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

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 advanc...

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Autores principales: Kobayashi, Eisuke, Naito, Yoichi, Asano, Naofumi, Maejima, Aiko, Endo, Makoto, Takahashi, Shunji, Megumi, Yasunori, Kawai, Akira
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886464/
https://www.ncbi.nlm.nih.gov/pubmed/31365116
http://dx.doi.org/10.1093/jjco/hyz096
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author Kobayashi, Eisuke
Naito, Yoichi
Asano, Naofumi
Maejima, Aiko
Endo, Makoto
Takahashi, Shunji
Megumi, Yasunori
Kawai, Akira
author_facet Kobayashi, Eisuke
Naito, Yoichi
Asano, Naofumi
Maejima, Aiko
Endo, Makoto
Takahashi, Shunji
Megumi, Yasunori
Kawai, Akira
author_sort Kobayashi, Eisuke
collection PubMed
description 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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spelling pubmed-68864642019-12-05 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 Jpn J Clin Oncol Original article 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) Oxford University Press 2019-07-31 /pmc/articles/PMC6886464/ /pubmed/31365116 http://dx.doi.org/10.1093/jjco/hyz096 Text en © The Author(s) 2019. Published by Oxford University Press. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original article
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
title Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
title_full Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
title_fullStr Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
title_full_unstemmed Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
title_short Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
title_sort interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
topic Original article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886464/
https://www.ncbi.nlm.nih.gov/pubmed/31365116
http://dx.doi.org/10.1093/jjco/hyz096
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