Key clinical point: Patients with psoriatic arthritis (PsA) who responded to tumor necrosis factor inhibitors (TNFi), such as adalimumab and etanercept, had higher serum drug levels (SDL), with non-trough SDL being able to differentiate responders from non-responders with substantial efficacy.

Major finding: At 3 months, patients with higher etanercept SDL (odds ratio [OR] 1.24; P = .018) or higher adalimumab SDL (OR 1.08; P = .047) were significantly more likely to be responders according to the European Alliance of Associations for Rheumatology criteria. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and non-responders with ~50% specificity and >60% sensitivity.

Study details: This study included patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97).

Disclosures: This study was supported by the UK National Institute for Health and Care Research Manchester Biomedical Research Centre and Versus Arthritis. Two authors declared receiving grant support, consulting fees, or travel fees from various sources, including the sponsors.

Source: Curry PDK et al. Non-trough serum drug levels of adalimumab and etanercept are associated with response in patients with psoriatic arthritis. Rheumatology (Oxford). 2023 (Dec 09) doi: 10.1093/rheumatology/kead666

Key clinical point: Patients with psoriatic arthritis (PsA) who responded to tumor necrosis factor inhibitors (TNFi), such as adalimumab and etanercept, had higher serum drug levels (SDL), with non-trough SDL being able to differentiate responders from non-responders with substantial efficacy.

Major finding: At 3 months, patients with higher etanercept SDL (odds ratio [OR] 1.24; P = .018) or higher adalimumab SDL (OR 1.08; P = .047) were significantly more likely to be responders according to the European Alliance of Associations for Rheumatology criteria. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and non-responders with ~50% specificity and >60% sensitivity.

Study details: This study included patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97).

Disclosures: This study was supported by the UK National Institute for Health and Care Research Manchester Biomedical Research Centre and Versus Arthritis. Two authors declared receiving grant support, consulting fees, or travel fees from various sources, including the sponsors.

Source: Curry PDK et al. Non-trough serum drug levels of adalimumab and etanercept are associated with response in patients with psoriatic arthritis. Rheumatology (Oxford). 2023 (Dec 09) doi: 10.1093/rheumatology/kead666

Key clinical point: Patients with psoriatic arthritis (PsA) who responded to tumor necrosis factor inhibitors (TNFi), such as adalimumab and etanercept, had higher serum drug levels (SDL), with non-trough SDL being able to differentiate responders from non-responders with substantial efficacy.

Major finding: At 3 months, patients with higher etanercept SDL (odds ratio [OR] 1.24; P = .018) or higher adalimumab SDL (OR 1.08; P = .047) were significantly more likely to be responders according to the European Alliance of Associations for Rheumatology criteria. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and non-responders with ~50% specificity and >60% sensitivity.

Study details: This study included patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97).

Disclosures: This study was supported by the UK National Institute for Health and Care Research Manchester Biomedical Research Centre and Versus Arthritis. Two authors declared receiving grant support, consulting fees, or travel fees from various sources, including the sponsors.

Source: Curry PDK et al. Non-trough serum drug levels of adalimumab and etanercept are associated with response in patients with psoriatic arthritis. Rheumatology (Oxford). 2023 (Dec 09) doi: 10.1093/rheumatology/kead666

Key clinical point: Patients with psoriatic arthritis (PsA) who had hyperuricemia (baseline serum uric acid level ≥ 360 µmol/L) presented with worsened clinical characteristics than those with normouricemia; however, secukinumab was equally effective in patients with and without hyperuricemia.

Major finding: Patients with hyperuricemia vs normouricemia presented with higher mean body mass index values (30.90 kg/m² vs 28.33 kg/m²), more frequent hypertension (43.8% vs 31.3%), diabetes mellitus (10.3% vs 8.6%), and dactylitis (34.5% vs 25.9%). More than 40% of patients achieved ≥ 50% improvement in the American College of Rheumatology scores with secukinumab, irrespective of the presence of hyperuricemia.

Study details: This post hoc analysis of the pooled data from five phase 3 clinical trials included 2504 patients with active PsA who received secukinumab, 32.8% of whom had hyperuricemia.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Four authors declared being employees, shareholders, or advisory board members of or receiving consulting fees from Novartis.

