Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

Key clinical point: Patients with breast cancer (BC) who did not achieve pathological complete response (pCR) after receiving neoadjuvant chemotherapy (NACT) showed improved survival outcomes after adjuvant aspirin use.

Major finding: The 5-year disease-free survival and distant metastasis-free survival were improved with vs without aspirin use in the whole cohort (adjusted hazard ratio [aHR] 0.48, P = .01; and aHR 0.57, P = .04, respectively) and in higher-risk patients with nodal disease (aHR 0.48, P = .02; and aHR 0.43, P = .008, respectively).

Study details: Findings are from a retrospective study including 637 patients with BC who did not achieve pCR after receiving NACT, of which 138 patients used aspirin after diagnosis.

Disclosures: This study did not receive any funding. Dr. Unni declared serving on advisory boards for various sources.

Source: Johns C et al. Aspirin use is associated with improvement in distant metastases outcome in patients with residual disease after neoadjuvant chemotherapy. Breast Cancer Res Treat. 2023 (Mar 30). Doi: 10.1007/s10549-023-06920-4

Key clinical point: Women who started receiving statins after the diagnosis of breast cancer (BC) had a significantly decreased risk for breast cancer-specific death (BCD).

Major finding: The risk for BCD was significantly lower in the overall cohort of patients who used vs never used statins (hazard ratio [HR] 0.74; 95% CI 0.63-0.86) and in the subgroup of patients with estrogen receptor-positive BC (HR 0.77; 95% CI 0.63-0.94), post-menopausal women (HR 0.74; 95% CI 0.63-0.88), and women with advanced stage BC (HR 0.65; 95% CI 0.49-0.84).

Study details: Findings are from a large, population-based cohort study including 14,976 women with newly diagnosed BC, of which 4060 patients received statins after the diagnosis of BC.

Disclosures: This study was supported by the Auckland Medical Research Foundation, New Zealand. The authors declared no conflict of interests.

Source: Scott OW et al. Post-diagnostic statin use and breast cancer-specific mortality: A population-based cohort study. Breast Cancer Res Treat. 2023 (Mar 17). Doi: 10.1007/s10549-022-06815-w

Key clinical point: Women who started receiving statins after the diagnosis of breast cancer (BC) had a significantly decreased risk for breast cancer-specific death (BCD).

Major finding: The risk for BCD was significantly lower in the overall cohort of patients who used vs never used statins (hazard ratio [HR] 0.74; 95% CI 0.63-0.86) and in the subgroup of patients with estrogen receptor-positive BC (HR 0.77; 95% CI 0.63-0.94), post-menopausal women (HR 0.74; 95% CI 0.63-0.88), and women with advanced stage BC (HR 0.65; 95% CI 0.49-0.84).

Study details: Findings are from a large, population-based cohort study including 14,976 women with newly diagnosed BC, of which 4060 patients received statins after the diagnosis of BC.

Disclosures: This study was supported by the Auckland Medical Research Foundation, New Zealand. The authors declared no conflict of interests.

Source: Scott OW et al. Post-diagnostic statin use and breast cancer-specific mortality: A population-based cohort study. Breast Cancer Res Treat. 2023 (Mar 17). Doi: 10.1007/s10549-022-06815-w

Key clinical point: Women who started receiving statins after the diagnosis of breast cancer (BC) had a significantly decreased risk for breast cancer-specific death (BCD).

Major finding: The risk for BCD was significantly lower in the overall cohort of patients who used vs never used statins (hazard ratio [HR] 0.74; 95% CI 0.63-0.86) and in the subgroup of patients with estrogen receptor-positive BC (HR 0.77; 95% CI 0.63-0.94), post-menopausal women (HR 0.74; 95% CI 0.63-0.88), and women with advanced stage BC (HR 0.65; 95% CI 0.49-0.84).

Study details: Findings are from a large, population-based cohort study including 14,976 women with newly diagnosed BC, of which 4060 patients received statins after the diagnosis of BC.

Disclosures: This study was supported by the Auckland Medical Research Foundation, New Zealand. The authors declared no conflict of interests.

Source: Scott OW et al. Post-diagnostic statin use and breast cancer-specific mortality: A population-based cohort study. Breast Cancer Res Treat. 2023 (Mar 17). Doi: 10.1007/s10549-022-06815-w

Key clinical point: First-line palbociclib plus letrozole proved to be a more effective treatment option than letrozole alone in a real-world population of older patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer (BC).

Major finding: Real-world progression-free survival (22.2 vs 15.8 months; adjusted hazard ratio 0.59; P < .001) was significantly prolonged and real-world best tumor response rate was significantly higher (52.4% vs. 22.1%; adjusted odds ratio 2.0; P < .001) in patients receiving palbociclib+letrozole vs letrozole alone.

Study details: Findings are from a retrospective cohort study including 796 women aged ≥65 years with HR+/HER2− metastatic BC who initiated first-line treatment with palbociclib+letrozole or letrozole alone.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees of and owning stocks in Pfizer Inc. The other authors declared receiving advisory board fees, consulting fees, honoraria, or research funding from Pfizer Inc and other sources.

