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Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

Author

Listed:
  • Hans-Christian Kolberg

    (Marienhospital Bottrop gGmbH)

  • Marco Colleoni

    (IEO, European Institute of Oncology, IRCCS)

  • Georgia Savva Demetriou

    (University of Witwatersrand)

  • Patricia Santi

    (Centro de Estudos de Hematologia e Oncologia)

  • Hans Tesch

    (Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus)

  • Yasuhiro Fujiwara

    (National Cancer Center Hospital)

  • Zorica Tomasevic

    (Institute for Oncology and Radiology of Serbia)

  • Vladimir Hanes

    (Amgen Inc)

Abstract

Introduction Although the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation. Objective In this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KANJINTI™) and the trastuzumab reference product (RP; Herceptin®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146). Methods In the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP 980 (n = 364) or trastuzumab RP (n = 361) plus paclitaxel (every 3 weeks [Q3W] or every week [QW]) for four cycles. After surgery, patients continued treatment Q3W for up to 1 year; ABP 980-treated patients continued ABP 980 (ABP 980/ABP 980; n = 364), and trastuzumab RP-treated patients either continued on the RP (trastuzumab RP/trastuzumab RP; n = 190) or switched to ABP 980 (trastuzumab RP/ABP 980; n = 171). Cardiac safety was monitored by computerized 12-lead electrocardiogram, and left ventricular ejection fraction (LVEF) was assessed by two-dimensional (2D) echocardiogram. LVEF decline was defined as LVEF value decrease from study baseline by ≥ 10 percentage points and to

Suggested Citation

  • Hans-Christian Kolberg & Marco Colleoni & Georgia Savva Demetriou & Patricia Santi & Hans Tesch & Yasuhiro Fujiwara & Zorica Tomasevic & Vladimir Hanes, 2020. "Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study," Drug Safety, Springer, vol. 43(3), pages 233-242, March.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:3:d:10.1007_s40264-019-00886-3
    DOI: 10.1007/s40264-019-00886-3
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