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sNfL and disease course in progressive MS without acute inflammation: Is there a link?
Key clinical point: Changes in serum neurofilament light chain (sNfL) may not be a dynamic biomarker related to confirmed disability progression (CDP) in patients with secondary progressive multiple sclerosis (SPMS) without acute inflammation.
Major finding: At 48 weeks, changes in sNfL were not associated with the risk for CDP in the natalizumab (odds ratio [OR] per 10% increase in sNfL 1.02; 95% CI 0.86-1.21) and placebo (OR per 10% increase in sNfL 0.90; 95% CI 0.64-1.27) groups.
Study details: The findings come from a post hoc analysis of the ASCEND trial involving 317 patients with SPMS without acute inflammation who were randomly assigned to receive either natalizumab (n = 214) or placebo (n = 103).
Disclosures: This study was supported by Biogen. Dr. Zetterberg and Dr. Fox reported receiving personal fees or research contracts from various sources including Biogen. Dr. Belachew reported being an employee and shareholder of Biogen.
Source: Gafson AR et al. JAMA Netw Open. 2022;5(2):e2147588 (Feb 8). Doi: 10.1001/jamanetworkopen.2021.47588
Key clinical point: Changes in serum neurofilament light chain (sNfL) may not be a dynamic biomarker related to confirmed disability progression (CDP) in patients with secondary progressive multiple sclerosis (SPMS) without acute inflammation.
Major finding: At 48 weeks, changes in sNfL were not associated with the risk for CDP in the natalizumab (odds ratio [OR] per 10% increase in sNfL 1.02; 95% CI 0.86-1.21) and placebo (OR per 10% increase in sNfL 0.90; 95% CI 0.64-1.27) groups.
Study details: The findings come from a post hoc analysis of the ASCEND trial involving 317 patients with SPMS without acute inflammation who were randomly assigned to receive either natalizumab (n = 214) or placebo (n = 103).
Disclosures: This study was supported by Biogen. Dr. Zetterberg and Dr. Fox reported receiving personal fees or research contracts from various sources including Biogen. Dr. Belachew reported being an employee and shareholder of Biogen.
Source: Gafson AR et al. JAMA Netw Open. 2022;5(2):e2147588 (Feb 8). Doi: 10.1001/jamanetworkopen.2021.47588
Key clinical point: Changes in serum neurofilament light chain (sNfL) may not be a dynamic biomarker related to confirmed disability progression (CDP) in patients with secondary progressive multiple sclerosis (SPMS) without acute inflammation.
Major finding: At 48 weeks, changes in sNfL were not associated with the risk for CDP in the natalizumab (odds ratio [OR] per 10% increase in sNfL 1.02; 95% CI 0.86-1.21) and placebo (OR per 10% increase in sNfL 0.90; 95% CI 0.64-1.27) groups.
Study details: The findings come from a post hoc analysis of the ASCEND trial involving 317 patients with SPMS without acute inflammation who were randomly assigned to receive either natalizumab (n = 214) or placebo (n = 103).
Disclosures: This study was supported by Biogen. Dr. Zetterberg and Dr. Fox reported receiving personal fees or research contracts from various sources including Biogen. Dr. Belachew reported being an employee and shareholder of Biogen.
Source: Gafson AR et al. JAMA Netw Open. 2022;5(2):e2147588 (Feb 8). Doi: 10.1001/jamanetworkopen.2021.47588
High or increasing sNfl level predictive of impending relapses in active multiple sclerosis
Key clinical point: Both elevated levels of baseline serum neurofilament light chain (sNfL) and increasing levels from a low baseline were associated with multiple sclerosis (MS) relapses, indicating the utility of sNfL in identifying patients who may benefit from early treatment optimization.
Major finding: A 2-fold increase in baseline sNfL was associated with a 1.9-fold increased risk for relapse during follow-up (adjusted hazard ratio [aHR] 1.90; P < .01) and a 2-fold longitudinal increase in sNfL from its first measurement increased the risk for relapse by 1.41-fold (aHR 1.41; P = .04).
Study details: Findings are from an analysis of 58 patients with active MS who were prospectively followed for 1 year as a part of clinical trial.
Disclosures: This study received funding from the MS Society of Canada, Fondazione Italiana Sclerosi Multipla, and Research Manitoba. The authors reported no conflict of interests.
