Phase III trial of Halaven (Eisai) shows QoL advantages for Breast Cancer patients

Results fromm a Phase III study (Study 301) of Halaven (eribulin mesylate), from Eisai, show the drug improved Global Health Status (GHS) and overall quality of life (QoL) more than capecitabine in patients with locally advanced or metastatic Breast Cancer previously treated with anthracyclines and taxanes. The study did not meet the co-primary endpoints for overall survival or progression-free survival. However, the data showed a trend toward improved overall survival in patients treated with Halaven with a median survival of 15.9 months versus 14.5 months with capecitabine.

The Phase III study also explored the QoL-related experiences of 1,102 women as a secondary endpoint. GHS/QoL scores were low at the start of the study for both drugs however results showed GHS/QoL and cognitive functioning had improved significantly more in patients receiving eribulin compared to capecitabine over the course of the study (15.3 [p0.001] and 6.5 [p=0.048] respectively). Emotional functioning was found to improve to a greater extent in the capecitabine patients (3.3 [p=0.033]). Halaven is indicated in Europe for the treatment of patients with locally advanced or metastatic Breast Cancer who have previously received at least two chemotherapeutic regimens.