicted serum magnesium with all three outcomes, suggesting that magnesium’s influence was at least partially mediated by systolic blood pressure.

“In addition to a blood pressure lowering effect, increased magnesium concentrations may reduce the risk of intracranial aneurysm rupture by improving endothelial function and reducing oxidative stress,” the investigators noted.

They caution that the data were derived from people of European ancestry, which limits the generalizability to other populations. “Caution should be taken when extrapolating findings from MR to infer the effect of a clinical intervention, and clinical trials are warranted to guide optimal practice,” they added.
 

Critical role in vascular health

In an accompanying editorial, Joanna Pera, MD, PhD, of Jagiellonian University Medical College, Krakow, Poland, and Christopher Anderson, MD, of Brigham and Women’s Hospital, Boston, noted that the study “adds to our understanding of the importance of magnesium in vascular health particularly related to cerebral aneurysms.”

There is a need for “both mechanistic and potentially therapeutic investigation into the role that magnesium plays in subarachnoid hemorrhage,” they added.

Further, they wrote, the results “raise interesting new questions about the links between circulating magnesium, intracranial aneurysms, and blood pressure. Arterial hypertension is a well-recognized risk factor for intracranial aneurysm development and rupture. Magnesium supplementation may lower blood pressure values.

“Could this mineral prove useful in developing interventions that could prevent intracranial aneurysm development and/or rupture over and above a simple lowering of blood pressure, perhaps through pleiotropic effects on endothelial function or other mechanisms? With these results in hand, work is clearly needed to learn more about the biology of magnesium in the vascular system and in intracranial aneurysm biology in particular,” Dr. Pera and Dr. Anderson concluded.

This study was supported by the Swedish Research Council for Health, Working Life and Welfare, the British Heart Foundation Research Center of Excellence at Imperial College London, and the National Institute for Health Research Clinical Lectureship at St. George’s, University of London. Dr. Larsson has disclosed no relevant financial relationships. Study coauthor Dipender Gill, PhD, is employed part time by Novo Nordisk. Dr. Pera has disclosed no relevant financial relationships. Dr. Anderson has received research support from the Bayer AG and has consulted for ApoPharma and Invitae.

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

Higher serum magnesium levels appear to reduce the risk for intracranial aneurysm and aneurysmal subarachnoid hemorrhage. The effects may be partially mediated by magnesium’s influence on systolic blood pressure, new research suggests.

“The modifiable risk factors for intracranial aneurysm are largely unknown. Our findings provided evidence of a causal association between increased serum magnesium levels and reduced risk of intracranial aneurysm,” said Susanna Larsson, PhD, Karolinska Institutet, Stockholm.

These results suggest that raising serum magnesium levels – through a magnesium-rich diet or magnesium supplementation – “may play a role in the primary prevention of intracranial aneurysm and associated hemorrhage,” Dr. Larsson added.

The study was published online June 22 in Neurology.
 

Lower risk for rupture

The researchers leveraged randomly allocated genetic variants related to serum magnesium concentrations in a two-sample Mendelian randomization (MR) study to assess whether higher genetically predicted serum magnesium correlates with reduced risk for intracranial aneurysm. They also performed a multivariable MR analysis to assess the role blood pressure might play in this association.

Source data came from a genome-wide association study (GWAS) involving 23,829 individuals that previously identified five single-nucleotide polymorphisms associated with serum magnesium. Genetic association estimates for intracranial aneurysm were derived from a GWAS in 79,429 people (7,495 case patients and 71,934 control patients), and genetic association estimates for systolic blood pressure were derived from a GWAS of 757,601 individuals.

The researchers found that higher genetically predicted serum magnesium concentrations were associated with lower risk for intracranial aneurysm.

The odds ratios per 0.1 mmol/L increment in genetically predicted serum magnesium concentrations were 0.66 (95% confidence interval, 0.49-0.91) for intracranial aneurysm (unruptured and ruptured combined), 0.57 (95% CI, 0.30-1.06) for unruptured intracranial aneurysm, and 0.67 (95% CI, 0.48-0.92) for aneurysmal subarachnoid hemorrhage.

Adjustment for genetically predicted systolic blood pressure partially attenuated the associations of genetically predicted serum magnesium with all three outcomes, suggesting that magnesium’s influence was at least partially mediated by systolic blood pressure.

“In addition to a blood pressure lowering effect, increased magnesium concentrations may reduce the risk of intracranial aneurysm rupture by improving endothelial function and reducing oxidative stress,” the investigators noted.

They caution that the data were derived from people of European ancestry, which limits the generalizability to other populations. “Caution should be taken when extrapolating findings from MR to infer the effect of a clinical intervention, and clinical trials are warranted to guide optimal practice,” they added.
 

Critical role in vascular health

In an accompanying editorial, Joanna Pera, MD, PhD, of Jagiellonian University Medical College, Krakow, Poland, and Christopher Anderson, MD, of Brigham and Women’s Hospital, Boston, noted that the study “adds to our understanding of the importance of magnesium in vascular health particularly related to cerebral aneurysms.”

There is a need for “both mechanistic and potentially therapeutic investigation into the role that magnesium plays in subarachnoid hemorrhage,” they added.

Further, they wrote, the results “raise interesting new questions about the links between circulating magnesium, intracranial aneurysms, and blood pressure. Arterial hypertension is a well-recognized risk factor for intracranial aneurysm development and rupture. Magnesium supplementation may lower blood pressure values.

