Remote electrical neuromodulation: A pill-free, needle-free option for long-term migraine management

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Key clinical point: This real-world study confirms the safety, efficacy, and tolerability of remote electrical neuromodulation (REN) for long-term management of acute migraine, thus establishing REN as a valuable comprehensive treatment for this chronic disease.

Major finding: Overall, 74.1% and 26.0% of patients achieved consistent pain relief and pain freedom with REN, respectively, and 70.2% and 33.7% achieved functional disability relief and functional disability freedom, respectively. The incidence of device-related adverse events (dAE) was low, ie, 1.96%, which included 0.49% negligible, 1.22% moderate, and 0.24% mild AE. No severe AE were reported, and all patients continued treatment despite dAE.

Study details: This real-world evidence study included 409 patients with migraine treated for 12 consecutive months with REN, a self-administered device used at the onset of migraine headache or aura for acute treatment.

Disclosures: This study was funded by Theranica Bio-Electronics Ltd. M Weinstein and A Synowiec declared serving as consultants for Theranica. A Stark-Inbar and A Ironi declared being employees of and hold stock options in Theranica. A Mauskop had no conflicts of interest to disclose.

Source: Synowiec A et al. One-year consistent safety, utilization, and efficacy assessment of remote electrical neuromodulation (REN) for migraine treatment. Adv Ther. 2023 (Oct 19). doi: 10.1007/s12325-023-02697-6

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Key clinical point: This real-world study confirms the safety, efficacy, and tolerability of remote electrical neuromodulation (REN) for long-term management of acute migraine, thus establishing REN as a valuable comprehensive treatment for this chronic disease.

Major finding: Overall, 74.1% and 26.0% of patients achieved consistent pain relief and pain freedom with REN, respectively, and 70.2% and 33.7% achieved functional disability relief and functional disability freedom, respectively. The incidence of device-related adverse events (dAE) was low, ie, 1.96%, which included 0.49% negligible, 1.22% moderate, and 0.24% mild AE. No severe AE were reported, and all patients continued treatment despite dAE.

Study details: This real-world evidence study included 409 patients with migraine treated for 12 consecutive months with REN, a self-administered device used at the onset of migraine headache or aura for acute treatment.

Disclosures: This study was funded by Theranica Bio-Electronics Ltd. M Weinstein and A Synowiec declared serving as consultants for Theranica. A Stark-Inbar and A Ironi declared being employees of and hold stock options in Theranica. A Mauskop had no conflicts of interest to disclose.

Source: Synowiec A et al. One-year consistent safety, utilization, and efficacy assessment of remote electrical neuromodulation (REN) for migraine treatment. Adv Ther. 2023 (Oct 19). doi: 10.1007/s12325-023-02697-6

Key clinical point: This real-world study confirms the safety, efficacy, and tolerability of remote electrical neuromodulation (REN) for long-term management of acute migraine, thus establishing REN as a valuable comprehensive treatment for this chronic disease.

Major finding: Overall, 74.1% and 26.0% of patients achieved consistent pain relief and pain freedom with REN, respectively, and 70.2% and 33.7% achieved functional disability relief and functional disability freedom, respectively. The incidence of device-related adverse events (dAE) was low, ie, 1.96%, which included 0.49% negligible, 1.22% moderate, and 0.24% mild AE. No severe AE were reported, and all patients continued treatment despite dAE.

Study details: This real-world evidence study included 409 patients with migraine treated for 12 consecutive months with REN, a self-administered device used at the onset of migraine headache or aura for acute treatment.

Disclosures: This study was funded by Theranica Bio-Electronics Ltd. M Weinstein and A Synowiec declared serving as consultants for Theranica. A Stark-Inbar and A Ironi declared being employees of and hold stock options in Theranica. A Mauskop had no conflicts of interest to disclose.

Source: Synowiec A et al. One-year consistent safety, utilization, and efficacy assessment of remote electrical neuromodulation (REN) for migraine treatment. Adv Ther. 2023 (Oct 19). doi: 10.1007/s12325-023-02697-6

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Ubrogepant and anti-CGRP mAb combo is effective for acute treatment of migraine

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Key clinical point: The use of ubrogepant in combination with anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) leads to meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization in patients with migraine.

Major finding: Following the first treated attack, 61.6% and 80.4% of patients achieved MPR and 34.7% and 55.5% of patients achieved RNF at 2 hours and 4 hours post-dose, respectively, in the ubrogepant plus anti-CGRP mAb arm. Moreover, 72.7% of patients reported being satisfied with ubrogepant when used in combination with anti-CGRP mAb, and 79.7% of patients achieved acute treatment optimization at 30 days.

Study details: Findings are from a prospective, observational study that included 245 patients with migraine who were treated with ubrogepant combined with anti-CGRP mAb, onabotulinumtoxinA, or both, for migraine prevention.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). RB Lipton declared receiving research support, honoraria, and royalties from, and serving as a consultant and advisory board member for various sources, including AbbVie or Allergan.

