FDA expands evinacumab approval to younger kids with HoFH

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The U.S. Food and Drug Administration has expanded the indicated age range for evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals), which was approved 2 years ago as an adjunct to other lipid-lowering therapies for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older.

Olivier Le Moal/Getty Images

The antibody-based agent’s indication now also covers patients aged 5-11 years with the rare genetic disorder, Regeneron announced. It blocks angiopoietin-like 3 (ANGPTL3), inhibiting lipoprotein lipase and endothelial lipase, thereby cutting LDL-cholesterol levels by mechanisms not directly involving the LDL receptor.

The expanded indication is based on a study that saw a 48% drop in LDL-cholesterol levels over 24 weeks, the primary endpoint, across 20 HoFH patients aged 5-11 years who received evinacumab-dgnb on top of maximally tolerated standard lipid-modifying therapy, the company reports.

Levels of apolipoprotein B, non-HDL cholesterol, and total cholesterol also fell significantly in the trial, which was completed in January.

The drug’s efficacy and safety resembled those of a previously reported larger study of patients with HoFH aged 12 years and older (mean age about 40 years) that led to its initial approval.

“The safety and effectiveness of Evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia,” the company states. Nor is it known whether the drug affects clinical outcomes.

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

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The U.S. Food and Drug Administration has expanded the indicated age range for evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals), which was approved 2 years ago as an adjunct to other lipid-lowering therapies for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older.

Olivier Le Moal/Getty Images

The antibody-based agent’s indication now also covers patients aged 5-11 years with the rare genetic disorder, Regeneron announced. It blocks angiopoietin-like 3 (ANGPTL3), inhibiting lipoprotein lipase and endothelial lipase, thereby cutting LDL-cholesterol levels by mechanisms not directly involving the LDL receptor.

The expanded indication is based on a study that saw a 48% drop in LDL-cholesterol levels over 24 weeks, the primary endpoint, across 20 HoFH patients aged 5-11 years who received evinacumab-dgnb on top of maximally tolerated standard lipid-modifying therapy, the company reports.

Levels of apolipoprotein B, non-HDL cholesterol, and total cholesterol also fell significantly in the trial, which was completed in January.

The drug’s efficacy and safety resembled those of a previously reported larger study of patients with HoFH aged 12 years and older (mean age about 40 years) that led to its initial approval.

“The safety and effectiveness of Evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia,” the company states. Nor is it known whether the drug affects clinical outcomes.

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

The U.S. Food and Drug Administration has expanded the indicated age range for evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals), which was approved 2 years ago as an adjunct to other lipid-lowering therapies for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older.

Olivier Le Moal/Getty Images

The antibody-based agent’s indication now also covers patients aged 5-11 years with the rare genetic disorder, Regeneron announced. It blocks angiopoietin-like 3 (ANGPTL3), inhibiting lipoprotein lipase and endothelial lipase, thereby cutting LDL-cholesterol levels by mechanisms not directly involving the LDL receptor.

The expanded indication is based on a study that saw a 48% drop in LDL-cholesterol levels over 24 weeks, the primary endpoint, across 20 HoFH patients aged 5-11 years who received evinacumab-dgnb on top of maximally tolerated standard lipid-modifying therapy, the company reports.

Levels of apolipoprotein B, non-HDL cholesterol, and total cholesterol also fell significantly in the trial, which was completed in January.

The drug’s efficacy and safety resembled those of a previously reported larger study of patients with HoFH aged 12 years and older (mean age about 40 years) that led to its initial approval.

“The safety and effectiveness of Evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia,” the company states. Nor is it known whether the drug affects clinical outcomes.

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

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Gender-based differences in treatment outcomes and persistence with ustekinumab or TNFi in PsA

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Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.

Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P .001), with 12.5% vs 22.1% discontinuing treatment, respectively.

Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.

Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.

Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089

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Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.

Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P .001), with 12.5% vs 22.1% discontinuing treatment, respectively.

Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.

Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.

Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089

Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.

Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P .001), with 12.5% vs 22.1% discontinuing treatment, respectively.

Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.

Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.

Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089

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Dietary Inflammatory Index and BC risk: Is there a link?

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Key clinical point: A pro-inflammatory diet, as indicated by an increasing Dietary Inflammatory Index (DII), is associated with an increased risk of developing breast cancer (BC).