“Could this mineral prove useful in developing interventions that could prevent intracranial aneurysm development and/or rupture over and above a simple lowering of blood pressure, perhaps through pleiotropic effects on endothelial function or other mechanisms? With these results in hand, work is clearly needed to learn more about the biology of magnesium in the vascular system and in intracranial aneurysm biology in particular,” Dr. Pera and Dr. Anderson concluded.

This study was supported by the Swedish Research Council for Health, Working Life and Welfare, the British Heart Foundation Research Center of Excellence at Imperial College London, and the National Institute for Health Research Clinical Lectureship at St. George’s, University of London. Dr. Larsson has disclosed no relevant financial relationships. Study coauthor Dipender Gill, PhD, is employed part time by Novo Nordisk. Dr. Pera has disclosed no relevant financial relationships. Dr. Anderson has received research support from the Bayer AG and has consulted for ApoPharma and Invitae.

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

Higher serum magnesium levels appear to reduce the risk for intracranial aneurysm and aneurysmal subarachnoid hemorrhage. The effects may be partially mediated by magnesium’s influence on systolic blood pressure, new research suggests.

“The modifiable risk factors for intracranial aneurysm are largely unknown. Our findings provided evidence of a causal association between increased serum magnesium levels and reduced risk of intracranial aneurysm,” said Susanna Larsson, PhD, Karolinska Institutet, Stockholm.

These results suggest that raising serum magnesium levels – through a magnesium-rich diet or magnesium supplementation – “may play a role in the primary prevention of intracranial aneurysm and associated hemorrhage,” Dr. Larsson added.

The study was published online June 22 in Neurology.
 

Lower risk for rupture

The researchers leveraged randomly allocated genetic variants related to serum magnesium concentrations in a two-sample Mendelian randomization (MR) study to assess whether higher genetically predicted serum magnesium correlates with reduced risk for intracranial aneurysm. They also performed a multivariable MR analysis to assess the role blood pressure might play in this association.

Source data came from a genome-wide association study (GWAS) involving 23,829 individuals that previously identified five single-nucleotide polymorphisms associated with serum magnesium. Genetic association estimates for intracranial aneurysm were derived from a GWAS in 79,429 people (7,495 case patients and 71,934 control patients), and genetic association estimates for systolic blood pressure were derived from a GWAS of 757,601 individuals.

The researchers found that higher genetically predicted serum magnesium concentrations were associated with lower risk for intracranial aneurysm.

The odds ratios per 0.1 mmol/L increment in genetically predicted serum magnesium concentrations were 0.66 (95% confidence interval, 0.49-0.91) for intracranial aneurysm (unruptured and ruptured combined), 0.57 (95% CI, 0.30-1.06) for unruptured intracranial aneurysm, and 0.67 (95% CI, 0.48-0.92) for aneurysmal subarachnoid hemorrhage.

Adjustment for genetically predicted systolic blood pressure partially attenuated the associations of genetically predicted serum magnesium with all three outcomes, suggesting that magnesium’s influence was at least partially mediated by systolic blood pressure.

“In addition to a blood pressure lowering effect, increased magnesium concentrations may reduce the risk of intracranial aneurysm rupture by improving endothelial function and reducing oxidative stress,” the investigators noted.

They caution that the data were derived from people of European ancestry, which limits the generalizability to other populations. “Caution should be taken when extrapolating findings from MR to infer the effect of a clinical intervention, and clinical trials are warranted to guide optimal practice,” they added.
 

Critical role in vascular health

In an accompanying editorial, Joanna Pera, MD, PhD, of Jagiellonian University Medical College, Krakow, Poland, and Christopher Anderson, MD, of Brigham and Women’s Hospital, Boston, noted that the study “adds to our understanding of the importance of magnesium in vascular health particularly related to cerebral aneurysms.”

There is a need for “both mechanistic and potentially therapeutic investigation into the role that magnesium plays in subarachnoid hemorrhage,” they added.

Further, they wrote, the results “raise interesting new questions about the links between circulating magnesium, intracranial aneurysms, and blood pressure. Arterial hypertension is a well-recognized risk factor for intracranial aneurysm development and rupture. Magnesium supplementation may lower blood pressure values.

“Could this mineral prove useful in developing interventions that could prevent intracranial aneurysm development and/or rupture over and above a simple lowering of blood pressure, perhaps through pleiotropic effects on endothelial function or other mechanisms? With these results in hand, work is clearly needed to learn more about the biology of magnesium in the vascular system and in intracranial aneurysm biology in particular,” Dr. Pera and Dr. Anderson concluded.

This study was supported by the Swedish Research Council for Health, Working Life and Welfare, the British Heart Foundation Research Center of Excellence at Imperial College London, and the National Institute for Health Research Clinical Lectureship at St. George’s, University of London. Dr. Larsson has disclosed no relevant financial relationships. Study coauthor Dipender Gill, PhD, is employed part time by Novo Nordisk. Dr. Pera has disclosed no relevant financial relationships. Dr. Anderson has received research support from the Bayer AG and has consulted for ApoPharma and Invitae.

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

Guillain-Barré syndrome, a rare peripheral nerve disorder that can occur after certain types of viral and bacterial infections, has not to date been definitively linked to infection by SARS-CoV-2 or with vaccination against the virus, despite surveillance searching for such associations.

