Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes

Eisuke Kobayashi, Yoichi Naito, Naofumi Asano, Aiko Maejima, Makoto Endo, Shunji Takahashi, Yasunori Megumi, Akira Kawai

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Abstract

BACKGROUND: Although eribulin is used to treat soft tissue sarcomas (STSs), treatment data for rare subtypes are limited. We conducted a post-marketing surveillance study to assess safety and efficacy of eribulin in STS patients stratified by subtype. METHODS: Japanese patients (n = 256) with advanced or metastatic STS receiving eribulin treatment were monitored for treatment status, adverse events, diagnostic imaging, and clinical outcomes at 3 months and 1 year. Interim analysis was performed. Patients will be monitored up to 2 years. RESULTS: Interim analysis included 3-month (n = 255), imaging (n = 226), and 1-year (n = 105) data. STS subtype distribution was normal. Median number of eribulin cycles was 3.0 (range: 1-17 cycles). Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5% (n = 17); stable disease, 34.5% (n = 78); and stable disease ≥11 weeks, 10.2% (n = 23). Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) for all patients were 7.5%, 42.0% and 17.7%, respectively. ORR, DCR, and CBR were 10.3%, 32.0% and 16.5%, respectively, for patients with STS subtypes other than liposarcoma and leiomyosarcoma and included responses from patients with rare STS subtypes. Adverse drug reactions (ADRs) occurred in 211 (82.7%) patients (42 [16.5%] patients had serious ADRs), and none led to death. ADRs leading to drug withdrawal and dose reduction occurred in 27 (10.6%) and 55 (21.6%) patients, respectively. CONCLUSION: Eribulin was generally well tolerated and showed antitumor activity against STSs, including rare subtypes that currently have few treatment options. CLINICAL TRIAL NUMBER: NCT03058406 (ClinicalTrials.gov).

Original languageEnglish
Pages (from-to)938-946
Number of pages9
JournalJapanese journal of clinical oncology
Volume49
Issue number10
DOIs
Publication statusPublished - 2019 Oct 1

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eribulin
Sarcoma
Observational Studies
Drug-Related Side Effects and Adverse Reactions
Liposarcoma

Keywords

  • Eribulin
  • post-marketing product surveillance
  • soft tissue sarcoma (STS)

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. / Kobayashi, Eisuke; Naito, Yoichi; Asano, Naofumi; Maejima, Aiko; Endo, Makoto; Takahashi, Shunji; Megumi, Yasunori; Kawai, Akira.

In: Japanese journal of clinical oncology, Vol. 49, No. 10, 01.10.2019, p. 938-946.

Research output: Contribution to journalArticle

Kobayashi, Eisuke ; Naito, Yoichi ; Asano, Naofumi ; Maejima, Aiko ; Endo, Makoto ; Takahashi, Shunji ; Megumi, Yasunori ; Kawai, Akira. / Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. In: Japanese journal of clinical oncology. 2019 ; Vol. 49, No. 10. pp. 938-946.
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abstract = "BACKGROUND: Although eribulin is used to treat soft tissue sarcomas (STSs), treatment data for rare subtypes are limited. We conducted a post-marketing surveillance study to assess safety and efficacy of eribulin in STS patients stratified by subtype. METHODS: Japanese patients (n = 256) with advanced or metastatic STS receiving eribulin treatment were monitored for treatment status, adverse events, diagnostic imaging, and clinical outcomes at 3 months and 1 year. Interim analysis was performed. Patients will be monitored up to 2 years. RESULTS: Interim analysis included 3-month (n = 255), imaging (n = 226), and 1-year (n = 105) data. STS subtype distribution was normal. Median number of eribulin cycles was 3.0 (range: 1-17 cycles). Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5{\%} (n = 17); stable disease, 34.5{\%} (n = 78); and stable disease ≥11 weeks, 10.2{\%} (n = 23). Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) for all patients were 7.5{\%}, 42.0{\%} and 17.7{\%}, respectively. ORR, DCR, and CBR were 10.3{\%}, 32.0{\%} and 16.5{\%}, respectively, for patients with STS subtypes other than liposarcoma and leiomyosarcoma and included responses from patients with rare STS subtypes. Adverse drug reactions (ADRs) occurred in 211 (82.7{\%}) patients (42 [16.5{\%}] patients had serious ADRs), and none led to death. ADRs leading to drug withdrawal and dose reduction occurred in 27 (10.6{\%}) and 55 (21.6{\%}) patients, respectively. CONCLUSION: Eribulin was generally well tolerated and showed antitumor activity against STSs, including rare subtypes that currently have few treatment options. CLINICAL TRIAL NUMBER: NCT03058406 (ClinicalTrials.gov).",
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AU - Naito, Yoichi