Source: Felten R et al. Impact of hyperuricaemia on patients with psoriatic arthritis treated with secukinumab in the FUTURE 2-5 and MAXIMISE studies. RMD Open. 2023;9(4):e003428. (Nov 9) doi: 10.1136/rmdopen-2023-003428

Key clinical point: Patients with psoriatic arthritis (PsA) who had hyperuricemia (baseline serum uric acid level ≥ 360 µmol/L) presented with worsened clinical characteristics than those with normouricemia; however, secukinumab was equally effective in patients with and without hyperuricemia.

Major finding: Patients with hyperuricemia vs normouricemia presented with higher mean body mass index values (30.90 kg/m² vs 28.33 kg/m²), more frequent hypertension (43.8% vs 31.3%), diabetes mellitus (10.3% vs 8.6%), and dactylitis (34.5% vs 25.9%). More than 40% of patients achieved ≥ 50% improvement in the American College of Rheumatology scores with secukinumab, irrespective of the presence of hyperuricemia.

Study details: This post hoc analysis of the pooled data from five phase 3 clinical trials included 2504 patients with active PsA who received secukinumab, 32.8% of whom had hyperuricemia.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Four authors declared being employees, shareholders, or advisory board members of or receiving consulting fees from Novartis.

Source: Felten R et al. Impact of hyperuricaemia on patients with psoriatic arthritis treated with secukinumab in the FUTURE 2-5 and MAXIMISE studies. RMD Open. 2023;9(4):e003428. (Nov 9) doi: 10.1136/rmdopen-2023-003428

Key clinical point: Patients with psoriatic arthritis (PsA) who had hyperuricemia (baseline serum uric acid level ≥ 360 µmol/L) presented with worsened clinical characteristics than those with normouricemia; however, secukinumab was equally effective in patients with and without hyperuricemia.

Major finding: Patients with hyperuricemia vs normouricemia presented with higher mean body mass index values (30.90 kg/m² vs 28.33 kg/m²), more frequent hypertension (43.8% vs 31.3%), diabetes mellitus (10.3% vs 8.6%), and dactylitis (34.5% vs 25.9%). More than 40% of patients achieved ≥ 50% improvement in the American College of Rheumatology scores with secukinumab, irrespective of the presence of hyperuricemia.

Study details: This post hoc analysis of the pooled data from five phase 3 clinical trials included 2504 patients with active PsA who received secukinumab, 32.8% of whom had hyperuricemia.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Four authors declared being employees, shareholders, or advisory board members of or receiving consulting fees from Novartis.

Source: Felten R et al. Impact of hyperuricaemia on patients with psoriatic arthritis treated with secukinumab in the FUTURE 2-5 and MAXIMISE studies. RMD Open. 2023;9(4):e003428. (Nov 9) doi: 10.1136/rmdopen-2023-003428

Key clinical point: In a real-world setting, secukinumab demonstrated substantial efficacy in improving disease activity scores, enthesitis, and dactylitis in patients with psoriatic arthritis (PsA).

Major finding: The proportion of patients who achieved low disease activity according to the Disease Activity Score-28 C-reactive protein measurements increased significantly from 25% at baseline to 66% after 6 months (P < .001), with the improvements maintained for up to 24 months (75%). After 6 months of secukinumab treatment, complete resolution of enthesitis and dactylitis was reported by the majority of patients (82% and 67%, respectively) along with an improvement in pain scores.

Study details: Findings are from an observational retrospective study including 178 patients with PsA who received secukinumab in the first-, second-, or third- or higher line setting.

Disclosures: This study was sponsored by Novartis Farmacéutica, S.A. Two authors declared financial and non-financial ties with various sources including Novartis. Other authors declared no conflicts of interest.

Source: Alegre-Sancho JJ et al. Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis. Front Med (Lausanne). 2023;10:1294247 (Nov 20). doi: 10.3389/fmed.2023.1294247

Key clinical point: In a real-world setting, secukinumab demonstrated substantial efficacy in improving disease activity scores, enthesitis, and dactylitis in patients with psoriatic arthritis (PsA).

Major finding: The proportion of patients who achieved low disease activity according to the Disease Activity Score-28 C-reactive protein measurements increased significantly from 25% at baseline to 66% after 6 months (P < .001), with the improvements maintained for up to 24 months (75%). After 6 months of secukinumab treatment, complete resolution of enthesitis and dactylitis was reported by the majority of patients (82% and 67%, respectively) along with an improvement in pain scores.

Study details: Findings are from an observational retrospective study including 178 patients with PsA who received secukinumab in the first-, second-, or third- or higher line setting.