Spikes in Guillain-Barré syndrome incidence have previously, but rarely, been associated with outbreaks of other viral diseases, including Zika, but not with vaccination, except for a 1976-1977 swine influenza vaccine campaign in the United States that was seen associated with a slight elevation in risk, and was halted when that risk became known. Since then, all sorts of vaccines in the European Union and United States have come with warnings about Guillain-Barré syndrome in their package inserts – a fact that some Guillain-Barré syndrome experts lament as perpetuating the notion that vaccines cause Guillain-Barré syndrome.

Epidemiologic studies in the United Kingdom and Singapore did not detect increases in Guillain-Barré syndrome incidence during the COVID-19 pandemic. And as mass vaccination against COVID-19 got underway early this year, experts cautioned against the temptation to attribute incident Guillain-Barré syndrome cases following vaccination to SARS-CoV-2 without careful statistical and epidemiological analysis. Until now reports of Guillain-Barré syndrome have been scant: clinical trials of a viral vector vaccine developed by Johnson & Johnson saw one in the placebo arm and another in the intervention arm, while another case was reported following administration of a Pfizer mRNA SARS-Cov-2 vaccine.
 

Recent case reports

Two reports published this month in the Annals of Neurology – one from India and one from the United Kingdom – describe multiple cases of Guillain-Barré syndrome following a first dose of the ChAdOx1-S/nCoV-19, (Covishield, AstraZeneca) vector vaccine. None of the patients had evidence of current SARS-CoV-2 infection.

From India, Boby V. Maramattom, MD, of Aster Medcity in Kochi, India, and colleagues reported on seven severe cases of Guillain-Barré syndrome occurring between 10 and 14 days after a first dose of the AstraZeneca vaccine. All but one of the patients were women, all had bilateral facial paresis, all progressed to areflexic quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement, which are rare in reports of Guillain-Barré syndrome from India, Dr. Maramattom and colleagues noted.

The authors argued that their findings “should prompt all physicians to be vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine. While the risk per patient (5.8 per million) may be relatively low, our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.”

The U.K. cases, reported by Christopher Martin Allen, MD, and colleagues at Nottingham (England) University Hospitals NHS Trust, describe bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine. This type of facial palsy, the authors wrote, was unusual Guillain-Barré syndrome variant that one rapid review found in 3 of 42 European patients diagnosed with Guillain-Barré syndrome following SARS-CoV-2 infection.

Dr. Allen and colleagues acknowledged that causality could not be assumed from the temporal relationship of immunization to onset of bifacial weakness in their report, but argued that their findings argued for “robust postvaccination surveillance” and that “the report of a similar syndrome in the setting of SARS-CoV-2 infection suggests an immunologic response to the spike protein.” If the link is casual, they wrote, “it could be due to a cross-reactive immune response to the SARS-CoV-2 spike protein and components of the peripheral immune system.”
 

‘The jury is still out’

Asked for comment, neurologist Anthony Amato, MD, of Brigham and Women’s Hospital, Boston, said that he did not see what the two new studies add to what is already known. “Guillain-Barré syndrome has already been reported temporally following COVID-19 along with accompanying editorials that such temporal occurrences do not imply causation and there is a need for surveillance and epidemiological studies.”

Robert Lisak, MD, of Wayne State University, Detroit, and a longtime adviser to the GBS-CIDP Foundation International, commented that “the relationship between vaccines and association with Guillain-Barré syndrome continues to be controversial in part because Guillain-Barré syndrome, a rare disorder, has many reported associated illnesses including infections. Many vaccines have been implicated but with the probable exception of the ‘swine flu’ vaccine in the 1970s, most have not stood up to scrutiny.”

With SARS-Cov-2 infection and vaccines, “the jury is still out,” Dr. Lisak said. “The report from the U.K. is intriguing since they report several cases of an uncommon variant, but the cases from India seem to be more of the usual forms of Guillain-Barré syndrome.”

Dr. Lisak noted that, even if an association turns out to be valid, “we are talking about a very low incidence of Guillain-Barré syndrome associated with COVID-19 vaccines,” one that would not justify avoiding them because of a possible association with Guillain-Barré syndrome.

The GBS-CIDP Foundation, which supports research into Guillain-Barré syndrome and related diseases, has likewise stressed the low risk presented by SARS-CoV-2 vaccines, noting on its website that “the risk of death or long-term complications from COVID in adults still far exceeds the risk of any possible risk of Guillain-Barré syndrome by several orders of magnitude.”

None of the study authors reported financial conflicts of interest related to their research. Dr. Amato is an adviser to the pharmaceutical firms Alexion and Argenx, while Dr. Lisak has received research support or honoraria from Alexion, Novartis, Hoffmann–La Roche, and others.

Guillain-Barré syndrome, a rare peripheral nerve disorder that can occur after certain types of viral and bacterial infections, has not to date been definitively linked to infection by SARS-CoV-2 or with vaccination against the virus, despite surveillance searching for such associations.

Spikes in Guillain-Barré syndrome incidence have previously, but rarely, been associated with outbreaks of other viral diseases, including Zika, but not with vaccination, except for a 1976-1977 swine influenza vaccine campaign in the United States that was seen associated with a slight elevation in risk, and was halted when that risk became known. Since then, all sorts of vaccines in the European Union and United States have come with warnings about Guillain-Barré syndrome in their package inserts – a fact that some Guillain-Barré syndrome experts lament as perpetuating the notion that vaccines cause Guillain-Barré syndrome.

