Incidence of peripheral neuropathy associated with eribulin mesylate versus vinorelbine in patients with metastatic breast cancer: sub-group analysis of a randomized phase III study



Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most significant neurologic complications of chemotherapy, impacting patient’s behavior and quality of life. CIPN is mostly sensory, with rare incidences of autonomic dysfunction and other neuropathy.


We conducted a single-center sub-group analysis of patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate (1.4 mg/m2 on days 1 and 8 every 21 days) with vinorelbine (25 mg/m2 on days 1, 8, and 15 every 21 days). The analysis investigated incidence of peripheral neuropathy, time to onset of neuropathy, and safety.


Our analysis included 110 women with a mean age of 50.7 (SD = 10.9). The median accumulated dose of eribulin was 11.2 mg/m2 and 125.0 mg/m2 for vinorelbine. Among patients in the eribulin group, a performance status (ECOG PS) of 2 was correlated with peripheral sensory neuropathy (p = 0.015), and accumulated eribulin dose (≥ 10 mg/m2) was associated with all neuropathy and peripheral sensory neuropathy (p = 0.003 and p = 0.007, respectively). In the vinorelbine group, patient age (≥ 65 years) was positively associated with all neuropathy (p = 0.043). The time to onset of neuropathy appeared to be longer for eribulin versus vinorelbine (35.3 vs. 34.6 weeks; p = 0.046), with a significantly higher incidence of autonomic neuropathy at weeks 2 and 10 observed among patients receiving vinorelbine (p = 0.008 and p = 0.043, respectively).


Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer. Furthermore, the onset of neurotoxicity appears to occur earlier with vinorelbine than eribulin.

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Fig. 1



Chemotherapy-induced peripheral neuropathy


Overall survival


Treatment of physician’s choice


Metastatic breast cancer


Peripheral neuropathy


Overall response rates


Complete response


Partial response


Progress free survival


Adverse event


Common Terminology Criteria for Adverse Events


Eastern Cooperative Oncology Group


Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389


Fluorescence in situ hybridization


Human epidermal growth factor receptor 2


Progesterone receptor


Patient-reported neurotoxicity questionnaire


Vibration perception threshold


Functional assessment of cancer therapy-taxane


European Organization for Research and Treatment of Cancer


Quality of Life Questionnaire


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We thank all the patients and investigators who participated in this study. Editorial support for this manuscript was provided by Jake Burrell, PhD (Rude Health Consulting).


The study was funded by Eisai Co., Ltd., Japan. Preparation assistance by Oxford PharmaGenesis was funded by Eisai Inc.

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Corresponding author

Correspondence to Xichun Hu.

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The study was conducted in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice, the Declaration of Helsinki, and the institutional review board/ethics committee at each site.


The sponsor played a role in designing the study, interpreting the data, and reviewing the draft manuscripts.

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The study was approved by the institutional ethical committee and the patient signed an informed consent to participate in the study.

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Wu, Y., Wang, Q., Zhang, J. et al. Incidence of peripheral neuropathy associated with eribulin mesylate versus vinorelbine in patients with metastatic breast cancer: sub-group analysis of a randomized phase III study. Support Care Cancer 28, 3819–3829 (2020).

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  • Eribulin mesylate
  • Vinorelbine
  • Peripheral neuropathy
  • Metastatic breast cancer