Source: Lipton RB et al. Real-world use of ubrogepant as acute treatment for migraine with an anti-calcitonin gene-related peptide monoclonal antibody: Results from COURAGE. Neurol Ther. 2023 (Nov 1). doi: 10.1007/s40120-023-00556-8

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Key clinical point: The use of ubrogepant in combination with anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) leads to meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization in patients with migraine.

Major finding: Following the first treated attack, 61.6% and 80.4% of patients achieved MPR and 34.7% and 55.5% of patients achieved RNF at 2 hours and 4 hours post-dose, respectively, in the ubrogepant plus anti-CGRP mAb arm. Moreover, 72.7% of patients reported being satisfied with ubrogepant when used in combination with anti-CGRP mAb, and 79.7% of patients achieved acute treatment optimization at 30 days.

Study details: Findings are from a prospective, observational study that included 245 patients with migraine who were treated with ubrogepant combined with anti-CGRP mAb, onabotulinumtoxinA, or both, for migraine prevention.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). RB Lipton declared receiving research support, honoraria, and royalties from, and serving as a consultant and advisory board member for various sources, including AbbVie or Allergan.

Source: Lipton RB et al. Real-world use of ubrogepant as acute treatment for migraine with an anti-calcitonin gene-related peptide monoclonal antibody: Results from COURAGE. Neurol Ther. 2023 (Nov 1). doi: 10.1007/s40120-023-00556-8

Key clinical point: The use of ubrogepant in combination with anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) leads to meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization in patients with migraine.

Major finding: Following the first treated attack, 61.6% and 80.4% of patients achieved MPR and 34.7% and 55.5% of patients achieved RNF at 2 hours and 4 hours post-dose, respectively, in the ubrogepant plus anti-CGRP mAb arm. Moreover, 72.7% of patients reported being satisfied with ubrogepant when used in combination with anti-CGRP mAb, and 79.7% of patients achieved acute treatment optimization at 30 days.

Study details: Findings are from a prospective, observational study that included 245 patients with migraine who were treated with ubrogepant combined with anti-CGRP mAb, onabotulinumtoxinA, or both, for migraine prevention.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). RB Lipton declared receiving research support, honoraria, and royalties from, and serving as a consultant and advisory board member for various sources, including AbbVie or Allergan.

Source: Lipton RB et al. Real-world use of ubrogepant as acute treatment for migraine with an anti-calcitonin gene-related peptide monoclonal antibody: Results from COURAGE. Neurol Ther. 2023 (Nov 1). doi: 10.1007/s40120-023-00556-8

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Effect of CGRP mAb rollout on prescription patterns of other migraine preventive therapies

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Key clinical point: The introduction of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) has led to a reduction in the prescription of other oral preventive therapies for chronic migraine, likely due to the similar efficacy and better safety profile of CGRP mAb.

Major finding: Overall, the percentage of commonly prescribed preventive medications reduced significantly from 46.3% before the introduction of CGRP mAb to 43.1% post introduction (P = .001), including a large decrease in the prescription of verapamil, tricyclic antidepressants, topiramate, onabotulinumtoxinA, valproate, duloxetine, memantine, and propranolol (all P < .05).

Study details: This retrospective cohort study compared the percentage of patients with chronic migraine who were prescribed oral preventive medications or onabotulinumtoxinA during the CGRP mAb pre-approval period (2015-2017; n = 3144) and post-approval period (2019-2021; n = 4629).

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

Source: Moskatel LS et al. The introduction of the CGRP monoclonal antibodies and their effect on the prescription patterns of chronic migraine preventive medications in a tertiary headache center: A retrospective, observational analysis. Headache. 2023 (Oct 26). doi: 10.1111/head.14642

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Key clinical point: The introduction of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) has led to a reduction in the prescription of other oral preventive therapies for chronic migraine, likely due to the similar efficacy and better safety profile of CGRP mAb.

Major finding: Overall, the percentage of commonly prescribed preventive medications reduced significantly from 46.3% before the introduction of CGRP mAb to 43.1% post introduction (P = .001), including a large decrease in the prescription of verapamil, tricyclic antidepressants, topiramate, onabotulinumtoxinA, valproate, duloxetine, memantine, and propranolol (all P < .05).

Study details: This retrospective cohort study compared the percentage of patients with chronic migraine who were prescribed oral preventive medications or onabotulinumtoxinA during the CGRP mAb pre-approval period (2015-2017; n = 3144) and post-approval period (2019-2021; n = 4629).

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

Source: Moskatel LS et al. The introduction of the CGRP monoclonal antibodies and their effect on the prescription patterns of chronic migraine preventive medications in a tertiary headache center: A retrospective, observational analysis. Headache. 2023 (Oct 26). doi: 10.1111/head.14642

Key clinical point: The introduction of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) has led to a reduction in the prescription of other oral preventive therapies for chronic migraine, likely due to the similar efficacy and better safety profile of CGRP mAb.