Source: Rugo HS et al. Real-world comparative effectiveness of palbociclib plus letrozole versus letrozole in older patients with metastatic breast cancer. Breast. 2023 (Mar 27). Doi: 10.1016/j.breast.2023.03.015

Key clinical point: First-line palbociclib plus letrozole proved to be a more effective treatment option than letrozole alone in a real-world population of older patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer (BC).

Major finding: Real-world progression-free survival (22.2 vs 15.8 months; adjusted hazard ratio 0.59; P < .001) was significantly prolonged and real-world best tumor response rate was significantly higher (52.4% vs. 22.1%; adjusted odds ratio 2.0; P < .001) in patients receiving palbociclib+letrozole vs letrozole alone.

Study details: Findings are from a retrospective cohort study including 796 women aged ≥65 years with HR+/HER2− metastatic BC who initiated first-line treatment with palbociclib+letrozole or letrozole alone.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees of and owning stocks in Pfizer Inc. The other authors declared receiving advisory board fees, consulting fees, honoraria, or research funding from Pfizer Inc and other sources.

Source: Rugo HS et al. Real-world comparative effectiveness of palbociclib plus letrozole versus letrozole in older patients with metastatic breast cancer. Breast. 2023 (Mar 27). Doi: 10.1016/j.breast.2023.03.015

Key clinical point: First-line palbociclib plus letrozole proved to be a more effective treatment option than letrozole alone in a real-world population of older patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer (BC).

Major finding: Real-world progression-free survival (22.2 vs 15.8 months; adjusted hazard ratio 0.59; P < .001) was significantly prolonged and real-world best tumor response rate was significantly higher (52.4% vs. 22.1%; adjusted odds ratio 2.0; P < .001) in patients receiving palbociclib+letrozole vs letrozole alone.

Study details: Findings are from a retrospective cohort study including 796 women aged ≥65 years with HR+/HER2− metastatic BC who initiated first-line treatment with palbociclib+letrozole or letrozole alone.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees of and owning stocks in Pfizer Inc. The other authors declared receiving advisory board fees, consulting fees, honoraria, or research funding from Pfizer Inc and other sources.

Source: Rugo HS et al. Real-world comparative effectiveness of palbociclib plus letrozole versus letrozole in older patients with metastatic breast cancer. Breast. 2023 (Mar 27). Doi: 10.1016/j.breast.2023.03.015

Key clinical point: Omission of surgical axillary staging (AS) worsened overall survival (OS) but not breast cancer-specific survival (BCSS) in older women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) early-stage breast cancer (BC).

Major finding: Women who did not undergo AS had similar BCSS (adjusted hazard ratio [HR] 0.98; 95% CI 0.77-1.25) but poorer OS (adjusted HR 1.14; 95% CI 1.04-1.25) compared with those who underwent AS.

Study details: Findings are from a population-based cohort study including 17,370 women aged 65-95 years with ER+/HER2− early-stage BC who underwent surgery, of which 1771 patients did not undergo AS.

Disclosures: This study was supported by the Ontario Ministry of Health and the Ministry of Long-Term Care, Canada. The authors declared no conflict of interests.

Source: Castelo M et al. The association between surgical axillary staging, adjuvant treatment use and survival in older women with early stage breast cancer: A population-based study. Ann Surg Oncol. 2023 (Mar 14). Doi: 10.1245/s10434-023-13274-0

Key clinical point: Omission of surgical axillary staging (AS) worsened overall survival (OS) but not breast cancer-specific survival (BCSS) in older women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) early-stage breast cancer (BC).

Major finding: Women who did not undergo AS had similar BCSS (adjusted hazard ratio [HR] 0.98; 95% CI 0.77-1.25) but poorer OS (adjusted HR 1.14; 95% CI 1.04-1.25) compared with those who underwent AS.

Study details: Findings are from a population-based cohort study including 17,370 women aged 65-95 years with ER+/HER2− early-stage BC who underwent surgery, of which 1771 patients did not undergo AS.

Disclosures: This study was supported by the Ontario Ministry of Health and the Ministry of Long-Term Care, Canada. The authors declared no conflict of interests.

Source: Castelo M et al. The association between surgical axillary staging, adjuvant treatment use and survival in older women with early stage breast cancer: A population-based study. Ann Surg Oncol. 2023 (Mar 14). Doi: 10.1245/s10434-023-13274-0

Key clinical point: Omission of surgical axillary staging (AS) worsened overall survival (OS) but not breast cancer-specific survival (BCSS) in older women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) early-stage breast cancer (BC).

Major finding: Women who did not undergo AS had similar BCSS (adjusted hazard ratio [HR] 0.98; 95% CI 0.77-1.25) but poorer OS (adjusted HR 1.14; 95% CI 1.04-1.25) compared with those who underwent AS.

Study details: Findings are from a population-based cohort study including 17,370 women aged 65-95 years with ER+/HER2− early-stage BC who underwent surgery, of which 1771 patients did not undergo AS.

Disclosures: This study was supported by the Ontario Ministry of Health and the Ministry of Long-Term Care, Canada. The authors declared no conflict of interests.

