Breast-conserving surgery without axillary surgery and radiotherapy safe in elderly BC patients

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Key clinical point: Breast-conserving surgery without axillary lymph node dissection as well as breast and axillary radiotherapy (BCSNR) was safe and resulted in survival rates comparable to mastectomy plus axillary lymph node dissection (MALND) in elderly patients with axillary lymph node-negative breast cancer (BC).

 

Major finding: At a median follow-up of 5 years, BCSNR vs MALND was not associated with significantly worsened distant recurrence-free survival (98.1% vs 93.2%; P  =  .990) and BC-specific survival (96.3% vs 99.3%; P  =  .076) rates but was associated with a significantly higher local recurrence rate (10.3% vs 2.2%; P  =  .001).

 

Study details: Findings are from a retrospective study including 541 patients aged ≥70 years with axillary lymph node-negative BC, of which 181 and 360 patients underwent MALND with negative axillary cleaning and BCSNR, respectively.

 

Disclosures: This study was supported by the CAMS Innovation Fund for Medical Sciences, China, and other sources. The authors declared no conflicts of interest.

 

Source: Zhong Y et al. Breast-conserving surgery without axillary surgery and radiation versus mastectomy plus axillary dissection in elderly breast cancer patients: A retrospective study. Front Oncol. 2023;13:1126104 (Mar 20). Doi: 10.3389/fonc.2023.1126104

 

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Key clinical point: Breast-conserving surgery without axillary lymph node dissection as well as breast and axillary radiotherapy (BCSNR) was safe and resulted in survival rates comparable to mastectomy plus axillary lymph node dissection (MALND) in elderly patients with axillary lymph node-negative breast cancer (BC).

 

Major finding: At a median follow-up of 5 years, BCSNR vs MALND was not associated with significantly worsened distant recurrence-free survival (98.1% vs 93.2%; P  =  .990) and BC-specific survival (96.3% vs 99.3%; P  =  .076) rates but was associated with a significantly higher local recurrence rate (10.3% vs 2.2%; P  =  .001).

 

Study details: Findings are from a retrospective study including 541 patients aged ≥70 years with axillary lymph node-negative BC, of which 181 and 360 patients underwent MALND with negative axillary cleaning and BCSNR, respectively.

 

Disclosures: This study was supported by the CAMS Innovation Fund for Medical Sciences, China, and other sources. The authors declared no conflicts of interest.

 

Source: Zhong Y et al. Breast-conserving surgery without axillary surgery and radiation versus mastectomy plus axillary dissection in elderly breast cancer patients: A retrospective study. Front Oncol. 2023;13:1126104 (Mar 20). Doi: 10.3389/fonc.2023.1126104

 

Key clinical point: Breast-conserving surgery without axillary lymph node dissection as well as breast and axillary radiotherapy (BCSNR) was safe and resulted in survival rates comparable to mastectomy plus axillary lymph node dissection (MALND) in elderly patients with axillary lymph node-negative breast cancer (BC).

 

Major finding: At a median follow-up of 5 years, BCSNR vs MALND was not associated with significantly worsened distant recurrence-free survival (98.1% vs 93.2%; P  =  .990) and BC-specific survival (96.3% vs 99.3%; P  =  .076) rates but was associated with a significantly higher local recurrence rate (10.3% vs 2.2%; P  =  .001).

 

Study details: Findings are from a retrospective study including 541 patients aged ≥70 years with axillary lymph node-negative BC, of which 181 and 360 patients underwent MALND with negative axillary cleaning and BCSNR, respectively.

 

Disclosures: This study was supported by the CAMS Innovation Fund for Medical Sciences, China, and other sources. The authors declared no conflicts of interest.

 

Source: Zhong Y et al. Breast-conserving surgery without axillary surgery and radiation versus mastectomy plus axillary dissection in elderly breast cancer patients: A retrospective study. Front Oncol. 2023;13:1126104 (Mar 20). Doi: 10.3389/fonc.2023.1126104

 

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Serum thymidine kinase 1 activity: A promising prognostic biomarker in advanced breast cancer

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Key clinical point: Serum thymidine kinase 1 activity (sTKa) proved to be an excellent biomarker of progression risk in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (BC) receiving first-line ribociclib+letrozole.

