Eribulin mesylate (ERI), a nontaxane microtubule dynamics inhibitor, has antitumor activity and can prolong overall survival in patients with recurrent breast cancer (BC). As data lack on peripheral neuropathy (PN) when using ERI as primary or secondary therapy for recurrent BC, we assessed the incidence of PN, the times to PN onset and recovery, and the risk factors for PN in patients with HER-2-negative recurrent or metastatic BC treated with ERI.
We analyzed data from an ongoing 2-year multicenter prospective observational study where the same number of patients who started ERI administration as primary or secondary therapy and as tertiary or later therapy were enrolled. PN events were defined as new onset or existing PN worsened after ERI administration. Logistic regression was run to assess the risk factors.
The analysis set comprised 458 patients who had completed 6-month follow-up after ERI administration. Mean age ± standard deviation was 59.4 ± 10.9 years, and 171 patients (37.3%) had a history of PN from previous chemotherapy and 190 (41.5%) had existing PN at start of ERI administration (baseline). PN events were observed in 115 patients (25.1%), with severity of Grade 1 in 55 (12.0%), Grade 2 in 51 (11.1%), and Grade 3 in 9 (2.0%) in accordance with the Common Terminology Criteria for Adverse Events version 4.0. After the PN events, 91 patients (79.1%) continued ERI, and 16 (13.9%) reduced the dose or underwent a drug holiday. Within 6 months after ERI administration, 39.0% recovered to the state at baseline. In 266 patients without PN at baseline, new PN appeared in 71 patients (26.7%), and median time to PN onset was 57.0 days (95% confidence interval, 43.0–66.0 days). Results also showed that “history of radiotherapy”, “hemoglobin level”, and “history of PN from previous chemotherapy” were significantly associated with PN events, but no evident association was found with the number of chemotherapy prior to baseline.
PN events were observed in about one-quarter of patients treated with ERI, most of which were mild, and about one-third of patients who developed PN recovered early. This suggests that ERI is well tolerated.
Clinical trial identification
NCT02371174 (First release on November 21, 2014)
Legal entity responsible for the study
Eisai Co., Ltd., Tokyo, Japan
Y. Sakata, H. Iwata, H. Ikezawa, R. Fudetani, D. Tonoda, Y. Uchida, H. Hasegawa, T. Matsuoka: Employee of Eisai Co., Ltd.