Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source

Key clinical point: Breast cancer (BC) diagnosed between five to <10 years postpartum (PP) was associated with a high mortality risk in women with young-onset BC (age ≤ 45 years) who had germline BRCA1/2 pathogenic variants (PV), particularly the BRCA1 mutation.

Major finding: Women with PPBC diagnosed within 5-10 years had an almost 1.5-fold higher mortality risk than nulliparous women (adjusted hazard ratio [aHR] 1.56; P = .03), with the risk being even more prominent in BRCA1 carriers (aHR 2.03; P = .02) and those with estrogen receptor-negative BC (aHR 3.12; P = .02).

Study details: This prospective cohort study included 903 women with germline BRCA1/2 PV diagnosed with stages I-III BC at age ≤ 45 years, of whom 224 were nulliparous at the time of BC diagnosis.

Disclosures: This study was supported by Oregon Health & Science University's Knight Cancer Institute, US National Institutes of Health, US National Cancer Institute, and other sources. Two authors declared receiving personal fees from various sources.

Source: Zhang Z, Ye S, Bernhardt SM, et al. Postpartum breast cancer and survival in women with germline BRCA pathogenic variants. JAMA Netw Open. 2024;7(4):e247421. doi: 10.1001/jamanetworkopen.2024.7421 Source

Key clinical point: Breast cancer (BC) diagnosed between five to <10 years postpartum (PP) was associated with a high mortality risk in women with young-onset BC (age ≤ 45 years) who had germline BRCA1/2 pathogenic variants (PV), particularly the BRCA1 mutation.

Major finding: Women with PPBC diagnosed within 5-10 years had an almost 1.5-fold higher mortality risk than nulliparous women (adjusted hazard ratio [aHR] 1.56; P = .03), with the risk being even more prominent in BRCA1 carriers (aHR 2.03; P = .02) and those with estrogen receptor-negative BC (aHR 3.12; P = .02).

Study details: This prospective cohort study included 903 women with germline BRCA1/2 PV diagnosed with stages I-III BC at age ≤ 45 years, of whom 224 were nulliparous at the time of BC diagnosis.

Disclosures: This study was supported by Oregon Health & Science University's Knight Cancer Institute, US National Institutes of Health, US National Cancer Institute, and other sources. Two authors declared receiving personal fees from various sources.

Source: Zhang Z, Ye S, Bernhardt SM, et al. Postpartum breast cancer and survival in women with germline BRCA pathogenic variants. JAMA Netw Open. 2024;7(4):e247421. doi: 10.1001/jamanetworkopen.2024.7421 Source

Key clinical point: Breast cancer (BC) diagnosed between five to <10 years postpartum (PP) was associated with a high mortality risk in women with young-onset BC (age ≤ 45 years) who had germline BRCA1/2 pathogenic variants (PV), particularly the BRCA1 mutation.

Major finding: Women with PPBC diagnosed within 5-10 years had an almost 1.5-fold higher mortality risk than nulliparous women (adjusted hazard ratio [aHR] 1.56; P = .03), with the risk being even more prominent in BRCA1 carriers (aHR 2.03; P = .02) and those with estrogen receptor-negative BC (aHR 3.12; P = .02).

Study details: This prospective cohort study included 903 women with germline BRCA1/2 PV diagnosed with stages I-III BC at age ≤ 45 years, of whom 224 were nulliparous at the time of BC diagnosis.

Disclosures: This study was supported by Oregon Health & Science University's Knight Cancer Institute, US National Institutes of Health, US National Cancer Institute, and other sources. Two authors declared receiving personal fees from various sources.

Source: Zhang Z, Ye S, Bernhardt SM, et al. Postpartum breast cancer and survival in women with germline BRCA pathogenic variants. JAMA Netw Open. 2024;7(4):e247421. doi: 10.1001/jamanetworkopen.2024.7421 Source

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Key clinical point: Young breast cancer (BC) survivors with a germline pathogenic variant had a higher risk for second primary breast cancer (SPBC) in the first 10 years after diagnosis than those without any mutation.

Major finding: Over a median follow-up of 10 years, 2.5% of BC survivors developed an SPBC. The SPBC risk was around five times higher in carriers vs noncarriers of germline pathogenic variants (subdistribution hazard ratio [sHR] 5.27; P = .01) and in women with primary in situ vs invasive BC (10.4% vs 2.1%; sHR 5.61; P = .01).