Major finding: Compared with the first DII quintile group (≥–25.91 to <–2.76), the hazard ratios for developing BC were 1.14 (95% CI 1.05-1.24) and 1.13 (95% CI 1.04-1.23) in the fourth (≥1.22 to <3.02) and fifth (≥3.02 to ≤13.37) DII quintile groups, respectively. The risk for BC was increased by 4% for 1 standard deviation increase in DII.

Study details: Findings are from a large population-based cohort study including 67,879 women without cancer who completed a dietary questionnaire, of which 5686 participants developed BC.

Disclosures: The E3N cohort is funded by the Mutuelle Générale de l’Education Nationale, France, and others. The authors declared no conflicts of interest.

Source: Hajji-Louati M et al. Dietary Inflammatory Index and risk of breast cancer: Evidence from a prospective cohort of 67,879 women followed for 20 years in France. Eur J Nutr. 2023 (Mar 4). Doi: 10.1007/s00394-023-03108-w

 

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Key clinical point: A pro-inflammatory diet, as indicated by an increasing Dietary Inflammatory Index (DII), is associated with an increased risk of developing breast cancer (BC).

Major finding: Compared with the first DII quintile group (≥–25.91 to <–2.76), the hazard ratios for developing BC were 1.14 (95% CI 1.05-1.24) and 1.13 (95% CI 1.04-1.23) in the fourth (≥1.22 to <3.02) and fifth (≥3.02 to ≤13.37) DII quintile groups, respectively. The risk for BC was increased by 4% for 1 standard deviation increase in DII.

Study details: Findings are from a large population-based cohort study including 67,879 women without cancer who completed a dietary questionnaire, of which 5686 participants developed BC.

Disclosures: The E3N cohort is funded by the Mutuelle Générale de l’Education Nationale, France, and others. The authors declared no conflicts of interest.

Source: Hajji-Louati M et al. Dietary Inflammatory Index and risk of breast cancer: Evidence from a prospective cohort of 67,879 women followed for 20 years in France. Eur J Nutr. 2023 (Mar 4). Doi: 10.1007/s00394-023-03108-w

 

Key clinical point: A pro-inflammatory diet, as indicated by an increasing Dietary Inflammatory Index (DII), is associated with an increased risk of developing breast cancer (BC).

Major finding: Compared with the first DII quintile group (≥–25.91 to <–2.76), the hazard ratios for developing BC were 1.14 (95% CI 1.05-1.24) and 1.13 (95% CI 1.04-1.23) in the fourth (≥1.22 to <3.02) and fifth (≥3.02 to ≤13.37) DII quintile groups, respectively. The risk for BC was increased by 4% for 1 standard deviation increase in DII.

Study details: Findings are from a large population-based cohort study including 67,879 women without cancer who completed a dietary questionnaire, of which 5686 participants developed BC.

Disclosures: The E3N cohort is funded by the Mutuelle Générale de l’Education Nationale, France, and others. The authors declared no conflicts of interest.

Source: Hajji-Louati M et al. Dietary Inflammatory Index and risk of breast cancer: Evidence from a prospective cohort of 67,879 women followed for 20 years in France. Eur J Nutr. 2023 (Mar 4). Doi: 10.1007/s00394-023-03108-w

 

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Meta-analysis demonstrates high hypothyroidism risk in BC survivors

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Key clinical point: Patients with breast cancer (BC) were significantly more likely to develop hypothyroidism, especially if they received radiation therapy to the supraclavicular region.

Major finding: BC survivors vs control individuals without BC had a 48% increased risk for hypothyroidism (pooled relative risk [RR] 1.48; 95% CI 1.17-1.87), with the risk being even higher in patients with BC who had received radiation therapy to supraclavicular lymph nodes vs breast and chest wall only (pooled RR 1.69; 95% CI 1.16-2.46).

Study details: Findings are from a meta-analysis of 20 studies including women with BC who had or had not received radiation therapy.

Disclosures: This study was supported by The Independent Research Fund Denmark, Medicine, and the Eva and Henry Frænkels Foundation, Denmark.. The authors declared no conflicts of interest.

Source: Solmunde E et al. Breast cancer, breast cancer-directed radiation therapy and risk of hypothyroidism: A systematic review and meta-analysis. Breast. 2023;68:216-224 (Feb 18). Doi: 10.1016/j.breast.2023.02.008

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Key clinical point: Patients with breast cancer (BC) were significantly more likely to develop hypothyroidism, especially if they received radiation therapy to the supraclavicular region.

