Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The Food and Drug Administration has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A.

The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery (perioperative management).

The manufacturer, Sanofi, says that this is “the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.”

With this product, “we have the opportunity to provide near-normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A,” said Angela Weyand, MD, of Michigan Medicine, who was involved in the pivotal phase 3 XTEND-1 trial that led to approval.

Results from the XTEND-1 trial were recently published online in The New England Journal of Medicine. The results show that one injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week, as previously reported by this news organization.

The researchers noted that the factor VIII therapies that have been available up to now need to be administered frequently.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” wrote Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University in New Orleans.

Sanofi said that Altuviiio is expected to be commercially available in April 2023. The company said that it will price the product at parity to the annual cost of treating a prophylaxis patient with its Eloctate product (antihemophilic factor [recombinant], Fc fusion protein). Sanofi will provide comprehensive patient support services and resources online and at 1-855-MyALTUVIIIO (855-692-5888).

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

The Food and Drug Administration has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A.

The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery (perioperative management).

The manufacturer, Sanofi, says that this is “the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.”

With this product, “we have the opportunity to provide near-normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A,” said Angela Weyand, MD, of Michigan Medicine, who was involved in the pivotal phase 3 XTEND-1 trial that led to approval.

Results from the XTEND-1 trial were recently published online in The New England Journal of Medicine. The results show that one injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week, as previously reported by this news organization.

The researchers noted that the factor VIII therapies that have been available up to now need to be administered frequently.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” wrote Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University in New Orleans.

Sanofi said that Altuviiio is expected to be commercially available in April 2023. The company said that it will price the product at parity to the annual cost of treating a prophylaxis patient with its Eloctate product (antihemophilic factor [recombinant], Fc fusion protein). Sanofi will provide comprehensive patient support services and resources online and at 1-855-MyALTUVIIIO (855-692-5888).

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

The Food and Drug Administration has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A.

The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery (perioperative management).

The manufacturer, Sanofi, says that this is “the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.”

With this product, “we have the opportunity to provide near-normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A,” said Angela Weyand, MD, of Michigan Medicine, who was involved in the pivotal phase 3 XTEND-1 trial that led to approval.

Results from the XTEND-1 trial were recently published online in The New England Journal of Medicine. The results show that one injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week, as previously reported by this news organization.

The researchers noted that the factor VIII therapies that have been available up to now need to be administered frequently.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” wrote Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University in New Orleans.

Sanofi said that Altuviiio is expected to be commercially available in April 2023. The company said that it will price the product at parity to the annual cost of treating a prophylaxis patient with its Eloctate product (antihemophilic factor [recombinant], Fc fusion protein). Sanofi will provide comprehensive patient support services and resources online and at 1-855-MyALTUVIIIO (855-692-5888).

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

Key clinical point: Magnetic resonance imaging (MRI) proved to be the best supplemental breast cancer (BC) screening modality in women with dense breasts and who had a negative mammogram who were at an average or intermediate risk for the disease.

Major finding: Among the screened patients with dense breasts and a negative mammogram, 541 cases of BC were detected using supplemental modalities. The incremental cancer detection rate was highest with MRI (1.54 per 1,000 screenings) compared with other supplemental modalities (P < .001).

Study details: Findings are from a meta-analysis of 22 randomized clinical trials and prospective observational studies including 261,233 patients, of which 120,081 patients had dense breasts and a negative mammogram.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Hussein H et al. Supplemental breast cancer screening in women with dense breasts and negative mammography: A systematic review and meta-analysis. Radiology. 2023;221785 (Jan 31). Doi: 10.1148/radiol.221785

Key clinical point: Magnetic resonance imaging (MRI) proved to be the best supplemental breast cancer (BC) screening modality in women with dense breasts and who had a negative mammogram who were at an average or intermediate risk for the disease.

Major finding: Among the screened patients with dense breasts and a negative mammogram, 541 cases of BC were detected using supplemental modalities. The incremental cancer detection rate was highest with MRI (1.54 per 1,000 screenings) compared with other supplemental modalities (P < .001).

