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A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab-pretreated patients with HER-2-positive metastatic breast cancer (E-VITA)

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The E-VITA study evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer. This multicenter, open-label phase II trial, randomly assigned patients with trastuzumab-pretreated HER-2-positive meta...

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Main Authors: Bischoff, Joachim (Author) , Barinoff, Jana (Author) , Mundhenke, Christoph (Author) , Bauerschlag, Dirk Olaf (Author) , Costa, Serban-Dan (Author) , Herr, Daniel (Author) , Lübbe, Kristina (Author) , Marmé, Frederik (Author) , Maass, Nicolai (Author) , Minckwitz, Gunter von (Author) , Grischke, Eva-Maria (Author) , Müller, Volkmar (Author) , Schmidt, Marcus (Author) , Gerber, Bernd (Author) , Kümmel, Sherko (Author) , Schumacher, Claudia (Author) , Krabisch, Petra (Author) , Seiler, Sabine (Author) , Thill, Marc (Author) , Nekljudova, Valentina (Author) , Loibl, Sibylle (Author)
Format: Article (Journal)
Language:English
Published: APR 2019
In: Anti-cancer drugs
Year: 2019, Volume: 30, Issue: 4, Pages: 394-401
ISSN:1473-5741
DOI:10.1097/CAD.0000000000000722
Online Access:Resolving-System, Volltext: https://dx.doi.org/10.1097/CAD.0000000000000722
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Author Notes:Joachim Bischoff, Jana Barinoff, Christoph Mundhenke, Dirk O. Bauerschlag, Serban-Dan Costa, Daniel Herr, Kristina Luebbe, Frederik Marme, Nicolai Maass, Gunter von Minckwitz, Eva-Maria Grischke, Volkmar Mueller, Marcus Schmidt, Bernd Gerber, Sherko Kuemmel, Claudia Schumacher, Petra Krabisch, Sabine Seiler, Marc Thill, Valentina Nekljudova, Sibylle Loibl
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Summary:The E-VITA study evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer. This multicenter, open-label phase II trial, randomly assigned patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer to lapatinib 1000 mg daily with eribulin 1.23 mg/m(2) (equivalent to 1.4 mg/m(2) eribulin mesylate) days 1+8 every 21 days (split-dose arm) or eribulin 1.76 mg/m(2) (equivalent to 2.0 mg/m(2) eribulin mesylate) day 1 every 21 days (3-weekly arm). Time to progression and tolerability were defined as primary end points; no sample size calculation for formal comparison of efficacy data has been performed. Secondary end points included objective response rate, clinical benefit rate, and overall survival. Overall, 43 patients of a planned number of 80 patients were recruited. At a median follow-up of 28.7 months, the median time to progression was 8.1 months [95% confidence interval (CI): 4.8-9.4] in the split-dose arm and 6.5 months (95% CI: 4.6-13.4) in the 3-weekly arm. Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively. Overall survival was also similar in both arms. The most frequent grade 3-4 adverse events were neutropenia (58.5%) and leukopenia (39.0%). The combination of eribulin and lapatinib showed an acceptable safety profile with less toxicity observed in the eribulin 1.23 mg/m(2) day 1+8 group. This might be an alternative regimen when other treatment options are exhausted. Therefore, further clinical studies are warranted.
Item Description:Gesehen am 08.05.2019
Physical Description:Online Resource
ISSN:1473-5741
DOI:10.1097/CAD.0000000000000722

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