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EMR screening in emergency department tags undiagnosed diabetes
A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.
“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.
In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.
The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m2 or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.
A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).
After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.
Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.
Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.
The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
Diabetes in underserved groups goes undetected
“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”
The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”
The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.
“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.
“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”
The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.
A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.
“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.
In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.
The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m2 or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.
A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).
After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.
Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.
Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.
The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
Diabetes in underserved groups goes undetected
“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”
The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”
The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.
“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.
“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”
The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.
A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.
“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.
In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.
The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m2 or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.
A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).
After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.
Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.
Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.
The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
Diabetes in underserved groups goes undetected
“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”
The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”
The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.
“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.
“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”
The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.
FROM JAMA NETWORK OPEN
Microcalcifications and high breast density increase risk for breast cancer
Key clinical point: Microcalcifications and breast density, as assessed by the Breast Imaging Reporting and Data System 4th edition (BI-RADS) were associated with a significantly increased risk for breast cancer (BC).
Major finding: Microcalcification appeared to be a significant risk factor for BC irrespective of breast density (adjusted hazard ratio [aHR] 3.09; 95% CI 2.83-3.36). Both microcalcification and high breast density (BI-RADS density classification 4) were associated with a 6.65-fold (95% CI 5.59-7.72) higher risk for BC, with the risk being the highest in postmenopausal women with microcalcifications and high breast density (aHR 7.26; 95% CI 5.01-10.53).
Study details: Findings are from a retrospective cohort study including 3,910,815 women who underwent breast cancer screening, of which 58,315 women were diagnosed with BC during a median follow-up of 10.8 years.
Disclosures: This study was supported by the National Research Foundation of Korea and other sources. The authors declared no conflicts of interest.
Source: Kim S et al. Microcalcifications, mammographic breast density, and risk of breast cancer: A cohort study. Breast Cancer Res. 2022;24:96 (Dec 21). Doi: 10.1186/s13058-022-01594-0
Key clinical point: Microcalcifications and breast density, as assessed by the Breast Imaging Reporting and Data System 4th edition (BI-RADS) were associated with a significantly increased risk for breast cancer (BC).
Major finding: Microcalcification appeared to be a significant risk factor for BC irrespective of breast density (adjusted hazard ratio [aHR] 3.09; 95% CI 2.83-3.36). Both microcalcification and high breast density (BI-RADS density classification 4) were associated with a 6.65-fold (95% CI 5.59-7.72) higher risk for BC, with the risk being the highest in postmenopausal women with microcalcifications and high breast density (aHR 7.26; 95% CI 5.01-10.53).
Study details: Findings are from a retrospective cohort study including 3,910,815 women who underwent breast cancer screening, of which 58,315 women were diagnosed with BC during a median follow-up of 10.8 years.
Disclosures: This study was supported by the National Research Foundation of Korea and other sources. The authors declared no conflicts of interest.
Source: Kim S et al. Microcalcifications, mammographic breast density, and risk of breast cancer: A cohort study. Breast Cancer Res. 2022;24:96 (Dec 21). Doi: 10.1186/s13058-022-01594-0
Key clinical point: Microcalcifications and breast density, as assessed by the Breast Imaging Reporting and Data System 4th edition (BI-RADS) were associated with a significantly increased risk for breast cancer (BC).
Major finding: Microcalcification appeared to be a significant risk factor for BC irrespective of breast density (adjusted hazard ratio [aHR] 3.09; 95% CI 2.83-3.36). Both microcalcification and high breast density (BI-RADS density classification 4) were associated with a 6.65-fold (95% CI 5.59-7.72) higher risk for BC, with the risk being the highest in postmenopausal women with microcalcifications and high breast density (aHR 7.26; 95% CI 5.01-10.53).
Study details: Findings are from a retrospective cohort study including 3,910,815 women who underwent breast cancer screening, of which 58,315 women were diagnosed with BC during a median follow-up of 10.8 years.
Disclosures: This study was supported by the National Research Foundation of Korea and other sources. The authors declared no conflicts of interest.
