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Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.
Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.
Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.
Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.
Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006
Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.
Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.
Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.
Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.
Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006
Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.
Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.
Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.
Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.
Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006