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Breast J. 2019 Feb 8. doi: 10.1111/tbj.13199. [Epub ahead of print]

Safety of eribulin as third-line chemotherapy in HER2-negative, advanced breast cancer pre-treated with taxanes and anthracycline: OnSITE study.

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Medical Oncology Department, Hospital 12 De Octubre, Madrid, Spain.
Medical Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.
Medical Oncology Department, Hospital "Fundacion Jiménez Díaz", Madrid, Spain.
Medical Oncology Department, Hospital Infanta Cristina, Badajoz, Spain.
Medical Oncology Department, Hospital San Pedro de Alcántara, Cáceres, Spain.
Medical Oncology Department, Hospital Severo Ochoa, Leganés, Spain.
Medical Oncology Department, Hospital Ramón y Cajal, Madrid, Spain.
Medical Oncology Department, Hospital de León, León, Spain.
Medical Oncology Department, Hospital Fundación Alcorcón, Alcorcón, Spain.
Medical Oncology Department, Hospital La Princesa, Madrid, Spain.
Medical Oncology Department, Hospital Virgen de la Salud, Toledo, Spain.


Eribulin is active and safe in heavily pre-treated metastatic breast cancer patients. Few safety data have been published in third line. We aimed to report the specific safety profile on third line beyond taxanes and anthracyclines in advanced breast cancer (ABC). A multicenter phase II, prospective study was conducted in anthracyclines and taxanes pre-treated HER2-negative ABC, programmed to receive eribulin as third-line chemotherapy. Adverse events (AEs) were assessed and classified according to CTCAE. In addition, efficacy, in terms of overall survival (OS) and progression-free survival (PFS), and the dynamics of circulating tumor cells (CTCs) during treatment were assessed. 59 patients fulfilled the criteria. All but one showed AEs with a cumulative number of 598 AEs. The most frequent grade 3/4 drug-related AEs were neutropenia (1.7%), febrile neutropenia (0.5%), leukopenia (0.5%), alopecia (0.5%), asthenia (0.3%), elevated gamma glutamyl transferase levels (0.2%), and respiratory tract infection (0.2%). Median PFS was 4 months (95% CI 3.1-5.9) and median OS was 13.6 months (11.8-not reached). The mean number of CTCs in peripheral blood was significantly reduced from baseline to cycle 2 (16.8 vs 5.4 CTCs; P < 0.001). Median OS was significantly longer in <5 baseline CTC patients compared to ≥5 baseline CTC patients (13.1 months [95% CI: 11.8-not reached] vs 12.5 months [95% CI: 7.6-not reached]; P = 0.045). A significant correlation (P = 0.0129) was observed between CTC levels at cycle 2 and death when CTCs were analyzed using cox regression. Eribulin chemotherapy is effective and safe as third line in advanced HER2-negative breast cancer. CTC levels correlate with overall survival.


adverse events; circulating tumor cells; eribulin; metastatic breast cancer; third-line treatment


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