Epidemiologic studies in the United Kingdom and Singapore did not detect increases in Guillain-Barré syndrome incidence during the COVID-19 pandemic. And as mass vaccination against COVID-19 got underway early this year, experts cautioned against the temptation to attribute incident Guillain-Barré syndrome cases following vaccination to SARS-CoV-2 without careful statistical and epidemiological analysis. Until now reports of Guillain-Barré syndrome have been scant: clinical trials of a viral vector vaccine developed by Johnson & Johnson saw one in the placebo arm and another in the intervention arm, while another case was reported following administration of a Pfizer mRNA SARS-Cov-2 vaccine.
 

Recent case reports

Two reports published this month in the Annals of Neurology – one from India and one from the United Kingdom – describe multiple cases of Guillain-Barré syndrome following a first dose of the ChAdOx1-S/nCoV-19, (Covishield, AstraZeneca) vector vaccine. None of the patients had evidence of current SARS-CoV-2 infection.

From India, Boby V. Maramattom, MD, of Aster Medcity in Kochi, India, and colleagues reported on seven severe cases of Guillain-Barré syndrome occurring between 10 and 14 days after a first dose of the AstraZeneca vaccine. All but one of the patients were women, all had bilateral facial paresis, all progressed to areflexic quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement, which are rare in reports of Guillain-Barré syndrome from India, Dr. Maramattom and colleagues noted.

The authors argued that their findings “should prompt all physicians to be vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine. While the risk per patient (5.8 per million) may be relatively low, our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.”

The U.K. cases, reported by Christopher Martin Allen, MD, and colleagues at Nottingham (England) University Hospitals NHS Trust, describe bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine. This type of facial palsy, the authors wrote, was unusual Guillain-Barré syndrome variant that one rapid review found in 3 of 42 European patients diagnosed with Guillain-Barré syndrome following SARS-CoV-2 infection.

Dr. Allen and colleagues acknowledged that causality could not be assumed from the temporal relationship of immunization to onset of bifacial weakness in their report, but argued that their findings argued for “robust postvaccination surveillance” and that “the report of a similar syndrome in the setting of SARS-CoV-2 infection suggests an immunologic response to the spike protein.” If the link is casual, they wrote, “it could be due to a cross-reactive immune response to the SARS-CoV-2 spike protein and components of the peripheral immune system.”
 

‘The jury is still out’

Asked for comment, neurologist Anthony Amato, MD, of Brigham and Women’s Hospital, Boston, said that he did not see what the two new studies add to what is already known. “Guillain-Barré syndrome has already been reported temporally following COVID-19 along with accompanying editorials that such temporal occurrences do not imply causation and there is a need for surveillance and epidemiological studies.”

Robert Lisak, MD, of Wayne State University, Detroit, and a longtime adviser to the GBS-CIDP Foundation International, commented that “the relationship between vaccines and association with Guillain-Barré syndrome continues to be controversial in part because Guillain-Barré syndrome, a rare disorder, has many reported associated illnesses including infections. Many vaccines have been implicated but with the probable exception of the ‘swine flu’ vaccine in the 1970s, most have not stood up to scrutiny.”

With SARS-Cov-2 infection and vaccines, “the jury is still out,” Dr. Lisak said. “The report from the U.K. is intriguing since they report several cases of an uncommon variant, but the cases from India seem to be more of the usual forms of Guillain-Barré syndrome.”

Dr. Lisak noted that, even if an association turns out to be valid, “we are talking about a very low incidence of Guillain-Barré syndrome associated with COVID-19 vaccines,” one that would not justify avoiding them because of a possible association with Guillain-Barré syndrome.

The GBS-CIDP Foundation, which supports research into Guillain-Barré syndrome and related diseases, has likewise stressed the low risk presented by SARS-CoV-2 vaccines, noting on its website that “the risk of death or long-term complications from COVID in adults still far exceeds the risk of any possible risk of Guillain-Barré syndrome by several orders of magnitude.”

None of the study authors reported financial conflicts of interest related to their research. Dr. Amato is an adviser to the pharmaceutical firms Alexion and Argenx, while Dr. Lisak has received research support or honoraria from Alexion, Novartis, Hoffmann–La Roche, and others.

Guillain-Barré syndrome, a rare peripheral nerve disorder that can occur after certain types of viral and bacterial infections, has not to date been definitively linked to infection by SARS-CoV-2 or with vaccination against the virus, despite surveillance searching for such associations.

Spikes in Guillain-Barré syndrome incidence have previously, but rarely, been associated with outbreaks of other viral diseases, including Zika, but not with vaccination, except for a 1976-1977 swine influenza vaccine campaign in the United States that was seen associated with a slight elevation in risk, and was halted when that risk became known. Since then, all sorts of vaccines in the European Union and United States have come with warnings about Guillain-Barré syndrome in their package inserts – a fact that some Guillain-Barré syndrome experts lament as perpetuating the notion that vaccines cause Guillain-Barré syndrome.

Epidemiologic studies in the United Kingdom and Singapore did not detect increases in Guillain-Barré syndrome incidence during the COVID-19 pandemic. And as mass vaccination against COVID-19 got underway early this year, experts cautioned against the temptation to attribute incident Guillain-Barré syndrome cases following vaccination to SARS-CoV-2 without careful statistical and epidemiological analysis. Until now reports of Guillain-Barré syndrome have been scant: clinical trials of a viral vector vaccine developed by Johnson & Johnson saw one in the placebo arm and another in the intervention arm, while another case was reported following administration of a Pfizer mRNA SARS-Cov-2 vaccine.
 

