Article

Key clinical point: Long-term topical corticosteroid (TCS) and tacrolimus (TAC) treatments had similar efficacy and impact on airway hyperresponsiveness or inflammation in children with moderate-to-severe atopic dermatitis (AD).

Major finding: At month 36, children treated with TCS and TAC had no significant difference in the mean body surface area (P  =  .12), mean Eczema Area and Severity Index score (P  =  .2), mean Investigator’s Global Assessment Score (P  =  .12), mean transepidermal water loss at eczema site (P  =  .96) and control site (P  =  .19), median exhaled nitric oxide level (P  =  .71), or median bronchial hyperresponsiveness to methacholine (P  =  .7).

Study details: Findings are from a single-center 3-year follow-up study including 152 children aged 1-3 years with moderate-to-severe AD who were randomly assigned to receive TCS (n = 75) or TAC (n = 77).

Disclosures: This study was supported by the Foundation for Paediatric Research, Finland, Orion Research Foundation, Finland, Orion Pharma, Finland, Astellas Pharma, Japan, and others. Orion and Astellas are commercial manufacturers of the TCS used in this study.

Source: Perälä M et al. Topical tacrolimus versus corticosteroids in childhood moderate-to-severe atopic dermatitis with impact on airways: A long-term randomized open-label study. Clin Exp Dermatol. 2023 (Mar 14). Doi: 10.1093/ced/llad098

Key clinical point: Long-term topical corticosteroid (TCS) and tacrolimus (TAC) treatments had similar efficacy and impact on airway hyperresponsiveness or inflammation in children with moderate-to-severe atopic dermatitis (AD).

Major finding: At month 36, children treated with TCS and TAC had no significant difference in the mean body surface area (P  =  .12), mean Eczema Area and Severity Index score (P  =  .2), mean Investigator’s Global Assessment Score (P  =  .12), mean transepidermal water loss at eczema site (P  =  .96) and control site (P  =  .19), median exhaled nitric oxide level (P  =  .71), or median bronchial hyperresponsiveness to methacholine (P  =  .7).

Study details: Findings are from a single-center 3-year follow-up study including 152 children aged 1-3 years with moderate-to-severe AD who were randomly assigned to receive TCS (n = 75) or TAC (n = 77).

Disclosures: This study was supported by the Foundation for Paediatric Research, Finland, Orion Research Foundation, Finland, Orion Pharma, Finland, Astellas Pharma, Japan, and others. Orion and Astellas are commercial manufacturers of the TCS used in this study.

Source: Perälä M et al. Topical tacrolimus versus corticosteroids in childhood moderate-to-severe atopic dermatitis with impact on airways: A long-term randomized open-label study. Clin Exp Dermatol. 2023 (Mar 14). Doi: 10.1093/ced/llad098

Key clinical point: Long-term topical corticosteroid (TCS) and tacrolimus (TAC) treatments had similar efficacy and impact on airway hyperresponsiveness or inflammation in children with moderate-to-severe atopic dermatitis (AD).

Major finding: At month 36, children treated with TCS and TAC had no significant difference in the mean body surface area (P  =  .12), mean Eczema Area and Severity Index score (P  =  .2), mean Investigator’s Global Assessment Score (P  =  .12), mean transepidermal water loss at eczema site (P  =  .96) and control site (P  =  .19), median exhaled nitric oxide level (P  =  .71), or median bronchial hyperresponsiveness to methacholine (P  =  .7).

Study details: Findings are from a single-center 3-year follow-up study including 152 children aged 1-3 years with moderate-to-severe AD who were randomly assigned to receive TCS (n = 75) or TAC (n = 77).

Disclosures: This study was supported by the Foundation for Paediatric Research, Finland, Orion Research Foundation, Finland, Orion Pharma, Finland, Astellas Pharma, Japan, and others. Orion and Astellas are commercial manufacturers of the TCS used in this study.

Source: Perälä M et al. Topical tacrolimus versus corticosteroids in childhood moderate-to-severe atopic dermatitis with impact on airways: A long-term randomized open-label study. Clin Exp Dermatol. 2023 (Mar 14). Doi: 10.1093/ced/llad098

Key clinical point: Baricitinib offers the flexibility of dose down-titration and improvement in atopic dermatitis (AD) signs and symptoms up to treatment week 104 in patients with moderate-to-severe AD.

Major finding: Among patients receiving 4 mg baricitinib, 51.2% and 47.6% achieved or maintained a validated Investigator’s Global Assessment for AD score of 0 or 1 and 82.1%, and 73.8% maintained an Eczema Area and Severity Index 75 response at weeks 52 and 104, respectively. The clinical response was maintained after down-titration to 2 mg baricitinib.