Study details: This prospective cohort study included 685 women diagnosed with stages 0-III BC at age ≤ 40 years who underwent unilateral mastectomy or lumpectomy as the primary surgery.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Four authors declared receiving grants or author royalties from various sources.

Source: Brantley KD, Rosenberg SM, Collins LC, et al. Second primary breast cancer in young breast cancer survivors. JAMA Oncol. 2024 (Apr 11). doi: 10.1001/jamaoncol.2024.0286 Source

Key clinical point: Young breast cancer (BC) survivors with a germline pathogenic variant had a higher risk for second primary breast cancer (SPBC) in the first 10 years after diagnosis than those without any mutation.

Major finding: Over a median follow-up of 10 years, 2.5% of BC survivors developed an SPBC. The SPBC risk was around five times higher in carriers vs noncarriers of germline pathogenic variants (subdistribution hazard ratio [sHR] 5.27; P = .01) and in women with primary in situ vs invasive BC (10.4% vs 2.1%; sHR 5.61; P = .01).

Study details: This prospective cohort study included 685 women diagnosed with stages 0-III BC at age ≤ 40 years who underwent unilateral mastectomy or lumpectomy as the primary surgery.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Four authors declared receiving grants or author royalties from various sources.

Source: Brantley KD, Rosenberg SM, Collins LC, et al. Second primary breast cancer in young breast cancer survivors. JAMA Oncol. 2024 (Apr 11). doi: 10.1001/jamaoncol.2024.0286 Source

Key clinical point: Young breast cancer (BC) survivors with a germline pathogenic variant had a higher risk for second primary breast cancer (SPBC) in the first 10 years after diagnosis than those without any mutation.

Major finding: Over a median follow-up of 10 years, 2.5% of BC survivors developed an SPBC. The SPBC risk was around five times higher in carriers vs noncarriers of germline pathogenic variants (subdistribution hazard ratio [sHR] 5.27; P = .01) and in women with primary in situ vs invasive BC (10.4% vs 2.1%; sHR 5.61; P = .01).

Study details: This prospective cohort study included 685 women diagnosed with stages 0-III BC at age ≤ 40 years who underwent unilateral mastectomy or lumpectomy as the primary surgery.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Four authors declared receiving grants or author royalties from various sources.

Source: Brantley KD, Rosenberg SM, Collins LC, et al. Second primary breast cancer in young breast cancer survivors. JAMA Oncol. 2024 (Apr 11). doi: 10.1001/jamaoncol.2024.0286 Source

Key clinical point: A once-daily dose of 300 mg aspirin in the adjuvant setting did not reduce risk for breast cancer (BC) recurrence or improve survival outcomes as compared with placebo in patients with high-risk nonmetastatic BC.

Major finding: Treatment with aspirin and placebo led to comparable invasive disease-free survival (hazard ratio [HR] 1.27; P = .06) and overall survival outcomes (HR 1.19; P = .36) along with similar rates of grades 3 and 4 adverse events.

Study details: This phase 3 trial included 3020 patients with high-risk nonmetastatic BC (age 18 to <70 years) and a history of human epidermal growth factor receptor 2-negative BC who were treated with standard therapy and were randomly assigned to receive 300 mg aspirin or placebo once daily.

Disclosures: This study was supported by the US Department of Defense Breast Cancer Research Program and other sources. Five authors declared receiving grants, royalties, or consulting fees from various sources.

Source: Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs placebo as adjuvant therapy for breast cancer: The Alliance A011502 randomized trial. JAMA. 2024 (Apr 29). doi: 10.1001/jama.2024.4840 Source

Key clinical point: A once-daily dose of 300 mg aspirin in the adjuvant setting did not reduce risk for breast cancer (BC) recurrence or improve survival outcomes as compared with placebo in patients with high-risk nonmetastatic BC.

Major finding: Treatment with aspirin and placebo led to comparable invasive disease-free survival (hazard ratio [HR] 1.27; P = .06) and overall survival outcomes (HR 1.19; P = .36) along with similar rates of grades 3 and 4 adverse events.

Study details: This phase 3 trial included 3020 patients with high-risk nonmetastatic BC (age 18 to <70 years) and a history of human epidermal growth factor receptor 2-negative BC who were treated with standard therapy and were randomly assigned to receive 300 mg aspirin or placebo once daily.

