Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19)

Abstract

Background Anthracycline (A) or taxane T-based regimens are the standard early-line chemotherapy for metastatic breast cancer (BC). A previous study has shown a survival benefit of eribulin in heavily pretreated advanced/recurrent BC patients. The present study aimed to compare the benefit of eribulin with treatment of physician’s choice (TPC) as first- or second-line chemotherapy for recurrent HER2-negative BC. Methods Patients with recurrent HER2-negative BC previously receiving anthracycline and taxane AT-based chemotherapy in the adjuvant or first-line setting were eligible for this open-label, randomized, parallel-group study. Patients were randomized 1:1 by the minimization method to receive either eribulin (1.4 mg/m2 on day one and eight of each 21-day cycle) or TPC (paclitaxel, docetaxel, nab-paclitaxel or vinorelbine) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included time to treatment failure (TTF), overall response rate (ORR), duration of response, and safety (UMIN000009886). Results Between May 2013 and January 2017, 58 patients were randomized, 57 of whom (26 eribulin and 31 TPC) were analyzed for efficacy. The median PFS was 6.6 months with eribulin versus 4.2 months with TPC (hazard ratio: 0.72 [95% confidence interval (CI), 0.40–1.30], p = 0.276). Median TTF was 6.0 months with eribulin versus 3.6 months with TPC (hazard ratio: 0.66 [95% CI, 0.39–1.14], p = 0.136). Other endpoints were also similar between groups. The most common grade ≥ 3 adverse event was neutropenia (22.2% with eribulin versus 16.1% with TPC). Conclusions Eribulin seemed to improve PFS or TTF compared with TPC without statistical significance. Further validation studies are needed.

Effectiveness, safety, and impact on quality of life of eribulin‐based therapy in heavily pretreated patients with metastatic breast cancer: A real‐world analysis

“…Recently, several studies have reported promising outcomes for eribulin combined with trastuzumab and pertuzumab in patients with HER2+ MBC or combined with anti‐angiogenesis agents and immune checkpoint inhibitors in HER2− MBC in front‐line therapy. 41 , 42 , 43 Unfortunately, patients included in this study were mainly heavily pre‐treated or had refractory disease, so the effectiveness of eribulin combination therapy in first‐line was not investigated. In addition, as the effectiveness of eribulin based therapy was analyzed retrospectively, there may have been selection bias.…”

Investigating the Role of CTCs with Stem/EMT-like Features in Metastatic Breast Cancer Patients Treated with Eribulin Mesylate

“…Pooled analysis of these studies further revealed a significant increase in OS with eribulin for patients who had received at least two prior lines of chemotherapy, including anthracyclines and taxanes, and especially those with HER2-negative and triple-negative BC [ 19 ]. Recent findings of a randomized phase II study also support that eribulin as first-line or second-line chemotherapy provided an important clinical benefit to patients with recurrent HER2-negative BC [ 20 ]. However, effective and readily available predictive biomarkers for eribulin treatment are still lacking, while the mechanisms involved in eribulin resistance were only recently investigated and require further elucidation [ 21 , 22 ].…”

Effects of Antibacterial Agents on Cancerous Cell Proliferation

“…2) Docetaxel (DTX) is used as a therapeutic against breast cancer and prostate cancer. 3,4) Treatment with these anticancer agents has side effects, such as myelosuppression, and increases the risk of various infectious diseases. Additionally, gallbladder cancer is refractory cancer that is difficult to detect early and has a low five-year survival rate.…”