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)

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/m2 (equivalent to 1.4 mg/m2 eribulin mesylate) days 1+8 every 21 days (split-dose arm) or eribulin 1.76 mg/m2 (equivalent to 2.0 mg/m2 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/m2 day 1+8 group. This might be an alternative regimen when other treatment options are exhausted. Therefore, further clinical studies are warranted. Presented in part at the 2016 ESMO meeting, Copenhagen, 7–11 October 2016. Correspondence to Sibylle Loibl, MD, German Breast Group, Martin-Behaim-Strasse 12, 63263 Neu-Isenburg, Germany Tel: +49 610 274 800; fax: +49 610 2748 0440; e-mail: sibylle.loibl@gbg.de Received April 17, 2018 Accepted November 3, 2018 Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

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