Selective internal radiation therapy effective and safe in patients with BC and hepatic metastasis

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Key clinical point: Selective internal radiation therapy (SIRT) with 90Y demonstrated favorable survival benefits in patients with breast cancer (BC) and hepatic metastasis, particularly in those with low liver tumor burden and without extrahepatic metastasis.

Major finding: Postembolization median survival time (MST) was 9.8 months, with MST being significantly higher in patients with <25% vs  >25% hepatic metastatic burden (10.5 vs  6.8 months; P < .0001) and localized vs  additional hepatic metastasis (15.0 vs  5.3 months; P < .0001). None of the adverse events were life-threatening.

Study details: Findings are from a meta-analysis of 24 studies including 412 patients with metastatic BC and hepatic metastasis who had received SIRT.

Disclosures: This study was funded by the Natural Science Foundation of Shandong Province, China. The authors declared no conflicts of interest.

Source: Liu C et al. Selective internal radiation therapy of metastatic breast cancer to the liver: A meta-analysis. Front Oncol. 2022;12:887653 (Nov 24). Doi: 10.3389/fonc.2022.887653

 

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Key clinical point: Selective internal radiation therapy (SIRT) with 90Y demonstrated favorable survival benefits in patients with breast cancer (BC) and hepatic metastasis, particularly in those with low liver tumor burden and without extrahepatic metastasis.

Major finding: Postembolization median survival time (MST) was 9.8 months, with MST being significantly higher in patients with <25% vs  >25% hepatic metastatic burden (10.5 vs  6.8 months; P < .0001) and localized vs  additional hepatic metastasis (15.0 vs  5.3 months; P < .0001). None of the adverse events were life-threatening.

Study details: Findings are from a meta-analysis of 24 studies including 412 patients with metastatic BC and hepatic metastasis who had received SIRT.

Disclosures: This study was funded by the Natural Science Foundation of Shandong Province, China. The authors declared no conflicts of interest.

Source: Liu C et al. Selective internal radiation therapy of metastatic breast cancer to the liver: A meta-analysis. Front Oncol. 2022;12:887653 (Nov 24). Doi: 10.3389/fonc.2022.887653

 

Key clinical point: Selective internal radiation therapy (SIRT) with 90Y demonstrated favorable survival benefits in patients with breast cancer (BC) and hepatic metastasis, particularly in those with low liver tumor burden and without extrahepatic metastasis.

Major finding: Postembolization median survival time (MST) was 9.8 months, with MST being significantly higher in patients with <25% vs  >25% hepatic metastatic burden (10.5 vs  6.8 months; P < .0001) and localized vs  additional hepatic metastasis (15.0 vs  5.3 months; P < .0001). None of the adverse events were life-threatening.

Study details: Findings are from a meta-analysis of 24 studies including 412 patients with metastatic BC and hepatic metastasis who had received SIRT.

Disclosures: This study was funded by the Natural Science Foundation of Shandong Province, China. The authors declared no conflicts of interest.

Source: Liu C et al. Selective internal radiation therapy of metastatic breast cancer to the liver: A meta-analysis. Front Oncol. 2022;12:887653 (Nov 24). Doi: 10.3389/fonc.2022.887653

 

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Triple-positive BC: Neoadjuvant pyrotinib+letrozole+dalpiciclib shows promise in phase 2

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Key clinical point: A chemotherapy-free combination of pyrotinib, letrozole, and dalpiciclib demonstrated promising antitumor activity and an acceptable safety profile in the neoadjuvant setting in patients with triple-positive breast cancer (TPBC).

Major finding: After 5 cycles of the 4-week treatment, a substantial proportion (30.4%) of patients achieved pathological complete response in both the breast and lymph nodes. The most common adverse events were neutropenia (93%), leukopenia (90%), diarrhea (86%), anemia (68%), and oral mucositis (63%).

Study details: Findings are from the phase 2, MUKDEN 01 trial including 81 patients with stage II-III TPBC who were assigned to receive neoadjuvant treatment with pyrotinib+letrozole+dalpiciclib.

Disclosures: This study did not report a source of funding. The authors declared no conflicts of interest.