Source: Kim S et al. Microcalcifications, mammographic breast density, and risk of breast cancer: A cohort study. Breast Cancer Res. 2022;24:96 (Dec 21). Doi: 10.1186/s13058-022-01594-0
Breast cancer: Nipple-sparing mastectomy after neoadjuvant chemotherapy is oncologically safe
Key clinical point: Nipple-sparing mastectomy (NSM), even when performed after neoadjuvant chemotherapy (NACT), resulted in a very low rate of locoregional recurrence and therefore was considered oncologically safe in women with breast cancer (BC).
Major finding: Cumulative incidences of local (P = .570), regional (P = .150), and systemic (P = .87) relapses were similar between patients who received vs did not receive NACT, with no cases of locoregional relapses being reported by the 30.3% of patients who had achieved pathological complete response in the NACT group. The rate of all complications was also similar with vs without NACT.
Study details: Findings are from a retrospective study including 112 cases of NSM after NACT in 111 women and 321 cases of primary NSM in 306 women.
Disclosures: This study was supported by Fondazione Prometeus, ONLUS, Italy. The authors declared no conflicts of interest.
Source: Meli EZ et al. Nipple-sparing mastectomy after neoadjuvant chemotherapy: Definitive results with a long-term follow-up evaluation. Ann Surg Oncol. 2023 (Jan 4). Doi: 10.1245/s10434-022-13035-5
Key clinical point: Nipple-sparing mastectomy (NSM), even when performed after neoadjuvant chemotherapy (NACT), resulted in a very low rate of locoregional recurrence and therefore was considered oncologically safe in women with breast cancer (BC).
Major finding: Cumulative incidences of local (P = .570), regional (P = .150), and systemic (P = .87) relapses were similar between patients who received vs did not receive NACT, with no cases of locoregional relapses being reported by the 30.3% of patients who had achieved pathological complete response in the NACT group. The rate of all complications was also similar with vs without NACT.
Study details: Findings are from a retrospective study including 112 cases of NSM after NACT in 111 women and 321 cases of primary NSM in 306 women.
Disclosures: This study was supported by Fondazione Prometeus, ONLUS, Italy. The authors declared no conflicts of interest.
Source: Meli EZ et al. Nipple-sparing mastectomy after neoadjuvant chemotherapy: Definitive results with a long-term follow-up evaluation. Ann Surg Oncol. 2023 (Jan 4). Doi: 10.1245/s10434-022-13035-5
Key clinical point: Nipple-sparing mastectomy (NSM), even when performed after neoadjuvant chemotherapy (NACT), resulted in a very low rate of locoregional recurrence and therefore was considered oncologically safe in women with breast cancer (BC).
Major finding: Cumulative incidences of local (P = .570), regional (P = .150), and systemic (P = .87) relapses were similar between patients who received vs did not receive NACT, with no cases of locoregional relapses being reported by the 30.3% of patients who had achieved pathological complete response in the NACT group. The rate of all complications was also similar with vs without NACT.
Study details: Findings are from a retrospective study including 112 cases of NSM after NACT in 111 women and 321 cases of primary NSM in 306 women.
Disclosures: This study was supported by Fondazione Prometeus, ONLUS, Italy. The authors declared no conflicts of interest.
Source: Meli EZ et al. Nipple-sparing mastectomy after neoadjuvant chemotherapy: Definitive results with a long-term follow-up evaluation. Ann Surg Oncol. 2023 (Jan 4). Doi: 10.1245/s10434-022-13035-5
HER2+ metastatic BC: Meta-analysis demonstrates superior efficacy of pyrotinib over lapatinib
Key clinical point: Pyrotinib plus chemotherapy outperformed lapatinib plus chemotherapy in terms of improving survival outcomes in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) but showed a worse toxicity profile.
Major finding: Progression-free survival was significantly improved with pyrotinib vs lapatinib in patients who had received prior trastuzumab therapy (hazard ratio [HR] 0.47; P < .001) and those with trastuzumab resistance (HR 0.52; P < .001). However, the incidence of grade ≥3 diarrhea was higher with pyrotinib vs lapatinib (risk ratio 2.68; P < .001).
Study details: Findings are from a meta-analysis of five studies including 843 patients with metastatic BC who received chemotherapy with pyrotinib (n = 392) or lapatinib (n = 451).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Yuan Y et al. Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure: A meta-analysis and systematic review. PLoS One. 2023;18(1):e0279775 (Jan 5). Doi: 10.1371/journal.pone.0279775
Key clinical point: Pyrotinib plus chemotherapy outperformed lapatinib plus chemotherapy in terms of improving survival outcomes in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) but showed a worse toxicity profile.
