Eribulin Plus Trastuzumab an Effective Combination

VBCC - March 2013 - San Antonio Breast Cancer Symposium 2012 Highlights - Breast Cancer
Caroline Helwick

Eribulin mesylate (Halaven) is currently used in patients with metastatic breast cancer whose disease has progressed on other treatments, but the drug may be useful in earlier lines of therapy. Eribulin is especially promising when paired with trastuzumab (Herceptin), according to a phase 2 clinical trial presented at the meeting.

Linda T. Vahdat, MD, Professor of Medicine, Director of the Breast Cancer Research Program, Chief of the Solid Tumor Service, Weill Cornell Medical College, New York, reported the results of a study using eribulin as a first-line treatment for patients with metastatic breast cancer who were HER2-positive. The results were striking for the combination of eribulin and trastuzumab in this patient population, Dr Vahdat said.

Objective responses were observed in 22 (55%) of the 40 patients, the disease control rate was 92%, and the duration of response in the 22 responders was 204 days (range, 141-541 days). For all patients receiving treatment with eribulin, the median progression-free survival (PFS) was 9.2 months (Figure 1).

Figure 1 - Progression-Free Survival
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“This combination performed terrifically,” Dr Vahdat said in an interview. “These are preliminary data, but what is really shocking is that only 1 patient out of 40 progressed. Look at the waterfall plot [Figure 2]. We usually see progression in 30% to 40% of patients. This appears to be a great combination.”

Figure 2 - Percentage Change from Baseline
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The approval of eribulin in the United States, Europe, Japan, and other countries was based on the Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389 (EMBRACE), a phase 3, open-label trial in which women with locally recurrent or metastatic breast cancer were randomly allocated to eribulin or to treatment of their physician’s choice (Cortes J, et al. Lancet. 2011;377:914-923).

Overall survival was significantly improved with eribulin—13.1 months versus 10.6 months with physician’s choice of treatment, a 19% risk reduction (P = .041).

Study Details

The focus of the current trial was to explore the antitumor activity and the safety of eribulin in combination with trastuzumab as first-line therapy for HER2-positive advanced breast cancer. As of October 2012, 40 of the 52 planned patients had received at least 1 dose of eribulin and could be evaluated for this preliminary analysis.

The median age of the patients was 58 years; 80% were white; 67% had estrogen receptor (ER)-positive disease; 75% had Eastern Cooperative Oncology Group performance status of 0; 40% had received previous therapy with trastuzumab; and 52% had metastasis to the liver, 42% to the lungs, and 35% to the bone. The median time from their original diagnosis was 2.4 years.

A total of 4 patients experienced treatment-related serious adverse events during the study. Febrile neutropenia occurred in 7.5% of patients; neutropenia in 5%; and anemia, fatigue, and peripheral neuropathy in 2.5% each. Dose reductions, interruptions, and discontinuation of therapy resulting from treatment- emergent adverse events occurred in 20%, 22.5%, and 12.5% of patients, respectively. Of the 40 total patients, 15% were receiving growth factor support.

For the 55% of patients who responded, the median duration of response was 6.7 months (with no difference between ER-positive and ER-negative patients). The median PFS was 9.2 months overall, increasing to 19.1 months among patients in the highest PFS quartile, Dr Vahdat reported.

“These preliminary results suggest that the combination of eribulin plus trastuzumab appears to have considerable activity with an acceptable toxicity profile as first-line therapy for HER2-positive locally advanced or metastatic breast cancer. The study has completed enrollment, and we expect final results by the end of next year,” she concluded.

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