Disclosures: This study was supported by the US Department of Defense Breast Cancer Research Program and other sources. Five authors declared receiving grants, royalties, or consulting fees from various sources.

Source: Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs placebo as adjuvant therapy for breast cancer: The Alliance A011502 randomized trial. JAMA. 2024 (Apr 29). doi: 10.1001/jama.2024.4840 Source

Key clinical point: A once-daily dose of 300 mg aspirin in the adjuvant setting did not reduce risk for breast cancer (BC) recurrence or improve survival outcomes as compared with placebo in patients with high-risk nonmetastatic BC.

Major finding: Treatment with aspirin and placebo led to comparable invasive disease-free survival (hazard ratio [HR] 1.27; P = .06) and overall survival outcomes (HR 1.19; P = .36) along with similar rates of grades 3 and 4 adverse events.

Study details: This phase 3 trial included 3020 patients with high-risk nonmetastatic BC (age 18 to <70 years) and a history of human epidermal growth factor receptor 2-negative BC who were treated with standard therapy and were randomly assigned to receive 300 mg aspirin or placebo once daily.

Disclosures: This study was supported by the US Department of Defense Breast Cancer Research Program and other sources. Five authors declared receiving grants, royalties, or consulting fees from various sources.

Source: Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs placebo as adjuvant therapy for breast cancer: The Alliance A011502 randomized trial. JAMA. 2024 (Apr 29). doi: 10.1001/jama.2024.4840 Source

TOPLINE:

Blood pressure (BP) self-monitoring and medication management may be better than usual care for controlling hypertension, a new study published in JAMA Network Open suggested. 

METHODOLOGY:

• The secondary analysis of a randomized, unblinded clinical trial included patients aged ≥ 40 years with uncontrolled hypertension in Valencia, Spain, between 2017 and 2020.
• The 111 patients in the intervention group received educational materials and instructions for self-monitoring of BP with a home monitor and medication adjustment as needed without contacting their healthcare clinicians.
• The 108 patients in the control group received usual care, including education on BP control.
• After 24 months, researchers recorded BP levels, the number of people who achieved a target BP (systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg), adverse events, quality of life, behavioral changes, and health service use.

TAKEAWAY:

• Patients in the intervention group had a lower average systolic BP reading at 24 months than patients who received usual care (adjusted mean difference, -3.4 mm Hg).
• Patients in the intervention group also had a lower average diastolic BP reading than usual care (adjusted mean difference, -2.5 mm Hg).
• The percentage of people who achieved the target BP was similar in both groups (64% in the intervention group compared with 54% in the control group).
• Researchers found no difference between groups in terms of adverse events, use of health services, behavioral changes such as smoking status or body weight, or quality of life.

IN PRACTICE:

“These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice.” 

SOURCE:

The study was led by Gabriel Sanfélix-Gimeno, PhD, Pharm D, head of the Health Services Research & Pharmacoepidemiology Unit at Fisabio Research Institute in Valencia, Spain.

LIMITATIONS:

Some study participants were lost to follow-up due to COVID-19 restrictions. The trial was unblinded, which may have led to biases among patients and clinicians. Clinicians treated both the control and intervention groups. The results may not be extrapolated to those with controlled hypertension, very high BP, or people who are pregnant because they were not included in the study.

DISCLOSURES:

Various authors reported receiving grants from RTI Health Solutions or personal fees from GSK and MSD outside the submitted work. No other disclosures were reported. The study was funded by the Instituto de Salud Carlos III at the Spanish Ministry of Research, Innovation and Universities, the European Regional Development Fund, and Spanish Clinical Research Network.

A version of this article appeared on Medscape.com.

TOPLINE:

Blood pressure (BP) self-monitoring and medication management may be better than usual care for controlling hypertension, a new study published in JAMA Network Open suggested. 

METHODOLOGY:

• The secondary analysis of a randomized, unblinded clinical trial included patients aged ≥ 40 years with uncontrolled hypertension in Valencia, Spain, between 2017 and 2020.
• The 111 patients in the intervention group received educational materials and instructions for self-monitoring of BP with a home monitor and medication adjustment as needed without contacting their healthcare clinicians.
• The 108 patients in the control group received usual care, including education on BP control.
• After 24 months, researchers recorded BP levels, the number of people who achieved a target BP (systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg), adverse events, quality of life, behavioral changes, and health service use.