Major finding: Progression-free survival was significantly improved with pyrotinib vs lapatinib in patients who had received prior trastuzumab therapy (hazard ratio [HR] 0.47; P < .001) and those with trastuzumab resistance (HR 0.52; P < .001). However, the incidence of grade ≥3 diarrhea was higher with pyrotinib vs lapatinib (risk ratio 2.68; P < .001).
Study details: Findings are from a meta-analysis of five studies including 843 patients with metastatic BC who received chemotherapy with pyrotinib (n = 392) or lapatinib (n = 451).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Yuan Y et al. Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure: A meta-analysis and systematic review. PLoS One. 2023;18(1):e0279775 (Jan 5). Doi: 10.1371/journal.pone.0279775
Key clinical point: Pyrotinib plus chemotherapy outperformed lapatinib plus chemotherapy in terms of improving survival outcomes in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) but showed a worse toxicity profile.
Major finding: Progression-free survival was significantly improved with pyrotinib vs lapatinib in patients who had received prior trastuzumab therapy (hazard ratio [HR] 0.47; P < .001) and those with trastuzumab resistance (HR 0.52; P < .001). However, the incidence of grade ≥3 diarrhea was higher with pyrotinib vs lapatinib (risk ratio 2.68; P < .001).
Study details: Findings are from a meta-analysis of five studies including 843 patients with metastatic BC who received chemotherapy with pyrotinib (n = 392) or lapatinib (n = 451).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Yuan Y et al. Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure: A meta-analysis and systematic review. PLoS One. 2023;18(1):e0279775 (Jan 5). Doi: 10.1371/journal.pone.0279775
Improved survival with systemic treatment+local ablative therapy in oligometastatic BC
Key clinical point: Local ablative treatment (LAT) combined with systemic therapy demonstrated superior survival outcomes compared with systemic therapy alone and was well tolerated in patients with oligometastatic breast cancer (BC).
Major finding: LAT+systemic treatment vs only systemic treatment significantly improved progression-free survival (hazard ratio [HR] 0.35; P = .001) and overall survival (HR 0.13; P < .001). LAT was well tolerated, with only one case of grade 3 toxicity being reported.
Study details: Findings are from a retrospective single-center study including 102 patients with oligometastatic BC, of which 62 and 40 patients received systemic treatment and LAT+systemic treatment, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Glemarec G et al. Systemic treatment with or without ablative therapies in oligometastatic breast cancer: A single institution analysis of patient outcomes. Breast. 2022 (Dec 29). Doi: 10.1016/j.breast.2022.12.035
Key clinical point: Local ablative treatment (LAT) combined with systemic therapy demonstrated superior survival outcomes compared with systemic therapy alone and was well tolerated in patients with oligometastatic breast cancer (BC).
Major finding: LAT+systemic treatment vs only systemic treatment significantly improved progression-free survival (hazard ratio [HR] 0.35; P = .001) and overall survival (HR 0.13; P < .001). LAT was well tolerated, with only one case of grade 3 toxicity being reported.
Study details: Findings are from a retrospective single-center study including 102 patients with oligometastatic BC, of which 62 and 40 patients received systemic treatment and LAT+systemic treatment, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Glemarec G et al. Systemic treatment with or without ablative therapies in oligometastatic breast cancer: A single institution analysis of patient outcomes. Breast. 2022 (Dec 29). Doi: 10.1016/j.breast.2022.12.035
Key clinical point: Local ablative treatment (LAT) combined with systemic therapy demonstrated superior survival outcomes compared with systemic therapy alone and was well tolerated in patients with oligometastatic breast cancer (BC).
Major finding: LAT+systemic treatment vs only systemic treatment significantly improved progression-free survival (hazard ratio [HR] 0.35; P = .001) and overall survival (HR 0.13; P < .001). LAT was well tolerated, with only one case of grade 3 toxicity being reported.
