Eribulin 1320micrograms/3ml solution for injection vials

Triple-negative breast cancer (TNBC) is an aggressive subtype characterized by the absence of ER, PR, and HER2 expression, with limited therapeutic targets and poor prognosis. Chemotherapy remains the cornerstone of treatment; however, response variability highlights the need for predictive biomarkers. This systematic review aims to evaluate biomarker-guided chemotherapy and immunotherapy responses in Asian TNBC populations. A literature search was conducted in PubMed following PRISMA 2020 guidelines, identifying 31,888 records, of which 7 studies met inclusion criteria. Eligible studies included randomized controlled trials, subgroup analyses, and observational studies assessing chemotherapy alone or combined with immunotherapy in Asian patients, reporting outcomes such as pathologic complete response (pCR), progression-free survival (PFS), and overall survival (OS). Across studies, combination regimens incorporating immune checkpoint inhibitors, particularly pembrolizumab and atezolizumab, demonstrated superior clinical outcomes compared to chemotherapy alone, including higher pCR rates and improved survival metrics. Biomarker analysis revealed that PD-L1 expression consistently predicted improved response to immunotherapy, while homologous recombination deficiency (HRD) was associated with enhanced sensitivity to platinum-based and eribulin regimens. Additional markers, including tumor-infiltrating lymphocytes (TILs) and tumor mutational burden (TMB), were linked to better therapeutic outcomes, whereas elevated microRNA-223 expression correlated with chemotherapy resistance and poorer prognosis. Safety profiles were generally manageable, with expected toxicities such as peripheral neuropathy and hematologic adverse events. These findings support the integration of molecular and immunological biomarkers into clinical decision-making to optimize treatment strategies. In conclusion, biomarker-guided chemo-immunotherapy represents a promising approach to improving outcomes in Asian TNBC patients, emphasizing the importance of precision medicine and the need for standardized biomarker assessment in future studies.

Abstract licence: CC BY

PURPOSE Trastuzumab-pertuzumab (HP) plus taxane is a current standard first-line therapy for recurrent or metastatic human epidermal growth factor 2 (HER2)+ breast cancer (BC). We investigated noninferiority of eribulin to a taxane when combined with dual HER2 blockade as first-line systemic treatment for locally advanced/metastatic HER2+ BC. METHODS In the phase III EMERALD trial (target sample size, 480; ClinicalTrials.gov identifier: NCT03264547/UMIN000027938), patients were randomly assigned (1:1) to receive eribulin 1.4 mg/m2 once daily on days 1 and 8 (eribulin group) or a taxane (docetaxel 75 mg/m2 once on day 1 or paclitaxel 80 mg/m2 once daily on days 1, 8, and 15; taxane group) intravenously in a 21-day cycle, each with HP on day 1. The primary end point was progression-free survival (PFS; intention-to-treat population). Secondary end points included objective response rate, overall survival (OS), patient-reported quality of life (QoL), and safety. Noninferiority was tested using the stratified Cox proportional hazards model to estimate hazard ratios (HRs) for PFS events, with a noninferiority HR margin of 1.33. RESULTS Between August 2017 and June 2021, 446 patients (median age, 56.0 years) were enrolled. The median PFS was 14.0 and 12.9 months in the eribulin group (n = 224) and taxane group (n = 222 [docetaxel/paclitaxel, n = 186/36]), respectively (HR, 0.95 [95% CI, 0.76 to 1.19]), which confirmed the noninferiority of the study regimen. The median OS was 65.3 months in the taxane group but has not been reached in the eribulin group. Median time to QoL deterioration was numerically longer with eribulin than with taxane. Adverse event (AE) rates were similar, despite the longer duration of eribulin use. Infusion reaction, skin-related AEs, diarrhea, and edema were more common with taxane, whereas neutropenia was more common with eribulin. CONCLUSION The results suggested that eribulin + HP is an option for first-line treatment of locally advanced/metastatic HER2+ BC.

Abstract licence: CC BY-NC-ND