Source: Castelo M et al. The association between surgical axillary staging, adjuvant treatment use and survival in older women with early stage breast cancer: A population-based study. Ann Surg Oncol. 2023 (Mar 14). Doi: 10.1245/s10434-023-13274-0

Key clinical point: Patients with early breast cancer (BC) who achieve pathological complete response (pCR) with neoadjuvant chemotherapy can nevertheless be at risk for disease relapse if there is nodal involvement at diagnosis and tumors are large and have lobular histology.

Major finding: Disease-free survival (DFS) was worse in the overall cohort (hazard ratio [HR] 1.94; P < .001) and in patients with triple-negative BC (TNBC; HR 2.45; P < .001) who did vs did not have initial positive lymph node involvement. Lobular histology (HR 3.55; P = .003) and large tumors (cT3/4; HR 2.07; P = .033) were also associated with a higher risk for shorter DFS in patients with TNBC and human epidermal growth factor receptor 2-positive BC, respectively.

Study details: This retrospective pooled analysis included 2066 patients with BC who had achieved pCR.

Disclosures: This study was funded by Projekt DEAL, Germany. Some authors declared receiving consulting fees, honoraria, travel expenses, research grants, or honoraria or having other ties with several sources.

Source: Huober J et al. Identifying breast cancer patients at risk of relapse despite pathological complete response after neoadjuvant therapy. NPJ Breast Cancer. 2023;9:23 (Apr 7). Doi: 10.1038/s41523-023-00525-2

Key clinical point: Patients with early breast cancer (BC) who achieve pathological complete response (pCR) with neoadjuvant chemotherapy can nevertheless be at risk for disease relapse if there is nodal involvement at diagnosis and tumors are large and have lobular histology.

Major finding: Disease-free survival (DFS) was worse in the overall cohort (hazard ratio [HR] 1.94; P < .001) and in patients with triple-negative BC (TNBC; HR 2.45; P < .001) who did vs did not have initial positive lymph node involvement. Lobular histology (HR 3.55; P = .003) and large tumors (cT3/4; HR 2.07; P = .033) were also associated with a higher risk for shorter DFS in patients with TNBC and human epidermal growth factor receptor 2-positive BC, respectively.

Study details: This retrospective pooled analysis included 2066 patients with BC who had achieved pCR.

Disclosures: This study was funded by Projekt DEAL, Germany. Some authors declared receiving consulting fees, honoraria, travel expenses, research grants, or honoraria or having other ties with several sources.

Source: Huober J et al. Identifying breast cancer patients at risk of relapse despite pathological complete response after neoadjuvant therapy. NPJ Breast Cancer. 2023;9:23 (Apr 7). Doi: 10.1038/s41523-023-00525-2

Key clinical point: Patients with early breast cancer (BC) who achieve pathological complete response (pCR) with neoadjuvant chemotherapy can nevertheless be at risk for disease relapse if there is nodal involvement at diagnosis and tumors are large and have lobular histology.

Major finding: Disease-free survival (DFS) was worse in the overall cohort (hazard ratio [HR] 1.94; P < .001) and in patients with triple-negative BC (TNBC; HR 2.45; P < .001) who did vs did not have initial positive lymph node involvement. Lobular histology (HR 3.55; P = .003) and large tumors (cT3/4; HR 2.07; P = .033) were also associated with a higher risk for shorter DFS in patients with TNBC and human epidermal growth factor receptor 2-positive BC, respectively.

Study details: This retrospective pooled analysis included 2066 patients with BC who had achieved pCR.

Disclosures: This study was funded by Projekt DEAL, Germany. Some authors declared receiving consulting fees, honoraria, travel expenses, research grants, or honoraria or having other ties with several sources.

Source: Huober J et al. Identifying breast cancer patients at risk of relapse despite pathological complete response after neoadjuvant therapy. NPJ Breast Cancer. 2023;9:23 (Apr 7). Doi: 10.1038/s41523-023-00525-2

Key clinical point: Data from a multi-institutional US database of more than 2.5 million screening mammograms showed that digital breast tomosynthesis (DBT) was superior to digital mammography (DM) for the purpose of breast cancer (BC) screening.

Major finding: Compared with DM, DBT led to significantly higher cancer detection rates (adjusted odds ratio [OR] 1.24), biopsy rate (adjusted OR 1.33), and positive predictive value of recall (adjusted OR 1.33; all P < .001).

Study details: Findings are from a retrospective study including 2,528,063 screening mammograms in 1,100,447 women aged 40-79 years.

Disclosures: This study did not report the source of funding. Some authors declared receiving grants, travel support, consulting fees, or payments from various sources.

Source: Conant EF et al. Mammographic screening in routine practice: Multisite study of digital breast tomosynthesis and digital mammography screenings. Radiology. 2023 (Mar 14). Doi: 10.1148/radiol.221571

Key clinical point: Data from a multi-institutional US database of more than 2.5 million screening mammograms showed that digital breast tomosynthesis (DBT) was superior to digital mammography (DM) for the purpose of breast cancer (BC) screening.

Major finding: Compared with DM, DBT led to significantly higher cancer detection rates (adjusted odds ratio [OR] 1.24), biopsy rate (adjusted OR 1.33), and positive predictive value of recall (adjusted OR 1.33; all P < .001).

Study details: Findings are from a retrospective study including 2,528,063 screening mammograms in 1,100,447 women aged 40-79 years.