Major finding: BC survivors vs control individuals without BC had a 48% increased risk for hypothyroidism (pooled relative risk [RR] 1.48; 95% CI 1.17-1.87), with the risk being even higher in patients with BC who had received radiation therapy to supraclavicular lymph nodes vs breast and chest wall only (pooled RR 1.69; 95% CI 1.16-2.46).

Study details: Findings are from a meta-analysis of 20 studies including women with BC who had or had not received radiation therapy.

Disclosures: This study was supported by The Independent Research Fund Denmark, Medicine, and the Eva and Henry Frænkels Foundation, Denmark.. The authors declared no conflicts of interest.

Source: Solmunde E et al. Breast cancer, breast cancer-directed radiation therapy and risk of hypothyroidism: A systematic review and meta-analysis. Breast. 2023;68:216-224 (Feb 18). Doi: 10.1016/j.breast.2023.02.008

Key clinical point: Patients with breast cancer (BC) were significantly more likely to develop hypothyroidism, especially if they received radiation therapy to the supraclavicular region.

Major finding: BC survivors vs control individuals without BC had a 48% increased risk for hypothyroidism (pooled relative risk [RR] 1.48; 95% CI 1.17-1.87), with the risk being even higher in patients with BC who had received radiation therapy to supraclavicular lymph nodes vs breast and chest wall only (pooled RR 1.69; 95% CI 1.16-2.46).

Study details: Findings are from a meta-analysis of 20 studies including women with BC who had or had not received radiation therapy.

Disclosures: This study was supported by The Independent Research Fund Denmark, Medicine, and the Eva and Henry Frænkels Foundation, Denmark.. The authors declared no conflicts of interest.

Source: Solmunde E et al. Breast cancer, breast cancer-directed radiation therapy and risk of hypothyroidism: A systematic review and meta-analysis. Breast. 2023;68:216-224 (Feb 18). Doi: 10.1016/j.breast.2023.02.008

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Longer interval between surgery and ET worsens survival outcomes in HR+ BC

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Tue, 04/11/2023 - 13:34

Key clinical point: Delay in adjuvant endocrine therapy (ET) worsened survival outcomes in patients with hormone receptor-positive (HR+) breast cancer (BC) who received adjuvant radiotherapy after neoadjuvant chemotherapy.

Major finding: An interval of >14 weeks between surgery and receipt of ET was associated with worse recurrence-free survival (hazard ratio 3.20; P = .02).

Study details: This study analyzed 179 patients with HR+ BC from a multi-institutional database who received adjuvant radiotherapy, of which 68 patients received adjuvant ET before or during radiotherapy and 111 patients received ET after cessation of radiotherapy.

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

Source: Sutton TL et al. Delayed adjuvant endocrine therapy is associated with decreased recurrence-free survival following neoadjuvant chemotherapy for breast cancer. Am J Surg. 2023 (Feb 24). Doi: 10.1016/j.amjsurg.2023.02.020

 

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Key clinical point: Delay in adjuvant endocrine therapy (ET) worsened survival outcomes in patients with hormone receptor-positive (HR+) breast cancer (BC) who received adjuvant radiotherapy after neoadjuvant chemotherapy.

Major finding: An interval of >14 weeks between surgery and receipt of ET was associated with worse recurrence-free survival (hazard ratio 3.20; P = .02).

Study details: This study analyzed 179 patients with HR+ BC from a multi-institutional database who received adjuvant radiotherapy, of which 68 patients received adjuvant ET before or during radiotherapy and 111 patients received ET after cessation of radiotherapy.

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

Source: Sutton TL et al. Delayed adjuvant endocrine therapy is associated with decreased recurrence-free survival following neoadjuvant chemotherapy for breast cancer. Am J Surg. 2023 (Feb 24). Doi: 10.1016/j.amjsurg.2023.02.020

 

Key clinical point: Delay in adjuvant endocrine therapy (ET) worsened survival outcomes in patients with hormone receptor-positive (HR+) breast cancer (BC) who received adjuvant radiotherapy after neoadjuvant chemotherapy.

Major finding: An interval of >14 weeks between surgery and receipt of ET was associated with worse recurrence-free survival (hazard ratio 3.20; P = .02).

Study details: This study analyzed 179 patients with HR+ BC from a multi-institutional database who received adjuvant radiotherapy, of which 68 patients received adjuvant ET before or during radiotherapy and 111 patients received ET after cessation of radiotherapy.