Study details: Findings are from a retrospective single-center study including 102 patients with oligometastatic BC, of which 62 and 40 patients received systemic treatment and LAT+systemic treatment, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Glemarec G et al. Systemic treatment with or without ablative therapies in oligometastatic breast cancer: A single institution analysis of patient outcomes. Breast. 2022 (Dec 29). Doi: 10.1016/j.breast.2022.12.035
HER2 expression has no impact on prognosis in metastatic TNBC
Key clinical point: A low expression of human epidermal growth factor receptor 2 (HER2) did not have any impact on survival outcomes in patients with metastatic triple-negative breast cancer (TNBC).
Major finding: Patients with HER2-low and HER2-0 TNBC had similar overall survival rates (hazard ratio 0.95; P = .545).
Study details: Findings are from a retrospective, multicenter analysis including 691 patients with metastatic TNBC, of which 221 patients were classified as having HER2-low TNBC.
Disclosures: This study was supported by grants from Daiichi Sankyo, Pfizer, Novartis, AstraZeneca, Eli Lilly, Seagen, Roche, and from Ministero della Salture d'Italia. Some authors declared serving as speakers or on advisory boards or receiving honoraria, research grants, or travel grants from several sources, including Daiichi Sankyo, Pfizer, Novartis, Astra Zeneca, Eli Lilly, Seagen, Roche, and others.
Source: Gampenrieder SP et al. Influence of HER2 expression on prognosis in metastatic triple-negative breast cancer-results from an international, multicenter analysis coordinated by the AGMT Study Group. ESMO Open. 2022;8(1):100747 (Dec 21). Doi: 10.1016/j.esmoop.2022.100747
Key clinical point: A low expression of human epidermal growth factor receptor 2 (HER2) did not have any impact on survival outcomes in patients with metastatic triple-negative breast cancer (TNBC).
Major finding: Patients with HER2-low and HER2-0 TNBC had similar overall survival rates (hazard ratio 0.95; P = .545).
Study details: Findings are from a retrospective, multicenter analysis including 691 patients with metastatic TNBC, of which 221 patients were classified as having HER2-low TNBC.
Disclosures: This study was supported by grants from Daiichi Sankyo, Pfizer, Novartis, AstraZeneca, Eli Lilly, Seagen, Roche, and from Ministero della Salture d'Italia. Some authors declared serving as speakers or on advisory boards or receiving honoraria, research grants, or travel grants from several sources, including Daiichi Sankyo, Pfizer, Novartis, Astra Zeneca, Eli Lilly, Seagen, Roche, and others.
Source: Gampenrieder SP et al. Influence of HER2 expression on prognosis in metastatic triple-negative breast cancer-results from an international, multicenter analysis coordinated by the AGMT Study Group. ESMO Open. 2022;8(1):100747 (Dec 21). Doi: 10.1016/j.esmoop.2022.100747
Key clinical point: A low expression of human epidermal growth factor receptor 2 (HER2) did not have any impact on survival outcomes in patients with metastatic triple-negative breast cancer (TNBC).
Major finding: Patients with HER2-low and HER2-0 TNBC had similar overall survival rates (hazard ratio 0.95; P = .545).
Study details: Findings are from a retrospective, multicenter analysis including 691 patients with metastatic TNBC, of which 221 patients were classified as having HER2-low TNBC.
Disclosures: This study was supported by grants from Daiichi Sankyo, Pfizer, Novartis, AstraZeneca, Eli Lilly, Seagen, Roche, and from Ministero della Salture d'Italia. Some authors declared serving as speakers or on advisory boards or receiving honoraria, research grants, or travel grants from several sources, including Daiichi Sankyo, Pfizer, Novartis, Astra Zeneca, Eli Lilly, Seagen, Roche, and others.
Source: Gampenrieder SP et al. Influence of HER2 expression on prognosis in metastatic triple-negative breast cancer-results from an international, multicenter analysis coordinated by the AGMT Study Group. ESMO Open. 2022;8(1):100747 (Dec 21). Doi: 10.1016/j.esmoop.2022.100747
HER2+ BC: Adding pyrotinib to neoadjuvant trastuzumab+docetaxel shows promise in phase 3 study
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received pyrotinib along with trastuzumab+docetaxel in the neoadjuvant setting achieved a significant improvement in the total pathological complete response (tpCR) rate without experiencing any unprecedented adverse events (AE).
