MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR(+), HER2(-)-Advanced Breast Cancer.
Por:
Neven, P, Johnston, S, Toi, M, Sohn, J, Inoue, K, Pivot, X, Burdaeva, O, Okera, M, Masuda, N, Kaufman, P, Koh, H, Grischke, E, Conte, P, Lu, Y, Haddad, N, Hurt, K, Llombart-Cussac, A and Sledge, G
Publicada:
1 nov 2021
Ahead of Print:
10 ago 2021
Resumen:
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.
Filiaciones:
Neven, P:
Univ Ziekenhuizen Leuven, Leuven, Belgium
Johnston, S:
Royal Marsden NHS Fdn Trust, London, England
Toi, M:
Kyoto Univ, Grad Sch Med, Kyoto, Japan
Sohn, J:
Yonsei Univ, Yonsei Canc Ctr, Coll Med, Seoul, South Korea
Inoue, K:
Saitama Canc Ctr, Saitama, Japan
Pivot, X:
INSERM, U110, Ctr Paul Strauss, Strasbourg, France
Burdaeva, O:
Arkhangelsk Reg Clin Oncol Dispensary, Arkhangelsk, Russia
Okera, M:
Adelaide Canc Ctr, Adelaide, SA, Australia
Masuda, N:
Osaka Natl Hosp, Natl Hosp Org, Osaka, Japan
Kaufman, P:
Univ Vermont, Ctr Canc, Burlington, VT USA
Koh, H:
Kaiser Permanente, Bellflower, CA USA
Grischke, E:
Eberhard Karls Univ Tubingen, Univ Frauenklin Tubingen, Tubingen, Germany
Conte, P:
DiSCOG Univ Padova, Padua, Italy
IRCCS, Med Oncol 2, Ist Oncol Veneto, Padua, Italy
Lu, Y:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Haddad, N:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Hurt, K:
Eli Lilly & Co, Indianapolis, IN 46285 USA
:
Hosp Arnau Vilanova, Valencia, Spain
Sledge, G:
Stanford Univ, Sch Med, 269 Campus Dr,CCSR-1115, Stanford, CA 94305 USA
Bronze
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