- 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.
- 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.
- 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.
- No randomization or control group.
- Small number of patients.