Study details: Findings are from a meta-analysis of 22 randomized clinical trials and prospective observational studies including 261,233 patients, of which 120,081 patients had dense breasts and a negative mammogram.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Hussein H et al. Supplemental breast cancer screening in women with dense breasts and negative mammography: A systematic review and meta-analysis. Radiology. 2023;221785 (Jan 31). Doi: 10.1148/radiol.221785

Key clinical point: Magnetic resonance imaging (MRI) proved to be the best supplemental breast cancer (BC) screening modality in women with dense breasts and who had a negative mammogram who were at an average or intermediate risk for the disease.

Major finding: Among the screened patients with dense breasts and a negative mammogram, 541 cases of BC were detected using supplemental modalities. The incremental cancer detection rate was highest with MRI (1.54 per 1,000 screenings) compared with other supplemental modalities (P < .001).

Study details: Findings are from a meta-analysis of 22 randomized clinical trials and prospective observational studies including 261,233 patients, of which 120,081 patients had dense breasts and a negative mammogram.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Hussein H et al. Supplemental breast cancer screening in women with dense breasts and negative mammography: A systematic review and meta-analysis. Radiology. 2023;221785 (Jan 31). Doi: 10.1148/radiol.221785

Key clinical point: Duration of endocrine therapy (ET) is an important risk factor for cognitive function impairment in patients with breast cancer (BC).

Major finding: Duration of ET was a significant risk factor for overall cognitive decline (odds ratio 1.296; 95% CI 1.008-1.665), with the prolongation of ET further increasing the risk for cognitive decline (linear-by-linear association test statistic 5.872; P < .05).

Study details: Findings are from a prospective, interventional single-center study including 127 women with BC, of which 49 patients were classified into the cognitive decline group.

Disclosures: This study was supported by Shanghai Science and Technology Innovation Action Plan and other sources. The authors declared no conflicts of interest.

Source: Yin Y et al. Association between endocrine therapy and cognitive decline in breast cancer based on propensity score matching. Front Med. 2023;10:1132287 (Jan 26). Doi: 10.3389/fmed.2023.1132287

Key clinical point: Duration of endocrine therapy (ET) is an important risk factor for cognitive function impairment in patients with breast cancer (BC).

Major finding: Duration of ET was a significant risk factor for overall cognitive decline (odds ratio 1.296; 95% CI 1.008-1.665), with the prolongation of ET further increasing the risk for cognitive decline (linear-by-linear association test statistic 5.872; P < .05).

Study details: Findings are from a prospective, interventional single-center study including 127 women with BC, of which 49 patients were classified into the cognitive decline group.

Disclosures: This study was supported by Shanghai Science and Technology Innovation Action Plan and other sources. The authors declared no conflicts of interest.

Source: Yin Y et al. Association between endocrine therapy and cognitive decline in breast cancer based on propensity score matching. Front Med. 2023;10:1132287 (Jan 26). Doi: 10.3389/fmed.2023.1132287

Key clinical point: Duration of endocrine therapy (ET) is an important risk factor for cognitive function impairment in patients with breast cancer (BC).

Major finding: Duration of ET was a significant risk factor for overall cognitive decline (odds ratio 1.296; 95% CI 1.008-1.665), with the prolongation of ET further increasing the risk for cognitive decline (linear-by-linear association test statistic 5.872; P < .05).

Study details: Findings are from a prospective, interventional single-center study including 127 women with BC, of which 49 patients were classified into the cognitive decline group.

Disclosures: This study was supported by Shanghai Science and Technology Innovation Action Plan and other sources. The authors declared no conflicts of interest.

Source: Yin Y et al. Association between endocrine therapy and cognitive decline in breast cancer based on propensity score matching. Front Med. 2023;10:1132287 (Jan 26). Doi: 10.3389/fmed.2023.1132287

Key clinical point: Low expression of human epidermal growth factor receptor 2 (HER2) protein was associated with improved survival outcomes in patients with early breast cancer (BC).

