Eribulin Mesylate

A Novel Halichondrin B Analogue for the Treatment of Metastatic Breast Cancer

Ali McBride, Pharm.D., M.S., BCPS; Sara K. Butler, Pharm.D., BCPS, BCOP


Am J Health Syst Pharm. 2012;69(9):745-755. 

In This Article


Eribulin is a halichondrin B analogue with a novel mechanism of action distinct from taxanes, vinca alkaloids, and ixabepilone. The unique mechanism of action, including the formation of nonfunctional tubulin aggregates, contributes to eribulin's efficacy in patients whose disease has progressed during taxane and anthracycline chemotherapy.

EMBRACE demonstrated an improvement of 2.1 months in overall survival with eribulin over a physician's choice chemotherapy in heavily pretreated patients with metastatic breast cancer.[29] Despite this information, many questions about eribulin remain. Currently, there are no data comparing eribulin with other single-agent chemotherapy regimens, such as capecitabine, taxanes, and anthracyclines. In the Phase III trials, the chemotherapy agents in the TPC group were very diverse and the efficacy of each chemotherapy drug used varied greatly. More information is needed to directly compare eribulin with standard chemotherapy agents used in the metastatic or advanced breast cancer setting. This information will help further define the treatment strategy for metastatic breast cancer.

The Phase III data that have been published thus far are for women who were heavily pretreated with a median of four previous chemotherapy regimens. The publication of Study 301 will help define the role of eribulin earlier in the treatment strategy for locally advanced or metastatic disease in patients who have received up to three prior chemotherapy regimens but no more than two prior regimens for advanced or metastatic disease. Study 301 will help determine where eribulin should be used in the arsenal of chemotherapy agents that are available for patients with metastatic breast cancer as it will provide information regarding overall survival and progression-free survival in patients receiving either eribulin or capecitabine.[28] Enrollment in Study 301 has been completed, and clinical results should be released in 2012.

As with many other breast cancer chemotherapies that are originally studied in the metastatic setting, the question remains of establishing eribulin's efficacy and safety in the adjuvant setting or in the first-line metastatic setting. Research is ongoing in this area.

Peripheral neuropathy is a significant concern and toxicity is common to women with metastatic breast cancer. While peripheral neuropathy remains one of eribulin's DLTs, the frequency is comparable to other chemotherapy regimens utilized in breast cancer. Studies will need to continue to observe the adverse effects of eribulin, especially neuropathy.


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