Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

Abstract

Background Data on eribulin as the first-or second-line treatment in a clinical setting, especially the overall survival (OS) of patients, are scarce. Therefore, we assessed the effectiveness and safety of eribulin as the first-, second-, and third-or later-line treatments in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in Japan. Methods This multicenter, prospective, post-marketing, observational study enrolled patients from September 2014 to February 2016 in Japan and followed them for 2 years. Patients were categorized by eribulin use into the first-, second-, and third-or later-line treatment groups. Results Of 651 registered patients, 637 patients were included in the safety and effectiveness analysis. In all, first-, second-, and third or later-line treatment groups, median OS (95% confidence interval) were 15.6 (13.8-17.6), 22.8 (17.3-31.0), 16.3 (12.4-19.9), and 12.6 (11.2-15.1) months and time to treatment failure (TTF) (95% confidence interval) were 4.2 (3.7-4.4), 5.2 (3.7-5.9), 4.2 (3.7-5.1), and 3.8 (3.5-4.2) months, respectively. Prolonged TTF was associated with complications of diabetes and the development of peripheral neuropathy after eribulin treatment, according to multivariate Cox regression analysis. Grade ≥ 3 adverse drug reactions (ADRs) were reported in 61.7% of the patients. Neutropenia (49.5%) was the most common grade ≥ 3 ADR in all groups. Conclusions The effectiveness and safety results of eribulin as the first-or second-line treatment were favorable. Thus, these suggest eribulin may be a first-line treatment candidate for patients with HER2-negative advanced breast cancer in Japan.

Indices of peripheral leukocytes predict longer overall survival in breast cancer patients on eribulin in Japan

“…This study aimed to confirm whether the results of the non-Asian, global EMBRACE study [ 7 ] hold true regardless of ethnicity. The details of the original post-marketing study of eribulin have been reported previously [ 4 , 5 ]. In this multicenter, prospective, post-marketing, observational study in Japan (ClinicalTrials.gov: NCT02371174), patients were enrolled from September 2014 to February 2016 and were followed for a maximum of 2 years.…”

“…The efficacy and safety of eribulin were also demonstrated in previous pre-approval and real-world studies [ 2 , 3 ]. To assess the safety and effectiveness of eribulin in clinical settings in Japan, a post-marketing observational study was conducted in patients with HER2-negative advanced breast cancer, which showed favorable results consistent with the results of clinical trials and real-world studies [ 4 , 5 ]. Despite the accumulated evidence on eribulin, the mechanisms of eribulin for efficacy outcomes are not fully understood; however, recent studies have suggested that the status of the tumor microenvironment may be the key to elucidate those [ 6 , 7 ].…”

“…To confirm whether the results of the EMBRACE study, which did not include Asian patients, hold true regardless of ethnicity, we performed a post hoc analysis and examined whether the baseline ALC and NLR are potential predictors of OS in Japanese patients treated with eribulin using data from a real-world post-marketing observational study in Japan [ 5 ].…”

Review A meta-analysis of the efficacy and safety of additional anti-HER2-targeting drugs in HER2-positive advanced breast cancers

“…The study found that rst-line treatment showed more enormous advantages than non-rst-line therapy in terms of e cacy. As tracked by Inoue [55] et al, the effectiveness and safety of the microtubule kinetics inhibitor Brin were bene cial as a rst-line or second-line treatment. Therefore, they suggested that Brin may be a rst-line treatment for patients with advanced HER2-negative breast cancer.…”

Clinical Utility of Eribulin Mesylate in the Treatment of Breast Cancer: A Chinese Perspective

“… 19 Prolonged survival with eribulin was also seen in this patient subgroup in a Japanese real-world analysis; median OS was 15.6 months in 637 patients with HER2-negative disease receiving eribulin as first-, second-, third-, or later-line therapy. 45 In addition, results from a Phase I trial of combination therapy with eribulin plus balixafortide in 54 patients with heavily pretreated HER2-negative disease showed promising results with an ORR of 30%. 46 An ongoing Phase III trial is further investigating this combination in HER2-negative patients with locally recurrent or metastatic breast cancer (NCT03786094).…”