Major finding: HER2-low expression vs HER2-zero BC was associated with a significant overall survival benefit in the entire population (hazard ratio [HR] 0.83; 95% CI 0.78-0.88) and in the subpopulations of patients with hormone receptor-positive BC (HR 0.83; 95% CI 0.77-0.89) and triple-negative BC (HR 0.78; 95% CI 0.70-0.87).

Study details: Findings are from a meta-analysis of 14 studies including 52,106 patients with early BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Wei T et al. Clinicopathologic characteristics and prognostic significance of HER2-low expression in patients with early breast cancer: A systematic review and meta-analysis. Front Oncol. 2023;13:1100332 (Feb 2). Doi: 10.3389/fonc.2023.1100332

Key clinical point: Low expression of human epidermal growth factor receptor 2 (HER2) protein was associated with improved survival outcomes in patients with early breast cancer (BC).

Major finding: HER2-low expression vs HER2-zero BC was associated with a significant overall survival benefit in the entire population (hazard ratio [HR] 0.83; 95% CI 0.78-0.88) and in the subpopulations of patients with hormone receptor-positive BC (HR 0.83; 95% CI 0.77-0.89) and triple-negative BC (HR 0.78; 95% CI 0.70-0.87).

Study details: Findings are from a meta-analysis of 14 studies including 52,106 patients with early BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Wei T et al. Clinicopathologic characteristics and prognostic significance of HER2-low expression in patients with early breast cancer: A systematic review and meta-analysis. Front Oncol. 2023;13:1100332 (Feb 2). Doi: 10.3389/fonc.2023.1100332

Key clinical point: Low expression of human epidermal growth factor receptor 2 (HER2) protein was associated with improved survival outcomes in patients with early breast cancer (BC).

Major finding: HER2-low expression vs HER2-zero BC was associated with a significant overall survival benefit in the entire population (hazard ratio [HR] 0.83; 95% CI 0.78-0.88) and in the subpopulations of patients with hormone receptor-positive BC (HR 0.83; 95% CI 0.77-0.89) and triple-negative BC (HR 0.78; 95% CI 0.70-0.87).

Study details: Findings are from a meta-analysis of 14 studies including 52,106 patients with early BC.

Disclosures: This study was funded by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Wei T et al. Clinicopathologic characteristics and prognostic significance of HER2-low expression in patients with early breast cancer: A systematic review and meta-analysis. Front Oncol. 2023;13:1100332 (Feb 2). Doi: 10.3389/fonc.2023.1100332

Key clinical point: According to the PERTAIN trial’s final analysis, the progression-free survival (PFS) benefit associated with the addition of pertuzumab to trastuzumab+aromatase inhibitor (AI) persisted even after >6 years of follow-up in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) metastatic breast cancer (BC).

Major finding: After a median follow-up of >70 months, a >2-year PFS benefit was observed in the pertuzumab+trastuzumab+AI vs trastuzumab+AI treatment group (20.6 vs 15.8 months; stratified hazard ratio 0.67; P = .006). No new safety signals were identified.

Study details: Findings are from the phase 2 PERTAIN study including 258 postmenopausal patients with previously untreated HER2+/HR+ metastatic or locally advanced BC who were randomly assigned to receive pertuzumab+trastuzumab+AI or trastuzumab+AI.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. Some authors declared serving as advisors or on speaker’s bureau for or receiving research grants, travel, or accommodation expenses from several sources. Four authors declared being employees of or owning stocks in F. Hoffmann-La Roche.

Source: Arpino G et al. Pertuzumab, trastuzumab, and an aromatase inhibitor for HER2-positive and hormone receptor-positive metastatic/locally advanced breast cancer: PERTAIN final analysis. Clin Cancer Res. 2023 (Jan 30). Doi: 10.1158/1078-0432.CCR-22-1092

Key clinical point: According to the PERTAIN trial’s final analysis, the progression-free survival (PFS) benefit associated with the addition of pertuzumab to trastuzumab+aromatase inhibitor (AI) persisted even after >6 years of follow-up in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) metastatic breast cancer (BC).

