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    Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas.

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    Authors
    Blay, J
    Leahy, Michael G
    Nguyen, B
    Patel, S
    Hohenberger, P
    Santoro, A
    Staddon, A
    Penel, N
    Piperno-Neumann, S
    Hendifar, A
    Lardelli, P
    Nieto, A
    Alfaro, V
    Chawla, S
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    Issue Date
    2014-02-07
    
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    Abstract
    Aim This randomised phase III trial evaluated first-line trabectedin versus doxorubicin-based chemotherapy (DXCT) in patients with advanced/metastatic translocation-related sarcomas (TRS). Methods Patients were randomly assigned (1:1) to receive trabectedin 1.5 mg/m2 24-h intravenous (i.v.) infusion every 3 weeks (q3wk) (Arm A), or doxorubicin 75 mg/m2 i.v. q3wk, or doxorubicin 60 mg/m2 i.v. plus ifosfamide (range, 6–9 g/m2) i.v. q3wk (Arm B). Progression-free survival (PFS) by independent review was the primary efficacy end-point. Results One hundred and twenty-one patients were randomised; 88 of them had TRS confirmed by central pathology review (efficacy population). Twenty-nine PFS events were assessed by independent review (16 with trabectedin; 13 with DXCT). PFS showed non-significant difference between arms (stratified log rank test, p = 0.9573; hazard ratio = 0.86, p = 0.6992). At the time of this analysis, 63.9% and 58.3% of patients were alive in trabectedin and DXCT arms, respectively. There was no statistically significant difference in survival curves. Response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) v.1.0 was significantly higher in DXCT arm (27.0% versus 5.9%), but response according to Choi criteria showed fewer differences between treatment arms (45.9% versus 37.3%). Safety profile was as expected for both arms, with higher incidence of severe neutropenia, alopecia and mucositis in the DXCT arm. Conclusion Neither trabectedin nor doxorubicin-based chemotherapy showed significant superiority in the first-line treatment of patients with advanced translocation-related sarcoma.
    Citation
    Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. 2014: Eur J Cancer
    Journal
    European Journal of Cancer
    URI
    http://hdl.handle.net/10541/314519
    DOI
    10.1016/j.ejca.2014.01.012
    PubMed ID
    24512981
    Type
    Article
    Language
    en
    ISSN
    1879-0852
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ejca.2014.01.012
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