Disclosures: This study did not report the source of funding. Some authors declared receiving grants, travel support, consulting fees, or payments from various sources.

Source: Conant EF et al. Mammographic screening in routine practice: Multisite study of digital breast tomosynthesis and digital mammography screenings. Radiology. 2023 (Mar 14). Doi: 10.1148/radiol.221571

Key clinical point: Data from a multi-institutional US database of more than 2.5 million screening mammograms showed that digital breast tomosynthesis (DBT) was superior to digital mammography (DM) for the purpose of breast cancer (BC) screening.

Major finding: Compared with DM, DBT led to significantly higher cancer detection rates (adjusted odds ratio [OR] 1.24), biopsy rate (adjusted OR 1.33), and positive predictive value of recall (adjusted OR 1.33; all P < .001).

Study details: Findings are from a retrospective study including 2,528,063 screening mammograms in 1,100,447 women aged 40-79 years.

Disclosures: This study did not report the source of funding. Some authors declared receiving grants, travel support, consulting fees, or payments from various sources.

Source: Conant EF et al. Mammographic screening in routine practice: Multisite study of digital breast tomosynthesis and digital mammography screenings. Radiology. 2023 (Mar 14). Doi: 10.1148/radiol.221571

Key clinical point: In patients with early, operable breast cancer (BC), peritumoral injection of a local anesthetic (lidocaine) prior to surgery improved survival outcomes.

Major finding: Peritumoral infiltration of lidocaine at the time of surgery led to 26% improvement in disease-free survival (hazard ratio [HR] 0.74; P = .017) and 29% improvement in overall survival (HR 0.71; P = .019) at a median follow-up of 68 months. No adverse events related to injection of lidocaine were reported.

Study details: Findings are from the phase 3 study including 1583 patients with early, operable BC who did not receive prior neoadjuvant treatment and were randomly assigned to undergo surgery with or without a peritumoral injection of 0.5% lidocaine 7-10 minutes preoperatively.

Disclosures: This study was supported by Department of Atomic Energy, India. Dr. Sudeep Gupta declared receiving research funding from several sources.

Source: Badwe RA et al. Effect of peritumoral infiltration of local anesthetic before surgery on survival in early breast cancer. J Clin Oncol. 2023 (Apr 6). Doi: 10.1200/JCO.22.01966

Key clinical point: In patients with early, operable breast cancer (BC), peritumoral injection of a local anesthetic (lidocaine) prior to surgery improved survival outcomes.

Major finding: Peritumoral infiltration of lidocaine at the time of surgery led to 26% improvement in disease-free survival (hazard ratio [HR] 0.74; P = .017) and 29% improvement in overall survival (HR 0.71; P = .019) at a median follow-up of 68 months. No adverse events related to injection of lidocaine were reported.

Study details: Findings are from the phase 3 study including 1583 patients with early, operable BC who did not receive prior neoadjuvant treatment and were randomly assigned to undergo surgery with or without a peritumoral injection of 0.5% lidocaine 7-10 minutes preoperatively.

Disclosures: This study was supported by Department of Atomic Energy, India. Dr. Sudeep Gupta declared receiving research funding from several sources.

Source: Badwe RA et al. Effect of peritumoral infiltration of local anesthetic before surgery on survival in early breast cancer. J Clin Oncol. 2023 (Apr 6). Doi: 10.1200/JCO.22.01966

Key clinical point: In patients with early, operable breast cancer (BC), peritumoral injection of a local anesthetic (lidocaine) prior to surgery improved survival outcomes.

Major finding: Peritumoral infiltration of lidocaine at the time of surgery led to 26% improvement in disease-free survival (hazard ratio [HR] 0.74; P = .017) and 29% improvement in overall survival (HR 0.71; P = .019) at a median follow-up of 68 months. No adverse events related to injection of lidocaine were reported.

Study details: Findings are from the phase 3 study including 1583 patients with early, operable BC who did not receive prior neoadjuvant treatment and were randomly assigned to undergo surgery with or without a peritumoral injection of 0.5% lidocaine 7-10 minutes preoperatively.

Disclosures: This study was supported by Department of Atomic Energy, India. Dr. Sudeep Gupta declared receiving research funding from several sources.

Source: Badwe RA et al. Effect of peritumoral infiltration of local anesthetic before surgery on survival in early breast cancer. J Clin Oncol. 2023 (Apr 6). Doi: 10.1200/JCO.22.01966

Key clinical point: In women with 2-3 ipsilateral foci of breast cancer (BC), breast-conserving surgery (BCS; lumpectomy plus adjuvant radiation) resulted in a local recurrence rate that was below the a priori determined clinically acceptable threshold of 8%.

Major finding: BCS resulted in a highly acceptable 5-year local recurrence rate of 3.1% (95% CI 1.3%-6.4%) in patients with multiple ipsilateral BC.

Study details: Findings are from the phase 2 American College of Surgeons Oncology Group Z11102 (Alliance) trial including 204 women aged ≥40 years with multiple ipsilateral BC who underwent BCS.

Disclosures: This study was supported by the US National Institutes of Health. Some authors declared owning stocks; serving on editorial boards, in leadership positions, or as employees; receiving research funding, honoraria, or travel and accommodation expenses; or having other ties with various sources.