Study details: This sub-study of the BREEZE-AD3 trial included 168 patients with moderate-to-severe AD who were responders or partial responders to 4 mg baricitinib in originating studies and were re-assigned (1:1) to receive 4 or 2 mg baricitinib at week 52.

Disclosures: This study was funded by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Thyssen JP et al. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023;34(1):2190430 (Apr 5). Doi: 10.1080/09546634.2023.2190430

Key clinical point: Baricitinib offers the flexibility of dose down-titration and improvement in atopic dermatitis (AD) signs and symptoms up to treatment week 104 in patients with moderate-to-severe AD.

Major finding: Among patients receiving 4 mg baricitinib, 51.2% and 47.6% achieved or maintained a validated Investigator’s Global Assessment for AD score of 0 or 1 and 82.1%, and 73.8% maintained an Eczema Area and Severity Index 75 response at weeks 52 and 104, respectively. The clinical response was maintained after down-titration to 2 mg baricitinib.

Study details: This sub-study of the BREEZE-AD3 trial included 168 patients with moderate-to-severe AD who were responders or partial responders to 4 mg baricitinib in originating studies and were re-assigned (1:1) to receive 4 or 2 mg baricitinib at week 52.

Disclosures: This study was funded by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Thyssen JP et al. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023;34(1):2190430 (Apr 5). Doi: 10.1080/09546634.2023.2190430

Key clinical point: Baricitinib offers the flexibility of dose down-titration and improvement in atopic dermatitis (AD) signs and symptoms up to treatment week 104 in patients with moderate-to-severe AD.

Major finding: Among patients receiving 4 mg baricitinib, 51.2% and 47.6% achieved or maintained a validated Investigator’s Global Assessment for AD score of 0 or 1 and 82.1%, and 73.8% maintained an Eczema Area and Severity Index 75 response at weeks 52 and 104, respectively. The clinical response was maintained after down-titration to 2 mg baricitinib.

Study details: This sub-study of the BREEZE-AD3 trial included 168 patients with moderate-to-severe AD who were responders or partial responders to 4 mg baricitinib in originating studies and were re-assigned (1:1) to receive 4 or 2 mg baricitinib at week 52.

Disclosures: This study was funded by Eli Lilly and Company under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Four authors declared being employees and stockholders of Eli Lilly.

Source: Thyssen JP et al. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023;34(1):2190430 (Apr 5). Doi: 10.1080/09546634.2023.2190430

Key clinical point: A dose of 4 mg baricitinib plus topical corticosteroids (TCS) demonstrated superior efficacy compared to placebo+TCS in pediatric patients with moderate-to-severe atopic dermatitis (AD), with the safety profile being consistent with previous studies involving adults with moderate-to-severe AD.

Major finding: At week 16, a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS achieved a validated Investigator’s Global Assessment for AD score of 0 or 1 with a ≥2-point improvement (41.7% vs 16.4%; P < .0001); no significant difference was observed between the 2 mg/1 mg baricitinib and placebo groups. No new safety signals were reported.

Study details: This multicenter phase 3 study, BREEZE-AD-PEDS, included 483 pediatric patients aged 2 to <18 years with moderate-to-severe AD and inadequate response to TCS or systemic treatments who were randomly assigned to receive 4 mg baricitinib+TCS, 2 mg baricitinib+TCS, 1 mg baricitinib+TCS, or placebo+TCS.

Disclosures: Baricitinib was developed by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported various ties, including employment and stock ownership, with Eli Lilly or others.

Source: Torrelo A et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in pediatric patients with moderate-to-severe atopic dermatitis with inadequate response to topical corticosteroids: Results from a phase 3, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS). Br J Dermatol. 2023 (Mar 31). Doi: 10.1093/bjd/ljad096

Key clinical point: A dose of 4 mg baricitinib plus topical corticosteroids (TCS) demonstrated superior efficacy compared to placebo+TCS in pediatric patients with moderate-to-severe atopic dermatitis (AD), with the safety profile being consistent with previous studies involving adults with moderate-to-severe AD.

Major finding: At week 16, a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS achieved a validated Investigator’s Global Assessment for AD score of 0 or 1 with a ≥2-point improvement (41.7% vs 16.4%; P < .0001); no significant difference was observed between the 2 mg/1 mg baricitinib and placebo groups. No new safety signals were reported.

Study details: This multicenter phase 3 study, BREEZE-AD-PEDS, included 483 pediatric patients aged 2 to <18 years with moderate-to-severe AD and inadequate response to TCS or systemic treatments who were randomly assigned to receive 4 mg baricitinib+TCS, 2 mg baricitinib+TCS, 1 mg baricitinib+TCS, or placebo+TCS.