TAKEAWAY:

• Patients in the intervention group had a lower average systolic BP reading at 24 months than patients who received usual care (adjusted mean difference, -3.4 mm Hg).
• Patients in the intervention group also had a lower average diastolic BP reading than usual care (adjusted mean difference, -2.5 mm Hg).
• The percentage of people who achieved the target BP was similar in both groups (64% in the intervention group compared with 54% in the control group).
• Researchers found no difference between groups in terms of adverse events, use of health services, behavioral changes such as smoking status or body weight, or quality of life.

IN PRACTICE:

“These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice.” 

SOURCE:

The study was led by Gabriel Sanfélix-Gimeno, PhD, Pharm D, head of the Health Services Research & Pharmacoepidemiology Unit at Fisabio Research Institute in Valencia, Spain.

LIMITATIONS:

Some study participants were lost to follow-up due to COVID-19 restrictions. The trial was unblinded, which may have led to biases among patients and clinicians. Clinicians treated both the control and intervention groups. The results may not be extrapolated to those with controlled hypertension, very high BP, or people who are pregnant because they were not included in the study.

DISCLOSURES:

Various authors reported receiving grants from RTI Health Solutions or personal fees from GSK and MSD outside the submitted work. No other disclosures were reported. The study was funded by the Instituto de Salud Carlos III at the Spanish Ministry of Research, Innovation and Universities, the European Regional Development Fund, and Spanish Clinical Research Network.

A version of this article appeared on Medscape.com.

TOPLINE:

Blood pressure (BP) self-monitoring and medication management may be better than usual care for controlling hypertension, a new study published in JAMA Network Open suggested. 

METHODOLOGY:

• The secondary analysis of a randomized, unblinded clinical trial included patients aged ≥ 40 years with uncontrolled hypertension in Valencia, Spain, between 2017 and 2020.
• The 111 patients in the intervention group received educational materials and instructions for self-monitoring of BP with a home monitor and medication adjustment as needed without contacting their healthcare clinicians.
• The 108 patients in the control group received usual care, including education on BP control.
• After 24 months, researchers recorded BP levels, the number of people who achieved a target BP (systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg), adverse events, quality of life, behavioral changes, and health service use.

TAKEAWAY:

• Patients in the intervention group had a lower average systolic BP reading at 24 months than patients who received usual care (adjusted mean difference, -3.4 mm Hg).
• Patients in the intervention group also had a lower average diastolic BP reading than usual care (adjusted mean difference, -2.5 mm Hg).
• The percentage of people who achieved the target BP was similar in both groups (64% in the intervention group compared with 54% in the control group).
• Researchers found no difference between groups in terms of adverse events, use of health services, behavioral changes such as smoking status or body weight, or quality of life.

IN PRACTICE:

“These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice.” 

SOURCE:

The study was led by Gabriel Sanfélix-Gimeno, PhD, Pharm D, head of the Health Services Research & Pharmacoepidemiology Unit at Fisabio Research Institute in Valencia, Spain.

LIMITATIONS:

Some study participants were lost to follow-up due to COVID-19 restrictions. The trial was unblinded, which may have led to biases among patients and clinicians. Clinicians treated both the control and intervention groups. The results may not be extrapolated to those with controlled hypertension, very high BP, or people who are pregnant because they were not included in the study.

DISCLOSURES:

Various authors reported receiving grants from RTI Health Solutions or personal fees from GSK and MSD outside the submitted work. No other disclosures were reported. The study was funded by the Instituto de Salud Carlos III at the Spanish Ministry of Research, Innovation and Universities, the European Regional Development Fund, and Spanish Clinical Research Network.

A version of this article appeared on Medscape.com.

Key clinical point: Red cell distribution width (RDW) and mean platelet volume (MPV) can be used to detect enthesitis in patients with psoriatic arthritis (psoriatic enthesopathy) with musculoskeletal ultrasound scores.

Major finding: There was a significant association between clinical tenderness, presence of enthesophytes on plain radiography, and musculoskeletal ultrasound findings at entheses sites (P < .001 for each). RDW (P = .010) and MPV (P = .001) levels were elevated in patients with psoriatic enthesopathy vs control individuals without the disease, with the hematological indices being positively correlated with disease activity scores (P < .001).

