Eribulin for heavily pre-treated metastatic breast cancer patients.

To discuss treatment with eribulin in clinical practice outside a clinical trial. Archives of patients treated for metastatic breast cancer were reviewed and 21 patients treated with the new chemotherapeutic eribulin mesylate, a synthetic analog of a natural marine product, were identified. Information on patients' characteristics and treatment outcomes was extracted. Treatment with eribulin mesylate was initiated at the recommended dose of 1.4 mg/m(2) on days 1 and 8 of a 21-day cycle in 17 patients and at a decreased dose of 1.1 mg/m(2) on days 1 and 8 of a 21-day cycle in 4 patients due to comorbidities and frailty. Efficacy of the drug was evaluated using the revised Response Evaluation Criteria in Solid Tumors criteria. Progression-Free Survival and overall survival (OS) were calculated using the Kaplan-Meier method starting from the date of eribulin therapy initiation to the date of disease progression documentation or death, respectively. The median age of patients at the time of eribulin mesylate treatment was 53 years (range 34-75). Sixteen patients had estrogen receptor (ER) and/or partial response (PR) positive disease and 5 had ER/PR negative disease (all triple negative). Eight patients had received 2 or 3 previous lines of chemotherapy for metastatic disease and 13 patients had received 4 or more lines of treatment. The median number of cycles of eribulin received was 3 (range 1-16 years). All patients, except one, discontinued treatment due to progressive disease and one patient due to adverse effects. Six patients had a dose reduction due to side effects. All patients had progressed at the time of the report with a median time to progression of 3 mo (range 1 to 14 mo). Fifteen patients had died with a median OS of 7 mo (range 1-18 mo). Six patients were alive with a median follow-up of 13.5 mo (range 7 to 19 mo). This series of patients confirms the activity of eribulin in a heavily pre-treated metastatic breast cancer population consistent with phase II and III trials