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

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Summary

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.

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A phase II study of eribulin in Japanese patients with heavily pretreated metastatic breast cancer.

K. Aogi, H. Iwata, N. Masuda … (2012)

Eribulin mesylate is a non-taxane microtubule dynamics inhibitor that recently gained Food and Drug Administration approval for late-line metastatic breast cancer (MBC). In this single-arm, multicentre open-label phase II trial Japanese patients pretreated with an anthracycline and a taxane received 1.4 mg/m(2) eribulin mesylate (2- to 5-min i.v. infusion on days 1 and 8 of a 21-day cycle). The primary efficacy end point was overall response rate (ORR) by independent review. Patients (N = 80) had received a median of three prior chemotherapy regimens (range 1-5). ORR was 21.3% [95% confidence interval (CI) 12.9-31.8; all partial responses (PRs)], stable disease (SD) occurred in 30 patients (37.5%) and the clinical benefit rate (complete response + PR + SD ≥6 months) was 27.5% (95% CI 18.1-38.6). Median duration of response was 3.9 months (95% CI 2.8-4.9), progression-free survival was 3.7 months (95% CI 2.0-4.4) and overall survival was 11.1 months (95% CI 7.9-15.8). The most frequent treatment-related grade 3/4 adverse events were neutropenia (95.1%), leukopenia (74.1%) and febrile neutropenia (13.6%). Grade 3 peripheral neuropathy occurred in 3.7% of patients (no grade 4). Eribulin exhibited efficacy and tolerability in Japanese patients with heavily pretreated MBC.

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Phase 2 study of eribulin mesylate as first-line therapy for locally recurrent or metastatic human epidermal growth factor receptor 2-negative breast cancer

Kristi J McIntyre, Joyce O’Shaughnessy, Lee S Schwartzberg … (2014)

Eribulin mesylate, a novel non-taxane microtubule dynamics inhibitor, is approved for treatment of metastatic breast cancer (MBC) in patients who have previously received at least 2 chemotherapeutic regimens for MBC that should have included an anthracycline and a taxane in the adjuvant or metastatic setting. This phase 2 study evaluated efficacy and safety of eribulin as first-line therapy for human epidermal growth factor receptor 2-negative (HER2-negative) MBC. Patients with measurable HER2-negative locally recurrent breast cancer or MBC with ≥12 months since prior neoadjuvant or adjuvant (neo/adjuvant) chemotherapy received eribulin mesylate 1.4 mg/m2 IV on days 1 and 8 of each 3-week cycle. Endpoints included objective response rate (ORR) per RECIST v1.1 (primary), safety, progression-free survival (PFS), clinical benefit rate (ORR + stable disease ≥6 months; CBR), and duration of response (DOR). Fifty-six patients were enrolled and received eribulin; 38 (68 %) had prior neo/adjuvant therapy, including 33 who had anthracycline and/or taxane-containing chemotherapy; 41 (73 %) had estrogen receptor-positive disease, and 12 (21 %) had estrogen receptor-negative, progesterone receptor-negative, and HER2-negative (triple-negative) disease. Patients received a median of 7 cycles (range 1–43); 6 (11 %) received treatment for ≥12 months. ORR was 29 % (95 % CI 17.3–42.2), CBR was 52 %, and median DOR was 5.8 months. Median PFS was 6.8 months. Thirty-six patients (64 %) had grade 3/4 treatment-related adverse events; most common were neutropenia (50 %), leukopenia (21 %), and peripheral neuropathy (21 %). These results demonstrate that eribulin has substantial antitumor activity as first-line treatment for HER2-negative MBC with acceptable safety.

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Impact of preoperative anemia on relapse and survival in breast cancer patients

Yingjun Zhang, Yuyang Chen, DongTai Chen … (2014)

Background Previous studies have shown that preoperative anemia is correlated with the prognoses of various solid tumors. This study was performed to determine the effect of preoperative anemia on relapse and survival in patients with breast cancer. Methods A total of 2960 patients with breast cancer who underwent surgery between 2002 and 2008 at the Sun Yat-sen University Cancer Center (Guangzhou, PR China) were evaluated in a retrospective analysis. A total of 2123 qualified patients were divided into an anemic group [hemoglobin (Hb) < 12.0 g/dL, N = 535)] and a nonanemic group (Hb ≥ 12.0 g/dL, N = 1588). The effects of anemia on local relapse-free survival (LRFS), lymph node metastasis-free survival (LNMFS), distant metastasis-free survival (DMFS), relapse-free survival (RFS), and overall survival (OS) were assessed using Kaplan–Meier analysis. Independent prognostic factors were identified in the final multivariate Cox proportional hazards regression model. Results Among the 2123 women who qualified for the analysis, 535 (25.2%) had a Hb level < 12.0 g/dL. The Kaplan–Meier curves showed that anemic patients had worse LRFS, LNMFS, DMFS, RFS, and OS than nonanemic patients, even in the same clinical stage of breast cancer. Cox proportional hazards regression model indicated that preoperative anemia was an independent prognostic factor of LRFS, LNMFS, DMFS, RFS, and OS for patients with breast cancer. Conclusions Preoperative anemia was independently associated with poor prognosis of patients with breast cancer.

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Author and article information

Contributors

Kenichi Inoue:

ORCID: http://orcid.org/0000-0003-2686-8732

ino.bad.ken@gmail.com

Journal

Journal ID (nlm-ta): Invest New Drugs

Journal ID (iso-abbrev): Invest New Drugs

Title: Investigational New Drugs

Publisher: Springer US (New York )

ISSN (Print): 0167-6997

ISSN (Electronic): 1573-0646

Publication date (Electronic): 16 January 2020

Publication date PMC-release: 16 January 2020

Publication date (Print): 2020

Volume: 38

Issue: 5

Pages: 1540-1549

Affiliations

[1 ]GRID grid.416695.9, ISNI 0000 0000 8855 274X, Division of Breast Oncology, , Saitama Cancer Center, ; Saitama, Japan

[2 ]GRID grid.415270.5, Department of Breast Surgery, , National Hospital Organization Hokkaido Cancer Center, ; Hokkaido, Japan

[3 ]GRID grid.497282.2, Division of Breast and Medical Oncology, , National Cancer Center Hospital East, ; Chiba, Japan

[4 ]GRID grid.414944.8, ISNI 0000 0004 0629 2905, Department of Breast and Endocrine Surgery, , Kanagawa Cancer Center, ; Kanagawa, Japan

[5 ]GRID grid.414976.9, ISNI 0000 0004 0546 3696, Department of Breast Surgery, , Kansai Rosai Hospital, ; Hyogo, Japan

[6 ]GRID grid.418765.9, ISNI 0000 0004 1756 5390, Clinical Planning and Development Department, Eisai Co., Ltd., ; Tokyo, Japan

[7 ]GRID grid.410714.7, ISNI 0000 0000 8864 3422, Advanced Cancer Translational Research Institute, , Showa University, ; Tokyo, Japan

[8 ]GRID grid.258622.9, ISNI 0000 0004 1936 9967, Department of Medical Oncology, , Kindai University, ; Osaka, Japan

Author information

Kenichi Inoue http://orcid.org/0000-0003-2686-8732

Article

Publisher ID: 890

DOI: 10.1007/s10637-019-00890-5

PMC ID: 7497681

PubMed ID: 31950374

SO-VID: b7e65db3-f953-46e1-ab02-304f88cb14a7

License:

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