Major finding: Overall, the percentage of commonly prescribed preventive medications reduced significantly from 46.3% before the introduction of CGRP mAb to 43.1% post introduction (P = .001), including a large decrease in the prescription of verapamil, tricyclic antidepressants, topiramate, onabotulinumtoxinA, valproate, duloxetine, memantine, and propranolol (all P < .05).

Study details: This retrospective cohort study compared the percentage of patients with chronic migraine who were prescribed oral preventive medications or onabotulinumtoxinA during the CGRP mAb pre-approval period (2015-2017; n = 3144) and post-approval period (2019-2021; n = 4629).

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

Source: Moskatel LS et al. The introduction of the CGRP monoclonal antibodies and their effect on the prescription patterns of chronic migraine preventive medications in a tertiary headache center: A retrospective, observational analysis. Headache. 2023 (Oct 26). doi: 10.1111/head.14642

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BMI and migraine risk in adolescents: What’s the link?

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Key clinical point: Adolescents who are underweight or obese are at an increased risk for migraine, with the risk being more pronounced in case of women.

Major finding: Adolescent women who were underweight or obese had 12% (adjusted odds ratio [aOR] 1.12; 95% CI 1.05-1.19) and 38% (aOR 1.38; 95% CI 1.31-1.46) higher risks for migraine, respectively, than women with low-normal body mass index (BMI) values. Men who were underweight or obese had 11% (aOR 1.11; 95% CI 1.06-1.16) and 24% (aOR 1,24; 95% CI 1.19-1.30) higher risks for migraine, respectively, than men with low-normal BMI values.

Study details: The data come from a retrospective cross-sectional study including 2,094,862 adolescents (age 16-19 years), of whom 57,385 had migraine.

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

Source: Zloof Y et al. Body mass index and migraine in adolescence: A nationwide study. Cephalalgia. 2023 (Oct 26). doi: 10.1177/03331024231209309

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Key clinical point: Adolescents who are underweight or obese are at an increased risk for migraine, with the risk being more pronounced in case of women.

Major finding: Adolescent women who were underweight or obese had 12% (adjusted odds ratio [aOR] 1.12; 95% CI 1.05-1.19) and 38% (aOR 1.38; 95% CI 1.31-1.46) higher risks for migraine, respectively, than women with low-normal body mass index (BMI) values. Men who were underweight or obese had 11% (aOR 1.11; 95% CI 1.06-1.16) and 24% (aOR 1,24; 95% CI 1.19-1.30) higher risks for migraine, respectively, than men with low-normal BMI values.

Study details: The data come from a retrospective cross-sectional study including 2,094,862 adolescents (age 16-19 years), of whom 57,385 had migraine.

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

Source: Zloof Y et al. Body mass index and migraine in adolescence: A nationwide study. Cephalalgia. 2023 (Oct 26). doi: 10.1177/03331024231209309

Key clinical point: Adolescents who are underweight or obese are at an increased risk for migraine, with the risk being more pronounced in case of women.

Major finding: Adolescent women who were underweight or obese had 12% (adjusted odds ratio [aOR] 1.12; 95% CI 1.05-1.19) and 38% (aOR 1.38; 95% CI 1.31-1.46) higher risks for migraine, respectively, than women with low-normal body mass index (BMI) values. Men who were underweight or obese had 11% (aOR 1.11; 95% CI 1.06-1.16) and 24% (aOR 1,24; 95% CI 1.19-1.30) higher risks for migraine, respectively, than men with low-normal BMI values.

Study details: The data come from a retrospective cross-sectional study including 2,094,862 adolescents (age 16-19 years), of whom 57,385 had migraine.

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

Source: Zloof Y et al. Body mass index and migraine in adolescence: A nationwide study. Cephalalgia. 2023 (Oct 26). doi: 10.1177/03331024231209309

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Anti-CGRP antibodies improve depressive symptoms in migraine

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Key clinical point: Treatment with anti-calcitonin gene-related peptide (CGRP) antibodies for 3 months significantly improved depressive symptoms in patients with migraine, independent of the reduction in monthly migraine days (MMD).

Major finding: The proportion of patients with active depression reduced significantly after 3 months of treatment with erenumab and fremanezumab (both P < .001) but not in the group receiving no active treatment. Anti-CGRP medication vs no active medication led to additional reduction in the Hospital Anxiety and Depression Scale scores (β 1.65; P = .01), independent of the reduction in MMD.

Study details: This prospective study included patients with migraine who received erenumab (n = 110), fremanezumab (n = 117), or no active medication (n = 68).

Disclosures: This study did not disclose any funding sources. Three authors declared receiving consultancy support, industry grant, or independent support from various sources. The other authors declared no conflicts of interest.