Source: Niu N et al. A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer. Nat Commun. 2022;13:7043 (Nov 17). Doi: 10.1038/s41467-022-34838-w

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Key clinical point: A chemotherapy-free combination of pyrotinib, letrozole, and dalpiciclib demonstrated promising antitumor activity and an acceptable safety profile in the neoadjuvant setting in patients with triple-positive breast cancer (TPBC).

Major finding: After 5 cycles of the 4-week treatment, a substantial proportion (30.4%) of patients achieved pathological complete response in both the breast and lymph nodes. The most common adverse events were neutropenia (93%), leukopenia (90%), diarrhea (86%), anemia (68%), and oral mucositis (63%).

Study details: Findings are from the phase 2, MUKDEN 01 trial including 81 patients with stage II-III TPBC who were assigned to receive neoadjuvant treatment with pyrotinib+letrozole+dalpiciclib.

Disclosures: This study did not report a source of funding. The authors declared no conflicts of interest.

Source: Niu N et al. A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer. Nat Commun. 2022;13:7043 (Nov 17). Doi: 10.1038/s41467-022-34838-w

Key clinical point: A chemotherapy-free combination of pyrotinib, letrozole, and dalpiciclib demonstrated promising antitumor activity and an acceptable safety profile in the neoadjuvant setting in patients with triple-positive breast cancer (TPBC).

Major finding: After 5 cycles of the 4-week treatment, a substantial proportion (30.4%) of patients achieved pathological complete response in both the breast and lymph nodes. The most common adverse events were neutropenia (93%), leukopenia (90%), diarrhea (86%), anemia (68%), and oral mucositis (63%).

Study details: Findings are from the phase 2, MUKDEN 01 trial including 81 patients with stage II-III TPBC who were assigned to receive neoadjuvant treatment with pyrotinib+letrozole+dalpiciclib.

Disclosures: This study did not report a source of funding. The authors declared no conflicts of interest.

Source: Niu N et al. A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer. Nat Commun. 2022;13:7043 (Nov 17). Doi: 10.1038/s41467-022-34838-w

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Acupuncture relieves AI-related joint pain for up to a year in BC patients

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Key clinical point: In patients with early-stage breast cancer (BC), a 12-week true acupuncture (TA) treatment was more effective than sham acupuncture (SA) or no acupuncture (waiting list control; WC) treatment in reducing aromatase inhibitor (AI)-related joint pain through 52 weeks.

Major finding: At week 52, the TA group reported a significantly higher improvement in the mean Brief Pain Inventory Worst Pain (BPI-WP) item score than the SA group (difference 1.08 points; P = .01) or the WC group (difference 0.99 points; P = .03).

Study details: Findings are from a multicenter trial including 226 postmenopausal women with stage I-III BC receiving a third-generation AI who had a BPI-WP item score of ≥3 and were randomly assigned to receive TA, SA, or WC.

Disclosures: This study was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health and other sources. Some authors declared being employees of or receiving payments and personal fees from several sources.

Source: Hershman DL et al. Comparison of acupuncture vs sham acupuncture or waiting list control in the treatment of aromatase inhibitor-related joint pain: A randomized clinical trial. JAMA Netw Open. 2022;5(11):e2241720 (Nov 11). Doi: 10.1001/jamanetworkopen.2022.41720

 

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Key clinical point: In patients with early-stage breast cancer (BC), a 12-week true acupuncture (TA) treatment was more effective than sham acupuncture (SA) or no acupuncture (waiting list control; WC) treatment in reducing aromatase inhibitor (AI)-related joint pain through 52 weeks.

Major finding: At week 52, the TA group reported a significantly higher improvement in the mean Brief Pain Inventory Worst Pain (BPI-WP) item score than the SA group (difference 1.08 points; P = .01) or the WC group (difference 0.99 points; P = .03).

Study details: Findings are from a multicenter trial including 226 postmenopausal women with stage I-III BC receiving a third-generation AI who had a BPI-WP item score of ≥3 and were randomly assigned to receive TA, SA, or WC.

