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Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial.

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Title: Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial.
Authors: Schöffski, Patrick, Chawla, Sant, Maki, Robert G., Italiano, Antoine, Gelderblom, Hans, Choy, Edwin, Grignani, Giovanni, Camargo, Veridiana, Bauer, Sebastian, Sun Young Rha, Blay, Jean-Yves, Hohenberger, Peter, D’Adamo, David, Guo, Matthew, Chmielowski, Bartosz, Le Cesne, Axel, Demetri, George D., Patel, Shreyaskumar R., Rha, Sun Young (AUTHOR), D'Adamo, David (AUTHOR)
Source: Lancet. 4/16/2016, Vol. 387 Issue 10028, p1629-1637. 9p.
Subjects: Drug efficacy, Eribulin, Dacarbazine, Liposarcoma, Soft tissue injuries, Therapeutics, Antineoplastic agents, Clinical trials, Comparative studies, Heterocyclic compounds, Ketones, Research methodology, Medical cooperation, Research, Soft tissue tumors, Survival analysis (Biometry), Evaluation research, Randomized controlled trials, Treatment effectiveness, Leiomyosarcoma, Tumor grading
Abstract: Background: A non-randomised, phase 2 study showed activity and tolerability of eribulin in advanced or metastatic soft-tissue sarcoma. In this phase 3 study, we aimed to compare overall survival in patients with advanced or metastatic soft-tissue sarcoma who received eribulin with that in patients who received dacarbazine (an active control).Methods: We did this randomised, open-label, phase 3 study across 110 study sites in 22 countries. We enrolled patients aged 18 years or older with intermediate-grade or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two previous systemic regimens for advanced disease (including an anthracycline). Using an interactive voice and web response system, an independent statistician randomly assigned (1:1) patients to receive eribulin mesilate (1·4 mg/m(2) intravenously on days 1 and 8) or dacarbazine (850 mg/m(2), 1000 mg/m(2), or 1200 mg/m(2) [dose dependent on centre and clinician] intravenously on day 1) every 21 days until disease progression. Randomisation was stratified by disease type, geographical region, and number of previous regimens for advanced soft-tissue sarcoma and in blocks of six. Patients and investigators were not masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. The study is registered with ClinicalTrials.gov, number NCT01327885, and is closed to recruitment, but treatment and follow-up continue.Findings: Between March 10, 2011 and May 22, 2013, we randomly assigned patients to eribulin (n=228) or dacarbazine (n=224). Overall survival was significantly improved in patients assigned to eribulin compared with those assigned to dacarbazine (median 13·5 months [95% CI 10·9-15·6] vs 11·5 months [9·6-13·0]; hazard ratio 0·77 [95% CI 0·62-0·95]; p=0·0169). Treatment-emergent adverse events occurred in 224 (99%) of 226 patients who received eribulin and 218 (97%) of 224 who received dacarbazine. Grade 3 or higher adverse events were more common in patients who received eribulin (152 [67%]) than in those who received dacarbazine (126 [56%]), as were deaths (10 [4%] vs 3 [1%]); one death (in the eribulin group) was considered treatment-related by the investigators.Interpretation: Overall survival was improved in patients assigned to eribulin compared with those assigned to an active control, suggesting that eribulin could be a treatment option for advanced soft-tissue sarcoma.Funding: Eisai. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Label: Title
  Group: Ti
  Data: Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial.
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  Data: <searchLink fieldCode="AR" term="%22Schöffski%2C+Patrick%22">Schöffski, Patrick</searchLink><br /><searchLink fieldCode="AR" term="%22Chawla%2C+Sant%22">Chawla, Sant</searchLink><br /><searchLink fieldCode="AR" term="%22Maki%2C+Robert+G%2E%22">Maki, Robert G.</searchLink><br /><searchLink fieldCode="AR" term="%22Italiano%2C+Antoine%22">Italiano, Antoine</searchLink><br /><searchLink fieldCode="AR" term="%22Gelderblom%2C+Hans%22">Gelderblom, Hans</searchLink><br /><searchLink fieldCode="AR" term="%22Choy%2C+Edwin%22">Choy, Edwin</searchLink><br /><searchLink fieldCode="AR" term="%22Grignani%2C+Giovanni%22">Grignani, Giovanni</searchLink><br /><searchLink fieldCode="AR" term="%22Camargo%2C+Veridiana%22">Camargo, Veridiana</searchLink><br /><searchLink fieldCode="AR" term="%22Bauer%2C+Sebastian%22">Bauer, Sebastian</searchLink><br /><searchLink fieldCode="AR" term="%22Sun+Young+Rha%22">Sun Young Rha</searchLink><br /><searchLink fieldCode="AR" term="%22Blay%2C+Jean-Yves%22">Blay, Jean-Yves</searchLink><br /><searchLink fieldCode="AR" term="%22Hohenberger%2C+Peter%22">Hohenberger, Peter</searchLink><br /><searchLink fieldCode="AR" term="%22D’Adamo%2C+David%22">D’Adamo, David</searchLink><br /><searchLink fieldCode="AR" term="%22Guo%2C+Matthew%22">Guo, Matthew</searchLink><br /><searchLink fieldCode="AR" term="%22Chmielowski%2C+Bartosz%22">Chmielowski, Bartosz</searchLink><br /><searchLink fieldCode="AR" term="%22Le+Cesne%2C+Axel%22">Le Cesne, Axel</searchLink><br /><searchLink fieldCode="AR" term="%22Demetri%2C+George+D%2E%22">Demetri, George D.</searchLink><br /><searchLink fieldCode="AR" term="%22Patel%2C+Shreyaskumar+R%2E%22">Patel, Shreyaskumar R.</searchLink><br /><searchLink fieldCode="AR" term="%22Rha%2C+Sun+Young%22">Rha, Sun Young</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22D'Adamo%2C+David%22">D'Adamo, David</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 4/16/2016, Vol. 387 Issue 10028, p1629-1637. 9p.
