Clinical Research Papers:

ABSTRACT

Eribulin mesylate, a microtubule dynamics inhibitor, has been approved for the treatment of several malignancies. Due to its novel mechanism of action, eribulin is often associated with a distinct profile of adverse events including hematologic toxicities. Here we searched PubMed and Embase database from reception to August 2017 for clinical trials with eribulin treatment. Eligible studies included trials with eribulin administered at a standard dose of 1.4 mg/m² intravenously on days 1 and 8 in a 21-day cycle, and adequate safety data profile reporting neutropenia, leucopenia, anemia, febrile neutropenia and thrombocytopenia. The overall incidence, relative risk (RR) and 95% confidence interval (CI) were calculated. A total of 39 studies with 6,092 subjects were included in this study. The incidences of eribulin related all-grade and high-grade hematologic toxicities were: neutropenia, 56% and 39%; leucopenia, 44% and 21%; anemia, 33% and 2%; febrile neutropenia, 5% and 5%; and thrombocytopenia, 12% and 12%. Compared with controls, eribulin was associated with a significant increased risk of all-grade (RR, 1.94; 95% CI, 1.37–2.74) and high-grade (RR, 2.58; 95% CI, 1.30–5.10) neutropenia, all-grade (RR, 1.81; 95% CI, 1.10–2.97) and high-grade (RR, 2.95; 95% CI, 1.36–6.39) leucopenia, but not with anemia and febrile neutropenia. Trial sequential analysis showed the results from neutropenia, leucopenia and anemia established sufficient and conclusive evidence. Our study suggested that eribulin therapy, compared with control, was associated with an increased risk of hematologic toxicities. Hence hematologic monitoring at regular intervals should be advised.