Key clinical point: Increased stromal tumor-infiltrating lymphocytes (sTIL) were associated with improved survival in young patients (<40 years old) with early-stage, node-negative (N0), triple negative breast cancer (TNBC) who were naive to systemic therapy.

Major finding: At 15 years, the cumulative incidence of distant metastasis or death was only 2.1% (95% CI 0%-5.0%) in patients with high sTIL (≥75%) compared with 38.4% (95% CI 32.1%-44.6%) in patients with low sTIL (<30%), with an increase in overall survival by 19% for every 10% increase in sTIL (adjusted hazard ratio 0.81; 95% CI 0.76-0.87).

Study details: The study evaluated prospectively collected population-based cohort data of 441 patients aged <40 years who had N0 TNBC and had not received neoadjuvant systemic therapy.

Disclosures: This study was supported by The Netherlands Organization for Health Research and Development, A Sister’s Hope, De Vrienden van UMC Utrecht, and other sources. The authors declared serving as consultants, advisors, or in speaker’s bureaus or receiving research grants or travel and accommodation expenses from several sources.

Source: de Jong VMT et al. Prognostic value of stromal tumor-infiltrating lymphocytes in young, node-negative, triple-negative breast cancer patients who did not receive (neo)adjuvant systemic therapy. J Clin Oncol. 2022 (Mar 30). Doi: 10.1200/JCO.21.01536

Key clinical point: Increased stromal tumor-infiltrating lymphocytes (sTIL) were associated with improved survival in young patients (<40 years old) with early-stage, node-negative (N0), triple negative breast cancer (TNBC) who were naive to systemic therapy.

Major finding: At 15 years, the cumulative incidence of distant metastasis or death was only 2.1% (95% CI 0%-5.0%) in patients with high sTIL (≥75%) compared with 38.4% (95% CI 32.1%-44.6%) in patients with low sTIL (<30%), with an increase in overall survival by 19% for every 10% increase in sTIL (adjusted hazard ratio 0.81; 95% CI 0.76-0.87).

Study details: The study evaluated prospectively collected population-based cohort data of 441 patients aged <40 years who had N0 TNBC and had not received neoadjuvant systemic therapy.

Disclosures: This study was supported by The Netherlands Organization for Health Research and Development, A Sister’s Hope, De Vrienden van UMC Utrecht, and other sources. The authors declared serving as consultants, advisors, or in speaker’s bureaus or receiving research grants or travel and accommodation expenses from several sources.

Source: de Jong VMT et al. Prognostic value of stromal tumor-infiltrating lymphocytes in young, node-negative, triple-negative breast cancer patients who did not receive (neo)adjuvant systemic therapy. J Clin Oncol. 2022 (Mar 30). Doi: 10.1200/JCO.21.01536

Key clinical point: Increased stromal tumor-infiltrating lymphocytes (sTIL) were associated with improved survival in young patients (<40 years old) with early-stage, node-negative (N0), triple negative breast cancer (TNBC) who were naive to systemic therapy.

Major finding: At 15 years, the cumulative incidence of distant metastasis or death was only 2.1% (95% CI 0%-5.0%) in patients with high sTIL (≥75%) compared with 38.4% (95% CI 32.1%-44.6%) in patients with low sTIL (<30%), with an increase in overall survival by 19% for every 10% increase in sTIL (adjusted hazard ratio 0.81; 95% CI 0.76-0.87).

Study details: The study evaluated prospectively collected population-based cohort data of 441 patients aged <40 years who had N0 TNBC and had not received neoadjuvant systemic therapy.

Disclosures: This study was supported by The Netherlands Organization for Health Research and Development, A Sister’s Hope, De Vrienden van UMC Utrecht, and other sources. The authors declared serving as consultants, advisors, or in speaker’s bureaus or receiving research grants or travel and accommodation expenses from several sources.

Source: de Jong VMT et al. Prognostic value of stromal tumor-infiltrating lymphocytes in young, node-negative, triple-negative breast cancer patients who did not receive (neo)adjuvant systemic therapy. J Clin Oncol. 2022 (Mar 30). Doi: 10.1200/JCO.21.01536

Key clinical point: Nearly 40% of patients with breast cancer reported severe cancer-related fatigue for up to 4 years after diagnosis, with depression and receipt of hormone therapy being the key risk factors.

Major finding: The estimated risk for severe global fatigue increased from 13.8% at diagnosis to 64.5% at 4 years postdiagnosis in 19% of patients clustered in the deteriorating group, whereas it remained persistently high in 21% of patients clustered in the high-risk group (94.8% at diagnosis and 64.6% at year 4). Depression (P < .001) and receipt of hormonal therapy (P = .0359) were associated with severe global fatigue trajectory.

Study details: This longitudinal analysis of the ongoing prospective CANcer TOxicity trial included 4173 women with stage I, II, or III breast cancer.

Disclosures: This study is supported by Susan G. Komen, Odyssea, French Foundation for Cancer Research, and others. The authors declared serving as consultants, advisory members, or leaders; owning stocks; or receiving honoraria, research funding, or travel and accommodation expenses from several sources.

Source: Vaz-Luis I et al. Long-term longitudinal patterns of patient-reported fatigue after breast cancer: A group-based trajectory analysis. J Clin Oncol. 2022 (Mar 15). Doi: 10.1200/JCO.21.01958

Key clinical point: Nearly 40% of patients with breast cancer reported severe cancer-related fatigue for up to 4 years after diagnosis, with depression and receipt of hormone therapy being the key risk factors.