Disclosures: Baricitinib was developed by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported various ties, including employment and stock ownership, with Eli Lilly or others.

Source: Torrelo A et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in pediatric patients with moderate-to-severe atopic dermatitis with inadequate response to topical corticosteroids: Results from a phase 3, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS). Br J Dermatol. 2023 (Mar 31). Doi: 10.1093/bjd/ljad096

Key clinical point: A dose of 4 mg baricitinib plus topical corticosteroids (TCS) demonstrated superior efficacy compared to placebo+TCS in pediatric patients with moderate-to-severe atopic dermatitis (AD), with the safety profile being consistent with previous studies involving adults with moderate-to-severe AD.

Major finding: At week 16, a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS achieved a validated Investigator’s Global Assessment for AD score of 0 or 1 with a ≥2-point improvement (41.7% vs 16.4%; P < .0001); no significant difference was observed between the 2 mg/1 mg baricitinib and placebo groups. No new safety signals were reported.

Study details: This multicenter phase 3 study, BREEZE-AD-PEDS, included 483 pediatric patients aged 2 to <18 years with moderate-to-severe AD and inadequate response to TCS or systemic treatments who were randomly assigned to receive 4 mg baricitinib+TCS, 2 mg baricitinib+TCS, 1 mg baricitinib+TCS, or placebo+TCS.

Disclosures: Baricitinib was developed by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported various ties, including employment and stock ownership, with Eli Lilly or others.

Source: Torrelo A et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in pediatric patients with moderate-to-severe atopic dermatitis with inadequate response to topical corticosteroids: Results from a phase 3, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS). Br J Dermatol. 2023 (Mar 31). Doi: 10.1093/bjd/ljad096

Key clinical point: Lebrikizumab significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adults and adolescents.

Major finding: At week 16, in the ADvocate1 and ADvocate2 trials, a significantly higher proportion of patients receiving lebrikizumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (43.1% vs 12.7% and 33.2% vs 10.8%, respectively) and a ≥75% improvement in the Eczema Area and Severity Index (58.8% vs 16.2% and 52.1% vs 18.1%, respectively; all P < .001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: Findings are from two identical phase 3 studies, ADvocate1 (n = 424) and ADvocate2 (n = 427), including adults (≥18 years) and adolescents (12 to <18 years) with moderate-to-severe AD who were randomly assigned to receive lebrikizumab or placebo over 16-week induction and 36-week maintenance periods.

Disclosures: This study was sponsored by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Some authors reported various ties, including employment, with Eli Lilly or others.

Source: Silverberg JI et al for the ADvocate1 and ADvocate2 Investigators. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091 (Mar 15). Doi: 10.1056/NEJMoa2206714

Key clinical point: Lebrikizumab significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adults and adolescents.

Major finding: At week 16, in the ADvocate1 and ADvocate2 trials, a significantly higher proportion of patients receiving lebrikizumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (43.1% vs 12.7% and 33.2% vs 10.8%, respectively) and a ≥75% improvement in the Eczema Area and Severity Index (58.8% vs 16.2% and 52.1% vs 18.1%, respectively; all P < .001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: Findings are from two identical phase 3 studies, ADvocate1 (n = 424) and ADvocate2 (n = 427), including adults (≥18 years) and adolescents (12 to <18 years) with moderate-to-severe AD who were randomly assigned to receive lebrikizumab or placebo over 16-week induction and 36-week maintenance periods.

Disclosures: This study was sponsored by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Some authors reported various ties, including employment, with Eli Lilly or others.

Source: Silverberg JI et al for the ADvocate1 and ADvocate2 Investigators. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091 (Mar 15). Doi: 10.1056/NEJMoa2206714

Key clinical point: Lebrikizumab significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adults and adolescents.

Major finding: At week 16, in the ADvocate1 and ADvocate2 trials, a significantly higher proportion of patients receiving lebrikizumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (43.1% vs 12.7% and 33.2% vs 10.8%, respectively) and a ≥75% improvement in the Eczema Area and Severity Index (58.8% vs 16.2% and 52.1% vs 18.1%, respectively; all P < .001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: Findings are from two identical phase 3 studies, ADvocate1 (n = 424) and ADvocate2 (n = 427), including adults (≥18 years) and adolescents (12 to <18 years) with moderate-to-severe AD who were randomly assigned to receive lebrikizumab or placebo over 16-week induction and 36-week maintenance periods.

Disclosures: This study was sponsored by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Some authors reported various ties, including employment, with Eli Lilly or others.