Source: de Vries Lentsch S, van der Arend BWH, et al. Depression and treatment with anti-calcitonin gene related peptide (CGRP) (ligand or receptor) antibodies for migraine. Eur J Neurol. 2023 (Oct 17). doi: 10.1111/ene.16106

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Key clinical point: Treatment with anti-calcitonin gene-related peptide (CGRP) antibodies for 3 months significantly improved depressive symptoms in patients with migraine, independent of the reduction in monthly migraine days (MMD).

Major finding: The proportion of patients with active depression reduced significantly after 3 months of treatment with erenumab and fremanezumab (both P < .001) but not in the group receiving no active treatment. Anti-CGRP medication vs no active medication led to additional reduction in the Hospital Anxiety and Depression Scale scores (β 1.65; P = .01), independent of the reduction in MMD.

Study details: This prospective study included patients with migraine who received erenumab (n = 110), fremanezumab (n = 117), or no active medication (n = 68).

Disclosures: This study did not disclose any funding sources. Three authors declared receiving consultancy support, industry grant, or independent support from various sources. The other authors declared no conflicts of interest.

Source: de Vries Lentsch S, van der Arend BWH, et al. Depression and treatment with anti-calcitonin gene related peptide (CGRP) (ligand or receptor) antibodies for migraine. Eur J Neurol. 2023 (Oct 17). doi: 10.1111/ene.16106

Key clinical point: Treatment with anti-calcitonin gene-related peptide (CGRP) antibodies for 3 months significantly improved depressive symptoms in patients with migraine, independent of the reduction in monthly migraine days (MMD).

Major finding: The proportion of patients with active depression reduced significantly after 3 months of treatment with erenumab and fremanezumab (both P < .001) but not in the group receiving no active treatment. Anti-CGRP medication vs no active medication led to additional reduction in the Hospital Anxiety and Depression Scale scores (β 1.65; P = .01), independent of the reduction in MMD.

Study details: This prospective study included patients with migraine who received erenumab (n = 110), fremanezumab (n = 117), or no active medication (n = 68).

Disclosures: This study did not disclose any funding sources. Three authors declared receiving consultancy support, industry grant, or independent support from various sources. The other authors declared no conflicts of interest.

Source: de Vries Lentsch S, van der Arend BWH, et al. Depression and treatment with anti-calcitonin gene related peptide (CGRP) (ligand or receptor) antibodies for migraine. Eur J Neurol. 2023 (Oct 17). doi: 10.1111/ene.16106

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Real-world evidence on efficacy of anti-CGRP mAbs in elderly patients with migraine

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Key clinical point: This study provides class-III real-world evidence that anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) are efficacious and safe in patients with migraine age > 65 years but may take more time to show effect in these patients vs those age < 55 years.

Major finding: A similar proportion of patients age > 65 years vs < 55 years achieved a 50% response rate at 20-24 weeks of initiating anti-CGRP mAb (P = .811). Patients age > 65 years vs < 55 years showed lesser reduction in mean monthly headache days at 10-12 weeks (P = .001) and higher reduction in mean monthly migraine days at 20-24 weeks (P = .04). Both groups had similar incidence of treatment-emergent adverse events.

Study details: This multicenter observational case-control study included 114 patients age > 65 years and 114 sex-matched patients age < 55 years with episodic or chronic migraine who received anti-CGRP mAb.

Disclosures: This study did not receive any funding. Several authors declared receiving research support, speaker honoraria, or lecture honoraria from or serving on the advisory boards of various sources.

Source: Gonzalez-Martinez A et al. Effectiveness, tolerability and response predictors of preventive anti-CGRP mAbs for migraine in patients over 65 years old: A multicenter real-world case-control study. Pain Med. 2023 (Oct 17). doi: 10.1093/pm/pnad141

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Key clinical point: This study provides class-III real-world evidence that anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) are efficacious and safe in patients with migraine age > 65 years but may take more time to show effect in these patients vs those age < 55 years.

Major finding: A similar proportion of patients age > 65 years vs < 55 years achieved a 50% response rate at 20-24 weeks of initiating anti-CGRP mAb (P = .811). Patients age > 65 years vs < 55 years showed lesser reduction in mean monthly headache days at 10-12 weeks (P = .001) and higher reduction in mean monthly migraine days at 20-24 weeks (P = .04). Both groups had similar incidence of treatment-emergent adverse events.

Study details: This multicenter observational case-control study included 114 patients age > 65 years and 114 sex-matched patients age < 55 years with episodic or chronic migraine who received anti-CGRP mAb.

Disclosures: This study did not receive any funding. Several authors declared receiving research support, speaker honoraria, or lecture honoraria from or serving on the advisory boards of various sources.

