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Poster display

2935 - A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab pre-treated patients with Her2-positive metastatic breast cancer - E-Vita -

Date

10 Oct 2016

Session

Poster display

Presenters

Joachim Bischoff

Citation

Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365

Authors

J. Bischoff1, J. Barinoff2, C. Mundhenke3, D. Bauerschlag4, S.D. Costa5, D. Herr6, K. Lübe7, F. Marmé8, N. Maass9, G. von Minckwitz10, E. Grischke11, V. Müller12, M. Schmidt13, B. Gerber14, S. Kümmel15, C. Schumacher16, P. Krabisch17, M. Thill2, V. Nekljudova18, S. Loibl18

Author affiliations

  • 1 Frauenklinik, Städtisches Klinikum Dessau, 06847 Dessau-Roßlau - Dessau/DE
  • 2 Frauenklinik, Kliniken Markus-Krankenhaus, Agaplesion, Frankfurt am Main/DE
  • 3 Universitätsfrauenklinik Kiel, UK-SH, Campus Kiel, Kiel/DE
  • 4 Universitätsfrauenklinik Kiel, UK-SH, Campus Kiel, 24105 - Kiel/DE
  • 5 Universitätsfrauenklinik Magdeburg, Otto-von Guericke-Universität, Magdeburg/DE
  • 6 Frauenklinik, University Hospital Wuerzburg, Würzburg/DE
  • 7 Brustzentrum, Henriettenstiftung, Hannover/DE
  • 8 Nationales Centrum Für Tumorerkrankungen, University Hospital Heidelberg, Heidelberg/DE
  • 9 Frauenklinik, UK-SH, Campus Kiel, Kiel/DE
  • 10 Department Of Medical Oncology, German Breast Group, Neu-Isenburg/DE
  • 11 Frauenklinik, Universitätsklinikum Tübingen, Tübingen/DE
  • 12 Frauenklinik, UKE Universitätsklinikum Hamburg-Eppendorf KMTZ, Hamburg/DE
  • 13 Frauenklinik, Universitätsmedizin Mainz, Mainz/DE
  • 14 Frauenklinik, Universitätsklinikum Rostock, Rostock/DE
  • 15 Frauenklinik, Kliniken Essen Mitte Evang. Huyssens-Stiftung, Essen/DE
  • 16 Brustzentrum, St. Elisabeth Krankenhaus Hohenlind, Köln/DE
  • 17 Frauenklinik, Klinikum Chemnitz gGmbH, Chemnitz/DE
  • 18 Medicine And Research, German Breast Group, 63263 - Neu-Isenburg/DE
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Resources

Abstract 2935

Background

Lapatinib (L) in combination with capecitabine has been approved for the treatment of HER2+ advanced breast cancer (ABC) progressed after anthracycline-, taxane-, and trastuzumab (T)-containing therapies. The use is limited by overlapping toxicities. Therefore, other combinations of L with less toxic agents are needed. In the E-VITA study two schedules of Eribulin (E) in association with L have been investigated.

Methods

E-VITA (NCT01534455) is a randomized phase II study to determine the efficacy and tolerability of two doses of E plus L in T pre-treated pts with HER2+ ABC. Main eligibility criteria were: ABC not suitable for surgery or radiotherapy alone; adjuvant and up to 3 chemotherapy regimen for ABC. Pts were randomized (1:1) to receive E 1.23mg/m2 iv d1,8 q21 (E1.23) or E 1.76mg/m2 d1 qd21 iv (E1.76) plus L 1000mg os d1-21 (3w cycle). Treatment was given until disease progression or unacceptable toxicity. Primary endpoints were time to progression (TTP), safety and compliance. Secondary endpoints were response rate (RR), clinical benefit rate (CBR) and overall survival (OS). It was planned to recruit a total of 80 pts.

Results

Between 2/2012 and 7/2014 43 pts were randomized (41 started treatment). The study was stopped in 7/2014 due to slow accrual. Median age was 54 yrs. Median TTP was 8.1 months (95% CI 4.8-9.4) with E1.23 vs 6.5 months (95% CI 4.6-13.4) with E1.76. No difference in OS was seen (23.1 [95% CI 12.5-35.0] vs 23.2 months [95%CI 13.7-30.1]). RR was 52.4% (95% CI 31.0-73.7) vs 45.0% (95% CI 23.2-66.8). CBR was 71.4% (95% CI 52.1-90.8) vs 75.0% (56.0-94.0). High grade adverse events (AEs) were more common under E1.76. Overall the most frequently grade 3-4 AEs were neutropenia (47.6% vs 70.0%), fatigue (19.0% vs 0.0%) and diarrhea (9.5% vs 5.0%). 5 pts discontinued therapy due to AEs (2 in E1.23 arm and 3 in E1.76), 13 pts in both arms due to progression.

Conclusions

The combination of E and L show an acceptable safety profile. Due to premature study termination, no definitive conclusion on efficacy can be drawn. However, due to its lower toxicity profile, the preferred regimen remains E1.23 d1,8 q21.

Clinical trial identification

NCT01534455

Legal entity responsible for the study

German Breast Group

Funding

Eisai

Disclosure

G. von Minckwitz: Institution received grant from Eisai. All other authors have declared no conflicts of interest.

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