Major finding: After a median follow-up of >70 months, a >2-year PFS benefit was observed in the pertuzumab+trastuzumab+AI vs trastuzumab+AI treatment group (20.6 vs 15.8 months; stratified hazard ratio 0.67; P = .006). No new safety signals were identified.

Study details: Findings are from the phase 2 PERTAIN study including 258 postmenopausal patients with previously untreated HER2+/HR+ metastatic or locally advanced BC who were randomly assigned to receive pertuzumab+trastuzumab+AI or trastuzumab+AI.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. Some authors declared serving as advisors or on speaker’s bureau for or receiving research grants, travel, or accommodation expenses from several sources. Four authors declared being employees of or owning stocks in F. Hoffmann-La Roche.

Source: Arpino G et al. Pertuzumab, trastuzumab, and an aromatase inhibitor for HER2-positive and hormone receptor-positive metastatic/locally advanced breast cancer: PERTAIN final analysis. Clin Cancer Res. 2023 (Jan 30). Doi: 10.1158/1078-0432.CCR-22-1092

Key clinical point: According to the PERTAIN trial’s final analysis, the progression-free survival (PFS) benefit associated with the addition of pertuzumab to trastuzumab+aromatase inhibitor (AI) persisted even after >6 years of follow-up in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) metastatic breast cancer (BC).

Major finding: After a median follow-up of >70 months, a >2-year PFS benefit was observed in the pertuzumab+trastuzumab+AI vs trastuzumab+AI treatment group (20.6 vs 15.8 months; stratified hazard ratio 0.67; P = .006). No new safety signals were identified.

Study details: Findings are from the phase 2 PERTAIN study including 258 postmenopausal patients with previously untreated HER2+/HR+ metastatic or locally advanced BC who were randomly assigned to receive pertuzumab+trastuzumab+AI or trastuzumab+AI.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. Some authors declared serving as advisors or on speaker’s bureau for or receiving research grants, travel, or accommodation expenses from several sources. Four authors declared being employees of or owning stocks in F. Hoffmann-La Roche.

Source: Arpino G et al. Pertuzumab, trastuzumab, and an aromatase inhibitor for HER2-positive and hormone receptor-positive metastatic/locally advanced breast cancer: PERTAIN final analysis. Clin Cancer Res. 2023 (Jan 30). Doi: 10.1158/1078-0432.CCR-22-1092

Key clinical point: Survival outcomes in human epidermal growth factor receptor 2-positive (HER2+) invasive lobular carcinoma (ILC), a rare and poorly characterized subtype of breast cancer (BC), were similar to those in HER2+ invasive ductal carcinoma (IDC) or HER2-negative (HER2−) ILC and did not improve with anti-HER2 treatment.

Major finding: Compared with patients with HER2+ ILC, patients with HER2+ IDC and HER2− ILC had similar overall survival (OS; P = .6 and P = .29, respectively) and disease-free survival (DFS; P = .69 and P = .18, respectively) outcomes. Anti-HER2 therapy did not improve OS or DFS in patients with HER2+/HER2−ILC (both P = .2), although it improved survival outcomes in patients with HER2+ IDC (P < .001).

Study details: Findings are from a population-based study including 833 patients with HER2+ IDC, 62 patients with HER2+ ILC, and 685 patients with HER2− ILC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Kada Mohammed S et al. HER2-positive invasive lobular carcinoma: A rare breast cancer which may not necessarily require anti-HER2 therapy. A population-based study. Breast Cancer. 2023 (Jan 30). Doi: 10.1007/s12282-022-01432-3

Key clinical point: Survival outcomes in human epidermal growth factor receptor 2-positive (HER2+) invasive lobular carcinoma (ILC), a rare and poorly characterized subtype of breast cancer (BC), were similar to those in HER2+ invasive ductal carcinoma (IDC) or HER2-negative (HER2−) ILC and did not improve with anti-HER2 treatment.