Major finding: Rate of tpCR was significantly higher in the pyrotinib vs placebo group (41% vs 22%; 1-sided P < .0001). The most common grade 3 or 4 AE in the pyrotinib and placebo treatment arms were diarrhea (44.4% and 5.1%, respectively), neutropenia (18.5% and 20.3%, respectively), and decreased white blood cell count (16.3% and 13.6%, respectively).
Study details: Findings are from the phase 3 PHEDRA study including 355 patients with early/locally advanced HER+ BC who were randomly assigned to receive trastuzumab+docetaxel with either pyrotinib or placebo.
Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Four authors declared being former employees of Hengrui. No other conflicts of interest were reported.
Source: Wu J, Jiang Z, Liu Z, Yang B, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): A double-blind, randomized phase 3 trial. BMC Med. 2022;20(1):498 (Dec 27). Doi: 10.1186/s12916-022-02708-3
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received pyrotinib along with trastuzumab+docetaxel in the neoadjuvant setting achieved a significant improvement in the total pathological complete response (tpCR) rate without experiencing any unprecedented adverse events (AE).
Major finding: Rate of tpCR was significantly higher in the pyrotinib vs placebo group (41% vs 22%; 1-sided P < .0001). The most common grade 3 or 4 AE in the pyrotinib and placebo treatment arms were diarrhea (44.4% and 5.1%, respectively), neutropenia (18.5% and 20.3%, respectively), and decreased white blood cell count (16.3% and 13.6%, respectively).
Study details: Findings are from the phase 3 PHEDRA study including 355 patients with early/locally advanced HER+ BC who were randomly assigned to receive trastuzumab+docetaxel with either pyrotinib or placebo.
Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Four authors declared being former employees of Hengrui. No other conflicts of interest were reported.
Source: Wu J, Jiang Z, Liu Z, Yang B, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): A double-blind, randomized phase 3 trial. BMC Med. 2022;20(1):498 (Dec 27). Doi: 10.1186/s12916-022-02708-3
Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received pyrotinib along with trastuzumab+docetaxel in the neoadjuvant setting achieved a significant improvement in the total pathological complete response (tpCR) rate without experiencing any unprecedented adverse events (AE).
Major finding: Rate of tpCR was significantly higher in the pyrotinib vs placebo group (41% vs 22%; 1-sided P < .0001). The most common grade 3 or 4 AE in the pyrotinib and placebo treatment arms were diarrhea (44.4% and 5.1%, respectively), neutropenia (18.5% and 20.3%, respectively), and decreased white blood cell count (16.3% and 13.6%, respectively).
Study details: Findings are from the phase 3 PHEDRA study including 355 patients with early/locally advanced HER+ BC who were randomly assigned to receive trastuzumab+docetaxel with either pyrotinib or placebo.
Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Four authors declared being former employees of Hengrui. No other conflicts of interest were reported.
Source: Wu J, Jiang Z, Liu Z, Yang B, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): A double-blind, randomized phase 3 trial. BMC Med. 2022;20(1):498 (Dec 27). Doi: 10.1186/s12916-022-02708-3
Early BC: No effect on survival outcomes with less frequent adjuvant zoledronate infusions
Key clinical point: A de-escalated zoledronate schedule (≤6 infusions) did not affect breast cancer (BC)-specific survival outcomes in patients with hormone receptor-positive early BC.
Major finding: After a median follow-up of 96 months, the rates of disease-free survival were similar between patients who received ≤6 and ≥7 infusions (stratified hazard ratio 0.88; log-rank P = .64); however, there was an increase in adverse events, particularly arthralgia (P = .012) and nausea (P = .017), among patients who received ≥7 vs ≤6 infusions.
Study details: Findings are a substudy of the ABCSG-12 trial including 725 premenopausal women with early BC who were randomly assigned to receive hormone therapy (tamoxifen or anastrozole with goserelin) with or without zoledronic acid.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Beltran-Bless AA et al. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12. Eur J Cancer. 2022;180:108-116 (Dec 31). Doi: 10.1016/j.ejca.2022.12.003
Key clinical point: A de-escalated zoledronate schedule (≤6 infusions) did not affect breast cancer (BC)-specific survival outcomes in patients with hormone receptor-positive early BC.