Disclosures: This study was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health and other sources. Some authors declared being employees of or receiving payments and personal fees from several sources.

Source: Hershman DL et al. Comparison of acupuncture vs sham acupuncture or waiting list control in the treatment of aromatase inhibitor-related joint pain: A randomized clinical trial. JAMA Netw Open. 2022;5(11):e2241720 (Nov 11). Doi: 10.1001/jamanetworkopen.2022.41720

 

Key clinical point: In patients with early-stage breast cancer (BC), a 12-week true acupuncture (TA) treatment was more effective than sham acupuncture (SA) or no acupuncture (waiting list control; WC) treatment in reducing aromatase inhibitor (AI)-related joint pain through 52 weeks.

Major finding: At week 52, the TA group reported a significantly higher improvement in the mean Brief Pain Inventory Worst Pain (BPI-WP) item score than the SA group (difference 1.08 points; P = .01) or the WC group (difference 0.99 points; P = .03).

Study details: Findings are from a multicenter trial including 226 postmenopausal women with stage I-III BC receiving a third-generation AI who had a BPI-WP item score of ≥3 and were randomly assigned to receive TA, SA, or WC.

Disclosures: This study was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health and other sources. Some authors declared being employees of or receiving payments and personal fees from several sources.

Source: Hershman DL et al. Comparison of acupuncture vs sham acupuncture or waiting list control in the treatment of aromatase inhibitor-related joint pain: A randomized clinical trial. JAMA Netw Open. 2022;5(11):e2241720 (Nov 11). Doi: 10.1001/jamanetworkopen.2022.41720

 

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Axillary radiotherapy: A good treatment option for sentinel node-positive cT1-2 breast cancer

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Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

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Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

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Axillary radiotherapy: A good treatment option for sentinel node-positive cT1-2 breast cancer

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Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

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Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

Key clinical point: In patients with sentinel node (SN)-positive cT1-2 primary breast cancer (BC), both axillary radiotherapy (ART) and axillary lymph node dissection (ALND) led to similar recurrence rates, but the rate of lymphedema was lower with ART.

Major finding: The 10-year axillary recurrence rates were similar between the ALND and ART treatment groups (hazard ratio 1.71; 95% CI 0.67-4.39), with a lower proportion of patients reporting lymphedema in the ART vs  ALND group (28.6% vs  44.2%).

Study details: Findings are from the phase 3, AMAROS trial including 1425 patients with clinically node-negative cT1-2 primary BC and a positive SN who were randomly assigned to receive ALND or ART.

Disclosures: This trial was sponsored by the European Organization for Research and Treatment of Cancer. The authors declared serving in leadership, consulting, or advisory roles or receiving honoraria or travel, accommodation, and expenses from several sources.

Source: Bartels SAL, Donker M et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2022 (Nov 16). Doi: 10.1200/JCO.22.01565

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Breast cancer: Postmastectomy implant reconstruction increases risk for anaplastic large cell lymphoma

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Key clinical point: The relative risk for anaplastic large cell lymphoma (ALCL) was significantly increased in women who underwent implant reconstruction after mastectomy for breast cancer (BC) or ductal carcinoma in situ.

Major finding: The relative risk for ALCL (standardized incidence ratio [SIR] 40.9; 95% CI 13.3-95.5) and T-cell lymphoma (SIR 34.8; 95% CI 12.8-75.8) increased significantly after postmastectomy implant reconstruction.

Study details: This study evaluated 56,784 women with ductal carcinoma in situ of the breast (18%) or invasive BC (72%) from the Surveillance, Epidemiology, and End Results 17 database who had undergone postmastectomy implant reconstruction.

Disclosures: This study did not report a source of funding. The authors declared serving as consultants or receiving grants, royalties, licenses, or personal fees from several sources.

Source: Kinslow CJ et al. Risk of anaplastic large cell lymphoma following postmastectomy implant reconstruction in women with breast cancer and ductal carcinoma in situ. JAMA Netw Open. 2022;5(11):e2243396 (Nov 22). Doi: 10.1001/jamanetworkopen.2022.43396

 

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Key clinical point: The relative risk for anaplastic large cell lymphoma (ALCL) was significantly increased in women who underwent implant reconstruction after mastectomy for breast cancer (BC) or ductal carcinoma in situ.