Source: Thebault S et al. Mult Scler Relat Disord. 2022;59:103535 (Jan 18). Doi: 10.1016/j.msard.2022.103535
Key clinical point: Both elevated levels of baseline serum neurofilament light chain (sNfL) and increasing levels from a low baseline were associated with multiple sclerosis (MS) relapses, indicating the utility of sNfL in identifying patients who may benefit from early treatment optimization.
Major finding: A 2-fold increase in baseline sNfL was associated with a 1.9-fold increased risk for relapse during follow-up (adjusted hazard ratio [aHR] 1.90; P < .01) and a 2-fold longitudinal increase in sNfL from its first measurement increased the risk for relapse by 1.41-fold (aHR 1.41; P = .04).
Study details: Findings are from an analysis of 58 patients with active MS who were prospectively followed for 1 year as a part of clinical trial.
Disclosures: This study received funding from the MS Society of Canada, Fondazione Italiana Sclerosi Multipla, and Research Manitoba. The authors reported no conflict of interests.
Source: Thebault S et al. Mult Scler Relat Disord. 2022;59:103535 (Jan 18). Doi: 10.1016/j.msard.2022.103535
Key clinical point: Both elevated levels of baseline serum neurofilament light chain (sNfL) and increasing levels from a low baseline were associated with multiple sclerosis (MS) relapses, indicating the utility of sNfL in identifying patients who may benefit from early treatment optimization.
Major finding: A 2-fold increase in baseline sNfL was associated with a 1.9-fold increased risk for relapse during follow-up (adjusted hazard ratio [aHR] 1.90; P < .01) and a 2-fold longitudinal increase in sNfL from its first measurement increased the risk for relapse by 1.41-fold (aHR 1.41; P = .04).
Study details: Findings are from an analysis of 58 patients with active MS who were prospectively followed for 1 year as a part of clinical trial.
Disclosures: This study received funding from the MS Society of Canada, Fondazione Italiana Sclerosi Multipla, and Research Manitoba. The authors reported no conflict of interests.
Source: Thebault S et al. Mult Scler Relat Disord. 2022;59:103535 (Jan 18). Doi: 10.1016/j.msard.2022.103535
Multiple sclerosis: Excellent response to SARS-CoV-2 vaccine in patients with MS
Key clinical point: Patients with multiple sclerosis (MS) who were untreated or received immunomodulatory disease-modifying treatments (IM-DMT) showed excellent seroconversion rates after SARS-CoV-2 vaccination; however, immunosuppressive DMT (IS-DMT) was associated with lower seroconversion rates.
Major finding: For these patients 3 months after vaccine dose seroconversion occurred in 96.7% of untreated, 97.1% of IM-DMT treated, and 61.1% of IS-DMT treated patients vs. 97.4% of healthy control individuals (P < .001), with IS-DMT being the only significant predictor of seroconversion (odds ratio 0.04; P < .001).
Study details: The finding comes from a multicenter, prospective study involving 456 patients with MS who were either untreated (n = 91) or treated with DMT (IM-DMT, n = 139; IS-DMT, n = 226) and 116 healthy control individuals, all of whom were willing to be vaccinated against SARS-CoV-2.
Disclosures: This study was supported by the Austrian Multiple Sclerosis Society and others. Some of the authors declared serving as an advisor or receiving speaker honoraria, scientific grants, travel funding, and consulting from various sources.
Source: Bsteh G et al. Eur J Neurol. 2022 (Feb 1). Doi: 10.1111/ene.15265
Key clinical point: Patients with multiple sclerosis (MS) who were untreated or received immunomodulatory disease-modifying treatments (IM-DMT) showed excellent seroconversion rates after SARS-CoV-2 vaccination; however, immunosuppressive DMT (IS-DMT) was associated with lower seroconversion rates.
Major finding: For these patients 3 months after vaccine dose seroconversion occurred in 96.7% of untreated, 97.1% of IM-DMT treated, and 61.1% of IS-DMT treated patients vs. 97.4% of healthy control individuals (P < .001), with IS-DMT being the only significant predictor of seroconversion (odds ratio 0.04; P < .001).
Study details: The finding comes from a multicenter, prospective study involving 456 patients with MS who were either untreated (n = 91) or treated with DMT (IM-DMT, n = 139; IS-DMT, n = 226) and 116 healthy control individuals, all of whom were willing to be vaccinated against SARS-CoV-2.