Major finding: After a median follow-up of 96 months, the rates of disease-free survival were similar between patients who received ≤6 and ≥7 infusions (stratified hazard ratio 0.88; log-rank P = .64); however, there was an increase in adverse events, particularly arthralgia (P = .012) and nausea (P = .017), among patients who received ≥7 vs ≤6 infusions.
Study details: Findings are a substudy of the ABCSG-12 trial including 725 premenopausal women with early BC who were randomly assigned to receive hormone therapy (tamoxifen or anastrozole with goserelin) with or without zoledronic acid.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Beltran-Bless AA et al. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12. Eur J Cancer. 2022;180:108-116 (Dec 31). Doi: 10.1016/j.ejca.2022.12.003
Key clinical point: A de-escalated zoledronate schedule (≤6 infusions) did not affect breast cancer (BC)-specific survival outcomes in patients with hormone receptor-positive early BC.
Major finding: After a median follow-up of 96 months, the rates of disease-free survival were similar between patients who received ≤6 and ≥7 infusions (stratified hazard ratio 0.88; log-rank P = .64); however, there was an increase in adverse events, particularly arthralgia (P = .012) and nausea (P = .017), among patients who received ≥7 vs ≤6 infusions.
Study details: Findings are a substudy of the ABCSG-12 trial including 725 premenopausal women with early BC who were randomly assigned to receive hormone therapy (tamoxifen or anastrozole with goserelin) with or without zoledronic acid.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Beltran-Bless AA et al. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12. Eur J Cancer. 2022;180:108-116 (Dec 31). Doi: 10.1016/j.ejca.2022.12.003
Adding ovarian function suppression to adjuvant endocrine therapy beneficial in HR+ BC
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen reduced the risk for recurrence in premenopausal patients with hormone receptor-positive (HR+) breast cancer (BC).
Major finding: Compared with tamoxifen alone, tamoxifen+OFS significantly improved the 12-year disease-free survival (hazard ratio [HR] 0.82; P = .03), with the improvement being greater with exemestane+OFS (HR 0.69; 95% CI 0.57-0.83).
Study details: Findings are from the SOFT trial including 3047 premenopausal women with HR+ BC who were randomly assigned to receive 5 years of adjuvant tamoxifen, tamoxifen+OFS, or exemestane+OFS.
Disclosures: This study was supported by Breast Cancer Trials Australia and New Zealand and other sources. The authors declared serving as consultants, advisors, or on speaker’s bureaus or receiving honoraria, research funding, or travel and accommodation expenses from several sources.
Source: Francis PA et al. Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol. 2022 (Dec 9). Doi: 10.1200/JCO.22.01065
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen reduced the risk for recurrence in premenopausal patients with hormone receptor-positive (HR+) breast cancer (BC).
Major finding: Compared with tamoxifen alone, tamoxifen+OFS significantly improved the 12-year disease-free survival (hazard ratio [HR] 0.82; P = .03), with the improvement being greater with exemestane+OFS (HR 0.69; 95% CI 0.57-0.83).
Study details: Findings are from the SOFT trial including 3047 premenopausal women with HR+ BC who were randomly assigned to receive 5 years of adjuvant tamoxifen, tamoxifen+OFS, or exemestane+OFS.
Disclosures: This study was supported by Breast Cancer Trials Australia and New Zealand and other sources. The authors declared serving as consultants, advisors, or on speaker’s bureaus or receiving honoraria, research funding, or travel and accommodation expenses from several sources.
Source: Francis PA et al. Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol. 2022 (Dec 9). Doi: 10.1200/JCO.22.01065
Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen reduced the risk for recurrence in premenopausal patients with hormone receptor-positive (HR+) breast cancer (BC).
Major finding: Compared with tamoxifen alone, tamoxifen+OFS significantly improved the 12-year disease-free survival (hazard ratio [HR] 0.82; P = .03), with the improvement being greater with exemestane+OFS (HR 0.69; 95% CI 0.57-0.83).
Study details: Findings are from the SOFT trial including 3047 premenopausal women with HR+ BC who were randomly assigned to receive 5 years of adjuvant tamoxifen, tamoxifen+OFS, or exemestane+OFS.
Disclosures: This study was supported by Breast Cancer Trials Australia and New Zealand and other sources. The authors declared serving as consultants, advisors, or on speaker’s bureaus or receiving honoraria, research funding, or travel and accommodation expenses from several sources.
