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

Abstract

BACKGROUND:

Eribulin mesylate is a non-taxane microtubule dynamics inhibitor that recently gained Food and Drug Administration approval for late-line metastatic breast cancer (MBC).

PATIENTS AND METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

Eribulin exhibited efficacy and tolerability in Japanese patients with heavily pretreated MBC.

• Authors: K Aogi, H Iwata, N Masuda, H Mukai, M Yoshida, Y Rai, K Taguchi, Y Sasaki, S Takashima
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 23 Issue 6 Pg. 1441-8 (Jun 2012) ISSN: 1569-8041 [Electronic] England
• PMID: 21989327 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anthracyclines
• Antineoplastic Agents
• Furans
• Ketones
• Taxoids
• eribulin

Topics

• Adult
• Aged
• Anthracyclines (pharmacology)
• Antineoplastic Agents (pharmacology, therapeutic use)
• Bone Neoplasms (drug therapy, mortality, secondary)
• Breast Neoplasms (drug therapy, mortality, pathology)
• Disease-Free Survival
• Drug Resistance, Neoplasm
• Female
• Furans (therapeutic use)
• Humans
• Japan
• Ketones (therapeutic use)
• Liver Neoplasms (drug therapy, mortality, secondary)
• Lung Neoplasms (drug therapy, mortality, secondary)
• Lymphatic Metastasis
• Middle Aged
• Taxoids (pharmacology)
• Treatment Outcome
• Tumor Burden (drug effects)