Major finding: The relative risk for ALCL (standardized incidence ratio [SIR] 40.9; 95% CI 13.3-95.5) and T-cell lymphoma (SIR 34.8; 95% CI 12.8-75.8) increased significantly after postmastectomy implant reconstruction.

Study details: This study evaluated 56,784 women with ductal carcinoma in situ of the breast (18%) or invasive BC (72%) from the Surveillance, Epidemiology, and End Results 17 database who had undergone postmastectomy implant reconstruction.

Disclosures: This study did not report a source of funding. The authors declared serving as consultants or receiving grants, royalties, licenses, or personal fees from several sources.

Source: Kinslow CJ et al. Risk of anaplastic large cell lymphoma following postmastectomy implant reconstruction in women with breast cancer and ductal carcinoma in situ. JAMA Netw Open. 2022;5(11):e2243396 (Nov 22). Doi: 10.1001/jamanetworkopen.2022.43396

 

Key clinical point: The relative risk for anaplastic large cell lymphoma (ALCL) was significantly increased in women who underwent implant reconstruction after mastectomy for breast cancer (BC) or ductal carcinoma in situ.

Major finding: The relative risk for ALCL (standardized incidence ratio [SIR] 40.9; 95% CI 13.3-95.5) and T-cell lymphoma (SIR 34.8; 95% CI 12.8-75.8) increased significantly after postmastectomy implant reconstruction.

Study details: This study evaluated 56,784 women with ductal carcinoma in situ of the breast (18%) or invasive BC (72%) from the Surveillance, Epidemiology, and End Results 17 database who had undergone postmastectomy implant reconstruction.

Disclosures: This study did not report a source of funding. The authors declared serving as consultants or receiving grants, royalties, licenses, or personal fees from several sources.

Source: Kinslow CJ et al. Risk of anaplastic large cell lymphoma following postmastectomy implant reconstruction in women with breast cancer and ductal carcinoma in situ. JAMA Netw Open. 2022;5(11):e2243396 (Nov 22). Doi: 10.1001/jamanetworkopen.2022.43396

 

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HR+/HER2− BC: Adjuvant abemaciclib+ET shows sustained positive benefit-risk profile

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Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) reduced the risk for recurrence and demonstrated a favorable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC) at a high risk for recurrence.

Major finding: Abemaciclib+ET helped sustain the invasive disease-free survival benefit compared with only ET even at 42 months of median follow-up (hazard ratio 0.664; nominal P < .0001). Although the frequency of grade ≥3 adverse events was higher with abemaciclib+ET (49.9%) vs  ET alone (16.9%), it was considered manageable and acceptable for patients with high-risk early BC.

Study details: Findings are from the phase 3, monarchE trial including 5637 patients with HR+/HER2−, node-positive, early BC who were randomly assigned to receive adjuvant ET with or without abemaciclib.

Disclosures: This study was funded by Eli Lilly. Five authors declared being employees and shareholders of Eli Lilly, and the other authors reported ties with several sources, including Eli Lilly.

Source: Johnston SRD et al on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 (Dec 6). Doi: 10.1016/S1470-2045(22)00694-5

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Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) reduced the risk for recurrence and demonstrated a favorable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC) at a high risk for recurrence.

Major finding: Abemaciclib+ET helped sustain the invasive disease-free survival benefit compared with only ET even at 42 months of median follow-up (hazard ratio 0.664; nominal P < .0001). Although the frequency of grade ≥3 adverse events was higher with abemaciclib+ET (49.9%) vs  ET alone (16.9%), it was considered manageable and acceptable for patients with high-risk early BC.

Study details: Findings are from the phase 3, monarchE trial including 5637 patients with HR+/HER2−, node-positive, early BC who were randomly assigned to receive adjuvant ET with or without abemaciclib.

Disclosures: This study was funded by Eli Lilly. Five authors declared being employees and shareholders of Eli Lilly, and the other authors reported ties with several sources, including Eli Lilly.

