Efficacy and safety of eribulin in Japanese patients (pts) with advanced breast cancer.

Iwata, H; Aogi, K.; Masuda, Norikazu; Mukai, H; Yoshida, M; Rai, Y.; Taguchi, Keisuke; Sasaki, Yoko; Takashima, S.

doi:10.1200/jco.2010.28.15_suppl.1081

Cited by 16 publications

(26 citation statements)

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“…Phase ii trials in patients with metastatic breast cancer [42][43][44] Patients had to have received both an anthracycline and a taxane, but additional treatments were also permitted; other eligibility criteria were standard, but pre-existing neuropathy Grade 1 42 or 1-2 43 was permitted. Objective response rate was the primary endpoint in all three studies, and responses were independently reviewed.…”

Section: -39mentioning

confidence: 99%

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Eribulin (Halaven): a new, effective treatment for women with heavily pretreated metastatic breast cancer

Menis

Twelves

2011

BCTT

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Although metastatic breast cancer remains essentially incurable, many patients previously treated with an anthracycline, taxane, and capecitabine are relatively fit and keen to receive further therapy. Several drugs are used in this setting, but with little evidence of clinically relevant benefit, and none have previously shown improved survival. Eribulin (Halaven ® ) is a nontaxane tubulin-binding agent with a novel mode of action, and was recently approved by the European Medicines Agency and US Food and Drug Agency as a single agent for patients with heavily pretreated metastatic breast cancer. This review provides an overview of the discovery, and preclinical and clinical development of eribulin, culminating in the recently published EMBRACE metastatic breast cancer study.

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Section: -39mentioning

confidence: 99%

“…Encouraging Phase II [42][43][44] data have been supplemented by recent Phase III 45 data showing eribulin to be the first monotherapy to prolong survival in women with heavily pretreated metastatic breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Eribulin (Halaven): a new, effective treatment for women with heavily pretreated metastatic breast cancer

Menis

Twelves

2011

BCTT

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“…The 21-day dosing schedule was also investigated in 81 Japanese patients pretreated with an anthracycline and a taxane (median of 3 prior chemotherapy regimens), who received eribulin mesylate 1.4 mg/m 2 on days 1 and 8. The ORR was 21.3% and the median duration of response was 3.9 months (20).…”

Section: Clinical Studiesmentioning

confidence: 96%

“…Phase II testing of eribulin mesylate was subsequently conducted in women with heavily pretreated breast cancer (18)(19)(20). It was hypothesized that eribulin might have activity in breast cancer refractory to other microtubuletargeted drugs, such as taxanes, given its unique mechanism of action and impressive preclinical activity.…”

Section: Clinical Studiesmentioning

confidence: 99%

Eribulin Mesylate

Jain

Vahdat

2011

Clinical Cancer Research

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Eribulin mesylate, a nontaxane, completely synthetic microtubule inhibitor, has recently been approved by the U.S. Food and Drug Administration as third-line treatment of metastatic breast cancer refractory to anthracyclines and taxanes. Eribulin is a synthetic analogue of halichondrin B, which inhibits microtubule polymerization by a mechanism distinct from other available antitubulin agents. Eribulin significantly increased overall survival (OS; median OS for the eribulin-treated group was 13.1 months versus 10.6 months for the group treated by investigator's choice) in a heavily pretreated metastatic breast cancer population. Eribulin has a manageable side-effect profile, notably neutropenia and fatigue, and a relatively low incidence of peripheral neuropathy. The mechanism of action, pharmacokinetics, preclinical antitumor activity, and clinical trials of eribulin in the metastatic breast cancer setting are reviewed here. Clin Cancer Res; 17(21); 6615-22. Ó2011 AACR.

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“…Grade 3 peripheral neuropathy occurred in 3.7% of patients (no grade 4). 28 These data are summarized in Table 1.…”

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confidence: 99%

Potential clinical applications of halichondrins in breast cancer and other neoplasms

Ortega¹,

Cortés²

2012

BCTT

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Halichondrin B is a large polyether macrolide found in a rare Japanese sponge, Halichondria okadai and has been shown to have anticancer activity. Eribulin mesylate is a completely synthetic analog of halichondrin B with a unique mechanism of action relative to other antimicrotubule agents. This new agent has demonstrated activity in preclinical studies, and it is being developed for the treatment of different tumor types. Eribulin has been approved by the United States Food and Drug Administration and the European Medicines Agency as lateline therapy for metastatic breast cancer patients previously treated with an anthracycline and a taxane. It has demonstrated superiority over other treatments in overall survival (OS) (hazard ratio: 0.81, P = 0.041), leading to its regulatory approbation for clinical practice use. Median OS for the eribulin-treated group was 13.1 months versus 10.6 months in the physician's treatmentof-choice group. Eribulin demonstrated a manageable toxicity profile. Most common adverse events associated with treatment were mild neutropenia and fatigue, mainly of grade 1 or 2. In contrast to other antimicrotubule agents, eribulin has a relatively low incidence of peripheral neuropathy and alopecia. Eribulin has been extensively studied in breast cancer and is currently being developed for treatment of other cancer types. Eribulin has demonstrated activity in Phase II trials in non-small cell lung cancer, pancreatic cancer, urothelial tract cancer, and sarcomas. Further studies in these cancers are ongoing. This article reviews pharmacology, mechanism of action, pharmacokinetics and efficacy of eribulin in breast cancer and other neoplasms.

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Efficacy and safety of eribulin in Japanese patients (pts) with advanced breast cancer.

Cited by 16 publications

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Eribulin (Halaven): a new, effective treatment for women with heavily pretreated metastatic breast cancer

Eribulin (Halaven): a new, effective treatment for women with heavily pretreated metastatic breast cancer

Eribulin Mesylate

Potential clinical applications of halichondrins in breast cancer and other neoplasms

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