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

Source: Sutton TL et al. Delayed adjuvant endocrine therapy is associated with decreased recurrence-free survival following neoadjuvant chemotherapy for breast cancer. Am J Surg. 2023 (Feb 24). Doi: 10.1016/j.amjsurg.2023.02.020

 

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No increase in mortality risk with estrogen therapy in HR+ BC

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Key clinical point: Estrogen therapy with or without the concurrent use of adjuvant aromatase inhibitors (AI) or tamoxifen did not increase the risk for mortality in women with early hormone receptor-positive (HR+) breast cancer (BC).

 

Major finding: No association was observed between BC mortality risk and receipt of estrogen therapy concurrent with AI, tamoxifen, or both AI and tamoxifen, although estrogen therapy without concurrent AI or tamoxifen was associated with decreased BC mortality risk (adjusted odds ratio 0.61; 95% CI 0.43-0.87).

 

Study details: Findings are from a population-based nested case-control study including patients with HR+ BC who received local estrogen therapy or AI, tamoxifen, or AI and tamoxifen sequentially, of which 1262 women died due to BC and were matched to 12,620 alive control individuals.

 

Disclosures: This study was supported by Bröstcancerförbundet, Sweden,and ALF Funding Region Örebro County, Sweden. The authors declared no conflicts of interest.

 

Source: Sund M et al. Estrogen therapy after breast cancer diagnosis and breast cancer mortality risk. Breast Cancer Res Treat. 2023 (Feb 11). Doi: 10.1007/s10549-023-06871-w

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Key clinical point: Estrogen therapy with or without the concurrent use of adjuvant aromatase inhibitors (AI) or tamoxifen did not increase the risk for mortality in women with early hormone receptor-positive (HR+) breast cancer (BC).

 

Major finding: No association was observed between BC mortality risk and receipt of estrogen therapy concurrent with AI, tamoxifen, or both AI and tamoxifen, although estrogen therapy without concurrent AI or tamoxifen was associated with decreased BC mortality risk (adjusted odds ratio 0.61; 95% CI 0.43-0.87).

 

Study details: Findings are from a population-based nested case-control study including patients with HR+ BC who received local estrogen therapy or AI, tamoxifen, or AI and tamoxifen sequentially, of which 1262 women died due to BC and were matched to 12,620 alive control individuals.

 

Disclosures: This study was supported by Bröstcancerförbundet, Sweden,and ALF Funding Region Örebro County, Sweden. The authors declared no conflicts of interest.

 

Source: Sund M et al. Estrogen therapy after breast cancer diagnosis and breast cancer mortality risk. Breast Cancer Res Treat. 2023 (Feb 11). Doi: 10.1007/s10549-023-06871-w

Key clinical point: Estrogen therapy with or without the concurrent use of adjuvant aromatase inhibitors (AI) or tamoxifen did not increase the risk for mortality in women with early hormone receptor-positive (HR+) breast cancer (BC).

 

Major finding: No association was observed between BC mortality risk and receipt of estrogen therapy concurrent with AI, tamoxifen, or both AI and tamoxifen, although estrogen therapy without concurrent AI or tamoxifen was associated with decreased BC mortality risk (adjusted odds ratio 0.61; 95% CI 0.43-0.87).

 

Study details: Findings are from a population-based nested case-control study including patients with HR+ BC who received local estrogen therapy or AI, tamoxifen, or AI and tamoxifen sequentially, of which 1262 women died due to BC and were matched to 12,620 alive control individuals.

 

Disclosures: This study was supported by Bröstcancerförbundet, Sweden,and ALF Funding Region Örebro County, Sweden. The authors declared no conflicts of interest.

 

Source: Sund M et al. Estrogen therapy after breast cancer diagnosis and breast cancer mortality risk. Breast Cancer Res Treat. 2023 (Feb 11). Doi: 10.1007/s10549-023-06871-w

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Preoperative breast MRI has no impact on survival in breast cancer

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Key clinical point: Preoperative magnetic resonance imaging (MRI) of the breast increased mastectomy rates but did not affect the local recurrence and overall survival (OS) rates in patients with breast cancer (BC) who were eligible for breast-conserving surgery (BCS).

