Source: DGNews  |  Posted 3 years ago

By Ed Susman

CHCAGO -- June 5, 2008 -- Treatment with the investigative tubulin inhibitor eribulin mesylate helped heavily pretreated metastatic breast cancer patients achieve more than a 4-month progression-free survival.

"Most of these patients have been through at least 4 previous chemotherapy regimens and their disease was progressing," explained lead investigator Linda Vahdat, MD, Weill Cornell Medical School, New York, New York. "We found this new drug is active in this population. It is also very well tolerated."

Eribulin mesylate, a nontaxane microtubule dynamics inhibitor, is in ongoing phase 3 trials for treatment of patients with metastatic breast cancer. The drug is administered in a 2 to 5 minute infusion of 1.4 mg/m² on day 1 and day 8 of a 21-day cycle.

Dr. Vahdat, in her poster presentation on June 3, said that median overall survival among her 269 patients was 10.4 months. She said about 72.3% of the patients survived for at least 6 months.

"We have 25 patients that achieved a partial response according to [Response Evaluation Criteria in Solid Tumors] standards," Dr. Vahdat said. "In addition, another 125 patients achieved disease stabilisation, so that our overall clinical benefit rate was 55.5%."

Dr. Vahdat noted that the women in the study had received regimens that included anthracyclines, taxanes, and capecitabine.

The trial was open to women with metastatic breast cancer who had documented progression of disease within the last 6 months of receiving chemotherapy. Previous treatment with 2 to 5 different breast cancer regimens was also required for eligibility.

The median duration of response or stable disease was 4.1 months, Dr. Vahdat said. Median progression-free survival for the entire 269-patient population was 2.6 months.

"There was activity across all subgroups," Dr. Vahdat said. "The response rate was higher in patients who were hormone-receptor positive than in triple negative [oestrogen, progesterone, and HER2-status] patients."

Funding for the study was provided by Eisai.

[Presentation title: Phase II Study of Eribulin Mesylate (E7389) in Patients (Pts) With Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated With Anthracycline, Taxane, and Capecitabine Therapy. Abstract 1084]