Recent case reports

Two reports published this month in the Annals of Neurology – one from India and one from the United Kingdom – describe multiple cases of Guillain-Barré syndrome following a first dose of the ChAdOx1-S/nCoV-19, (Covishield, AstraZeneca) vector vaccine. None of the patients had evidence of current SARS-CoV-2 infection.

From India, Boby V. Maramattom, MD, of Aster Medcity in Kochi, India, and colleagues reported on seven severe cases of Guillain-Barré syndrome occurring between 10 and 14 days after a first dose of the AstraZeneca vaccine. All but one of the patients were women, all had bilateral facial paresis, all progressed to areflexic quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement, which are rare in reports of Guillain-Barré syndrome from India, Dr. Maramattom and colleagues noted.

The authors argued that their findings “should prompt all physicians to be vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine. While the risk per patient (5.8 per million) may be relatively low, our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.”

The U.K. cases, reported by Christopher Martin Allen, MD, and colleagues at Nottingham (England) University Hospitals NHS Trust, describe bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine. This type of facial palsy, the authors wrote, was unusual Guillain-Barré syndrome variant that one rapid review found in 3 of 42 European patients diagnosed with Guillain-Barré syndrome following SARS-CoV-2 infection.

Dr. Allen and colleagues acknowledged that causality could not be assumed from the temporal relationship of immunization to onset of bifacial weakness in their report, but argued that their findings argued for “robust postvaccination surveillance” and that “the report of a similar syndrome in the setting of SARS-CoV-2 infection suggests an immunologic response to the spike protein.” If the link is casual, they wrote, “it could be due to a cross-reactive immune response to the SARS-CoV-2 spike protein and components of the peripheral immune system.”
 

‘The jury is still out’

Asked for comment, neurologist Anthony Amato, MD, of Brigham and Women’s Hospital, Boston, said that he did not see what the two new studies add to what is already known. “Guillain-Barré syndrome has already been reported temporally following COVID-19 along with accompanying editorials that such temporal occurrences do not imply causation and there is a need for surveillance and epidemiological studies.”

Robert Lisak, MD, of Wayne State University, Detroit, and a longtime adviser to the GBS-CIDP Foundation International, commented that “the relationship between vaccines and association with Guillain-Barré syndrome continues to be controversial in part because Guillain-Barré syndrome, a rare disorder, has many reported associated illnesses including infections. Many vaccines have been implicated but with the probable exception of the ‘swine flu’ vaccine in the 1970s, most have not stood up to scrutiny.”

With SARS-Cov-2 infection and vaccines, “the jury is still out,” Dr. Lisak said. “The report from the U.K. is intriguing since they report several cases of an uncommon variant, but the cases from India seem to be more of the usual forms of Guillain-Barré syndrome.”

Dr. Lisak noted that, even if an association turns out to be valid, “we are talking about a very low incidence of Guillain-Barré syndrome associated with COVID-19 vaccines,” one that would not justify avoiding them because of a possible association with Guillain-Barré syndrome.

The GBS-CIDP Foundation, which supports research into Guillain-Barré syndrome and related diseases, has likewise stressed the low risk presented by SARS-CoV-2 vaccines, noting on its website that “the risk of death or long-term complications from COVID in adults still far exceeds the risk of any possible risk of Guillain-Barré syndrome by several orders of magnitude.”

None of the study authors reported financial conflicts of interest related to their research. Dr. Amato is an adviser to the pharmaceutical firms Alexion and Argenx, while Dr. Lisak has received research support or honoraria from Alexion, Novartis, Hoffmann–La Roche, and others.

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

No link between fertility treatment and an increase in the risk for breast cancer was found in the largest study of the issue to date.

This study “provides the evidence needed to reassure women and couples seeking fertility treatments,” commented senior author Sesh Sunkara, MD, a reproductive medicine specialist at King’s College London in a press release.

With an increasing number of women seeking help to become mothers, the question “is a matter of great importance” and a source of considerable concern among patients, the study authors comment.

This is the largest meta-analysis to date, involving 1.8 million women who were followed for an average of 27 years. The investigators found no link with the use of gonadotropins or clomiphene citrate to increase egg production in fertility cycles.

There has been concern over the years that fertility treatment could stimulate estrogen-sensitive precursor breast cancer cells.

More than 4,000 studies of this issue have been conducted since 1990, and results have been conflicting. The investigators analyzed results from the 20 strongest ones.

The new meta-analysis included nine retrospective studies, five case-control studies, five prospective studies, and one comparative study

The team cautioned that the quality of evidence in even these top 20 studies was “very low” but that such an approach is perhaps the best possible on this issue because a randomized trial among women seeking help to have children would be “ethically challenging.”

In the study, the team compared breast cancer incidence among women who underwent ovarian stimulation with the incidence in both age-matched unexposed women in the general population and unexposed infertile women.

There was no significant increase in the risk for breast cancer among women treated with any ovarian stimulation drug (pooled odds ratio, 1.03; 95% confidence interval, 0.86-1.23, but with substantial heterogeneity between study outcomes).

There was also no increased risk when the analysis was limited to the eight studies in which women were treated with both gonadotropins and clomiphene citrate (pooled OR, 0.92; 95% CI, 0.52-1.60, with substantial heterogeneity).

The authors noted that, among the many study limitations, no distinction was made between physiological dosing for anovulation and supraphysiological dosing for in vitro fertilization cycles. In addition, because the treated women were generally young, the follow-up period fell short of the age at which they’d be most at risk for breast cancer.

