FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

Osgood, Christy; Chuk, Meredith K.; Theoret, Marc R.; Huang, Lan; He, Kun; Her, Leah; Keegan, Patricia; Pazdur, Richard

doi:10.1158/1078-0432.ccr-16-2422

Cited by 41 publications

(32 citation statements)

References 16 publications

(13 reference statements)

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“…Therefore, eribulin can be expected to improve OS in patients with liposarcoma. Further analyses showed eribulin to be effective for patients with dedifferentiated liposarcoma (HR 0.45; 95% CI 0.25–0.82) and pleomorphic liposarcoma (HR 0.21; 95% CI 0.06–0.76) [26]. …”

Section: Resultsmentioning

confidence: 99%

Systemic Therapy for Soft Tissue Sarcoma: Proposals for the Optimal Use of Pazopanib, Trabectedin, and Eribulin

Kawai¹,

Yonemori²,

Takahashi

et al. 2017

Adv Ther

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Soft tissue sarcoma (STS) is a rare tumor with more than 50 histologic subtypes. Although treatment outcomes for patients with STS have improved greatly over the past few decades owing to the adoption of a multidisciplinary approach, patients with advanced disease have a poor prognosis. The development of anticancer drugs has been directed toward improving overall survival (OS). Doxorubicin monotherapy is currently the only standard option for the first-line treatment of STS. However, there is no standard therapy for second-line and later treatment at present. Since 2012, three anticancer drugs—pazopanib, trabectedin, and eribulin—have been approved in Japan for the second-line or later treatment of patients with advanced STS of any histologic subtype. However, the chemosensitivity of STS to each of these drugs varies by histologic subtype and their safety profiles differ; thus, histologic subtype and patient characteristics must be considered when determining optimal treatment. In this article, we review data from clinical studies related to the efficacy of all three drugs, including their effect on OS, and propose optimal treatment strategies for advanced STS by histologic subtype. In addition, with regard to the safety profiles, we highlight the key issues to be considered when selecting patients for treatment with pazopanib, trabectedin, or eribulin and ensuring their appropriate use, based on our combined clinical experience as specialists in the treatment of patients with STS. The proposed treatment strategies as well as treatment precautions based on clinical experience would benefit patients by maximizing the therapeutic effects and enhancing the proper use of these drugs. Funding: Eisai Co., Ltd.

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Section: Resultsmentioning

confidence: 99%

Systemic Therapy for Soft Tissue Sarcoma: Proposals for the Optimal Use of Pazopanib, Trabectedin, and Eribulin

Kawai¹,

Yonemori²,

Takahashi

et al. 2017

Adv Ther

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“…In that trial, eribulin prolonged the patients' OS compared to dacarbazine [24]. However, a subanalysis of the trial's data revealed that the OS benefit provided by eribulin was remarkable in the liposarcoma patients but not in the leiomyosarcoma patients [34,35]; as the result, FDA approved eribulin only for liposarcoma [36].…”

Section: Histology-based Chemotherapy Investigations Based On Clinicamentioning

confidence: 99%

Precision Medicine in Soft Tissue Sarcoma Treatment

Nakano

Takahashi

2020

Cancers

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Soft tissue sarcoma (STS) is a rare component of malignant diseases. STS includes various histological subtypes, and there are some important differences among the different histological subtypes regarding the mutation profile and sensitivity to antitumor agents. Many clinical trials of STS incorporating many different histological subtypes in various populations have been conducted; it is difficult to compare the findings and make conclusions about clinical efficacy. Targeted therapies focusing on specific histological subtypes and precision therapy focusing on the specific genetic mutation(s) of each STS patient are being investigated. Since STS patients are a small population, new clinical trial designs are required to evaluate and establish new targeted therapies for each histological subtype that has a limited number of patients, and preclinical investigations are needed to detect targetable mutations. Now that cancer genome profiling is used in clinical practice, it is urgently necessary to connect the genome profiling data obtained in clinical settings to the optimal clinical treatment strategies. Herein we review the development and challenges of precision therapy in the management of STS patients.

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“…Eribulin has recently been granted US FDA and EMA approval for the treatment of advanced LPS in patients pretreated with anthracycline chemotherapy. 58 It can be argued that the cost-effectiveness of the drug could be a potential obstacle to widespread use of eribulin, and this needs to be addressed in subsequent trials, including quality of life measurements. However, a Phase III trial has shown a significant survival benefit and an obvious question is the possible role of eribulin in the neoadjuvant/adjuvant setting and its role in the first-line setting compared to anthracycline therapy in LPS patients.…”

Section: Resultsmentioning

confidence: 99%

Advances in the treatment of soft tissue sarcoma: focus on eribulin

Koliou

Karavasilis

Theochari

et al. 2018

CMAR

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Eribulin mesylate is a synthetic derivative of halichondrin B isolated from a marine sponge. Its mechanism of action is through microtubule inhibition, which is different from that of taxanes. Eribulin has been approved for the treatment of metastatic breast cancer and more recently for non-operable or metastatic liposarcoma in patients who have received prior anthracycline chemotherapy. The major side effects of eribulin are bone marrow suppression including neutropenia, leukopenia, anemia, and fatigue/weakness, which can be well managed. In this article, we reviewed evidence from the latest published data on eribulin and its use in the treatment of soft tissue sarcomas. We explored the drug’s mechanism of action, pharmacodynamics, pharmacokinetics, and metabolism. Lastly, we reviewed all preclinical studies as well as clinical trials that investigated eribulin.

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FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

Cited by 41 publications

References 16 publications

Systemic Therapy for Soft Tissue Sarcoma: Proposals for the Optimal Use of Pazopanib, Trabectedin, and Eribulin

Systemic Therapy for Soft Tissue Sarcoma: Proposals for the Optimal Use of Pazopanib, Trabectedin, and Eribulin

Precision Medicine in Soft Tissue Sarcoma Treatment

Advances in the treatment of soft tissue sarcoma: focus on eribulin

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