Source: Francis PA et al. Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol. 2022 (Dec 9). Doi: 10.1200/JCO.22.01065
HR+/ERBB2+ BC: Endocrine therapy-containing first-line regimens show benefits even without chemotherapy
Key clinical point: A first-line chemotherapy-free treatment regimen containing endocrine therapy (ET) and human epidermal growth factor receptor 2 (ERBB2)-targeted therapy led to excellent survival outcomes in patients with hormone receptor-positive (HR+) and ERBB2-positive (ERBB2+) metastatic breast cancer (BC).
Major finding: No significant difference was observed in overall survival (hazard ratio [HR] 1.03; P = .80) or progression-free survival (HR 1.00; P > .99) between patients receiving ERBB2-targeted therapy and chemotherapy with or without ET and patients receiving ERBB2-targeted therapy with ET only, regardless of the type of ERBB2-targeted therapy.
Study details: Findings are from a cohort study including 1723 patients with HR+/ERBB2+ metastatic BC who received ERBB2-targeted therapy and chemotherapy with or without ET (n = 1520) or ERBB2-targeted therapy with ET only (n = 203).
Disclosures: This study was supported by Unicancer. The authors declared receiving personal fees, research funding, grants, or travel expenses from several pharmaceutical companies.
Source: Carausu M et al. Association of endocrine therapy for HR+/ERBB2+ metastatic breast cancer with survival outcomes. JAMA Netw Open. 2022;5(12):e2247154 (Dec 15). Doi: 10.1001/jamanetworkopen.2022.47154
Key clinical point: A first-line chemotherapy-free treatment regimen containing endocrine therapy (ET) and human epidermal growth factor receptor 2 (ERBB2)-targeted therapy led to excellent survival outcomes in patients with hormone receptor-positive (HR+) and ERBB2-positive (ERBB2+) metastatic breast cancer (BC).
Major finding: No significant difference was observed in overall survival (hazard ratio [HR] 1.03; P = .80) or progression-free survival (HR 1.00; P > .99) between patients receiving ERBB2-targeted therapy and chemotherapy with or without ET and patients receiving ERBB2-targeted therapy with ET only, regardless of the type of ERBB2-targeted therapy.
Study details: Findings are from a cohort study including 1723 patients with HR+/ERBB2+ metastatic BC who received ERBB2-targeted therapy and chemotherapy with or without ET (n = 1520) or ERBB2-targeted therapy with ET only (n = 203).
Disclosures: This study was supported by Unicancer. The authors declared receiving personal fees, research funding, grants, or travel expenses from several pharmaceutical companies.
Source: Carausu M et al. Association of endocrine therapy for HR+/ERBB2+ metastatic breast cancer with survival outcomes. JAMA Netw Open. 2022;5(12):e2247154 (Dec 15). Doi: 10.1001/jamanetworkopen.2022.47154
Key clinical point: A first-line chemotherapy-free treatment regimen containing endocrine therapy (ET) and human epidermal growth factor receptor 2 (ERBB2)-targeted therapy led to excellent survival outcomes in patients with hormone receptor-positive (HR+) and ERBB2-positive (ERBB2+) metastatic breast cancer (BC).
Major finding: No significant difference was observed in overall survival (hazard ratio [HR] 1.03; P = .80) or progression-free survival (HR 1.00; P > .99) between patients receiving ERBB2-targeted therapy and chemotherapy with or without ET and patients receiving ERBB2-targeted therapy with ET only, regardless of the type of ERBB2-targeted therapy.
Study details: Findings are from a cohort study including 1723 patients with HR+/ERBB2+ metastatic BC who received ERBB2-targeted therapy and chemotherapy with or without ET (n = 1520) or ERBB2-targeted therapy with ET only (n = 203).
Disclosures: This study was supported by Unicancer. The authors declared receiving personal fees, research funding, grants, or travel expenses from several pharmaceutical companies.
Source: Carausu M et al. Association of endocrine therapy for HR+/ERBB2+ metastatic breast cancer with survival outcomes. JAMA Netw Open. 2022;5(12):e2247154 (Dec 15). Doi: 10.1001/jamanetworkopen.2022.47154