Abstract
The treatment goals for metastatic breast cancer (MBC) are prolonging survival and improving the quality of life. Eribulin, a non-taxane tubulin inhibitor, demonstrated improved survival in previous studies and also showed mild toxicity when used in late-line therapy for MBC. We conducted a phase II study to investigate the efficacy of eribulin mesylate as the first-line chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative MBC. This was a phase II, open-label, single-arm, multicenter trial conducted in Japan. Patients with HER2-negative MBC received intravenous eribulin (1.4 mg/m2 on days 1 and 8 of each 21-day cycle). The primary efficacy outcome was overall response rate (ORR). Secondary outcomes included time to treatment failure, progression-free survival (PFS), overall survival (OS), and safety. A total of 35 patients were enrolled and received a median of 8 (range 1–21) cycles of eribulin therapy. ORR and clinical benefit rate were 54.3 and 62.9 %, respectively. Median PFS was 5.8 months and median OS was 35.9 months. Grade 3 or 4 neutropenia was observed in 63 % of patients. The majority of non-hematological adverse events were mild in severity. The present trial demonstrated that eribulin has antitumor activity comparable with other key established cytotoxic agents with acceptable safety and tolerability. Thus, eribulin as first-line chemotherapy might be beneficial for patients with HER2-negative MBC.
Highlights
The prognosis for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) has improved significantly since anti-HER2 therapies became commercially available
Patients A total of 35 patients with HER2-negative MBC were enrolled between September 2011 and May 2014; none were excluded from our primary analysis
As eribulin has the potential to prolong survival in HER2-negative MBC patients, and has demonstrated acceptable safety and tolerability, it could be beneficial for such patients when used as a first-line therapy
Summary
The prognosis for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) has improved significantly since anti-HER2 therapies became commercially available. In a phase 3, open-label, randomized trial (EMBRACE study), eribulin showed a significant and clinically meaningful improvement in OS compared to treatment of the physician’s choice in patients with heavily pretreated MBC (Cortes et al 2011). The survival benefit of eribulin was similar to that of capecitabine in patients with MBC who had previously been treated with anthracycline- and taxane-based regimens (Kaufman et al 2015). In addition to OS benefit, the nonhematological toxicity reported with eribulin treatment is mostly mild These two findings suggest that eribulin would be a suitable option for early-line treatment of MBC to minimize toxicity and maximize survival benefit
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