Individual patient data were also not available, but 14 studies did adjust for confounders, including weight, race, parity, age at first birth, age at menarche, and family history of breast cancer.

Although the findings are reassuring, “further long-term and detailed studies are now needed to confirm” them, Kotryna Temcinaite, PhD, senior research communications manager at the U.K. charity Breast Cancer Now, said in the press release.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.

The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.

The OlympiA trial results, as reported by this news organization, were presented during the plenary session of the ASCO 2021 annual meeting and were published June 3 in The New England Journal of Medicine.

“These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting,” states an ASCO press release.

The previous 2020 guidelines stated: “There are insufficient data ... to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.

The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] and tumor size greater than 2 cm or any involved axillary nodes. For patients with hormone receptor–positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score greater than or equal to 3.”

“The findings from the OlympiA trial – presented just last week – mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.

“ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible,” she said.

A formal assessment and submission for publication in the Journal of Clinical Oncology will follow the release notes.

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

Key clinical point: A high number of young women with breast cancer receive guideline-concordant care (GCC).

Major finding: GCC was given to 81.7% of the patients. Patients with stage III vs. stage I or II disease (93.4% vs. 88.4%) received GCC more frequently in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive or HR-negative/HER-positive subtypes. In women with HR-negative/HER2-negative or HR-positive/HER2-negative tumors, a higher proportion of patients with stage II vs stage I or III disease received GCC (91.8% vs. 83.7%).

Study details: A retrospective study of 1,295 young women with invasive breast cancer diagnosed in 2013.

Disclosures: This study was supported by the National Cancer Institute. Dr. AW Kurian received research funding from Myriad Genetics and served on the board of directors of a patient advocacy group outside this work. The other authors reported no conflicts of interest.

Source: White DP. Cancer. 2021 Jun 1. doi: 10.1002/cncr.33652.

Key clinical point: A high number of young women with breast cancer receive guideline-concordant care (GCC).

Major finding: GCC was given to 81.7% of the patients. Patients with stage III vs. stage I or II disease (93.4% vs. 88.4%) received GCC more frequently in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive or HR-negative/HER-positive subtypes. In women with HR-negative/HER2-negative or HR-positive/HER2-negative tumors, a higher proportion of patients with stage II vs stage I or III disease received GCC (91.8% vs. 83.7%).

Study details: A retrospective study of 1,295 young women with invasive breast cancer diagnosed in 2013.

Disclosures: This study was supported by the National Cancer Institute. Dr. AW Kurian received research funding from Myriad Genetics and served on the board of directors of a patient advocacy group outside this work. The other authors reported no conflicts of interest.

Source: White DP. Cancer. 2021 Jun 1. doi: 10.1002/cncr.33652.

Key clinical point: A high number of young women with breast cancer receive guideline-concordant care (GCC).

Major finding: GCC was given to 81.7% of the patients. Patients with stage III vs. stage I or II disease (93.4% vs. 88.4%) received GCC more frequently in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive or HR-negative/HER-positive subtypes. In women with HR-negative/HER2-negative or HR-positive/HER2-negative tumors, a higher proportion of patients with stage II vs stage I or III disease received GCC (91.8% vs. 83.7%).

Study details: A retrospective study of 1,295 young women with invasive breast cancer diagnosed in 2013.

Disclosures: This study was supported by the National Cancer Institute. Dr. AW Kurian received research funding from Myriad Genetics and served on the board of directors of a patient advocacy group outside this work. The other authors reported no conflicts of interest.

Source: White DP. Cancer. 2021 Jun 1. doi: 10.1002/cncr.33652.

Key clinical point: High or medium human trophoblast cell-surface antigen-2 (Trop-2) expression is associated with numerically higher survival with sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: The median progression-free survival in the sacituzumab govitecan group was 6.9, 5.6, and 2.7 months in the patients with high, medium, and low Trop-2 H-scores, respectively. The median overall survival with sacituzumab govitecan was 14.2, 14.9, and 9.3 months in patients with high, medium, and low Trop-2 scores, respectively. The germline BRCA1/2 mutation status did not affect the outcomes in the sacituzumab govitecan vs. chemotherapy group.

Study details: A prespecified, exploratory biomarker analysis from the ASCENT trial evaluated the association between tumor Trop-2 expression and germline BRCA1/2 mutation status with clinical outcomes in patients with metastatic TNBC. The patients were randomly assigned to sacituzumab govitecan or chemotherapy.

Disclosures: This study was sponsored by Immunomedics, Inc. The authors received consulting/advisory fees, research funding, travel/accommodations/expenses, speaker fees, nonfinancial support, and/or declared intellectual property rights, patents, and royalties from various companies/organizations. Dr. K Kalinsky reported spouse employment at Array Biopharma. The authors disclosed no other potential conflicts of interest.

Source: Bardia A et al. Ann Oncol. 2021 Jun 8. doi: 10.1016/j.annonc.2021.06.002.

Key clinical point: High or medium human trophoblast cell-surface antigen-2 (Trop-2) expression is associated with numerically higher survival with sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: The median progression-free survival in the sacituzumab govitecan group was 6.9, 5.6, and 2.7 months in the patients with high, medium, and low Trop-2 H-scores, respectively. The median overall survival with sacituzumab govitecan was 14.2, 14.9, and 9.3 months in patients with high, medium, and low Trop-2 scores, respectively. The germline BRCA1/2 mutation status did not affect the outcomes in the sacituzumab govitecan vs. chemotherapy group.