Disclosures: This study was supported by the Austrian Multiple Sclerosis Society and others. Some of the authors declared serving as an advisor or receiving speaker honoraria, scientific grants, travel funding, and consulting from various sources.
Source: Bsteh G et al. Eur J Neurol. 2022 (Feb 1). Doi: 10.1111/ene.15265
Key clinical point: Patients with multiple sclerosis (MS) who were untreated or received immunomodulatory disease-modifying treatments (IM-DMT) showed excellent seroconversion rates after SARS-CoV-2 vaccination; however, immunosuppressive DMT (IS-DMT) was associated with lower seroconversion rates.
Major finding: For these patients 3 months after vaccine dose seroconversion occurred in 96.7% of untreated, 97.1% of IM-DMT treated, and 61.1% of IS-DMT treated patients vs. 97.4% of healthy control individuals (P < .001), with IS-DMT being the only significant predictor of seroconversion (odds ratio 0.04; P < .001).
Study details: The finding comes from a multicenter, prospective study involving 456 patients with MS who were either untreated (n = 91) or treated with DMT (IM-DMT, n = 139; IS-DMT, n = 226) and 116 healthy control individuals, all of whom were willing to be vaccinated against SARS-CoV-2.
Disclosures: This study was supported by the Austrian Multiple Sclerosis Society and others. Some of the authors declared serving as an advisor or receiving speaker honoraria, scientific grants, travel funding, and consulting from various sources.
Source: Bsteh G et al. Eur J Neurol. 2022 (Feb 1). Doi: 10.1111/ene.15265
Differential impact of multiple sclerosis therapies on SARS-CoV-2 vaccine-induced immune response
Key clinical point: Spike receptor-binding domain (RBD) immunoglobulin G (IgG) levels following SARS-CoV-2 vaccination were higher in patients with multiple sclerosis (MS) treated with dimethyl fumarate or natalizumab vs. healthy controls; however, the levels were significantly lower in patients receiving sphingosine-1-phosphate receptor modulators (S1P) or anti-CD20 monoclonal antibody (mAb).
Major finding: Postvaccination spike RBD IgG levels were significantly higher in patients treated with dimethyl fumarate (P = .038) and natalizumab (P < .0001) than in healthy controls, whereas patients receiving S1P (P = .01), rituximab (P = .002), or ocrelizumab (P = .0004) showed significantly reduced levels.
Study details: The findings come from a prospective observational study including healthy controls (n = 13) and patients with MS who were either untreated (n = 9) or received treatment with glatiramer acetate (n = 5), dimethyl fumarate (n = 5), natalizumab (n = 6), S1P (n = 7), or anti-CD20 mAbs, including rituximab (n = 13) or ocrelizumab (n = 22).
Disclosures: The study was supported by the National Institutes of Health and others. Some of the authors declared serving on Data Safety Monitoring Boards for or receiving research grant funding and consulting/speaking honoraria from various sources.
Source: Sabatino JJ Jr et al. JCI Insight. 2022 (Jan 14). Doi: 10.1172/jci.insight.156978
Key clinical point: Spike receptor-binding domain (RBD) immunoglobulin G (IgG) levels following SARS-CoV-2 vaccination were higher in patients with multiple sclerosis (MS) treated with dimethyl fumarate or natalizumab vs. healthy controls; however, the levels were significantly lower in patients receiving sphingosine-1-phosphate receptor modulators (S1P) or anti-CD20 monoclonal antibody (mAb).
Major finding: Postvaccination spike RBD IgG levels were significantly higher in patients treated with dimethyl fumarate (P = .038) and natalizumab (P < .0001) than in healthy controls, whereas patients receiving S1P (P = .01), rituximab (P = .002), or ocrelizumab (P = .0004) showed significantly reduced levels.
Study details: The findings come from a prospective observational study including healthy controls (n = 13) and patients with MS who were either untreated (n = 9) or received treatment with glatiramer acetate (n = 5), dimethyl fumarate (n = 5), natalizumab (n = 6), S1P (n = 7), or anti-CD20 mAbs, including rituximab (n = 13) or ocrelizumab (n = 22).
Disclosures: The study was supported by the National Institutes of Health and others. Some of the authors declared serving on Data Safety Monitoring Boards for or receiving research grant funding and consulting/speaking honoraria from various sources.