Source: Johnston SRD et al on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 (Dec 6). Doi: 10.1016/S1470-2045(22)00694-5

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) reduced the risk for recurrence and demonstrated a favorable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC) at a high risk for recurrence.

Major finding: Abemaciclib+ET helped sustain the invasive disease-free survival benefit compared with only ET even at 42 months of median follow-up (hazard ratio 0.664; nominal P < .0001). Although the frequency of grade ≥3 adverse events was higher with abemaciclib+ET (49.9%) vs  ET alone (16.9%), it was considered manageable and acceptable for patients with high-risk early BC.

Study details: Findings are from the phase 3, monarchE trial including 5637 patients with HR+/HER2−, node-positive, early BC who were randomly assigned to receive adjuvant ET with or without abemaciclib.

Disclosures: This study was funded by Eli Lilly. Five authors declared being employees and shareholders of Eli Lilly, and the other authors reported ties with several sources, including Eli Lilly.

Source: Johnston SRD et al on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 (Dec 6). Doi: 10.1016/S1470-2045(22)00694-5

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Clinical Edge Journal Scan Commentary: Breast Cancer January 2023
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Long lasting benefit with dose-dense adjuvant chemotherapy in high-risk early BC

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Thu, 01/26/2023 - 10:55

Key clinical point: In patients with high-risk early breast cancer (BC), a dose-dense adjuvant chemotherapy improved disease-free survival (DFS), whereas the addition of fluorouracil to the chemotherapy regimen failed to demonstrate any survival benefits.

Major finding: After a median follow-up of 15.1 years, the median DFS was similar with and without the addition of fluorouracil to the combination therapy of epirubicin, cyclophosphamide, and paclitaxel (EC-P; log-rank P = .11) and was significantly improved in the dose-dense vs  standard interval group (hazard ratio 0.77; P = .0004). The most common grade 3-4 adverse events were neutropenia and alopecia.

Study details: Findings are end of study results from the GIM2 trial including 2091 patients with node-positive early BC who were randomly assigned to receive standard-interval EC-P, standard-interval fluorouracil+EC-P (FEC-P), dose-dense EC-P, or dose-dense FEC-P.

Disclosures: This study was funded by Bristol-Myers Squibb, Pharmacia, Dompè Biotec Italy, Italian Ministry of Health, Fondazione Italiana per la Ricerca sul Cancro, and Alliance Against Cancer. The authors declared receiving fees, research grants, honoraria, or support for attending meetings or travel from several sources.

Source: Del Mastro L et al on behalf of the Gruppo Italiano Mammella Investigators. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): End-of-study results from a randomised, phase 3 trial. Lancet Oncol. 2022;23(12):1571-1582 (Nov 9). Doi: 10.1016/S1470-2045(22)00632-5

 

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Key clinical point: In patients with high-risk early breast cancer (BC), a dose-dense adjuvant chemotherapy improved disease-free survival (DFS), whereas the addition of fluorouracil to the chemotherapy regimen failed to demonstrate any survival benefits.

Major finding: After a median follow-up of 15.1 years, the median DFS was similar with and without the addition of fluorouracil to the combination therapy of epirubicin, cyclophosphamide, and paclitaxel (EC-P; log-rank P = .11) and was significantly improved in the dose-dense vs  standard interval group (hazard ratio 0.77; P = .0004). The most common grade 3-4 adverse events were neutropenia and alopecia.

Study details: Findings are end of study results from the GIM2 trial including 2091 patients with node-positive early BC who were randomly assigned to receive standard-interval EC-P, standard-interval fluorouracil+EC-P (FEC-P), dose-dense EC-P, or dose-dense FEC-P.

Disclosures: This study was funded by Bristol-Myers Squibb, Pharmacia, Dompè Biotec Italy, Italian Ministry of Health, Fondazione Italiana per la Ricerca sul Cancro, and Alliance Against Cancer. The authors declared receiving fees, research grants, honoraria, or support for attending meetings or travel from several sources.