 

Major finding: Disease progression risk was significantly higher in patients with high vs low sTKa levels at baseline (hazard ratio 2.21; P  =  .0002). Patients with high sTKa levels on day 1 of cycle 2 after initial decrease on day 15 of cycle 1 (C1D15; hazard ratio 2.89; P  =  .0006) or on C1D15 (hazard ratio 5.65; P < .0001) had worse prognosis than those with low sTKa levels at all time points.

 

Study details: This phase 3 BioItaLEE study included 287 postmenopausal women with HR+/HER2– advanced BC who received ribociclib+letrozole as first-line therapy.

 

Disclosures: This study was supported by Novartis Farma SpA, Italy. Some authors declared participating on advisory boards and receiving grants, fees, honoraria, or travel support from several sources, including Novartis.

 

Source: Malorni L et al. Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer. 2023;186:1-11 (Mar 7). Doi: 10.1016/j.ejca.2023.03.001

 

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Key clinical point: Serum thymidine kinase 1 activity (sTKa) proved to be an excellent biomarker of progression risk in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (BC) receiving first-line ribociclib+letrozole.

 

Major finding: Disease progression risk was significantly higher in patients with high vs low sTKa levels at baseline (hazard ratio 2.21; P  =  .0002). Patients with high sTKa levels on day 1 of cycle 2 after initial decrease on day 15 of cycle 1 (C1D15; hazard ratio 2.89; P  =  .0006) or on C1D15 (hazard ratio 5.65; P < .0001) had worse prognosis than those with low sTKa levels at all time points.

 

Study details: This phase 3 BioItaLEE study included 287 postmenopausal women with HR+/HER2– advanced BC who received ribociclib+letrozole as first-line therapy.

 

Disclosures: This study was supported by Novartis Farma SpA, Italy. Some authors declared participating on advisory boards and receiving grants, fees, honoraria, or travel support from several sources, including Novartis.

 

Source: Malorni L et al. Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer. 2023;186:1-11 (Mar 7). Doi: 10.1016/j.ejca.2023.03.001

 

Key clinical point: Serum thymidine kinase 1 activity (sTKa) proved to be an excellent biomarker of progression risk in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (BC) receiving first-line ribociclib+letrozole.

 

Major finding: Disease progression risk was significantly higher in patients with high vs low sTKa levels at baseline (hazard ratio 2.21; P  =  .0002). Patients with high sTKa levels on day 1 of cycle 2 after initial decrease on day 15 of cycle 1 (C1D15; hazard ratio 2.89; P  =  .0006) or on C1D15 (hazard ratio 5.65; P < .0001) had worse prognosis than those with low sTKa levels at all time points.

 

Study details: This phase 3 BioItaLEE study included 287 postmenopausal women with HR+/HER2– advanced BC who received ribociclib+letrozole as first-line therapy.

 

Disclosures: This study was supported by Novartis Farma SpA, Italy. Some authors declared participating on advisory boards and receiving grants, fees, honoraria, or travel support from several sources, including Novartis.

 

Source: Malorni L et al. Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer. 2023;186:1-11 (Mar 7). Doi: 10.1016/j.ejca.2023.03.001

 

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Worse survival in BRCA1/2 germline mutation carriers receiving ET for HR+/HER2− BC

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Key clinical point: In a pre-cyclin-dependent kinase 4 and 6 inhibitors era, patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who had BRCA1/2 germline mutation (gBRCAm) vs wild type (gBRCAwt) had worse survival outcomes, especially those who received first-line endocrine therapy (ET).

 

Major finding: Compared with gBRCAwt carriers, gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P  =  .024) and progression-free survival (PFS; aHR 1.21; P  =  .017), with both OS (aHR 1.54; P  =  .037) and PFS (aHR 1.58; P  =  .003) being further attenuated in patients receiving first-line ET.