Major finding: Compared with patients with HER2+ ILC, patients with HER2+ IDC and HER2− ILC had similar overall survival (OS; P = .6 and P = .29, respectively) and disease-free survival (DFS; P = .69 and P = .18, respectively) outcomes. Anti-HER2 therapy did not improve OS or DFS in patients with HER2+/HER2−ILC (both P = .2), although it improved survival outcomes in patients with HER2+ IDC (P < .001).

Study details: Findings are from a population-based study including 833 patients with HER2+ IDC, 62 patients with HER2+ ILC, and 685 patients with HER2− ILC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Kada Mohammed S et al. HER2-positive invasive lobular carcinoma: A rare breast cancer which may not necessarily require anti-HER2 therapy. A population-based study. Breast Cancer. 2023 (Jan 30). Doi: 10.1007/s12282-022-01432-3

Key clinical point: Survival outcomes in human epidermal growth factor receptor 2-positive (HER2+) invasive lobular carcinoma (ILC), a rare and poorly characterized subtype of breast cancer (BC), were similar to those in HER2+ invasive ductal carcinoma (IDC) or HER2-negative (HER2−) ILC and did not improve with anti-HER2 treatment.

Major finding: Compared with patients with HER2+ ILC, patients with HER2+ IDC and HER2− ILC had similar overall survival (OS; P = .6 and P = .29, respectively) and disease-free survival (DFS; P = .69 and P = .18, respectively) outcomes. Anti-HER2 therapy did not improve OS or DFS in patients with HER2+/HER2−ILC (both P = .2), although it improved survival outcomes in patients with HER2+ IDC (P < .001).

Study details: Findings are from a population-based study including 833 patients with HER2+ IDC, 62 patients with HER2+ ILC, and 685 patients with HER2− ILC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Kada Mohammed S et al. HER2-positive invasive lobular carcinoma: A rare breast cancer which may not necessarily require anti-HER2 therapy. A population-based study. Breast Cancer. 2023 (Jan 30). Doi: 10.1007/s12282-022-01432-3

Key clinical point: Trastuzumab emtansine (T-DM1) led to superior survival outcomes compared with lapatinib plus capecitabine (LC) in patients with breast cancer brain metastases (BCBM).

Major finding: After a median follow-up of 30.7 months, overall survival was significantly improved with T-DM1 vs LC (hazard ratio 0.55; P = .013), with significant improvements observed in other endpoints, such as time to next relevant treatment or death (P = .005) and real-world progression-free survival (P < .001).

Study details: Findings are from a real-world study including 214 patients with HER2+ BCBM who initiated treatment with T-DM1 (n = 161) or LC (n = 53).

Disclosures: This study was funded by F. Hoffmann-La Roche. Three authors declared being employees of and owning stocks in Roche. The other authors declared receiving honoraria, consulting, or advisory fees from, being employees of, or owning stocks in other sources.

Source: Sanglier T et al. Trastuzumab emtansine vs lapatinib and capecitabine in HER2-positive metastatic breast cancer brain metastases: A real-world study. Breast. 2023 (Jan 15). Doi: 10.1016/j.breast.2023.01.007

Key clinical point: Trastuzumab emtansine (T-DM1) led to superior survival outcomes compared with lapatinib plus capecitabine (LC) in patients with breast cancer brain metastases (BCBM).

Major finding: After a median follow-up of 30.7 months, overall survival was significantly improved with T-DM1 vs LC (hazard ratio 0.55; P = .013), with significant improvements observed in other endpoints, such as time to next relevant treatment or death (P = .005) and real-world progression-free survival (P < .001).

Study details: Findings are from a real-world study including 214 patients with HER2+ BCBM who initiated treatment with T-DM1 (n = 161) or LC (n = 53).

Disclosures: This study was funded by F. Hoffmann-La Roche. Three authors declared being employees of and owning stocks in Roche. The other authors declared receiving honoraria, consulting, or advisory fees from, being employees of, or owning stocks in other sources.

Source: Sanglier T et al. Trastuzumab emtansine vs lapatinib and capecitabine in HER2-positive metastatic breast cancer brain metastases: A real-world study. Breast. 2023 (Jan 15). Doi: 10.1016/j.breast.2023.01.007

Key clinical point: Trastuzumab emtansine (T-DM1) led to superior survival outcomes compared with lapatinib plus capecitabine (LC) in patients with breast cancer brain metastases (BCBM).

