Abstract
Eribulin mesylate has efficacy in patients who have received ≥2 prior chemotherapies for metastatic breast cancer (MBC) including an anthracycline and taxane. Phase 2 trials showed clinical activity and acceptable tolerability of first-line eribulin (HER2− MBC; Study 206) and eribulin plus trastuzumab (HER2+ MBC; Study 208). Prespecified analyses evaluated efficacy by prior anthracycline and/or taxane use. Patients received eribulin mesylate (1.4 mg/m2 IV; Days 1 and 8) and, in Study 208, trastuzumab (8 mg/kg IV/Cycle 1, then 6 mg/kg; Day 1) in 21-day cycles. Endpoints included objective response rate (ORR), progression-free survival (PFS), and tolerability. In Study 206 (N = 56), 48 % of patients had received prior anthracycline, 46 % prior taxane, 36 % prior anthracycline and taxane, and 41 % were chemotherapy-naïve. In Study 208 (N = 52), these percentages were 21, 44, 17, and 52 %, respectively. In Study 206, ORR and median PFS were similar for anthracycline-pretreated (25.9 %, 5.8 months), taxane-pretreated (26.9 %, 5.8 months), anthracycline- and taxane-pretreated (25.0 %, 6.7 months), and anthracycline/taxane-naïve patients (30.4 %, 7.6 months). In Study 208, ORR/median PFS were 63.6 %/6.7 months among anthracycline-pretreated patients, 56.5 %/6.8 months among taxane-pretreated patients, 55.6 %/5.9 months among anthracycline- and taxane-pretreated patients, and 81.5 %/13.1 months among anthracycline/taxane-naïve patients. Tolerability was generally similar among subgroups. In these studies, first-line eribulin in HER2− MBC and eribulin/trastuzumab in HER2+ MBC was effective with acceptable tolerability, regardless of prior anthracycline/taxane treatment. Prior chemotherapy was associated with lower ORR and shorter PFS with eribulin/trastuzumab in HER2+ MBC but not with eribulin in HER2− MBC.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-015-1322-y) contains supplementary material, which is available to authorized users.
Highlights
In the United States (US), approximately 5–10 % of women diagnosed with breast cancer (BC) have de novo metastatic disease and have an estimated 5-year survival rate of 24.3 %(National Cancer Institute 2014; American Cancer Society 2014)
First-line eribulin in human epidermal growth factor receptor 2 (HER2)− metastatic breast cancer (MBC) and eribulin/trastuzumab in HER2+ MBC was effective with acceptable tolerability, regardless of prior anthracycline/taxane treatment
Safety/tolerability In Study 206, rates of serious treatment-emergent adverse event (TEAE) were similar in patients who had received prior anthracycline (29.6 %) and in those who had received prior taxane treatment (26.9 %); rates were 20.0 % in patients who had received both anthracycline and taxane, and 26.1 % in patients who were anthracycline- and taxane-naive
Summary
O’Shaughnessy et al SpringerPlus (2015) 4:532 receptor 2 (HER2) expression, site and burden of metastases, disease-related symptoms, prior treatment history, toxicity, comorbid conditions, patient age, and menopausal status, amongst others (National Comprehensive Cancer Network 2015; Partridge et al 2014). Current guidelines recommend sequential singleagent chemotherapy (in most cases) for HER2-negative (HER2−) MBC that is hormone receptor-negative or endocrine-resistant; there is not a single specific preferred chemotherapy agent or regimen (National Comprehensive Cancer Network 2015; Partridge et al 2014). For women with HER2-positive (HER2+) metastatic disease, trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of HER2 (Valabrega et al 2007), combined with recently approved pertuzumab and a taxane (docetaxel or paclitaxel) are recommended as first-line therapy (National Comprehensive Cancer Network 2015; Giordano et al 2014)
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