Major finding: Among BCS-eligible patients, surgical procedure was changed to mastectomy in 8.3% vs 0.4% of patients in the MRI vs routine radiologic exam group, respectively. There was no difference in local recurrence-free survival (hazard ratio [HR] 0.72; log-rank test P = .7) and OS (HR 1.37; log-rank test P = .8) between both patient populations.

Study details: Findings are from the phase 3 BREAST-MRI study including 524 patients with stage 0-III BC who were eligible for BCS and were randomly assigned to undergo preoperative MRI or radiologic exam routine with mammography and ultrasound.

Disclosures: This publication was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil (FAPESP 2018/24224-9). The authors declared no conflicts of interest.

Source: Mota BS et al. Effects of preoperative magnetic resonance image on survival rates and surgical planning in breast cancer conservative surgery: Randomized controlled trial (BREAST-MRI trial). Breast Cancer Res Treat. 2023 (Feb 14). Doi: 10.1007/s10549-023-06884-5

 

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Key clinical point: Preoperative magnetic resonance imaging (MRI) of the breast increased mastectomy rates but did not affect the local recurrence and overall survival (OS) rates in patients with breast cancer (BC) who were eligible for breast-conserving surgery (BCS).

Major finding: Among BCS-eligible patients, surgical procedure was changed to mastectomy in 8.3% vs 0.4% of patients in the MRI vs routine radiologic exam group, respectively. There was no difference in local recurrence-free survival (hazard ratio [HR] 0.72; log-rank test P = .7) and OS (HR 1.37; log-rank test P = .8) between both patient populations.

Study details: Findings are from the phase 3 BREAST-MRI study including 524 patients with stage 0-III BC who were eligible for BCS and were randomly assigned to undergo preoperative MRI or radiologic exam routine with mammography and ultrasound.

Disclosures: This publication was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil (FAPESP 2018/24224-9). The authors declared no conflicts of interest.

Source: Mota BS et al. Effects of preoperative magnetic resonance image on survival rates and surgical planning in breast cancer conservative surgery: Randomized controlled trial (BREAST-MRI trial). Breast Cancer Res Treat. 2023 (Feb 14). Doi: 10.1007/s10549-023-06884-5

 

Key clinical point: Preoperative magnetic resonance imaging (MRI) of the breast increased mastectomy rates but did not affect the local recurrence and overall survival (OS) rates in patients with breast cancer (BC) who were eligible for breast-conserving surgery (BCS).

Major finding: Among BCS-eligible patients, surgical procedure was changed to mastectomy in 8.3% vs 0.4% of patients in the MRI vs routine radiologic exam group, respectively. There was no difference in local recurrence-free survival (hazard ratio [HR] 0.72; log-rank test P = .7) and OS (HR 1.37; log-rank test P = .8) between both patient populations.

Study details: Findings are from the phase 3 BREAST-MRI study including 524 patients with stage 0-III BC who were eligible for BCS and were randomly assigned to undergo preoperative MRI or radiologic exam routine with mammography and ultrasound.

Disclosures: This publication was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil (FAPESP 2018/24224-9). The authors declared no conflicts of interest.

Source: Mota BS et al. Effects of preoperative magnetic resonance image on survival rates and surgical planning in breast cancer conservative surgery: Randomized controlled trial (BREAST-MRI trial). Breast Cancer Res Treat. 2023 (Feb 14). Doi: 10.1007/s10549-023-06884-5

 

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Vaginal laser treatment not superior to sham laser therapy for genitourinary syndrome of menopause in BC survivors

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Key clinical point: Vaginal laser treatment was not superior in improving sexual function and was less well tolerated than sham laser therapy (SLT) in survivors of breast cancer (BC) with genitourinary syndrome of menopause (GSM) who received treatment with aromatase inhibitors (AI).

Major finding: At 6 months, patients receiving fractional carbon dioxide laser therapy (CLT) and those receiving SLT had similar improvement in the female sexual function index score (P = .15), with the CLT vs SLT group having a significantly lower mean tolerance score (3.3 vs 4.1; P = .007).

Study details: Findings are from the randomized clinical trial LIGHT including 84 patients with BC who were receiving AI for GSM and were randomly assigned to receive a first-line therapy based on nonhormonal moisturizers and vaginal vibrator stimulation with fractional CLT or SLT.

Disclosures: This study was funded by grants from Instituto de Salud Carlos III and the European Union, with various items provided by DEKA, IntherPharma, CumLaude Lab, and BCNatal. The authors declared no conflicts of interest.