AU - Asano, Naofumi

AU - Maejima, Aiko

AU - Endo, Makoto

AU - Takahashi, Shunji

AU - Megumi, Yasunori

AU - Kawai, Akira

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N2 - BACKGROUND: Although eribulin is used to treat soft tissue sarcomas (STSs), treatment data for rare subtypes are limited. We conducted a post-marketing surveillance study to assess safety and efficacy of eribulin in STS patients stratified by subtype. METHODS: Japanese patients (n = 256) with advanced or metastatic STS receiving eribulin treatment were monitored for treatment status, adverse events, diagnostic imaging, and clinical outcomes at 3 months and 1 year. Interim analysis was performed. Patients will be monitored up to 2 years. RESULTS: Interim analysis included 3-month (n = 255), imaging (n = 226), and 1-year (n = 105) data. STS subtype distribution was normal. Median number of eribulin cycles was 3.0 (range: 1-17 cycles). Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5% (n = 17); stable disease, 34.5% (n = 78); and stable disease ≥11 weeks, 10.2% (n = 23). Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) for all patients were 7.5%, 42.0% and 17.7%, respectively. ORR, DCR, and CBR were 10.3%, 32.0% and 16.5%, respectively, for patients with STS subtypes other than liposarcoma and leiomyosarcoma and included responses from patients with rare STS subtypes. Adverse drug reactions (ADRs) occurred in 211 (82.7%) patients (42 [16.5%] patients had serious ADRs), and none led to death. ADRs leading to drug withdrawal and dose reduction occurred in 27 (10.6%) and 55 (21.6%) patients, respectively. CONCLUSION: Eribulin was generally well tolerated and showed antitumor activity against STSs, including rare subtypes that currently have few treatment options. CLINICAL TRIAL NUMBER: NCT03058406 (ClinicalTrials.gov).

AB - BACKGROUND: Although eribulin is used to treat soft tissue sarcomas (STSs), treatment data for rare subtypes are limited. We conducted a post-marketing surveillance study to assess safety and efficacy of eribulin in STS patients stratified by subtype. METHODS: Japanese patients (n = 256) with advanced or metastatic STS receiving eribulin treatment were monitored for treatment status, adverse events, diagnostic imaging, and clinical outcomes at 3 months and 1 year. Interim analysis was performed. Patients will be monitored up to 2 years. RESULTS: Interim analysis included 3-month (n = 255), imaging (n = 226), and 1-year (n = 105) data. STS subtype distribution was normal. Median number of eribulin cycles was 3.0 (range: 1-17 cycles). Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5% (n = 17); stable disease, 34.5% (n = 78); and stable disease ≥11 weeks, 10.2% (n = 23). Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) for all patients were 7.5%, 42.0% and 17.7%, respectively. ORR, DCR, and CBR were 10.3%, 32.0% and 16.5%, respectively, for patients with STS subtypes other than liposarcoma and leiomyosarcoma and included responses from patients with rare STS subtypes. Adverse drug reactions (ADRs) occurred in 211 (82.7%) patients (42 [16.5%] patients had serious ADRs), and none led to death. ADRs leading to drug withdrawal and dose reduction occurred in 27 (10.6%) and 55 (21.6%) patients, respectively. CONCLUSION: Eribulin was generally well tolerated and showed antitumor activity against STSs, including rare subtypes that currently have few treatment options. CLINICAL TRIAL NUMBER: NCT03058406 (ClinicalTrials.gov).

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