Disclosures: This study was sponsored by Novartis Farmacéutica, S.A. Two authors declared financial and non-financial ties with various sources including Novartis. Other authors declared no conflicts of interest.

Source: Alegre-Sancho JJ et al. Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis. Front Med (Lausanne). 2023;10:1294247 (Nov 20). doi: 10.3389/fmed.2023.1294247

Key clinical point: In a real-world setting, secukinumab demonstrated substantial efficacy in improving disease activity scores, enthesitis, and dactylitis in patients with psoriatic arthritis (PsA).

Major finding: The proportion of patients who achieved low disease activity according to the Disease Activity Score-28 C-reactive protein measurements increased significantly from 25% at baseline to 66% after 6 months (P < .001), with the improvements maintained for up to 24 months (75%). After 6 months of secukinumab treatment, complete resolution of enthesitis and dactylitis was reported by the majority of patients (82% and 67%, respectively) along with an improvement in pain scores.

Study details: Findings are from an observational retrospective study including 178 patients with PsA who received secukinumab in the first-, second-, or third- or higher line setting.

Disclosures: This study was sponsored by Novartis Farmacéutica, S.A. Two authors declared financial and non-financial ties with various sources including Novartis. Other authors declared no conflicts of interest.

Source: Alegre-Sancho JJ et al. Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis. Front Med (Lausanne). 2023;10:1294247 (Nov 20). doi: 10.3389/fmed.2023.1294247

Key clinical point: Female patients with psoriatic arthritis (PsA) were less likely to achieve efficacy endpoints with treatment than male patients with PsA, with the differences being most pronounced when biological disease-modifying antirheumatic drug (bDMARD) therapy was administered.

Major finding: The odds of achieving ≥20% improvement in American College of Rheumatology score was higher in men vs women (odds ratio [OR] 1.49; 95% CI 1.29-1.71), with the difference being more pronounced in case of all bDMARD, such as tumor necrosis factor inhibitors (OR 1.55; 95% CI 1.11-2.18), interleukin (IL)-17 inhibitors (OR 1.70; 95% CI 1.38-2.11), IL-23 inhibitors (OR 1.46; 95% CI 1.20-1.78), and IL-12 and IL-23 inhibitors (OR 2.67; 95% CI 1.39-5.09).

Study details: This meta-analysis of 54 randomized controlled trials included 22,621 patients with PsA who received targeted advanced therapies, bDMARD, or placebo.

Disclosures: This study was funded by the Canadian Rheumatology Association. Four authors declared financial or non-financial ties with various sources. Other authors declared no conflicts of interest.

Source: Eder L et al. Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomized clinical trials in psoriatic arthritis: A systematic literature review and meta-analysis. Lancet Rheumatol. 2023;5(12):E716-E727 (Nov 13). doi: 10.1016/S2665-9913(23)00264-3

Key clinical point: Female patients with psoriatic arthritis (PsA) were less likely to achieve efficacy endpoints with treatment than male patients with PsA, with the differences being most pronounced when biological disease-modifying antirheumatic drug (bDMARD) therapy was administered.

Major finding: The odds of achieving ≥20% improvement in American College of Rheumatology score was higher in men vs women (odds ratio [OR] 1.49; 95% CI 1.29-1.71), with the difference being more pronounced in case of all bDMARD, such as tumor necrosis factor inhibitors (OR 1.55; 95% CI 1.11-2.18), interleukin (IL)-17 inhibitors (OR 1.70; 95% CI 1.38-2.11), IL-23 inhibitors (OR 1.46; 95% CI 1.20-1.78), and IL-12 and IL-23 inhibitors (OR 2.67; 95% CI 1.39-5.09).

Study details: This meta-analysis of 54 randomized controlled trials included 22,621 patients with PsA who received targeted advanced therapies, bDMARD, or placebo.

Disclosures: This study was funded by the Canadian Rheumatology Association. Four authors declared financial or non-financial ties with various sources. Other authors declared no conflicts of interest.

Source: Eder L et al. Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomized clinical trials in psoriatic arthritis: A systematic literature review and meta-analysis. Lancet Rheumatol. 2023;5(12):E716-E727 (Nov 13). doi: 10.1016/S2665-9913(23)00264-3

Key clinical point: Female patients with psoriatic arthritis (PsA) were less likely to achieve efficacy endpoints with treatment than male patients with PsA, with the differences being most pronounced when biological disease-modifying antirheumatic drug (bDMARD) therapy was administered.