Source: Sabatino JJ Jr et al. JCI Insight. 2022 (Jan 14). Doi: 10.1172/jci.insight.156978
Key clinical point: Spike receptor-binding domain (RBD) immunoglobulin G (IgG) levels following SARS-CoV-2 vaccination were higher in patients with multiple sclerosis (MS) treated with dimethyl fumarate or natalizumab vs. healthy controls; however, the levels were significantly lower in patients receiving sphingosine-1-phosphate receptor modulators (S1P) or anti-CD20 monoclonal antibody (mAb).
Major finding: Postvaccination spike RBD IgG levels were significantly higher in patients treated with dimethyl fumarate (P = .038) and natalizumab (P < .0001) than in healthy controls, whereas patients receiving S1P (P = .01), rituximab (P = .002), or ocrelizumab (P = .0004) showed significantly reduced levels.
Study details: The findings come from a prospective observational study including healthy controls (n = 13) and patients with MS who were either untreated (n = 9) or received treatment with glatiramer acetate (n = 5), dimethyl fumarate (n = 5), natalizumab (n = 6), S1P (n = 7), or anti-CD20 mAbs, including rituximab (n = 13) or ocrelizumab (n = 22).
Disclosures: The study was supported by the National Institutes of Health and others. Some of the authors declared serving on Data Safety Monitoring Boards for or receiving research grant funding and consulting/speaking honoraria from various sources.
Source: Sabatino JJ Jr et al. JCI Insight. 2022 (Jan 14). Doi: 10.1172/jci.insight.156978
Multiple sclerosis: Evidence spanning 3 decades finds no influence of DMTs on neoplasm incidence
Key clinical point: Disease-modifying treatments (DMT) do not influence the risk for neoplasms in patients with multiple sclerosis (MS), indicating either a low carcinogenic potential of DMTs or neoplasia latencies exceeding the typical trial observation periods.
Major finding: The pooled analysis of trials conducted between 1991 and 2020 showed no increased risk for neoplasm between active-DMT treated vs. placebo arms (incidence rate ratio 1.0797; P = .5711).
Study details: This was a meta-analysis of 42 randomized controlled trials of DMTs published between 1991 and 2020, involving 16,360 active-DMT treated and 10,638 placebo-treated patients with MS.
Disclosures: This study received no external funding. D Papadopoulos, DD Mitsikostas, and R Nicholas reported receiving speaker/consultancy fees and travel grants from various sources.
Source: Papadopoulos D et al. J Neurol. 2022 (Jan 23). Doi: 10.1007/s00415-021-10932-9
Key clinical point: Disease-modifying treatments (DMT) do not influence the risk for neoplasms in patients with multiple sclerosis (MS), indicating either a low carcinogenic potential of DMTs or neoplasia latencies exceeding the typical trial observation periods.
Major finding: The pooled analysis of trials conducted between 1991 and 2020 showed no increased risk for neoplasm between active-DMT treated vs. placebo arms (incidence rate ratio 1.0797; P = .5711).
Study details: This was a meta-analysis of 42 randomized controlled trials of DMTs published between 1991 and 2020, involving 16,360 active-DMT treated and 10,638 placebo-treated patients with MS.
Disclosures: This study received no external funding. D Papadopoulos, DD Mitsikostas, and R Nicholas reported receiving speaker/consultancy fees and travel grants from various sources.
Source: Papadopoulos D et al. J Neurol. 2022 (Jan 23). Doi: 10.1007/s00415-021-10932-9
Key clinical point: Disease-modifying treatments (DMT) do not influence the risk for neoplasms in patients with multiple sclerosis (MS), indicating either a low carcinogenic potential of DMTs or neoplasia latencies exceeding the typical trial observation periods.
Major finding: The pooled analysis of trials conducted between 1991 and 2020 showed no increased risk for neoplasm between active-DMT treated vs. placebo arms (incidence rate ratio 1.0797; P = .5711).
Study details: This was a meta-analysis of 42 randomized controlled trials of DMTs published between 1991 and 2020, involving 16,360 active-DMT treated and 10,638 placebo-treated patients with MS.
Disclosures: This study received no external funding. D Papadopoulos, DD Mitsikostas, and R Nicholas reported receiving speaker/consultancy fees and travel grants from various sources.
Source: Papadopoulos D et al. J Neurol. 2022 (Jan 23). Doi: 10.1007/s00415-021-10932-9
Multiple sclerosis relapses are prevalent after natalizumab cessation during pregnancy
Key clinical point: At 1 year postpartum, clinically meaningful disability from pregnancy-related multiple sclerosis (MS) relapses after natalizumab cessation was retained by over 10% of patients with neither restarting natalizumab shortly after delivery nor solely breastfeeding the infant, providing protection against relapse.