Major finding: After a median follow-up of 30.7 months, overall survival was significantly improved with T-DM1 vs LC (hazard ratio 0.55; P = .013), with significant improvements observed in other endpoints, such as time to next relevant treatment or death (P = .005) and real-world progression-free survival (P < .001).

Study details: Findings are from a real-world study including 214 patients with HER2+ BCBM who initiated treatment with T-DM1 (n = 161) or LC (n = 53).

Disclosures: This study was funded by F. Hoffmann-La Roche. Three authors declared being employees of and owning stocks in Roche. The other authors declared receiving honoraria, consulting, or advisory fees from, being employees of, or owning stocks in other sources.

Source: Sanglier T et al. Trastuzumab emtansine vs lapatinib and capecitabine in HER2-positive metastatic breast cancer brain metastases: A real-world study. Breast. 2023 (Jan 15). Doi: 10.1016/j.breast.2023.01.007

Key clinical point: Neoadjuvant treatment with trastuzumab improved the rate of pathological complete response (pCR) achievement and thereby survival outcomes in patients with lymph node-positive, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: Trastuzumab therapy significantly improved the odds of achieving pCR (adjusted odds ratio 4.87; 95% CI 3.34-7.10) in patients with HER2+ early BC, with overall survival outcomes being better with vs without trastuzumab treatment in patients who achieved pCR (adjusted hazard ratio 0.30; 95% CI 0.11-0.84).

Study details: Findings are from a real-world study including 1178 patients with HER2+ early BC and 354 patients with early triple-negative BC who received trastuzumab-based and platinum-based neoadjuvant treatments, respectively.

Disclosures: This study was supported by the Ministry of Science and Technology in Taiwan and Roche Products Ltd. Three authors declared being employees of Roche Products Ltd.

Source: Chung WP et al. Real-life analysis of neoadjuvant-therapy-associated benefits for pathological complete response and survival in early breast cancer patients - role of trastuzumab in HER2+ BC and platinum in TNBC. Front Oncol. 2023;12:1022994 (Jan 24). Doi: 10.3389/fonc.2022.1022994

Key clinical point: Neoadjuvant treatment with trastuzumab improved the rate of pathological complete response (pCR) achievement and thereby survival outcomes in patients with lymph node-positive, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: Trastuzumab therapy significantly improved the odds of achieving pCR (adjusted odds ratio 4.87; 95% CI 3.34-7.10) in patients with HER2+ early BC, with overall survival outcomes being better with vs without trastuzumab treatment in patients who achieved pCR (adjusted hazard ratio 0.30; 95% CI 0.11-0.84).

Study details: Findings are from a real-world study including 1178 patients with HER2+ early BC and 354 patients with early triple-negative BC who received trastuzumab-based and platinum-based neoadjuvant treatments, respectively.

Disclosures: This study was supported by the Ministry of Science and Technology in Taiwan and Roche Products Ltd. Three authors declared being employees of Roche Products Ltd.

Source: Chung WP et al. Real-life analysis of neoadjuvant-therapy-associated benefits for pathological complete response and survival in early breast cancer patients - role of trastuzumab in HER2+ BC and platinum in TNBC. Front Oncol. 2023;12:1022994 (Jan 24). Doi: 10.3389/fonc.2022.1022994

Key clinical point: Neoadjuvant treatment with trastuzumab improved the rate of pathological complete response (pCR) achievement and thereby survival outcomes in patients with lymph node-positive, human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC).

Major finding: Trastuzumab therapy significantly improved the odds of achieving pCR (adjusted odds ratio 4.87; 95% CI 3.34-7.10) in patients with HER2+ early BC, with overall survival outcomes being better with vs without trastuzumab treatment in patients who achieved pCR (adjusted hazard ratio 0.30; 95% CI 0.11-0.84).

Study details: Findings are from a real-world study including 1178 patients with HER2+ early BC and 354 patients with early triple-negative BC who received trastuzumab-based and platinum-based neoadjuvant treatments, respectively.