Study details: This case-control study included 30 patients with psoriatic enthesopathy and 20 control individuals without the disease (age > 18 years).

Disclosures: This study received open access funding from The Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflict of interests.

Source: Amer AS, Al Shambaky AY, Ameen SG, Sobih AK. Hematological indices in psoriatic enthesopathy: Relation to clinical and ultrasound evaluation. Clin Rheumatol. Published online April 8, 2024. Source

Key clinical point: Red cell distribution width (RDW) and mean platelet volume (MPV) can be used to detect enthesitis in patients with psoriatic arthritis (psoriatic enthesopathy) with musculoskeletal ultrasound scores.

Major finding: There was a significant association between clinical tenderness, presence of enthesophytes on plain radiography, and musculoskeletal ultrasound findings at entheses sites (P < .001 for each). RDW (P = .010) and MPV (P = .001) levels were elevated in patients with psoriatic enthesopathy vs control individuals without the disease, with the hematological indices being positively correlated with disease activity scores (P < .001).

Study details: This case-control study included 30 patients with psoriatic enthesopathy and 20 control individuals without the disease (age > 18 years).

Disclosures: This study received open access funding from The Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflict of interests.

Source: Amer AS, Al Shambaky AY, Ameen SG, Sobih AK. Hematological indices in psoriatic enthesopathy: Relation to clinical and ultrasound evaluation. Clin Rheumatol. Published online April 8, 2024. Source

Key clinical point: Red cell distribution width (RDW) and mean platelet volume (MPV) can be used to detect enthesitis in patients with psoriatic arthritis (psoriatic enthesopathy) with musculoskeletal ultrasound scores.

Major finding: There was a significant association between clinical tenderness, presence of enthesophytes on plain radiography, and musculoskeletal ultrasound findings at entheses sites (P < .001 for each). RDW (P = .010) and MPV (P = .001) levels were elevated in patients with psoriatic enthesopathy vs control individuals without the disease, with the hematological indices being positively correlated with disease activity scores (P < .001).

Study details: This case-control study included 30 patients with psoriatic enthesopathy and 20 control individuals without the disease (age > 18 years).

Disclosures: This study received open access funding from The Science, Technology & Innovation Funding Authority in cooperation with The Egyptian Knowledge Bank. The authors declared no conflict of interests.

Source: Amer AS, Al Shambaky AY, Ameen SG, Sobih AK. Hematological indices in psoriatic enthesopathy: Relation to clinical and ultrasound evaluation. Clin Rheumatol. Published online April 8, 2024. Source

Key clinical point: Ultrasound assessment showed reduced thickness of nail bed and adjacent skin in clinically healthy nails of patients with psoriatic arthritis (PsA) than in control individuals without the disease.

Major finding: Ultrasound identified more morphological changes in the clinically healthy nails of patients with PsA vs control individuals (16.89% vs 3.33%; P = .03), along with significantly lower thickness of nail bed (1.77 mm vs 2.07 mm; P = .027) and adjacent skin (2.26 mm vs 2.59 mm; P = .003). Also, the adjacent skin thickness was positively correlated with tender joint count (correlation coefficient, 0.46; P = .03), suggesting that it can be used as a disease activity indicator.

Study details: This cross-sectional study involved the ultrasound assessment of clinically healthy nails in 22 patients with PsA (219 nails) who were compared with 21 control individuals without PsA (210 nails).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Mahmoud I, Rouached L, Rahmouni S, et al. Ultrasound assessment of psoriatic arthritis patients with clinically normal nails and evaluation of its correlation with the disease activity: A case-control study. J Ultrasound Med. Published online April 18, 2024. Source

Key clinical point: Ultrasound assessment showed reduced thickness of nail bed and adjacent skin in clinically healthy nails of patients with psoriatic arthritis (PsA) than in control individuals without the disease.

Major finding: Ultrasound identified more morphological changes in the clinically healthy nails of patients with PsA vs control individuals (16.89% vs 3.33%; P = .03), along with significantly lower thickness of nail bed (1.77 mm vs 2.07 mm; P = .027) and adjacent skin (2.26 mm vs 2.59 mm; P = .003). Also, the adjacent skin thickness was positively correlated with tender joint count (correlation coefficient, 0.46; P = .03), suggesting that it can be used as a disease activity indicator.