Source: Boughey JC et al. Local recurrence after breast-conserving therapy in patients with multiple ipsilateral breast cancer: Results from ACOSOG Z11102 (Alliance). J Clin Oncol. 2023 (Mar 28). Doi: 10.1200/JCO.22.02553

Key clinical point: In women with 2-3 ipsilateral foci of breast cancer (BC), breast-conserving surgery (BCS; lumpectomy plus adjuvant radiation) resulted in a local recurrence rate that was below the a priori determined clinically acceptable threshold of 8%.

Major finding: BCS resulted in a highly acceptable 5-year local recurrence rate of 3.1% (95% CI 1.3%-6.4%) in patients with multiple ipsilateral BC.

Study details: Findings are from the phase 2 American College of Surgeons Oncology Group Z11102 (Alliance) trial including 204 women aged ≥40 years with multiple ipsilateral BC who underwent BCS.

Disclosures: This study was supported by the US National Institutes of Health. Some authors declared owning stocks; serving on editorial boards, in leadership positions, or as employees; receiving research funding, honoraria, or travel and accommodation expenses; or having other ties with various sources.

Source: Boughey JC et al. Local recurrence after breast-conserving therapy in patients with multiple ipsilateral breast cancer: Results from ACOSOG Z11102 (Alliance). J Clin Oncol. 2023 (Mar 28). Doi: 10.1200/JCO.22.02553

Key clinical point: In women with 2-3 ipsilateral foci of breast cancer (BC), breast-conserving surgery (BCS; lumpectomy plus adjuvant radiation) resulted in a local recurrence rate that was below the a priori determined clinically acceptable threshold of 8%.

Major finding: BCS resulted in a highly acceptable 5-year local recurrence rate of 3.1% (95% CI 1.3%-6.4%) in patients with multiple ipsilateral BC.

Study details: Findings are from the phase 2 American College of Surgeons Oncology Group Z11102 (Alliance) trial including 204 women aged ≥40 years with multiple ipsilateral BC who underwent BCS.

Disclosures: This study was supported by the US National Institutes of Health. Some authors declared owning stocks; serving on editorial boards, in leadership positions, or as employees; receiving research funding, honoraria, or travel and accommodation expenses; or having other ties with various sources.

Source: Boughey JC et al. Local recurrence after breast-conserving therapy in patients with multiple ipsilateral breast cancer: Results from ACOSOG Z11102 (Alliance). J Clin Oncol. 2023 (Mar 28). Doi: 10.1200/JCO.22.02553

Key clinical point: A dose of 25 mg exemestane 3 times weekly was noninferior to the standard once-daily dose in decreasing serum estradiol levels in postmenopausal women with stage 0-II estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Compared with once-daily exemestane, 3-times-weekly exemestane was noninferior (difference in percentage change 2.0%; P for noninferiority = .02) whereas once-weekly exemestane was less effective in decreasing serum estradiol levels in participants who received ≥80% of the active scheduled pills and underwent blood testing as per protocol. The adverse event rate was similar across all treatment arms.

Study details: This phase 2b trial included 180 postmenopausal women with stage 0-II, ER+ BC who were randomly assigned to receive 25 mg exemestane once daily, 3 times weekly, or once weekly for 4-6 weeks before surgery.

Disclosures: This study was supported by the US National Cancer Institute and other sources. Two authors declared being principal investigators, holding stocks, or receiving partial salary support or personal fees from various sources.

Source: Serrano D et al. Efficacy of alternative dose regimens of exemestane in postmenopausal women with stage 0 to II estrogen receptor-positive breast cancer: A randomized clinical trial. JAMA Oncol. 2023 (Mar 23). Doi: 10.1001/jamaoncol.2023.0089

Key clinical point: A dose of 25 mg exemestane 3 times weekly was noninferior to the standard once-daily dose in decreasing serum estradiol levels in postmenopausal women with stage 0-II estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Compared with once-daily exemestane, 3-times-weekly exemestane was noninferior (difference in percentage change 2.0%; P for noninferiority = .02) whereas once-weekly exemestane was less effective in decreasing serum estradiol levels in participants who received ≥80% of the active scheduled pills and underwent blood testing as per protocol. The adverse event rate was similar across all treatment arms.

Study details: This phase 2b trial included 180 postmenopausal women with stage 0-II, ER+ BC who were randomly assigned to receive 25 mg exemestane once daily, 3 times weekly, or once weekly for 4-6 weeks before surgery.

Disclosures: This study was supported by the US National Cancer Institute and other sources. Two authors declared being principal investigators, holding stocks, or receiving partial salary support or personal fees from various sources.

Source: Serrano D et al. Efficacy of alternative dose regimens of exemestane in postmenopausal women with stage 0 to II estrogen receptor-positive breast cancer: A randomized clinical trial. JAMA Oncol. 2023 (Mar 23). Doi: 10.1001/jamaoncol.2023.0089

Key clinical point: A dose of 25 mg exemestane 3 times weekly was noninferior to the standard once-daily dose in decreasing serum estradiol levels in postmenopausal women with stage 0-II estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Compared with once-daily exemestane, 3-times-weekly exemestane was noninferior (difference in percentage change 2.0%; P for noninferiority = .02) whereas once-weekly exemestane was less effective in decreasing serum estradiol levels in participants who received ≥80% of the active scheduled pills and underwent blood testing as per protocol. The adverse event rate was similar across all treatment arms.