Source: Silverberg JI et al for the ADvocate1 and ADvocate2 Investigators. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091 (Mar 15). Doi: 10.1056/NEJMoa2206714

Key clinical point: Achievement of pathologic complete response (pCR) or residual tumor cellularity (RTC) <40% is associated with improved survival outcomes in patients with breast cancer (BC) who have received neoadjuvant chemotherapy (NAC).

Major finding: Early clinical stage (cT1-2), human epidermal growth factor receptor 2-positive BC subtype, and absence of vascular invasion predicted the achievement of pCR after NAC (all P  =  .001). Patients who achieved pCR vs pathologic partial response (pPR) had significantly longer overall survival (OS), disease-free survival (DFS), and distant disease-free survival (DDFS; all P < .001). However, among patients with pPR, RTC <40% vs ≥40% was associated with significantly longer DFS (P  =  .033) and DDFS (P  =  .015).

Study details: Findings are from a retrospective analysis including 495 patients with BC who underwent NAC, of which 29.9% of patients achieved pCR.

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

Source: Gentile D et al. Pathologic response and residual tumor cellularity after neo-adjuvant chemotherapy predict prognosis in breast cancer patients. Breast. 2023;69:323-329 (Mar 27). Doi: 10.1016/j.breast.2023.03.016

Key clinical point: Achievement of pathologic complete response (pCR) or residual tumor cellularity (RTC) <40% is associated with improved survival outcomes in patients with breast cancer (BC) who have received neoadjuvant chemotherapy (NAC).

Major finding: Early clinical stage (cT1-2), human epidermal growth factor receptor 2-positive BC subtype, and absence of vascular invasion predicted the achievement of pCR after NAC (all P  =  .001). Patients who achieved pCR vs pathologic partial response (pPR) had significantly longer overall survival (OS), disease-free survival (DFS), and distant disease-free survival (DDFS; all P < .001). However, among patients with pPR, RTC <40% vs ≥40% was associated with significantly longer DFS (P  =  .033) and DDFS (P  =  .015).

Study details: Findings are from a retrospective analysis including 495 patients with BC who underwent NAC, of which 29.9% of patients achieved pCR.

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

Source: Gentile D et al. Pathologic response and residual tumor cellularity after neo-adjuvant chemotherapy predict prognosis in breast cancer patients. Breast. 2023;69:323-329 (Mar 27). Doi: 10.1016/j.breast.2023.03.016

Key clinical point: Achievement of pathologic complete response (pCR) or residual tumor cellularity (RTC) <40% is associated with improved survival outcomes in patients with breast cancer (BC) who have received neoadjuvant chemotherapy (NAC).

Major finding: Early clinical stage (cT1-2), human epidermal growth factor receptor 2-positive BC subtype, and absence of vascular invasion predicted the achievement of pCR after NAC (all P  =  .001). Patients who achieved pCR vs pathologic partial response (pPR) had significantly longer overall survival (OS), disease-free survival (DFS), and distant disease-free survival (DDFS; all P < .001). However, among patients with pPR, RTC <40% vs ≥40% was associated with significantly longer DFS (P  =  .033) and DDFS (P  =  .015).

Study details: Findings are from a retrospective analysis including 495 patients with BC who underwent NAC, of which 29.9% of patients achieved pCR.

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

Source: Gentile D et al. Pathologic response and residual tumor cellularity after neo-adjuvant chemotherapy predict prognosis in breast cancer patients. Breast. 2023;69:323-329 (Mar 27). Doi: 10.1016/j.breast.2023.03.016

Key clinical point: Preterm birth was positively associated with the risk for incident premenopausal breast cancer (BC) in women aged <55 years who experienced preeclampsia or gestational hypertension.

Major finding: Overall, a history of preterm birth was not associated with the risk for premenopausal BC (hazard ratio [HR] 1.02; 95% CI 0.92-1.14). However, it was positively associated with the risk for premenopausal BC in women who had preeclampsia or gestational hypertension (HR 1.52; 95% CI 1.06-2.18). Preeclampsia on the other hand was inversely associated with premenopausal BC risk (HR 0.86; 95% CI 0.75-0.99).

Study details: Findings are from an analysis of six cohort studies including 184,866 premenopausal women aged <55 years, of which 3096 women were diagnosed with premenopausal BC.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Nichols HB et al. Hypertensive conditions of pregnancy, preterm birth, and premenopausal breast cancer risk: A premenopausal breast cancer collaborative group analysis. Breast Cancer Res Treat. 2023 (Apr 5). Doi: 10.1007/s10549-023-06903-5

Key clinical point: Preterm birth was positively associated with the risk for incident premenopausal breast cancer (BC) in women aged <55 years who experienced preeclampsia or gestational hypertension.