Study details: This cross-sectional study involved the ultrasound assessment of clinically healthy nails in 22 patients with PsA (219 nails) who were compared with 21 control individuals without PsA (210 nails).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Mahmoud I, Rouached L, Rahmouni S, et al. Ultrasound assessment of psoriatic arthritis patients with clinically normal nails and evaluation of its correlation with the disease activity: A case-control study. J Ultrasound Med. Published online April 18, 2024. Source

Key clinical point: Ultrasound assessment showed reduced thickness of nail bed and adjacent skin in clinically healthy nails of patients with psoriatic arthritis (PsA) than in control individuals without the disease.

Major finding: Ultrasound identified more morphological changes in the clinically healthy nails of patients with PsA vs control individuals (16.89% vs 3.33%; P = .03), along with significantly lower thickness of nail bed (1.77 mm vs 2.07 mm; P = .027) and adjacent skin (2.26 mm vs 2.59 mm; P = .003). Also, the adjacent skin thickness was positively correlated with tender joint count (correlation coefficient, 0.46; P = .03), suggesting that it can be used as a disease activity indicator.

Study details: This cross-sectional study involved the ultrasound assessment of clinically healthy nails in 22 patients with PsA (219 nails) who were compared with 21 control individuals without PsA (210 nails).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Mahmoud I, Rouached L, Rahmouni S, et al. Ultrasound assessment of psoriatic arthritis patients with clinically normal nails and evaluation of its correlation with the disease activity: A case-control study. J Ultrasound Med. Published online April 18, 2024. Source

Key clinical point: Bimekizumab demonstrated superior efficacy than placebo and had an acceptable safety profile in patients with psoriatic arthritis (PsA).

Major finding: Bimekizumab vs placebo led to a significantly higher response rate for minimal disease activity (risk ratio [RR], 4.188; P < .001), ≥ 70% improvement in the American College of Rheumatology criteria (RR, 7.932; P < .0001). Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR, 1.423; P = .023), whereas that for serious malignancies, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both.

Study details: This meta-analysis of four placebo-controlled randomized clinical trials included 1323 patients with PsA (age, ≥ 18 years), of whom 853 received bimekizumab.

Disclosures: This study was supported by the National Science Foundation of China and the Natural Science Foundation of Shanxi Province. The authors declared no conflict of interests.

Source: Su QY, Yang L, Cao TY, et al. Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis. Expert Opin Drug Saf. Published online April 23, 2024. Source

Key clinical point: Bimekizumab demonstrated superior efficacy than placebo and had an acceptable safety profile in patients with psoriatic arthritis (PsA).

Major finding: Bimekizumab vs placebo led to a significantly higher response rate for minimal disease activity (risk ratio [RR], 4.188; P < .001), ≥ 70% improvement in the American College of Rheumatology criteria (RR, 7.932; P < .0001). Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR, 1.423; P = .023), whereas that for serious malignancies, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both.

Study details: This meta-analysis of four placebo-controlled randomized clinical trials included 1323 patients with PsA (age, ≥ 18 years), of whom 853 received bimekizumab.

Disclosures: This study was supported by the National Science Foundation of China and the Natural Science Foundation of Shanxi Province. The authors declared no conflict of interests.

Source: Su QY, Yang L, Cao TY, et al. Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis. Expert Opin Drug Saf. Published online April 23, 2024. Source

Key clinical point: Bimekizumab demonstrated superior efficacy than placebo and had an acceptable safety profile in patients with psoriatic arthritis (PsA).

Major finding: Bimekizumab vs placebo led to a significantly higher response rate for minimal disease activity (risk ratio [RR], 4.188; P < .001), ≥ 70% improvement in the American College of Rheumatology criteria (RR, 7.932; P < .0001). Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR, 1.423; P = .023), whereas that for serious malignancies, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both.

Study details: This meta-analysis of four placebo-controlled randomized clinical trials included 1323 patients with PsA (age, ≥ 18 years), of whom 853 received bimekizumab.

Disclosures: This study was supported by the National Science Foundation of China and the Natural Science Foundation of Shanxi Province. The authors declared no conflict of interests.

Source: Su QY, Yang L, Cao TY, et al. Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis. Expert Opin Drug Saf. Published online April 23, 2024. Source