Major finding: Overall, 10.58% of pregnancies accrued significant relapse-related disability at 1 year postpartum. Exclusive breastfeeding (adjusted hazard ratio [aHR] 1.34; 95% CI 0.86-2.10) or restarting natalizumab within 4 weeks postpartum (aHR 1.06; 95% CI 0.48-2.36) was not linked to a lower risk for early postpartum relapses 6 months after delivery.
Study details: The findings come from a prospective cohort study that evaluated 274 successful pregnancies in 255 women with MS from the German MS and Pregnancy Registry. The patients stopped natalizumab before pregnancy or in the first trimester.
Disclosures: The registry was partly supported by the German Federal Joint Committee's Innovation Fund and various pharmaceutical companies. Some authors reported receiving speaker fees, honoraria, research support, and travel grants from or serving on advisory boards for various sources.
Source: Hellwig K et al. JAMA Netw Open. 2022;5(1):e2144750 (Jan 24). Doi: 10.1001/jamanetworkopen.2021.44750
Key clinical point: At 1 year postpartum, clinically meaningful disability from pregnancy-related multiple sclerosis (MS) relapses after natalizumab cessation was retained by over 10% of patients with neither restarting natalizumab shortly after delivery nor solely breastfeeding the infant, providing protection against relapse.
Major finding: Overall, 10.58% of pregnancies accrued significant relapse-related disability at 1 year postpartum. Exclusive breastfeeding (adjusted hazard ratio [aHR] 1.34; 95% CI 0.86-2.10) or restarting natalizumab within 4 weeks postpartum (aHR 1.06; 95% CI 0.48-2.36) was not linked to a lower risk for early postpartum relapses 6 months after delivery.
Study details: The findings come from a prospective cohort study that evaluated 274 successful pregnancies in 255 women with MS from the German MS and Pregnancy Registry. The patients stopped natalizumab before pregnancy or in the first trimester.
Disclosures: The registry was partly supported by the German Federal Joint Committee's Innovation Fund and various pharmaceutical companies. Some authors reported receiving speaker fees, honoraria, research support, and travel grants from or serving on advisory boards for various sources.
Source: Hellwig K et al. JAMA Netw Open. 2022;5(1):e2144750 (Jan 24). Doi: 10.1001/jamanetworkopen.2021.44750
Key clinical point: At 1 year postpartum, clinically meaningful disability from pregnancy-related multiple sclerosis (MS) relapses after natalizumab cessation was retained by over 10% of patients with neither restarting natalizumab shortly after delivery nor solely breastfeeding the infant, providing protection against relapse.
Major finding: Overall, 10.58% of pregnancies accrued significant relapse-related disability at 1 year postpartum. Exclusive breastfeeding (adjusted hazard ratio [aHR] 1.34; 95% CI 0.86-2.10) or restarting natalizumab within 4 weeks postpartum (aHR 1.06; 95% CI 0.48-2.36) was not linked to a lower risk for early postpartum relapses 6 months after delivery.
Study details: The findings come from a prospective cohort study that evaluated 274 successful pregnancies in 255 women with MS from the German MS and Pregnancy Registry. The patients stopped natalizumab before pregnancy or in the first trimester.
Disclosures: The registry was partly supported by the German Federal Joint Committee's Innovation Fund and various pharmaceutical companies. Some authors reported receiving speaker fees, honoraria, research support, and travel grants from or serving on advisory boards for various sources.
Source: Hellwig K et al. JAMA Netw Open. 2022;5(1):e2144750 (Jan 24). Doi: 10.1001/jamanetworkopen.2021.44750
Third COVID-19 vaccine dose shows benefit in MS patients with a weak response after 2 doses
Key clinical point: The third dose of COVID-19 mRNA vaccine increased the levels of anti-SARS-CoV-2 spike receptor-binding domain (RBD) immunoglobulin G (IgG) antibodies in patients with multiple sclerosis (MS) treated with anti-CD20 therapy or fingolimod who had a weak humoral response after 2 doses of mRNA COVID-19 vaccine.
Major finding: After revaccination, the mean levels of anti-SARS-CoV-2 spike RBD IgG titers increased significantly in both anti-CD20 (75.7 arbitrary units [AU]; P < .001) and fingolimod (29.6 AU; P = .006) treated groups. No serious adverse events were recorded.