Source: Mension E et al. Effect of fractional carbon dioxide vs sham laser on sexual function in survivors of breast cancer receiving aromatase inhibitors for genitourinary syndrome of menopause: The LIGHT randomized clinical trial. JAMA Netw Open. 2023;6(2):e2255697 (Feb 10). Doi: 10.1001/jamanetworkopen.2022.55697

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Key clinical point: Vaginal laser treatment was not superior in improving sexual function and was less well tolerated than sham laser therapy (SLT) in survivors of breast cancer (BC) with genitourinary syndrome of menopause (GSM) who received treatment with aromatase inhibitors (AI).

Major finding: At 6 months, patients receiving fractional carbon dioxide laser therapy (CLT) and those receiving SLT had similar improvement in the female sexual function index score (P = .15), with the CLT vs SLT group having a significantly lower mean tolerance score (3.3 vs 4.1; P = .007).

Study details: Findings are from the randomized clinical trial LIGHT including 84 patients with BC who were receiving AI for GSM and were randomly assigned to receive a first-line therapy based on nonhormonal moisturizers and vaginal vibrator stimulation with fractional CLT or SLT.

Disclosures: This study was funded by grants from Instituto de Salud Carlos III and the European Union, with various items provided by DEKA, IntherPharma, CumLaude Lab, and BCNatal. The authors declared no conflicts of interest.

Source: Mension E et al. Effect of fractional carbon dioxide vs sham laser on sexual function in survivors of breast cancer receiving aromatase inhibitors for genitourinary syndrome of menopause: The LIGHT randomized clinical trial. JAMA Netw Open. 2023;6(2):e2255697 (Feb 10). Doi: 10.1001/jamanetworkopen.2022.55697

Key clinical point: Vaginal laser treatment was not superior in improving sexual function and was less well tolerated than sham laser therapy (SLT) in survivors of breast cancer (BC) with genitourinary syndrome of menopause (GSM) who received treatment with aromatase inhibitors (AI).

Major finding: At 6 months, patients receiving fractional carbon dioxide laser therapy (CLT) and those receiving SLT had similar improvement in the female sexual function index score (P = .15), with the CLT vs SLT group having a significantly lower mean tolerance score (3.3 vs 4.1; P = .007).

Study details: Findings are from the randomized clinical trial LIGHT including 84 patients with BC who were receiving AI for GSM and were randomly assigned to receive a first-line therapy based on nonhormonal moisturizers and vaginal vibrator stimulation with fractional CLT or SLT.

Disclosures: This study was funded by grants from Instituto de Salud Carlos III and the European Union, with various items provided by DEKA, IntherPharma, CumLaude Lab, and BCNatal. The authors declared no conflicts of interest.

Source: Mension E et al. Effect of fractional carbon dioxide vs sham laser on sexual function in survivors of breast cancer receiving aromatase inhibitors for genitourinary syndrome of menopause: The LIGHT randomized clinical trial. JAMA Netw Open. 2023;6(2):e2255697 (Feb 10). Doi: 10.1001/jamanetworkopen.2022.55697

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No detrimental effect of ET on cognitive functioning in early BC

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Key clinical point: Endocrine therapy (ET) did not have any detrimental effect on cognitive abilities in women aged ≥70 years with early breast cancer (BC).

Major finding: Patients receiving ET had a Mini-Mental State Examination (MMSE) score of 28.1, with mild and severe cognitive impairments observed in 25% and 2% of patients, respectively. The MSME score improved by 0.4 points (P = .013) after 15 months and by 0.5 points (P = .018) after 27 months in patients receiving ET.

Study details: Findings are from the observational CLIMB study including 273 women with stage I-III BC who were ≥70 years old, of which 48% received ET.

Disclosures: This study was funded by the KWF Dutch Cancer Society. The authors declared no conflicts of interest.

Source: Baltussen JC et al. Association between endocrine therapy and cognitive decline in older women with early breast cancer: Findings from the prospective CLIMB study. Eur J Cancer. 2023 (Feb 16). Doi: 10.1016/j.ejca.2023.02.008

 

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Key clinical point: Endocrine therapy (ET) did not have any detrimental effect on cognitive abilities in women aged ≥70 years with early breast cancer (BC).

Major finding: Patients receiving ET had a Mini-Mental State Examination (MMSE) score of 28.1, with mild and severe cognitive impairments observed in 25% and 2% of patients, respectively. The MSME score improved by 0.4 points (P = .013) after 15 months and by 0.5 points (P = .018) after 27 months in patients receiving ET.