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  Data: <searchLink fieldCode="DE" term="%22Drug+efficacy%22">Drug efficacy</searchLink><br /><searchLink fieldCode="DE" term="%22Eribulin%22">Eribulin</searchLink><br /><searchLink fieldCode="DE" term="%22Dacarbazine%22">Dacarbazine</searchLink><br /><searchLink fieldCode="DE" term="%22Liposarcoma%22">Liposarcoma</searchLink><br /><searchLink fieldCode="DE" term="%22Soft+tissue+injuries%22">Soft tissue injuries</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink><br /><searchLink fieldCode="DE" term="%22Antineoplastic+agents%22">Antineoplastic agents</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Heterocyclic+compounds%22">Heterocyclic compounds</searchLink><br /><searchLink fieldCode="DE" term="%22Ketones%22">Ketones</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+cooperation%22">Medical cooperation</searchLink><br /><searchLink fieldCode="DE" term="%22Research%22">Research</searchLink><br /><searchLink fieldCode="DE" term="%22Soft+tissue+tumors%22">Soft tissue tumors</searchLink><br /><searchLink fieldCode="DE" term="%22Survival+analysis+%28Biometry%29%22">Survival analysis (Biometry)</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+research%22">Evaluation research</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Leiomyosarcoma%22">Leiomyosarcoma</searchLink><br /><searchLink fieldCode="DE" term="%22Tumor+grading%22">Tumor grading</searchLink>
– Name: Abstract
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  Data: <bold>Background: </bold>A non-randomised, phase 2 study showed activity and tolerability of eribulin in advanced or metastatic soft-tissue sarcoma. In this phase 3 study, we aimed to compare overall survival in patients with advanced or metastatic soft-tissue sarcoma who received eribulin with that in patients who received dacarbazine (an active control).<bold>Methods: </bold>We did this randomised, open-label, phase 3 study across 110 study sites in 22 countries. We enrolled patients aged 18 years or older with intermediate-grade or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two previous systemic regimens for advanced disease (including an anthracycline). Using an interactive voice and web response system, an independent statistician randomly assigned (1:1) patients to receive eribulin mesilate (1·4 mg/m(2) intravenously on days 1 and 8) or dacarbazine (850 mg/m(2), 1000 mg/m(2), or 1200 mg/m(2) [dose dependent on centre and clinician] intravenously on day 1) every 21 days until disease progression. Randomisation was stratified by disease type, geographical region, and number of previous regimens for advanced soft-tissue sarcoma and in blocks of six. Patients and investigators were not masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. The study is registered with ClinicalTrials.gov, number NCT01327885, and is closed to recruitment, but treatment and follow-up continue.<bold>Findings: </bold>Between March 10, 2011 and May 22, 2013, we randomly assigned patients to eribulin (n=228) or dacarbazine (n=224). Overall survival was significantly improved in patients assigned to eribulin compared with those assigned to dacarbazine (median 13·5 months [95% CI 10·9-15·6] vs 11·5 months [9·6-13·0]; hazard ratio 0·77 [95% CI 0·62-0·95]; p=0·0169). Treatment-emergent adverse events occurred in 224 (99%) of 226 patients who received eribulin and 218 (97%) of 224 who received dacarbazine. Grade 3 or higher adverse events were more common in patients who received eribulin (152 [67%]) than in those who received dacarbazine (126 [56%]), as were deaths (10 [4%] vs 3 [1%]); one death (in the eribulin group) was considered treatment-related by the investigators.<bold>Interpretation: </bold>Overall survival was improved in patients assigned to eribulin compared with those assigned to an active control, suggesting that eribulin could be a treatment option for advanced soft-tissue sarcoma.<bold>Funding: </bold>Eisai. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=114561996
RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/S0140-6736(15)01283-0
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        Text: English
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      – SubjectFull: Drug efficacy
        Type: general
      – SubjectFull: Eribulin
        Type: general
      – SubjectFull: Dacarbazine
        Type: general
      – SubjectFull: Liposarcoma
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