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Results from E-VITA trial conducted with HER2-positive metastatic breast cancer patients

10.04.2019

We are pleased to inform you that the results of the E-VITA study that evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER2-positive metastatic breast cancer has been published in the Anticancer Drugs.

E-VITA (GBG 64, NCT01534455) was a randomized, multicenter, open-label, phase II trial aimed to determine the efficacy and tolerability of two dosing schedules of eribulin plus lapatinib in trastuzumab pretreated patients with HER2-positive metastatic breast cancer (mBC). Eribulin (E7389) is a mechanistically unique antagonist of microtubule dynamics among the different tubulin-targeted agents, leading to inhibition of microtubule growth in the absence of effects on microtubule shortening, and formation of nonproductive tubulin aggregates. Eribulin was approved for the treatment of mBC after at least two chemotherapy regimens including anthracyclines and taxanes. Lapatinib, a dual tyrosine kinase inhibitor of HER2 and EGFR, in combination with capecitabine has been approved for the treatment of HER2-positive mBC in patients who had progressed on prior trastuzumab-based therapy. In the E-VITA study, patients were randomly assigned to receive either eribulin at a dose of 1.23 mg/m² (equivalent to 1.4 mg/m² eribulin mesylate) on days 1 and 8 of a 21-day cycle (standard split-dose arm) or eribulin at a dose of 1.76 mg/m² (equivalent to 2.0 mg/m² eribulin mesylate) intravenously on day 1, once every 3 weeks (experimental 3-weekly arm). Time to progression (TTP) and tolerability were defined as primary end points. Secondary end points included objective response rate (ORR), clinical benefit rate (CBR), and overall survival (OS). Because of the recruitment difficulties, the study was amended for a prolongation in November 2013 and finally stopped in July 2014 with only 43 patients of the planned 80 patients recruited. After a median follow-up of 28.7 months (range 4.1-36.1), 36 TTP events and 26 deaths were observed. Of the 43 patients enrolled in the trial, 65.8% had received previous (neo-)adjuvant chemotherapy and 53.7% had anti-HER2 (neo-)adjuvant treatment. The median TTP was 8.1 months (95%CI 4.8–9.4) in the split-dose and 6.5 months (95%CI 4.6-13.4) in the 3-weekly arm and ORR was 52.4% (95%CI 31.0–73.7) and 45.0% (95%CI 23.2-66.8), respectively. CBR was 71.4% (95%CI 52.1-90.8) in the split-dose and 75.0% (95%CI 56.0-94.0) in the 3-weekly arm. Similarly, OS was comparable in both arms (23.1 months [95%CI 12.5-35.0] in the split-dose and 23.2 months [95%CI 13.7-30.1] in the 3-weekly arm). Overall, the toxicity profile was acceptable with less high grade (grade 3-4) adverse events in the split-dose arm. Therefore, eribulin at a dose of 1.23 mg/m² on days 1 and 8 of a 21-day cycle might be considered as an alternative regimen when other treatment options are exhausted. However, further clinical studies are warranted.

Bischoff J, Barinoff J, Mundhenke C, Bauerschlag DO, Costa SD, Herr D, Lübbe K, Marmé F, Maass N, von Minckwitz G, Grischke EM, Müller V, Schmidt M, Gerber B, Kümmel S, Schumacher C, Krabisch P, Seiler S, Thill M, Nekljudova V, Loibl S. 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). Anticancer Drugs. 2019 Apr;30(4):394-401.
Link in PubMed




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