Source: Del Mastro L et al on behalf of the Gruppo Italiano Mammella Investigators. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): End-of-study results from a randomised, phase 3 trial. Lancet Oncol. 2022;23(12):1571-1582 (Nov 9). Doi: 10.1016/S1470-2045(22)00632-5

 

Key clinical point: In patients with high-risk early breast cancer (BC), a dose-dense adjuvant chemotherapy improved disease-free survival (DFS), whereas the addition of fluorouracil to the chemotherapy regimen failed to demonstrate any survival benefits.

Major finding: After a median follow-up of 15.1 years, the median DFS was similar with and without the addition of fluorouracil to the combination therapy of epirubicin, cyclophosphamide, and paclitaxel (EC-P; log-rank P = .11) and was significantly improved in the dose-dense vs  standard interval group (hazard ratio 0.77; P = .0004). The most common grade 3-4 adverse events were neutropenia and alopecia.

Study details: Findings are end of study results from the GIM2 trial including 2091 patients with node-positive early BC who were randomly assigned to receive standard-interval EC-P, standard-interval fluorouracil+EC-P (FEC-P), dose-dense EC-P, or dose-dense FEC-P.

Disclosures: This study was funded by Bristol-Myers Squibb, Pharmacia, Dompè Biotec Italy, Italian Ministry of Health, Fondazione Italiana per la Ricerca sul Cancro, and Alliance Against Cancer. The authors declared receiving fees, research grants, honoraria, or support for attending meetings or travel from several sources.

Source: Del Mastro L et al on behalf of the Gruppo Italiano Mammella Investigators. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): End-of-study results from a randomised, phase 3 trial. Lancet Oncol. 2022;23(12):1571-1582 (Nov 9). Doi: 10.1016/S1470-2045(22)00632-5

 

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Clinical Edge Journal Scan Commentary: Breast Cancer January 2023
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Severe OSA tied to poor prognoses in stroke patients

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Wed, 12/21/2022 - 14:49

Patients with acute ischemic stroke had a worse prognosis if they had also experienced severe obstructive sleep apnea (OSA), based on data from 125 individuals.

OSA is on the rise, and is associated with pathophysiological changes, and data from previous studies suggest that severe OSA doubles the risk of stroke and increases risk of stroke recurrence, according to Juan Xu, PhD, of Soochow University, Suzhou, China, and colleagues.

“There is a high comorbidity between stroke and OSA,” and effective sleep is important to cerebral function recovery, the researchers wrote. Early prediction of stroke prognosis may inform treatment in stroke patients, but the value of OSA as a predictor of functional prognosis has not been explored.

In a study published in Sleep Medicine, the researchers analyzed data from 125 adults with mild to moderate ischemic stroke and OSA. The participants underwent polysomnography within a week of stroke onset between January 2015 and June 2020 and were grouped by severity according to apnea-hypopnea index (AHI) of either less than 30/h (not severe) or 30/h or higher (severe). The mean age of the patients was 58 years, and 87% were men. Approximately one-third of the participants met the criteria for severe OSA.

The researchers assessed the impact of OSA on functional prognosis in the acute phase of stroke, and reviewed quantitative electroencephalography (EEG) markers in stroke patients during sleep.

Overall, individuals with severe OSA were significantly more likely than those with less severe OSA to have comorbid hypertension (85.4% vs. 56%; P = .002) and a higher body mass index (28 vs. 24; P < .001). Other factors including blood pressure, smoking history, alcohol use, and comorbid diabetes were similar between the groups.

Quantitative EEG among patients with severe OSA showed lower relative power of high-frequency bands (alpha, beta, and sigma). The EEG also showed higher delta/alpha power ratio and slowing ratio, and higher delta relative power (delta RP) in severe OSA (P < .05 for all).

In addition, severe OSA was associated with more than triple the risk (3.6-fold increase) of poor prognosis, defined as a Modified Rankin Scale score of 3 or higher (24.4% for severe OSA vs. 8.3% for nonsevere OSA; P = .03).

“Our study confirmed that severe OSA is an independent risk factor for poor functional prognosis in the acute phase of ischemic stroke,” the researchers wrote. “Integrating the alteration of quantitative EEG parameters may improve the accuracy of early predictions of functional prognosis in patients with stroke.”