Major finding: The estimated risk for severe global fatigue increased from 13.8% at diagnosis to 64.5% at 4 years postdiagnosis in 19% of patients clustered in the deteriorating group, whereas it remained persistently high in 21% of patients clustered in the high-risk group (94.8% at diagnosis and 64.6% at year 4). Depression (P < .001) and receipt of hormonal therapy (P = .0359) were associated with severe global fatigue trajectory.

Study details: This longitudinal analysis of the ongoing prospective CANcer TOxicity trial included 4173 women with stage I, II, or III breast cancer.

Disclosures: This study is supported by Susan G. Komen, Odyssea, French Foundation for Cancer Research, and others. The authors declared serving as consultants, advisory members, or leaders; owning stocks; or receiving honoraria, research funding, or travel and accommodation expenses from several sources.

Source: Vaz-Luis I et al. Long-term longitudinal patterns of patient-reported fatigue after breast cancer: A group-based trajectory analysis. J Clin Oncol. 2022 (Mar 15). Doi: 10.1200/JCO.21.01958

Key clinical point: Nearly 40% of patients with breast cancer reported severe cancer-related fatigue for up to 4 years after diagnosis, with depression and receipt of hormone therapy being the key risk factors.

Major finding: The estimated risk for severe global fatigue increased from 13.8% at diagnosis to 64.5% at 4 years postdiagnosis in 19% of patients clustered in the deteriorating group, whereas it remained persistently high in 21% of patients clustered in the high-risk group (94.8% at diagnosis and 64.6% at year 4). Depression (P < .001) and receipt of hormonal therapy (P = .0359) were associated with severe global fatigue trajectory.

Study details: This longitudinal analysis of the ongoing prospective CANcer TOxicity trial included 4173 women with stage I, II, or III breast cancer.

Disclosures: This study is supported by Susan G. Komen, Odyssea, French Foundation for Cancer Research, and others. The authors declared serving as consultants, advisory members, or leaders; owning stocks; or receiving honoraria, research funding, or travel and accommodation expenses from several sources.

Source: Vaz-Luis I et al. Long-term longitudinal patterns of patient-reported fatigue after breast cancer: A group-based trajectory analysis. J Clin Oncol. 2022 (Mar 15). Doi: 10.1200/JCO.21.01958

Key clinical point: Patients with trastuzumab-refractory human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer achieved satisfactory clinical efficacy after switching to lapatinib as the HER2-blockade therapy.

Major finding: After a median follow-up of 33.1 months, patients achieved a median progression free survival (PFS) of 8.5 months, with brain metastases (hazard ratio [HR] 1.582; P = .041) and ≥2 metastatic sites (HR 1.679; P = .007) being independent prognostic markers for PFS. Diarrhea (3.8%) and hand-foot syndrome (9.4%) were the most common grade ≥3 adverse events.

Study details: Findings are from the phase 2 SYSUCC-005 study including 159 women with HER2-positive refractory metastatic breast cancer who rapidly progressed during prior adjuvant/first-line trastuzumab therapy and switched to lapatinib with either capecitabine or vinorelbine.

Disclosures: This study was funded by the Joint Fund of the National Natural Science Foundation of China and Natural Science Foundation of Guangdong Province, among other sources. The authors declared no conflicts of interest.

Source: Duan F et al. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: A phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022;22:271 (Mar 15). Doi: 10.1186/s12885-022-09399-2

Key clinical point: Patients with trastuzumab-refractory human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer achieved satisfactory clinical efficacy after switching to lapatinib as the HER2-blockade therapy.

Major finding: After a median follow-up of 33.1 months, patients achieved a median progression free survival (PFS) of 8.5 months, with brain metastases (hazard ratio [HR] 1.582; P = .041) and ≥2 metastatic sites (HR 1.679; P = .007) being independent prognostic markers for PFS. Diarrhea (3.8%) and hand-foot syndrome (9.4%) were the most common grade ≥3 adverse events.

Study details: Findings are from the phase 2 SYSUCC-005 study including 159 women with HER2-positive refractory metastatic breast cancer who rapidly progressed during prior adjuvant/first-line trastuzumab therapy and switched to lapatinib with either capecitabine or vinorelbine.

Disclosures: This study was funded by the Joint Fund of the National Natural Science Foundation of China and Natural Science Foundation of Guangdong Province, among other sources. The authors declared no conflicts of interest.

Source: Duan F et al. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: A phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022;22:271 (Mar 15). Doi: 10.1186/s12885-022-09399-2

Key clinical point: Patients with trastuzumab-refractory human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer achieved satisfactory clinical efficacy after switching to lapatinib as the HER2-blockade therapy.

Major finding: After a median follow-up of 33.1 months, patients achieved a median progression free survival (PFS) of 8.5 months, with brain metastases (hazard ratio [HR] 1.582; P = .041) and ≥2 metastatic sites (HR 1.679; P = .007) being independent prognostic markers for PFS. Diarrhea (3.8%) and hand-foot syndrome (9.4%) were the most common grade ≥3 adverse events.

Study details: Findings are from the phase 2 SYSUCC-005 study including 159 women with HER2-positive refractory metastatic breast cancer who rapidly progressed during prior adjuvant/first-line trastuzumab therapy and switched to lapatinib with either capecitabine or vinorelbine.

Disclosures: This study was funded by the Joint Fund of the National Natural Science Foundation of China and Natural Science Foundation of Guangdong Province, among other sources. The authors declared no conflicts of interest.

Source: Duan F et al. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: A phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022;22:271 (Mar 15). Doi: 10.1186/s12885-022-09399-2

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104