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Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2-Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Studyopen access

Authors
Perez, EA[Perez, Edith A.]Barrios, C[Barrios, Carlos]Eiermann, W[Eiermann, Wolfgang]Toi, M[Toi, Masakazu]Im, YH[Im, Young-Hyuck]Conte, P[Conte, Pierfranco]Martin, M[Martin, Miguel]Pienkowski, T[Pienkowski, Tadeusz]Pivot, X[Pivot, Xavier]Burris, H[Burris, Howard, III]Petersen, JA[Petersen, Jennifer A.]Stanzel, S[Stanzel, Sven]Strasak, A[Strasak, Alexander]Patre, M[Patre, Monika]Ellis, P[Ellis, Paul]
Issue Date
10-Jan-2017
Publisher
AMER SOC CLINICAL ONCOLOGY
Citation
JOURNAL OF CLINICAL ONCOLOGY, v.35, no.2, pp.141 - +
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF CLINICAL ONCOLOGY
Volume
35
Number
2
Start Page
141
End Page
+
URI
https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/30508
DOI
10.1200/JCO.2016.67.4887
ISSN
0732-183X
Abstract
Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study. Methods In the MARIANNE study, 1,095 patients with centrally assessed, HER2-positive, advanced breast cancer and no prior therapy for advanced disease were randomly assigned 1: 1: 1 to control (trastuzumab plus taxane), T-DM1 plus placebo, hereafter T-DM1, or T-DM1 plus pertuzumab at standard doses. Primary end point was progression-free survival (PFS), as assessed by independent review. Results T-DM1 and T-DM1 plus pertuzumab showed noninferior PFS compared with trastuzumab plus taxane (median PFS: 13.7 months with trastuzumab plus taxane, 14.1 months with T-DM1, and 15.2 months with T-DM1 plus pertuzumab). Neither experimental arm showed PFS superiority to trastuzumab plus taxane. Response rate was 67.9% in patients who were treated with trastuzumab plus taxane, 59.7% with T-DM1, and 64.2% with T-DM1 plus pertuzumab; median response duration was 12.5 months, 20.7 months, and 21.2 months, respectively. The incidence of grade >= 3 adverse events was numerically higher in the control arm (54.1%) versus the T-DM1 arm (45.4%) and T-DM1 plus pertuzumab arm (46.2%). Numerically fewer patients discontinued treatment because of adverse events in the T-DM1 arms, and health-related quality of life was maintained for longer in the T-DM1 arms. Conclusion T-DM1 showed noninferior, but not superior, efficacy and better tolerability than did taxane plus trastuzumab for first-line treatment of HER2-positive, advanced breast cancer. (C) 2016 by American Society of Clinical Oncology.
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