Clinical Edge Journal Scan

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source