Disclosures: This study was supported by the Ministry of Science and Technology in Taiwan and Roche Products Ltd. Three authors declared being employees of Roche Products Ltd.

Source: Chung WP et al. Real-life analysis of neoadjuvant-therapy-associated benefits for pathological complete response and survival in early breast cancer patients - role of trastuzumab in HER2+ BC and platinum in TNBC. Front Oncol. 2023;12:1022994 (Jan 24). Doi: 10.3389/fonc.2022.1022994

Key clinical point: In patients with stage II/III estrogen receptor-positive (ER+) breast cancer (BC), neoadjuvant endocrine therapy (ET) with aromatase inhibitors downstaged a fair proportion of tumors to allow breast-conserving surgery (BCS) and resulted in low local-regional recurrence rates.

Major finding: After receiving neoadjuvant ET, local-regional recurrence rates were low (1.53%) and 50.4% of the 226 patients who were thought to require a mastectomy or have an inoperable BC underwent BCS.

Study details: Findings are from an analysis of the phase 2, American College of Surgeons Oncology Group Z1031 trial including 509 postmenopausal women with invasive, stage II/III, ER+ BC who received exemestane, anastrozole, or letrozole for 16-18 weeks.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health. The authors declared serving as employees, consultants, or advisors or receiving research funding from various sources.

Source: Hunt KK et al. Local-regional recurrence after neoadjuvant endocrine therapy: Data from ACOSOG Z1031 (Alliance), a randomized phase 2 neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-positive clinical stage 2 or 3 breast cancer. Ann Surg Oncol. 2023 (Jan 18). Doi: 10.1245/s10434-022-12972-5

Key clinical point: In patients with stage II/III estrogen receptor-positive (ER+) breast cancer (BC), neoadjuvant endocrine therapy (ET) with aromatase inhibitors downstaged a fair proportion of tumors to allow breast-conserving surgery (BCS) and resulted in low local-regional recurrence rates.

Major finding: After receiving neoadjuvant ET, local-regional recurrence rates were low (1.53%) and 50.4% of the 226 patients who were thought to require a mastectomy or have an inoperable BC underwent BCS.

Study details: Findings are from an analysis of the phase 2, American College of Surgeons Oncology Group Z1031 trial including 509 postmenopausal women with invasive, stage II/III, ER+ BC who received exemestane, anastrozole, or letrozole for 16-18 weeks.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health. The authors declared serving as employees, consultants, or advisors or receiving research funding from various sources.

Source: Hunt KK et al. Local-regional recurrence after neoadjuvant endocrine therapy: Data from ACOSOG Z1031 (Alliance), a randomized phase 2 neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-positive clinical stage 2 or 3 breast cancer. Ann Surg Oncol. 2023 (Jan 18). Doi: 10.1245/s10434-022-12972-5

Key clinical point: In patients with stage II/III estrogen receptor-positive (ER+) breast cancer (BC), neoadjuvant endocrine therapy (ET) with aromatase inhibitors downstaged a fair proportion of tumors to allow breast-conserving surgery (BCS) and resulted in low local-regional recurrence rates.

Major finding: After receiving neoadjuvant ET, local-regional recurrence rates were low (1.53%) and 50.4% of the 226 patients who were thought to require a mastectomy or have an inoperable BC underwent BCS.

Study details: Findings are from an analysis of the phase 2, American College of Surgeons Oncology Group Z1031 trial including 509 postmenopausal women with invasive, stage II/III, ER+ BC who received exemestane, anastrozole, or letrozole for 16-18 weeks.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health. The authors declared serving as employees, consultants, or advisors or receiving research funding from various sources.

Source: Hunt KK et al. Local-regional recurrence after neoadjuvant endocrine therapy: Data from ACOSOG Z1031 (Alliance), a randomized phase 2 neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-positive clinical stage 2 or 3 breast cancer. Ann Surg Oncol. 2023 (Jan 18). Doi: 10.1245/s10434-022-12972-5