Major finding: Overall, a history of preterm birth was not associated with the risk for premenopausal BC (hazard ratio [HR] 1.02; 95% CI 0.92-1.14). However, it was positively associated with the risk for premenopausal BC in women who had preeclampsia or gestational hypertension (HR 1.52; 95% CI 1.06-2.18). Preeclampsia on the other hand was inversely associated with premenopausal BC risk (HR 0.86; 95% CI 0.75-0.99).

Study details: Findings are from an analysis of six cohort studies including 184,866 premenopausal women aged <55 years, of which 3096 women were diagnosed with premenopausal BC.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Nichols HB et al. Hypertensive conditions of pregnancy, preterm birth, and premenopausal breast cancer risk: A premenopausal breast cancer collaborative group analysis. Breast Cancer Res Treat. 2023 (Apr 5). Doi: 10.1007/s10549-023-06903-5

Key clinical point: Preterm birth was positively associated with the risk for incident premenopausal breast cancer (BC) in women aged <55 years who experienced preeclampsia or gestational hypertension.

Major finding: Overall, a history of preterm birth was not associated with the risk for premenopausal BC (hazard ratio [HR] 1.02; 95% CI 0.92-1.14). However, it was positively associated with the risk for premenopausal BC in women who had preeclampsia or gestational hypertension (HR 1.52; 95% CI 1.06-2.18). Preeclampsia on the other hand was inversely associated with premenopausal BC risk (HR 0.86; 95% CI 0.75-0.99).

Study details: Findings are from an analysis of six cohort studies including 184,866 premenopausal women aged <55 years, of which 3096 women were diagnosed with premenopausal BC.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Nichols HB et al. Hypertensive conditions of pregnancy, preterm birth, and premenopausal breast cancer risk: A premenopausal breast cancer collaborative group analysis. Breast Cancer Res Treat. 2023 (Apr 5). Doi: 10.1007/s10549-023-06903-5

Key clinical point: Sonography features, such as spiculated morphology and antiparallel orientation, were significantly associated with worsened survival outcomes in patients with primary breast cancer (BC; tumor size <20 mm).

Major finding: The presence of spiculated morphology and antiparallel orientation on ultrasound was a significant risk factor for poor breast cancer-specific survival (hazard ratio [HR] 7.45; P < .001) and disease-free survival (HR 6.42; P < .001), with age ≥55 years (P < .05) and positive lymph node metastases (P < .001) also being associated with worse prognosis.

Study details: Findings are from a retrospective study including 790 women with small primary BC (tumor size <20 mm).

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Shao S et al. Ultrasound features for prediction of long-term outcomes of women with primary breast cancer <20 mm. Front Oncol. 2023;13:1103397 (Mar 16). Doi: 10.3389/fonc.2023.1103397

Key clinical point: Sonography features, such as spiculated morphology and antiparallel orientation, were significantly associated with worsened survival outcomes in patients with primary breast cancer (BC; tumor size <20 mm).

Major finding: The presence of spiculated morphology and antiparallel orientation on ultrasound was a significant risk factor for poor breast cancer-specific survival (hazard ratio [HR] 7.45; P < .001) and disease-free survival (HR 6.42; P < .001), with age ≥55 years (P < .05) and positive lymph node metastases (P < .001) also being associated with worse prognosis.

Study details: Findings are from a retrospective study including 790 women with small primary BC (tumor size <20 mm).

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Shao S et al. Ultrasound features for prediction of long-term outcomes of women with primary breast cancer <20 mm. Front Oncol. 2023;13:1103397 (Mar 16). Doi: 10.3389/fonc.2023.1103397

Key clinical point: Sonography features, such as spiculated morphology and antiparallel orientation, were significantly associated with worsened survival outcomes in patients with primary breast cancer (BC; tumor size <20 mm).

Major finding: The presence of spiculated morphology and antiparallel orientation on ultrasound was a significant risk factor for poor breast cancer-specific survival (hazard ratio [HR] 7.45; P < .001) and disease-free survival (HR 6.42; P < .001), with age ≥55 years (P < .05) and positive lymph node metastases (P < .001) also being associated with worse prognosis.

Study details: Findings are from a retrospective study including 790 women with small primary BC (tumor size <20 mm).

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Shao S et al. Ultrasound features for prediction of long-term outcomes of women with primary breast cancer <20 mm. Front Oncol. 2023;13:1103397 (Mar 16). Doi: 10.3389/fonc.2023.1103397

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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