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)

Bischoff J, Barinoff J, Mundhenke C, Bauerschlag DO, Costa SD, Herr D, Luebbe K, Marme F, Maass N, Von Minckwitz G, Grischke EM, Mueller V, Schmidt M, Gerber B, Kuemmel S, Schumacher C, Krabisch P, Seiler S, Thill M, Nekljudova V, Loibl S (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Anti-Cancer Drugs Lippincott, Williams & Wilkins

Book Volume: 30

Pages Range: 394-401

Journal Issue: 4

DOI: 10.1097/CAD.0000000000000722

Abstract

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. ©

Authors with CRIS profile

Christoph Mundhenke

Involved external institutions

Universitätsklinikum Tübingen DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) Städtisches Klinikum Dessau DE Germany (DE) Agaplesion Markus Krankenhaus DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Otto-von-Guericke-Universität Magdeburg DE Germany (DE) Universitätsklinikum Würzburg DE Germany (DE) Krankenhaus Diakovere Friederikenstift Hannover DE Germany (DE) Universitätsklinikum Heidelberg DE Germany (DE) GBG Forschungs GmbH (German Breast Group) DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE) Universitätsmedizin Rostock DE Germany (DE) St. Elisabeth-Krankenhaus Köln-Hohenlind DE Germany (DE) Klinikum Chemnitz DE Germany (DE) Kliniken Essen-Mitte DE Germany (DE)

How to cite

APA:

Bischoff, J., Barinoff, J., Mundhenke, C., Bauerschlag, D.O., Costa, S.-D., Herr, D.,... Loibl, S. (2019). 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). Anti-Cancer Drugs, 30(4), 394-401. https://doi.org/10.1097/CAD.0000000000000722

MLA:

Bischoff, Joachim, et al. "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)." Anti-Cancer Drugs 30.4 (2019): 394-401.

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