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Abstract. Prognostic factors for breast cancer include axillary lymph node status, tumor size, histology, nuclear grade, presence of estrogen and progesterone receptors, HER2/neu status, and mean microvessel density (MVD). In this study, we evaluated the usefulness of a new marker, D2-40, by investigating lymph vascular invasion of the tumor immunohistochemically in 132 patients with breast cancer and compared it with those of well-known prognostic indicators. Positive immunostaining of lymphatic endothelium with D2-40 outlining tumor emboli in the lumen of lymphatics was defined as D2-LVI, and lymphatic invasion following conventional hematoxylin and eosin staining was defined as HE-LVI. Significant correlation was observed between HE-LVI and D2-LVI (p<0.001), between lymph node status and HE-LVI (p=0.005), and between recurrent status and D2-LVI (p=0.008) by univariate analysis. Based on multivariate analysis, lymph node status (p<0.001, OR=6.993), tumor size (p=0.005, OR=5.504), D2-LVI (p=0.006, OR=4.740), and MVD (p=0.002, OR=4.484) were independent prognostic factors of disease recurrence. A significant difference in disease-free survival was also found between patients with and without D2-LVI (p=0.0067), but not with or without HE-LVI. Even in node-positive cases, D2-LVI had prognostic meaning. D2-LVI may play a crucial role for predicting recurrence of breast cancers much more than expected. Our data identifying D2-LVI expression in tumors of patients with a poor disease-free survival prognosis provides an easier and more accurate prognostic method than identifying HE-LVI.

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.

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