 

Study details: Findings are from a study including 13,776 patients with metastatic BC from the ESME (Épidémio-Stratégie Médico-Economique) metastatic BC database, of which 676 and 170 patients were gBRCAwt and gBRCAm carriers, respectively.

 

Disclosures: The ESME metastatic BC database received financial support from various sources. Some authors declared receiving grants, personal fees, or non-financial support, or having other ties with several sources.

 

Source: Frenel JS et al. Efficacy of front-line treatment for hormone receptor-positive HER2-negative metastatic breast cancer with germline BRCA1/2 mutation. Br J Cancer. 2023 (Apr 3). Doi: 10.1038/s41416-023-02248-4

 

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Key clinical point: In a pre-cyclin-dependent kinase 4 and 6 inhibitors era, patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who had BRCA1/2 germline mutation (gBRCAm) vs wild type (gBRCAwt) had worse survival outcomes, especially those who received first-line endocrine therapy (ET).

 

Major finding: Compared with gBRCAwt carriers, gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P  =  .024) and progression-free survival (PFS; aHR 1.21; P  =  .017), with both OS (aHR 1.54; P  =  .037) and PFS (aHR 1.58; P  =  .003) being further attenuated in patients receiving first-line ET.

 

Study details: Findings are from a study including 13,776 patients with metastatic BC from the ESME (Épidémio-Stratégie Médico-Economique) metastatic BC database, of which 676 and 170 patients were gBRCAwt and gBRCAm carriers, respectively.

 

Disclosures: The ESME metastatic BC database received financial support from various sources. Some authors declared receiving grants, personal fees, or non-financial support, or having other ties with several sources.

 

Source: Frenel JS et al. Efficacy of front-line treatment for hormone receptor-positive HER2-negative metastatic breast cancer with germline BRCA1/2 mutation. Br J Cancer. 2023 (Apr 3). Doi: 10.1038/s41416-023-02248-4

 

Key clinical point: In a pre-cyclin-dependent kinase 4 and 6 inhibitors era, patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who had BRCA1/2 germline mutation (gBRCAm) vs wild type (gBRCAwt) had worse survival outcomes, especially those who received first-line endocrine therapy (ET).

 

Major finding: Compared with gBRCAwt carriers, gBRCAm carriers had shorter overall survival (OS; adjusted hazard ratio [aHR] 1.26; P  =  .024) and progression-free survival (PFS; aHR 1.21; P  =  .017), with both OS (aHR 1.54; P  =  .037) and PFS (aHR 1.58; P  =  .003) being further attenuated in patients receiving first-line ET.

 

Study details: Findings are from a study including 13,776 patients with metastatic BC from the ESME (Épidémio-Stratégie Médico-Economique) metastatic BC database, of which 676 and 170 patients were gBRCAwt and gBRCAm carriers, respectively.

 

Disclosures: The ESME metastatic BC database received financial support from various sources. Some authors declared receiving grants, personal fees, or non-financial support, or having other ties with several sources.

 

Source: Frenel JS et al. Efficacy of front-line treatment for hormone receptor-positive HER2-negative metastatic breast cancer with germline BRCA1/2 mutation. Br J Cancer. 2023 (Apr 3). Doi: 10.1038/s41416-023-02248-4

 

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Progress, gaps as pediatricians expand mental health roles

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Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

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Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

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Low-dose tamoxifen continues to prevent BC recurrence in breast noninvasive neoplasia

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Key clinical point: In women with noninvasive neoplasia of the breast, treatment with low-dose tamoxifen for 3 years continued to prevent breast cancer (BC) recurrence, with an optimal safety profile, for at least 7 years after treatment cessation.

 

Major finding: After a median follow-up of 9.7 years, fewer cases of both invasive and in-situ BC (hazard ratio [HR] 0.58; log-rank P  =  .03) and contralateral BC (HR 0.36; P  =  .025) were reported in the tamoxifen vs placebo group. There was no increase in serious adverse events during tamoxifen therapy.

 

Study details: Findings are from a 10-year follow-up analysis of the phase 3 TAM-01 trial including 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen or placebo.