Study details: A prespecified, exploratory biomarker analysis from the ASCENT trial evaluated the association between tumor Trop-2 expression and germline BRCA1/2 mutation status with clinical outcomes in patients with metastatic TNBC. The patients were randomly assigned to sacituzumab govitecan or chemotherapy.

Disclosures: This study was sponsored by Immunomedics, Inc. The authors received consulting/advisory fees, research funding, travel/accommodations/expenses, speaker fees, nonfinancial support, and/or declared intellectual property rights, patents, and royalties from various companies/organizations. Dr. K Kalinsky reported spouse employment at Array Biopharma. The authors disclosed no other potential conflicts of interest.

Source: Bardia A et al. Ann Oncol. 2021 Jun 8. doi: 10.1016/j.annonc.2021.06.002.

Key clinical point: High or medium human trophoblast cell-surface antigen-2 (Trop-2) expression is associated with numerically higher survival with sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: The median progression-free survival in the sacituzumab govitecan group was 6.9, 5.6, and 2.7 months in the patients with high, medium, and low Trop-2 H-scores, respectively. The median overall survival with sacituzumab govitecan was 14.2, 14.9, and 9.3 months in patients with high, medium, and low Trop-2 scores, respectively. The germline BRCA1/2 mutation status did not affect the outcomes in the sacituzumab govitecan vs. chemotherapy group.

Study details: A prespecified, exploratory biomarker analysis from the ASCENT trial evaluated the association between tumor Trop-2 expression and germline BRCA1/2 mutation status with clinical outcomes in patients with metastatic TNBC. The patients were randomly assigned to sacituzumab govitecan or chemotherapy.

Disclosures: This study was sponsored by Immunomedics, Inc. The authors received consulting/advisory fees, research funding, travel/accommodations/expenses, speaker fees, nonfinancial support, and/or declared intellectual property rights, patents, and royalties from various companies/organizations. Dr. K Kalinsky reported spouse employment at Array Biopharma. The authors disclosed no other potential conflicts of interest.

Source: Bardia A et al. Ann Oncol. 2021 Jun 8. doi: 10.1016/j.annonc.2021.06.002.

Key clinical point: Olaparib monotherapy is effective in germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in a real-world setting.

Major finding: The median progression-free survival was 8.11 months, and the clinical response rate was 48.6%. The grade 3 or higher treatment-related adverse event rate was 25.4%. There were no new safety signals.

Study details: An interim analysis of an open-label, single-arm, phase 3b LUCY trial including 252 previously treated patients with HER2-negative metastatic breast cancer with a germline BRCA mutation who received olaparib.

Disclosures: The study was funded by AstraZeneca. Dr. S McCutcheon was an employee and stockholder of AstraZeneca LP. Dr. J Bennett and Dr. G Walker were contractors for AstraZeneca LP. The authors received consulting/speaker fees or research support from various sources.

Source: Gelmon KA et al. Eur J Cancer. 2021 Jun 1. doi: 10.1016/j.ejca.2021.03.029.

Key clinical point: Olaparib monotherapy is effective in germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in a real-world setting.

Major finding: The median progression-free survival was 8.11 months, and the clinical response rate was 48.6%. The grade 3 or higher treatment-related adverse event rate was 25.4%. There were no new safety signals.

Study details: An interim analysis of an open-label, single-arm, phase 3b LUCY trial including 252 previously treated patients with HER2-negative metastatic breast cancer with a germline BRCA mutation who received olaparib.

Disclosures: The study was funded by AstraZeneca. Dr. S McCutcheon was an employee and stockholder of AstraZeneca LP. Dr. J Bennett and Dr. G Walker were contractors for AstraZeneca LP. The authors received consulting/speaker fees or research support from various sources.

Source: Gelmon KA et al. Eur J Cancer. 2021 Jun 1. doi: 10.1016/j.ejca.2021.03.029.

Key clinical point: Olaparib monotherapy is effective in germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in a real-world setting.

Major finding: The median progression-free survival was 8.11 months, and the clinical response rate was 48.6%. The grade 3 or higher treatment-related adverse event rate was 25.4%. There were no new safety signals.

Study details: An interim analysis of an open-label, single-arm, phase 3b LUCY trial including 252 previously treated patients with HER2-negative metastatic breast cancer with a germline BRCA mutation who received olaparib.

Disclosures: The study was funded by AstraZeneca. Dr. S McCutcheon was an employee and stockholder of AstraZeneca LP. Dr. J Bennett and Dr. G Walker were contractors for AstraZeneca LP. The authors received consulting/speaker fees or research support from various sources.

Source: Gelmon KA et al. Eur J Cancer. 2021 Jun 1. doi: 10.1016/j.ejca.2021.03.029.

Key clinical point: The Internet–based-targeted psychological interventions fail to reduce fear of recurrence among early breast cancer survivors.

Major finding: The Fear of Cancer Recurrence Inventory (FCRI) scores significantly decreased at 8 weeks from baseline in all groups (P less than .001). The magnitude of reduction in FCRI scores was similar in cognitive-behavioral interventions and attention controls.

Study details: The randomized controlled FoRtitude study of breast cancer survivors who completed primary treatment. The survivors were randomly assigned to 4 Internet-based interventions or controls. The 4 interventions given for 4 weeks consisted of 3 cognitive behavioral interventions (relaxation, cognitive restructuring, and worry practice vs. attention controls) and telecoaching (motivational interviewing to improve adherence vs. no telecoaching).