The findings were limited by several factors including the retrospective design and the lack of a sizable non-OSA control group, the researchers noted. Other limitations included the use of an AHI of 30/h or higher to define severity and the use of data from medical histories, with the potential for information bias, and the use of only 30-second continuous polysomnography segments.

However, the results suggest that increased delta RP and TSR, and decreased alpha, beta, and sigma RP, may be independent predictors of a poor functional prognosis in stroke patients with OSA, and that the prognosis could be improved by treating the OSA, they concluded.

The study was supported by the Natural Science Foundation of China and the Discipline Construction Program of the Second Affiliated Hospital of Soochow University. The researchers reported no financial conflicts.

A version of this article first appeared on Medscape.com.

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Patients with acute ischemic stroke had a worse prognosis if they had also experienced severe obstructive sleep apnea (OSA), based on data from 125 individuals.

OSA is on the rise, and is associated with pathophysiological changes, and data from previous studies suggest that severe OSA doubles the risk of stroke and increases risk of stroke recurrence, according to Juan Xu, PhD, of Soochow University, Suzhou, China, and colleagues.

“There is a high comorbidity between stroke and OSA,” and effective sleep is important to cerebral function recovery, the researchers wrote. Early prediction of stroke prognosis may inform treatment in stroke patients, but the value of OSA as a predictor of functional prognosis has not been explored.

In a study published in Sleep Medicine, the researchers analyzed data from 125 adults with mild to moderate ischemic stroke and OSA. The participants underwent polysomnography within a week of stroke onset between January 2015 and June 2020 and were grouped by severity according to apnea-hypopnea index (AHI) of either less than 30/h (not severe) or 30/h or higher (severe). The mean age of the patients was 58 years, and 87% were men. Approximately one-third of the participants met the criteria for severe OSA.

The researchers assessed the impact of OSA on functional prognosis in the acute phase of stroke, and reviewed quantitative electroencephalography (EEG) markers in stroke patients during sleep.

Overall, individuals with severe OSA were significantly more likely than those with less severe OSA to have comorbid hypertension (85.4% vs. 56%; P = .002) and a higher body mass index (28 vs. 24; P < .001). Other factors including blood pressure, smoking history, alcohol use, and comorbid diabetes were similar between the groups.

Quantitative EEG among patients with severe OSA showed lower relative power of high-frequency bands (alpha, beta, and sigma). The EEG also showed higher delta/alpha power ratio and slowing ratio, and higher delta relative power (delta RP) in severe OSA (P < .05 for all).

In addition, severe OSA was associated with more than triple the risk (3.6-fold increase) of poor prognosis, defined as a Modified Rankin Scale score of 3 or higher (24.4% for severe OSA vs. 8.3% for nonsevere OSA; P = .03).

“Our study confirmed that severe OSA is an independent risk factor for poor functional prognosis in the acute phase of ischemic stroke,” the researchers wrote. “Integrating the alteration of quantitative EEG parameters may improve the accuracy of early predictions of functional prognosis in patients with stroke.”

The findings were limited by several factors including the retrospective design and the lack of a sizable non-OSA control group, the researchers noted. Other limitations included the use of an AHI of 30/h or higher to define severity and the use of data from medical histories, with the potential for information bias, and the use of only 30-second continuous polysomnography segments.

However, the results suggest that increased delta RP and TSR, and decreased alpha, beta, and sigma RP, may be independent predictors of a poor functional prognosis in stroke patients with OSA, and that the prognosis could be improved by treating the OSA, they concluded.

The study was supported by the Natural Science Foundation of China and the Discipline Construction Program of the Second Affiliated Hospital of Soochow University. The researchers reported no financial conflicts.

A version of this article first appeared on Medscape.com.

Patients with acute ischemic stroke had a worse prognosis if they had also experienced severe obstructive sleep apnea (OSA), based on data from 125 individuals.

OSA is on the rise, and is associated with pathophysiological changes, and data from previous studies suggest that severe OSA doubles the risk of stroke and increases risk of stroke recurrence, according to Juan Xu, PhD, of Soochow University, Suzhou, China, and colleagues.