Study details: Findings are from the observational CLIMB study including 273 women with stage I-III BC who were ≥70 years old, of which 48% received ET.

Disclosures: This study was funded by the KWF Dutch Cancer Society. The authors declared no conflicts of interest.

Source: Baltussen JC et al. Association between endocrine therapy and cognitive decline in older women with early breast cancer: Findings from the prospective CLIMB study. Eur J Cancer. 2023 (Feb 16). Doi: 10.1016/j.ejca.2023.02.008

 

Key clinical point: Endocrine therapy (ET) did not have any detrimental effect on cognitive abilities in women aged ≥70 years with early breast cancer (BC).

Major finding: Patients receiving ET had a Mini-Mental State Examination (MMSE) score of 28.1, with mild and severe cognitive impairments observed in 25% and 2% of patients, respectively. The MSME score improved by 0.4 points (P = .013) after 15 months and by 0.5 points (P = .018) after 27 months in patients receiving ET.

Study details: Findings are from the observational CLIMB study including 273 women with stage I-III BC who were ≥70 years old, of which 48% received ET.

Disclosures: This study was funded by the KWF Dutch Cancer Society. The authors declared no conflicts of interest.

Source: Baltussen JC et al. Association between endocrine therapy and cognitive decline in older women with early breast cancer: Findings from the prospective CLIMB study. Eur J Cancer. 2023 (Feb 16). Doi: 10.1016/j.ejca.2023.02.008

 

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Delaying BC surgery after diagnosis worsens survival

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Key clinical point: Patients with breast cancer (BC) should be recommended to undergo primary breast surgery within 8 weeks from BC diagnosis for best survival outcomes.

Major finding: Overall survival outcomes were worsened by ≥15% when the interval between BC diagnosis and surgery was ≥9 weeks compared with 0-4 weeks (hazard ratio at 9 weeks 1.15; P < .001).

 

Study details: Findings are from a case series study including 373,334 female patients with stage I-III BC who underwent primary breast surgery.

 

Disclosures: This study was supported by grants from the US National Cancer Institute and other sources. LG Wilke declared being the founder of and stock owner in Elucent Medical. BM Hanlon declared receiving grants from the US National Institutes of Health outside the submitted work.

 

Source: Wiener AA et al. Reexamining time from breast cancer diagnosis to primary breast surgery. JAMA Surg. 2023 (Mar 1). Doi: 10.1001/jamasurg.2022.8388

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Key clinical point: Patients with breast cancer (BC) should be recommended to undergo primary breast surgery within 8 weeks from BC diagnosis for best survival outcomes.

Major finding: Overall survival outcomes were worsened by ≥15% when the interval between BC diagnosis and surgery was ≥9 weeks compared with 0-4 weeks (hazard ratio at 9 weeks 1.15; P < .001).

 

Study details: Findings are from a case series study including 373,334 female patients with stage I-III BC who underwent primary breast surgery.

 

Disclosures: This study was supported by grants from the US National Cancer Institute and other sources. LG Wilke declared being the founder of and stock owner in Elucent Medical. BM Hanlon declared receiving grants from the US National Institutes of Health outside the submitted work.

 

Source: Wiener AA et al. Reexamining time from breast cancer diagnosis to primary breast surgery. JAMA Surg. 2023 (Mar 1). Doi: 10.1001/jamasurg.2022.8388

Key clinical point: Patients with breast cancer (BC) should be recommended to undergo primary breast surgery within 8 weeks from BC diagnosis for best survival outcomes.

Major finding: Overall survival outcomes were worsened by ≥15% when the interval between BC diagnosis and surgery was ≥9 weeks compared with 0-4 weeks (hazard ratio at 9 weeks 1.15; P < .001).

 

Study details: Findings are from a case series study including 373,334 female patients with stage I-III BC who underwent primary breast surgery.

 

Disclosures: This study was supported by grants from the US National Cancer Institute and other sources. LG Wilke declared being the founder of and stock owner in Elucent Medical. BM Hanlon declared receiving grants from the US National Institutes of Health outside the submitted work.

 

Source: Wiener AA et al. Reexamining time from breast cancer diagnosis to primary breast surgery. JAMA Surg. 2023 (Mar 1). Doi: 10.1001/jamasurg.2022.8388

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