Source: Gonzalez-Martinez A et al. Effectiveness, tolerability and response predictors of preventive anti-CGRP mAbs for migraine in patients over 65 years old: A multicenter real-world case-control study. Pain Med. 2023 (Oct 17). doi: 10.1093/pm/pnad141

Key clinical point: This study provides class-III real-world evidence that anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) are efficacious and safe in patients with migraine age > 65 years but may take more time to show effect in these patients vs those age < 55 years.

Major finding: A similar proportion of patients age > 65 years vs < 55 years achieved a 50% response rate at 20-24 weeks of initiating anti-CGRP mAb (P = .811). Patients age > 65 years vs < 55 years showed lesser reduction in mean monthly headache days at 10-12 weeks (P = .001) and higher reduction in mean monthly migraine days at 20-24 weeks (P = .04). Both groups had similar incidence of treatment-emergent adverse events.

Study details: This multicenter observational case-control study included 114 patients age > 65 years and 114 sex-matched patients age < 55 years with episodic or chronic migraine who received anti-CGRP mAb.

Disclosures: This study did not receive any funding. Several authors declared receiving research support, speaker honoraria, or lecture honoraria from or serving on the advisory boards of various sources.

Source: Gonzalez-Martinez A et al. Effectiveness, tolerability and response predictors of preventive anti-CGRP mAbs for migraine in patients over 65 years old: A multicenter real-world case-control study. Pain Med. 2023 (Oct 17). doi: 10.1093/pm/pnad141

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Ketogenic diets improve symptoms and fatigue in chronic and high-frequency episodic migraine

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Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

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

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

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Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

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

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

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

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

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Commentary: Obesity, Pregnancy, and Adjuvant Chemotherapy in BC, December 2023

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Changed
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Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0>
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi: 10.1093/annonc/mdx308
Author and Disclosure Information

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Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

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Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
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Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Dr. Roesch scans the journals so you don't have to!
Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0>
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi: 10.1093/annonc/mdx308

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0>
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi: 10.1093/annonc/mdx308
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Commentary: Obesity, Pregnancy, and Adjuvant Chemotherapy in BC, December 2023

Article Type
Changed
Tue, 11/21/2023 - 15:48
Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi:10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi:10.1093/annonc/mdx308
Author and Disclosure Information

Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

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Author and Disclosure Information

Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Author and Disclosure Information

Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Dr. Roesch scans the journals so you don't have to!
Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi:10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi:10.1093/annonc/mdx308

Erin Roesch, MD
Obesity and other metabolic comorbidities (including glucose intolerance, hypertension, and dyslipidemia) have been associated with poorer prognosis among breast cancer patients.1 The underlying mechanisms for which obesity is linked to inferior breast cancer outcomes is complex and may also involve drug efficacy in these patients. Data from the ATAC trial showed that there was a higher risk for recurrence among patients with obesity who were receiving an aromatase inhibitor (AI) vs patients with a healthy body weight receiving an AI; however, patients receiving tamoxifen did not exhibit this difference.2 A Danish Breast Cancer Group cohort study including 13,230 postmenopausal patients with stage I-III hormone receptor–positive (HR+) breast cancer treated with AI investigated the association of body mass index with recurrence (Harborg et al). There was a significantly increased risk for recurrence among those patients with obesity (adjusted hazard ratio 1.18; 95% CI 1.01-1.37) and severe obesity (adjusted hazard ratio 1.32; 95% CI 1.08-1.62) vs patients with healthy body weight. These results highlight the importance of lifestyle interventions targeting obesity and metabolic factors in breast cancer patients and support future studies investigating optimal drug selection based on body composition.

Breast cancer in young women presents a unique set of challenges owing to life-stage at the time of diagnosis and treatment. Oncofertility, family planning, and pregnancy are essential issues to address at the time of initial consultation and throughout the survivorship setting. Various studies have provided supportive evidence regarding the safety of pregnancy after breast cancer diagnosis and treatment.3 HR+ breast cancer is associated with its own distinctive considerations related to pregnancy and its timing, including the use of endocrine therapy for 5-10 years, the role of female hormones during pregnancy, and late patterns of recurrence that characterize this subtype. A meta-analysis including eight eligible studies and 3805 women with HR+ early breast cancer investigated the prognostic impact of future pregnancy among these patients (Arecco et al). A total of 1285 women had a pregnancy after breast cancer diagnosis and treatment; there was no difference in disease-free survival (hazard ratio 0.96; 95% CI 0.75-1.24; P = .781) and better overall survival (OS; hazard ratio 0.46; 95% CI 0.27-0.77; P < .005) in those with vs those without subsequent pregnancy. Added to this body of data is the prospective POSITIVE trial, which showed that a temporary pause of endocrine therapy for an attempt at conceiving appears to be safe in young women with early HR+ breast cancer with short-term follow-up.4 Future research efforts investigating outcomes after assisted reproductive technologies in this population, those with germline mutations, and extended follow-up of studies, such as POSITIVE, will continue to inform guidance for and management of young women with breast cancer.

