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MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR +, HER2 --Advanced Breast Cancer

 Patrick Neven  ;  Stephen R D Johnston  ;  Masakazu Toi  ;  Joohyuk Sohn  ;  Kenichi Inoue  ;  Xavier Pivot  ;  Olga Burdaeva  ;  Meena Okera  ;  Norikazu Masuda  ;  Peter A Kaufman  ;  Han Koh  ;  Eva-Maria Grischke  ;  PierFranco Conte  ;  Yi Lu  ;  Nadine Haddad  ;  Karla C Hurt  ;  Antonio Llombart-Cussac  ;  George W Sledge 
 CLINICAL CANCER RESEARCH, Vol.27(21) : 5801-5809, 2021-11 
Journal Title
Issue Date
Aminopyridines / administration & dosage* ; Antineoplastic Agents, Hormonal / administration & dosage* ; Benzimidazoles / administration & dosage* ; Breast Neoplasms / chemistry ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / pathology ; Drug Combinations ; Female ; Fulvestrant / administration & dosage* ; Humans ; Neoplasm Staging ; Progression-Free Survival ; Receptor, ErbB-2 / analysis ; Treatment Outcome
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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