Major finding: The odds of achieving ≥20% improvement in American College of Rheumatology score was higher in men vs women (odds ratio [OR] 1.49; 95% CI 1.29-1.71), with the difference being more pronounced in case of all bDMARD, such as tumor necrosis factor inhibitors (OR 1.55; 95% CI 1.11-2.18), interleukin (IL)-17 inhibitors (OR 1.70; 95% CI 1.38-2.11), IL-23 inhibitors (OR 1.46; 95% CI 1.20-1.78), and IL-12 and IL-23 inhibitors (OR 2.67; 95% CI 1.39-5.09).

Study details: This meta-analysis of 54 randomized controlled trials included 22,621 patients with PsA who received targeted advanced therapies, bDMARD, or placebo.

Disclosures: This study was funded by the Canadian Rheumatology Association. Four authors declared financial or non-financial ties with various sources. Other authors declared no conflicts of interest.

Source: Eder L et al. Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomized clinical trials in psoriatic arthritis: A systematic literature review and meta-analysis. Lancet Rheumatol. 2023;5(12):E716-E727 (Nov 13). doi: 10.1016/S2665-9913(23)00264-3

Key clinical point: Chemotherapy failed to show long-term survival benefits in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) invasive lobular breast cancer (BC) treated with adjuvant endocrine therapy.

Major finding: Patients who did vs did not receive chemotherapy had comparable recurrence-free survival (hazard ratio [HR] 1.20; 95% CI 0.63-2.31), breast cancer-specific survival (HR 1.24; 95% CI 0.60-2.58), and overall survival (HR 0.97; 95% CI 0.56-1.66) outcomes.

Study details: Findings are from a retrospective cohort study including 520 women with ER+/HER2− invasive lobular BC treated with adjuvant endocrine therapy who had an indication for chemotherapy, 379 of whom received chemotherapy.

Disclosures: This study did not receive any funding. JWM Martens declared receiving grants from and serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: Öztekin S et al. The effect of (neo)adjuvant chemotherapy on long-term survival outcomes in patients with invasive lobular breast cancer treated with endocrine therapy: A retrospective cohort study. Cancer. 2023 (Nov 20). doi: 10.1002/cncr.35125

Key clinical point: Chemotherapy failed to show long-term survival benefits in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) invasive lobular breast cancer (BC) treated with adjuvant endocrine therapy.

Major finding: Patients who did vs did not receive chemotherapy had comparable recurrence-free survival (hazard ratio [HR] 1.20; 95% CI 0.63-2.31), breast cancer-specific survival (HR 1.24; 95% CI 0.60-2.58), and overall survival (HR 0.97; 95% CI 0.56-1.66) outcomes.

Study details: Findings are from a retrospective cohort study including 520 women with ER+/HER2− invasive lobular BC treated with adjuvant endocrine therapy who had an indication for chemotherapy, 379 of whom received chemotherapy.

Disclosures: This study did not receive any funding. JWM Martens declared receiving grants from and serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: Öztekin S et al. The effect of (neo)adjuvant chemotherapy on long-term survival outcomes in patients with invasive lobular breast cancer treated with endocrine therapy: A retrospective cohort study. Cancer. 2023 (Nov 20). doi: 10.1002/cncr.35125

Key clinical point: Chemotherapy failed to show long-term survival benefits in patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2−) invasive lobular breast cancer (BC) treated with adjuvant endocrine therapy.

Major finding: Patients who did vs did not receive chemotherapy had comparable recurrence-free survival (hazard ratio [HR] 1.20; 95% CI 0.63-2.31), breast cancer-specific survival (HR 1.24; 95% CI 0.60-2.58), and overall survival (HR 0.97; 95% CI 0.56-1.66) outcomes.

Study details: Findings are from a retrospective cohort study including 520 women with ER+/HER2− invasive lobular BC treated with adjuvant endocrine therapy who had an indication for chemotherapy, 379 of whom received chemotherapy.

Disclosures: This study did not receive any funding. JWM Martens declared receiving grants from and serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: Öztekin S et al. The effect of (neo)adjuvant chemotherapy on long-term survival outcomes in patients with invasive lobular breast cancer treated with endocrine therapy: A retrospective cohort study. Cancer. 2023 (Nov 20). doi: 10.1002/cncr.35125

Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033