Guidelines favor the use of adjuvant chemotherapy for small, node-negative, triple-negative breast cancer (TNBC), specifically T1b and T1c tumors.5 However, high-quality data to inform this decision-making are sparse, and it is valuable to consider the magnitude of benefit weighed against possible risks and side effects of treatment, as well as patient comorbidities. A retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) database including 11,510 patients (3388 with T1b and 8122 with T1c TNBC) evaluated the impact of adjuvant chemotherapy on OS and breast cancer–specific survival (BCSS) (Carbajal-Ochoa et al). The use of adjuvant chemotherapy was associated with improved OS (hazard ratio 0.54; 95% CI 0.47-0.62; P < .001) and BCSS (hazard ratio 0.79; 95% CI 0.63-0.99; P = .043) among T1c TNBC. For those with T1b tumors, adjuvant chemotherapy improved OS (hazard ratio 0.52; 95% CI 0.41-0.68; P < .001) but did not improve BCSS (hazard ratio 0.70; 95% CI 0.45-1.07; P = .10). A better understanding of the molecular drivers implicated in this heterogeneous subtype, and predictors of response and resistance, will aid in identifying those patients who have greater benefit and those who can potentially be spared chemotherapy-related toxicities.

Additional References

  1. Anwar SL, Cahyono R, Prabowo D, et al. Metabolic comorbidities and the association with risks of recurrent metastatic disease in breast cancer survivors. BMC Cancer. 2021;21:590. doi: 10.1186/s12885-021-08343-0
  2. Sestak I, Distler W, Forbes JF, et al. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: An exploratory analysis from the ATAC trial. J Clin Oncol. 2010;28:3411-3415. doi: 10.1200/JCO.2009.27.2021
  3. Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
  4. Partridge AH, Niman SM, Ruggeri M, et al for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi:10.1056/NEJMoa2212856
  5. Curigliano G, Burstein HJ, Winer EP, et al. De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28:1700-1712. doi:10.1093/annonc/mdx308
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Commentary: JAK Inhibitors and Comorbidities in AD, December 2023

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Dr. Feldman scans the journals, so you don’t have to!

Steven R. Feldman, MD, PhD
This mercifully brief report from Yosipovitch and colleagues describes how lebrikizumab improves itch and improves sleep very rapidly in patients with moderate to severe atopic dermatitis. This is not surprising, as we know that interleukin-13 inhibition is a very good way to treat atopic dermatitis, and we should expect itch and sleep to improve as atopic dermatitis gets better. The take-home message from this report is that the improvements in itch and sleep can occur very quickly, in just a few days.

Schlösser and colleagues provide a real-world report of 48 patients treated with upadacitinib for atopic dermatitis, many of whom had previously been treated with cyclosporine and dupilumab. The upbeat authors concluded, "Overall, adverse events were mostly well tolerated." Being a cynical, glass-is-half-empty kind of person, I wondered what that meant. Most patients (56%) reported adverse events, the most common being acne (25% of patients treated), nausea (13%), respiratory tract infections (10%), and herpes virus (8%). The herpes virus signal is not just a bit of a concern for me, but it also makes it hard for me to convince patients to take a Janus kinase (JAK) inhibitor, as when I even mention herpes, patients reply, often rather emphatically, "I don't want herpes!" I'll be encouraging patients to get vaccinated for shingles when starting them on JAK inhibitors.

Dupilumab seems to work great in real-life use. In Martinez-Cabriales and colleagues' study of 62 children age < 12 with atopic dermatitis, only four discontinued the treatment. One of these was a nonresponder who took only one injection and had flushing, and one of the other three discontinued because their skin had completely cleared.

When I saw the title of Rand and colleagues' article, "Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab Versus Dupilumab in Moderate-to-Severe Atopic Dermatitis," I thought, Oh, this is great — a head-to-head, long-term trial comparing lebrikizumab and dupilumab. I was disappointed to find that this was simply a retrospective analysis of data reported from different studies. The study found little difference in efficacy or safety of the two drugs. Both seem to be excellent medications for atopic dermatitis.

Here's another study (Zhou et al) that reports possible increased risk for a comorbidity (cognitive dysfunction) associated with atopic dermatitis. This study reports that there is an elevated hazard ratio that is statistically significant; the article fails to report what the increased absolute risk is for cognitive dysfunction associated with atopic dermatitis. My guess is that it is small and probably clinically unimportant. The hazard ratio for developing dementia was 1.16. It's hard to know how that translates into absolute risk, but my brilliant friend and former partner, Dr Alan Fleischer, once told me that the odds ratio for smoking and lung cancer is something like 100; the hazard ratio is in the range of 20. On the basis of a hazard ratio of 1.16, I don't think patients with atopic dermatitis need to be any more worried about dementia than those without. (Though, to be honest, I think we can all be worried about developing dementia.)