 

Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared serving as employees, consultants, or advisors, or receiving honoraria and travel and accommodation expenses from several sources.

 

Source: Lazzeroni M et al. Randomized placebo controlled trial of low-dose tamoxifen to prevent recurrence in breast noninvasive neoplasia: A 10-year follow-up of TAM-01 study. J Clin Oncol. 2023 (Mar 14). Doi: 10.1200/JCO.22.02900

 

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Key clinical point: In women with noninvasive neoplasia of the breast, treatment with low-dose tamoxifen for 3 years continued to prevent breast cancer (BC) recurrence, with an optimal safety profile, for at least 7 years after treatment cessation.

 

Major finding: After a median follow-up of 9.7 years, fewer cases of both invasive and in-situ BC (hazard ratio [HR] 0.58; log-rank P  =  .03) and contralateral BC (HR 0.36; P  =  .025) were reported in the tamoxifen vs placebo group. There was no increase in serious adverse events during tamoxifen therapy.

 

Study details: Findings are from a 10-year follow-up analysis of the phase 3 TAM-01 trial including 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen or placebo.

 

Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared serving as employees, consultants, or advisors, or receiving honoraria and travel and accommodation expenses from several sources.

 

Source: Lazzeroni M et al. Randomized placebo controlled trial of low-dose tamoxifen to prevent recurrence in breast noninvasive neoplasia: A 10-year follow-up of TAM-01 study. J Clin Oncol. 2023 (Mar 14). Doi: 10.1200/JCO.22.02900

 

Key clinical point: In women with noninvasive neoplasia of the breast, treatment with low-dose tamoxifen for 3 years continued to prevent breast cancer (BC) recurrence, with an optimal safety profile, for at least 7 years after treatment cessation.

 

Major finding: After a median follow-up of 9.7 years, fewer cases of both invasive and in-situ BC (hazard ratio [HR] 0.58; log-rank P  =  .03) and contralateral BC (HR 0.36; P  =  .025) were reported in the tamoxifen vs placebo group. There was no increase in serious adverse events during tamoxifen therapy.

 

Study details: Findings are from a 10-year follow-up analysis of the phase 3 TAM-01 trial including 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen or placebo.

 

Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared serving as employees, consultants, or advisors, or receiving honoraria and travel and accommodation expenses from several sources.

 

Source: Lazzeroni M et al. Randomized placebo controlled trial of low-dose tamoxifen to prevent recurrence in breast noninvasive neoplasia: A 10-year follow-up of TAM-01 study. J Clin Oncol. 2023 (Mar 14). Doi: 10.1200/JCO.22.02900

 

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Both combined and progestagen-only contraceptives associated with slightly increased BC risk

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Key clinical point: Current or recent use of either progestagen-only or oral estrogen+progestagen contraceptives increased the risk for breast cancer (BC) by 20%-30% in premenopausal women aged <50 years.

 

Major finding: Risk for incident BC was significantly increased in women who used vs did not use oral estrogen+progestagen (adjusted odds ratio [aOR] 1.23; P < .001), oral progestagen (aOR 1.26; P < .001), injectable progestagens (aOR 1.25; P  =  .004), or progestagen intra-uterine devices (aOR 1.32; P < .001).

 

Study details: Findings are from a nested case-control study including 9498 premenopausal women aged <50 years with BC and 18,171 matched control individuals and a meta-analysis including 12 observational studies for progestagen-only preparations.

 

Disclosures: This study was supported by the Cancer Epidemiology Unit by Cancer Research UK and UK Medical Research Council. The authors declared no conflicts of interest.

 

Source: Fitzpatrick D et al. Combined and progestagen-only hormonal contraceptives and breast cancer risk: A UK nested case–control study and meta-analysis. PLoS Med. 2023;20(3):e1004188 (Mar 21). Doi: 10.1371/journal.pmed.1004188

 

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Key clinical point: Current or recent use of either progestagen-only or oral estrogen+progestagen contraceptives increased the risk for breast cancer (BC) by 20%-30% in premenopausal women aged <50 years.

