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Phase III Study: No Difference Between Eribulin (Halaven) and Capecitabine (Xeloda) in Breast Cancer Survival

Data show trend toward improved overall survival with eribulin (Dec. 7)

Results from a phase III trial that compared eribulin mesylate (Halaven, Eisai) with capecitabine (Xeloda, Genentech) in locally advanced or metastatic breast cancer were presented at the 2012 CTRC–AACR San Antonio Breast Cancer Symposium.

The randomized open-label study compared eribulin with capecitabine in 1,102 patients with locally advanced or metastatic breast cancer who had failed on prior treatment with anthracyclines and taxanes. Most of the patients received study treatment as their first- or second-line chemotherapeutic regimen for metastatic disease. The co-primary endpoints of the study were overall survival (OS) and progression-free survival (PFS).

The study results indicated a trend favoring improved OS with eribulin compared with capecitabine, although the improvement was not statistically significant. Patients treated with eribulin had a median period of OS of 15.9 months versus 14.5 months with capecitabine (hazard ratio [HR]: 0.879; P = 0.056). Moreover, no difference was observed in the median PFS of the two treatment groups (4.1 months and 4.2 months for eribulin and capecitabine, respectively; HR: 1.079; P = 0.305).

The study included an exploratory analysis based on the expression status of human epidermal growth factor receptors (HER2s), along with other analyses based on hormone receptor expression status. These analyses showed that, in a subset of HER2-negative patients (n = 755), the median OS was 15.9 months for eribulin and 13.5 months for capecitabine (HR: 0.838; nominal P = 0.030). Further, in patients with triple-negative breast cancer (n = 284) — a group in which the disease is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative — the median OS was 14.4 months for eribulin and 9.4 months for capecitabine (HR: 0.702; nominal P = 0.006).

Adverse events (AEs) were consistent with the known side-effect profiles of both drugs. The most common AEs (incidence rate of at least 20%) for eribulin and capecitabine were neutropenia (54% vs. 16%, respectively), hand-foot syndrome (0.2% vs. 45%), alopecia (35% vs. 4%), leukopenia (31% vs. 10%), diarrhea (14% vs. 29%), and nausea (22% vs. 24%).

Halaven (eribulin) is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

Xeloda (capecitabine), in combination with docetaxel, is indicated for the treatment of patients with metastatic breast cancer after the failure of prior anthracycline-containing chemotherapy. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated.

Sources: Eisai; December 7, 2012; Halaven PI; February 2012; and Xeloda PI; February 2011.

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