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    Evaluation of antitumor activity using change in tumor size of the Survivin Antisense Oligonucleotide LY2181308 in combination with Docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study.

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    Authors
    Natale, R
    Blackhall, Fiona H
    Kowalski, D
    Ramlau, R
    Bepler, G
    Grossi, F
    Lerchenmüller, C
    Pinder-Schenck, M
    Mezger, J
    Danson, S
    Gadgeel, S
    Summers, Yvonne J
    Callies, S
    André, V
    Das, M
    Lahn, M
    Talbot, D
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    Affiliation
    Cedars-Sinai Medical Center, Los Angeles, California
    Issue Date
    2014-11
    
    Metadata
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    Abstract
    Chemoresistance is mediated, in part, by the inhibition of apoptosis in tumor cells. Survivin is an antiapoptotic protein that blocks chemotherapy-induced apoptosis. To investigate whether blocking survivin expression enhances docetaxel-induced apoptosis in patients with non-small-cell lung cancer (NSCLC), we compared the antitumor activity of the survivin inhibitor LY2181308 plus docetaxel with docetaxel alone. We used change in tumor size (CTS) as a primary endpoint to assess its use in early decision-making for this and future studies of novel agents in NSCLC. Patients (N = 162) eligible for second-line NSCLC treatment (stage IIIB/IV) with an Eastern Cooperative Oncology Group performance status of 0 to 1 were randomized 2:1 to receive LY2181308 (750 mg intravenously, weekly) and docetaxel (75 mg/m intravenously, day 1) or docetaxel alone every 21 days. CTS from baseline to the end of cycle 2 was compared between the two treatment arms. The mean (SD) tumor size ratio for LY2181308/docetaxel and docetaxel was 1.05 (0.21) and 1.00 (0.15) (p = 0.200), respectively, suggesting no significant improvement in antitumor activity between the arms. Because there was also no significant difference between the two arms for progression-free survival (PFS) (2.83 months with LY2181308/docetaxel and 3.35 months with docetaxel [p = 0.191]), both arms were combined. Using the combined arms, CTS correlated with PFS (PFS = 4.63 months in patients with decreased CTS compared with 2.66 months in patients with increased CTS), supporting its use in early decision-making in phase II studies.
    Citation
    Evaluation of antitumor activity using change in tumor size of the Survivin Antisense Oligonucleotide LY2181308 in combination with Docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study 2014, 9 (11):1704-8 J Thorac Oncol
    Journal
    Journal of Thoracic Oncology
    URI
    http://hdl.handle.net/10541/337975
    DOI
    10.1097/JTO.0000000000000285
    PubMed ID
    25436803
    Type
    Article
    Language
    en
    ISSN
    1556-1380
    ae974a485f413a2113503eed53cd6c53
    10.1097/JTO.0000000000000285
    Scopus Count
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    All Christie Publications

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