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    Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial.

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    Authors
    Le Cesne, Axel
    Blay, Jean-Yves
    Judson, Ian R
    Van Oosterom, A
    Verweij, Jaap
    Radford, John A
    Lorigan, Paul C
    Rodenhuis, Sjoerd
    Ray-Coquard, Isabelle
    Bonvalot, S
    Collin, F
    Jimeno, J
    Di Paola, E
    Van Glabbeke, Martine M
    Nielsen, O S
    Show allShow less
    Affiliation
    Department of Medicine, Institut Gustave Roussy, 94805 Villejuif Cedex, France. lecesne@igr.fr
    Issue Date
    2005-01-20
    
    Metadata
    Show full item record
    Abstract
    PURPOSE: This nonrandomized multicenter phase II study was performed to evaluate the activity and safety of Ecteinascidin (ET-743) administered at a dose of 1.5 mg/m(2) as a 24-hour continuous infusion every 3 weeks in patients with pretreated advanced soft tissue sarcoma. PATIENTS AND METHODS: Patients with documented progressive advanced soft tissue sarcoma received ET-743 as second- or third-line chemotherapy. Antitumor activity was evaluated every 6 weeks until progression, excessive toxicity, or patient refusal. RESULTS: One hundred four patients from eight European institutions were included in the study (March 1999 to November 2000). A total of 410 cycles were administered in 99 assessable patients. Toxicity mainly involved reversible grade 3 to 4 asymptomatic elevation of transaminases in 40% of patients, and grade 3 to 4 neutropenia was observed in 52% of patients. There were eight partial responses (PR; objective regression rate, 8%), 45 no change (NC; > 6 months in 26% of patients), and 39 progressive disease. A progression arrest rate (PR + NC) of 56% was observed in leiomyosarcoma and 61% in synovialosarcoma. The median duration of the time to progression was 105 days, and the 6-month progression-free survival was 29%. The median duration of survival was 9.2 months. CONCLUSION: ET-743 seems to be a promising active agent in advanced soft tissue sarcoma, with no cumulative toxicities. The 6-months progression-free survival observed in advanced soft tissue sarcoma compares favorably with those obtained with other active drugs tested in second-line chemotherapy in previous European Organisation for the Research and Treatment of Cancer trials. The median overall survival was unusually long in these heavily pretreated patients mainly due to the high number of patients who benefit from the drug in terms of tumor control.
    Citation
    Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. 2005, 23 (3):576-84 J. Clin. Oncol.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/76799
    DOI
    10.1200/JCO.2005.01.180
    PubMed ID
    15659504
    Type
    Article
    Language
    en
    ISSN
    0732-183X
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2005.01.180
    Scopus Count
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