Study details: This phase 2b trial included 180 postmenopausal women with stage 0-II, ER+ BC who were randomly assigned to receive 25 mg exemestane once daily, 3 times weekly, or once weekly for 4-6 weeks before surgery.

Disclosures: This study was supported by the US National Cancer Institute and other sources. Two authors declared being principal investigators, holding stocks, or receiving partial salary support or personal fees from various sources.

Source: Serrano D et al. Efficacy of alternative dose regimens of exemestane in postmenopausal women with stage 0 to II estrogen receptor-positive breast cancer: A randomized clinical trial. JAMA Oncol. 2023 (Mar 23). Doi: 10.1001/jamaoncol.2023.0089

The sex of a red blood cell donor has no effect on the survival of a transfusion recipient, data suggest.

In a randomized clinical trial with almost 9,000 patients, the adjusted hazard ratio of death among recipients of female donors’ blood, compared with recipients of male donors’ blood, was 0.98. The data contradict the finding of previous observational studies that donor sex is associated with recipient outcomes.

“The key finding was that we actually had a null result,” study author Dean Fergusson, MD, PhD, senior scientist at the Ottawa Hospital Research Institute, said in an interview. “We went in thinking that male donor blood would confer a benefit over female donor blood, and we found that there’s absolutely no difference between the donor sexes on recipient outcomes – mortality and other major secondary outcomes,” Dr. Fergusson added.

The study was published in the New England Journal of Medicine.
 

Differences ‘don’t matter’

A 2015 article from the National Heart, Lung, and Blood Institute identified a potential effect of donor sex on transfusion recipient survival. Since then, several observational studies have suggested that donor sex may influence survival after transfusion. This research includes two large studies, one from Canada and one from the Netherlands, that reported a heightened risk of death among recipients of red-cell units from female donors or donors who had been pregnant. Other studies, however, yielded conflicting results.

“The rationale was that female blood, because of biochemical properties, different hormones, exposure to babies and other males, all led to a different product, if you will, and these subtle changes could affect the blood product in terms of shelf life and potency,” said Dr. Fergusson. “That itself would have downstream effects on the recipient.”

The current double-blind study included 8,719 patients who received transfusions from September 2018 to December 2020 at three academic medical centers in Canada. Of this group, 5,190 received male donor blood, and 3,529 received blood from female donors.

The researchers randomly assigned patients in a 60:40 ratio to male and female donor groups. Data collection and follow-up were performed by the Ottawa Hospital Data Warehouse, Canadian Blood Services, and ICES, an independent research institute. Patient characteristics were similar in both trial groups at baseline.

After an average follow-up of 11.2 months, with a maximum follow-up of 29 months, 1,141 patients in the female donor group and 1,712 in the male donor group died. The study found no statistically significant difference in overall survival between the two groups. The unadjusted HR for death, with the male group as the reference, was 0.97, and the adjusted HR was 0.98. The rates of overall survival were 58% and 56.1% in the female and male donor groups, respectively.

The study did not prove that differences in outcome based on donor sex do not exist, said Dr. Fergusson. “But those differences really don’t matter in the recipient.”

The design of the trial itself was unique, Dr. Fergusson said. After patients consented to participate and underwent randomization, the study used routinely collected data from the participating hospitals’ electronic medical records rather than collect data anew for each patient. “That had a profound effect on the efficiency of the trial. We did this trial for a cost of less than $300,000, and typically it would cost $9 million by using high-quality electronic health data.”

The study also evaluated several secondary outcomes. Recipients of female donor blood had twice the incidence of MRSA infection. In addition, an unadjusted subgroup analysis suggested a 10% lower risk of death among male patients assigned to the female donor group, compared with those assigned to the male donor group.

The risk of death was almost three times higher among patients in the female donor group who received units from donors aged 20-29.9 years (HR, 2.93). “The inconsistency of the point estimates across groups and the multiplicity of analyses increase the risk that those findings were due to chance,” according to the authors.
 

Big data

Commenting on the study, Jeannie Callum, MD, professor and director of transfusion medicine at Queen’s University, Kingston, Ont., said that the use of routinely collected data from the participating hospitals’ electronic medical records was “one of the really great things about this paper.”

This use of Big Data “allows you to do a trial like this with almost 9,000 patients without spending millions and millions of dollars to have people go through charts and record data,” she added.

Dr. Callum also pointed out some of the trial’s limitations. “One of the things that kind of detracts from the study in my mind is that they randomized everybody that was getting a transfusion, but outpatients getting a transfusion have a very low mortality rate. So, you have a group of patients that are never going to have that endpoint being included in the study, and that might’ve diluted the findings.”

About 11.4% of participants received blood from a donor group other than the one to which they had been assigned, and this factor may further dilute the findings, said Dr. Callum. “That’s a difficult thing to avoid.” She noted that a trial in which she is collaborating, called Sex Matters, may answer some of these questions about the use of female versus male donor blood.

