Metastatic or advanced TNBC: eribulin+gemcitabine pack a punch in the ERIGE trial

  • Pellegrino B & al.
  • ESMO Open
  • 31 Dec 2020

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • The combination of eribulin plus gemcitabine delivers an overall response rate (ORR) of 37.3% with moderate toxicity in patients with locally advanced or metastatic triple-negative breast cancer (TNBC), according to results of the ERIGE trial.

Why this matters

  • The combination therapy of a microtubule inhibitor (eribulin) with a nucleoside analog (gemcitabine) may work synergistically against a tumor type with high cell proliferation, aggressive behavior, and chemoresistance.
  • The findings are promising enough to warrant progression to phase 3.

Study design

  • Open-label, multicenter, phase 2 trial (N=83) of eribulin (0.88 mg/m2) in combination with gemcitabine (1000 mg/m2) on days 1 and 8 of a 21-day cycle as first- or second-line therapy for locally advanced or metastatic TNBC.
  • Funding: Roche; Gruppo Oncologico Italiano di Ricerca Clinica; others.

Key results

  • Median follow-up was 28.8 months.
  • ORR: 37.3%.
    • Complete response: 2.4%.
    • Partial response: 34.9%.
  • Clinical benefit rate: 48.8%.
  • Median response duration: 6.6 months.
  • Median PFS: 5.1 months.
  • Median OS: 14.5 months.
  • Most frequent grade 3/4 adverse events were aminotransferase elevation in 25% of patients and neutropenia in 23.8%.
  • Patients with BRCA1/2 mutations had worse ORR, PFS, and OS than those with wild-type BRCA.

Limitations

  • No randomization or control group.
  • Small number of patients.
  • Open-label.