“There is a high comorbidity between stroke and OSA,” and effective sleep is important to cerebral function recovery, the researchers wrote. Early prediction of stroke prognosis may inform treatment in stroke patients, but the value of OSA as a predictor of functional prognosis has not been explored.

In a study published in Sleep Medicine, the researchers analyzed data from 125 adults with mild to moderate ischemic stroke and OSA. The participants underwent polysomnography within a week of stroke onset between January 2015 and June 2020 and were grouped by severity according to apnea-hypopnea index (AHI) of either less than 30/h (not severe) or 30/h or higher (severe). The mean age of the patients was 58 years, and 87% were men. Approximately one-third of the participants met the criteria for severe OSA.

The researchers assessed the impact of OSA on functional prognosis in the acute phase of stroke, and reviewed quantitative electroencephalography (EEG) markers in stroke patients during sleep.

Overall, individuals with severe OSA were significantly more likely than those with less severe OSA to have comorbid hypertension (85.4% vs. 56%; P = .002) and a higher body mass index (28 vs. 24; P < .001). Other factors including blood pressure, smoking history, alcohol use, and comorbid diabetes were similar between the groups.

Quantitative EEG among patients with severe OSA showed lower relative power of high-frequency bands (alpha, beta, and sigma). The EEG also showed higher delta/alpha power ratio and slowing ratio, and higher delta relative power (delta RP) in severe OSA (P < .05 for all).

In addition, severe OSA was associated with more than triple the risk (3.6-fold increase) of poor prognosis, defined as a Modified Rankin Scale score of 3 or higher (24.4% for severe OSA vs. 8.3% for nonsevere OSA; P = .03).

“Our study confirmed that severe OSA is an independent risk factor for poor functional prognosis in the acute phase of ischemic stroke,” the researchers wrote. “Integrating the alteration of quantitative EEG parameters may improve the accuracy of early predictions of functional prognosis in patients with stroke.”

The findings were limited by several factors including the retrospective design and the lack of a sizable non-OSA control group, the researchers noted. Other limitations included the use of an AHI of 30/h or higher to define severity and the use of data from medical histories, with the potential for information bias, and the use of only 30-second continuous polysomnography segments.

However, the results suggest that increased delta RP and TSR, and decreased alpha, beta, and sigma RP, may be independent predictors of a poor functional prognosis in stroke patients with OSA, and that the prognosis could be improved by treating the OSA, they concluded.

The study was supported by the Natural Science Foundation of China and the Discipline Construction Program of the Second Affiliated Hospital of Soochow University. The researchers reported no financial conflicts.

A version of this article first appeared on Medscape.com.

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Multiple myeloma diagnosed more via emergency care during COVID

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Wed, 01/11/2023 - 16:55

The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.

Key takeaway

Patients with multiple myeloma were diagnosed at a significantly higher rate through emergency care during the COVID-19 pandemic, compared with before.

Why this matters

While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.

Study design

Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.

Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
 

Key results

Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.

Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; = .03).

Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.

Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; = .014).

Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID. 

Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
 

Limitations

The study does not provide a clear time frame of delays in diagnosis.

Disclosures

The study authors did not report any conflicts of interest.

A version of this article first appeared on Medscape.com .

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The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.

Key takeaway

Patients with multiple myeloma were diagnosed at a significantly higher rate through emergency care during the COVID-19 pandemic, compared with before.

Why this matters

While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.

Study design

Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.

Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
 

Key results

Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.

Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; = .03).

Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.

Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; = .014).

Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID. 

Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
 

Limitations

The study does not provide a clear time frame of delays in diagnosis.

Disclosures

The study authors did not report any conflicts of interest.

A version of this article first appeared on Medscape.com .

The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.

Key takeaway

Patients with multiple myeloma were diagnosed at a significantly higher rate through emergency care during the COVID-19 pandemic, compared with before.

Why this matters

While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.

Study design

Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.

Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
 

Key results

Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.

Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; = .03).

Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.

Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; = .014).

Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID. 

Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
 

Limitations

The study does not provide a clear time frame of delays in diagnosis.

Disclosures

The study authors did not report any conflicts of interest.

A version of this article first appeared on Medscape.com .

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