 

Major finding: Risk for incident BC was significantly increased in women who used vs did not use oral estrogen+progestagen (adjusted odds ratio [aOR] 1.23; P < .001), oral progestagen (aOR 1.26; P < .001), injectable progestagens (aOR 1.25; P  =  .004), or progestagen intra-uterine devices (aOR 1.32; P < .001).

 

Study details: Findings are from a nested case-control study including 9498 premenopausal women aged <50 years with BC and 18,171 matched control individuals and a meta-analysis including 12 observational studies for progestagen-only preparations.

 

Disclosures: This study was supported by the Cancer Epidemiology Unit by Cancer Research UK and UK Medical Research Council. The authors declared no conflicts of interest.

 

Source: Fitzpatrick D et al. Combined and progestagen-only hormonal contraceptives and breast cancer risk: A UK nested case–control study and meta-analysis. PLoS Med. 2023;20(3):e1004188 (Mar 21). Doi: 10.1371/journal.pmed.1004188

 

Key clinical point: Current or recent use of either progestagen-only or oral estrogen+progestagen contraceptives increased the risk for breast cancer (BC) by 20%-30% in premenopausal women aged <50 years.

 

Major finding: Risk for incident BC was significantly increased in women who used vs did not use oral estrogen+progestagen (adjusted odds ratio [aOR] 1.23; P < .001), oral progestagen (aOR 1.26; P < .001), injectable progestagens (aOR 1.25; P  =  .004), or progestagen intra-uterine devices (aOR 1.32; P < .001).

 

Study details: Findings are from a nested case-control study including 9498 premenopausal women aged <50 years with BC and 18,171 matched control individuals and a meta-analysis including 12 observational studies for progestagen-only preparations.

 

Disclosures: This study was supported by the Cancer Epidemiology Unit by Cancer Research UK and UK Medical Research Council. The authors declared no conflicts of interest.

 

Source: Fitzpatrick D et al. Combined and progestagen-only hormonal contraceptives and breast cancer risk: A UK nested case–control study and meta-analysis. PLoS Med. 2023;20(3):e1004188 (Mar 21). Doi: 10.1371/journal.pmed.1004188

 

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Mastectomy associated with worse frailty in older women with early-stage breast cancer

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Key clinical point: Older patients with ductal carcinoma in situ (DCIS) of the breast or hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) early-stage breast cancer (BC) who underwent mastectomy vs lumpectomy experienced a significantly greater decline in frailty status.

 

Major finding: Women who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39).

 

Study details: Findings are from a cohort study including 31,084 women aged ≥65 years with DCIS (n = 9962) or HR+/ERBB2+ (n = 21,122) stage I BC, of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively.

 

Disclosures: This study was funded by the Brigham and Women’s Hospital Department of Surgery, Utah. Some authors declared serving as advisors, on the board of directors, and on steering committees, or receiving grants, personal fees, honoraria, or funding from various sources.

 

Source: Minami CA et al. Association of surgery with frailty status in older women with early-stage breast cancer. JAMA Surg. 2023 (Mar 15). Doi: 10.1001/jamasurg.2022.8146

 

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Key clinical point: Older patients with ductal carcinoma in situ (DCIS) of the breast or hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) early-stage breast cancer (BC) who underwent mastectomy vs lumpectomy experienced a significantly greater decline in frailty status.

 

Major finding: Women who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39).

 

Study details: Findings are from a cohort study including 31,084 women aged ≥65 years with DCIS (n = 9962) or HR+/ERBB2+ (n = 21,122) stage I BC, of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively.

 

Disclosures: This study was funded by the Brigham and Women’s Hospital Department of Surgery, Utah. Some authors declared serving as advisors, on the board of directors, and on steering committees, or receiving grants, personal fees, honoraria, or funding from various sources.

 

Source: Minami CA et al. Association of surgery with frailty status in older women with early-stage breast cancer. JAMA Surg. 2023 (Mar 15). Doi: 10.1001/jamasurg.2022.8146

 

Key clinical point: Older patients with ductal carcinoma in situ (DCIS) of the breast or hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) early-stage breast cancer (BC) who underwent mastectomy vs lumpectomy experienced a significantly greater decline in frailty status.

