Eribulin-Induced Peripheral Neuropathy in Locally Advanced or Metastatic Breast Cancer: Final Analysis of the Prospective Cohort IRENE Study.

Eribulin is a preferred treatment for patients with advanced breast cancer (BC) following anthracyclines and taxanes. The final analysis of the IRENE study assessed the incidence and resolution of eribulin-induced peripheral neuropathy (EIPN), along with safety and quality of life (QoL), in patients with advanced/metastatic BC. IRENE was an observational, single-arm, prospective, multicenter cohort study. Patients aged ≥18 years with locally advanced/metastatic BC that progressed after 1-3 prior chemotherapeutic regimens received eribulin and were monitored for new-onset or worsening EIPN. Secondary endpoints included time to disease progression, safety, and health-related QoL. In total, 108 (32.2%) out of 335 patients experienced EIPN; 18 (5.4%) experienced grade ≥3 EIPN. Median time to EIPN resolution (EIPN ended or returned to baseline) was 78.7 weeks (95% CI 77.1-not estimable). Median time to disease progression was 4.5 months (95% CI 3.9-5.5). Treatment-emergent adverse events (TEAEs) occurred in 322 (96.1%) patients; serious TEAEs occurred in 185 (55.2%) patients. Incidence and resolution rates of EIPN were comparable with existing evidence from previous trials. TEAEs were consistent with the established eribulin safety profile, with no new safety signals. Eribulin treatment did not appear to affect QoL, as measured by EQ-5D-3L and EQ-VAS, or patient-reported neuropathy symptoms, as measured by the PNQ.