The investigators also noted that the findings may not be generalizable to other countries. “Just because we didn’t find something in Canada with our blood production system doesn’t mean that the United States might not find it different, because how they manufacture their red blood cells for transfusion is different than how we do them in Canada,” said Dr. Callum.

Nonetheless, this study shows the potential of using Big Data in medicine. “This is the future of large randomized clinical trials to quickly answer questions,” said Dr. Callum. “In the United States, Canada, and other countries that have these large electronic medical records systems, this kind of trial would be able to be done in other centers.”

The study was funded by the Canadian Institutes of Health Research. Dr. Fergusson and Dr. Callum disclosed no relevant financial relationships.

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

The sex of a red blood cell donor has no effect on the survival of a transfusion recipient, data suggest.

In a randomized clinical trial with almost 9,000 patients, the adjusted hazard ratio of death among recipients of female donors’ blood, compared with recipients of male donors’ blood, was 0.98. The data contradict the finding of previous observational studies that donor sex is associated with recipient outcomes.

“The key finding was that we actually had a null result,” study author Dean Fergusson, MD, PhD, senior scientist at the Ottawa Hospital Research Institute, said in an interview. “We went in thinking that male donor blood would confer a benefit over female donor blood, and we found that there’s absolutely no difference between the donor sexes on recipient outcomes – mortality and other major secondary outcomes,” Dr. Fergusson added.

The study was published in the New England Journal of Medicine.
 

Differences ‘don’t matter’

A 2015 article from the National Heart, Lung, and Blood Institute identified a potential effect of donor sex on transfusion recipient survival. Since then, several observational studies have suggested that donor sex may influence survival after transfusion. This research includes two large studies, one from Canada and one from the Netherlands, that reported a heightened risk of death among recipients of red-cell units from female donors or donors who had been pregnant. Other studies, however, yielded conflicting results.

“The rationale was that female blood, because of biochemical properties, different hormones, exposure to babies and other males, all led to a different product, if you will, and these subtle changes could affect the blood product in terms of shelf life and potency,” said Dr. Fergusson. “That itself would have downstream effects on the recipient.”

The current double-blind study included 8,719 patients who received transfusions from September 2018 to December 2020 at three academic medical centers in Canada. Of this group, 5,190 received male donor blood, and 3,529 received blood from female donors.

The researchers randomly assigned patients in a 60:40 ratio to male and female donor groups. Data collection and follow-up were performed by the Ottawa Hospital Data Warehouse, Canadian Blood Services, and ICES, an independent research institute. Patient characteristics were similar in both trial groups at baseline.

After an average follow-up of 11.2 months, with a maximum follow-up of 29 months, 1,141 patients in the female donor group and 1,712 in the male donor group died. The study found no statistically significant difference in overall survival between the two groups. The unadjusted HR for death, with the male group as the reference, was 0.97, and the adjusted HR was 0.98. The rates of overall survival were 58% and 56.1% in the female and male donor groups, respectively.

The study did not prove that differences in outcome based on donor sex do not exist, said Dr. Fergusson. “But those differences really don’t matter in the recipient.”

The design of the trial itself was unique, Dr. Fergusson said. After patients consented to participate and underwent randomization, the study used routinely collected data from the participating hospitals’ electronic medical records rather than collect data anew for each patient. “That had a profound effect on the efficiency of the trial. We did this trial for a cost of less than $300,000, and typically it would cost $9 million by using high-quality electronic health data.”

The study also evaluated several secondary outcomes. Recipients of female donor blood had twice the incidence of MRSA infection. In addition, an unadjusted subgroup analysis suggested a 10% lower risk of death among male patients assigned to the female donor group, compared with those assigned to the male donor group.

The risk of death was almost three times higher among patients in the female donor group who received units from donors aged 20-29.9 years (HR, 2.93). “The inconsistency of the point estimates across groups and the multiplicity of analyses increase the risk that those findings were due to chance,” according to the authors.
 

Big data

Commenting on the study, Jeannie Callum, MD, professor and director of transfusion medicine at Queen’s University, Kingston, Ont., said that the use of routinely collected data from the participating hospitals’ electronic medical records was “one of the really great things about this paper.”

This use of Big Data “allows you to do a trial like this with almost 9,000 patients without spending millions and millions of dollars to have people go through charts and record data,” she added.

Dr. Callum also pointed out some of the trial’s limitations. “One of the things that kind of detracts from the study in my mind is that they randomized everybody that was getting a transfusion, but outpatients getting a transfusion have a very low mortality rate. So, you have a group of patients that are never going to have that endpoint being included in the study, and that might’ve diluted the findings.”

About 11.4% of participants received blood from a donor group other than the one to which they had been assigned, and this factor may further dilute the findings, said Dr. Callum. “That’s a difficult thing to avoid.” She noted that a trial in which she is collaborating, called Sex Matters, may answer some of these questions about the use of female versus male donor blood.

The investigators also noted that the findings may not be generalizable to other countries. “Just because we didn’t find something in Canada with our blood production system doesn’t mean that the United States might not find it different, because how they manufacture their red blood cells for transfusion is different than how we do them in Canada,” said Dr. Callum.