Study details: The findings come from an observational cohort study involving 130 patients with MS treated with anti-CD20 therapy (n = 101) or fingolimod (n = 29) who had a weak humoral response after 2 doses of mRNA COVID-19 vaccines and were offered a third dose.
Disclosures: The Coalition for Epidemic Preparedness Innovations and Oslo university hospital provided funding for conducting the study. Dr. König and Dr. Holmøy reported receiving speaker honoraria from various sources.
Source: König M et al. JAMA Neurol. 2022 (Jan 24). Doi: 10.1001/jamaneurol.2021.5109
Key clinical point: The third dose of COVID-19 mRNA vaccine increased the levels of anti-SARS-CoV-2 spike receptor-binding domain (RBD) immunoglobulin G (IgG) antibodies in patients with multiple sclerosis (MS) treated with anti-CD20 therapy or fingolimod who had a weak humoral response after 2 doses of mRNA COVID-19 vaccine.
Major finding: After revaccination, the mean levels of anti-SARS-CoV-2 spike RBD IgG titers increased significantly in both anti-CD20 (75.7 arbitrary units [AU]; P < .001) and fingolimod (29.6 AU; P = .006) treated groups. No serious adverse events were recorded.
Study details: The findings come from an observational cohort study involving 130 patients with MS treated with anti-CD20 therapy (n = 101) or fingolimod (n = 29) who had a weak humoral response after 2 doses of mRNA COVID-19 vaccines and were offered a third dose.
Disclosures: The Coalition for Epidemic Preparedness Innovations and Oslo university hospital provided funding for conducting the study. Dr. König and Dr. Holmøy reported receiving speaker honoraria from various sources.
Source: König M et al. JAMA Neurol. 2022 (Jan 24). Doi: 10.1001/jamaneurol.2021.5109
Key clinical point: The third dose of COVID-19 mRNA vaccine increased the levels of anti-SARS-CoV-2 spike receptor-binding domain (RBD) immunoglobulin G (IgG) antibodies in patients with multiple sclerosis (MS) treated with anti-CD20 therapy or fingolimod who had a weak humoral response after 2 doses of mRNA COVID-19 vaccine.
Major finding: After revaccination, the mean levels of anti-SARS-CoV-2 spike RBD IgG titers increased significantly in both anti-CD20 (75.7 arbitrary units [AU]; P < .001) and fingolimod (29.6 AU; P = .006) treated groups. No serious adverse events were recorded.
Study details: The findings come from an observational cohort study involving 130 patients with MS treated with anti-CD20 therapy (n = 101) or fingolimod (n = 29) who had a weak humoral response after 2 doses of mRNA COVID-19 vaccines and were offered a third dose.
Disclosures: The Coalition for Epidemic Preparedness Innovations and Oslo university hospital provided funding for conducting the study. Dr. König and Dr. Holmøy reported receiving speaker honoraria from various sources.
Source: König M et al. JAMA Neurol. 2022 (Jan 24). Doi: 10.1001/jamaneurol.2021.5109
HR-positive BC: Sulindac relieves musculoskeletal symptoms in patients receiving aromatase inhibitors
Key clinical point: Sulindac relieved musculoskeletal symptoms in patients with hormone receptor-positive (HR+) breast cancer (BC) who received aromatase inhibitor (AI) for ≥3 months.
Major finding: At 12 months, patients receiving sulindac reported a significant improvement in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; − 5.85; P = .003), pain (−5.40; P = .043), stiffness (−9.53, P < .001), and physical function (− 5.61; P = .006) with 37% of patients with higher baseline symptoms reporting ≥50% improvement in total WOMAC along with an overall tolerable safety profile.
Study details: Findings are from a phase 2 study of postmenopausal women with HR+ BC stable on AI therapy for ≥3 months, of which 43 women received 150 mg sulindac twice daily for 12 months whereas 40 women formed the non-randomized control arm.
Disclosures: This study was supported by the US National Cancer Institute. The authors declared no conflicts of interest.
Source: Martinez JA et al. Breast Cancer Res Treat. 2022;192:113-122 (Jan 18). Doi: 10.1007/s10549-021-06485-0.
Key clinical point: Sulindac relieved musculoskeletal symptoms in patients with hormone receptor-positive (HR+) breast cancer (BC) who received aromatase inhibitor (AI) for ≥3 months.