In this tour de force analysis of 83 trials with over 20,000 participants, Drucker and colleagues determined that high doses of abrocitinib and upadacitinib are more effective than even dupilumab for atopic dermatitis. The standard doses of these JAK inhibitors were similar in efficacy to dupilumab. I think it's safe to say that JAK inhibitors are, at least at their high doses, more effective than dupilumab, but safety remains a critical factor in treatment decision-making. I think JAK inhibitors are a great option for patients who need the most effective treatment or who fail to respond to dupilumab.

The title of the article by Oh and colleagues, "Increased Risk of Renal Malignancy in Patients With Moderate to Severe Atopic Dermatitis," seems like it could terrify patients. The study involved an analysis of an enormous number of people, including tens of thousands with atopic dermatitis and millions of controls. The investigators did find statistically significant differences in the rate of malignancy. The rate of renal cancer was about 1.6 per 10,000 person-years for people without atopic dermatitis or people with mild atopic dermatitis; the rate was about 2.5 per 10,000 people for patients with moderate to severe atopic dermatitis. While the rate of renal cancer was statistically significantly higher in patients with moderate to severe atopic dermatitis (ie, the higher rate was unlikely to be occurring due to chance alone), these patients have very little risk for renal malignancy. The authors' conclusion that regular checkups for renal malignancy are recommended for patients with severe atopic dermatitis seems unnecessary to me.

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Dr. Feldman scans the journals, so you don’t have to!
Dr. Feldman scans the journals, so you don’t have to!

Steven R. Feldman, MD, PhD
This mercifully brief report from Yosipovitch and colleagues describes how lebrikizumab improves itch and improves sleep very rapidly in patients with moderate to severe atopic dermatitis. This is not surprising, as we know that interleukin-13 inhibition is a very good way to treat atopic dermatitis, and we should expect itch and sleep to improve as atopic dermatitis gets better. The take-home message from this report is that the improvements in itch and sleep can occur very quickly, in just a few days.

Schlösser and colleagues provide a real-world report of 48 patients treated with upadacitinib for atopic dermatitis, many of whom had previously been treated with cyclosporine and dupilumab. The upbeat authors concluded, "Overall, adverse events were mostly well tolerated." Being a cynical, glass-is-half-empty kind of person, I wondered what that meant. Most patients (56%) reported adverse events, the most common being acne (25% of patients treated), nausea (13%), respiratory tract infections (10%), and herpes virus (8%). The herpes virus signal is not just a bit of a concern for me, but it also makes it hard for me to convince patients to take a Janus kinase (JAK) inhibitor, as when I even mention herpes, patients reply, often rather emphatically, "I don't want herpes!" I'll be encouraging patients to get vaccinated for shingles when starting them on JAK inhibitors.

Dupilumab seems to work great in real-life use. In Martinez-Cabriales and colleagues' study of 62 children age < 12 with atopic dermatitis, only four discontinued the treatment. One of these was a nonresponder who took only one injection and had flushing, and one of the other three discontinued because their skin had completely cleared.

When I saw the title of Rand and colleagues' article, "Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab Versus Dupilumab in Moderate-to-Severe Atopic Dermatitis," I thought, Oh, this is great — a head-to-head, long-term trial comparing lebrikizumab and dupilumab. I was disappointed to find that this was simply a retrospective analysis of data reported from different studies. The study found little difference in efficacy or safety of the two drugs. Both seem to be excellent medications for atopic dermatitis.

Here's another study (Zhou et al) that reports possible increased risk for a comorbidity (cognitive dysfunction) associated with atopic dermatitis. This study reports that there is an elevated hazard ratio that is statistically significant; the article fails to report what the increased absolute risk is for cognitive dysfunction associated with atopic dermatitis. My guess is that it is small and probably clinically unimportant. The hazard ratio for developing dementia was 1.16. It's hard to know how that translates into absolute risk, but my brilliant friend and former partner, Dr Alan Fleischer, once told me that the odds ratio for smoking and lung cancer is something like 100; the hazard ratio is in the range of 20. On the basis of a hazard ratio of 1.16, I don't think patients with atopic dermatitis need to be any more worried about dementia than those without. (Though, to be honest, I think we can all be worried about developing dementia.)

In this tour de force analysis of 83 trials with over 20,000 participants, Drucker and colleagues determined that high doses of abrocitinib and upadacitinib are more effective than even dupilumab for atopic dermatitis. The standard doses of these JAK inhibitors were similar in efficacy to dupilumab. I think it's safe to say that JAK inhibitors are, at least at their high doses, more effective than dupilumab, but safety remains a critical factor in treatment decision-making. I think JAK inhibitors are a great option for patients who need the most effective treatment or who fail to respond to dupilumab.