Nonetheless, this study shows the potential of using Big Data in medicine. “This is the future of large randomized clinical trials to quickly answer questions,” said Dr. Callum. “In the United States, Canada, and other countries that have these large electronic medical records systems, this kind of trial would be able to be done in other centers.”

The study was funded by the Canadian Institutes of Health Research. Dr. Fergusson and Dr. Callum disclosed no relevant financial relationships.

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

The sex of a red blood cell donor has no effect on the survival of a transfusion recipient, data suggest.

In a randomized clinical trial with almost 9,000 patients, the adjusted hazard ratio of death among recipients of female donors’ blood, compared with recipients of male donors’ blood, was 0.98. The data contradict the finding of previous observational studies that donor sex is associated with recipient outcomes.

“The key finding was that we actually had a null result,” study author Dean Fergusson, MD, PhD, senior scientist at the Ottawa Hospital Research Institute, said in an interview. “We went in thinking that male donor blood would confer a benefit over female donor blood, and we found that there’s absolutely no difference between the donor sexes on recipient outcomes – mortality and other major secondary outcomes,” Dr. Fergusson added.

The study was published in the New England Journal of Medicine.
 

Differences ‘don’t matter’

A 2015 article from the National Heart, Lung, and Blood Institute identified a potential effect of donor sex on transfusion recipient survival. Since then, several observational studies have suggested that donor sex may influence survival after transfusion. This research includes two large studies, one from Canada and one from the Netherlands, that reported a heightened risk of death among recipients of red-cell units from female donors or donors who had been pregnant. Other studies, however, yielded conflicting results.

“The rationale was that female blood, because of biochemical properties, different hormones, exposure to babies and other males, all led to a different product, if you will, and these subtle changes could affect the blood product in terms of shelf life and potency,” said Dr. Fergusson. “That itself would have downstream effects on the recipient.”

The current double-blind study included 8,719 patients who received transfusions from September 2018 to December 2020 at three academic medical centers in Canada. Of this group, 5,190 received male donor blood, and 3,529 received blood from female donors.

The researchers randomly assigned patients in a 60:40 ratio to male and female donor groups. Data collection and follow-up were performed by the Ottawa Hospital Data Warehouse, Canadian Blood Services, and ICES, an independent research institute. Patient characteristics were similar in both trial groups at baseline.

After an average follow-up of 11.2 months, with a maximum follow-up of 29 months, 1,141 patients in the female donor group and 1,712 in the male donor group died. The study found no statistically significant difference in overall survival between the two groups. The unadjusted HR for death, with the male group as the reference, was 0.97, and the adjusted HR was 0.98. The rates of overall survival were 58% and 56.1% in the female and male donor groups, respectively.

The study did not prove that differences in outcome based on donor sex do not exist, said Dr. Fergusson. “But those differences really don’t matter in the recipient.”

The design of the trial itself was unique, Dr. Fergusson said. After patients consented to participate and underwent randomization, the study used routinely collected data from the participating hospitals’ electronic medical records rather than collect data anew for each patient. “That had a profound effect on the efficiency of the trial. We did this trial for a cost of less than $300,000, and typically it would cost $9 million by using high-quality electronic health data.”

The study also evaluated several secondary outcomes. Recipients of female donor blood had twice the incidence of MRSA infection. In addition, an unadjusted subgroup analysis suggested a 10% lower risk of death among male patients assigned to the female donor group, compared with those assigned to the male donor group.

The risk of death was almost three times higher among patients in the female donor group who received units from donors aged 20-29.9 years (HR, 2.93). “The inconsistency of the point estimates across groups and the multiplicity of analyses increase the risk that those findings were due to chance,” according to the authors.
 

Big data

Commenting on the study, Jeannie Callum, MD, professor and director of transfusion medicine at Queen’s University, Kingston, Ont., said that the use of routinely collected data from the participating hospitals’ electronic medical records was “one of the really great things about this paper.”

This use of Big Data “allows you to do a trial like this with almost 9,000 patients without spending millions and millions of dollars to have people go through charts and record data,” she added.

Dr. Callum also pointed out some of the trial’s limitations. “One of the things that kind of detracts from the study in my mind is that they randomized everybody that was getting a transfusion, but outpatients getting a transfusion have a very low mortality rate. So, you have a group of patients that are never going to have that endpoint being included in the study, and that might’ve diluted the findings.”

About 11.4% of participants received blood from a donor group other than the one to which they had been assigned, and this factor may further dilute the findings, said Dr. Callum. “That’s a difficult thing to avoid.” She noted that a trial in which she is collaborating, called Sex Matters, may answer some of these questions about the use of female versus male donor blood.

The investigators also noted that the findings may not be generalizable to other countries. “Just because we didn’t find something in Canada with our blood production system doesn’t mean that the United States might not find it different, because how they manufacture their red blood cells for transfusion is different than how we do them in Canada,” said Dr. Callum.

Nonetheless, this study shows the potential of using Big Data in medicine. “This is the future of large randomized clinical trials to quickly answer questions,” said Dr. Callum. “In the United States, Canada, and other countries that have these large electronic medical records systems, this kind of trial would be able to be done in other centers.”

The study was funded by the Canadian Institutes of Health Research. Dr. Fergusson and Dr. Callum disclosed no relevant financial relationships.

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