Major finding: At 12 months, patients receiving sulindac reported a significant improvement in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; − 5.85; P = .003), pain (−5.40; P = .043), stiffness (−9.53, P < .001), and physical function (− 5.61; P = .006) with 37% of patients with higher baseline symptoms reporting ≥50% improvement in total WOMAC along with an overall tolerable safety profile.
Study details: Findings are from a phase 2 study of postmenopausal women with HR+ BC stable on AI therapy for ≥3 months, of which 43 women received 150 mg sulindac twice daily for 12 months whereas 40 women formed the non-randomized control arm.
Disclosures: This study was supported by the US National Cancer Institute. The authors declared no conflicts of interest.
Source: Martinez JA et al. Breast Cancer Res Treat. 2022;192:113-122 (Jan 18). Doi: 10.1007/s10549-021-06485-0.
Key clinical point: Sulindac relieved musculoskeletal symptoms in patients with hormone receptor-positive (HR+) breast cancer (BC) who received aromatase inhibitor (AI) for ≥3 months.
Major finding: At 12 months, patients receiving sulindac reported a significant improvement in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; − 5.85; P = .003), pain (−5.40; P = .043), stiffness (−9.53, P < .001), and physical function (− 5.61; P = .006) with 37% of patients with higher baseline symptoms reporting ≥50% improvement in total WOMAC along with an overall tolerable safety profile.
Study details: Findings are from a phase 2 study of postmenopausal women with HR+ BC stable on AI therapy for ≥3 months, of which 43 women received 150 mg sulindac twice daily for 12 months whereas 40 women formed the non-randomized control arm.
Disclosures: This study was supported by the US National Cancer Institute. The authors declared no conflicts of interest.
Source: Martinez JA et al. Breast Cancer Res Treat. 2022;192:113-122 (Jan 18). Doi: 10.1007/s10549-021-06485-0.
HER2-negative BC: Better pathological response with nab-paclitaxel vs. docetaxel in real world
Key clinical point: Nanoparticle albumin-bound (nab) paclitaxel showed a superior pathological complete response (pCR) rate but similar disease-free survival (DFS) compared with docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC).
Major finding: Rate of pCR was significantly higher in the nab-paclitaxel vs. docetaxel group (36.71% vs. 20.00%; P = .031); however, DFS was not significantly different (P = .331). At least 1 drug-related adverse event was reported in 94.94% vs. 95.00% patients in the nab-paclitaxel vs. docetaxel group.
Study details: Findings are from a retrospective analysis of 159 patients with HER2-negative invasive BC who underwent surgery after receiving nab-paclitaxel (n = 79) or docetaxel (n = 80), both with epirubicin and cyclophosphamide.
Disclosures: This study was funded by the Postdoctoral Science Foundation of China, Natural Science Foundation of Shandong Province, and others. The authors declared no conflicts of interest.
Source: Lv Z-D et al. Front Oncol. 2022 (Jan 11). Doi: 10.3389/fonc.2021.760655.
Key clinical point: Nanoparticle albumin-bound (nab) paclitaxel showed a superior pathological complete response (pCR) rate but similar disease-free survival (DFS) compared with docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC).
Major finding: Rate of pCR was significantly higher in the nab-paclitaxel vs. docetaxel group (36.71% vs. 20.00%; P = .031); however, DFS was not significantly different (P = .331). At least 1 drug-related adverse event was reported in 94.94% vs. 95.00% patients in the nab-paclitaxel vs. docetaxel group.
Study details: Findings are from a retrospective analysis of 159 patients with HER2-negative invasive BC who underwent surgery after receiving nab-paclitaxel (n = 79) or docetaxel (n = 80), both with epirubicin and cyclophosphamide.
Disclosures: This study was funded by the Postdoctoral Science Foundation of China, Natural Science Foundation of Shandong Province, and others. The authors declared no conflicts of interest.
Source: Lv Z-D et al. Front Oncol. 2022 (Jan 11). Doi: 10.3389/fonc.2021.760655.
Key clinical point: Nanoparticle albumin-bound (nab) paclitaxel showed a superior pathological complete response (pCR) rate but similar disease-free survival (DFS) compared with docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC).
