Portal de investigación
MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR(+), HER2(-)-Advanced Breast Cancer.
Fecha de publicación:
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Autores de FISABIO
Autores ajenos a FISABIO
- Neven, P
- Johnston, SRD
- Toi, M
- Sohn, J
- Inoue, K
- Pivot, X
- Burdaeva, O
- Okera, M
- Masuda, N
- Kaufman, PA
- Koh, H
- Grischke, EM
- Conte, P
- Lu, Y
- Haddad, N
- Hurt, KC
- Sledge, GW
Grupos de Investigación
Abstract
PURPOSE: In MONARCH 2, abemaciclib plus fulvestrant significantly prolonged progression-free survival (PFS) and overall survival (OS) versus placebo plus fulvestrant in patients with hormone receptor positive (HR(+)), HER2(-) advanced breast cancer. This exploratory analysis assessed the efficacy of abemaciclib plus fulvestrant across subgroups of patients receiving study therapy as first- or second-line treatment for metastatic disease. PATIENTS AND METHODS: Improvements were estimated using Cox models, and a test of interactions of subgroups with treatment was performed. RESULTS: The benefit in PFS [first-line, HR, 0.57; 95% confidence interval (CI), 0.45-0.73; second-line, HR, 0.48; 95% CI, 0.36-0.64] and OS (first-line, HR, 0.85; 95% CI, 0.64-1.14; second-line, HR, 0.66; 95% CI, 0.46-0.94) was observed across both subgroups, consistent with the intent-to-treat (ITT) population. In first-line patients (abemaciclib arm, n = 265; placebo arm, n = 133), the numerically largest effect on PFS and OS was observed in patients with primary resistance to endocrine therapy (ET; PFS, HR, 0.40; 95% CI, 0.26-0.63; OS, HR, 0.58; 95% CI, 0.35-0.97) and visceral disease (PFS, HR, 0.54; 95% CI, 0.39-0.73; OS, HR, 0.82; 95% CI, 0.58-1.20). In second-line patients (abemaciclib arm, n = 170; placebo arm, n = 86), a numerical benefit in PFS and OS was observed across primary and secondary ET resistance, with numerically more pronounced effects observed in patients with visceral disease (PFS, HR, 0.39; 95% CI, 0.27-0.57; OS, HR, 0.51; 95% CI, 0.33-0.81). Prolongation of time to second disease progression, time to chemotherapy, and chemotherapy-free survival was observed in both subgroups. CONCLUSIONS: Consistent with the ITT population, a benefit in PFS and OS was observed across the first- and second-line subgroups in MONARCH 2.
©2021 American Association for Cancer Research.
Datos de la publicación
- ISSN/ISSNe:
- 1078-0432, 1557-3265
- Tipo:
- Article
- Páginas:
- 5801-5809
- PubMed:
- 34376533
CLINICAL CANCER RESEARCH AMER ASSOC CANCER RESEARCH
Citas Recibidas en Web of Science: 9
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