Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes.

Abstract

OBJECTIVES:

Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC.

MATERIALS AND METHODS:

In this phase II, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed human epidermal growth factor receptor 2-negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014). Objective response rate (ORR; primary endpoint), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety were evaluated.

RESULTS:

Of 53 recruited patients, 47 were enrolled. The ORR was 17.0% (95% confidence interval, 7.6-30.8), DCR was 66.0% (51.2-77.8), median PFS was 4.9 months (3.5-7.0), DOR was 6.6 months (1.9-14.3), and median OS was 17.4 months (10.1-not evaluable). The common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leucopenia (16 patients; 42.1%) and febrile neutropenia (4 patients; 8.5%). Toxicity did not increase during the long-term treatment. Subgroup analysis indicated that first-line treatment led to higher ORR and prolonged PFS and OS than second-/third-line treatment and that incidence of adverse events in patients of second-/third-line treatment was not higher than that in patients of first-line treatment.

CONCLUSION:

Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).

• Authors: Shigeto Maeda, Michiyo Saimura, Shigeki Minami, Kaname Kurashita, Reiki Nishimura, Yuichiro Kai, Hiroshi Yano, Kohjiro Mashino, Shoshu Mitsuyama, Mototsugu Shimokawa, Kazuo Tamura, Kyushu Breast Cancer Study Group
• Journal: Breast (Edinburgh, Scotland) (Breast) Vol. 32 Pg. 66-72 (Apr 2017) ISSN: 1532-3080 [Electronic] Netherlands
• PMID: 28056400 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Anthracyclines
• Furans
• Ketones
• Taxoids
• eribulin

Topics

• Adult
• Aged
• Anthracyclines (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Confidence Intervals
• Disease-Free Survival
• Female
• Furans (therapeutic use)
• Humans
• Japan
• Ketones (therapeutic use)
• Middle Aged
• Neoplasm Metastasis
• Neutropenia (chemically induced)
• Taxoids (therapeutic use)
• Time Factors
• Treatment Outcome