Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial.

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Tác giả: Giampaolo Bianchini, Aarti R Chawla, Umut Demirci, Stephanie L Graff, Erika Hamilton, Sara A Hurvitz, Rinath Jeselsohn, Kevin Kalinsky, Peter A Kaufman, Holly Knoderer, Jiun-I Lai, Rachel M Layman, Lacey M Litchfield, Miguel Martin, Montserrat Muñoz, Bastien Nguyen, Kyong Hwa Park, Elizabeth Ravenberg, Sarah Sammons, Cynthia Sandoval, Lillian Smyth, Seth A Wander, Yanhong Zhou

Ngôn ngữ: eng

Ký hiệu phân loại: 373.236 Lower level

Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 700406

 PURPOSE: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first-line treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC)
  however, disease progression occurs in almost all patients and additional treatment options are needed. Herein, we report outcomes of the postMONARCH trial investigating a switch in ET with/without CDK4/6 inhibition with abemaciclib after disease progression on CDK4/6i. METHODS: This double-blind, randomized phase III study enrolled patients with disease progression on previous CDK4/6i plus aromatase inhibitor as initial therapy for advanced disease or recurrence on/after adjuvant CDK4/6i + ET. Patients were randomly assigned (1:1) to abemaciclib + fulvestrant or placebo + fulvestrant. The primary end point was investigator-assessed progression-free survival (PFS). Secondary end points included PFS by blinded independent central review, objective response rate (ORR), and safety. RESULTS: This study randomly assigned 368 patients (abemaciclib + fulvestrant, n = 182 placebo + fulvestrant, n = 186). At the primary analysis (258 events), the hazard ratio (HR) was 0.73 (95% CI, 0.57 to 0.95
  nominal CONCLUSION: Abemaciclib + fulvestrant significantly improved PFS after disease progression on previous CDK4/6i + ET in patients with HR+, HER2- ABC, offering an additional targeted therapy option for these patients.
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