Major finding: Rate of pCR was significantly higher in the nab-paclitaxel vs. docetaxel group (36.71% vs. 20.00%; P = .031); however, DFS was not significantly different (P = .331). At least 1 drug-related adverse event was reported in 94.94% vs. 95.00% patients in the nab-paclitaxel vs. docetaxel group.
Study details: Findings are from a retrospective analysis of 159 patients with HER2-negative invasive BC who underwent surgery after receiving nab-paclitaxel (n = 79) or docetaxel (n = 80), both with epirubicin and cyclophosphamide.
Disclosures: This study was funded by the Postdoctoral Science Foundation of China, Natural Science Foundation of Shandong Province, and others. The authors declared no conflicts of interest.
Source: Lv Z-D et al. Front Oncol. 2022 (Jan 11). Doi: 10.3389/fonc.2021.760655.
HER2-low expression is dynamic in breast cancer
Key clinical point: Human epidermal growth factor receptor 2 (HER2)-low expression was significantly discordant between early and advanced stages of invasive breast cancer (BC), with the expression being enriched in the advanced stages.
Major finding: Significant discordance in HER2 expression between the primary tumor and matched biopsy samples was observed in the overall population (Cohen’s kappa coefficient (K) 0.33; 95% CI 0.21-0.44) and in subgroups of estrogen receptor-positive (ER+) BC (K 0.32; 95% CI 0.19-0.45) and triple-negative (TN) BC (K 0.18; 95% CI −0.09 to 0.46) with HER2-low expression being enriched in advanced-stage biopsies vs. primary tumors in the overall population (64% vs. 53%), ER+ BC (71% vs. 57%), and TNBC (38% vs. 36%).
Study details: Findings are from a retrospective analysis of 232 patients with HER2-negative invasive BC.
Disclosures: This study was partially funded by the Italian Ministry of Health with Ricerca Corrente. Some of the authors declared serving as an advisor and consultant or receiving honoraria from several sources.
Source: Tarantino P et al. Eur J Cancer. 2022;163:P35-43 (Jan 13). Doi: 10.1016/j.ejca.2021.12.022.
Key clinical point: Human epidermal growth factor receptor 2 (HER2)-low expression was significantly discordant between early and advanced stages of invasive breast cancer (BC), with the expression being enriched in the advanced stages.
Major finding: Significant discordance in HER2 expression between the primary tumor and matched biopsy samples was observed in the overall population (Cohen’s kappa coefficient (K) 0.33; 95% CI 0.21-0.44) and in subgroups of estrogen receptor-positive (ER+) BC (K 0.32; 95% CI 0.19-0.45) and triple-negative (TN) BC (K 0.18; 95% CI −0.09 to 0.46) with HER2-low expression being enriched in advanced-stage biopsies vs. primary tumors in the overall population (64% vs. 53%), ER+ BC (71% vs. 57%), and TNBC (38% vs. 36%).
Study details: Findings are from a retrospective analysis of 232 patients with HER2-negative invasive BC.
Disclosures: This study was partially funded by the Italian Ministry of Health with Ricerca Corrente. Some of the authors declared serving as an advisor and consultant or receiving honoraria from several sources.
Source: Tarantino P et al. Eur J Cancer. 2022;163:P35-43 (Jan 13). Doi: 10.1016/j.ejca.2021.12.022.
Key clinical point: Human epidermal growth factor receptor 2 (HER2)-low expression was significantly discordant between early and advanced stages of invasive breast cancer (BC), with the expression being enriched in the advanced stages.
Major finding: Significant discordance in HER2 expression between the primary tumor and matched biopsy samples was observed in the overall population (Cohen’s kappa coefficient (K) 0.33; 95% CI 0.21-0.44) and in subgroups of estrogen receptor-positive (ER+) BC (K 0.32; 95% CI 0.19-0.45) and triple-negative (TN) BC (K 0.18; 95% CI −0.09 to 0.46) with HER2-low expression being enriched in advanced-stage biopsies vs. primary tumors in the overall population (64% vs. 53%), ER+ BC (71% vs. 57%), and TNBC (38% vs. 36%).
Study details: Findings are from a retrospective analysis of 232 patients with HER2-negative invasive BC.
Disclosures: This study was partially funded by the Italian Ministry of Health with Ricerca Corrente. Some of the authors declared serving as an advisor and consultant or receiving honoraria from several sources.
Source: Tarantino P et al. Eur J Cancer. 2022;163:P35-43 (Jan 13). Doi: 10.1016/j.ejca.2021.12.022.