Disclosures: This work was supported by the National Cancer Institute at the National Institutes of Health and the ECOG-ACRIN Medical Research Foundation. The authors did not disclose any conflict of interest.

Source: Wagner LI. J Natl Cancer Inst. 2021 May 31. doi: 10.1093/jnci/djab100.

Key clinical point: The Internet–based-targeted psychological interventions fail to reduce fear of recurrence among early breast cancer survivors.

Major finding: The Fear of Cancer Recurrence Inventory (FCRI) scores significantly decreased at 8 weeks from baseline in all groups (P less than .001). The magnitude of reduction in FCRI scores was similar in cognitive-behavioral interventions and attention controls.

Study details: The randomized controlled FoRtitude study of breast cancer survivors who completed primary treatment. The survivors were randomly assigned to 4 Internet-based interventions or controls. The 4 interventions given for 4 weeks consisted of 3 cognitive behavioral interventions (relaxation, cognitive restructuring, and worry practice vs. attention controls) and telecoaching (motivational interviewing to improve adherence vs. no telecoaching).

Disclosures: This work was supported by the National Cancer Institute at the National Institutes of Health and the ECOG-ACRIN Medical Research Foundation. The authors did not disclose any conflict of interest.

Source: Wagner LI. J Natl Cancer Inst. 2021 May 31. doi: 10.1093/jnci/djab100.

Key clinical point: The Internet–based-targeted psychological interventions fail to reduce fear of recurrence among early breast cancer survivors.

Major finding: The Fear of Cancer Recurrence Inventory (FCRI) scores significantly decreased at 8 weeks from baseline in all groups (P less than .001). The magnitude of reduction in FCRI scores was similar in cognitive-behavioral interventions and attention controls.

Study details: The randomized controlled FoRtitude study of breast cancer survivors who completed primary treatment. The survivors were randomly assigned to 4 Internet-based interventions or controls. The 4 interventions given for 4 weeks consisted of 3 cognitive behavioral interventions (relaxation, cognitive restructuring, and worry practice vs. attention controls) and telecoaching (motivational interviewing to improve adherence vs. no telecoaching).

Disclosures: This work was supported by the National Cancer Institute at the National Institutes of Health and the ECOG-ACRIN Medical Research Foundation. The authors did not disclose any conflict of interest.

Source: Wagner LI. J Natl Cancer Inst. 2021 May 31. doi: 10.1093/jnci/djab100.

Key clinical point: The survival among patients with metastatic breast cancer has improved over past 3 decades.

Major finding: During 1988-2015, 1-year overall survival (OS) rate increased from 62.3% to 72.4% and 1-year cancer-specific survival (CSS) rate increased from 64.7% to 74.1%. Similarly, 5-year OS rate increased from 19.4% to 24.3% and 5-year CSS rate increased from 23.4% to 28.0% during 1998-2011.

Study details: A retrospective cohort study of 47,034 patients with de novo metastatic breast cancer in the Surveillance, Epidemiology, and End Results database from 1988 to 2016.

Disclosures: This study is in part supported by Duke Cancer Institute. Dr. OM Fayanju is supported by the National Institutes of Health. Some of the authors received research funding and consulting/advisory fees from various sources. Dr. JK Plichta and Dr. ES Hwang have served on various Cancer Committees. The other authors reported no competing interests.

Source: Taskindoust M. Ann Surg Oncol. 2021 May 28. doi: 10.1245/s10434-021-10227-3.

Key clinical point: The survival among patients with metastatic breast cancer has improved over past 3 decades.

Major finding: During 1988-2015, 1-year overall survival (OS) rate increased from 62.3% to 72.4% and 1-year cancer-specific survival (CSS) rate increased from 64.7% to 74.1%. Similarly, 5-year OS rate increased from 19.4% to 24.3% and 5-year CSS rate increased from 23.4% to 28.0% during 1998-2011.

Study details: A retrospective cohort study of 47,034 patients with de novo metastatic breast cancer in the Surveillance, Epidemiology, and End Results database from 1988 to 2016.

Disclosures: This study is in part supported by Duke Cancer Institute. Dr. OM Fayanju is supported by the National Institutes of Health. Some of the authors received research funding and consulting/advisory fees from various sources. Dr. JK Plichta and Dr. ES Hwang have served on various Cancer Committees. The other authors reported no competing interests.

Source: Taskindoust M. Ann Surg Oncol. 2021 May 28. doi: 10.1245/s10434-021-10227-3.

Key clinical point: The survival among patients with metastatic breast cancer has improved over past 3 decades.

Major finding: During 1988-2015, 1-year overall survival (OS) rate increased from 62.3% to 72.4% and 1-year cancer-specific survival (CSS) rate increased from 64.7% to 74.1%. Similarly, 5-year OS rate increased from 19.4% to 24.3% and 5-year CSS rate increased from 23.4% to 28.0% during 1998-2011.

Study details: A retrospective cohort study of 47,034 patients with de novo metastatic breast cancer in the Surveillance, Epidemiology, and End Results database from 1988 to 2016.

Disclosures: This study is in part supported by Duke Cancer Institute. Dr. OM Fayanju is supported by the National Institutes of Health. Some of the authors received research funding and consulting/advisory fees from various sources. Dr. JK Plichta and Dr. ES Hwang have served on various Cancer Committees. The other authors reported no competing interests.

Source: Taskindoust M. Ann Surg Oncol. 2021 May 28. doi: 10.1245/s10434-021-10227-3.