The title of the article by Oh and colleagues, "Increased Risk of Renal Malignancy in Patients With Moderate to Severe Atopic Dermatitis," seems like it could terrify patients. The study involved an analysis of an enormous number of people, including tens of thousands with atopic dermatitis and millions of controls. The investigators did find statistically significant differences in the rate of malignancy. The rate of renal cancer was about 1.6 per 10,000 person-years for people without atopic dermatitis or people with mild atopic dermatitis; the rate was about 2.5 per 10,000 people for patients with moderate to severe atopic dermatitis. While the rate of renal cancer was statistically significantly higher in patients with moderate to severe atopic dermatitis (ie, the higher rate was unlikely to be occurring due to chance alone), these patients have very little risk for renal malignancy. The authors' conclusion that regular checkups for renal malignancy are recommended for patients with severe atopic dermatitis seems unnecessary to me.

Steven R. Feldman, MD, PhD
This mercifully brief report from Yosipovitch and colleagues describes how lebrikizumab improves itch and improves sleep very rapidly in patients with moderate to severe atopic dermatitis. This is not surprising, as we know that interleukin-13 inhibition is a very good way to treat atopic dermatitis, and we should expect itch and sleep to improve as atopic dermatitis gets better. The take-home message from this report is that the improvements in itch and sleep can occur very quickly, in just a few days.

Schlösser and colleagues provide a real-world report of 48 patients treated with upadacitinib for atopic dermatitis, many of whom had previously been treated with cyclosporine and dupilumab. The upbeat authors concluded, "Overall, adverse events were mostly well tolerated." Being a cynical, glass-is-half-empty kind of person, I wondered what that meant. Most patients (56%) reported adverse events, the most common being acne (25% of patients treated), nausea (13%), respiratory tract infections (10%), and herpes virus (8%). The herpes virus signal is not just a bit of a concern for me, but it also makes it hard for me to convince patients to take a Janus kinase (JAK) inhibitor, as when I even mention herpes, patients reply, often rather emphatically, "I don't want herpes!" I'll be encouraging patients to get vaccinated for shingles when starting them on JAK inhibitors.

Dupilumab seems to work great in real-life use. In Martinez-Cabriales and colleagues' study of 62 children age < 12 with atopic dermatitis, only four discontinued the treatment. One of these was a nonresponder who took only one injection and had flushing, and one of the other three discontinued because their skin had completely cleared.

When I saw the title of Rand and colleagues' article, "Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab Versus Dupilumab in Moderate-to-Severe Atopic Dermatitis," I thought, Oh, this is great — a head-to-head, long-term trial comparing lebrikizumab and dupilumab. I was disappointed to find that this was simply a retrospective analysis of data reported from different studies. The study found little difference in efficacy or safety of the two drugs. Both seem to be excellent medications for atopic dermatitis.

Here's another study (Zhou et al) that reports possible increased risk for a comorbidity (cognitive dysfunction) associated with atopic dermatitis. This study reports that there is an elevated hazard ratio that is statistically significant; the article fails to report what the increased absolute risk is for cognitive dysfunction associated with atopic dermatitis. My guess is that it is small and probably clinically unimportant. The hazard ratio for developing dementia was 1.16. It's hard to know how that translates into absolute risk, but my brilliant friend and former partner, Dr Alan Fleischer, once told me that the odds ratio for smoking and lung cancer is something like 100; the hazard ratio is in the range of 20. On the basis of a hazard ratio of 1.16, I don't think patients with atopic dermatitis need to be any more worried about dementia than those without. (Though, to be honest, I think we can all be worried about developing dementia.)

In this tour de force analysis of 83 trials with over 20,000 participants, Drucker and colleagues determined that high doses of abrocitinib and upadacitinib are more effective than even dupilumab for atopic dermatitis. The standard doses of these JAK inhibitors were similar in efficacy to dupilumab. I think it's safe to say that JAK inhibitors are, at least at their high doses, more effective than dupilumab, but safety remains a critical factor in treatment decision-making. I think JAK inhibitors are a great option for patients who need the most effective treatment or who fail to respond to dupilumab.

The title of the article by Oh and colleagues, "Increased Risk of Renal Malignancy in Patients With Moderate to Severe Atopic Dermatitis," seems like it could terrify patients. The study involved an analysis of an enormous number of people, including tens of thousands with atopic dermatitis and millions of controls. The investigators did find statistically significant differences in the rate of malignancy. The rate of renal cancer was about 1.6 per 10,000 person-years for people without atopic dermatitis or people with mild atopic dermatitis; the rate was about 2.5 per 10,000 people for patients with moderate to severe atopic dermatitis. While the rate of renal cancer was statistically significantly higher in patients with moderate to severe atopic dermatitis (ie, the higher rate was unlikely to be occurring due to chance alone), these patients have very little risk for renal malignancy. The authors' conclusion that regular checkups for renal malignancy are recommended for patients with severe atopic dermatitis seems unnecessary to me.

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