 

Major finding: Women who underwent mastectomy vs lumpectomy were more likely to experience worse frailty (adjusted odds ratio 1.31; 95% CI 1.23-1.39).

 

Study details: Findings are from a cohort study including 31,084 women aged ≥65 years with DCIS (n = 9962) or HR+/ERBB2+ (n = 21,122) stage I BC, of which 22.6% and 77.4% of patients underwent mastectomy and lumpectomy, respectively.

 

Disclosures: This study was funded by the Brigham and Women’s Hospital Department of Surgery, Utah. Some authors declared serving as advisors, on the board of directors, and on steering committees, or receiving grants, personal fees, honoraria, or funding from various sources.

 

Source: Minami CA et al. Association of surgery with frailty status in older women with early-stage breast cancer. JAMA Surg. 2023 (Mar 15). Doi: 10.1001/jamasurg.2022.8146

 

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Weight loss after bariatric surgery may reduce risk of developing breast cancer

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Key clinical point: Weight loss after bariatric surgery reduced the risk of developing breast cancer (BC) in women with prior obesity to a level equivalent to that in women with a body mass index (BMI) of <25 kg/m2.

 

Major finding: After a 1-year washout period, women who did vs did not undergo bariatric surgery had significantly reduced BC risk (hazard ratio [HR] 1.40; P < .001), equivalent to that in women with BMI <25 kg/m2 (HR 1.07; P  =  .10). Weight loss after bariatric surgery was associated with reduced BC risk at 2- and 5-year washout periods as well (both P < .001).

 

Study details: Findings are from a population-based, multiple cohort study including 13,852 women with obesity who underwent bariatric surgery and 55,408 age- and BC screening status-matched women with no history of bariatric surgery, of which 659 women were diagnosed BC.

 

Disclosures: This study was supported by the Ontario Bariatric Registry, Canada, and ICES, Canada. The authors declared no conflicts of interest.

 

Source: Doumouras AG et al. Residual risk of breast cancer after bariatric surgery. JAMA Surg. 2023 (Apr 12). Doi: 10.1001/jamasurg.2023.0530

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Key clinical point: Weight loss after bariatric surgery reduced the risk of developing breast cancer (BC) in women with prior obesity to a level equivalent to that in women with a body mass index (BMI) of <25 kg/m2.

 

Major finding: After a 1-year washout period, women who did vs did not undergo bariatric surgery had significantly reduced BC risk (hazard ratio [HR] 1.40; P < .001), equivalent to that in women with BMI <25 kg/m2 (HR 1.07; P  =  .10). Weight loss after bariatric surgery was associated with reduced BC risk at 2- and 5-year washout periods as well (both P < .001).

 

Study details: Findings are from a population-based, multiple cohort study including 13,852 women with obesity who underwent bariatric surgery and 55,408 age- and BC screening status-matched women with no history of bariatric surgery, of which 659 women were diagnosed BC.

 

Disclosures: This study was supported by the Ontario Bariatric Registry, Canada, and ICES, Canada. The authors declared no conflicts of interest.

 

Source: Doumouras AG et al. Residual risk of breast cancer after bariatric surgery. JAMA Surg. 2023 (Apr 12). Doi: 10.1001/jamasurg.2023.0530

Key clinical point: Weight loss after bariatric surgery reduced the risk of developing breast cancer (BC) in women with prior obesity to a level equivalent to that in women with a body mass index (BMI) of <25 kg/m2.

 

Major finding: After a 1-year washout period, women who did vs did not undergo bariatric surgery had significantly reduced BC risk (hazard ratio [HR] 1.40; P < .001), equivalent to that in women with BMI <25 kg/m2 (HR 1.07; P  =  .10). Weight loss after bariatric surgery was associated with reduced BC risk at 2- and 5-year washout periods as well (both P < .001).

 

Study details: Findings are from a population-based, multiple cohort study including 13,852 women with obesity who underwent bariatric surgery and 55,408 age- and BC screening status-matched women with no history of bariatric surgery, of which 659 women were diagnosed BC.

