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

Authors
 Patrick Sch?ff ski  ;  Sant Chawla  ;  Robert G Maki  ;  Antoine Italiano  ;  Hans Gelderblom  ;  Edwin Choy  ;  Giovanni Grignani  ;  Veridiana Camargo  ;  Sebastian Bauer  ;  Sun Young Rha  ;  Jean-Yves Blay  ;  Peter Hohenberger  ;  David D’Adamo  ;  Matthew Guo  ;  Bartosz Chmielowski  ;  Axel Le Cesne  ;  George D Demetri  ;  Shreyaskumar R Patel 
Citation
 LANCET, Vol.387(10028) : 1629-1637, 2016 
Journal Title
LANCET
ISSN
 0140-6736 
Issue Date
2016
MeSH
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use* ; Antineoplastic Agents, Alkylating/adverse effects ; Antineoplastic Agents, Alkylating/therapeutic use ; Dacarbazine/adverse effects ; Dacarbazine/therapeutic use* ; Female ; Furans/adverse effects ; Furans/therapeutic use* ; Humans ; Ketones/adverse effects ; Ketones/therapeutic use* ; Leiomyosarcoma/drug therapy* ; Leiomyosarcoma/pathology ; Leiomyosarcoma/secondary ; Liposarcoma/drug therapy* ; Liposarcoma/pathology ; Liposarcoma/secondary ; Male ; Middle Aged ; Neoplasm Grading ; Soft Tissue Neoplasms/drug therapy* ; Survival Analysis ; Treatment Outcome ; Young Adult
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.
Full Text
http://www.sciencedirect.com/science/article/pii/S0140673615012830?via%3Dihub
DOI
10.1016/S0140-6736(15)01283-0
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/152179
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