 

Disclosures: This study was supported by the Ontario Bariatric Registry, Canada, and ICES, Canada. The authors declared no conflicts of interest.

 

Source: Doumouras AG et al. Residual risk of breast cancer after bariatric surgery. JAMA Surg. 2023 (Apr 12). Doi: 10.1001/jamasurg.2023.0530

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Lower nodal positivity in patients receiving neoadjuvant chemotherapy vs upfront surgery in cT1-T2N0 HER2+ BC

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Key clinical point: Overall incidence of nodal disease was lower in patients with clinical T1-T2 (cT1-cT2)N0M0, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received neoadjuvant chemotherapy (NAC) vs surgery.

 

Major finding: Incidence of nodal disease was ~20% in patients with cT1-cT2N0 BC who underwent upfront surgery, which increased to ~25% in patients with cT1c tumors, but was ~10% in patients with cT1-cT2N0 BC who received NAC. Receipt of NAC was significantly associated with a decreased risk for nodal positivity (adjusted odds ratio 0.411; P = .014).

 

Study details: Findings are from an analysis of two international cohorts including patients with cT1-cT2N0M0 HER2+ BC.

 

Disclosures: This study was funded by the US National Cancer Institute and other sources. The authors declared receiving fees, grants, or research funding, or having other ties with several sources.

 

Source: Weiss A et al. Nodal positivity and systemic therapy among patients with clinical T1-T2N0 human epidermal growth factor receptor-positive breast cancer: Results from two international cohorts. Cancer. 2023 (Mar 23). Doi: 10.1002/cncr.34750

 

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Key clinical point: Overall incidence of nodal disease was lower in patients with clinical T1-T2 (cT1-cT2)N0M0, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received neoadjuvant chemotherapy (NAC) vs surgery.

 

Major finding: Incidence of nodal disease was ~20% in patients with cT1-cT2N0 BC who underwent upfront surgery, which increased to ~25% in patients with cT1c tumors, but was ~10% in patients with cT1-cT2N0 BC who received NAC. Receipt of NAC was significantly associated with a decreased risk for nodal positivity (adjusted odds ratio 0.411; P = .014).

 

Study details: Findings are from an analysis of two international cohorts including patients with cT1-cT2N0M0 HER2+ BC.

 

Disclosures: This study was funded by the US National Cancer Institute and other sources. The authors declared receiving fees, grants, or research funding, or having other ties with several sources.

 

Source: Weiss A et al. Nodal positivity and systemic therapy among patients with clinical T1-T2N0 human epidermal growth factor receptor-positive breast cancer: Results from two international cohorts. Cancer. 2023 (Mar 23). Doi: 10.1002/cncr.34750

 

Key clinical point: Overall incidence of nodal disease was lower in patients with clinical T1-T2 (cT1-cT2)N0M0, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received neoadjuvant chemotherapy (NAC) vs surgery.

 

Major finding: Incidence of nodal disease was ~20% in patients with cT1-cT2N0 BC who underwent upfront surgery, which increased to ~25% in patients with cT1c tumors, but was ~10% in patients with cT1-cT2N0 BC who received NAC. Receipt of NAC was significantly associated with a decreased risk for nodal positivity (adjusted odds ratio 0.411; P = .014).

 

Study details: Findings are from an analysis of two international cohorts including patients with cT1-cT2N0M0 HER2+ BC.

 

Disclosures: This study was funded by the US National Cancer Institute and other sources. The authors declared receiving fees, grants, or research funding, or having other ties with several sources.

 

Source: Weiss A et al. Nodal positivity and systemic therapy among patients with clinical T1-T2N0 human epidermal growth factor receptor-positive breast cancer: Results from two international cohorts. Cancer. 2023 (Mar 23). Doi: 10.1002/cncr.34750

 

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Breast cancer patients may benefit from adjuvant aspirin

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Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

 

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

 

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

 

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

 

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

 

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Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

 

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

 

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

 

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

 

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

 

Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

 

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

 

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

 

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

 

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

 

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